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PubMed1996

Prescription writing in Gondar outpatient teaching hospital, Ethiopia.

A total of 19,119 prescriptions consecutively written between January-July 1992 were collected from Gondar outpatient hospital selling pharmacy and reviewed to determine physician's adherence to the basic principles of prescription order writing. In 36.6%, 16.8% and 12.4% of the prescriptions, respectively, age, sex and chart numbers of patients were not recorded. Twelve percent, 7%, 6.4%, 5.8% and 1.6% of the prescriptions did not indicate routes of drug administration, directions for drug use, frequency of drug administration, drug dose and duration of treatment, respectively. No prescription order had special advice or warnings to the patient and in 10.8% of the cases date was omitted. Out of the dispensed drugs, 82.9% were written in generic names and over 70% were included in the Essential Drug List of Ethiopia. The five most commonly dispensed individual drugs were ampicillin (10.4%), paracetamol (9.5%), TB 450 + isoniazid (7.4%), penicillin G (6.8%) and aspirin (5.8%). As therapeutic classes, antiinfectives were most common (47.8%) of which antibacterials constituted 38.1%, followed by analgesic-antipyretics (17.5%). Most drugs were prescribed by young medical interns and dispensed by less qualified personnel. Our preliminary survey indicates that essential components of a prescription order were omitted to a great extent and suggested to modify the existing undergraduate pharmacotherapeutic teaching in order to promote rational use and prescribing before bad habits get a chance to develop. The type of drugs dispensed at the selling pharmacy could not be beneficial to the patient without competent professional patient counselling, delivery of correct information as well as appropriate prescription monitoring.

Drug Prescriptions↗
PubMed1997

[Anticipated effects of experimental heroin prescription on the method of administration and the use of other drugs].

OBJECTIVE: Pending a Dutch heroin prescription trial (intended to regulate drug abuse), preliminary research was conducted into client factors that may influence the course and outcome, notably into administration patterns and changes in concomitant use of other drugs. DESIGN: Interview. SETTING: Methadone programme Baan in Rotterdam, the Netherlands. METHOD: In a Rotterdam methadone programme, 60 clients were identified matching the target group of a heroin prescription trial; 42 respondents were interviewed. Using a semistructured questionnaire, data were collected on characteristics of drug use in the preceding month. RESULTS: In addition to their methadone supply, the majority (90%) of the respondents used both heroin and cocaine. Heroin and cocaine were smoked as well as injected by 22% and 31% respectively. In the choice of a route of administration individually experienced effects played a major part, which suggests that participation in a prescription trial will not lead to shifts in employed routes of administration. Cocaine was often found to have a central position in polydrug use, while the function of heroin was mostly that of a modulator. This suggests that no direct effect on the use of cocaine can be expected from the prescription of heroin. On the contrary, the relationship between the available amount of money and the cocaine used was such that, considering that participants in a prescription trial may be left with more money, a prescription trial might lead to an increased use of cocaine. CONCLUSION: The prescription of heroin does not seem to have a direct effect on the use of cocaine. Indirectly the use of cocaine might increase.

Adult↗
PubMed2006

Use of an online surveillance system for screening drug interactions in prescriptions in community pharmacies.

OBJECTIVE: Computerised surveillance systems have become available for screening potential adverse drug interactions during drug prescribing and dispensing. The purpose of this study was to analyse the frequency and profile of alerts given by one such system in two community pharmacies in Finland. METHODS: In a prospective study, all interaction alerts given by the surveillance system were collated during September-November 2004 in two community pharmacies in Southern Finland. The alerts were categorised into four classes (A-D) according to their clinical significance. RESULTS: During the 3-month study period, a total of 39,539 prescriptions were dispensed. The system flagged 3,861 prescriptions as having potential interactions (9.8% of all prescriptions). Since one prescription could be the source of several interaction alerts, a total of 5,647 alerts were given. The clinically most significant interactions (class D) represented 0.4% of prescriptions (3.0% of all interactions). Class C alerts were most prevalent (9.4% of all prescriptions, 65.9% of all interactions). The most commonly encountered interaction in class D was between warfarin and non-steroidal anti-inflammatory drugs. CONCLUSIONS: Although the incidence of potentially most hazardous interactions in prescriptions is rather low in this study (0.4%), the overall incidence is relatively high (9.8%). Implementation of the interaction surveillance system in the participating pharmacies makes it possible to study in the future in quantitative terms whether the quality of drug dispensing is improved.

