1. Name of the Project: 2. Location: 3. Authority responsible for: Sponsoring Execution Operation and maintenance Concerned Federal Ministry / Provincial Department 4. a) Plan Provision PLANNING COMISSION PC –1 PERFORMA Chief Minister’s Initiative for Hepatitis Free Sindh Entire Sindh Province Health Department Government of Sindh Health Department Government of Sindh Program Implementation Unit Health Department Government of Sindh Department of Health Government of Sindh / Ministry of Health Government of Pakistan Included in Health Sector Medium Term Plan 200 Million earmarked in the ADP for 2008-09 Indicators for the improvement in the health are based on reduction of mortality and morbidity due to preventable diseases. Pakistan is a country under epidemiological transition where almost 40% of the burden of disease is accounted for by the infectious / communicable diseases. Following 03 areas of National Health Policy 2001 are related to the proposed objectives of the project. 5. Project Objectives and relationship with the sectoral objectives: 1 Key area number 1 warrants the control of widespread communicable diseases. 2 Key area number 06; removal of managerial and professional deficiencies in the district health system 3 Key area number 09; creation of mass awareness in matters of public health Provincial Health Policy 2005 identifies that Viral Hepatitis prevalence in Sindh is higher than the reported world average. It aims at reducing the virus transmission by encouraging safe blood transfusion, safe invasive procedures at health care settings and discouraging unsafe injection delivery, tattooing, IV drug abuse & unethical practices of quacks. Following key areas have direct relationship to the program Page | 1 1 Key area number 1.5 asking for interrupting the virus transmission of Hepatitis B and C 2 Key area number 10 stressing upon training of paramedical staff 3 Key area number 11 identifying need for a comprehensive epidemic response 4 Key area number 18; warranting fresh health legislation. Medium Term Development Framework envisages safe blood transfusion and establishment of screening centers at District Headquarter Hospital. In recent years Viral Hepatitis has emerged as a leading cause of mortality and morbidity. Ministry of Health estimates the number of chronic carriers of Hepatitis B up to 06 million and that of Hepatitis C up to 7.5 million carriers in Pakistan. As a public health response Ministry of Health Government of Pakistan launched a federal funded scheme in August 2005 under the name of “Prime Minister’s Program for Prevention and Control of Hepatitis”. Total cost of program is 2.56 billion rupees for five years 2005-2010, and the covenant elements of the program are as follows: 1) Hepatitis B vaccination for high risk groups 2) Safety of blood and blood products against hepatitis 3) Safe Injection delivery, invasive medical devises and proper hospital waste management. 4) Establishment of water purification plants. 5) BCC strategy implemented through media and interpersonal communication channel. 6) Capacities building of health care providers for the prevention and control of hepatitis. 7) a) Surveillance and diagnostic lab services for Hepatitis and Epidemic response b) Operational research including monitoring & evaluation c) Counseling and treatment interventions at teaching and district headquarter hospitals d) Program management However due to the enormity of the task, rising trends of the disease and demand supply mismatch, a fresh initiative on part of the Health Department Government of Sindh is needed. Page | 2 Adopting a pro-poor approach the “Chief Minister’s Initiative for Hepatitis Free Sindh” will work within a framework of following five broad strategic areas. 1. 2. 3. 4. 5. 6. Description and Justification of the Project: Preventing the acute infections Addressing the chronic infections Raising the public awareness Changing the policy environment Health System Strengthening For details see annexure 1(Framework of Action for CM Initiative). A: BACKGROUND OF THE DISEASE 1.VIRAL HEPATITIS: Viral Hepatitis is inflammation of the liver caused by 05 distinct types of viruses. Hepatitis A: It accounts for 50-60% of the acute viral hepatitis and is completely self-limiting disease. In most areas of the developing world 97% of the population has had one episode of Hepatitis A. Prevention is done through safe drinking water, hygienic food and promotion of environmental sanitation and personal hygiene. Hepatitis B: Hepatitis B is transmitted through contaminated blood and blood products, body fluids and through sexual contact. Infected mothers also transmit the virus to their newborn babies during birth. The disease becomes chronic in younger age group and spontaneously clears if contracted by an adult. The graph shows relationship of chronicity with age. Page | 3 Hepatitis C: It is also a blood borne virus spread through infected blood and blood products. Unsafe use of medical devises (injections) is major cause of its spread. 85% of the people who are infected become chronic carriers. Hepatitis D or (Delta ): see below Hepatitis E: The mode of transmission is same as Hepatitis A. The disease is endemic in Pakistan. Mortality is increased in pregnant women only. In other population subgroups it is selflimiting leaving lifelong immunity. 2: EXTENT OF PROBLEM: Viral Hepatitis has emerged as a serious public health threat in recent years. There is a dearth of community-based data on the prevalence of Hepatitis. On the basis of more than 200 research studies Federal Ministry of Health has made mathematical estimates of presence 6 million patients of Hepatitis B and 7.5 million patients of Hepatitis C in Pakistan. Extrapolation of these figures gives us a staggering number of 1.5 million chronic carriers of Hepatitis B and 1.8 million chronic carriers of Hepatitis C in Sindh. Empirical evidence suggests that Sindh may have disease burden more than the current estimates. Reason being the deepened poverty, statutory ambiguity in certain laws, health practices of public & professionals and lack of universal access to health care. It is pertinent to note here that Pakistan Medical and Research Council is in process of conducting a National Prevalence Survey of Viral Hepatitis. The results of the survey will further fine tune the interventions of Chief Minister’s Initiative for Hepatitis Free Sindh. Till the results are available following direct and indirect evidence is to be considered. 