REDEFINING MINIMUM STANDARDS FOR PHARMACY PRACTICE TO IMPROVE

REDEFINING MINIMUM STANDARDS FOR PHARMACY PRACTICE TO IMPROVE THE USE OF MEDICINE IN THE ASIA PACIFIC REGION Passmore, P. , 1 Sunderland, V. B. , 1 Tongnopnua, N. 2 & Joshua, I. B. 3 1 Curtin University, Australia; 2 Srinakarinwirot University, Thailand; 3 University Of Papua New Guinea Abstract ID: 229 Problem Statement: All countries in the Asia Pacific Region have defined a legal framework within which pharmacy practice is intended to operate. Considerable differences in the content of law, interpretation of law or adherence to the law results in different standards or quality of day-to-day practice, which directly impacts on improving use of medicines. Objectives: To identify work practices within the pharmaceutical sector that hinder improving use of medicines, to identify minimum measurable standards of practice that directly improve use of medicines. Design: As part of a broader study to review the quality of management of antimalarial drugs in the Asia- Pacific Region during the period June 2000 to October 2003, a retrospective review of the laws governing the practice of pharmacy in Australia, the Mekong countries and Papua New Guinea was conducted. The study included an observational assessment of pharmacy practice in Australia, Cambodia, Papua New Guinea, Thailand, and Vietnam against established good pharmacy practice guidelines. Setting and Population: Pharmaceutical sector in the Asia Pacific Region, especially Mekong countries Intervention: Country visits, review of pharmacy literature and law, observational visits in manufacturing, wholesale and retail pharmaceutical establishments, discussions with national pharmaceutical leaders. Comparisons made against good practice guidelines covering personnel, premises, products, and practices. Outcome Measures: Pharmacist registration, pharmacy technician registration, pharmacy registration, drug registration, good manufacturing practice (GMP) and drug quality requirements, drug import and export requirements including internet procurement, drug storage and distribution requirements, government monitoring and supervision. Results: There are considerable deficiencies in the pharmaceutical sector law in some countries and deficiencies in the quality of pharmacy practice as compared to accepted published standards. Unqualified persons in control of drug storage and distribution, illegal dispensing, illegal drug imports, non-GMP compliant manufacturing, poor government control over practitioners’ adherence to law were major factors suggested to contribute to poor pharmacy practices which directly contribute to poor use of medicines. Conclusion: Redefining of the minimum standards for pharmacy practice and for governments and the health professions in the Region to collaborate and monitor adherence to minimum practice standards should improve quality of medicines and their usage. Study Funding : Curtin University of Technology School of Pharmacy Introduction From June 2000 to October 2003 a study was conducted to assess the quality of artemisinin based antimalarial products and the quality of the management of those products in National Malaria Control Programs, particularly in the Mekong countries. That study also provided opportunity to review laws and procedures governing the practice of pharmacy, including pharmacist registration, pharmacy technician registration, pharmacy premises registration, drug registration, good manufacturing practices (GMP), drug quality requirements, drug import and export, drug storage and distribution and monitoring aspects of the sector by government. In addition, by using standards of good pharmacy practice (GPP) (FIP 1998) 1 as a comparative tool and reviewing other published documents such as National Drug Policies, holding discussions with health authorities, and directly observing pharmacy practice, data was collated and provided a basis for a qualitative assessment of pharmacy practice standards in the particular countries and in the Australasia-Pacific Region as a whole. The findings and suggested consequences of the findings and possible ways forward are presented to stimulate discussion and planning towards continuous quality improvement in the pharmaceutical sector. Results Individual country data is not presented. Results are presented for the pharmaceutical sector in the Region. Only situations which are commonplace are reported. Personnel • Significant sale, dispensing, storage and distribution of potent medicines is conducted by unqualified persons; • considerable numbers of hospitals don’t have a pharmacist on staff; Training • Continuing education rarely available to pharmacists and pharmacy technicians; • Considerable increase in the potency of newer active pharmaceutical ingredients yet no significant upgrade or change in the skills of personnel engaged in the dispensing or management of the pharmaceutical products; Standards • Many premises where potent drugs are sold are not of a standard befitting a pharmacy; • Dispensing standards highly variable ranging from highly professional, following quality assured procedures through to unlabelled drugs in newspaper • Many potent medicines dispensed where no labels are present and patients receive no verbal or written instructions • Considerable amount of dispensing occurs from premises where the environment of the premises is not conducive to maintaining the integrity of the product through satisfactory storage; • Many pharmacies keep few or no records of medications dispensed to individuals in the public • Many potent drugs generally accepted as requiring medical supervision of patients requiring the medication, are supplied on request with no professional involvement from qualified persons; • Pharmaceutical sector personnel feel ill equipped to make judgements regarding product quality and authenticity; • Systems of drug recall almost non-existent in some locations; • Principles of GMP and licensing not fully adopted or embraced resulting in variable quality in local manufacture; • Lack of supply of essential drugs results in irrational drug usage practices Legislation and National Drug Policy • Considerable deficiencies in pharmaceutical law, many ambiguities allow for poor interpretation of law which adversely affects quality of products and practices; • Principles of essential drug lists are not fully utilised in the