Community Pharmacy Services↗
PubMed2006

Exploring racial and ethnic disparities in prescription drug spending and use among Medicare beneficiaries.

BACKGROUND: Little is known about why minority Medicare beneficiaries spend less on and use fewer prescription drugs than white Medicare beneficiaries. OBJECTIVE: We explored whether population differences in demographic characteristics, socioeconomic status, and health status were associated with observed disparities by race and ethnicity in the prescription drug spending and use of noninstitutionalized elderly Medicare beneficiaries. METHODS: We used a nationally representative sample of 8101 white, 816 black, and 642 Hispanic Medicare beneficiaries from the 1999 Medicare Current Beneficiary Survey Cost and Use files. For each of these groups, we calculated total prescription drug spending, out-of-pocket spending, and number of prescriptions. We then used the Oaxaca-Blinder decomposition method to separate the impact of race and ethnicity on disparities in spending and use from the impact of differences in population characteristics across racial and ethnic groups. RESULTS: Much of the disparity in spending between whites and blacks and some of the disparity between whites and Hispanics can be attributed to race/ethnicity. Because of race/ethnicity, total spending for whites was 8.9% more than for blacks and 5.4% more than for Hispanics. Similarly, total out-of pocket spending for whites was 28.8% more than for blacks and 10.7% more than for Hispanics. Race/ethnicity also influenced the amount of prescription drug use. Whites used 2.3 more prescriptions than blacks and 1.6 more than Hispanics. However, these differences in use were offset by the impact of differences in population characteristics. CONCLUSIONS: Differences in factors identified in the Andersen model of access to care do not fully explain observed disparities in prescription drug use and spending. The portion of the disparities due to race and ethnicity may reflect patients' skepticism about medicine and medical care in general, patients' adherence to medical advice, patient-physician communication, physicians' prescribing habits, and usual source of care. Future research should explore whether these and other unobserved factors associated with race and ethnicity are responsible for disparities in drug spending and use.

Black or African American↗
PubMed2005

Antibiotic prescription practice in an intensive care unit using twice-weekly collection of screening specimens: a prospective audit in a large UK teaching hospital.

Controversy exists regarding the optimal method of managing intensive care unit (ICU)-acquired infection. Antibiotic prescriptions in 177 sequential admissions to our ICU, which collected twice-weekly screening samples, were audited. Seventy-seven percent of patients received at least one antibiotic prescription, and 45% of patients received at least one prescription for suspected or proven sepsis. Of the 353 antibiotic prescriptions audited, 86 were prophylactic and 61 were first prescribed prior to ICU admission. One hundred and eighty-three were prescribed for sepsis; of these, 108 (59%) were empirical prescriptions and only 21% of these were subsequently changed. For the 75 prescriptions for specific organisms, 28% targeted organisms isolated at least four days previously. Clinicians in our ICU reviewed the data and reached consensus that screening was associated with decision making that did not represent current evidence-based practice, because empirical prescriptions were rarely changed or stopped on the basis of new samples, and those prescribed for confirmed infection frequently targeted organisms isolated before the septic episode. After our audit, we stopped regular collection of screening samples and used more targeted and invasive sampling, in response to clinical suspicion, to guide therapy and maintain data concerning local microbial epidemiology.

Anti-Bacterial Agents↗
PubMed2006

Assessment of antibiotic prescription in acute urinary tract infections in adults.

