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Increased prescription of thrombolytic treatment to elderly patients with suspected acute myocardial infarction associated with audit.

OBJECTIVES: To assess prescription of thrombolytic treatment to elderly patients with suspected acute myocardial infarction and the incidence of side effects. DESIGN: Retrospective analysis of prescriptions during five months (first audit) followed by prospective analysis of uptake of treatment during five months after interventions in clinical management; prospective assessment of adverse events during thrombolytic treatment. SETTING: Coronary care unit of large district general hospital. PATIENTS: 110 patients aged greater than or equal to 65 with subsequently proved acute myocardial infarction admitted in first audit and 119 admitted in the second. MAIN OUTCOME MEASURES: Site of infarct, prescription of thrombolysis treatment, reasons for nonprescription, complications. RESULTS: Before intervention thrombolytic treatment was prescribed to 13/110 (12%) patients with subsequently confirmed myocardial infarction and after intervention to 55/119 (46%) patients (p less than 0.01). In the first audit no patients with angina received thrombolytic treatment whereas 13/79 (16%) were treated in the second audit. Increased prescription of thrombolytic treatment in the second audit was associated with significantly fewer exclusions owing to dyspepsia (p less than 0.05) and unstated or unsatisfactory reasons (p less than 0.01) Streptokinase infusions were completed uneventfully in 75% (48/64) and 77% (10/13) of patients with infarction and angina respectively. Side effects of treatment were more common in patients with inferior than with anterior infarcts (16/42 (30%) v 3/24 (13%), p less than 0.05). CONCLUSIONS: Low rates of prescription of thrombolytic treatment to elderly patients with suspected acute myocardial infarction were identified and corrected. Streptokinase treatment was associated with transient arrhythmias or hypotension in about a third of these patients with infarcts, particularly those with electrocardiographic changes in inferior leads.

Aged↗

Evidence based educational outreach visits: effects on prescriptions of non-steroidal anti-inflammatory drugs.

AIMS: To evaluate the effectiveness of an evidence based group educational outreach visit on prescription patterns of non-steroidal anti-inflammatory drugs (NSAIDs) in primary care. DESIGN: Randomised controlled simple blind trial, with randomisation into three groups: experimental (evidence based educational outreach visit), placebo (conventional education session), and control (without intervention). SETTING: The 24 primary care centres of the National Institute of Healthcare Network in a rural province of Aragon, Spain. PARTICIPANTS: The 24 primary health care teams of the network, with 158 general practitioners (GPs). The teams were randomised into the groups, experimental (8 teams, 48 GPs), placebo (8 teams, 54 GPs), and control (8 teams, 56 GPs). INTERVENTION: Experimental group: one group educational outreach visit, conveying data based on a systematic review of the literature that was reinforced with printed material; placebo group: one non-structured educational session; control group: no intervention. Both educational sessions emphasised that there are no differences in the effectiveness of the NSAIDs reviewed (diclofenac, piroxicam, and tenoxicam); a recommendation was made to prescribe diclofenac over tenoxicam because of price differences. MAIN OUTCOME MEASURES: Changes in the number of packages prescribed for each of the drugs and changes in the cost per package of NSAIDs prescribed during the six months before, and after the intervention. RESULTS: There were no differences in the basal characteristics of the three groups, except for the number of prescriptions during the six months before the intervention. Prescriptions for NSAIDs decreased homogeneously in the three groups. For tenoxicam, the experimental group reduced prescriptions by 22.5% (95%CI: 34.42 to -10.76), compared with a reduction of 9.78% (95%CI: -17.70 to -1.86) in the placebo group and an increase of 14.44% (95%CI: 5.22 to 23.66) in the control group. The average cost per prescription decreased by 1.91% (95%CI: -0.33% to -3.49%) in the experimental group, 0.16% (95%CI: -0.27% to -2.93%) in the placebo group, and rose by 1.76% (95%CI: 0.35% to 3.17%) in the control group. CONCLUSIONS: Evidence based educational outreach visits are more effective than no intervention at all. Results suggest that evidence based educational outreach visits are incrementally more effective than conventional educational sessions, which in turn are more effective than no intervention at all.

Anti-Inflammatory Agents, Non-Steroidal↗

A trial of education, prompts, and opinion leaders to improve prescription of lipid modifying therapy by primary care physicians for patients with ischemic heart disease.

