APPLICATION FORM AFFORDABLE MEDICINES FACILITY – MALARIA (AMFM) PHASE 1* Country Ghana Applicant Name Country Coordinating Mechanism, Ghana Application Type Affordable Medicines Facility - Malaria (AMFm), Phase 1 Duration Start (month and year): Deadline for submission of application: 03/2010 End (month and year): 02/2012 1 July 2009 12 noon (Central European Time) IMPORTANT: Applicants are strongly encouraged to read the Guidelines for AMFm Phase 1 Applications before completing this Application Form and refer to the guidelines as they respond to each section. *“AMFm Phase 1” refers to the initial operational period of AMFm and should not be confused with the “Phase 1” of standard Global Fund grants. The Global Fund Board decided that AMFm will be launched in a small group of countries (AMFm Phase 1) and assessed through an independent evaluation. The results of this evaluation will be used by the Board to decide whether to proceed to a global roll-out of AMFm. ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 1 of 57 1. Contact and summary information (1a) Applicant contact details Primary contact Secondary contact Name Mr. Frank Boateng Dr. Keziah L. Malm Title Chairman Deputy Program Manager Organization Country Coordinating Mechanism, Ghana National Malaria Control Program Mailing address PMB CT380, Cantonments, Accra P.O. Box, KB 493, Korle-Bu, Ghana Telephone (mobile where possible) +233 21 786239 / +233 244 377461 +233 21 661 484 / +233 244 237564 Fax +233 21 786241 +233 21 680 418 / +233 21 687 982 E-mail address fabbychem@yahoo.co.uk kezmalm@yahoo.com Alternate e-mail address frankboateng@hotmail.com (1b) Currency (‘Tick’ () which currency is used throughout the application) (1c) Or EURO List of abbreviations and acronyms used by the applicant Acronym/ Abbreviation ACT ADR AL AMFm ASAQ BCC CBO CCM CDD CEM CHAG CHIM CHO CHPS CMS CQ DHA-P USD Meaning Artemisinin Combination Therapy Adverse Drug Reaction Artemether-Lumefantrine Affordable Medicines Facility-malaria Artesunate-Amodiaquine Behavior Change Communication Community Based Organization Country Coordinating Mechanism Community Drug Distributors Cohort Event Monitoring Christian Health Association of Ghana Center for Health Information Management Community Health Officer Community Health Planning Services Central Medical Store Chloroquine Dihydroartemisinin-piperaquine __________________________________________________________________________________________________ _ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 2 of 57 1. Contact and summary information DHIMS DHMT DHS DSS ECOWAS EPI FBO FDB GHS Global Fund GMP GSMF HBC HPLC HPU HSS ICB IEC INESS IPTp IRS JSI KAP LCS LLIN M&E MAM MCA MDG MICS MOH MOU NCB NCC NGO NHIL NHIS NMCP OPD OTC PHMHB PMI PNFP PPME PR PV RBM RCC RDT RHMT District Health Information Management Software District Health Management Team Demographic and Health Survey Demographic Surveillance Sites Economic Community of West African States Expanded Program of Immunization Faith Based Organization Food and Drugs Board Ghana Health Services The Global Fund to Fight AIDS, Tuberculosis and Malaria Good manufacturing practice Ghana Social Marketing Foundation Home-based care High Performance Liquid Chromatograph Health Promotion Unit Health Systems Strengthening International Competitive Bidding Information Education Communication INDEPTH Effectiveness and Safety Studies Intermittent Preventive Treatment of Malaria in Pregnancy Internal Revenue Service John Snow, Inc. Knowledge, Attitudes and Practices Survey Licensed Chemical Seller Long lasting insecticide nets (check) Monitoring and Evaluation Mobilize Against Malaria Medicine Counter Assistant Millennium Development Goals Multiple Indicator Cluster Survey Ministry of Health for Ghana Memorandum of Understanding National Competitive Bidding National Communications Committee Non-governmental Organization National Health Insurance Levy National Health Insurance Scheme National Malaria Control Program Outpatient Department Over-the-counter Private Hospitals and Maternity Homes Board President’s Malaria Initiative Private Not For Profit Policy, Planning, Monitoring and Evaluation Principal Recipient Pharmacovigilance Roll Back Malaria Rolling Continuation Channel – relating to the Global Fund Round 4 grant for malaria Rapid Diagnostic Test Regional Health Management Team __________________________________________________________________________________________________ _ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 3 of 57 1. Contact and summary information RMS Round 8 SDP SOP SP SR TOT UNICEF UNIDO USAID USP VAT VOICES WHO Regional Medical Store Ghana’s approved Global Fund Round 8 grant for malaria Service Delivery Point Standard Operating Procedure Sulfadoxine-Pyrimethamine Sub-recipient Trainers of Trainers United Nations Children’s Education Fund United Nations International Development Organization United States Agency for International Development United States Pharmacopoeia (check) Value Added Tax Voices for a malaria free future World Health Organization __________________________________________________________________________________________________ _ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 4 of 57 2. Applicant summary (2a) AMFm ‘host’ grant Funding for AMFm supporting interventions will be disbursed through an existing Global Fund malaria grant. This “host grant” will be amended to include the budget and performance indicators for AMFm supporting interventions. Applicants are recommended to nominate a “host” grant with an ACT procurement component; however, this is not compulsory. Refer to the Guidelines for AMFm Phase 1 Applications for further information and also see Section 7 of this application form. In the table below, nominate an existing Global Fund malaria grant through which funding for AMFm supporting interventions can be disbursed. Provide the name of the current Principal Recipient for this grant. Details AMFm ‘host’ grant number GHN-405-GO4-M Name of current Principal Recipient Ministry of Health / Ghana Health Service (2b) Principal Recipient(s) for AMFm Phase 1 Applicants may choose to nominate the existing Principal Recipient for the ‘host’ grant to receive and manage funds for AMFm Phase 1 supporting interventions. Alternatively, applicants may choose to nominate a different Principal Recipient. Applicants must ensure that the nominated Principal Recipient(s) has the capacity for responsible management of Global Fund for finances and grant management and is capable of leading rapid implementation of supporting interventions. Yes i. Is the Principal Recipient nominated for AMFm Phase 1 the same as the existing Principal Recipient for the AMFm ‘host’ grant? Proceed to Section 2c No Complete Sections 2bii and 2biii ii. Describe the process used to make a transparent selection of the Principal Recipient(s) for AMFm Phase 1 [1/2 page maximum]. Attach the signed and dated minutes of the meeting(s) at which this Principal Recipient(s) was selected. [Insert Annex Number] PR Selection Process The Principal Recipient (Ministry of Health) nominated for AMFm Phase 1 is the same as the existing PR for the AMFm host grant. This decision was confirmed by the CCM who agreed to have the PR remain the same and eschew a process to select a different or additional PR. The CCM took into consideration the track record of the __________________________________________________________________________________________________ _ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 5 of 57 2. Applicant summary current PR, the fact that it is currently the PR for the AMFm “host” grant and is therefore familiar with Global Fund requirements, and is capable of leading rapid implementation of supporting interventions taking heed of the limited time available. SR Selection Process Sub-recipients for expanded or new activities are yet to be identified and will be selected following the submission of the proposal. The CCM will place adverts in the national dailies inviting interested institutions to apply as sub-recipients for the implementation of identified activities. In addition, representatives of CCM constituencies will be encouraged to inform their constituents about the selection of sub-recipients for implementation of activities outlined in the application. All SRs will be selected through a national competitive tendering process according to Ghana’s Procurement Law for openness and transparency. Organizations whose proposals are short listed will be requested to go through a tendering process. The applicant organizations will be asked to submit a detailed proposal with budgets. A committee will be set up to review all the proposals and budgets after which successful applicants will be announced and contracts signed between them and the PR. Whenever necessary, new advertisements will be placed to invite additional subrecipients to apply for procurement of specified goods and services according to the Procurement Law. Criteria to be applied during the selection process for prequalification will include capacity to deliver, strong performance track record, current legal status, experience with malaria interventions, experience with Global Fund activities, reputation, area of expertise, and location. iii. Provide the name and contact details of the Principal Recipient(s) nominated for AMFm Phase 1, if different from the existing Principal Recipient for the nominated ‘host’ grant. Principal Recipient nominated for AMFm Phase 1 Name Mailing address Telephone Fax E-mail address Alternate e-mail address [Add columns as necessary if nominating more than one Principal Recipient] (2c) i. CCM endorsement of AMFm Phase 1 application Have all CCM members completed and signed Attachment C to indicate their endorsement of this AMFm Phase 1 application? Yes No __________________________________________________________________________________________________ _ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 6 of 57 2. Applicant summary Provide a summary of the AMFm application [1 PAGE MAXIMUM]. The opportunity of the AMFm in Ghana Malaria remains hyper-endemic within Ghana, with the entire population at high risk of infection. Malaria is the primary cause of morbidity and mortality in Ghana, and accounts for 31.5% of all outpatient illnesses, 30.3% of 1 all hospital admissions and 18.3% of all deaths in Ghana. As such, the National Malaria Strategic Plan (200815) has set a goal of reducing malarial burden (mortality and morbidity) by 75% by 2015 (using 2006 as a base line). Through highly successful implementation of Round 2 and 4 Global Fund grants, and the imminent signing of Round 8 and RCC grants, Ghana is well placed to deliver this target. Historically, the predominant focus of Global Fund grants and supporting partners such as PMI and UNICEF has been on increasing treatment within the public sector. However, this does not take into account the fact 2 that 60% of Ghanaians seek initial treatment from outside public health facilities , where the level of provider training is lower, and the cost of appropriate treatment prohibitive, with ACTs costing between $3 and $9. The AMFm, through its copayment facility and targeted supporting interventions, offers the unique opportunity to address this specific challenge through dramatically increasing the affordability and accessibility of ACTs outside of the public sector. The objectives of the AMFm which are amended host grant (RCC GHN-405-G04M) objectives are as follows: • • Objective 1: To promote prompt and effective treatment of malaria by increasing the proportion of malaria patients receiving treatment with the recommended anti-malarials by 2012: o In public health facilities from 30 to 70% in children under five years and 45 to 80% in adults o In private outlets to 60% o In 26 underserved districts through community-based care Objective 4: To strengthen monitoring and evaluation, and undertake operational research on malaria case management Implementation of the AMFm The PR for the host grant, the Ministry of Health / Ghana Health Service, will also serve this function for the AMFm to ensure successful implementation of a comprehensive package of interventions. In order to ensure the rapid uptake and responsible use of quality assured ACTs, the following supporting interventions will be implemented: • • 1 2 Consistent and coordinated public awareness and behavioural change campaigns - Campaigns will target all Ghanaians to provide them with knowledge on the importance of prompt treatment seeking, the use of ACTs as the primary treatment for malaria, and the broad availability and affordability of these drugs under the AMFm, among others. Building on existing communication strategies, a broad range of media and community-based channels will be used to ensure maximum reach and effectiveness of these messages. Provider training and supervision - The AMFm seeks to train a total of 3,000 public facility workers and 23, 268 private sector workers and medical counter assistants. The training program will cover malaria case management and diagnosis, pharmacovigilance, and data quality assurance will be conducted. Training will be followed up with supervisory visit to ensure ongoing compliance with key practices in both public NMCP Annual Report (2008) SPS (2008) __________________________________________________________________________________________________ _ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 7 of 57 2. Applicant summary • • • and private outlets Strengthening drug quality surveillance - To ensure that the increased accessibility of ACTs is safe for patients, cohort event monitoring, drug quality surveillance and thorough training of regional and district pharmacovigilance focal points will be implemented Strengthening regulation of the private sector - To support the anticipated increase in accessibility of ACT treatment within the private sector, the Pharmacy Council will conduct more consistent regulatory visits of private sector outlets to ensure that appropriate treatment dispensing and stocking practices are followed Intervention to reach the poor - Building on Round 8 targets, the AMFm will accelerate the expansion of home-based care through community health workers to 26 underserved districts. This approach has been shown to increase coverage of effective ACT treatment among remote and poor populations who have lower access to formal health facilities and is therefore critical to the equitable achievement of Ghana’s national treatment goals. Supply Chain Strengthening While Ghana has secured funding to procure a sufficient quantity of ACTs to meet the estimated need in the public sector, significant challenges with the public supply chain prevent these drugs from being efficiently distributed to health facilities and patients. These challenges include poor storage conditions and weak transport capacity at the Central Medical Stores and insufficient space, equipment, and transport at the Regional Medical Stores. If unresolved, these issues could undermine the success of the AMFm in Ghana and the achievement of the country’s national malaria treatment goals. As such, Ghana plans to use a portion of the savings to address some of these challenges and significantly increase the quality and efficiency of ACT supply through the public sector. Monitoring the AMFm In addition to the Independent Evaluation carried out by the Global Fund, Ghana will strengthen its in-country M&E activities in order to monitor supporting interventions and assure data quality, particularly from the private sector. To complement the existing M&E system, data quality audits and a range of activities targeted at improving the frequency and reporting of data from the private sector will be carried out. To optimize its case management strategy in the context of the AMFm and increased availability of ACTs in the private sector, Ghana will also implement a number of targeted operational research studies that will help influence future policy decisions and implementation strategies: • • • The feasibility of expanding the use of RDTs within the private sector to improve diagnosis; The feasibility of expanding health insurance accreditation of private drug outlets to increase affordability of ACTs in rural areas; and The impact of using a drug wholesaler incentive to facilitate accessibility of ACTs in the most rural private outlets. Funding request The total reprogrammable budget is $25,366,612 of which $22,038,134 will be used on supporting interventions (including M&E and operational research) while $68, 485 M will procure additional ACTs to deliver to underserved populations through home-based care and $3,138,193 will be used to strengthen the public sector supply chain. __________________________________________________________________________________________________ _ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 8 of 57 3. AMFm in national malaria context Malaria Disease Profile (3a) Provide a brief overview any characteristics of the malaria profile in your country (including patterns of incidence or mortality) that have changed significantly since your last application to the Global Fund [1/2 page maximum]. Ghana’s National Malaria Control Program has successfully implemented two previous Global Fund proposals and has made significant progress in reducing the burden of malaria in the country since 2003. Malaria, however, remains hyper-endemic throughout Ghana, with no areas benefitting from reduced risk of the disease. The prevalence of the disease peaks seasonally, with a majority of cases recorded at the end of the rainy season. Malaria remains the primary cause of morbidity and mortality in Ghana, with only modest changes in key indicators since 2007 as shown in Table 1 below. Table 1: Malaria Indicators Indicators 2007 (Source: 2007 NMCP Annual Report) 2008 (Source: 2008 NMCP Annual Report) % of all outpatient cases* 37.5% 31.5% % of children under five years as outpatient cases 36-40% 36-40% % of hospital admissions due to malaria* 36% 30.3% % of pregnant women as outpatients 13.8% 16.3% % of pregnant women admitted to hospitals 10.6% 14.4% % of pregnant women deaths in hospitals due to malaria* 9.4% 5.9% % of all deaths in children under five due to malaria* 33.4% 30.3% % of all deaths due to malaria* 19.7% 18.3% *These indicators have shown improvement, while the others remain the same or slightly worse. National Supply and Distribution of ACTs (3b) What is the current estimated population coverage of ACTs, with a breakdown by sector (public, private and the not-for-profit, if known)? Ghana changed its national treatment policy for the management of uncomplicated malaria to ACTs, specifically artesunate-amodiaquine (ASAQ), in 2004 and received funding to procure and distribute these drugs through the public sector from Round 2 and 4 Global Fund grants and more recently from the President’s Malaria Initiative (PMI). A USAID study conducted in 2008 demonstrated that almost all public facilities (96%) prescribe ASAQ as ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 9 of 57 3. AMFm in national malaria context the first-line treatment for malaria. Within the private sector, only 33% of private sector providers were 3 prescribing ASAQ. ACT usage is particularly low in the private sector, although approximately 60% of the population seeks initial treatment from outside of public health facilities. Despite the recent effort to increase access to ACTs, the recent 2008 DHS survey revealed that only 12% of febrile children under 5 years received an ACT, with many continuing to use sub-optimal therapies. The DHS similarly shows that usage of anti-malarials, including ACTs, is lower in rural than urban areas, reflecting the challenges that patients in these areas have in reaching health providers. Among children under five, treatment 4 of fever with ACTs is proportionately lower in rural (9.3%) than in urban populations (17.1%). 