OBJECTIVES: To assess the appropriateness of antibiotic prescription for urinary tract infections in several hospital emergency services and to evaluate the variability of antibiotic prescription among these services. METHODS: A cross-sectional study was carried out in the emergency services of 10 hospitals from different Spanish regions. The sample was composed of patients diagnosed with acute urinary infection, aged> or =14 years. A Consensus Conference, held by a panel of experts, established first-choice, second-choice and inappropriate antibiotic treatments for each type of urinary tract infection, based on the available scientific evidence. All the observed prescriptions in our study were classified according to this pattern. The main variables were: type of urinary infection, antibiotic prescription, urine culture request, comorbidity and hospital admission. RESULTS: A sample of 3797 acute urinary tract infections was studied. Eighty-one percent were lower urinary tract infections. The most commonly used antibiotics were ciprofloxacin and amoxicillin-clavulanate. The global percentages of first-choice, alternative-choice and inappropriate antibiotic prescriptions were: 42.4% (95% CI: 40.8-43.9), 44.1 (95% CI: 42.5-45.7) and 13.6% (95% CI: 12.5-14.7), respectively. We observed a significant variability in appropriateness of antibiotic prescriptions among the participating centres (p<0.001). CONCLUSIONS: Physicians at Spanish emergency rooms prescribe an excessive number of second-choice antibiotics for urinary tract infection treatment. There exists a high variability in antibiotic prescription among hospitals from different regions.

Adolescent↗
PubMed2005

[Adequate prescription of antibiotic therapy for urinary tract infections in hospital: identifying and correcting non-observance of guidelines].

OBJECTIVE: We analyzed the adequacy of antibiotic therapy prescribed for urinary tract infections (UTI): prostatitis, pyelonephritis, indwelling catheter-associated UTIs, or other undefined UTIs. DESIGN: The adequacy of prescriptions to local guidelines was assessed retrospectively in two wards (Internal Medicine and Surgical Urology) of the Nantes University Hospital. The principal criteria involved simultaneously: choice of the molecule, dose, and treatment duration. Non-observances of guidelines were major (non-adequacy of the molecule, prescription of a non-active molecule according to in vitro susceptibility tests, non-appropriate treatment abstention), or minor (non-justified treatment, non-justified bitherapy, no prescription of bitherapy when requested, no treatment adaptation when requested, too short or too long treatment length, dosage mistakes). RESULTS: One thousand eighty-six infections were collected over a 24-month period. The overall rate of adequate prescriptions was 40.1% (46.6% in Internal Medicine and 36.5% in Surgical Urology). In Internal Medicine (226 non observance among 389 prescriptions), the ratio of major non-observance of guidelines was 9.8%. Among them, 44.7% were non-appropriate treatment abstentions. In Surgical Urology (539 non observance out of 695 prescriptions), non-observance related to treatment length were the most frequent. The ratio of major non-observance was 19.9%. Among them, non-adequacy of the molecule reached 60.7%. Non-justified treatment and non-appropriate bitherapies were frequent. CONCLUSIONS: For both units, indwelling catheter-related UTIs and other UTIs accounted for more than 50% of the infections although not detailed in the local guidelines. Identifying and analyzing Non observance may lead to targeted correcting actions to improve prescription quality.

Adult↗
PubMed1999

Racial differences in hormone replacement therapy prescriptions.

OBJECTIVE: To examine racial differences in hormone replacement therapy (HRT) use by analyzing the relative risks and rates of HRT prescriptions for black and white women. METHODS: Data on visits to hospital outpatient departments and office-based physicians by black and white women aged 45-64 years were obtained from 25,203 visits sampled in the 1993-1995 National Ambulatory Medical Care Surveys and National Hospital Ambulatory Medical Care Surveys. The relative effect of race on the provision of an HRT prescription at an ambulatory visit was estimated by controlling confounders using logistic regression. Population-based rates of physician visits and visits with HRT prescriptions were also calculated to address issues involving access to care. RESULTS: Approximately 98,787,000 annual visits were made by black and white women 45-64 years of age, 9.2% of which involved prescriptions for HRT. The percentage of visits by black women in which prescriptions for HRT were reported (4.5%) was roughly half that of white women (9.7%). The association persisted after controlling for type of physician, practice type, geographic region, payment source, and non-HRT prescription(s) (odds ratio 2.1; 95% confidence interval 1.5, 2.9). The rate of ambulatory care among black women (3.82 visits per year per woman) was virtually identical to that of white women (3.94 visits per year), whereas the rate of visits with HRT prescriptions for white women was twice as high as for black women (0.38 and 0.17 visits per year, respectively). CONCLUSION: Apparent racial differences in HRT use persist after controlling for physician and visit factors not explored in previous studies.