BACKGROUND: Recent clinical trials indicate that treatment with lipid modifying therapy improves outcomes in patients with ischemic heart disease (IHD) and low levels of high density lipoprotein (HDL) cholesterol. The results of these trials, however, have not been widely implemented in clinical practice. OBJECTIVES: To develop and test an intervention designed to increase the rate of prescription of lipid modifying therapy and to determine the relative effectiveness of three different prompts (progress notes, patient letters, or computer chart reminders). METHODS: The study was conducted in 11 US Department of Veterans Affairs Medical Centers. The effect of the intervention on the proportion of eligible patients receiving lipid modifying therapy was compared between five intervention sites and six matched control sites using a controlled before and after study design. Additionally, 92 providers within the intervention clinics were randomized to receive one of the three prompts. Data were analyzed using logistic regression modeling which incorporated terms to account for the clustered nature of the data. RESULTS: At the intervention sites the prescription rate increased from 8.3% during the pre-intervention period to 39.1% during the intervention (OR = 6.5, 95% CI 5.2 to 8.2, p<0.0001) but remained unchanged at the control sites. The interaction between group (control v intervention) and time period was highly significant (p<0.0001). The adjusted odds of receiving a prescription during the intervention period was 3.1 times higher at the intervention sites than at the control sites (95% CI 2.1 to 4.7). Overall, there was no significant difference in prescription rates among the three prompt groups. However, there was a significant interaction between prompt group and site, indicating that the efficacy of the prompts differed by site. CONCLUSION: An intervention for primary care providers consisting of an educational workshop, opinion leader influence, and prompts substantially increased the prescription rate of lipid modifying therapy.

Aged↗

[Efficacy of educational sessions to modify the prescription of new drugs].

OBJECTIVE: To evaluate the efficacy of an educational intervention to minimise the prescription of those new medicines whose therapeutic effects are of little benefit. DESIGN: Controlled and randomised experimental study. SETTING: 27 health centres in the province of Sevilla, Spain. PARTICIPANTS: 376 general practitioners. The 264 who worked in the same posts were randomised for the 6 pre-intervention months. 10 of them did not complete the post-intervention period. INTERVENTIONS: Four 45-minute training sessions in a 2-month period, given by health team doctors, with a critical reading of the studies available on recently marketed drugs, plus personal feed-back on prescription and bulletins on therapeutic novelties. The control group received only the feed-back and bulletins. MAIN MEASUREMENTS: Prescription of new medication of little benefit, measured as the number of packages out of the total. Second, the amount of coxib and eprosartan measured as defined daily doses. RESULTS: In the 6 months after the educational sessions, the doctors in the intervention group prescribed proportionately fewer therapeutic novelties of little benefit than those allocated to the control group (1.34% vs 1.62%; P<.001). The coxib and eprosartan prescribed showed only a non-significant trend towards less prescription by the intervention group. CONCLUSIONS: The group educational sessions, run by doctors trained in aspects of evidence-based medicine and prepared jointly with the pharmacy unit, reduced discreetly the prescription of new medicines that were not very innovative.

Drug Prescriptions↗

[Trends in preventive drug prescription in the Primary Care District of Seville [2000-2003]].

OBJECTIVES: To describe trends in prescription rates for biphosphonates, raloxifene, calcitonin, statins and hormone replacement therapy (HRT) between 2000 and 2003 and to assess the impact of mass media information on the interruption of the Women's Health Initiative trial on HRT prescription rates. METHODOLOGY: We performed a descriptive, ecological study, with time (month) as the observation unit. Monthly rates of bisphosphonate, calcitonin, raloxifene, statins and HRT prescription, in defined daily doses per 1000 persons, were measured in the population assigned to 249 family physicians in 27 health centers in Seville. Trend graphs and time series analysis were carried out. RESULTS AND DISCUSSION: The prescription of preventive drugs has tended to increase between 2000 and 2003. The HRT prescription rate has decreased since the interruption of the Women's Health Initiative trial.

Drug Prescriptions↗

[Definition and validation of quality indicators of prescription in primary care].