2.1. Indirect Empirical Evidence: Janjua & Hutin (2005) have shown that Sindh has the highest rate of per capita injection delivery i.e. 13 injections per person per year and out of which 47% are unsafe1. National Institute of Population Studies, in a survey conducted in 2003, has shown that unawareness about 1 Janjua, NZ, Hutin Y, International Journal for Quality in Health Care 2005; Volume 17, Number 5: pp. 401–408 Page | 4 the established modes of disease transmission is very high; proportion of females in province knowing about the 03 established modes of hepatitis C transmission is as follows: • • • Used Syringes Used Blades Through Blood 9.84 % 1.09% 4.37% If we match these two separate pieces of information a bleak picture emerges. That is, 90% of the female population in Sindh does not know that Hepatitis is spread by used syringes in a situation where every person is receiving at least 13 injections in a year and 7 times it is un sterile. Direct Evidence: Recently published epidemiologic studies by Mujeeb and Pearce show a steady increase in the prevalence of Hepatitis C in blood donors from the interior Sindh over the period of 2004 – 2007. The overall sero-prevalence was 7.5% and has increased from 7.2% in 2004 to 8.9% in 20072. 2.2. Screening Data of Hepatitis Laboratories3: Screening data being generated from the District Headquarter Hospital show a higher proportion of disease as under: CATEGORY NATIONAL ESTIMATES Hepatitis Hepatitis C B PROVINCIAL DATA Hepatitis Hepatitis C B Health 6% 5.4% 7.29% Workers General 2.6% 5.3% 16.32% Population High Risk 4% 6% 11.6% Groups NB: High Risk Groups include Thallasemics, Prison Pregnant Women 6.16% 27.15% 20.17% Inmates, 2 Mujeeb SA, Pearce MS, Temporal Trends in Hepatitis B & C in family blood donors from interior Sindh, BMC Infectious Diseases 2008, 8:43 3 Sentinel Surveillance data of PM’s Program for Prevention and Control of Hepatitis. Aug. 2006Aug.2007 Page | 5 There is a significant difference among the national estimates and provincial data. A detailed break up of these figures district wise is attached as annexure II. 2.2.1.Epidemic Investigation Reports Various epidemic investigations in general population has identified clusters of high prevalence as under: AREA SAMPLE SIZE Nasarpur, Matiari Kazi Ahmed, N/shah Shah Godryo, Dadu Shahdadkot, Kamber Matli, Badin (LHWs) HEP. B HEP.C 565 70 (12.3%) 209 (37%) 48 (8.4%) 151 62 (41%) 4 (6%) 00 3 (4%) 00 91 694 30 (314%) 100 (14%) 195 14 (7%) Mirpur Mathelo 135 19(14% Tando Haider Hyderabad 197 93 (47%) 118 (17%) 43 (22%) 29 (24%) 67(34%) DUAL INFECTION 00 00 00 00 2.2.2. Hepatitis Delta Delta hepatitis is the uncommon and possibly the most severe form of chronic viral hepatitis of humans. It is caused by an incomplete virus, which needs the presence of Hepatitis B virus for causing disease. Inoculation of HDV in the absence of HBV will not cause disease. Little information is available about epidemiology of HDV in Pakistan. Dr. Huma Qureshi et al describes identification of 531 patients of HDV, 68% belonged to Northern Sindh, followed by 17% from adjoining areas of Balochistan. Dr. Badar Fayaz Zuberi et al identifies 28% prevalence of Hepatitis Delta in Hepatitis B infected patients in Civil Hospital Karachi. Most of them belonged to Larkana4. Saeed Hamid et al (2005) calculated the prevalence of Hepatitis Delta in Pakistan as 16.4%. However the major burden of disease is in 02 districts of Kamber and Larkana. 4 Personal Communication by one of the authors of the said paper published by CPSP in 2006. Page | 6 A large pocket of Hepatitis Delta has been identified at Kamber and the estimated quantum of disease at Kamber is 24000 patients as in August 2007. The underlying assumptions are given as annexure III. It is pertinent to note here that each patient is able to transfer the virus even by co-habitation only. There is no effective treatment and patient rapidly progresses to cirrhosis & liver failure. Mortality due to Hepatitis Delta is 10 times higher than Hepatitis B alone.5 Presently the PM’s Program has adopted a three pronged strategy; to address the presence of Delta in any area i.e. Screening of all the household and close contacts of the patient Vaccination of all the people who are negative of Hepatitis B. Interpersonal communication about the risk factors and spread. A strategy paper for combating the delta is attached as annexure IV. As the knowledge about the epidemiology of Hepatitis Delta increases the strategy will be modified. The treatment of Hepatitis B super-infected with Hepatitis Delta very limited success rate and vaccination against Hepatitis B is the most cost effective intervention for reducing the virus transmission. 2.3. Economic and Societal Cost of the disease: No economic studies have been conducted regarding Viral Hepatitis in Pakistan. A conservative estimate of the direct and indirect cost of uncomplicated chronic liver disease is as follows Direct Medical Cost Indirect Cost 72300 Rs. 25000 Rs. However the cost increases 4 times once the chronic liver disease patient enters into the “Non-Responder” category. For a patient of decompensate liver failure only viable option is the Liver Transplant. The overall loss to the national productivity due to the days out of work is also substantial. 5 Prevesani N, Lavanchy D, Hepatitis Delta, World health Organization document number WHO/CDS/CSR/ NCS/2001. Page | 7 2.4. Quality of Life for Chronic Liver Disease Patients: The health related quality of life scores are higher for Hepatitis B patients and lower for Hepatitis C patients. The quality of life is decreased for Hepatitis C patients. B:DESCRIPTION OF THE FRAMEWORK & PROGRAM OUTPUTS: (A detailed Logical Framework is attached as annexure V) As market failure exists in terms of treating the hepatitis and large externalities are present if the government intervenes. The Chief Minister’s Initiative will work in a pro-poor manner and will adopt the Framework for the Prevention and Control of Hepatitis. 1.To prevent Acute Viral Hepatitis Infections Any infectious / communicable disease needs a host, vector, agent complex for its spread. The disease spread can be effectively stopped by breaking this complex. For preventing the Hepatitis B & D virus, an effective vaccine is available in the market since 1980’s. It is rightly termed as the world’s first anti-cancer vaccine. High level of HepB3 coverage among the newborns, safe blood transfusion, vaccination against Hepatitis B amongst the high risk groups and preventing iatrogenic infection will reduce the chances of acute infections. The specific outputs of the component are: Outputs: 1.1. To maintain the HepB3 coverage amongst newborns at 100% 1.2. To deliver birth dose of Hepatitis B vaccine to 100% children through EPI. 1.3. To preferentially screen the pregnant women against Hepatitis B 1.4. To vaccinate 75% high risk group population in province. 1.5. To provide Hepatitis B vaccine at the level of Rural Health Center in districts/areas affected by the Hepatitis Delta. 1.6. To vaccinate hard to reach population groups like Hijra, MSM & IDUs through special campaigns 1.7. Create a partnership among 03 tiers of governments for the subsidy of Hepatitis B vaccine. 1.8. To ensure safe injection delivery at all public sector hospitals. 1.9. To strengthen the capacity of public sector hospitals in the disposal of hospital waste. 