5 2006 data states that 28.5% of Ghanaians are under the poverty line, with an urbanization rate of 49%. However, specific data on anti-malarial usage by socioeconomic status are not available, but as populations in rural areas are significantly poorer than those in urban areas it is assumed that the poor have lower access to anti-malarials. (3c) Describe the current supply chain for anti-malarials (including ACTs) within the public, private and not-for-profit sectors in your country [2 pages maximum]. This description should address: i. First-line buyer purchase from manufacturers ii. Supply to outlets iii. Sale or provision to patients Applicants should also identify any points in the supply chain that may inhibit widespread availability of ACTs under AMFm. Refer to the Guidelines on AMFm Phase 1 Applications for detailed guidance. 3 SPS, 2008 DHS (2008 preliminary report) 5 Dalberg, MIT Zaragoza – “Private sector role in health supply chains”, 2008 4 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 10 of 57 3. AMFm in national malaria context The Ghanaian pharmaceutical supply chain comprises the public, private and NGO sectors. The figure below depicts the current supply chain system. Figure 1: The Public and Private supply chain in Ghana Private sector Public sector NGO sector Local Manufacturer (32) International manufacturers Donations Importer (60) CMS (1) NGO Medical Stores Private wholesaler (150) RMS (10) FBO/NGO Private retailers Public health facilities (2,200) LCS (10,000) Private Private pharmacies (1,400) practitioners (1,000) TH QH RH DH HC CH PS FB Clinics (150) CDD Key: CMS – Central Medical Store RMS – Regional Medical Store TH – Teaching Hospital QH – Quasi Hospital (e.g. police hospitals) LCS – Licensed Chemical Seller RH - Regional Hospital DH- District Hospital HC – Health Centre CHPS – Community Health Provider Service FB – Faith Based CDD – Community Drug Distributor Public sector 6 The public sector provides health services to 40% of the total population in Ghana . Ghana’s drug storage and distribution services operate as a three-tiered system that includes the Central Medical Stores (CMS), regional medical stores (RMS) and the peripheral service delivery points. Procurement – The CMS is the first line buyer for the public sector. Procurement of medical products, which is the responsibility of the Procurement Unit of MOH, is conducted via International Competitive Bidding (ICB), National Competitive Bidding (NCB) and through donations: • ICB is conducted for drugs like psychotropics and drugs that address local priority endemic diseases 6 SPS - 2008 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 11 of 57 3. AMFm in national malaria context • • such as malaria and are funded by international donors (the Global Fund, UNITAID, World Bank and USAID). As such, the drugs must adhere to international quality assurance standards and conform to the national drug policy. ACTs are included in this category. A national procurement quantity assessment is performed in the third quarter of each year which is followed by tender announcements for international competitive bidding, followed by a process of an open public bid NCB is used for essential drugs that are not procured through ICB. The product qualification requirements for NCB are FDB product registration and local GMP certification and hence can be served by the local market. Only 1% of national anti-malarial drugs are procured through the NCB process Donors such as UNICEF and PMI also provide anti-malarials through their own procurement channels. Many donors have their own stores and distribute some products through CMS and others directly to their project districts In accordance with Ghana’s Procurement Law, buying authority is decentralized with procurement occurring at all tiers within the system. When products are not available from the designated public sector supplier, facilities are able to buy directly from the open market with prerequisite FDB registration and local GMP certification. Distribution – The CMS distributes directly to teaching hospitals and to the 10 RMSs who then further distribute directly to public health facilities throughout the country. Overall, the distribution system is a tiered pull system – the RMSs travel to the CMS to collect products and the service delivery points (SDPs) travel to the RMS to pick up products on demand. Facilities rarely place an advance order and thus usually submit the order upon arrival, waiting until the order is fulfilled. It is important to note, however, that in the northern regions CMS conducts deliveries to the respective RMSs but is challenged by transport inadequacies. In 2003, MOH approved a new policy to implement a scheduled delivery service from the RMS to the SDPs. However, currently only 3 of the 10 regions have implemented a scheduled delivery system due to a lack of funding and improper procedures. JSI DELIVER is currently rolling out a training program on revised SOP for logistics management; however there are remaining infrastructure challenges which will be addressed in section 9b. Furthermore, there are storage challenges at many of the RMSs which will also be addressed in section 9b. Price mark-ups (as detailed below) are designed to prevent the re-selling of large volumes of cheaper drugs. The mark-ups factor in the costs incurred for transport and the management of storage facilities, and are set based on the level of distribution and product source as follows: Table 2: Average Public Sector Markups Markups in the public sector CMS RMS Health Facility Total ICB 20% 15% 10% 45% NCB 15% 15% 10% 40% Source: Malaria Pharmaceutical Management Survey, 2009 Dispensing - Patients can access treatment from the public sector via public hospitals, clinics and Community Health Planning Services (CHPS). Drugs can also be obtained at the community level through the community drug distributors in the districts where home-based care exists (see section 4d). End User Price -The end user price in the public sector ranges from $1.50 - $2. Challenges • • • The storage conditions and transport capacity at the CMS is insufficient and unreliable leading to poor distribution of and quality risks for ACTs and other essential drugs; The combination of the push/pull demand system and poor forecasting and weak logistics management leads to stock outs at the RMSs and/or health facilities There is inadequate number of staff at RMSs. Those who are there are not properly trained to effectively manage the supply. There is limited storage capacity as well as insufficient transportation available for RMS staff to make timely deliveries to health facilities ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 12 of 57 3. AMFm in national malaria context • Forecasting at the RMS is not robust owing to poor consumption data (especially at the lower level) and inadequate training on data quantification and logistics management Private sector Favorable national laws and regulations in Ghana have contributed to the development of a large and complex private pharmaceutical sector. Chloroquine, SP, artemisinin monotherapies and ACTs are available for sale through private outlets. While the FDB has instituted an official ban on the importation, production, and sale of artemisinin monotherapies, the lack of a viable alternative in the form of affordable ACTs has inhibited the ability of the FDB to enforce the ban. Local manufacturing – CQ and SP have been prohibited from importation but there is a strong local manufacturing capacity; these manufacturers have the license to manufacture for other countries but some of the drugs end up on the local market. Thirty-five manufacturers in Ghana produce about 30%7 of total medicines on the market, with a few (six) producing ACTs (predominantly ASAQ). None of these manufacturers have received WHO Prequalification for any essential drug. Importers / wholesalers - Most ACTs (ASAQ and AL) are imported from India and China. There are currently 60 importers (or first line buyers) registered. Most international manufacturers grant exclusive or restricted agent relationships with first-line buyers. Beyond these first-line buyers, a network of 150 wholesalers (sub-distributors which also include some local manufacturers) are registered. Retailing - Ghana has a vibrant private retail drug sector, with a range of outlets legally selling anti-malarials and other medicines, including: • Private pharmacies (1,400): these require a registered superintendent pharmacist assigned to it and are predominantly located within urban regions • Private practitioners (1,000): these include private doctors and mid-wives 8 • Licensed chemical sellers (10,000): approximately 66% of Ghanaians visit a licensed chemical seller as their first point of care and treatment seeking. However, most chemical sellers in Ghana have little or no training in healthcare or pharmaceutical dispensing and sell only OTC products. Unlike pharmacies, chemical sellers are often located in the remote areas owing to their more informal nature. Table 3: Average Markups in the Private Sector Markups in the private sector Importer Wholesaler Retailer Total 10% 20% 20-30% 50-60% Source: Management Sciences for Health Research End user price - There is variation both in the public and private sectors as well as in rural versus urban areas. Prices in the private sector are much higher than the public sector and may range from $3 to $9. Even within same geographic areas, medicine prices vary due to lack of pricing policy and weak monitoring of medicine prices. Health insurance however provides a leverage where reimbursements are the same across the board but delay in reimbursements erodes private sector profits. Challenges • Geographical reach – private sector facilities and outlets tend to cluster in regions where there is substantial commercial activity. As such, there are limited retail outlets within rural areas • High price – as the private sector does not receive ACTs from donor funding, the end user price is comparatively very high to less effective alternative treatments 7 8 Dalberg, MIT Zaragoza – “Private sector role in health supply chains”, 2008 Dalberg, MIT Zaragoza – “Private sector role in health supply chains”, 2008 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 13 of 57 3. AMFm in national malaria context • • Policy - Lack of pricing policy and weak monitoring of medicine prices Exclusive importers – manufacturers that are eligible to supply co-paid ACTs under the AMFm operate with exclusive relationships or a restricted number of certain first-line buyers within Ghana. This reduced population of importers could impact on the availability and affordability of ACTs Private - Not For Profit (PNFP) The PNFP health care providers are important sources of care in Ghana, providing a significant share of all services. This sector is dominated by faith-based organizations (FBOs), primarily the Christian Health Association of Ghana (CHAG). The focus of FBOs is primary and secondary health services in rural areas. CHAG, which has a memorandum of understanding (MOU) with the MOH to provide services on behalf of the Government and also accounts for most of the NGO health delivery in Ghana. CHAG is composed of 16 member Christian organizations, representing 144 health care facilities, nearly two-thirds run by the Catholic Diocese. At times, drugs procured by NGOs do not always adhere to the standard drug policy. In addition, the CHAG manages a revolving drug fund with a small warehouse that has been struggling to survive for a variety of reasons including weak management. The Catholic Drug Services also manages its own pharmaceutical supply system that includes small-scale manufacturing, procurement and a tiered distribution to the Catholic hospitals, complemented by an educational component to promote rational medicine use. The CHAG and other mission sector institutions have had cash flow problems, e.g. the large increase in patient numbers since the introduction of the NHIS. The opportunity of the AMFm to promote widespread access of ACTs The National Malaria Strategic Plan (2008-15) includes the following goals to be achieved by 2015: • All (100%) health facilities will provide prompt and effective treatment using ACTs • At least 90% of all patients with uncomplicated malaria will be correctly managed at public and private health facilities using ACTs As a high malaria burden country with a large and active private sector, the AMFm provides Ghana with a unique opportunity to assist and accelerate the achievement of its core malaria control goals. Furthermore, greater demand for ACTs resulting from their increased affordability, IEC/BCC campaigns (section 4b), and HSS activities (section 9b) will contribute to developing a more efficient distribution chain; and more thorough and widespread provider training (section 4d and 4k) and monitoring (section 4g and 5b) will further improve the quality of patient care from public, private, and NGO sectors. ACTs to be co-paid under AMFm Phase 1 (3d) Complete the table below to nominate which ACT combinations and regimens you are requesting to be co-paid under the AMFm, in accordance with the criteria provided in the Guidelines for AMFm Phase 1 Applications. List the requested ACTs by international non-proprietary name (INN). Do not list by manufacturer or brand name. ACT INN ASAQ Strength 1) 2-11 months (Infants) AS: 25 mg, AQ: 67.5 mg Presentation Fixed dose Listed in WHO STG [yes or no] Yes Listed in national STG [yes or no] Yes ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 14 of 57 3. AMFm in national malaria context 2) 1-5 years (Young Children) AS: 50 mg, AQ: 135 mg 3) 6-13 years (Children) AS: 100 mg, AQ: 270 mg 4) >13 years (Adolescents & Adults) AS: 100 mg, AQ: 270 mg AL Artemether 20mg, Lumefantrine 120 mg Fixed dose Yes Please note: if you request an ACT combination that is listed in the national standard treatment guidelines but not in the WHO standard treatment guidelines, or vice versa, you must attach a technical rationale to justify its inclusion under AMFm. See the Guidelines for AMFm Phase 1 Applications Has been incorporated into new STG to be adopted in 2009 [Insert Annex name and number if providing a technical rationale for inclusion of certain ACTs] ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 15 of 57 4. Supporting interventions Supporting interventions for AMFm In order to support the implementation of the co-payment on ACTs, the AMFm requires countries to implement supporting interventions to improve malaria case management and ensure safe and effective scale-up of ACT use. Required supporting interventions include: • Public awareness raising and education regarding ACTs • Training, supervision and ongoing support for ACT providers • National drug monitoring, including pharmacovigilance, resistance monitoring and quality surveillance • Improving the regulatory environment for ACT distribution; and • Interventions to reach poor people, children and other vulnerable groups Applicants must demonstrate that all required supporting interventions either are already implemented, or will be implemented, in order to purchase co-paid ACTs through AMFm Phase 1. Applicants are also encouraged to include additional supporting interventions to improve malaria case management, such as introducing/expanding the use of diagnostics and introducing patientfriendly packaging on co-paid ACTs. Applicants are strongly advised to refer to the Guidelines for AMFm Phase 1 Applications for specific guidance on each supporting intervention. Public awareness and education campaigns for ACT treatment (4a) Existing public awareness and education campaigns for ACT treatment Describe any existing efforts to promote the effectiveness, availability and/or affordability of ACTs in your country [1 page maximum]. Effective behavior change communication (BCC) is critical to the achievement of two of the core objectives of Ghana’s current National Malaria Strategy (2008-15): (i) that 90% of caretakers and parents will be able to recognize early symptoms and signs of malaria; and (ii) that 90% of malaria patients visiting public and private facilities will be correctly managed using ACTs. As a result, Ghana is currently implementing a range of BCC activities to promote use of ACTs and other optimal treatment seeking behavior. Existing Activities Public sector Education on ACT use is given to patients and the general public during hospital visits, antenatal care visits and at child welfare and outreach clinics. However, the frequency and consistency of the information provided to patients varies widely between facilities. Since 2004, the Health Promotion Unit of the MOH has leveraged Global Fund support to conduct a number of nationwide campaigns via TV, radio, leaflets and durbars (community outreach gatherings) under the message “let’s come together and drive malaria away”, informing the public on the importance of ACTs to treat malaria. The campaigns were launched targeting mothers, fathers, schools, and care givers. Through the home-based care (HBC) program that has been implemented in 16 districts, community agents ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 16 of 57 4. Supporting interventions educate the public about ACT use through house-to-house meetings, church meetings, and at market places while distributing the drugs. A number of community-based organizations (CBOs) and NGOs also educate the public at the community level on proper case management. The Voices for a malaria free future (VOICES) project funded by Johns Hopkins is currently conducting a range of activities to promote desired malaria treatment behavior and advocate for local and national support for malaria control work. The strategy used includes advocacy efforts such as the Ghana Malaria Advocacy Guide, as well as mass media campaigns promoting ACT usage including documentaries, songs and music videos and TV spots targeting Ghanaian leaders and health providers. Private sector Specific BCC activities to encourage appropriate ACT use by patients seeking treatment in the private sector have been limited to date. The only current effort is a Pfizer funded project, ‘Mobilize Against Malaria,’ which is implementing a mass media campaign in the Ashanti and Brong Ahafo regions. Through radio programs and community information centers, MAM encourages people to seek treatment at those licensed chemical sellers who are trained to properly dispense ACTs. Planned Activities Ghana’s approved RCC grant enables the scale-up of a range of public awareness activities to promote prompt and effective malaria treatment. Minute-long television and radio spots will be aired daily for one month each quarter during the first year of RCC. Ghana also received approval