region; • Drug procurement using public funds are not always related to essential drugs reflecting disease burden and epidemiological realities; • Considerable lack of protection of the health and safety of populations results when many unregistered products are available; • Public funding often insufficient to guarantee supply of essential drugs; • Access to essential drugs is often not related to those most in need; • Wastage within pharmaceutical sector due to poor management is considerable; • Disposal of pharmaceutical products do not always follow environmental requirements; • Lack of regional approach to sharing technical and management expertise to achieve minimum standards of drug quality through systematic registration of therapeutic substances and devices; • Public sector institutions such as hospitals are forced to purchase essential drugs and medical supplies at high retail prices, using trust fund money, when public funded supplies are in short supply; • Personal expenditure on perceived pharmaceutical supplies can be high, especially when public funded systems fail to guarantee supply; • Wide variation in monitoring, evaluation and enforcement of standards between countries • National Health Statistics • Preventable communicable diseases still cause unacceptable levels of morbidity and mortality, especially amongst poorer communities; • Poor quality pharmaceutical products pose a risk for disease prevention programs Methods A review of laws and procedures governing the practice of pharmacy and observation of practice was conducted in Australia, the Mekong countries and Papua New Guinea, from June 2000 to October 2003. Standards and Procedures assessed Pharmacist registration Pharmacy technician registration Pharmacy premises registration Drug registration Good Manufacturing Practice (GMP) Drug quality requirements Drug export and Import requirements (including internet procurement) Drug storage and distribution from central levels Monitoring and supervision of standards and enforcement protocols Human resources development Drug selection, procurement, storage, distribution and usage at various levels below central levels National health statistics Discussion Since the Alma-Ata declaration in 1978, it has become accepted that a vital component of Primary Health Care (PHC) is an adequate pharmaceutical service. 2 Considerable progress has been made by national governments often with support from international organisations to promote strategic actions to improve their pharmaceutical sector. These ongoing developments are vital and require ongoing support. The results of our study suggest however, that the populations in a number of countries in the region are still not being afforded the protection of a well managed pharmaceutical sector that should guarantee affordable access to appropriate quality assured essential drugs for the prevention and treatment of disease. The level of pharmaceutical services in some countries studied, is increasingly out of balance with the sophisticated technology of production and nature of many new pharmaceutical products. The variation in the quality of pharmaceutical services between countries and within countries is extreme. If PHC goals and the pharmaceutical sector goals are essentially the same and are to be achieved to improve the health of populations, details regarding how much variation is acceptable needs to be determined. What are the minimum standards for pharmacy practice to enable essential drug and primary health care goals to be reached? For public health reasons, which medicines must be managed more closely than others? What are the consequences of poor management of standards within the pharmaceutical sector? What constitutes minimum standards within the pharmaceutical sector to guarantee safety and efficacy of products and quality assurance of selection, procurement, storage, distribution and usage of potent essential drugs to promote healthier people? These questions become important when such extremes in service delivery are witnessed. Continuing high morbidity and mortality due to preventable diseases, especially amongst the poor, together with evidence of high morbidity associated with improper use of medicines, strongly suggests more efforts needs to be made by health care authorities and professionals working in the sector, to redefine and sustain minimum standards of pharmacy practice that routinely contributes to improved public health. Recent well publicised adverse public health events demonstrates that we live in a global village and our neighbours public health difficulties are also our own. Possibly we all need to grasp that our neighbours pharmaceutical sector problems are also our own and hence endorse a more Regional approach to attain minimum standards. Regional Pharmaceutical authorities could assist national governments work toward these minimum standards in: • safe and effective products and services; • appropriately trained personnel; • management of guaranteed supply of quality assured therapeutic substances and devices in both public and private health services; • access for all people to essential drugs, especially those effective against communicable diseases; • people equipped to use therapeutic substances properly; Conclusion Our study conclusively demonstrated that the quality and scope of pharmaceutical services in the Australasia-Pacific regions varies considerably. Many people therefore are not being afforded the protection of a well managed pharmaceutical sector. The lack of quality in pharmaceutical services must adversely affect the achievement of public health goals. We suggest that minimum standards that guarantee supply of quality assured essential therapeutic substances and devices, that are managed well by appropriately trained professionals, within systems that enable affordable access, and equip people to use the products to achieve a healthier life are vital. It is further suggested that a regional approach be taken to assist all countries attain these minimum standards in the shortest possible time. References 1. Good Pharmacy Practice in Developing Countries, Recommendations for step-wise Implementation, FIP 1998 2. Primary Health Care – Report of the International Conference on Primary Health Care, Alma-Ata, USSR 1978 Acknowledgements The support of Curtin University of Technology, School of Pharmacy, is gratefully acknowledged