1.10. To provide the Standard Operating Procedures and Quality Assurance Tools in infection control practices to the public Page | 8 sector hospitals. 1.11. To strengthen the capacity of public sector hospitals in achieving the optimum infection control level. 1.12. To facilitate the public sector hospitals in quality assurance by providing trainings in infection control practices. Among the high-risk groups identified for the vaccination Chief Minister’s Initiative will address the general population living in the high-risk districts. The supplies will be complemented by the federal supplies. For hard to reach groups like Men having Sex with Men, Hijra Population and Intravenous drug Users the database available with the Enhanced HIV/AIDS Control Program Service Delivery Providers (SDP) will be utilized. Vaccine will be made available at STI Clinics of the HIV/AIDS in public sector hospitals, for NGO SDPs Program Manager HIV/AIDS will be made the Principal Recipient and vaccine will be utilized through the vaccination center of nearest public sector hospital. For general population program through its social mobilization campaign will stress upon demand side of the intervention. This will facilitate in the continuity of the vaccination. The transmission of blood-borne infections within the healthcare setting can occur in three directions: From patient to patient; From healthcare worker (HCW) to patient; From patient to HCW. Although epidemiological evidence suggests that healthcare-related exposures are not the primary source of hepatitis B virus (HBV) or hepatitis C virus (HCV) transmission, the fact that any transmissions occur within this setting gives rise to concern. From Patient to Patient: Patient-to-patient transmission is usually indirect and is often a result of failure to adhere to basic principles of aseptic technique for the preparation and administration of parenteral medications in multidose vials. The burden of disease associated with unsafe therapeutic injection practices in Pakistan is very high. The number of injection per person per year has been estimated to be in the range of 8.2 to 13.6, one of the highest in developing world. Extrapolating this number to the whole country would result in 1.5 billion injections per year. Approximately 4% (75 million) of these are administered for immunization while the remainders are used for therapeutic use. Of these, 94.2% are unnecessary. In Pakistan, an initiative for the safe and appropriate use of injections would cost US$ 93 million in each Page | 9 year in the country and would avert 168 191 DALY in 2000-2030 (cost effectiveness ratio: US$ 553 per DALY averted). A high proportion of the intervention costs are represented by the cost of single use injection devices because of high injection use. This cost is often covered by patients’ out-of-pocket expenses From patient to healthcare worker (HCW): This usually happens as a needle stick injury (NSI) or by a sharp surgical instrument contaminated by the blood of an infected patient. The risk of HBV infection in a HCW after a needle stick injury and in the absence of vaccination or post-exposure prophylaxis is 37%- 62% if the source patient is HBeAg positive and 23%-37% if the patient is HBeAg negative. A research on NSI in Karachi show that at least 60% of health care workers have had one episode of NSI in 12 months and only 50% of them were vaccinated against Hepatitis B. From health care worker to patient: Surgery is a major risk factor for transmission from an HBV-infected HCW, with the level of risk varying by the type of procedure (e.g., exposure-prone invasive procedures are associated with a higher risk of transmission). No data is available currently about this mode of spread in Pakistan. 1.1 Exposure prone procedures: The risk of healthcare related transmission of HBV and HCV, and to a lesser extent HIV, is increased during the performance of exposureprone procedures (EPPs). The EPPs are defined as, “invasive procedures where there is a risk that injury to the worker may result in the exposure of the patient’s open tissues to the blood of the worker. These include procedures where the worker’s gloved hands may be in contact with sharp instruments, needle tips, or sharp tissues (e.g., spicules of bone or teeth) inside a patient’s open body cavity, wound or confined anatomical space where the hands or fingertips may not be completely visible at all times 1.2 Risk Categories: It is somewhat difficult to precisely define the degree of risk per procedure, but an attempt has been made to divide procedures into groups and categorize them as high, variable, or low risk: High-risk: Any sub mucosal invasion with sharp, hand-held instruments or procedures dealing with sharp pathology / bone Page | 10 spicules, usually in poorly visualized or confined spaces (e.g., orthopedic surgery, trauma surgery, and internal cavity surgery). Variable risk: Minor dental procedures (excluding examination), routine dental extractions, internal / instrument examinations / biopsy (e.g., endoscopy, vaginal examination, laparoscopy), minor skin surgery Low risk: Interview consultation, dental examination, non-invasive examinations or procedures (aural testing, electrocardiograph, abdominal ultrasound), intact skin palpation (gloves not required), injections / Venipuncture (gloves required). The initiative aims at reducing the virus transmission through these known routes of transmission by following strategies: 1. Developing written Standard Operating Procedures SOPs in local languages for health care workers working in high risk to variable risk EPPs 2. Training of health care workers upon these SOPs 3. Integration of preventive messages for population in the health promotion campaign to increase the awareness and reduce the risk of virus transmission. 4. Supporting the hospital waste management system installed by the federal program. 5. Provision of autoclaves and other sterilization material. 6. Monitoring and Supervision. 7. Encouraging the accreditation of hospitals The hospital waste management system is envisaged to operate in close coordination with local TMAs, EPA and community. To achieve a broad based consensus and assure maximum cooperation 4 intersectoral meetings per year will be conducted. 