for IEC/BCC activities in its Round 8 proposal that would support the scale up of HBC treatment by improving communities’ and health workers’ awareness and knowledge of effective malaria case management and prevention. However, owing to budgetary shortfalls, this activity was removed from the amended Round 8 budget. Within the first year of its 2-year malaria operational plan, PMI is currently supporting the implementation of BCC/IEC activities to promote adherence to the new malaria treatment policy. In 2010, PMI will support a range of activities that target both healthcare workers and the general public. These campaigns will be implemented through: • NGOs and HBC agents at the community level • Private and public health care providers at the district level • Mass media campaigns at the regional and national levels Gap While a number of efforts to promote ACT use have been conducted in recent years, the current public awareness campaigns do not meet the national need. The primary focus of education on ACTs has been through public facilities, with broader campaigns typically targeting limited areas of the country. As a result, the many patients who seek treatment from private facilities receive little or no education. Therefore there is a need for a consistent and coordinated public awareness campaign that reaches all Ghanaians regardless of whether they access treatment from public or private facilities. This public awareness campaign will need to have sufficient geographical reach and high effectiveness of communication regarding malaria case management, the safety/efficacy of ACTs and now also the increased accessibility and affordability of ACTs. Another challenge the country has faced in conducting effective BCC on ACT use and other malaria interventions has been the lack of coordination between the various organizations implementing the activities. To address this, a multi-stakeholder national communications committee (NCC), led by the NMCP, has recently been constituted with the primary objective of coordinating all malaria messages to the public. (4b) New or expanded public awareness and education campaigns for ACT treatment Summarize your proposal for new or expanded public awareness and education campaigns to ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 17 of 57 4. Supporting interventions promote the effectiveness, availability and/or affordability of ACTs. [1½ pages maximum]. To ensure rapid uptake and appropriate use of co-paid ACTs under the AMFm, there needs to be improved public awareness and malaria-related behavior in a number of important areas, including: 1. The recognition of malarial symptoms and seeking prompt treatment; 2. The safety and efficacy of ACT treatment for uncomplicated malaria; 3. The increased affordability and accessibility of ACT treatment, including in the public sector As such, a broad range of media channels will be used to communicate the messages to the entire population, including in remote, underserved areas. The messages promoted will build on those planned for existing campaigns to include specific points about the low price of ACTs and availability in the private sector. The funding requested in this proposal will further scale-up activities supported by other donors and/or those that were planned but removed from existing grants. Service Delivery Area 1.1: Public education and awareness Market research will be conducted with support from the MOH prior to IEC/BCC design in order to gain a thorough understanding of current public knowledge and perception around malaria case management and ACTs. This will be conducted before the implementation of the AMFm. The newly formed National Malarial Communications Committee will then hold a workshop to develop the research findings into a series of detailed messages that will respond directly to the gaps in public knowledge that were identified. The design of campaign materials, under the coordination of NMCP/NMCC’s guidelines and messages, will be contracted to organizations specializing in this area through a competitive process to ensure the campaigns have the maximum impact. Market research and the communications workshop will be completed on grant approval to allow for rapid commencement of well-researched BCC campaigns and will be funded with support from MOH and other partners. Activity 1.1.1: Conduct stakeholder meetings to inform national and regional leaders about the AMFm. The support of leaders from both the public and private sectors will be important to the success of the AMFm. As such, one stakeholder meeting will be held at national level while smaller stakeholder meetings will be held in all ten regions. Participants will include key members of the government, NGOs and FBOs, and private sector representation at each level. At the community level, durbars (meetings involving chiefs, opinion leaders and the community at large) will be organized to promote issues on AMFm (see section 4l). Activity 1.1.2: Conduct TV advertisements and talk shows. Spots promoting key messages on ACT use will be aired on two national TV stations, which reach approximately 50% of the total population. Specific time slots and channels will be researched and chosen to target key populations such as mothers. Adverts will air three times per day from March to June in the first year to create mass awareness at the start of the AMFm. This will reduce to once every other day in the following year from March to May. There will also be airings once per day from September to November in each year to coincide with the late year malaria season. Once a month in the first quarter of AMFm launch, television talk shows will be conducted with the purpose of allowing Q&A sessions for viewers to field questions to qualified medical practitioners versed on proper malaria case management and ACT use. Potential implementers include: NMCP/Health Promotion Unit, Ghana Social Marketing Foundation and others. Activity 1.1.3: Conduct radio adverts and discussions. Radio advertisements will be aired at eight radio stations with the broadest coverage in the country, reaching an estimated 60-70% of the population. In regions where language or cultural differences exist, local radio stations will be used to tailor the messages to the local audience and therefore increase their effectiveness. Radio slots will air five times per day at all eight radio stations during the first five months following implementation, reducing to two times per day for four stations in the second year. Further, radio ads will run for three times per day in all eight stations in October and November each year to coincide with the late year malaria season. Radio talk shows will be conducted through four stations with the purpose of allowing Q&A sessions for listeners to field questions to qualified medical practitioners versed on proper malaria case management and ACT use. Potential implementers include: NMCP/HPU, GSMF, ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 18 of 57 4. Supporting interventions Coalition of NGOs for Malaria and others. Activity 1.1.4: Conduct a print media campaign. Printed materials such as posters and leaflets reinforce the messaging provided by radio and television and fill the gap in rural areas that these media do not typically reach. Print also offers the opportunity to provide people with more detailed information than electronic media. The print media will also be varied by format (e.g. low literate) and by content (e.g. level of detail) depending upon their targeted use. One hundred thousand posters and 1.5 million leaflets will be printed and distributed at the start of the AMFm (March 2010) and the same number of posters and leaflets will be reprinted and redistributed one year later to refresh and reinforce the messaging. These materials will be distributed through the nearly 30,000 public and private facilities from which health workers have been trained (see section 4d and 4l). These leaflets will serve as job aids to providers and CDDs providing a wealth of information and detail on key training topics. Potential implementers include: NMCP/HPU, GSMF, Coalition of NGOs for Malaria, Pharmaceutical Society of Ghana, Ghana Sustainable Change Project and others. Activity 1.1.5: Conduct a Community Information Center public awareness campaign targeted at remote/rural communities. In remote areas where radio listenership is low, community information centers (e.g. public announcements at markets) are an effective means of reaching target populations, including mothers and the poor. This method is being employed by the MAM project in its target regions and has proven to be an effective, low cost medium for communicating relevant messages. Ten variations of messaging will be designed for localization and adaption to different languages and community traditions. Messages will be aired six times per day at 50 information centers in the months of March to June and September to November each year. Potential implementers include NMCP/HPU, GSMF and others. Activity 1.1.6: Conduct a mobile video unit public awareness campaign: Mobile video units will be rented from the Ministry of Information to travel to each of the 170 districts and air TV adverts and talk shows promoting key treatment and ACT-related messages to remote populations. This approach is particularly effective for the most rural communities where TV ownership is low. The adverts will be screened in conjunction with a popular film/show in order to reach a captive audience. The mobile vans will travel to each district twice per quarter during Mar-May and Sept-Oct each year. Potential implementers include: Information Services Department of the Ministry of Information and others. Provider training, supervision and ongoing support (multi-sector) (4c) Existing provider training, supervision and ongoing support to promote safe and effective use of ACTs Describe any existing efforts to train providers in the safe and effective use of ACTs [1 page maximum]. Existing Activities Public Sector Public health workers were trained on the appropriate dispensing and use of ACTs in the year following the change of the national treatment policy in 2004. However, since that time, no additional targeted trainings have been conducted despite high turnover of health staff. The training was limited to artesunate-amodiaquine as it was then the only ACT approved for uncomplicated malaria. Supervision in the public sector is generally weak and inadequate and follow-up trainings are almost non-existent. Since 2003, a successful UNICEF funded HBC program has been implemented in 16 districts, where CHOs and CDDs have been provided training in malaria case management. Private Sector ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 19 of 57 4. Supporting interventions The Pharmacy Council, the unit of the Ministry of Health responsible for pharmacy practice regulation, is mandated to provide training for all private pharmacists, LCSs and medicine counter assistants. However, the Council’s training is very broad, covering all aspects of pharmaceutical practice with little attention to malaria case management. The Pharmacy Council also conducts supervisory visits – covering about 60% of pharmacies and 20% of LCSs. Visits are conducted to check if a pharmacy is following standard procedures covering a wide range of dispensing topics and are either pre-warned or unscheduled. The Mobilize Against Malaria (MAM) project funded by Pfizer has sought to increase training in the private sector by providing malaria case management training for LCSs in 2 out of 10 regions in the country (Ashanti and Brong Ahafo). By the end of 2009, 1,000 LCSs will have received two day training in recognition of malaria 9 symptoms and treatment using ACTs for uncomplicated malaria. Preliminary analysis shows that stocking of ACTs in these targeted outlets increased from 6% to 26% in the year following the training despite the fact that ACTs are yet to be subsidized. There have been no other large-scale efforts to train private providers on malaria outside of this project. Planned Activities A number of additional training activities that will be supported by other donors have not yet been implemented but are expected to begin before the start of the AMFm. Public Sector The approved RCC grant provides funding to scale-up training to providers in public facilities by providing two day training to 870 public health facility workers covering malaria case management, including the management of severe malaria. The approved Round 8 grant also seeks to increase home-based care through provider training at the community level. This is detailed in section 4l. Private Sector Training of private sector providers remains limited. The RCC grant also supports the training of 120 private health practitioners on malaria case management while PMI will support the training of 254 LCSs in targeted districts during 2009-2010. This would increase total LCSs trained by both PMI and MAM to 1,254. Emphasis will be placed on malaria case management with ACTs. Gap The greatest gap in current and planned efforts for training health providers on malaria case management is in the private sector. Outside of the MAM focus regions, only a small fraction of private health practitioners, pharmacists, LCSs, and medicine counter assistants will have received training on malaria case management and ACTs by the end of 2009. The effect of this gap is emphasized by a recent USAID study that found that only 10 20% of private providers cited the correct dosing schedule of ACTs compared to 59% in the public sector. The current RCC training targets were cut owing to the need for efficiency savings by the Global Fund. However, there is still an inherent need and capacity for training in both the public and private sectors. It is anticipated that the AMFm will increase accessibility of ACTs greatest in the private sector, where training has been low despite patient preference for first line treatment seeking. As such, there is a particular need to up-scale provider training within the private sector In order to support the up scaling of training, there will be the need to increase capacity of supervisors to cover the large increase of those trained. This is particularly true for the specific increase of training for district level facilities and LCSs who inherently require more frequent supervision. Whilst Round 8 provides an up scaling of HBC, there is a need for this 5 year plan to be accelerated to help ensure that vulnerable groups such as the rural poor are able to access ACTs. Further detail on the training and 9 Ghana Social Marketing Foundation, 2009 PMI - Malaria Operational Plan — Year Two (FY09) 10 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 20 of 57 4. Supporting interventions supervision requirements is provided in section 4l). (4d) New or expanded provider training, supervision and ongoing support to promote safe and effective use of ACTs Summarize your proposal for new or expanded provider training, supervision and ongoing support to promote safe and effective use of ACTs across the public, private and not-for-profit sectors [1½ pages maximum]. Given the significant gaps identified in section 4c and the importance of training on the appropriate usage of ACTs, training will be a major focus of the interventions Ghana implements to support the roll-out of the AMFm in the country. Particular effort will be devoted to the private sector given the prominent role that they are likely to 11 play in distributing ACTs under the AMFm. The evidence from the MAM project and studies in other countries show that targeted training can significantly improve dispensing behavior at private shops. Table 4: Summary of Public and Private Provider Training Training One day orientation Public facility workers Private practitioners Licensed Chemical Sellers Three day training Public facility workers Private Practitioners Private Practitioner Medical Counter Assistants Licensed Chemical Sellers Licensed Chemical Seller Medical Counter Assistants Pharmacists Pharmacy Medical Counter Assistants/Technician Trained by RCC - Trained by Additional to be other trained under partners AMFm - - 870 120 - 870 120 - 1,254 - Total to have received training from all sources 1,254 870 120 1,254 2,130 680 1,600 7,500 8,754 1,120 2,240 3,000 800 1,600 8,754 8,754 1,120 2,240 Service Delivery Area 1.2: Treatment: Prompt, effective anti-malarial treatment Training will cover malaria diagnosis, appropriate dispensing of ACTs, and following regulations such as proper storage and recording of medicines and reporting adverse drug reactions, and an understanding of the AMFm. Of the three days, one will be devoted to regulatory compliance issues. Both training and follow up supervisory activities will be carried out be the same implementing partners and will be cascading, beginning with training of trainers at the national level who will then train the regional trainers that will be responsible for district level training. Expanded Activities Activity 1.2.1: Provide a one-day additional orientation/training day for 870 public health workers and 120 private practitioners to be trained under RCC to include the extra curriculum for the AMFm. Under the RCC proposal, 870 public health workers and 120 private practitioners will receive a two day training course. This training will be undertaken during AMFm implementation. However, in order to ensure consistency and uniformity with the other workers that will be trained, an extra day of training will be added for these 990 staff. Activity 1.2.2: Provide a three day training course for an additional 2,130 public health workers on malaria case management and on associated dispensing activities. The original RCC training targets were cut owing to 11 Marsh VM, Mutemi WM, Muturi J, et al. 1999 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 21 of 57 4. Supporting interventions budget constraints, as such there is both an inherent need and capacity to train further public health workers. Therefore, this proposal seeks to support the training of 2,130 additional staff to meet an overall target of 3,000 out of 36,480 public heath facility workers in the country. This training will last three days to include the original curriculum of malaria case management and the additional day on regulatory compliance and understanding of the AMFm, Activity 1.2.3: Provide a one-day additional orientation/training day for the 1,254 licensed chemical sellers already trained by MAM and PMI to include the extra curriculum for the AMFm. MAM and PMI are currently training LCSs in malaria case management. As these LCSs would have been trained prior to the launch of the AMFm, they will each be provided with a one-day orientation to ensure consistency of training across all trained licensed chemical sellers. The additional one-day orientation will include components on regulation and an understanding of AMFm implications. Activity 1.2.4: Provide a three day training course for an additional 680 private practitioners on malaria case management and on associated dispensing activities. There are a total of 1,000 private practitioners in the country. The existing RCC malaria grant has proposed to train 120 private medical practitioners on malaria case management; however this was cut from an original target owing to budgetary constraints. This