Pharmacy Practice in Developing Countries: Gaps and Challenges Mohamed Izham M.I., PhD Professor of Social & Administrative Pharmacy College of Pharmacy, Qatar University Doha, Qatar Congress of Scientific Association of the Pharmacy Colleges in the Arab World Acknowledgement Omdurman Islamic University, Faculty of Pharmacy 2. Academic Press, Elsevier Inc. (Book: Pharmacy Practice in Developing Countries, 2016) 3. Co-editors: Dr. Ahmed Fathelrahman & Professor Albert I. Wertheimer 4. All contributors from 19 LMICs 1. Presentation Outlines Background How was the analysis done? Findings Gaps and challenges Recommendations Conclusions Introduction People across the globe are living longer Positive development of the health care system ◦ ◦ ◦ ◦ ◦ ◦ technology advancement new cost-effective medicines better lifestyles better understanding of diseases various research discoveries better trained health care personnel At the same time, we could also observe: ◦ ◦ ◦ ◦ growth in population increase in life expectancy more people experiencing chronic diseases people consume more medicines The improvement in the quality and responsible use of medicines in society is very much dependent on the overall quality of the health care and pharmaceutical system There is a great need for an effective pharmacy practice to ensure responsible and quality use of medicines from all perspectives The question is: ARE WE/PHARMACISTS READY WITH THESE DEMANDS AND CHALLENGES? Good pharmacy practice (GPP) ◦ FIP first adopted the guidelines in 1993 ◦ WHO then endorsed a revised version in 1997 ◦ In 2011, both the FIP and the WHO adopted an updated version of GPP ◦ WHO in addition produced guidelines in relation to community and hospital practice HOW FAR SINCE 1993 (AFTER MORE THAN 2 DECADES) HAS PHARMACY PRACTICE IN THE DEVELOPING COUNTRIES IMPROVED AND RESPONDED TO THE PROPOSAL AND GUIDELINES? Study on 19 LMI countries Critically analyze the status of the 19 countries in terms of the practice of pharmacy in each country and to compare between them Objectives: ◦ to find, via comparisons, which countries are practicing well based on satisfying community needs and making use of resources; ◦ to identify the gaps (present situations vs recommended conditions); and ◦ to recommend the way forward How was the analysis done? We divided countries into categories based on the World Bank list of countries by income classifications A list of variables was used to compare the pharmacy practice, policy and regulation, and education and training aspects Performance was then compared to see how well a country was doing generally and compared to other countries of similar wealth Scores were assigned to positive practices in countries (maximum of 14) Data were analyzed descriptively (i.e., frequency (%), mean (SD), and median (IQR)) using IBM SPSS Statistics® version 22 Findings Table 1: Country – Economies by per capita GNI in 2012 UN category based on income Low income Income bracket Country $1,035 or less Burkina Faso, Nepal Lower middle income $1,036 to $4,085 Upper middle income $4,086 to $12,615 Egypt, India, Indonesia, Nigeria, Pakistan, Palestine, Sri Lanka, Sudan,Yemen China, Iraq, Jordan, Malaysian, Thailand High income $12,616 or more Chile, Qatar, Saudi Arabia Source: World Bank. World development indicators: size of the economy. 2014 Table 2: Criteria in low income country Criteria for comparison Country Burkina Faso Nepal 18,365,123 (2014) 1,700 (2014 est) 30,986,975 (2014) 2,400 (2014 est) 54.78 409 (0.2) 67.19 1200* (0.387) No No What is the popular areas of practice? Community pharmacy Pharmaceutical industry Any unique services? How controlled substances are handled? None Only with prescription None Only with prescription Is continuing education for pharmacist required? Yes No Is there enough pharmacists to cover the community needs? No No Does practice matching available resources? No No Using e-health technologies in pharmacy practice No No Country background Population (million)** GDP per capita ($, ppp)** Life expectancy (years)** Number of licensed pharmacist (per 10,000 of population) Practice criteria Is selling medicines outside of pharmacies allowed? Policy and regulation Is state licensure is required to practice? Yes Is a non-pharmacy degree holder allowed to operate a retail pharmacy without a Yes (but under the pharmacist? license of a pharmacist) Yes Yes Must a pharmacy shop have a registered/licensed pharmacist present to operate? Yes Yes (due to the lack of pharmacists license is given to pharmacy assistant) Are there location requirements for opening a community pharmacy? Yes No Is there regulation to handle controlled substances? Yes Yes Yes 9/14 Yes 7/14 Does NDP exist? Score Table 3: Criteria in lower middle income country Criteria for compari son Palestine 7/14 Yemen 6/14 Sri Lanka Pakistan 12/14 11/14 Nigeria 8/14 Sudan 9/14 Indonesia Score India Egypt Country 10/14 9/14 12/14 Table 4: Criteria in upper middle income country Criteria for compari son Score Country China 9/14 Iraq 10/14 Jordan 12/14 Malaysia 10/14 Thailand 8/14 Table 5: Criteria in high income country Criteria for comparison Score Country Chile Saudi Arabia Qatar 7/14 13/14 10/14 Number of Arab countries above average = 6/8 More critical analysis….. Population: India – Qatar LE: Chile & Qatar – Nigeria GDP per capita: Qatar – Burkina faso Number of pharmacists per 10,000 population ratio: Jordan – Burkina Faso Five (26%) countries do not allow selling of medicines outside of pharmacies Most popular area of practice is community pharmacy (n = 10; 53%) Majority of the countries do not have any unique service in the pharmacy practice (n = 12; 63%) All countries have laws that regulate controlled substances Pharmacists in 13 (68%) countries are not required to do their CE; only one country require pharmacists to attend CE for their renewal of registration 17 (90%) countries do not have enough pharmacists 14 (74%) countries are not matching available resources 6 (32%) countries use e-health technologies to a certain extent Only four (21%) countries allow a nonpharmacy degree holder to operate a retail pharmacy Only three (16%) countries do not require a pharmacy shop to have a registered/licensed pharmacist present to operate 42% (n = 8) of the countries put a requirement on the location for opening a community pharmacy All countries have regulations on handling controlled substances Only