1.3. Prevention of Perinatal Hepatitis B Transmission: Vaccination against Hepatitis B has not gained attention of major development stakeholders in the broader context of maternal and child health. Perinatal transmission is responsible for 35-40% of new HBV infections every year worldwide. For a newborn infant whose mother is positive for both HBsAg and HBeAg (high-risk infants), the risk for chronic HBV infection is 70%-90% by age 6 months when no HBV vaccine or HBV immunoglobulin (HBIg)-prophylaxis is given. For infants of HbsAg positive but HBeAg-negative mothers (low-risk infants), the risk of chronic infection is <10%. Page | 11 Large pockets of high prevalence of Hepatitis B have been identified at Dadu, Hyderabad, Khairpur, Nawabshah, Kamber and Tharparker. Among one of these pockets at Kamber high prevalence of Hepatitis Delta is also identified. Isolated screening of pregnant mothers for Hepatitis B at Mirpurkhas has shown that 13% mothers were Hepatitis B reactive. Hence the perinatal transmission cannot be ignored in Sindh. The initiative aims at perinatal virus transmission interruption by: 1. Modulation of Political Will: Desire for improvement in the MCH indicators exist at the highest level and incorporating the agenda of perinatal hepatitis B transmission in a broader context of Maternal & Child Health will help in reducing the disease burden 2. At Birth Delivery of Hepatitis B Vaccine: There is enough supportive evidence to prove that at birth administration of Hepatitis B vaccine prevents 95% neonates from becoming chronic carriers of HBV. Concomitant administration of HBIG and HBV vaccine increases this proportion to 97%. The marginal advantage is of 3%. Current EPI policy does not favor at birth delivery of HBV vaccine to susceptible neonates. Till the policy formulation, mothers in the high endemic districts will be preferentially screened for Hepatitis B, and all outreach staff will be utilized in vaccinating the neonate within 24 hours after birth. An effective linkage will be developed with the Expanded Program on Immunization for the provision of at birth dose to the newborns along with BCG; the remaining doses will be covered through routine immunization schedule. In case of institutional deliveries the parents will be informed about the follow-up vaccination schedule for Hepatitis B. 3. Screening of Mothers for Hepatitis B: At present ELISA screening facilities are available at the district headquarter hospital (DHQ) level. Antenatal Clinics in these DHQs will be encouraged to do the screening of this group. At all other antenatal clinics in these high-risk districts immunochromatogrpahy kits for Hepatitis B will be provided and the staff will be trained to perform the test. Reactive patients may get the confirmation from DHQ laboratory. LHWs will be trained to refer the pregnant women registered Page | 12 to the peripheral filter clinics for subsequent confirmation through sentinel sites. For a broader understanding of the issue and acceptance in the medical community awareness seminars will be conducted at the district level through active involvement of Pakistan Medical Association. 2. To address chronic hepatitis infections There are a substantial number of chronic liver diseases present in Sindh. The estimations of Ministry of Health are as under: Hepatitis B reactive population in Pakistan 6.0 Million Hepatitis C reactive population in Pakistan 7.5 Million6 Estimations for Sindh are: Hepatitis B reactive: 1.5 Million Hepatitis C reactive: 1.7 Million 80% of the adult population if contracts Hepatitis B will automatically clears the virus. 20% remains chronic carriers with variable viral activity. For Hepatitis C 85% of the people who are infected will retain virus and only 15% clears the virus. Pakistan Integrated Household survey 2001 shows that 22% of the population comes to a public sector hospital for curative care. Based on these figures with underlying assumption that virus transmission is halted it is estimated that an absolute number of 374000 patients of Hepatitis C will report to the public sector for treatment. Similarly 66000 patients of active hepatitis B are expected to come to public sector hospitals for treatment. Matching the variables of Financial Allocations from District Governments, Cold Storage Capacity and Health System’s Capacity to manage the patient workload and information generated, initiative will provide treatment to 1000 patients of Hepatitis C at each district hospital. This enormous task will be met through program allocations however all the relevant partners like Pakistan Bait-ul-Maal, Social Security and District Governments will be encouraged to contribute to the effort. As the 22% of the chronic hepatitis C patients will go into decompensate liver failure, hence the capacity building of medical 6 PC-1 Performa of the Prime Minister’s Program for Prevention and Control of Hepatitis, 2005 Page | 13 and paramedical staff of District Headquarter level in managing the end stage liver disease will facilitate the patients in getting the expert care near to their homes. Currently the screening of the Viral Hepatitis B & C is offered in the public sector at District Headquarter Hospital level through Prime Minister’s Program for Prevention and Control of Hepatitis. For Molecular Diagnosis of the Viral Hepatitis the expenditure is mainly out of pocket. Under the Chief Minister’s Initiative the screening facilities will be taken down to the THQ Hospital and RHC level. PCR laboratory will be established at 02 divisional headquarter medical college hospitals for molecular diagnosis of viral hepatitis. The existing body of knowledge about the disease is rapidly changing hence all cadres of health care delivery system needs to be trained in the prevention and control of hepatitis. The screening services will be strengthened and will work in coordination with the Prime Minister’s Program work plans so as to avoid duplications. As the kits for Hepatitis Delta and Hepatitis B yenvelop antigen are not supplied through Prime Minister’s Program, the Chief Minister’s Initiative will provide these kits and reagents. The distribution of kits will be made on the average monthly consumption of the stock as per standard operating procedures. The distribution will be proposed by the Program Manager and is to be ratified by the Technical Committee. The specific outputs of the component are: Outputs: 2.1. To provide the E LISA screening facility at Taluka Hospital level 2.2. To provide ICT screening facility up to the Rural Health Center level 2.3. To establish Molecular Biology Laboratories at three divisional headquarters 2.4. To formulate the standard operating procedures and Quality Assurance Tools for laboratories. 2.5. To provide curative support against Hepatitis C and B to the eligible patient population. 2.6. To create an effective partnership with all the partners working towards financing for cure of Hepatitis like Pakistan Bait-ulMaal and Social Security. 2.7. To train the staff at District Headquarter Hospital in managing the viral hepatitis, liver failure and end stage liver diseases. 2.8. To train the health staff at sub-district level in diagnosis and referral of Hepatitis patient The aim of providing ICT kits to RHC level is to establish filter centers Page | 14 around the central District Headquarter Hospital. Out of 112 RHCs in the province 60 RHCs, where a LHV is posted with functional Antenatal clinic and the daily OPD is greater than 100 patients will be strengthened as a filter centers. Provision of drugs to the hepatitis delta patients and non-responders will be done after the approval of technical and steering committee. 