proposal seeks to provide a three day training course to an additional 680 private practitioners where there is both inherent need and capacity to increase training. New Activities In addition to expanding training for public and private health facility workers, the NMCP and its partners will conduct new trainings for a large number of private pharmacists and LCSs. Supportive supervision will also be initiated to ensure that public and private providers are correctly following the practices on which they are trained and limiting the need for refresher trainings. Activity 1.2.5: Provide a three day training course for 1,600 private practitioners’ medical counter assistants on malaria case management and on associated dispensing activities. Two MCAs per private practitioner will be selected owing to the relatively high levels of assistants used. Each assistant will be provided with three day training on malaria case management and dispensing practices. Activity 1.2.6: Provide a three day training course for 7,500 licensed chemical sellers on malaria case management and on associated dispensing activities. With approximately 10,000 outlets around the country (including a strong concentration within rural areas) LCSs represent one of the most important sources of antimalarials. It is therefore imperative that they are appropriately trained to handle and dispense the co-paid ACTs that they will have access to under the AMFm. In addition to the training being provided by the MAM project and PMI, an additional 7,500 LCS dispensers (75% of shops) will be trained in all areas of the country. Activity 1.2.7: Provide a three day training course for 8,754 LCS medical counter assistants on malaria case management and on associated dispensing activities. As medical counter assistant typically operate the outlet when the registered practitioner is not available, it will be important that medical counter assistants be appropriately trained to handle and dispense the co-paid ACTs that they will have access to under the AMFm. As such, a medical counter assistant for each of the LCS trained by MAM, PMI (1,254) and the AMFm (7,500) will receive three day training. Activity 1.2.8: Provide a three day training course for 1,120 private pharmacists on malaria case management and on associated dispensing activities With more than 1,400 outlets around the country, pharmacists represent a sizeable source for malaria treatment in the private sector. Pharmacists must be appropriately trained to handle and dispense the co-paid ACTs they will have access to under the AMFm. The AMFm will target training 1,120 pharmacists (80% of pharmacies) in all areas of the country. Activity 1.2.9: Provide a three day training course for 2,240 pharmacy medical counter assistants on malaria case management and on associated dispensing activities. As medical counter assistant typically operate the ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 22 of 57 4. Supporting interventions outlet when the registered practitioner is not available, it will be important that medical counter assistants be appropriately trained. Two assistants (medical counter assistants or pharmacy technicians) per store will receive three day training. Activity 1.2.10: Print training manual for all recipients and facilitators of the one day orientation and three day training courses. The majority of the training materials have already been developed to support RCC training programs; however, manuals on pharmacovigilance and data collecting practices will be developed and printed. Activity 1.2.11: Conduct regular supervisor visits of public health facilities. Supportive supervision is important to ensure that practices are followed and provides an opportunity for on-site training that complements the initial training providers will receive. Supervisory visits will be performed at different frequencies according to facility level: quarterly at the national level, bimonthly at the regional level and monthly at the district level. Supervisory visits increase as we move from higher levels to lower levels due to lower levels of skill and qualification. All ten regions of the country are divided into three zones under the NMCP. Vehicles will be procured to support the supervisory visits: three to cover each national zone, ten to cover each region and five to the most remote and underserved districts. Visits will focus on monitoring compliance with treatment guidelines, providing overall performance feedback, and checking ACT stock availability. Activity 1.2.12: Conduct regular supervisory visits of private sector outlets. In conjunction with the NMCP, the same implementing partners that conduct provider training will provide supportive supervision of LCS and private pharmacists in the months following their initial training. Visits will be conducted once per quarter at each of the 170 districts and will focus on observing private businesses management of febrile patients and other practices relevant to proper ACT dispensing, providing feedback on performance. Importantly, these visits will be positioned as an extension of the training and a form of support to the shops in order to ensure their trust and therefore acceptance of the supervision. As shops are unlikely to engage in normal practice when a regulator (Pharmacy Council) is present, the supervisors will be chosen from those who provided the training in order to foster a more supportive supervisory environment. Separate regulatory visits will be conducted by the Pharmacy Council (see section 4g). Potential implementers to conduct training and supervision include: Pharmaceutical Society of Ghana, Pharmacy Council, Community Practice Pharmacists Association, District Health Management Team, Regional Health Management Team, MOH/Policy Planning Monitoring and Evaluation Unit at National Level, NMCP and others. National drug monitoring, including pharmacovigilance, resistance monitoring and quality surveillance (4e) National focal point for pharmacovigilance Complete the table below to nominate a national focal point for pharmacovigilance. National focal point for pharmacovigilance Name Delese Darko Position Head Department Drug Evaluation and Registration, Food and Drugs Board Telephone +233 21 235100 Fax +233 21 229794 E-mail address Mimidarko66@yahoo.co.uk ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 23 of 57 4. Supporting interventions (4f) Existing national drug monitoring efforts Describe the existing system for national drug monitoring, including the national systems for pharmacovigilance, quality surveillance and resistance monitoring. Identify any weaknesses in the system [1 page maximum]. [Insert annex name and number if providing an extract from a national policy document] The national drug regulatory agency, the Food and Drugs Board (FDB) is responsible for the safety, quality and efficacy of all medicines manufactured, prepared, sold, imported into and exported out of Ghana. The FDB carries out safety and quality surveillance monitoring, but partners with the Noguchi Memorial Institute for resistance testing at sentinel sites since it currently does not have in-house capacity for the latter. Drug Quality Monitoring Existing The FDB, as part of routine post-marketing activities, carries out quality monitoring of all medicines. The FDB laboratory in Accra, in collaboration with the Drug Post-Market Surveillance Unit and all its zonal offices, designs strategies for collecting medicines from the market and analyzing them for quality and content. Zonal and port officers are typically trained in the use of minilabs for quality evaluation, though this training is usually inadequate and insufficient to capture the breadth and sophisticated detail required to perform useful evaluations. The laboratory also carries out quality assessments for anti-malarials and other products submitted for registration. However, its ability to carry out quality monitoring of registered products is limited due to lack of staff capacity. In the past year, the laboratory received about 2,500 products for analysis, a significant proportion of which could not be fully analyzed due to staff, equipment and space constraints. Resistance Monitoring Ghana has 10 sentinel sites where the resistance of anti-malarials, notably chloroquine, SP and amodiaquine are routinely tested. Following the introduction of ACTs, staff at these sentinel sites are being trained and resourced to carry out resistance monitoring of ACTs though the technical capability for this is yet to be fully developed. The RCC proposal has provisioned resources to monitor anti-malarial drug efficacy at the 10 sentinel sites. Planned The FDB is currently collaborating with the United States Pharmacopoeia (USP) which is providing training for staff in the area of quality monitoring of ACTs. This is a pilot activity scheduled to end in December 2009 with the main expected output of equipping staff with the knowledge needed to routinely carry out quality assessment of ACTs. The FDB will retain the five minilabs bought for the study. Pharmacovigilance Existing The FDB hosts the National Centre for Pharmacovigilance which operates a spontaneous reporting system wherein adverse drug reaction (ADR) reporting forms are used to collect information on suspected adverse events. All healthcare workers and patients are primary reporters and can report any suspected ADR to the FDB head office in Accra or through any of the zonal or institutional representatives. The FDB has one Pharmacovigilance Zonal Desk Officer in each of the 7 zonal offices. These officers work with designated institutional contact persons for pharmacovigilance in selected key health facilities, including all the teaching and regional hospitals. A 13-member multi-disciplinary National Technical Advisory Committee on Pharmacovigilance formed by the FDB in 2006 meets quarterly to carry out case causality assessments of all reported ADRs and provides the ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 24 of 57 4. Supporting interventions FDB with guidance and support on pharmacovigilance policy and practice. In addition, the FDB collaborates actively with institutions in Ghana that are involved in medicine safety monitoring or research, including the Pharmacovigilance Resource Centre at the University of Ghana Medical School, the Health Research Unit of the Ghana Health Service, and national disease control programs. The NMCP, the National AIDS Control Program and the National TB Control Program provision funds for focused pharmacovigilance studies. Planned The INDEPTH network for safety and effectiveness studies (INESS) intends to carry out specific safety and effectiveness studies of anti-malarials in three DHS sites in Ghana namely, Dodowa, Kintampo and Navrongo. These studies are intended to provide real life safety information of anti-malarials used in these districts. The specific methodologies to be used for the safety monitoring component of INESS are: a) Spontaneous reporting using the national spontaneous reporting forms developed and deployed by the FDB. INESS will seek to strengthen the existing spontaneous reporting systems in each of these districts b) Cohort Event Monitoring: a cohort of at least 10,000 exposures will be followed up for any new antimalarial deployed with an aim of capturing rare adverse events occurring at a rate of 1 in 3000. The number of exposures will be cumulated such that CEM studies per drug will be terminated once the total number of 10,000 exposures is reached c) Pregnancy exposure registers: registers will be developed to capture outcomes following exposure to anti-malarials during pregnancy. Gap Despite the significant steps in progress towards improving the drug quality and pharmacovigilance systems in country, there are still a number of existing weaknesses, including: • • • • • • Low number of ADR reports received per annum (only 200) Low participation of the private sector in this system Dearth of reporting forms distributed in private facilities Limited human resources for pharmacovigilance Inadequate training of health workers on pharmacovigilance Insufficient equipment and poorly trained staff for drug quality testing With the influx of ACTs into the country, it will be necessary to ensure that ADRs amongst patients are identified and reported. As such, additional CEM studies will be necessary to focus specifically on ACTs (in addition to anti-malarials being studied by INESS). Public and private sector health workers often lack the necessary training on pharmacovigilance and ADR reporting to assist patients in need - this weakness is addressed in section 4d. It is important to note, however, that private sector providers often do not have access to ADR reporting forms and forego crucial data from the significant number of patients who seek treatment in private outlets, contributing to the low number of ADR reports received per annum. Though USP will be providing five minilabs per region for drug quality testing, there is still a gap of five regions that will require minilabs to test products purchased at the facility level. There is also still a significant gap in human resources to be able to undertake the testing and analysis of the quantum of drugs that are sampled at each regional minilab. (4g) Strengthening the national drug monitoring system Summarize your proposal for strengthening the national system of pharmacovigilance, quality surveillance and/or resistance monitoring through AMFm [1½ pages maximum]. In line with the national drug policy objective to strengthen quality assurance by ensuring that only safe and effective drugs are sold or supplied to consumers by both the public and private sector, the existing quality surveillance and pharmacovigilance systems in Ghana will need to be strengthened in order to monitor and ensure the maximum possible safety of ACTs used under the AMFm. The key focus areas include: ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 25 of 57 4. Supporting interventions • • • monitoring risk for adverse drug reactions associated with co-paid ACTs provisioning resources for improved drug quality testing of ACT samples across the country provisioning resources to increase participation of private sector providers into the existing regulatory system The activities listed below will directly contribute to strengthening of the existing drug quality and pharmacovigilance systems to ensure the safe and efficacious roll-out of co-paid ACTs into the country. Strengthening of the existing system will complement ongoing efforts by USP and INDEPTH. Service Delivery Area 4.1: Monitoring anti-malarial drug efficacy Activity 4.1.1: Training of key pharmacovigilance personnel including FDB members and pharmacovigilance focal points. Three-day training will be conducted to expand the knowledge base of key pharmacovigilance personnel on basic PV systems, the reporting and management of adverse drug reactions, and communication of safety concerns through the existing reporting structure. The 30 trainees will consist of one regional hospital focal person, one FDB representative and one district hospital focal person from each of the ten regions. Training will be implemented by the FDB and conducted within the first quarter of AMFm launch. Activity 4.1.2: Print adverse drug reaction reporting forms for private sector outlets. As described in section 4d, private sector providers will be trained on malaria case management and receive one day training specific to pharmacovigilance issues and filling adverse reporting forms. To ensure involvement of the private sector to gather conclusive and complete data on ADR events, 100 reporting forms per store will be printed and distributed during training. Activity 4.1.3: Conduct cohort event monitoring studies for two ACTs. Cohort event monitoring studies for two ACTs will be conducted to identify potential adverse reactions. Patient diary cards and informed consent forms will be printed and distributed to private and public sector health facilities with high patient load and OPD attendance to capture patient medical history and exposures to ACTs. The CEM study will be terminated after 10,000 exposures (calculated by number of diary register cards collected by field workers) and is estimated to last for 6 months beginning at the launch of the AMFm. One full time coordinator will be hired to oversee all CEM activities while two research assistants will double as data entry personnel to collect ADR forms and produce reports to FDB. Twenty volunteer field workers will be utilized to make home visits and phone calls to prompt patients for adverse drug events. For those patients who do report ADR, field workers will refer patients to receive appropriate follow-up treatment. All workers including coordinators, research assistants and field workers will be given five day training on how to effectively execute the CEM project. Activity 4.1.4: Host national level data review meeting. A meeting will be held with twenty experts (including medical professionals, statisticians and regulatory representation) to meet to review data collected during the first six months of Year 1. The team will meet to synthesize information and print and disseminate a report to NMCP and key stakeholders to assess progress to date. Activity 4.1.5: Conduct periodic quality surveillance of ACTs. Samples of ACTs will be taken from both public and private sector facilities (LCSs, pharmacies, clinics and hospitals) and quality tested. A research assistant will travel to 30 facilities over five working days per quarter to collect samples of ACTs, procuring two ACTs per facility. Three 4x4 pick up trucks will be purchased to support regulatory visits to the ten regions. Drug samples will be returned to regional minilabs; five minilabs and reagent will be procured to supplement the five minilabs provided by USP (section 4f). In addition, five full time lab technicians will be resourced to conduct minilab tests and analysis at each minilab site. Tests will be conducted every quarter over the entire course of AMFm implementation. Drugs that fail minilab tests at the regional level will be sent for high performance liquid chromatograph (HPLC) testing. HPLC is used as a method to more accurately test drug quality of products that would have failed minilab testing. As a crucial step to drug quality testing, one HPLC and reagent will be purchased to conduct ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 26 of 57 4. Supporting interventions confirmatory tests of products collected at the facility level. One full time lab technician will be hired to manage testing and analysis at the site. The results of all tests conducted will be compiled into a report and disseminated to FDB headquarters to inform ongoing drug policy and regulation. Activity 4.1.6: Conduct regular visits to supervise drug quality monitoring activities. One full time BPharm degree holder will be recruited to oversee drug quality evaluation at all ports of entry in the country. The recruit will serve as drug quality coordinator, working in the field to perform supervisory visits of FDB personnel stationed to monitor drug quality at each of the regional centers and ports. The quality coordinator will be based at FDB headquarters, but expected to travel around the country spending ten days per month on field visits. As such, one