National adverse drug reaction reporting 1984-1989

Article Abstract:

Before a new drug can be approved for marketing in the United States, it must be put through an extended series of clinical studies to determine safety, efficacy, and side effects. The results of these studies are reported to the Food and Drug Administration (FDA), which makes a decision to approve or not approve the drug. In spite of the rigorous premarket testing that must be done, not all possible complications and side effects of a particular drug will emerge during studies with the limited group sizes that are employed. Consequently, some adverse effects will only become apparent after the drug is marketed and prescribed for the very old, the very young, the very sick, and other groups of patients who may not be well represented in the test populations. Hence, it is critical that physicians and others involved in prescribing and using drugs keep manufacturers apprised of any adverse reactions that they observe. Beginning in 1962, soon after a catastrophic series of birth defects were caused by the sedative Thalidomide, the FDA established a program to collect postapproval information on adverse drug reactions (ADRs). Beginning in 1985 (with the regulations updated again in 1987), manufacturers were required to submit reports from foreign studies and ongoing clinical trials, as well as any ADRs reported by physicians. Information and forms for reporting ADRs were disseminated in a widely used pharmaceutical product reference manual (Physicians Desk Reference) and in the FDA Bulletin. As a result, ADR reporting has dramatically risen in the past five years. Between 1985 and 1989, 251,515 drug reaction reports were received by the FDA, most of which originated with practicing physicians who contacted the manufacturer. The majority of ADR reports concerned relatively serious reactions to newly approved drugs. This reporting strategy has led to between 50 and 100 safety investigations annually, resulting in numerous changes in both drug usage and the safety information supplied with products. (Consumer Summary produced by Reliance Medical Information, Inc.)

Drugs, Laws, regulations and rules, United States. Food and Drug Administration, Adverse drug reactions

---

The adverse effects of hospitalization on drug regimens

Article Abstract:

When medications are prescribed to treat a patient's illness, they can not be effective if they are not taken in the proper dosage and at the proper intervals (or if they are not taken at all). The failure to adhere to prescribed dosages and frequencies of medication, known as noncompliance, is a particularly important problem among patients taking numerous medications. Noncompliance may take the form of continuing to take a discontinued medication, failing to take (or continue) a prescribed medication, and making errors in dosage and timing. The period during and immediately following hospitalization can be particularly problematic with respect to patient compliance: it has been calculated that 40 percent of the drugs taken at the time of admission are discontinued during hospitalization, and 45 percent of the drugs that will be prescribed following discharge are begun during hospitalization. With the combination of stopping medication, starting medication, and the stress of hospitalization, the patient's chances of making an error with respect to his or her medicine is great. To quantify the effects of hospitalization on compliance with drug regimens, 157 consecutive patients discharged from a hospital who were taking four or more different medications were identified, of whom 94 were potential participants in the study. Of the 43 patients who lived locally, 79 percent were interviewed within one month of discharge and 55 percent of the 51 nonlocal patients responded to a mailed questionnaire. Overall, 32 percent of the respondents had incorrectly added or deleted a drug from their regimen, while 18 percent reported errors in dosing. Twelve potentially serious errors were detected. Patients who reported no errors were taking significantly fewer different drugs (5.1 versus 6.1) and had significantly fewer drug changes during hospitalization (1.9 versus 2.7) than patients reporting errors. (Consumer Summary produced by Reliance Medical Information, Inc.)

Health aspects, Patient compliance, Drug therapy, Hospital patients, Drug use

---

Similar abstracts:

• Abstracts: Nobel Laureate Martin Rodbell dies. The when, where, and how of environmental hazards. Exposure to indoor background radiation and urinary concentrations of 8-hydroxydeoxyguanosine, a marker of oxidative DNA damage
• Abstracts: Developing and Implementing Computerized Protocols for Standardization of Clinical Decisions. CAPTURE! SHOCK! EXCITE! Clinical trial acronyms and the "branding" of clinical research
• Abstracts: Factors related to self-reporting of the pre-menstrual syndrome. Interepisodic morbidity in Kleine-Levin syndrome
• Abstracts: Risk factors for gestational trophoblastic disease: a separate analysis of complete and partial hydatidiform moles
• Abstracts: Serial abuse in children who are shaken. Bacterial meningitis in older children. Mediterranean spotted fever in children returning from France

This website is not affiliated with document authors or copyright owners. This page is provided for informational purposes only. Unintentional errors are possible.