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      Validation of pharmacy records in drug exposure assessment.

      Journal of Clinical Epidemiology
      Aged, Aged, 80 and over, Community Pharmacy Services, Cross-Sectional Studies, Drug Prescriptions, Drug Utilization, standards, Family Practice, Female, Humans, Male, Medical Records, Patient Compliance, Questionnaires, Reproducibility of Results, Sensitivity and Specificity, Time Factors

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          Abstract

          The validity of drug exposure measurement based on pharmacy records was investigated taking into account completeness of data, drug compliance, and different methods of drug exposure measurement in pharmacy records. Data on prescription drug use were collected from home inventories and community pharmacies in a survey on drug use and compliance in 115 elderly people. To compare drug exposure in pharmacy records with exposure in the home inventory, three different methods for exposure measurement in pharmacy records were used. Two employed a fixed time window of 30 and 90 days, respectively, and the third method was based on the calculated duration of use of a prescription ("legend time"). Drug exposure in the home inventory was taken as the gold standard and sensitivity, specificity, and positive predictive values of the different methods were calculated for the most frequently used drugs and drug categories. The specificity and positive predictive value of all three methods was generally high (0.93-1.00 and 0.67-1.00, respectively). The 90-day fixed method and the legend time method generally showed high sensitivity (range: 0.67-1.00 and 0.63-0.83, respectively) for drugs that were used on a chronic basis, while the 30-day fixed method had poor sensitivity (range: 0.29-0.69). Drugs that were used according to the home inventory but not according to the pharmacy records methods could be almost completely retrieved in the pharmacy records of a one-year period showing that these records were virtually complete with regard to prescription drugs. We conclude that computerized pharmacy records can be a reliable source of the true drug exposure as estimated in a home inventory, when adequate attention is paid to the definition of the exposure time-window and when these records are comprehensive with regard to prescription drugs.

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          Psychotropic drug use and the risk of hip fracture.

          To assess the risk of hip fracture associated with the use of four classes of psychotropic drugs, we performed a case-control study of 1021 patients with hip fractures and 5606 controls among elderly Medicaid enrollees. Persons treated with hypnotics-anxiolytics having short (less than or equal to 24 hours) elimination half-lives had no increased risk of hip fracture. By contrast, a significantly increased risk was associated with current use of hypnotics-anxiolytics having long (greater than 24 hours) elimination half-lives (odds ratio, 1.8; 95 percent confidence interval, 1.3 to 2.4), tricyclic antidepressants (odds ratio, 1.9; 95 percent confidence interval, 1.3 to 2.8), and antipsychotics (odds ratio, 2.0; 95 percent confidence interval, 1.6 to 2.6). The risk increased in relation to the doses of drugs in these three classes. An analysis for possible confounding by dementia did not alter the results. Previous but noncurrent use of drugs in these classes conferred no increase in risk. Although a cause-and-effect relation was not proved, these data support the hypothesis that the sedative and autonomic effects of psychotropic drugs increase the risk of falling and fractures in elderly persons. The results suggest the need for studies of this association in other populations and for evaluation of newer psychotropic drugs with fewer undesirable sedative and autonomic effects.
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            How often is medication taken as prescribed? A novel assessment technique.

            The evaluation of the efficacy of medication is confounded when patients do not adhere to prescribed regimens. Overdosing, underdosing, and erratic dosing intervals can diminish drug action or cause adverse effects. Using a new method with epilepsy as a model, we assessed compliance with long-term medications among newly treated and long-term patients. Medication Event Monitor Systems (Aprex Corporation, Fremont, Calif) are standard pill bottles with micro-processors in the cap to record every bottle opening as a presumptive dose. Compliance rates averaged 76% during 3428 days observed: 87% of the once daily, 81% of the twice daily, 77% of the three times a day, and 39% of the four times a day dosages were taken as prescribed. Coefficients of variation of drug serum concentrations had no significant relationship to compliance rates. Pill counts overestimated compliance increasingly as compliance with the prescribed regimen declined. Neither drug serum concentrations nor pill counts would have identified the frequency of missed doses that were revealed with continuous dose observations.
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              RELIABILITY OF RECALL OF DRUG USAGE AND OTHER HEALTH-RELATED INFORMATION1

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