Black or African American↗
PubMed2003

[Circannual Periodicity of Prescriptions in a Psychiatric Hospital]

The total number per month of prescribed antibiotics or psychiatric drugs during one year (1998) was assessed by means of sine wave models [Y(t) = M + A x sin(2 x pi x t/tau + Phi)]. M (no. of prescriptions per month) denotes mean frequency over one period, A (no. per month) denotes amplitude, tau (month) corresponds to the period and Phi (month) to the phase of the fitted curve. Data were evaluated descriptively and chronograms including 95 %-confidence limits were given. Significant nonlinear regression models could be calculated for amoxicillin, paroxetine, citalopram, amitriptyline and buspirone prescription behaviour. Both circannual and ultra-annual (period shorter than one year) rhythms of prescription were found. Peak values for antibiotic drug prescription during fall and winter is probably associated with higher incidence of infectious diseases. Antidepressant drug prescription has maxima in spring and fall, which is in keeping with the epidemiology of depressive disorders. The seasonality of buspirone prescription may reflect a basic periodicity of anxiety disorders. In conclusion, the chronopharmaco-epidemiological data of antibiotic and antidepressant drug prescription with circannual and ultra-annual rhythms may reflect the periodicity of infectious and psychiatric diseases.

Journal Article↗
PubMed2006

Prescription drug spending for Medicare+Choice beneficiaries in the last year of life.

BACKGROUND: In 2006, Medicare implemented its prescription benefit plan. Therefore, insights into medication costs at the end of life may help guide clinicians to navigate Medicare Part D coverage for chronically ill individuals. OBJECTIVES: We examined drug spending by disease and demographics for Medicare+Choice (M+C) beneficiaries in the last year of life (LYOL). RESEARCH DESIGN: Retrospective review of M+C decedents' drug claims and enrollment data collected between January 1998 and December 2000, supplemented by the Medicare denominator file and 1990 Census data. SUBJECTS: Four thousand six hundred two beneficiaries in a large national managed care organization. MEASURES: We analyzed the relationship between prescription drug expenditures and sociodemographic descriptors, insurance characteristics, and cause of death. RESULTS: The mean annual number of prescriptions filled was 36.9; the managed care organization (MCO) paid $539 and beneficiaries paid $627. Higher expenditures were significantly correlated with female gender, higher number of comorbidities, and whether beneficiaries obtained the insurance as an employer-based retiree benefit. Minority beneficiaries had 26% fewer prescriptions. Increasing levels of annual median household income corresponded with a 20% increase in the number of prescriptions and a 25% increase in mean out-of-pocket expenses, between those with a median household income of less than $20,000 and those with $40,000 or greater. In the LYOL, chronic obstructive pulmonary disease and diabetes had the highest average number of prescriptions and total expenditures. Individuals dying from strokes or other unclassifiable conditions had the lowest average number of prescriptions and average total expenditures. CONCLUSION: Medication expenditures in the LYOL were highly dependent upon selected sociodemographic, insurance characteristics, and disease states.

Aged↗
PubMed1990

Effects of labeling techniques on memory and comprehension of prescription information in young and old adults.

We conducted a study to determine the effects of presenting prescription information in a pictorial compared to a verbal format on comprehension and memory in young and old adults. Both comprehension and memory for drug information were studied as a function of age and presentation method. Participants received prescription instructions on actual medicine bottles in one of two formats: verbal instructions only, or verbal instructions mixed with pictorial representations. Results indicated that (a) younger adults' memory for prescription information was facilitated by the mixed instructions, but that mixed instructions appeared to hamper older adults' memory for prescription information; (b) younger adults recalled more information overall relative to older adults across both presentation conditions; and (c) older adults were less able to comprehend prescription information relative to younger adults. Results suggest that well-organized verbal prescription labels are more facilitative for the elderly and that additional efforts must be undertaken to improve the clarity of labeling on prescription drugs.

