PubMed · 15550366
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Lesley Jones, Paul Coe. 2004. Extravasation.. https://doi.org/10.1016/j.ejon.2003.10.003
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PURPOSE: The General Practice Research Database (GPRD) is a database of longitudinal patient records from general practices in the United Kingdom. It is an important data source for pharmacoepidemiology studies, but until now it has been tedious to calculate the daily dose and duration of exposure to drugs prescribed. This is because general practitioners routinely record dosage instructions as free text rather than in a structured way. The objective was to develop and assess the validity of an automated algorithm to derive the daily dose from text dosage instructions. METHODS: A computer program was developed to derive numerical information from unstructured text dosage instructions. It was tested on dosage texts from a random sample of one million prescription entries. A random sample of 1,000 of these converted texts were manually checked for their accuracy. RESULTS: Out of the sample of one million prescription entries, 74.5% had text containing the daily dose, 14.5% had text but did not include a quantitative daily dose statement and 11.0% had no text entered. Of the 1000 texts which were checked manually, 767 stated the daily dose. The program interpreted 758 (98.8%) of these correctly, produced errors in four cases and failed to extract the dose from five texts. CONCLUSIONS: An automated algorithm has been developed which can accurately extract the daily dose from almost 99% of general practitioners' text dosage instructions. It increases the utility of GPRD and other prescription data sources by enabling researchers to estimate the duration of drug exposure more efficiently.
PURPOSE: To use computerized medical records to study the frequency of adverse drug reactions (ADR) as a cause for acute admission to a university hospital. METHODS: Computerized medical records in 168 consecutively acutely admitted cases to a short-term internal medicine ward at a university hospital were retrospectively evaluated to see if an ADR could have caused the admission. RESULTS: In 18 cases (11%), an ADR was judged to be the reason for acute admission to the hospital. Augmented pharmacological effects (type A reactions) accounted for 89% of the cases. An additional eight cases (5%) were intentional intoxications with prescription drugs. ADR-associated hospital admissions were age-related (average age 72 compared to 65 in patients admitted for other reasons) and also associated with poly-pharmacy (8.3 drugs compared to 5.2). The ADR was considered to arise from a drug-drug interaction in four cases (22%). Although all ADRs fulfilled the criteria for mandatory reporting, none of them were reported to the Swedish Adverse Drug Reactions Advisory Committee (SADRAC). CONCLUSIONS: The observed frequency of ADR-related acute hospital admissions in this pilot study is similar to earlier reported data from Sweden and abroad. Almost all of these reactions were known pharmacological (type A) reactions and many therefore theoretically preventable. In contrast to many prospective and costly studies, this retrospective analysis of computerized medical records offered a simple method that can be used in routine health care and also serve as an indicator of the quality of drug use.
The Center for Veterinary Medicine, U.S. Food and Drug Administration (FDA/CVM) has authority under the United States Code 21 under Section 514.80 to monitor for adverse experiences of approved animal products. Although veterinarians voluntarily report suspect drug-related events to manufacturers, firms that market FDA-approved animal products must report serious events to the FDA within 15 working days of the veterinarian or pet-owner's call to them. Under the present regulations, canine heartworm preventatives are approved for 100% efficacy after testing in laboratory and field conditions. The report of lack of efficacy against heartworm larvae is a serious adverse drug event because the resulting condition or the treatment of the condition is life threatening. Information on lack of effect that are deemed possibly, probably, or definitely drug-related available for review under generic product on the FDA/CVM website Surveillance of these reports indicates there are some failures for virtually all heartworm prevention product categories. Most failures have been reported in heartworm-endemic states. At this time, it is unclear whether these are representative of the rare occurrences of failure that have been in existence for a long time, but not reported regularly or promptly, or whether there is a true increase in complaints of ineffectiveness and real variability between products. This paper discusses methods, personnel, and procedures in place in the Division of Surveillance that will aid the FDA to better assess heartworm preventive treatment failures. It discusses scoring paradigms presently utilized by FDA/CVM to assess severity of complaints of lack of efficacy against heartworms, and welcomes audience input as to how to improve existing processes. Results suggest that more comprehensive reporting will provide FDA/CVM more accurate surveillance information regarding efficacy problems. Such practices will permit FDA/CVM to better interpret both incidence and severity of in-effect and possible patterns of emerging resistance and to convey this in any necessary updated labeling. It also indicates that as part of that process, practitioners should return to a more conservative testing schedule.