ABSTRACT
BACKGROUND: Quality issues in pharmaceuticals are identified as a huge global and public health problem, especially with reference to low- and middle-income countries like Pakistan. The 2011 "Fake Drug Crisis" acted as a driving force to reform the regulatory structures of the country and for establishing the autonomous "Drug Regulatory Authority of Pakistan". Despite the fact that Pakistan possesses a huge pharmaceutical industry, there is a severe dearth of published literature and scientific evidence for the country regarding medicine quality and the prevalence of counterfeit and low-quality products, respectively. AIMS AND OBJECTIVES: This narrative review covers relevant features of the regulatory framework for pharmaceuticals in Pakistan, its national pharmaceutical industry, as well as a compilation and analysis of published literature for documentation of the country's situation regarding the overall quality of medicines. METHODS: Available data including scientific publications on the quality of pharmaceuticals in peer reviewed journals, research reports, notifications, and alerts issued by the World Health Organization and other agencies were accessed and compiled. Post graduate dissertations were used to represent unpublished research data and drug safety alerts issued from the local Pakistan authority were analysed to assess the type and number of quality failures reported for pharmaceuticals. RESULTS: It could be clearly shown that there is negligible scientific data available on the issue of medicine quality in Pakistan. The anticipated number of 40-50% of poor-quality drugs in Pakistan cannot be defended by data available from the literature. Accessible technologies and strategies used in recent years at global level, especially in developing countries, were also reviewed and recommendations are devised for Pakistan to combat the fight against poor-quality medicines. CONCLUSION: The case reports, investigations, and general data listed for Pakistan suggest the need of strengthening regulatory systems for premises and GMP inspections, analytical laboratories, as well as an overall capacity building in the field of unravelling and controlling substandard and falsified medicines. It is proposed that well-planned and properly funded studies need to be carried out for collecting critical statistics regarding the prevalence of substandard and falsified medicines in Pakistan.
ABSTRACT
World Health Organization (WHO) states access to medicine as a priority area for universal health coverage, wherein a well-functioning medicine supply chain is indispensable. Optimization of supply chains to cut losses related to overstocking, expiration, and inefficiencies protect the investments and strengthen health systems to better deliver the health services. This article shares the experience of developing a service-driven-software for pharmaceutical supplies during emergency conditions and disasters, and the advantages gained. In 2005, Logistic Support System (LSS), the updated version of SUMA (Supply Management), was introduced by WHO during the earthquake in Pakistan which had offered valuable but limited services to many countries. Moving from ad hoc to a more organized approach, the medical donations and stockpiles of essential medicinal supplies were inventoried on LSS database for managing the dispatch of medical supplies to the disaster-hit area in a shortest possible time. Post disaster rescue and rehabilitation work further instigated the need for development of a new software, Pharmaceutical Information Management System (PIMS), that was effective in the emergency as well as routine inventory operations. It was used for efficient and improved access of medicines and faster decision making. The new systems proved vital to anticipate over/under stocking through proactive alerts and prompting. The updated information on epidemiological and drug utilization needs were crucial for the effective quantification and ordering throughout the supply chain. Implementation of PIMS demanded appreciable customization including conversion of system from stand-alone to online system with consolidation of information on stocks from all locations. Provision of multi-user option allowed facilitation according to the user authorization, and was equipped with improved-speed, efficiency, and security. PIMS was successfully replicated by the pioneer team of pharmacist from Pakistan in other countries.
