Ethical Decision-Making and ADE Reporting

Ethical Decision-Making and ADE Reporting

Ethical decision-making governs our everyday practice. Among the many choices and potential behaviors that lie before them, pharmacists have an obligation to contribute toward pharmacovigilance, the ongoing monitoring of drugs epidemiologically for safety. Whether informally or formally part of Phase IV clinical drug trials, this is critical, because the randomized controlled trials in Phases I-III of new drug development might not catch some of the untoward events from drugs being taken by larger number of persons in the real world who are not under the strict surveillance of those trials. Pharmacists can report suspected adverse drug reactions (ADRs) to the FDA using its MedWatch program, which is electronic and wherein the reporting can be done quite easily.

Stergiopolous et al examined adverse drug event (ADE) reporting.1 They discuss the underreporting of ADRs worldwide. Their study explored the process for reporting ADEs in US hospitals, ambulatory settings, and retail pharmacies; the gaps and inconsistencies in the reporting process; and the causes of under-reporting ADEs in these settings among various health care professionals (HCPs). They conducted surveys and interviews of thought leaders around the U.S. A total of 123 individuals completed the survey (42% were pharmacists; 27% were nurses; 15 % were physicians; and 16 % were classified as ‘other’). HCPs indicated that the main reasons for under-reporting were difficulty in determining the cause of the ADE, given that most patients receive multiple therapies simultaneously; HCPs lack sufficient time to report ADEs; there is poor integration of ADE-reporting systems; there exists uncertainty about reporting procedures; and that their organization's culture does not really reward or facilitate the reporting of ADEs, with some stating that their organization gets concerned with bureaucracy, time waste, and even potential litigation, which would appear unlikely given reporting of drug-centric events to a Federal agency.

Pharmacists must demonstrate the ethical cognition and understanding that reporting ADEs contributes to the public good. Pharmacy managers must encourage and provide training when necessary for pharmacists to have the proper decision-making, easy access, and autonomy to do the right thing. They must promote the cultures of “safety first” and “patient first”. Proper ethical decision-making will do much toward proper reporting of ADE reporting.

Additional information about Ethical Decision Making and Risk Management in Contemporary Pharmacy Practice can be found in Pharmacy Management: Essentials for All Practice Settings, 5e.

1Stergiopolous S, Brown CA, Felix T, Grampp G, Getz KA. A survey of adverse event reporting practices among US healthcare professionals. Drug Safety. 2016;39:1117-1127.

Authored by:

Shane P. Desselle, RPh, PhD, FAPhA, Professor of Social/Behavioral Pharmacy at Touro University California

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