Adult↗
PubMed1994

Consumers' preference and willingness to pay for pharmacist counselling for non-prescription medicines.

Pharmacist counselling for non-prescription medicine purchases is one way of ensuring that these medicines are used in a safe and effective manner. Data collected as part of a larger study of information sources on non-prescription medicines were used to determine consumers' preference for pharmacist counselling for non-prescription medicine purchases, their willingness to pay for the service, and the amount they were willing to pay. A total of 458 (15.2%) consumers from six contiguous states in the U.S.A. responded to the mailed questionnaire. Of the consumers who responded, 63.4% indicated a preference for such a counselling service and, of these consumers, 20.4% indicated a willingness to pay for the service. Of the consumers who indicated a willingness to pay for pharmacist counselling for non-prescription medicines, 56.5% were willing to pay between 50 cents and $1.50, 28.2% between $1.51 and $3, and about 15.3% were willing to pay more than $3. Significant differences were noted in consumers' preference for pharmacist counselling when compared on the basis of certain consumer characteristics. Consumers who indicated a preference for pharmacist counselling for non-prescription medicines showed a significantly higher involvement in non-prescription medicine purchase decision, perceived pharmacists to be more credible, and indicated more favourable previous encounters with pharmacists than consumers who did not prefer pharmacist counselling. Consumers who consulted pharmacists and usually accepted their recommendations were also more likely to prefer pharmacist counselling for non-prescription medicines.

Adult↗
PubMed2006

Effectiveness of written guidelines on the appropriateness of thromboprophylaxis prescriptions for medical patients: a prospective randomized study.

OBJECTIVE: To assess the effectiveness of providing doctors with written thromboprophylaxis prescription aids based on current recommendations. DESIGN: A prospective trial of specific anticoagulant prescription forms: a 1-day survey before and after the intervention in each centre. SETTING: 30 Internal Medicine departments of Assistance Publique-Hôpitaux de Paris. SUBJECTS: All inpatients were included, except those who were either admitted or discharged on the day of the survey, and those receiving curative anticoagulant treatment. INTERVENTIONS: The study included three parts: (i) a 1-day baseline survey; (ii) over the following 3-month period, departments were randomized into two groups: all practitioners in wards allocated to the intervention group were required to systematically use specific anticoagulant prescription forms, whilst doctors in the control group continued prescribing according to their usual practices and (iii) a 1-day postintervention survey. MAIN OUTCOME MEASURE: The proportion of prescriptions in accordance with the recommendations. RESULTS: 1,469 patients were included. The intervention produced a significant reduction in the frequency of over-prescriptions, from 25% to 14% of the patients who did not meet the guideline criteria (adjusted OR: 0.3; 95% CI: 0.1-0.8). Using specific forms did not improve under-prescription of anticoagulants. A little over 60% of the patients who met guideline criteria for thromboprophylaxis were prescribed anticoagulants in both intervention and control wards, either at baseline or after intervention. CONCLUSIONS: Multitargeted interventions using a variety of means and strategies should still be considered to improve prescriptions that may have a significant impact on health expenses and, most importantly, on patients outcomes.

Aged↗
PubMed2004

Antipsychotic drug prescription for schizophrenia in East Asia: rationale for change.