2.9. Polymerase Chain Reaction Test The PCR Test is a confirmatory test for the presence or absence of the virus in the blood and is mandatory in all cases of Viral Hepatitis. Currently the only two public sector institutes viz: Liaquat University of Medical and Health Sciences and Dow University of Medical and Health Sciences offer PCR. Nawabshah Medical College Hospital has recently established a PCR machine facility and it is anticipated to be functional soon. Geographically the districts of north Sindh are devoid of public sector PCR machine facility. The initiative aims to establish PCR machine facility at 03 divisional headquarters viz Chandka Medical College Larkana and Ghulam Mohammed Mahar Medical College Sukkur and Civil Hospital Mirpurkhas. The diagnostic needs of Mirpurkhas, Umerkot, Tharparker Tando Allahyar districts are being catered through a public private partnership between Mohammadi Medical College Hospital Mirpurkhas and Center of Excellence in Microbiology Lahore. The functional frameworks of installing a PCR machine will be reviewed after clearance from Steering Committee. 3. To Raise the Public Awareness Improved health is the defining objective for any health system. Together with fair financing and responsiveness it represents the broader health system goals (WHO, 2000). Successful health system’s performance is related to the degree population health is maximized within the constraints of the available human, capital and financial resources in a specific country. From this perspective, health promotion programs play an important role to produce health gain and to control costs. It is already described earlier that Sindh has the lowest level of awareness regarding hepatitis spread. Analyzing the national data on Knowledge, Perceptions and Practices reveals that populace is aware of the disease especially the term Jaundice (Peelia) as most of the people have had at least one episode of hepatitis A. 97% people were aware of the disease when compared to 62.3% people who were aware of Hepatitis B & C (Kaari Kaman) Page | 15 Qualitative data suggests that people are also aware of the possibility of transmission of disease from parents to off springs though the exact mode is not known. Proportion of female population knowing about the modes of Transmission of Hepatitis C is attached as annexure VI (a). Launching a robust, sustained and effective health promotion campaign, which addresses various sectors, is needed to stop the virus transmission. The health promotion campaign will address following sectors of population on priority. 1. School going youth (specifically higher secondary & college going students 2. Female Population 3. Health Care Providers. 4. Barbers and Beauticians 5. Population living in the high prevalence areas The school going youth is group amenable to health promotion messages and will be reached through innovative techniques of : Interactive health promotion sessions Poster Competitions Assembly speeches by the teachers in the schools The barbers and beauticians are service delivery cadres spread out deep into the communities. These groups will be reached out through their respective associations and monitoring mechanism will be planned out through the local TMAs. The female population will be reached out through Interpersonal Communication Model successfully in implementation at the Lady Health Workers Program. LHW is a front line worker of the health system and often is the population’s first contact with formal health system. The orientation of LHWs about prevention and control of Hepatitis at their continuous education sessions at the PHC facilities will be coordinated by the health department. It is anticipated that un-qualified health care practitioners may be a hard to reach population group, but resources of District Governments and Taluka Municipal Administrations will be utilized. For reducing the unsafe injection delivery a campaign focusing on a right-based approach will be launched, encouraging the safe injection OR no injection. A mix media approach will be used to support the campaign. The conceptual framework is attached as annexure VI (b) .A parliamentarian’s network will be formed for advocacy. The specific component outputs are: Page | 16 Outputs: 3.1. To incorporate the lesson on Hepatitis in the continuous education sessions of LHWs 3.2. To raise the level of awareness amongst entire female population covered through LHWs. 3.3. To disseminate the health promotion messages against Viral Hepatitis to the population through the outreach health staff in district other than LHWs. 3.4. To formulate targeted health promotion messages for population to be disseminated through mix media approach. 3.5. To launch a “Safe Injection or Say No to Injection” campaign in the province. 3.6. To coordinate and formulate a network of parliamentarians against Hepatitis. 3.7. 3.8. To arrange interactive health promotion seminars in the schools with the support from Health Education Cell. To arrange health promotion seminars for barbers and beauticians. Raising the public awareness level is a multi-sectoral task and to achieve it effectively, links with the National Rural Support Program, Pakistan Medical Association and Community Based Organizations working in the province will be made. The program implementation unit will develop a communication plan every year to be presented before technical committee and which will in turn be ratified by the steering committee for implementation. 4. To Change the Policy Environment Any government intervention cannot thrive until policies and laws are not favorable. The most needed laws in context of Sindh are antiquakery law, regulation of a huge private sector. However to make the process participatory a broad based consultation will be made with all the relevant actors in the process of health care delivery in a district health system and identify ambiguous statutes for a better and comprehensive and effective legislation. The specific outputs are: Outputs: 4.1. To identify the statutory ambiguity in the law towards communicable / blood borne diseases control. 4.2. To draft a law for the infectious diseases control in private and public sector. Page | 17 4.3. To re-draft the law against the quackery in the province 4.4. To enhance the capacity of District Governments for providing stewardship to the special service delivery cadres. 