Time to Act on Drug Safety

Moore, Thomas J.; Psaty, Bruce M.; Furberg, Curt D.

doi:10.1001/jama.279.19.1571

Cited by 95 publications

(37 citation statements)

References 14 publications

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“…For example, liver reactions associated with some antibiotics were first identified worldwide by Australian reports. It is estimated that 50 per cent of marketed medicines have serious adverse drug reactions first detected after marketing (Moore et al 1998).…”

Section: Adverse Drug Reactionsmentioning

confidence: 99%

Reducing medication errors in hospital discharge summaries: a randomised controlled trial

Tong

Roman

Mitra

et al. 2017

Medical Journal of Australia

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Objectives: To evaluate whether pharmacists completing the medication management plan in the medical discharge summary reduced the rate of medication errors in these summaries. Design: Unblinded, cluster randomised, controlled investigation of medication management plans for patients discharged after an inpatient stay in a general medical unit. Setting: The Alfred Hospital, an adult major referral hospital in metropolitan Melbourne, with an annual emergency department attendance of about 60000 patients. Participants: The evaluation included patients' discharge summaries for the period 16 March 2015 – 27 July 2015. Interventions: Patients randomised to the intervention arm received medication management plans completed by a pharmacist (intervention); those in the control arm received standard medical discharge summaries (control). Main outcome measures: The primary outcome variable was a discharge summary including a medication error identified by an independent assessor. Results: At least one medication error was identified in the summaries of 265 of 431 patients (61.5%) in the control arm, compared with 60 of 401 patients (15%) in the intervention arm (P<0.01). The absolute risk reduction was 46.5% (95% CI, 40.7–52.3%); the number needed to treat (NNT) to avoid one error was 2.2 (95% CI, 1.9–2.5). The absolute risk reduction for a high or extreme risk error was 9.6% (95% CI, 6.4–12.8%), with an NNT of 10.4 (95% CI, 7.8–15.5). Conclusions: Pharmacists completing medication management plans in the discharge summary significantly reduced the rate of medication errors (including errors of high and extreme risk) in medication summaries for general medical patients. Australia New Zealand Clinical Trials Registry number: ACTRN12616001034426.

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Section: Adverse Drug Reactionsmentioning

confidence: 99%

Reducing medication errors in hospital discharge summaries: a randomised controlled trial

Tong

Roman

Mitra

et al. 2017

Medical Journal of Australia

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“…suicide in depression, or heart disease in diabetes). In the event, clinically important post-marketing safety concerns have emerged for 50% of approved drugs [15]. This, somewhat unfairly, is seen as a failure of regulation rather than a success for pharmacovigilance.…”

Section: Catch-22mentioning

confidence: 99%

Collateral damage: the conundrum of drug safety

Gale

2009

Diabetologia

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“…But in the opinion of some, FDA lacks the mandate, the money, and the staff to provide effective and efficient surveillance of over 5000 drugs already in the marketplace. 24 Although reporting of adverse effects by manufacturers is mandatory, late or nonreporting of cases by drug companies are major problems. Some companies have been prosecuted for failure to report, and the FDA has issued several warning letters as a result of late reporting.…”

Section: Postmarketing Surveillance Of New Productsmentioning

confidence: 99%

Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice

Deyo

2004

The Journal of the American Board of Family Medicine

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Using clinical literature and web sites addressing FDA procedures, that review concisely described the FDA's history, the official approval process, and recent developments in drug approval. However, it did not delve into common misconceptions about the FDA, tensions within the agency, or conflicts of interest in the drug approval process. The rapidly growing business of medical device development, distinct from the drug approval process, also was not addressed. Although most aspects of the FDA review process are highly successful, its limitations deserve careful consideration, because they may have important implications for choosing treatments in practice.Recent recalls of drugs and devices call attention to limitations of the approval process.2-4 Recent news about complications of hormone replacement therapy 5,6 and new data supporting the superiority of diuretic therapy over newer, more expensive alternatives for hypertension 7 emphasize gaps in the process. Clinicians should be aware of regulatory limitations as they prescribe treatments and counsel patients, so they have realistic ideas about what FDA approval does and does not mean. Because controversies relating to internal conflicts or political issues are infrequently reported in scientific journals, this discussion draws not only on scientific articles, but also internet resources, news accounts, and interviews. The goal was not to be exhaustive, but to provide examples of tensions, conflicts, and gaps in the FDA process.As Lipsky and Sharp noted, the FDA approves new drugs and devices (as well as assuring that foods and cosmetics are safe). It monitors over $1 trillion worth of products, which represents nearly a fourth of consumer spending.

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Time to Act on Drug Safety

Cited by 95 publications

References 14 publications

Reducing medication errors in hospital discharge summaries: a randomised controlled trial

Reducing medication errors in hospital discharge summaries: a randomised controlled trial

Collateral damage: the conundrum of drug safety

Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice

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