vehicle and one driver will be provided to facilitate travel around the country. The quality coordinator will be responsible for evaluating the effectiveness of product quality assessment efforts at ports of entry, compiling data and reporting back to FDB. National policy and regulatory environment efforts (4h) Existing national policy and regulatory environment Summarize your existing national policy on the classification (“scheduling”) of ACTs either as ‘over the counter’ or ‘prescription only’ medicines. [Insert annex name and number if providing an extract from a national policy] In 2006, the Ministerial Task Force of the MOH recommended the reclassification of ACTs as over-the-counter medication. Due to the absence of a governing Board for the FDB, this recommendation was not immediately implemented. That Board has been recently reconstituted (May 2009) and it is expected to approve ACTs for over the counter use by September 2009, well in advance of the potential launch of the AMFm in the country.. (4i) Efforts to improve the national policy and regulatory environment for ACTs If ACTs are not widely available ‘over the counter’ in your country, describe the actions you are proposing to ensure that the AMFm objectives of increasing ACT availability and use will be achieved. Also describe any other actions you propose to strengthen the policy and regulatory environment to relevant to the AMFm in this section [1½ pages maximum]. With the reclassification expected by the Board of the FDB, ACTs will be widely available over the counter in the many private outlets that distribute basic medicines in Ghana. The Pharmacy Council currently supervises LCSs and pharmacists in the public and private sector, but currently experiences low rates of inspection due to persistent issues such as inadequate transportation and human resources. Inspecting pharmacists are tasked (i) to ensure rational drug use (ii) to ensure that only medicines of good quality are stored in and supplied from licensed premises and (iii) uphold and enforce professional conduct in the delivery of pharmaceutical care. There is currently a dearth of inspecting pharmacists in each region making it difficult to conduct timely and thorough visits to all stores and shops. Inadequate supervision leads to a compromise in pharmaceutical services provision, which negatively impacts the end consumers. To ensure that subsidized ACTs are used responsibly and appropriately, particularly in the private sector, Ghana will strengthen the Pharmacy Council to conduct more regular and effective oversight. Specific strengthening activities will be dedicated to support Pharmacy Council regulatory visits to pharmacies and LCSs. Service Delivery Area 1.3: National Policy and Regulatory Preparedness Activity 1.3.1: Conduct quarterly regulatory visits of private sector outlets. Four pharmacists will be recruited to conduct regulatory visits to private sector outlets (LCSs and pharmacies) to monitor rational drug use and adherence to standards of practice. Two supervisors will be based in the Accra region and will conduct day trips to facilities, spending one day per week performing administrative tasks in the office. Two pharmacists will be ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 27 of 57 4. Supporting interventions based outside of Accra and responsible for conducting four-day long trips to visit facilities in regions around the country. To support visits, a 4x4 car will be procured for each of the traveling pharmacists. (4j) Tax exemption for AMFm co-paid ACTs Explain whether ACTs co-paid by AMFm (including those purchased by public, private and not-forprofit sector buyers) will be exempt from duties and taxes. If they are not exempt, explain how the higher cost of co-paid ACTs will be mitigated to ensure that the price to patients becomes comparable to that of less-effective anti-malarials [1/2 page maximum]. Tax exemptions for pharmaceutical and medical commodities are negotiated annually with parliament. Under schedule A of the VAT Amendments Act 670 of 2004, several product ingredients are deemed “essential medicines” and do attract tax reliefs. These included amodiaquine powder, quinine sulphate powder, sulphadoxine powder and pyrimethamine powder all meant for local production of anti-malarials. In addition, quinine sulphate tablets and injections were added as the only anti-malarial finished products which were tax exempt. All other anti-malarials, including ACTs, are exempt from the 10% import duty but are subject to all other taxes (i.e., VAT+NHIL, port inspection, ECOWAS Levy, Development Investment Funds levy, network charges, and IRS). There is a provision for applying to Parliament for tax exemption of products annually. This provision has been successfully utilized to obtain tax exemption for anti-malarials in previous Global Fund grants (Rounds 2 and 4). In order to ensure affordable ACTs are broadly available under the AMFm, the Ministry of Health will actively explore applying for such an exemption for finished ACTs in the months preceding the launch of the Facility. Reaching poor people and other vulnerable groups (4k) Existing interventions to reach poor people, children and other vulnerable groups How do your national malaria treatment interventions, with special reference to ACT treatment, currently reach and/or target poor people, children (particularly those under 5 years of age), women and other vulnerable groups? [1 page maximum] [Insert Annex name and number if providing an extract from a national malaria control plan, a Global Fund Round 7 or 8 proposal] As stated in the Minister’s foreword to the National Malaria Strategy (2008-2015), “the success of the malaria control program is under-pinned in the principles of rapid scale up and expansion of all relevant and proven interventions, universal access to proven and cost effective interventions, and ensuring equity through community based and gender based approaches that focus on hard to reach communities…” One of the core aims of Ghana’s health system is rapidly scaling up high impact health intervention and services (including those for malaria), targeting especially the poor, disadvantaged and vulnerable groups. As outlined below, a number of systems and policies have been put in place to target these goals. Existing Activities Comprehensive Health Insurance In Ghana, the NHIS was launched in 2004 with the intent to provide universal coverage and to replace the “cash and carry” system that had made health care costs prohibitive for a large portion of Ghana’s poor. Through using a copayment mechanism, medicines have become more affordable. Subscribers of the NHIS are entitled to 100% reimbursement of the cost of ACTs from accredited facilities. Subscription to NHIS costs between $5 and $16 per year depending on income level. However, the following groups are exempted from paying premiums on services provided by the scheme: (i) children less than 18 years of age whose parents or guardians are ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 28 of 57 4. Supporting interventions contributors (ii) the elderly over 70 years and (iii) indigents (those without residence and income). The NHIS regularly accredits public and private health facilities that are eligible to receive reimbursements. Currently, all public facilities and 3.4 % of LCS, 28% of pharmacies 76% of private practitioners are accredited under NHIS. To date, 61.29% of the population in Ghana is registered under the NHIS. Despite the coverage, there is still a gap in reaching the many rural poor people who do not have the means to access public health facilities where they may register to benefit from the scheme. According to NHIS data, only 2% of participants registered are indigents under NHIS. The NHIS has also faced a number of implementation challenges, notably delays in reimbursement of facilities. These delays limit the working capital of facilities and therefore their ability to consistently stock ACTs and other essential products. The consequence is that facilities then tend to favor patients who are not subscribers of NHIS. The government has recognized these issues and is taking action to reduce reimbursement time from 3 months to 6-8 weeks by potentially moving claims processing from the district to the regional level as well as consideration of outsourcing claims processing to a private institution. Home-Based Management of Malaria In home-based care, healthcare is brought to the communities through the use of community drug distributors (see Round 8). The UNICEF-funded HBC program has been successfully scaled up and implemented in 16 districts in the very poor Upper East and West regions of Ghana and is designed specifically to reach poorer and more vulnerable populations that do not have access to formal facilities. Evaluation of this approach has found that community agents correctly prescribe ACT treatment more than 95% of the time and that their presence 12 significantly reduced the time before members of the community sought treatment for fever. As described in section 4l, the approved Round 8 grant will support the NMCP to scale up to 44 districts over the first two years of the grant, with a further 63 districts planned to be implemented in the following three years. CDDs are currently providing ACTs on the basis of clinical diagnosis for malaria and referring patients with potential severe disease to public facilities. Figure 2: Geographic Distribution of Districts targeted by HBC 12 Chinbuah et al. ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 29 of 57 4. Supporting interventions Free Maternal Health Care Reducing maternal mortality and reaching the Millennium Development Goal (MDG) 5 target by 2015 has proven to be a significant challenge for Ghana. The estimate of the maternal mortality ratio (MMR) in Ghana in 2005 was 560 per 100,000 live births (range: 200–1,300), putting it clearly in the category of countries with a high burden of maternal mortality. To address this challenge, an exemptions policy for delivery fees was introduced in 2004 to cover all facility costs for intrapartum care in both public and private facilities. The exemptions extend to ACTs and other antimalarials and so will ensure that pregnant women (except those in the first trimester according to the national treatment guidelines) will obtain free treatment under the AMFm. Since the introduction of this scheme, there has been evidence of improvement, though additional efforts will be needed to reach the targeted reduction in mortality. (4l) New or expanded interventions to reach poor people, children and other vulnerable groups Summarize your proposal to introduce new or expanded interventions to reach poor people and other vulnerable groups with affordable ACTs [1½ pages maximum]. Refer to the Guidelines for AMFm Phase 1 Applications for specific guidance. The home-based care strategy is a critical strategy to achieving one of the objectives of Ghana’s national malaria strategic plan of ensuring all communities have access to treatment for uncomplicated malaria and 90% of children under five years receive an appropriate ACT within 24 hours of fever onset by 2015. In order to reach poor and remote populations that are not adequately served by formal facilities and LCS, Ghana will scale-up the HBC program under the AMFm to reach an additional 26 districts. The original Round 8 five year plan was going to provide training of HBC to cover an additional 107 districts to the 16 trained by the UNICEF program. Forty-four of the 107 districts will be trained by the end of Round 8 Phase 1 (2 years). However, owing to the importance of the HBC to provide treatment and access of ACTs to the rural and poor areas, Ghana will accelerate the Round 8 plan to cover a total of 70 districts by the end of AMFm Phase 1. All of the activities required to train, incentivize and supervise CHOs and CDDs are identical to those proposed in the approved Round 8 grant and are only amended to reach an additional 26 underserved ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 30 of 57 4. Supporting interventions districts. Service Delivery Area 1.4: Community Systems Strengthening for malaria HBC The accelerated training of CHOs and CDDs will developed in line with lessons and experiences learned from work already being conducted by the Coalition of NGOs, PMI and UNICEF. Training will be implemented through community health officers (five per district) who both train and supervise CDDs (183 per district). CHOs are salaried GHS workers and based at district health facilities while CDDs are volunteers. Activity 1.4.1: Conduct training of CHOs and CDDs for the provision of HBC in an additional 26 districts. Three day training courses will be provided for CHOs and CDDs in 26 of the more remote and underserved districts not provided for under Round 8 Phase 1. The 26 districts will be chosen in accordance with the high-level phasing that has already been determined as detailed in the approved Round 8 grant (see figure 2). Within each district, five CHOs will be trained who will then train an average of 183 CDDs per district on symptom recognition and malaria case management. As such, a total of 130 CHOs and 4,758 CDDs will be provided three day training that will cover the causes of malaria, symptom recognition, malaria prevention, appropriate treatment using ACTs pre-referral treatment and referrals, record keeping and maintenance of CDD registers, drug management, follow up of clients, and compliance monitoring. Potential implementers include Ghana Health Service, with support from PMI and the National Coalition of NGOs and others. Activity 1.4.2: Procure implementation kits for each additional CDD. At the end of their training, each of the 4,758 CDDs will be provided with a range of tools to help them effectively carry out their duties including, bicycles to reach remote areas, leaflets providing key malaria information (section 4b), registers and other stationary, and drug storage boxes to properly store ACTs and other products. Activity 1.4.3: Procure incentive pack for each additional CDD and CHO: Each of the additional 130 CHOs and 4,758 CDDs will be provided with an incentive package. Further, Round 8 did not provide for incentives, in which case all 220 CHOs to be trained under Round 8 will also receive a package. Each incentive pack will include a backpack, torch, T-shirt, raincoat and wellington boots. As described in section 4b, consistent and coordinated messages to reach the public will be developed to inform on ACT accessibility and affordability. Most of the mass media approaches that will be used to distribute these messages will have less reach in the most remote and poor areas owing reduce propensity to own TVs and radios. As a result, a complementary approach of delivering key messages at the community in conjunction with the expansion of the HBC program will be implemented as part of community systems strengthening. These activities have been successfully employed alongside the HBC program in the initial 16 districts and are scheduled to be scaled-up to a further 44 districts through Round 8. As with the core HBC program, this proposal will enable these activities to be expanded to the remaining 26 districts. Activity 1.4.4: Organize durbar community meetings in each of the 26 target districts. Orientation and sensitization of communities on HBC for malaria will be undertaken through community durbars which will be organized by CHOs and CDDs. These meetings will be used to introduce newly trained CDDs to their communities as well as share information on AMFm specific issues. Activity 1.4.5: Orientation of members of community based organizations on HBC. Ten members of CBOs/NGOs will receive a three day orientation on HBC to ensure maximum cooperation and ownership at the community level. Training workshops will focus on conducting outreach on malaria case management in remote, underserved areas. Transport and fuel will be provided for CBOs to reach out to communities to achieve strong BCC in underserved areas Activity 1.4.6: Provide resources for CBO/NGO networks to support community sensitization to HBC. Fuel and allowances will be provided to support CBOs/NGOs to conduct community outreach activities with the aim of ensuring HBC has maximum impact and ownership at the community level. ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 31 of 57 4. Supporting interventions Activity 1.4.7: Perform supervisory visits of CDDs. CHOs are responsible for regularly supervising CDDs to ensure they are effectively fulfilling their duties. Visits will be conducted by each CHO five times per month for one day to ensure that CDDs are accepted into their communities and ensure that they are following proper case management practices. To enable them to efficiently move around the large geographic areas for which they are responsible, CDDs will be provided with motorbikes (already procured by Government of Ghana) and appropriate fuel. One motorbike will provided to each CHO or 5 for each of the 26 target districts. In addition to these interventions, an operational research project will be conducted to explore the feasibility of expanding the use of NHIS at LCSs so that more poor and vulnerable people can access free treatment from these outlets. This research is described in section 6. The potential expansion of this approach as an effective means of increasing ACT access for the poor will be considered based on the results from that project. Additional supporting interventions (4m) Additional supporting interventions to promote safe and effective use of ACTs If applicable, summarize your proposal for other additional supporting interventions to promote safe and effective use of ACTs across the public, private and not-for-profit sectors. [1½ pages maximum] Service Delivery Area 1.5: Program Management and Administration Given the unique need for collaboration between the public and private sectors in the AMFm, successful implementation will be particularly reliant on effective coordination and communication between the various organizations involved, including private importers. Activity 1.5.1: Conduct a quarterly AMFm coordination committee meeting to ensure effective implementation of the initiative. Full day meetings of the AMFm coordination committee will be held quarterly to discuss implementation progress and challenges. Meeting attendees will consist of 30 participants from public and private sector stakeholders, including implementers and regulatory bodies. Activity 1.5.2: Recruit additional NMCP staff to coordinate and manage additional AMFm activities. NMCP will recruit one AMFm focal person to oversee the coordination and timely implementation of all AMFm related activities. The additional staff member will be responsible for managing all AMFm implementation activities including supervision of SRs and supporting intervention activities, and maintaining communication with the private sector. The focal person will sit within the NMCP to ensure that AMFm activities are well coordinated with other malaria control interventions implemented in the country. Activity 1.5.3: Strengthen human resources at national ports of entry. Currently, there are two official ports of entry or exit of drugs, the Accra International Airport and the Tema fishing port. Though the Tema fishing port