5. To strengthen the Health System In an order to effectively achieve the program objectives program implementation unit at the Directorate General of Health Services Sindh needs to be strengthened in terms of logistics and human resource. Similar strengthening is required at the district level. The positions thus created will be taken over to no-development budget after the completion of program. Currently Prime Minister's Program for Prevention and Control of Hepatitis in Sindh is utilizing the cold storage facilities of Expanded Program on Immunization at two divisional stores viz: Kotri & Sukkur. The storage space at Kotri it is 7400 cu liters. These cold spaces are inadequate for the dual storage of EPI and Hepatitis Program. Hence a need is felt to install a separate cold storage of at least 2500 cu Liters capacity at Kotri , Larkana and at Sukkur. The sentinel sites will also be provided with an 800 liters refrigerator under the Chief Minister’s Initiative. The functional integration of program’s vaccination services at the Voluntary Counseling and Testing Centers and at Blood Transfusion Counters will improve the access to service. 5.1. Surveillance and epidemic investigation capacity at Provincial and District Level: Surveillance and epidemic investigation is a basic function of any disease control intervention. By surveillance trends of disease spread can be assessed and future resource allocations can be made. Key elements of a surveillance system are: 1. Detection and notification of a health event 2. Investigation and confirmation (epidemiological, clinical, laboratory) 3. Collection of data 4. Analysis and interpretation of data 5. Feedback and dissemination of results 6. Response—a link to public health programs, specifically actions for prevention and control Program will extend operational support to the provincial epidemic investigation cell at the Directorate General of Health Services Sindh. The Deputy Program Manager will head the epidemic investigation, who will be assisted by the Epidemiologist, Surveillance Officer and a Page | 18 computer operator. The program will work in liaison with the provincial epidemic investigation cell at DGHS to provide the leadership to the district and coordinate with federal epidemic investigation cell. Similarly focal points at the district level will also be identified and their capacity will be built through short term and long term courses and trainings. This cell will focus upon the epidemics of viral hepatitis on priority but not be confined to hepatitis only and will provide leadership to district epidemic investigation cells in matters related to all kinds of epidemic. During the outbreaks / epidemic of Hepatitis A, chlorine tablets will be distributed in the community for making the water safe. 5.2. Interventions at the Jails The prison inmates have been identified as a high-risk group hardly hit by the disease. Efforts will be taken under the aegis of Chief Minister’s Initiative to institutionalize the activities of prevention and control of Hepatitis in prisoners with the active collaboration of Jail authorities. Specifically the orientation of Jail staff towards Hepatitis, vaccinating all the inmates, screening the suspected cases of Hepatitis and provision of syringes. Reputable Non-Governmental organizations will also be taken on-board for these interventions B: VACCINATION AND IMMUNIZATION: An overarching phenomena behind all interventions will be availability of Monovalent Hepatitis B Vaccine for adults and children so that all high risk groups may be vaccinated when found non reactive against Hepatitis B. Some of the union councils in the province are hyperendemic for Hepatitis B, a flexible policy of at birth vaccination through outreach health staff including Lady Health Workers will be adopted. Expanded Program on Immunization will be made a partner in this. As a longer term measure those institutions will be strengthened which intend to produce Hepatitis B Vaccine indigenously like ASV and ARV Laboratory. For a regular review of the activities a monthly review meeting regarding the Hepatitis B vaccination of the neonates will be conducted. C: IMPLEMENTATION STRATEGY Effective management is the key to success for any development intervention. For a sustainable program management, a Program Implementation Unit will be established at the Directorate General of Page | 19 Health Services Sindh. The details of the staffing position are given as annexure VII (a) and their job descriptions are given as annexure VII (b). Chief Minister’s Initiative will work as a gender sensitive program and recruitment quota for females will be followed. Necessary furniture and fixture will be provided to the staff for proper working environment. Directorate General of Health Services Sindh will be the focal point for the program with Director General Health Services Sindh working as the Chairman of the Program Implementation Unit. Overall steward ship will lie with the Health Department Government of Sindh. Following implementation strategies will be adopted: There will be a separate program implementation unit with a Program Manager, Deputy Program Manager supported by the pertinent work-force. For the purpose of developing a functional interface with federal program, the Program PIU will be established in the Directorate General of Health Services Sindh and Federal Program will be made part of the program management. The Program Manager / Deputy Program Manager will develop an implementation plan in line chart correlating with the phasing of physical activities of the program and present it before Technical Committee, later to be ratified by the Steering Committee. Program Staff will be hired as per existing government rules & procedures, following the laid down qualification and experience criteria. If suitable candidates are not available inside the department, hiring will be made from market on contractual basis, later to be taken over to non-development side. Provincial Coordinator Federal Program will serve as the Chief Technical Advisor of the program. For an effective service delivery and to prevent the dilution effect of the investments program will be launched in a phased manner with a modular approach. In first phase five districts will be selected for the program launch viz: Larkana, Khairpur, Nawabshah, Badin, and Kamber. The subsequent phasing of the program will be made on the disease trends and available data. At present various cadres of service delivery management and coordination are working as one “District Viral Hepatitis Control Committee”. This team manages and monitors all the Page | 20 inputs received from Prime Minister’s Program for Prevention and Control of Hepatitis. The composition of these crossfunctional multi-layered teams formed by the Program is as follows: At Teaching Hospital Level: Medical Superintendent Chairman Physician/Gastroenterologist Secretary/Convener Pathologist Member Hospital Pharmacy I/Charge Member Representative of Pakistan Bait-ul-Maal Member Social Welfare Officer Member Representative of District Government Member At District Headquarter Hospital Level Executive District Officer (Health) Chairman Medical Superintendent Secretary / Convener Physician Member Pathologist Member Hospital Pharmacy I/Charge Member Representative of Pakistan Bait-ul-Maal Member Social Welfare Officer Member Representative of District Government Member Apart from these cross functional multi-layered team a District Task Force for Hepatitis