The purpose of this international collaborative study was to investigate the prescription patterns of antipsychotic drugs for schizophrenia in East Asia and to analyze factors that affect these patterns. Prescription patterns for patients admitted for treatment of schizophrenia were surveyed using a standardized protocol from six East-Asian region/countries: China, Hong Kong, Japan, Korea, Singapore and Taiwan. Patients' social and clinical characteristics, psychiatric symptoms, course of illness, and adverse effects of medications were systematically assessed and recorded. Prescriptions of the first- and second-generation antipsychotic drugs were compared. A total of 2399 patients were recruited. The second-generation drugs comprised 28.1% of all prescribed antipsychotics, and 46% of the antipsychotic prescriptions were in the context of polypharmacy. The mean dosage of antipsychotics for the whole sample was 675.3 + 645.1 mg chlorpromazine equivalents. Japan had a high frequency of prescribing high doses and polypharmacy; Singapore had a high utilization of depot injections while China had a higher prescription of clozapine. Using multiple logistic regression analysis, distinctions in the prescription patterns of antipsychotic drugs were found: first-generation drugs were mainly for controlling aggressive behavior, while second-generation drugs were targeted at the alleviation of positive, negative psychotic symptoms as well as disruptive behavior in schizophrenia. The present collaborative study highlighted differences in the prescription patterns, especially the under-utilization of second-generation antipsychotic drugs in East Asia. The pattern of antipsychotic medication use varied from country to country and is likely to be influenced by the prevailing health-care system, the availability and cost of the drugs.

Adult↗
PubMedDate not supplied

Impact of a limited fluoroquinolone reimbursement policy on antimicrobial prescription claims.

OBJECTIVE: To examine the influence on administrative pharmacy claims of a policy that limited the reimbursement of the fluoroquinolones and other antimicrobials in the senior population within Nova Scotia, Canada. METHODS: The administrative claims database of the Nova Scotia Seniors' Pharmacare Program was used to identify all prescription claims for orally administered antibiotics and urinary antiinfectives. The number of beneficiaries receiving antimicrobials and the number, duration, and cost of prescriptions for antimicrobials were measured monthly. Descriptive time-series plots were used to compare antimicrobial use for two 12-month periods before the institution of the policy (December 1, 1994-November 30, 1995, and December 1, 1995-November 30, 1996) and the 12 months after the policy took effect (January 1, 1997-December 31, 1997). RESULTS: Following the implementation of the fluoroquinolone reimbursement policy, the number of patients using antimicrobials decreased by 2.2% and the number of prescriptions for antimicrobials decreased by 3.4%. Fluoroquinolone prescriptions decreased by 80.2%; prescriptions for sulfonamides and trimethoprim increased by 34.9%, cephalosporins by 17.0%, and macrolides and lincosamides by 16.5%. The only prescription duration to change was the fluoroquinolones, which increased by 25%. The average cost per antimicrobial user/year decreased from $35.24 during prepolicy period 2 to $27.51 during the postpolicy period. CONCLUSIONS: Prescription claims for fluoroquinolones in seniors decreased following the introduction of the policy. Total antimicrobial use also decreased, although this may be related to other factors. The effect of this policy change on patient outcomes requires further study.

Aged↗
PubMed2001

Prescription drug use, diagnoses, and healthcare utilization among the elderly.

BACKGROUND: More elderly patients affected by severe and chronic diseases are treated in primary care. Reports on the use of prescription drugs by the general elderly population are scarce, and more investigations are needed to optimize pharmaceutical care for these patients. OBJECTIVE: To analyze prescription drug use, diagnoses, and healthcare utilization among noninstitutionalized elderly patients. DESIGN: Retrospective cohort study. SETTING AND PATIENTS: All people > or =65 years old (n = 4642) living in the community of Tierp, Sweden, in 1994 were included. Prescription drug use and healthcare utilization have been registered for all inhabitants of the community since 1972. Information about filled prescriptions and diagnoses were obtained from a computerized research register. RESULTS: Prescription drug use was high among the elderly (78%); the most used pharmacologic groups were cardiovascular, nervous system, and gastrointestinal medications. Women used more prescription drugs than men (average 4.8 vs. 3.8) and had more nonfatal diagnoses. Use of five or more different prescription drugs during 1994 was common (39.0%), and multivariate analysis showed that the greatest number of primary care visits occurred with multiple drug use (> or =5 drugs over 1 y). CONCLUSIONS: This study shows an extensive multiple drug use among elderly people living at home. Whether this multiple drug use per se is harmful to the patients or not could not be evaluated in this study. Further focused investigations are needed to assess the effect of multiple drug use in an elderly population.