has ten terminals, they are only resourced to monitor the flow of drugs in three of these terminals thus copaid ACTs could be carried through any of these other terminals. Four staff will be recruited and receive two-day orientation to support monitoring of drug flow of ACTs and other products at the vulnerable terminals. The additional staff capacity will increase the regulatory authority’s ability to monitor massive leakages to other countries. Work plan (4n) Workplan for new or expanded supporting interventions You must support your proposal for new or expanded supporting interventions for AMFm by attaching a detailed Work Plan for the See Attachment D – Detailed Budget for Supporting Interventions ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 32 of 57 4. Supporting interventions duration of AMFm Phase 1 (attached a separate annex). The detailed budget for these activities should also be provided in Section 8e of this application form. Risk Analysis (4o) Complete the following table to identify any potential risks to the successful implementation of AMFm in your country and to describe the measures that will be undertaken to mitigate these. A non-exhaustive list of possible risks is included in the table. If you believe that a listed risk does not apply to your country, you must provide an explanation of why this is the case. Insert additional rows to include further potential risks and mitigation strategies. Potential risk Slow implementation of supporting interventions Lack of demand for ACTs Lack of supply of ACTs through supply chain Mitigation strategy Some training and BCC activities will be launched under the Round 8 and RCC so implementation will have begun before subsidized ACTs begin flowing. Ghana will also undertake a number of preparatory activities such as market research (section 4b) to inform the design of an appropriate communications strategy and revision of training materials in advance of AMFm implementation to enable rapid implementation once the grant is signed. Due to preparatory activities, well-designed IEC/BCC campaigns will be launched concurrently with the arrival of subsidized ACTs in the country to rapidly generate demand throughout the country. Training of public providers and CDDs will also have been completed in many districts through existing grants, with those staff actively promoting ACTs among patients and communities. Additional training, inclusive of private providers, will be rapidly scaled-up following the launch of the AMFm to build demand in other districts. Public Sector: This application proposes strengthening CMS and RMS to allow a more efficient and regular supply to all public sector health facilities (section 9b). Private Sector: An OR project will be launched to pilot volume incentives in the private sector distribution chain (section 6). Findings will be utilized to inform large scale roll-out to help ensure consistent flow of ACTs along the private sector supply chain. A central message of the IEC/BCC campaign will be that ACTs should be purchased at a low, affordable price. This will be broadly communicated and enable consumers to hold retailers accountable for potential excessive mark-ups. Excessive price mark-up through the supply chain In addition, a meeting will be held with all private sector stakeholders prior to the launch of the AMFm in order to encourage limitation of first line markups and broad distribution of subsidized ACTs throughout the country. Analysis will be prepared and presented on the potential profit gains of distributing ACTs at low cost and high volumes. The AMFm coordination committee will also regularly review data from central and district level and determine an appropriate response if bottlenecks are identified. ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 33 of 57 4. Supporting interventions Limited purchase of ACTs by private sector first-line buyers The rapid implementation of a large-scale IEC/BCC campaign will generate strong demand for ACTs which will in turn incentivize first line buyers to purchase ACTs. Information about demand generation activities and forecasting of corresponding volumes will be presented at the initial private sector meeting to encourage rapid purchasing. Poor diagnosis and inappropriate supply of ACTs by providers Through the RCC grant, Ghana will scale-up use of RDTs in the public sector to improve diagnosis of malaria and appropriate prescribing of ACTs. The use of RDTs by community agents is also being piloted under Round 8 and the feasibility of introducing RDTs into the private sector will be tested through a project under this proposal (see section 6). To support appropriate diagnosis and dispensing in the private sector before this intervention is potentially scaled-up; training of private providers will include a strong focus on differential diagnosis of fever and referral of patients that exhibit serious symptoms. Inappropriate use of ACTs by patients The BCC/IEC campaign will include strong messages about the importance of obtaining an appropriate ACT dose and completing the full course of medicine. In addition, public and private providers and community agents will all be trained to dispense correct doses and provide patients with detailed instructions on the use of the drugs. Evaluation of the HBC program has shown that these interventions have the desired impact: 95% of patients obtained the correct ACT dose and 92% adhered to the recommended 13 treatment course, and therefore this application proposes the scale up of HBC activities. Inadequate interventions to increase coverage of poor, people, children and other vulnerable populations Existing policies in Ghana, notably the National Health Insurance Scheme and HBC, provide a strong foundation for delivering free or low cost ACTs to poor and vulnerable groups. The expansion of HBC to additional underserved districts will expand ACT access for young children and the poor in these areas and the piloted introduction of the NHIS into private shops will also aim to increase equity of treatment access in the private sector. Supervisory visits to both the public and private sector will target underserved areas and the information gathered will be fed back to the AMFm coordination committee to potentially develop additional solutions for reaching these areas. Massive leakage of co-paid ACTs to non-AMFm countries The public sector currently has a system in place which reports on the distribution of ACTs. In the private sector, importers / distributors will be bound by their contracts with manufacturers to sell co-paid ACTs within the borders. FDB will monitor product flow, particularly in border towns and at ports of entry. FDB will also monitor product flow amongst large volume wholesalers and legally ban the exportation of co-paid ACTs meant for the country. Increase in poor quality or counterfeit ACTs Co-paid ACTs will be WHO pre-qualified which will ensure the quality and efficacy of the drugs. The ACTs will also be much cheaper, detracting from the potential profit to be made by counterfeiters on small volume deals. Additionally, FDB will be strengthened to carry out more drug quality monitoring activities as outlined in section 4g of this proposal. Appropriate legal action will be taken against perpetrators which will also serve as a deterrent. Lack of participation from local Local manufacturers are important participants within the supply chain. 13 Chinbuah et al. ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 34 of 57 4. Supporting interventions manufacturers However, none of them produce ACTs that meet the Global Fund’s quality assurance policy, and consequently manufacturers may try to disrupt AMFm implementation as it poses a threat to their business. Manufacturers will be encouraged to participate within the supply chain to earn additional revenues whilst they work towards obtaining WHO Prequalification. Assistance will be sought from the government and international partners such as the RBM Partnership, UNIDO and the World Bank who have expressed an active desire for this. ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 35 of 57 5. Monitoring AMFm Phase 1 In-country monitoring of AMFm Phase 1 The purpose of in-country monitoring for AMFm Phase 1 is to monitor progress in implementation, measure performance in delivering supporting interventions, inform decisions during implementation, and help identify problems that need the attention of managers. Applicants are requested to outline their monitoring system for AMFm Phase 1 in this section. Independent Evaluation The independent evaluation will assess whether and the extent to which AMFm Phase 1 achieves its objectives. The main parameters for evaluation are as follows: • Availability of ACTs in outlets across the public, NGO and private sectors • Affordability of ACTs to patients in outlets across the public, NGO and private sectors • Market share of ACTs relative to monotherapies (e.g., AMTs, SP, CQ, AQ) • Access to and use of ACTs by vulnerable groups of interest (e.g., poor people and children) The Independent Evaluation will be undertaken by an independent contractor. Applicants are required to ensure cooperation with the independent contractor. Applicants are not asked to respond to questions regarding the Independent Evaluation in this application form. (5a) Describe the in-country monitoring system, including its strengths and weaknesses, that will be used to monitor the AMFm supporting interventions and other relevant activities, including drug procurement and supply chain management. If relevant, refer to and attach as separate annexes extracts from previously submitted applications to the Global Fund or applicable health sector documents [1 page maximum]. [Insert annex name and number if referring to health sector documents or applications previously submitted to the Global Fund] Public, Private and NGO Sectors The routine reporting system within the health sector in Ghana involves a monthly, quarterly and annual reporting and review process for accountability and stewardship from all levels by all agencies. The routine reporting process covers all sectors (public, private and NGO) and involves monthly and quarterly reports from sub-districts (health centres and communities) through to the national level by all agencies of the MOH. At the sub-district level monthly reports are submitted to the District Health Directorate (DHD). The DHD (including district hospitals) submits monthly reports to the Regional Health Directorate (RHD). The RHD (including regional hospitals) submits quarterly reports to GHS headquarters (PPME). GHS as an agency compiles and consolidates the quarterly regional reports from the ten regions and submits to the Ministry of Health (PPME) each quarter. All other agencies of the MOH report quarterly to the MOH. The Centre for Health Information Management (CHIM) located in GHS is the central repository for health information (both public and private). There are a variety of tools used in the compilation and consolidation of data reported from the district level to the national level. The sub-district level captures primary data using forms and registers. Aggregated data from the sub-district levels are compiled and consolidated using the District Health Information System Software (DHIMS). District data are submitted through regional to national (GHS) using the DHIMS software. The DHIMS software is used to generate the set of performance indicators for at the district, region and national levels. Hospital data are captured into the DHIMS either at the hospital or at the District and Regional Health Directorates for district and regional hospitals respectively. There are other tools (e.g. NHIS software) used to capture data especially at the hospital and programme level. Such relevant data are manually re-entered into the DHIMS at the respective levels. The Monitoring and Evaluation system takes place at the regional and national levels. A set of national and regional performance indicators are used for monitoring. The monitoring indicators cover all areas of work including all planned activities and procurement (including drugs). Regional teams are expected to conduct quarterly monitoring and evaluation ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 36 of 57 5. Monitoring AMFm Phase 1 visits to all districts within their region. Agencies are expected to conduct quarterly visits to all regions. Specialised agencies such as the Private Homes and Maternity Boards (PHMB), Pharmacy Council (PC), Food and Drugs Board (FDB), Nurses and Midwives Council (NMC), Ghana Medical Association (GMA) and the Association of Private Midwives (APM) conduct M&E visits to their members on their activities. The MOH (at headquarters) conducts quarterly visits to its agencies, visiting each region at least once per year. In addition, national disease control programmes conduct quarterly monitoring and evaluation visits to the regions. Programme M&E visits are also used to collect data on programme indicators that are currently not included in the DHIMS. In addition surveys are conducted periodically by MOH or other Government Ministries (e.g. Ghana Statistical Service) to capture data on indicators that may not be generated by routine reporting, examples include: • Multiple Indicator Cluster Survey (MICS) is conducted every two years capturing general malaria indicators • Demographic and Health Survey (DHS) is conducted once every five years under the leadership of the Ghana Statistical Services and captures detailed malaria data • There are three Demographic Surveillance Sites (DSS) located in three ecological zones in Ghana where malaria data is captured The strength of the M&E, routine reporting and annual review process is in the organization, management and structure. It is very participatory and involves all major stakeholders (public and private heath facilities, and NGOs). Each level has a clear understanding of their reporting requirements and the frequency of reporting. There are however many weaknesses across all sectors that limit the successful achievement of complete, timely and quality information for decision making at all levels. The weaknesses include: 1. Though the district and regional reviews are open and participatory, not all private sector associations and NGOs participate and/or make presentations (e.g. associations of private pharmacies, private midwives and chemical sellers) 2. The M&E and reporting system is inadequate and does not adequately cover the private and NGO sectors. This is due to the inadequate number of M&E staff and logistics to conduct quarterly visits 3. Most of the staff at the regional and national level (including programmes and other agencies in the public, private sector and NGO sectors) who conduct M&E visits do not have adequate training and skills in M&E 4. The enforcement and feedback mechanism for reporting is weak contributing to late and incomplete reporting 5. Most primary data (especially at health facilities and hospitals) are captured and processed (aggregated) manually, compromising data quality 6. The absence of routine data quality audits contributes to poor data quality 7. The DHIMS, which is the central database system, focuses on selected national indicators leaving gaps in data that lead to the development of parallel systems to address other data needs especially for programmes 8. DHIMS does not adequately address the private and NGO reporting requirements and other specialised and ad hoc reports. 9. There is no centralized data repository system in place to support integration of other information systems contributing to and creating the demand for other parallel systems 10. Inadequate ICT infrastructure and staff to support electronic data capture, reporting and analysis contributes to poor data quality, late reporting, and lack of analysis of data. 11. Absence of a central logistics and inventory management software and effective monitoring system for the supply chain management system contributes to poor forecasting, stock outs and wastages. (5b) Explain how the weaknesses of the existing monitoring system will be addressed, so AMFm activities and achievements can be monitored [1/2 page maximum] Ghana is submitting an HSS proposal for Global Fund Round 9 with the TB application. This HSS proposal, if approved, ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 37 of 57 5. Monitoring AMFm Phase 1 will address the weakness numbers 5 and 6-9 outlined above in section 5a. The interventions outlined below will strengthen the M&E systems (weakness numbers. 1-4 and 11) which will directly contribute to monitor AMFm supportive activities. Under the implementation of the AMFm, monitoring of stock outs, distribution, and storage of ACTs will be strengthened and improved in the private sector. The capacity to monitor BCC/IEC messages across the population will be also strengthened. Service Delivery Area 4.2: Other - Monitoring and Evaluation Activity 4.2.1: Organize one day workshop to optimize approaches to best collect information from the private sector A two-day private sector workshop with 30 attendees will be held to discuss best practices for collecting data from the private sector and incorporating it into public sector reporting. Best practices will be incorporated into the private sector provider training as described in section 4d. Activity 4.2.2: Print extra reporting forms and registers for the private sector. Under the RCC, all forms were provided for public sector facilities; however, given the up scaling of private sector involvement under the AMFm they will form a crucial part of overall M&E and they will need to be provided with requisite reporting forms. These will be collected during the supervisory/M&E visits proposed in section 4d. Four reporting forms will be printed per facility per month and one register per facility per year will be distributed to providers during training to be conducted (section 4d). Activity 4.2.3: Conduct quarterly district review meetings to improve data collection and collation. Provide resources to include private health service providers in the quarterly district review meetings to improve data collection and collation. A quarterly district review meeting will be held with participants from both the public and private health service sectors to collate data and discuss data collection practices. These two-day review meetings will initially be piloted in 30 districts (10 in the northern regions, 10 in the central regions, and 10 in the south). Activity 4.2.4: Assessment of CDD acceptance in the community. An external resource institute will be contracted to perform a yearly assessment of CDD acceptance into the community per district. Activity 4.2.5: Monitor radio and TV adverts. In order to monitor the outputs of TV and radio adverts, Ghana will subscribe to an independent monitoring agency that will ensure that the adverts were aired at the planned times and frequency. Subscription is a percentage of airtime cost. To assess the potential impact of the targeted time slots, Ghana will subscribe to a monthly household survey that monitors weekly radio and television viewership within the southern Ghana axis per timeslot by demographic. Activity 4.2.6: Conduct a survey on public Knowledge, Attitudes, and Practices on co-paid ACTs to inform ongoing communications activities. A KAP survey will be conducted to gather public perception on ACTs. The survey will measure the impact of launched IEC/BCC campaigns and inform design and implementation of further campaigns. One survey will be conducted at the end of Year 1 and again at the end of Year 2 to inform potential Phase 2 implementation. Activity 4.2.7: Quarterly review meetings for private sector implementers of training and supervision, and NGOs. Twenty participants from each of the potential implementers (private sector and NGO) will meet quarterly to discuss the ongoing implementation of supporting interventions for the AMFm (training and supervision). (5c) Describe the in-country data quality assurance systems (including tools) that will be used and/or strengthened to provide regular and quality data to monitor AMFm activities and achievements [1/2 page maximum] Public Sector The data quality assurance system in Ghana has major gaps. Primary data is collected at the community levels and in health facilities on a daily basis. Most of the data is manually recorded and then collated, but at the primary level, there is lack of human resource capacity to review the data. Private Sector / NGO Sector The private sector is assumed to have a good system of data quality assurance, but this has not been well evaluated. ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 38 of 57 5. Monitoring AMFm Phase 1 There is an informal system that provides some information, but there is a serious need in Ghana to formalize this process. Many of the constraints of data quality assurance are due to lack of capacity and resources. Except for the larger international NGOs, the majority of organizations do not have any system of data quality checks. One section. Strengthening Data Quality Assurance Primary data collection at hospitals, health facilities and clinics will be captured electronically. This will involve strengthening existing NHIS software and integrating with the enhanced DHIMS (provided in Global Fund Round 9 HSS application). This will reduce data errors and improve quality. Regional and national capacity to conduct data quality audits will be strengthened through training. Quarterly data quality audits will be conducted at the regional level and selected health facilities across the regions. Results of the DQA will be discussed through a feedback mechanism with follow-up visits to ensure that recommendations are being implemented. Service Delivery Area 4.2: Other - Monitoring and Evaluation Activity 4.2.8: Print revised Standard Operating Procedure for systematic data verification. The updated SOP will be printed and distributed across public and private health facilities. Activity 4.2.9: Conduct refresher trainings for district and regional level hospital managers and information officers on data audit tools (including SOP) and to improve data management skills. Training will be conducted targeting to 330 health information officers (170 district health information officers, 140 district hospital managers, and 10 regional health information officers and 10 regional hospital managers). Activity 4.2.10: Conduct data quality audits at the facility level. Regional level managers will verify data at the regional level. Each region has 1-2 officers who will visit about 3 facilities each quarter. District level managers will also conduct data quality audits at district facilities. Data quality visits will occur 10 days per quarter in each region, and 5 days every 6 months in each district. Data quality audits will be used to ensure that reporting forms in both the public and private sector are being completed correctly. (5d) Provide a summary budget for activities to monitoring AMFm Phase 1 in your country. This should also include any funds requested to strengthen the existing monitoring system. For detailed budget please see Attachment D – Detailed Budget Summary M&E budget Strengthening the M&E system 4.2.1 Workshop to optimise data collection from the private sector 4.2.2 Print extra data collection forms for the private sector 4.2.3 Conduct quarterly district review meetings to improve data collection 4.2.4 Assessment of CDDs performance and acceptance by community 4.2.5 Contacting agencies to monitor TV and Radio campaigns 4.2.6 Undertake a KAP survey Strengthening Data Quality Assurance 4.2.7 Quarterly review meetings for private sector and NGO 4.2.8 Revise SOPs on data verification 4.2.9 Conduct refresher training on SOPs 4.2.10 Conduct district level data quality audits 4.2.11 Hire a consultant to assist in M&E strengthening Overhead at 5% Year 1 $14,950 Year 2 $0 Total $14,950 $143,425 $216,000 $2,500 $56,281 $33,411 $5,909 $222,480 $6,695 $56,281 $34,414 $149,334 $438,480 $9,195 $112,561 $67,825 $76,800 $4,500 $33,274 $202,300 $16,000 $79,104 $0 $0 $208,369 $0 $155,904 $4,500 $33,274 $410,669 $16,000 $39,972 $30,663 $70,635 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 39 of 57 5. Monitoring AMFm Phase 1 Total $839,413 (5e) Include as an attachment a draft revised version of the Performance Framework of the ‘host’ malaria grant. If available, attach the updated monitoring and evaluation plan for the AMFm ‘host’ grant14. $643,914 $1,483,327 See Attachment E – Performance Framework 14 Upon grant amendment, countries will be encouraged to share a complete description of the ‘AMFm Monitoring Plan’ as an addendum to the Monitoring and Evaluation plan of the AMFm ‘host’ grant. The AMFm Monitoring Plan will be required to enable disbursements for AMFm supporting interventions. ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 40 of 57 6. Operational research Operational research This refers to studies whose findings will be applicable to the local context, to enable “learning by doing” and to alleviate constraints on implementation. The emphasis is on relevance and application of knowledge in a particular context. Countries will identify and either perform or commission operational research for their own use during AMFm Phase 1. The operational research questions should be directly relevant to the objectives of the AMFm and the real-life barriers to the achievement of those objectives. Suggested areas for investigation are provided in the Guidelines to the AMFm Phase 1 Application Form. In addition to this country-specific operational research, multi-country operational research will examine cross-cutting questions across sub-sets of Phase 1 countries. The design and conduct of multi-country operational research will be contracted by the Global Fund to qualified research and academic institutions. The cost of multi-country operational research will be funded directly by the Global Fund. Applicants are not asked to respond to sections regarding multi-country operational research in this application form. (6a) Operational research planned during AMFm Phase 1 Complete the table below for each proposed operational research topic to be addressed during AMFm Phase 1. Copy and paste the rows below to complete the table for each proposed operational research topic. [1 page maximum per research topic] Title Assess the feasibility of expanding use of RDTs within the private sector Commencement: Second Quarter (May) of 2010 Duration: Duration Design and methods • Baseline and design: 5 months, May – September 2010 • Implementation: One year, October 2010 – October 2011 • Analysis and policy recommendation: 2 months, November – December 2011 The current national malaria treatment guidelines require the confirmation of suspected malaria in patients over the age of 5 years. The confirmation can either be done by microscopy of RDTs. With the support of the Round 8 grant, Ghana is scaling-up the availability and use of RDTs at public health facilities over the coming five years. In addition, the RCC will support operational research to examine the feasibility of introducing RDTs through CDDs as part of the HBC model. However, there is currently little or no strategy for promoting diagnosis in private pharmacies and LCS, despite the fact that the majority of patients seek malaria treatment from these outlets. As such, many people without malaria are receiving anti-malarials from private shops and which will lead to significant overuse of subsidized ACTs once the AMFm is active in the country. To address this challenge, Ghana will examine the feasibility of introducing RDTs into the private retail sector. The study will center on the introduction of RDTs at subsidized prices (to ensure they are less expensive than subsidized ACTs) to 60 shops in 10 targeted districts. Districts will be selected to include representation from the 3 malaria zones within Ghana and a mix of urban, peri-urban, and rural areas ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 41 of 57 6. Operational research and will be randomized to either receive the intervention or serve as a control. In addition to distribution of subsidized RDTs, key interventions will include: • • • Training pharmacists and LCSs on proper RDT use and storage; Regular supportive supervision of pharmacists and LCSs to observe and provide feedback on diagnosis practices; and Targeted BCC/IEC activities to generate consumer demand for RDTs. Exit interviews of patients emerging from LCS shops and pharmacies and retail audits of shops/pharmacies will be conducted at baseline and three times during implementation. The core outcome will be the proportion of febrile patients at LCSs and pharmacies who are confirmed with RDT tests. Other key metrics that will be measured will include: • Recommendation of RDT usage by LCSs and pharmacists; • Quality of RDT administration by shops and rate of false negatives/positives; • The retail price of RDTs and its impact on ACT purchasing; • Storage conditions of RDTs and disposal of sharps by shops/pharmacies; • The treatment or referral of consumer following a negative or positive result Lead research organization Health Research Unit of Ghana Health Service Translation of results into improved performance The results of this study will provide the NMCP and its partner organizations with essential evidence on whether introducing RDTs into private shops is an effective way of reducing overuse of ACTs and improving case management in these outlets. Depending on the results, Ghana may consider scaling-up this approach during Phase 2 of the AMFm to improve case management in the country. Complete the table below for each proposed operational research topic to be addressed during AMFm Phase 1. Copy and paste the rows below to complete the table for each proposed operational research topic. [1 page maximum per research topic] Title Assessing the feasibility of expanding health insurance to private drug shops to increase access to ACTs and other essential medicines Commencement: Q2 (May) 2010 Duration: Duration • Baseline and design: 3 months, May – July 2010 • Implementation: 18 months, July 2010 – December 2011 Analysis and policy recommendation: 2 months, December 2011 – January 2012 Design and methods One of Ghana’s principle strategies to increasing access to effective malaria treatment and other health services among poor and vulnerable people is the National Health Insurance Scheme. Public and private facilities accredited by the NHIS are able to provide services to target populations for free at the point of service delivery and then get reimbursed. Currently, however, only 337 of 10,000 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 42 of 57 6. Operational research LCSs are currently accredited by the NHIS despite the fact that they are a common source of anti-malarial treatment in remote areas. A study will thus be conducted with the aim of answering the key question: “will the expansion of the NHIS to LCSs result in a sustainable increase in the number of poor people obtaining ACT treatment at these shops?” Key issues that will be explored in the study will include ensuring that LCSs meet the standards to be accredited for the NHIS, the timeliness of submission and reimbursement, changes in patient behavior in response to NHIS availability, and compliance of LCSs with NHIS policies and guidelines. The project will be implemented in 15 districts within Ghana selected based on factors including malaria endemicity, socioeconomic status, and population density. A sample of comparable districts will be selected and then randomized to receive the intervention or serve as a control. The package of interventions that will be implemented in the target districts will include: • Facilitating the accreditation of more LCSs by NHIS in a timely manner; • Training of LCS owners and dispensers on NHIS policies and procedures; • Supportive supervision of LCSs by NHIS and implementing partner on ongoing compliance with policies and procedures; • Conducting IEC/BCC in the catchment area of target LCSs to inform the population about availability of NHIS reimbursement at the shops. The core outcomes that will be examined through the study will include: 1. Number of people obtaining ACT treatment from LCSs; 2. Socioeconomic status of people obtaining ACT treatment from LCSs; 3. Number of people seeking prompt treatment for malaria in the public or private sectors; Other key indicators that will be captured will include the reimbursement time and corresponding financial liquidity of LCSs using the NHIS, the price paid for ACTs by people using the NHIS, the type of treatment obtained by consumers using NHIS at LCSs, and a number of qualitative factors, including shopkeepers and consumers perceptions of the NHIS operation within LCSs. Exit interviews of consumers emerging from LCSs, household surveys, and in-depth interviews of shop owners will be the primary data collection methods. Data collection will occur once at baseline, once during implementation and once at the end of the project. As a key concern about the approach is that slow reimbursement not be viable for small shops with limited working capital, the final analysis will examine financial factors as well as health outcomes. Lead research organization To be competitively selected, but possible implementers include University of Ghana Medical School (UGMS), School of Public Health, University of Ghana Translation of results into improved performance The final analysis will be discussed by the NHIS, NMCP, and other key stakeholders within the Ministry of Health and private sector to determine the interpretation and implications of the outcomes. The results of this project will enable the Ministry of Health to determine whether investing in expansion of NHIS to LCS is an effective way of increasing access to effective malaria treatment in poorer, remote areas. If the project suggests this is a cost-effective intervention, the Ministry could scale-up the approach to other regions during the second phase of the AMFm or through the ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 43 of 57 6. Operational research support of other donors and partners. Complete the table below for each proposed operational research topic to be addressed during AMFm Phase 1. Copy and paste the rows below to complete the table for each proposed operational research topic. [1 page maximum per research topic] Title Assess the feasibility of using wholesaler financial incentives to increase coverage of ACT stocking by retailers within rural areas Commencement: Second Quarter (May) of 2010 Duration: Duration • Baseline and design: 3 months (March-May 2010) • Implementation: 18 months (June 2010 – Dec 2011) • Analysis and policy recommendation: 2 months, December 2011 – Jan 2012) 15 In 2006, Ghana had an urbanization rate of 49% meaning that the majority of the population resides within rural areas. Whilst LCSs are relatively well represented within rural regions, there is often insufficient incentive for wholesalers to travel to the more rurally located LCSs as a result of the higher cost of delivery and smaller market size potential. As such, many patients in the rural regions, for whom LCSs are the primary source of treatment seeking, may not gain access to ACTs. Whilst the AMFm and associated interventions such as provider training (section 4d) and IEC campaigns (section 4b) will increase both the accessibility and demand for copaid ACTs, the reduced price of ACTs also reduces the absolute profit per dose earned by a wholesaler travelling to a costly remote region. Design and methods To address this challenge, Ghana will examine the feasibility of using a wholesaler financial incentive to sustainably increase the coverage of LCSs and other private facilities that are stocking co-paid ACTs which will thus result in more equitable patient treatment. Two rural and remote districts each will be selected from the middle and northern zones as they are furthest away from the capital, making supply of drugs to these areas more difficult. A baseline survey will be conducted to determine the current reach of ACTs in the private sector distribution system. An appropriate financial incentive will be paid to wholesalers in the selected districts based upon the number of private sector outlets in the selected districts that he/she supplies regularly. After six months of the intervention, a survey will be repeated to access the reach of ACTs in the private sector distribution system. The level of wholesaler incentive will be calculated based on a detailed analysis of the costs of delivery to the targeted areas and will aim to provide businesses with sufficient financial interest to change their behavior without wasting funding. Other outcomes that will be assessed include the following: 15 Dalberg, MIT Zaragoza – “Private sector role in health supply chains”, 2008 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 44 of 57 6. Operational research • Stocking and use of alternative monotherapies • Price paid for ACTs • Proportion of febrile illnesses treated with ACTs at these outlets Lead research organization To be competitively selected Translation of results into improved performance The results of this study will help inform policy makers of a potential solution to ensuring consistent supply of ACTs to private outlets regardless of geographical distance. This will help increase treatment to the many patients living within Ghana’s rural communities and could be scaled up during the second phase of the AMFm if the results indicate it would be appropriate. (6b) Financing for operational research Provide a summary budget for operational research over the period of AMFm Phase 1. This summary must also be included within the detailed budget requested in Section 8e of this application form. For detailed budget please see Attachment D – Detailed Budget OR Summaries Project 1 Management and Performance Indicators Procurement of RDTs Training IEC/BCC Campaign Data collection Supervision Administration and coordination Total for Project 1 Year 1 Year 2 Total $37,900 $97,200 $56,832 $48,970 $51,800 $15,000 $30,770 $338,472 $35,020 $0 $0 $0 $53,354 $15,450 $10,382 $114,206 $72,920 $97,200 $56,832 $48,970 $105,154 $30,450 $41,153 $452,679 Project 2 Coordination Incentives Mystery Shoppers Surveyors Administration and coordination Total for Project 2 $42,100 $15,000 $40,500 $16,520 $19,221 $133,341 $40,582 $30,900 $41,715 $17,016 $21,932 $152,144 $82,682 $45,900 $82,215 $33,536 $41,153 $285,485 Project 3 Coordination Training IEC / BCC Campaign Supervision Surveys Administration and coordination Total for