Prevention and Control Activities will be notified. The composition will be as under: District Coordination Officer Chairman Executive District Officer (Health) Secretary Medical Superintendent DHQ Hospital Convener Executive District Officer (Education) Member Executive District Officer Community Development Member District Public Prosecutor / Attorney Member President Pakistan Medical Association Member The district task force will support the Viral Hepatitis Control Committee in the implementation and integration of project activities. The details of the existing standard operating procedures are given as annexure 6. Page | 21 For health education and promotion campaigns the pertinent staff of health education cell will be taken on-board. Training modules developed by the Prime Minister’s Program for Prevention and Control of Hepatitis for the health staff in diagnosis, prevention and cure of the disease will be improvised and utilized for the training Training will be done at the DHQ Hospital and nearest Medical College Hospital by teaching staff of the college. Specialized short course trainings on epidemiology and disease investigation will be arranged for three people from one district viz: District Officer Health (Medical & Public), Epidemiologist and a medical officer with experience in field epidemiology. Competency based trainings will be arranged at PHDC; however options available in private sector with good standing will also be explored. A perinatal hepatitis B prevention unit will be set at Directorate of Reproductive and Child Health at DGHSS to implement the interventions smoothly. D: MONITORING & SUPERVISION: Monitoring and Supervision is the key to success in any programmatic intervention. It provides a constant check through feedbacks and keeps the interventions on track. Supportive supervision to the staff produces ownership and enhances the performance of the staff in a given task. For a comprehensive M&S of the project an internal monitoring unit will be established headed by the Deputy Program Manger. The unit will be supported by the Monitoring Officers who will carry the desk and field monitoring of the activities. This unit will review the progress of the project and submit reports to Director General Health Services Sindh and Health Department Government of Sindh on monthly basis. The unit will also generate monthly feedback reports to various sentinel sites in the province. The monitoring framework utilized will draw it’s base from the systems model as under: INPUT PROCESS OUTPUT OUTCOME It will be the first and prime responsibility of the Program Manager to identify monitoring indicators after a broad based consultative process and float these before Technical Committee. The HMIS does not have the relevant disease specific indicators however efforts will Page | 22 be taken to incorporate the Hepatitis specific indicators in the new DHIS. The existing tools for monthly reporting and monitoring developed by the Federal Program will be utilized and where appropriate will be tailored to the provincial needs with the approval of the National Program so as to ensure the uniformity of reporting at the National Level. The tools will be made available through the project at all sentinel sites of the province. The Technical Committee in turn will recommend these indicators to the Steering Committee for ratification. At the district level monitoring units will work under the overall guidance of Executive District Officers (Health) / Medical Superintendent Teaching Hospitals and District Officer (Public Health) / a suitable officer of the teaching hospital shall be responsible for running the monitoring units. The key performance indicators identified in the Logical Framework will be utilized for the monitoring. A quarterly review meeting of the district / hospital authorities will be held under the chairman ship of Director General Health Services Sindh. Twice in the year meeting will be chaired by the Secretary Health Department and once a year the meeting will be chaired by the Chief Secretary Sindh. Stewardship of any public sector initiative is mandatory, in an order to steer the project, identify the technical issues and provide the necessary technical inputs, a technical committee will be constituted, comprising of following. 1. Technical Committee Director General Health Services Chairman Program Manager Secretary Provincial Coordinator PM’s Program Technical Advisor Additional Secretary Development Wing Member Provincial Hepatologist and Pathologist Member Secretary Blood Transfusion Authority Member Project Director EPI Member Program Manager HIV/AIDS Program Member Director Public Health DGHS Member Representatives of International Members Development Agencies in Sindh Chief (Health), P&D Department Member Provincial Coordinator LHW-Program Member One Medical Superintendent and Executive District Officer (Health) will be nominated on rotatory basis, for a better input from the end user’s perspective. Page | 23 Committee will meet on quarterly basis and minutes will be shared with all the partners. To provide an overall strategic guidance to the program implementation unit a Steering Committee with following composition. Committee will meet every two months to review the progress. 2. Steering Committee: To provide the strategic guidance to the program implementation unit and strengthen the interdepartmental linkages a Steering Committee with the following configuration will be notified: Additional Chief Secretary P&D Chairman Secretary Health Department Member Director General Health Services Sindh Secretary Rep. Finance Department not less than AS Member Rep. Law Department not less than AS Member General Secretary Pakistan Medical Association Member Representative of NRSP Consortium Member Representative of AKHSP Member Director SIUT Member Vice Chancellor DUHS Member Program Manager Member For a broad based coverage of the population inputs in the patients’ selection will be taken from the NGOs working with Rural Support Program and PPHI. 3. Procurement Committee: The Procurement Committee will be formulated by the Project Steering Committee with the incorporation of relevant experts. 4. Provincial Task Force The objectives of the initiative need highest level commitment and sustained inter-sectoral collaboration. For ownership and stewardship at the higher level a Provincial Task Force will oversee the implementation of the initiative. The task force will meet once a year and provide necessary stewardship. The composition of the task force will be as follows. 