Black box warnings (BBWs) are the Food and Drug Administration's (FDA) strongest labeling requirements for high-risk medicines. It is unknown how frequently physicians prescribe BBW drugs and whether they do so in compliance with the warnings. The purpose of the present study was to assess the frequency of use of BBW medications in ambulatory care and prescribing compliance with BBW recommendations.
This retrospective study used automated claims data of 929 958 enrollees in 10 geographically diverse health plans in the United States to estimate frequency of use in ambulatory care of 216 BBW drugs/drug groups between 1/1/99 and 31/6/01. We assessed dispensing compliance with the BBW requirements for selected drugs.
During a 30-month period, more than 40% of enrollees received at least one medication that carried a BBW that could potentially apply to them. We found few instances of prescribing during pregnancy of BBW drugs absolutely contra-indicated in pregnancy. There was almost no co-prescribing of contra-indicated drugs with the two QT-interval-prolonging BBW drugs evaluated. Most non-compliance occurred with recommendations for baseline laboratory monitoring (49.6% of all therapy initiations that should have been accompanied by baseline laboratory monitoring were not).
Many individuals receive drugs considered to carry the potential for serious risk. For some of these drugs, use is largely consistent with their BBW, while for others it is not. Since it will not be possible to avoid certain drug- associated risks, it will be important to develop effective methods to use BBWs and other methods to minimize risks.
"These studies find significant (although generally modest) declines in prescribing in response to FDA information. However, one study found that 40 percent of patients received at least one medication with a black-box warning that could have applied to them, suggesting that FDA warnings may not result in targeted reductions in use of labeled drugs (Wagner et al. 2006). Past studies have also examined consumption responses to various forms of medical information, such as drug withdrawals, medical report cards, and academic studies. "
[Show abstract][Hide abstract] ABSTRACT: We examine how consumer use of antidepressant medications was influenced by warnings provided by the Food and Drug Administration (FDA) about the increased risk of suicidality associated with antidepressant use among children. Using data from the Medical Expenditure Panel Survey, we find evidence consistent with reduced use of antidepressants among the intended population (children), as well as spillover effects of reduced use among an unintended population (adults). Our results indicate that consumers may perceive extra risks beyond those specifically mentioned in warnings.
Review of Economics of the Household 10/2008; DOI:10.2139/ssrn.1292082 · 0.64 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: It regularly happens that medications are found to cause severe adverse effects that remained undetected during premarketing research. From the perspective of the patient, the public and drug manufacturers there is a need for better tools for earlier detection, quantification and mechanistic unraveling of associations between drug exposure and adverse health outcomes in patient populations. A tool that is considered to be valuable for this purpose is a database with patient-oriented data on medication exposure and laboratory test results collected in clinical care. The objective of this thesis was to investigate the value of laboratory data collected in patient care for drug safety research. We focused on drug-induced thrombocytopenia as an example. First, we investigated the association between thrombocytopenia and exposure to drugs most often reported to cause thrombocytopenia. For this study we used data from the PHARMO Record Linkage System. To identify patients with thrombocytopenia hospital discharge diagnoses were used. An increased risk for thrombocytopenia following exposure to beta-lactam antibiotics was found. The expected increase in risk for thrombocytopenia could not be confirmed for the other medications investigated. This may be the result of limited statistical power, in which incomplete identification of patients with drug-induced thrombocytopenia by using hospital discharge diagnoses could play a role. Following-up this study we compared the use of hospital discharge diagnoses for thrombocytopenia with the use of platelet measurements as strategy for case-finding potential drug-induced thrombocytopenia from health care data. We found that using platelet measurements is a more sensitive approach for this purpose. However a low platelet count was observed to be non-specific for potential drug-induced thrombocytopenia. For this study we used data from the Utrecht Patient Oriented Database (UPOD). UPOD is a recently established database for (pharmaco-)epidemiological research, encompassing automated data on laboratory test results, medication exposure, hospital discharge diagnoses, medical procedures and patient demographics for all patients treated at the UMC Utrecht. By using data from UPOD we performed three studies concerning different aspects of drug-induced thrombocytopenia: the incidence and relative risk of chemotherapy-induced thrombocytopenia, a biomarker for the mechanism of chemotherapy-induced thrombocytopenia and compliance with recommendations for monitoring the platelet count for heparin-induced thrombocytopenia. We respectively found that the cytostatic drugs carboplatin, gemcitabine and paclitaxel are associated with the highest risk for thrombocytopenia in oncology patients treated in clinical practice, platelet size indices can not be used to distinguish bone marrow and immune-related causes of chemotherapy-induced thrombocytopenia and compliance to recommendations to monitor for heparin-induced thrombocytopenia in patients treated with low molecular weight heparin is low. We concluded that linking laboratory and medication data with in a research database is a valuable tool for investigating the safety of drugs in patient populations, including the investigation of the incidence, risk factors and monitoring for adverse drug reactions that can be detected with a biochemical test (such as drug-induced blood disorders) and the identification of potential biomarkers for adverse drug reactions. The knowledge from this research is valuable in maximizing the benefits of effective medications in patients treated in clinical practice.
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