Age Distribution↗
PubMedDate not supplied

Private dental and prescription-drug coverage in children: data from the medical expenditure panel survey.

OBJECTIVE: Most studies on health insurance have examined primarily basic medical insurance coverage; few have looked at supplemental insurance and/or dental-insurance coverage. Prescription-drug and dental-insurance coverage are becoming increasingly important due to continued increase in health care costs and changes in cost-sharing structure of health plans. This study examined prescription-drug coverage and dental-insurance coverage in the context of overall insurance coverage. METHOD: This study utilized the Household Component File from the 2000 Medical Expenditure Panel Survey (MEPS), a national survey on medical care conducted by the Agency for Healthcare Research and Quality (AHRQ). Univariate and bivariate analyses were performed to provide estimates on children's prescription-drug and dental-insurance coverage. Multivariate logistic regression analyses were conducted to identify demographic and socioeconomic factors that influence coverage. RESULTS: In 2000, 68.5% of US children had private insurance, 22.2% had public insurance, and 9.3% were uninsured. Among children with private insurance, only 56.9% had dental-insurance coverage and 76.3% had prescription-drug coverage. Family income level, maternal education, and race were significant predictors of dental insurance and prescription-drug coverage. CONCLUSION: Although significant strides have been made to insure US children, a large percentage of children still do not have comprehensive coverage. Even among privately insured children, many are without dental or prescription-drug coverage. Those who were poor, minority, and with low maternal education had lower likelihood of dental and prescription-drug coverage.

Child↗
PubMed2001

Age- and gender-specific asthma death rates in patients taking long-acting beta2-agonists: prescription event monitoring pharmacosurveillance studies.

OBJECTIVE: Prescription event monitoring is a national drug safety surveillance scheme in which prescribers are prompted to report events and deaths following prescription of newly marketed drugs. This paper presents age- and gender-specific asthma death rates in patients prescribed the long-acting beta2-agonists salmeterol and bambuterol. DESIGN AND SETTING: Pharmacosurveillance cohort study of general practice patients in England. PATIENTS AND PARTICIPANTS: 15 406 patients prescribed salmeterol between December 1990 and May 1991, and 8098 patients prescribed bambuterol between February 1993 and December 1995. METHODS: Patients prescribed these drugs by general practitioners in England were identified using the national pharmacovigilance system of prescription event monitoring, in which details of all dispensed prescriptions were provided in confidence by the Prescription Pricing Authority. Questionnaires were sent to the prescriber asking for details of events occurring after the first prescription. In each study an attempt was made to establish the cause of all deaths reported on the questionnaires, via retrieval of the patients' medical notes or examination of death certificates. OUTCOME MEASURES AND RESULTS: There was little evidence of heterogeneity in the drug-specific death rates and we therefore present the combined age- and gender-specific death rates for the 2 cohorts. Overall, there were 85 asthma deaths among people taking the long-acting beta2-agonists studied (bambuterol and salmeterol cohorts combined). The overall death rate was 2.33 [95% confidence interval (CI) 1.84 to 2.84] per 10000 months of observation. There were 37 asthma deaths among male patients (rate 2.40 per 10000 months of observation; 95% CI 1.74 to 3.40) and 48 asthma deaths among female patients (rate 3.08 per 10000 months of observation; 95% CI 2.21 to 3.98). There was no difference in death rates when male and female patients were compared (rate ratio 0.78; 95% CI 0.49 to 1.22; p = 0.26). CONCLUSION: Prescription event monitoring is a form of prompted surveillance allowing rapid, uniform, national and practical assessment of newly marketed drugs on large cohorts of patients in England. These data provide benchmark rates from which to assess the performance of newly prescribed anti-asthma drugs and generate hypotheses for later analytical investigation in which confounding by indication and asthma severity can be controlled for. Any differences in these rates should be considered as a source of signal generation within the context of a surveillance programme, rather than as robust evidence of any mortality differential between drugs.

Adrenergic beta-Agonists↗