The use of evidence in pharmacovigilance

Arnaiz, Juan A.; Carné, Xavier; Riba, N.; Codina, Carles; Ribas, José Antônio Silva; Trilla, Antoni

doi:10.1007/s002280100265

Cited by 74 publications

(12 citation statements)

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“…Nonetheless, for the reasons noted above, RCTs are disadvantaged in adverse event detection, and case reports and postmarketing surveillance are commonly responsible for the first identification of important adverse events, including those that ultimately lead to regulatory actions such as “black box” warnings and product withdrawals [26], [27]. Each approach has an important role, and complements the other to extend the understanding of drug benefits versus risks.…”

Section: Discussionmentioning

confidence: 99%

A Survey of the FDA's AERS Database Regarding Muscle and Tendon Adverse Events Linked to the Statin Drug Class

et al. 2012

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BackgroundCholesterol management drugs known as statins are widely used and often well tolerated; however, a variety of muscle-related side effects can arise. These adverse events (AEs) can have serious impact, and form a significant barrier to therapy adherence. Surveillance of post-marketing AEs is of vital importance to understand real-world AEs and reporting differences between individual statin drugs. We conducted a review of post-approval muscle and tendon AE reports in association with statin use, to assess differences within the drug class.MethodsWe analyzed all case reports from the FDA AE Reporting System (AERS) database linking muscle-related AEs to statin use (07/01/2005–03/31/2011). Drugs examined were: atorvastatin, simvastatin, lovastatin, pravastatin, rosuvastatin, and fluvastatin.ResultsRelative risk rates for rosuvastatin were consistently higher than other statins. Atorvastatin and simvastatin showed intermediate risks, while pravastatin and lovastatin appeared to have the lowest risk rates. Relative risk of muscle-related AEs, therefore, approximately tracked with per milligram LDL-lowering potency, with fluvastatin an apparent exception. Incorporating all muscle categories, rates for atorvastatin, simvastatin, pravastatin, and lovastatin were, respectively, 55%, 26%, 17%, and 7.5% as high, as rosuvastatin, approximately tracking per milligram potency (Rosuvastatin>Atorvastatin>Simvastatin>Pravastatin≈Lovastatin) and comporting with findings of other studies. Relative potency, therefore, appears to be a fundamental predictor of muscle-related AE risk, with fluvastatin, the least potent statin, an apparent exception (risk 74% vs rosuvastatin).InterpretationAE reporting rates differed strikingly for drugs within the statin class, with relative reporting aligning substantially with potency. The data presented in this report offer important reference points for the selection of statins for cholesterol management in general and, especially, for the rechallenge of patients who have experienced muscle-related AEs (for whom agents of lower expected potency should be preferred).

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Section: Discussionmentioning

confidence: 99%

A Survey of the FDA's AERS Database Regarding Muscle and Tendon Adverse Events Linked to the Statin Drug Class

et al. 2012

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“…This publication created a huge awareness among the healthcare professionals and the regulatory authorities to initiate pharmacovigilance programs in their countries. The individual case reports have also played an important role in withdrawal of harmful drugs from the market 13. However, one systematic review identified that case reports of suspected ADRs are of limited value as suspicions are seldom subjected to confirmatory investigation 14…”

Section: Discussionmentioning

confidence: 99%

Pattern and quality of scientific communications on drug safety produced by a regional pharmacovigilance center in Nepal

Palaian

Ibrahim

Mishra

2010

Pharmacy Practice (Internet)

