Surge of Branded Generics and Antimicrobial Resistance: Analyzing the Antibiotic Market Dynamics in Pakistan Through the WHO Essential Medicines and AWaRe Lens

Background: Access to safe and effective antibiotics is crucial in low- and middle-income countries (LMICs) coupled with reducing overuse to reduce antimicrobial resistance (AMR). We sought to systematically analyze the extent of branded generic antibiotics in Pakistan particularly Watch antibiotics given concerns with AMR in Pakistan. Methodology: Data on registered antibiotics was collected from the Drug Regulatory Authority of Pakistan (DRAP) and the Pharmaguides. 257 antibiotics were analyzed using the AWaRe classification. Results: Of these, 99 were registered in Pakistan including 91 single entities and 8 combinations, with 6,025 brands and 14,076 presentations. Distribution across AWaRe categories included Access - 37, Watch – 56, and Reserve - 6. Cephalosporins (2186 brands, 6447 presentations) and Quinolones (1333 brands, 2586 presentations) are the most prevalent, with Ciprofloxacin (393 brands, 1158 presentations) leading in brand and presentation counts. 6 antibiotics from the WHO Essential Medicines List lacked registered brands in Pakistan, while many available antibiotics were not included in the WHO framework. Conclusion: Extensive availability of branded generics particularly Watch antibiotics in Pakistan poses a serious risk, exacerbated by current misuse of antibiotics. Improving regulatory frameworks and strengthening stewardship are critical to reducing AMR in Pakistan along with addressing uncontrolled registration by DRAP

Development of a quality indicator set to measure and improve quality of ICU care in low- and middle-income countries

PURPOSE: To develop a set of actionable quality indicators for critical care suitable for use in low- or middle-income countries (LMICs). METHODS: A list of 84 candidate indicators compiled from a previous literature review and stakeholder recommendations were categorised into three domains (foundation, process, and quality impact). An expert panel (EP) representing stakeholders from critical care and allied specialties in multiple low-, middle-, and high-income countries was convened. In rounds one and two of the Delphi exercise, the EP appraised (Likert scale 1–5) each indicator for validity, feasibility; in round three sensitivity to change, and reliability were additionally appraised. Potential barriers and facilitators to implementation of the quality indicators were also reported in this round. Median score and interquartile range (IQR) were used to determine consensus; indicators with consensus disagreement (median < 4, IQR ≤ 1) were removed, and indicators with consensus agreement (median ≥ 4, IQR ≤ 1) or no consensus were retained. In round four, indicators were prioritised based on their ability to impact cost of care to the provider and recipient, staff well-being, patient safety, and patient-centred outcomes. RESULTS: Seventy-one experts from 30 countries (n = 45, 63%, representing critical care) selected 57 indicators to assess quality of care in intensive care unit (ICU) in LMICs: 16 foundation, 27 process, and 14 quality impact indicators after round three. Round 4 resulted in 14 prioritised indicators. Fifty-seven respondents reported barriers and facilitators, of which electronic registry-embedded data collection was the biggest perceived facilitator to implementation (n = 54/57, 95%) Concerns over burden of data collection (n = 53/57, 93%) and variations in definition (n = 45/57, 79%) were perceived as the greatest barrier to implementation. CONCLUSION: This consensus exercise provides a common set of indicators to support benchmarking and quality improvement programs for critical care populations in LMICs

Contribution of pharmacy education to pharmaceutical research and development: critical insights from educators

Aims: This article examines the outputs of pharmaceutical education with the development of the pharmacy profession and how that affects pharmaceutical innovation. It also discusses different models of collaboration between the academic and pharmaceutical industry in order to achieve a healthy collaboration between the stakeholders. Methods: The perspective, experiences and insights of educators from various backgrounds, origin and educational levels were sought regarding the role of pharmacy education in providing pharmaceutical research and development workforce. Results: Many countries around the world are currently undertaking major reforms in pharmacy education due to the changing landscape of health and healthcare delivery. These reforms must be accompanied by robust systems to assure that the quality of educational structures, processes and outcomes will produce competent pharmacy graduates in the future. It is also considered imperative that pharmacy academic institutions should establish collaboration with the drug development units, the pharmaceutical industry and government agencies for sustainability and positive research outcomes. Conclusion: Shortcomings in pharmacy curricula need to be addressed and the authors have proposed the ‘TARGET’ approach for the development of integrated pharmacy curriculum to substantially contribute to pharmaceutical research and development. </jats:sec

Barriers to Implement Generic Medicine Prescribing and Dispensing Policies in Pakistan: Current Challenges and Future Implication

Background: Prescriptions comprising of generic names have made place as the norm in many countries owing to established drug regulatory regimes. Nevertheless, generics have greatly reduced worldwide pharmaceutical and healthcare spending. Objective: The current review comprehensively explores research studies focused on generic medicine in Pakistan, utilizing a variety of research methodologies. The prime objective of this review is to assess the barriers toward the implementation of generic medicine prescribing and dispensing policies in Pakistan in order to reduce the prescription cost. Methodology: The articles were filtered using databases: Google Scholar and PubMed. The research questions were developed and focused exclusively on all literature available regarding generic medicine in Pakistan. Results: Google Scholar and Pub-Med were searched for the period 2000-2023. 45 studies were included as per our criteria. The selected papers were grouped into different themes. Seven (7) papers were included regarding knowledge, attitude, perception & practice of healthcare givers regarding generic medicine in Pakistan. Seven (7) studies were related to Availability, Affordability, Pricing of Generic Medicine in Pakistan while 31 studies were included regarding percentage of generic prescribing as per WHO Core indicators. Both quantitative and qualitative research studies were eligible for inclusion. the selected papers were grouped into different themes. Conclusion: With the help of the evidence available through screening, it has been revealed that situation of generic medicine is quite alarming in Pakistan. Bioequivalence regulations as well as proper generic policy are need of the day. Educational interventions and uncompromising compliance to the drug policies of WHO may play a part in generic medication prescribing. Implementation of pricing policies is compulsory to promote rational use of drugs and to enhance availability. Presence of qualified pharmacists and electronic health system at every level of healthcare setups is need of an hour