Ethical Decision-Making and ADR Rerporting

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Last week’s Tip of the Week explored ethical decision-making. 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 informal or formally part of Phase IV clinical drug trials, this is critical, because the randomized controlled trials of 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 not so strictly governed by such trials. Pharmacists can report suspected adverse drug reactions (ADRs) to the FDA using their MedWatch program, which is electronic and can be done relatively easily.

Stergiopolous et al examine 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 interview 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; that 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 even mentioning their organization gets concerned with bureaucracy, time waste, and even 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 encouragement to do the right thing.

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. If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to Pharmacy Management: Essentials for All Practice Settings, 5e. If your institution does not provide access, ask your medical librarian about subscribing.

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.

Shane Desselle

Professor of Social and Behavioral Pharmacy, Touro University California

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Go to the profile of Shane Desselle
7 months ago

Greater ethical reasoning results in greater likelihood of reporting ADEs. Managers can support ethical reasoning training and skills, in addition to creating a safety climate for the entire staff.