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Analyzing the pattern and quality of scientific communications on pharmacovigilance can help the regional centers in Nepal and other developing countries to develop approaches for communicating effectively medicine safety issues. This kind of research is lacking in developing countries.Objectives:To analyze the pattern and quality of scientific communications on drug safety produced by the regional pharmacovigilance center at western Nepal.Methodology:Various conference abstracts and journal publications produced by the center during its initial four years of establishment (14th September 2004 till 13th September 2008) were identified. These communications were categorized in to case reports, review articles, conference presentations, short communications, newsletter and bulletin articles, original research and case series. In addition, the quality of the case reports were evaluated as per International Society of Pharmacovigilance/International Society of Pharmacoepidemiology (ISoP/ISPE) guidelines on the requirements for submitting case reports on adverse event reports in biomedical journals.Results:During the study period, 53 scientific communications were produced by the staff of the regional pharmacovigilance center in relation with drug safety. Among these, 18 (34%) were related to case reports and letters. The median (interquartile range) age of the patients described in the case reports was 46.5 (21.7-51.2) years. Among the total 18 ADRs, four were fixed drug eruptions, followed by contact dermatitis (n=2). Majority of the published case reports were related to skin (n=13; 72.2%). Antimicrobials were responsible for 27.8% (n=5) of the case reports. Among the 18 case reports published by the pharmacovigilance center, a majority followed the ISoP/ISPE guidelines. Few parameters like physical examination of the patient experiencing ADR, patient disposition, dosage and administration of the suspected drugs, and drug-reaction interface were missing in few of the cases.Conclusion:A high percentage of the scientific communications were ‘case reports’. A high proportion of the case reports produced by the center were of international standards. There were lacunae in ‘patient disposition’ in few of the reports.

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“…However, the absence of a control group and the lack of a denominator indicate that the attributable rate of the ADR cannot be calculated 28. Case reports are the main source of information used to withdraw a drug from the market for safety reasons 29. In assessing the culprit drug, it is difficult to determine whether the report is a genuine alert or a false alarm 30.…”

Section: Discussionmentioning

confidence: 99%

Signal detection to identify serious adverse events (neuropsychiatric events) in travelers taking mefloquine for chemoprophylaxis of malaria

Naing¹,

Aung²,

Ahmed³

et al. 2012

DHPS

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BackgroundFor all medications, there is a trade-off between benefits and potential for harm. It is important for patient safety to detect drug-event combinations and analyze by appropriate statistical methods. Mefloquine is used as chemoprophylaxis for travelers going to regions with known chloroquine-resistant Plasmodium falciparum malaria. As such, there is a concern about serious adverse events associated with mefloquine chemoprophylaxis. The objective of the present study was to assess whether any signal would be detected for the serious adverse events of mefloquine, based on data in clinicoepidemiological studies.Materials and methodsWe extracted data on adverse events related to mefloquine chemoprophylaxis from the two published datasets. Disproportionality reporting of adverse events such as neuropsychiatric events and other adverse events was presented in the 2 × 2 contingency table. Reporting odds ratio and corresponding 95% confidence interval [CI] data-mining algorithm was applied for the signal detection. The safety signals are considered significant when the ROR estimates and the lower limits of the corresponding 95% CI are ≥2.ResultsTwo datasets addressing adverse events of mefloquine chemoprophylaxis (one from a published article and one from a Cochrane systematic review) were included for analyses. Reporting odds ratio 1.58, 95% CI: 1.49–1.68 based on published data in the selected article, and 1.195, 95% CI: 0.94–1.44 based on data in the selected Cochrane review. Overall, in both datasets, the reporting odds ratio values of lower 95% CI were less than 2.ConclusionBased on available data, findings suggested that signals for serious adverse events pertinent to neuropsychiatric event were not detected for mefloquine. Further studies are needed to substantiate this.

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The use of evidence in pharmacovigilance

Cited by 74 publications

References 0 publications

A Survey of the FDA's AERS Database Regarding Muscle and Tendon Adverse Events Linked to the Statin Drug Class

A Survey of the FDA's AERS Database Regarding Muscle and Tendon Adverse Events Linked to the Statin Drug Class

Pattern and quality of scientific communications on drug safety produced by a regional pharmacovigilance center in Nepal

Signal detection to identify serious adverse events (neuropsychiatric events) in travelers taking mefloquine for chemoprophylaxis of malaria

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