1. Chief Secretary Government of Sindh Chairman 2. Additional Chief Secretary (P&D) Co-Chairman 3. Secretary Health Department Convener 4. Secretary Finance Department Member 5. Director General Health Services Member 6. Deans Faculty of Medical Page | 24 LUMHS Jamshoro & DUHS Karachi 7. Program Manager CM Initiative 8. (3) District Coordination Officers On rotation basis 7. Capital Cost Estimates 8. Demand and Supply Analysis Member Secretary Members COST IN YEAR 1 COST IN YEAR 2 COST IN YEAR 3 795,141,368 797,020,168 735,186,668 The cost estimates are based on the market surveys and previous experience of the Prime Minister’s Program for Prevention and Control of Hepatitis, as on May 2008. Total Project Cost: Rs. 2350 Million in three years See annexure IX Viral Hepatitis has emerged as a common blood borne infection in the community. High number of patients is identified through the surveillance system of PM Program as given above. The current estimate for number of Chronic Viral Hepatitis patients is 3.1 million in Sindh alone. The number is likely to increase if a comprehensive, vigorous and sustained provincial input is not provided. A mismatch exists between the public demand for information, vaccines, diagnostic and curative services. At present the Federal Ministry of Health is providing; 1. Preventive Vaccine for 50,000 people per year 2. Screening Kits for 36000 patients per year 3. Free of cost PCR Test facility for 800 patients per month 4. Treatment for 250 patients of chronic Hepatitis B 5. Treatment for 1740 patients in year 1 and 2500 patients of Hepatitis C in year 2 Details of the supplies made by the Federal Ministry of Health till date is given as annexure X. As per estimation Prime Minister’s Program for Prevention and Control of Hepatitis is providing: 1. Vaccination to 1 in 800 persons. 2. Screening facility to 1 patient of Hepatitis in 86 patients. 3. Treatment of Hepatitis B to 1 in 6000 patients 4. Treatment of Hepatitis C to 1 in 450 patients. On the contrary the demand side of the intervention mismatches the supply. Substantial of patients are put on the waiting lists and supply from Ministry of Health is outstripped by the demand. The existing Program Unit has developed an effective linkage with the Page | 25 District Governments and has attempted to meet the demand side by diverting the district finances into the Hepatitis Prevention and Control Activities. The magnitude of district support has matched the curative component of the federal program for the year 1 of its implementation (see annexure XI). Market failure exists in the provision of treatment against Hepatitis C hence the government intervention is needed in the case. The CM initiative will reach up to 1000 patients of Hepatitis C in each district and 2000 patients of Hepatitis B per year for 03 years. As all the 03 tiers of government are financing the treatment component and program vouches to prevent the acute infections, it is anticipated that community demand will be met. 9. Source of Financing 10.Program benefits and analysis Proposed financing of the scheme is as under 1. Federal PSDP Rs. 2,350 Million 2. Provincial ADP In three years 3. District Government 4. Pakistan Bait-ul-Maal 5. Donor agencies support Viral Hepatitis B & C are chronic diseases, which by the morbidity cause huge loss in the human capital and consequently the consumption rate per capita and revenue generation for the state. There exists a market failure in the treatment of Hepatitis and existing interventions improve the health of population without increasing the cost of society greater than benefit. Moreover large externalities exist through preventive intervention. Published Research, Needs Assessment Exercise and inputs from various partners suggests that the disease is rampant in small towns and peri-urban slums. An area with a low earning population referring to a nearby quack for health needs and getting unnecessary injection delivery is a typical scenario of disease spread in Sindh. Hence all the District Headquarter Hospitals / Major Hospitals will be expecting at least 1000 patients of Hepatitis B and C respectively for 10 years. In the same context diagnostic needs of the population is expected to be quadrupled in next five years owing to the level of awareness and other variables. The Chief Minster’s Initiative for Hepatitis Free Sindh has a larger societal benefit of raising the awareness of people and hence preventing the disease spread. The Program vouches to save the valuable human resource from the morbidity and mortality due to Page | 26 Viral Hepatitis and thus qualitatively contributes to the boosting of local economy and National GDP. The initiative will also create direct employment opportunities for the skilled and un-skilled workforce. 25 vacancies will be generated through this initiative which will serve to reduce the unemployment in the province. The positions will be shifted to the non-development side after 03 years of the program implementation. Delay in the program implementation will increase the number of patients and cost of equipments and consumables due to inflation. Year of Start: 2008-09 11. Implementation schedule Year of End: 20010-11 of the project. (A) The Item-wise/year-wise implementation schedule in line chart corelated with the phasing of physical activities will be prepared by the Program Manager / Deputy Program Manager in the first quarter of implementation. As described above the initiative will be monitored on a systems (B)Result Based Monitoring model of input, process, and output. The logical framework will Indicators provide the major RBM Indicators. However by first quarter of the implementation a detailed M&E Framework with indicators duly approved by the technical committee will be formulated. The Initiative will be implemented through a Program Implementation Unit headed by a Program Manager. The details of the staffing position are attached as annexure. 12. Management Structure Provincial Coordinator PM Program will serve as the Technical Advisor of the project to the Health Department Government of Sindh on the interventions of the program. The steering committee will decide the strategic direction to the program and technical committee will monitor the progress on the Objectively Verifiable Indicators. 13. Additional Project / Decision Required to maximize the socio economic benefits from the project Sustained political commitment to the slogan of Hepatitis Free Sindh. A potent and sustained anti quackery drive is required for the success of the project It is also pertinent that HepB3 Coverage of the province reaches more than 98% to produce a birth cohort immunized against Hepatitis B and hence producing the herd immunity in the community. Sustained supply of vaccine in the global market. Page | 27 CERTIFICATE: This is to certify that PC-1 has been prepared as per instructions for the preparation of PC-1 for social sectors Prepared By: Dr. Zulfikar Ali Gorar Provincial Coordinator (Sindh) Prime Minister’s Program for Prevention and Control of Hepatitis Checked By: Dr. Ghulam Nabi Memon Director General Health Services Sindh Verified By: Dr. Srichand Ochani Additional Secretary (Development Wing) Health Department Government of Sindh Approved By Mohammed Hussain Syed Secretary Health Department Government of Sindh Page | 28