The underreporting of suspected adverse drug reactions hinders pharmacovigilance. Solutions to underreporting are oftentimes directed at clinicians and health care professionals. However, given the recent rise of public inclusion in medical science, solutions may soon begin more actively involving patients. I aim to offer an evaluative framework for future possible proposals that would engage patients with the aim of mitigating underreporting. The framework may also have value in evaluating current reporting practices. The offered framework is composed of three criteria (...) that are bioethical, social-epistemic, and pragmatic: (i) patients should not be exposed to undue harms, e.g., nocebo effects; (ii) data should be collected, analyzed, and communicated prioritizing pharmacovigilance’s aims, i.e., free from industry bias; and (iii) proposals should account for existing and foreseeable pragmatic constraints like clinician ‘buy in’ and existing reporting infrastructure. Proposals to engage patients in pharmacovigilance that fulfil or address these criteria are preferable to those that do not. (shrink)

The underreporting of suspected adverse drug reactions remains a primary issue for contemporary post-market drug surveillance or ‘pharmacovigilance.’ Pharmacovigilance pioneer W.H.W. Inman argued that ‘deadly sins’ committed by clinicians are to blame for underreporting. Of these ‘sins,’ ignorance and lethargy are the most obvious and impactful in causing underreporting. However, recent analyses show that diffidence, insecurity, and indifference additionally play a major role. I aim to augment our understanding of diffidence, insecurity, and indifference by arguing these sins are (...) underwritten by value judgments arising via epistemic risk. I contend that ‘evidence-based’ medicine codifies these sins. (shrink)

Abstract: To improve the countries’ pharmaceutical situation and to monitor the progress, the World Health Organization (WHO) and member states developed a system of indicators to measure the respective important aspects as a prerequisite step. Level I indicators to assess the country’s pharmaceutical situation include the national drug policy; legislation and regulations; drug accessibility and affordability; essential drug list; quality control; pharmacovigilance; storage and distribution; information and rational use. This study is aimed to document the professional opinion of 20 (...) pharmacy practice professionals on Libya’s current pharmaceutical situation, utilizing WHO indicator-based approach. The core indicators measure the most important information needed to understand the pharmaceutical situation in a country. A closed-end questionnaire was distributed to ten practicing pharmacists and ten pharmacy teaching staff members who practice pharmacy. The questionnaires were handed over personally and collected on the same day. The responses were analyzed using simple statistics. The results were argued in the light of the first author’s observation and view, being expert in this field, with reference to the other experts’ views, relevant publications’ findings and WHO reports’ conclusions on these indicators. Suggestions and recommendations for a proper situation assessment, planning and action taking are presented. Primarily, government’s commitment towards appropriate restructuring, management and monitoring of the pharmaceutical sector is crucial. That is to enhance the country’s pharmaceutical situation, to provide and sustain efficient pharmaceutical services and to improve the overall health care system’s performance. (shrink)