four (21%) countries are without a national medicines (drug) policy Scores ranged from 6.0 to 14.0 (mean score (SD) = 9.4 (2.0)) ◦ ◦ ◦ ◦ low income countries = 8.0 (1.4) lower middle income countries = 9.3 (2.0) upper middle income countries = 9.8 (1.5) high income countries = 10.0 (3.0) a clear upward trend; the higher the income category, the higher the mean score, which indicates more positive practices Many countries have a national medicines policy and pharmaceutical acts and regulations, but ◦ ◦ ◦ ◦ ineffective policies weaknesses in enforcement lack of punitive action lack of motivated and dedicated authorities Low salaries of employees ◦ vulnerable to corruption ◦ lack of motivation & commitment Lack of human resources All these will contribute to poor pharmaceutical sector In addition, the market possibly be exposed to ◦ substandard and counterfeit drugs ◦ illegal distribution of Western medicines There are countries with few (earlier was none) colleges of pharmacy ◦ allowing non-pharmacy graduates with few or no qualifications to operate a retail pharmacy or drugstore ◦ controlled medicines that can be bought easily without prescription Plus countries with lack of enforcement, matters get worse Lack of ethical practices and professionalism plus the conditions explained above: ◦ makes the pharmaceutical sector weak, and ◦ places the society at risk In many of the developing countries, prices of medicines are not effectively controlled ◦ medicine availability and affordability are a major concern ◦ unhealthy business – “price wars” In many of the developing countries, issues of medicine production, procurement, and consumption are critical ◦ domestic medicines production is not sufficient for the country ◦ medicines have to be imported ◦ none or ineffective generic medicines policy ◦ high public out-of-pocket expenditures ◦ inefficient of procurement process Ill health and poverty are closely associated Ineffective financing systems have placed a high burden on the poor people What else are we suffering from? ◦ Quality of the pharmacy colleges Lack of faculty members Lack of qualified and quality faculty and staff Lack of quality infrastructure Lack of quality graduates Lack of quality curriculum Mismatch between curriculum content & knowledge and skills needed in practice ◦ Quality of the government Weak, incompetent, inexperienced ◦ Continuous crisis….. Gaps and Challenges How far is the gap? Gap analysis: a technique for identifying needed improvements by comparing the current environment and current processes against an envisioned future state ◦ the gap between current practice and the desired practice Benchmark countries with a high score ◦ better practice standards, within the same category of economy, environment, or geographical type ◦ look for best practices learn, adopt, and adapt a set of best practices Few considerations: 1. Professionalism—How far is the professionalism factor built in the pharmacy practice? 2. Decision-making—Are pharmacists the main players and key decision-makers in matters related to medicine use? 3. Health care team—Are pharmacists key players on the health care team? And how is the pharmacist’s relationship with other members of the health care team? 4. Patient information—Do pharmacists have access to patient information, e.g., medication profile, in order to perform effective pharmaceutical care? 5. Academic programs—Does the country have adequate pharmacy colleges? And what is the quality of the pharmacy program and the credentials of the faculty members in the pharmacy colleges? 6. CE—Do pharmacists have the opportunity to upgrade or improve their knowledge, skill, and competency throughout their career? 7. Standard of practice—Does the country has a minimum standard of practice in all pharmacy settings? 8. Scholarly activity—How far is the pharmacy practice research? How many publications in quality journals? And what is the impact on pharmacy practice and pharmaceutical policy? What is next? A way forward Brodie (1981): pharmacists must identify the boundaries of duty and responsibilities and he encouraged the practice of pharmacy to move toward the patient and fulfill the needs of the society In 1980, the American Public Health Association recognized pharmacy as a profession with major responsibilities for public health FIP and the WHO (2011) reemphasized the importance of the role of pharmacists through their GPP guidelines Albanese and Rouse (2009) in their article “Scope of contemporary pharmacy practice: roles, responsibilities, and functions of pharmacists and pharmacy technicians” concluded that ◦ the evolution of health care and pharmacy practice has created excellence opportunities for pharmacists to serve the society beyond the traditional roles Conduct quality studies to evaluate the status of pharmacy practice and the overall pharmaceutical sector in the country Build more evidence-based information and research Effort is critically needed to narrow the gap of practice within a country, and between countries Pharmacy education in each developing country should be directed toward addressing local needs and making use of the available opportunities ◦ ◦ ◦ ◦ Hospital pharmacy Community pharmacy Public health pharmacy Industrial pharmacy Examine guidelines and best practices from most advanced countries Develop and strengthen the national medicines policy Ensure an essential medicines list exists and benefits the society Ensure an effective drug regulatory system exists Review the quality of pharmacy education and build a competence-based education Build a quality CE program and progressively implement compulsory CE points for registration renewal of pharmacists Strengthen the research capacity in the area of pharmacy practice Conclusions…take home message ! It is clearly indicate that for many countries, gaps, barriers, and challenges to effective pharmacy practice still exist The role of pharmacists still has a long way to go The pressure on the whole health care system worldwide will continue; there is no escape for the pharmaceutical sector The pain of the pressure is felt more by the low- and middle-income countries Further work and effort in the developing countries is warranted to bring the pharmacy practice and profession to another level and standard References World Bank (2014) Brodie (1981) American Public Health Association (1980) FIP-WHO (2011) Albanese and Rouse (2009)