Project 3 $40,700 $85,248 $34,085 $16,200 $22,400 $29,663 $228,296 $22,454 $0 $0 $8,343 $46,144 $11,490 $88,431 $63,154 $85,248 $34,085 $24,543 $68,544 $41,153 $316,727 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 45 of 57 6. Operational research GRANT TOTAL $700,109 $354,781 $1,054,890 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 46 of 57 7. Estimated savings in existing grants Where the AMFm ‘host’ grant and/or other existing Global Fund malaria grants contain an ACT procurement component, it is expected that substantial savings will be generated from the AMFm AMFm_P1_CCM_GHN_M_PF_10Jul09_Enco-payment on the cost of ACTs. Applicants may reallocate these savings to fund AMFm supporting interventions. The Global Fund encourages countries to return any savings remaining after supporting interventions have been funded (‘excess’ savings) to the Global Fund. Alternatively, an implementing country may choose to spend these savings on malaria control activities. In this case, the Global Fund requires that savings must be reallocated in the grant budget according to the following order of priorities: 1. To fund additional ACT procurement through the public sector to expand access, with a focus on the poor and children 2. To fund ACT-related activities to strengthen the health system (HSS) Applicants are able to propose reallocating savings towards these priorities in the budget table in Section 8a and in Sections 9a and 9b. Savings from ACT budgets cannot be used for any other purpose and ‘excess’ savings must be returned to the Global Fund. Clarified Section 7a: (7a) Estimated savings gained in existing malaria grants through lower cost of ACTs Complete the table below to estimate the savings that will be gained in your country’s existing Global Fund malaria grants, through purchasing ACTs at the lower, AMFm price. Refer to the Guidelines for AMFm Phase 1 Applications for further guidance on completing this table. [Add additional columns as necessary to complete for all relevant malaria grants. Grant 1 [ RCC] [Use the columns below for different ACT weight dosages, as appropriate] Artesunate amodiaquine LINE A Number ACT treatme nts to be procure d in grant during AMFm Arthemether lumefantrine 25mg+ 67.5mg 50mg+135 mg 20mg+1 20mg 100mg+27 0mg 20mg+ 120mg 40mg+2 40mg 60mg+3 60mg 40mg+4 80mg 829,861 7,468,752 2,368,94 5 15,570,639 35,164 306,204 71,068 467,119 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 47 of 57 7. Estimated savings in existing grants Phase 1 LINE B 0.52 0.52 0.80 1.20 0.53 1.06 1.59 2.12 Current budgete d unit cost of ACT treatme nt LINE C [“LINE A” MULTIPL IED BY “LINE B”] Estimat ed total cost of planned ACT procure ment at original budgete d cost LINE D 431528 0.05 3883751 0.05 1895156 0.05 18684767 0.05 18637 0.05 324576 0.05 112998 0.05 990292 0.05 Estimat ed unit cost of ACT treatme nt to Principa l Recipie nt under AMFm Phase 1 LINE E [“LINE A” MULTIPL IED BY “LINE D”] Estimat ed total cost of planned ACT 41493 373438 118447 778532 1758 15310 3553 23356 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 48 of 57 7. Estimated savings in existing grants procure ment at estimat ed AMFm Phase 1 cost LINE F [“LINE C” LESS “LINE E”] Estimat ed savings gained in existing grants LINE G TOTAL ESTIMA TED SAVING S 390035 3510314 24,985,81 9 1776709 17906235 16878 309266 109445 966937 Grant 2 - Round 8 [Use the columns below for different ACT weight dosages, as appropriate] 25mg+67.5mg 50mg+135mg 161,821 1,438,411 0.15 0.30 24,273 431,523 0.05 0.05 8,091 71,921 LINE A Number ACT treatments to be procured in grant during AMFm Phase 1 LINE B Current budgeted unit cost of ACT treatment LINE C [“LINE A” MULTIPLIED BY “LINE B”] Estimated total cost of planned ACT procurement at original budgeted cost LINE D Estimated unit cost of ACT treatment to Principal Recipient under AMFm Phase 1 LINE E [“LINE A” MULTIPLIED BY “LINE D”] Estimated total cost of planned ACT procurement at estimated AMFm Phase 1 cost ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 49 of 57 7. Estimated savings in existing grants LINE F [“LINE C” LESS “LINE E”] Estimated savings gained in existing grants 16,182 359,603 LINE G TOTAL ESTIMATED SAVINGS $375,785 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 50 of 57 8. Budget for Supporting Interventions and Funding Request Clarified Table 8a: (8a) Summary of Funding Request to the Global Fund Note: The estimated savings identified in Line B are based on the estimated cost to the country of AMFm co-paid ACTs. The Applicant understands that the net additional funding request is therefore subject to adjustment based on the actual price of AMFm co-paid ACTs, which will be set prior to the Global Fund Board’s decision on the Applicant’s funding request. (Use the same currency as indicated at the start of this application form) Budget item (where applicable) Year 1 Year 2 Total Note: If preferred, adjust the above year headings from AMFm funding years to financial years to align with “host” grant cycles, national planning and fiscal periods. Funding may be requested for 24 months. LINE A: Total budget for new and expanded AMFm supporting interventions [MUST equal annual amounts and totals provided in the detailed budget (Section 8e) and in sections 8b and 8c] $14,385,781 $7,693,772 $22,079,554 $13,047,844 $12,315,109 $25,361,604 -$4,621,337 -$3,282,050 LINE B: Total estimated funds from reallocating savings from existing Global Fund malaria grants [as estimated in Section 7] LINE C: Total funds from other sources [Must equal total funds from other sources listed in section 8d] LINE D: [LINE A, LESS LINE B, LESS LINE C] Net Additional Funding Request to the Global Fund [Where amount is NEGATIVE, applicants may propose additional ACT procurement and additional HSS activities relevant to ACT scale-up. These proposals should be detailed in Section 9] $1,337,937 ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 51 of 57 8. Budget for Supporting Interventions and Funding Request Clarified Table 8b: (8b) Summary of detailed budget for AMFm supporting interventions by objective and service delivery area Objective Number (Use same numbering as in revised Performance Framework for ‘host’ grant) (Use the same currency as indicated at the start of this application form) Year 1 Note: If preferred, adjust the above year headings from AMFm funding years to financial years to align with “host” grant cycles, national planning and fiscal periods. Funding may be requested for 24 months. SDA 1.1: Public education and awareness 1 SDA 1.2: Treatment: Prompt, effective antimalarial treatment 1 1 Total Service delivery area 1 1 Year 2 SDA 1.3: National Policy and Regulatory Preparedness SDA 1.4: Community Systems Strengthening for home-based care (HBC) SDA 1.5: Program Management and Administration 4 SDA 4.1: Monitoring anti-malarial drug efficacy 4 SDA 4.2: Other – Monitoring and Evaluation $4,482,170 $2,817,998 $7,300,168 $6,468,072 $2,092,486 $8,560,558 $308,285 $203,228 $511,513 $649,730 $1,199,582 $1,849,312 $176,237 $232,471 $408,708 $761,765 $149,311 $911,077 $1,539,522 $998,696 $2,538,218 $14,385,781 $7,693,772 $22,079,554 [use "Add Extra Row Below" from "Table" menu in Microsoft Word menu bar to add as many additional rows as required] Total budget for new and expanded AMFm supporting interventions [MUST equal annual amounts and totals provided in the detailed budget] ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 52 of 57 8. Budget for Supporting Interventions and Funding Request Clarified Table 8c: (8c) Summary of detailed budget for AMFm supporting interventions by cost category (Use the same currency as indicated at the start of this application form) Cost category Avoid using the "other" category unless necessary. Human resources Year 1 Year 2 Total Note: If preferred, adjust the above year headings from AMFm funding years to financial years to align with “host” grant cycles, national planning and fiscal periods. Funding may be requested for 24 months. $548,637 $433,185 $981,822 $12,000 $0 $12,000 $4,943,667 $95,419 $5,039,086 $80,000 $20,600 $100,600 Pharmaceutical products (medicines) $0 $0 $0 Procurement and supply management costs (PSM) $0 $0 $0 Infrastructure and other equipment $1,680,665 $915,754 $2,596,419 Communication Materials $4,084,700 $2,578,296 $6,662,996 Monitoring & Evaluation (including operational research) $1,820,430 $2,730,995 $4,551,425 $0 $0 $0 Planning and administration $600,190 $372,161 $972,351 Overheads $615,493 $547,362 $1,162,855 $0 $0 $0 $14,385,781 $7,693,772 $22,079,554 Technical and Management Assistance Training Health products and equipment (NOT pharmaceuticals) Living support to clients/ target populations Other: (Use to meet national budget planning categories, if required) Total budget for new and expanded AMFm supporting interventions [MUST equal annual amounts and totals provided in the detailed budget] ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 53 of 57 8. Budget for Supporting Interventions and Funding Request (8d) Funding from other sources If applicable, detail any funding for new or expanded supporting interventions that will be provided from sources other than the Global Fund (including domestic resources or other donor funds). List the specific interventions, the source of funding and the amount of funding that will be provided in the table below. [Add extra rows to the table below as required] Intervention Funding source Year 1 Year 2 Total Total funding from other sources [Must equal total funds from other sources listed in Line C, Section 8a] (8e) Detailed budget for AMFm supporting interventions Submit a detailed budget for new and/or expanded AMFm Phase 1 supporting interventions in Microsoft Excel format (only) as a clearly numbered annex. The detailed budget should account for all new and/or expanded supporting interventions for AMFm Phase 1. The detailed budget should also include a summary budget for monitoring AMFm Phase 1 and operational research (as provided in Sections 5d and 6b). It should not include funding for additional ACT procurement nor additional health system strengthening activities. These activities may only be funded when savings gained in existing Global Fund malaria grants exceed funding required for AMFm supporting interventions. These proposals should be detailed in Section 9 of the application form. See Attachment D – Detailed Budget Applicants may use their own budget tools to provide this detailed budget, or, if preferred, may use the detailed budget template found at Attachment D. ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 54 of 57 9. Use of savings in existing Global Fund grants (9a) Additional ACT procurement through savings gained from lower AMFm cost of ACTs As explained in Section 7, applicants may propose to use ‘excess’ savings gained from ACT budgets in existing Global Fund malaria grants to purchase additional ACTs for the public sector, if there are savings remaining after supporting interventions for AMFm have been budgeted. The total cost of additional ACT procurement must be less than or equal to these remaining savings. Yes i. Do you propose to reallocate savings to fund additional ACT procurement in your existing Global Fund malaria grant(s)? Complete Sections 9aii and 9aiii No ii. Provide a rationale for this additional procurement, demonstrating the need for additional ACTs and identify the target population. [2 pages maximum] In 2008, 18.3% of all deaths were attributable to malaria amongst all ages, whilst among deaths in children under five years malaria accounted for 30.3% of deaths. One of the primary objectives stated in Ghana’s National Malaria Strategy (2008-2015) is to reduce the proportion of hospital admissions and deaths due to severe malaria. As such, it will be crucial to provide CDDs with the appropriate treatment of severe malaria at the community level, particularly to children under 5 years of age. As additional districts are being served under home-based care, artesunate suppositories will be procured for each additional CDD to provide pre-referral treatment for severe malaria cases. Where a child does not respond to treatment in 24 hours, the CDDs will be instructed to promptly refer the client to the nearest health facility. Where a child shows signs of severe or complicated malaria, the CDD will administer rectal artesunate prior to referral. Additionally, ACTs will be procured for each CDD to provide appropriate treatment to febrile patients with uncomplicated malaria. ACTs for CDDs in the additional 26 districts under the AMFm will need to be procured for the treatment of children under 5 years. The procurement and distribution of Artesunate-Amodiaquine and artesunate suppositories under the AMFm will follow standard MOH procurement procedures: from the national levels, to districts, regions, to CHPS compounds and finally to the trained CDDs who will be given two weeks to one month supply by CHOs or subdistrict staff depending on their location. The cost of distributing the additional medicines to the community level will be 5% of the total drug cost. iii. Complete Table B1 in Attachment B of this application form to provide details of the proposed increased ACT procurement. Clarified Section 9b (9b) Additional health system strengthening (HSS) activities Applicants may propose to use ‘excess’ savings gained in existing Global Fund malaria grants to fund additional health system strengthening activities relevant to ACT scale-up, if there are savings remaining after supporting interventions and any additional ACT procurement have been budgeted. The total cost of additional health system strengthening activities must be less than or equal to these remaining savings. ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 55 of 57 9. Use of savings in existing Global Fund grants Yes i. Do you propose to reallocate savings to fund additional health system strengthening activities relevant to ACT scale-up? Complete Sections 9bii and 9biii No ii. Summarize your proposal to introduce additional health system strengthening activities relevant to ACT scale-up. Refer to the Guidelines for AMFm Phase 1 Applications for guidance on activities that will be supported. [2 pages maximum] The AMFm seeks to promote both the affordability and accessibility of safe and efficacious co-paid ACTs. The AMFm proposal has detailed supporting interventions to increase the uptake of ACTs through IEC/BCC campaigns (section 4b), provider training at the facility level (section 4d) and at the community level (section 4l). However, the core of any effort ACT scale-up effort is to ensure that the drugs are regularly available and stored properly in health facilities. Section 3c discusses the critical role the Central Medical Stores and Regional Medical Stores play in distributing ACTs and other medicines through the public sector. However, the CMS and RMSs are underfunded which has resulted in inappropriate storage conditions and lack of transport for ACTs and other essential medicines. As a result, many ACTs and other medicines do not reach facilities and patients in a timely manner and those that do are at significant risk of deteriorating in quality prior to use. It is imperative that this challenge be resolved for the AMFm to be successful and Ghana to achieve its national malaria treatment goals. Following a comprehensive assessment of the steps needed to address the challenges at the CMS and RMSs, this proposal seeks to improve both storage conditions and supply chain efficiencies that will support the appropriate and timely storage and distribution of co-paid ACTs and other essential medicines to improve malaria case management. Activity 1: Procure trucks and articulated lorries for the CMS in order to improve distribution to the RMS and tertiary facilities. The CMS, located in the greater Accra region, is furthest away from the three northern most regions of Ghana. As such, scheduled deliveries are made to RMSs located in the north. The existing vehicles used to make deliveries are out of date, break down often and incur large and excessive maintenance costs. Two 7-tonne trucks and one articulated truck will be procured to facilitate delivery of essential medicines, including ACTs, to the northern most remote regions of the country. Activity 2: Purchase of climate control equipment (air-conditioners, ventilation units back-up generator) to provide consistent appropriate storage conditions for ACTs and other essential drugs. The CMS is currently served by a central air conditioning unit. However, it suffers from frequent power outages owing to its lack of compatibility with the CMS power supply. This could lead to deterioration in the efficacy of the drugs stored at the CMS. An overhaul of the CMS’s power transformer would be cost prohibitive and thus Ghana will procure a series of smaller air conditioning units to be positioned around the CMS to be served by a back-up generator. Activity 3: Improve storage conditions in six regional medical stores. To improve storage conditions of ACTs and essential medicines in six regional medical stores, a number of tools and technical equipment will be purchased. Each structure will undergo general structural refurbishment and expansion to increase storage capacity. Step ladders, pallets, hand-operated pallet lifts and picking trolleys will be purchased in order to improve overall operations within the RMSs and maximize use of storage space in the facilities. In addition, air conditioners will be purchased and mounted to improve cooling conditions and storage of ACTs and other essential medicines. Activity 4: Increase the effectiveness of drug distribution through the procurement of logistics vehicles: To date, route mapping has been done to clearly define the routes for the monthly distribution to service delivery points. What has remained a logistical challenge is the unavailability of appropriate vehicles for the distribution of commodities. To progress the improvement of the delivery of ACTs from RMS to SDPs, seven 3.5 tonne trucks ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 56 of 57 9. Use of savings in existing Global Fund grants will be procured, one for each of the RMSs not doing scheduled deliveries (see section 3c). In addition, two station wagons will be purchased to support monitoring and supervisory visits. Activity 5: Procure air condition storage containers. Currently the RMSs are constrained by storage capacity for ACTs and other essential drugs. A 40ft air conditioned storage container will be purchased to support each of 4 regional medical stores where their expansion is cost prohibitive or not possible due to lack of space. iii. Provide a summary budget for the proposed additional health system strengthening activities relevant to ACT scale-up. For detailed budget please see Attachment F – HSS Budget Summary HSS Budget Strengthening Logistics at the CMS Improving storage conditions at the CMS Improve storage conditions at 6 RMS Procure vehicles to assist in scheduling delivery system Extra storage Overhead Year 1 $390,000 $103,828 $1,859,880 $325,000 $20,000 $133,935 Year 2 $0 $0 $0 $0 $0 $0 $390,000 $103,828 $1,859,880 $325,000 $20,000 $133,935 Total $2,832,643 $0 $2,832,643 Total ___________________________________________________________________________________________________ AMFm_P1_CCM_GHN_M_PF_31Jul09_En Page 57 of 57