OBJECTIVE: To define and validate a battery of prescription indicators on the use of anti-hypertensives, lipid-lowerers, diabetes drugs, and insulin, as measurements of family doctors' quality of prescription in primary health care. DESIGN: Transversal, descriptive study. SETTING: Two primary care health districts, Camas and Sierra Norte, Spain. PARTICIPANTS: Eighty three family doctors, 94.32% of the doctors in the study area. DEFINITION AND VALIDATION OF INDICATORS: To construct the prescription indicators, we used evidence found in the scientific bibliography available. To validate it, we analysed its statistical relationship with a series of selected clinical tests, collected from the clinical records. RESULTS: For each doctor, there was a statistically significant relationship between the index of quality of prescription and the clinical quality seen in the records (P=.004). The variables of age, sex, and training fine-tuned the model. CONCLUSIONS: There is a statistically significant relationship between a good prescription indicator and proper control of intermediate health variables.

Adult↗

[Inspection validation of prescription: guaranteeing proper use of medicines or a cost-control measure?].

OBJECTIVE: To assess the views of primary care physicians (PCPs) in Spain regarding the purpose of inspection validation of prescriptions (IVP) and its impact on prescription and patients, as well as doctors' acceptance of this measure. DESIGN: Cross-sectional study through a telephone survey. SETTING: Primary care centres. PARTICIPANTS: PCPs prescribing oral diabetes drugs requiring IVP, or who were familiar with IVP. METHODS: Telephone survey conducted in October-November, 2003, of 1471 PCPs. Sample size was calculated to ensure accuracy to 10% in each autonomous region. RESULTS: 91.9% of the 1600 PCPs contacted who agreed to participate in the study met the inclusion criteria. On average, they prescribed 30.6 drugs requiring IVP per month (95% CI, 28.0-33.2), requiring an additional 4.6 minutes per prescription (95% CI, 4.4-4.8). 64.7% of PCPs increased their clinical work-time for this reason. 71.3% of PCPs (95% CI, 69.0-73.6) considered IVP an obstacle when prescribing a drug that requires it and 44.5% (95% CI, 42.0-47.0) believed that the IVP puts patients' right to receive the appropriate treatment at risk. PCPs considered that inspectors refuse authorization of their prescriptions requiring IVP for administrative (43.3%), economic (36.5%), or clinical (13.2%) reasons. 87.1% of PCPs stated that medical prescription is a sufficient control system and that IVP is not necessary for medicines for diseases managed in primary care such as Type-2 DM. 76.2% believed that the health authorities imposed the IVP requirement for some oral diabetes drugs in order to control expenditure on drugs, and 75.4% supported its withdrawal. CONCLUSION: According to PCPs, the objective of the IVP is mainly economic and may affect negatively their clinical practice and patients. Therefore, in general, they do not support it, at least for drugs for diseases mainly managed in primary care.

Cost Control↗

Racial disparities in antipsychotic prescription patterns for patients with schizophrenia.

OBJECTIVE: This study aimed to examine the extent and type of variation in antipsychotic prescription patterns between African American and Caucasian patients with schizophrenia. METHOD: Subjects were 2,515 adult Medicaid recipients treated for schizophrenia in 1995 with one of four types of antipsychotic medication (traditional antipsychotics, clozapine, risperidone, or depot antipsychotics). Prescription and mental health service use data were collected from Medicaid claims files for the 12 months following the first filled antipsychotic prescription. Patterns of antipsychotic prescription were compared for African American (N=1,538, 61%) and Caucasian (N=977, 39%) subjects. RESULTS: African American subjects were significantly younger and more likely to receive Supplemental Security Income than were the Caucasian subjects, who received mental health services more continuously. African American subjects were less likely than Caucasian subjects to receive clozapine (8% versus 15%, respectively) and risperidone (25% versus 31%) and more likely to receive depot antipsychotics (26% versus 14%). The likelihood of receiving clozapine or risperidone remained significantly different after demographic and service use characteristics were controlled. CONCLUSIONS: This study found ethnic disparities in antipsychotic prescription patterns among a large number of publicly insured clients treated for schizophrenia. Given the rapidly changing pharmacological treatment environment, these findings have significant implications for differential quality of care for African American patients. Future studies employing client and provider characteristics are urgently needed to test alternative explanations for ethnic disparities.

Adolescent↗

Are international guidelines for the prescription of adjuvant treatment for early breast cancer followed in clinical practice? Results of a population-based study on 1547 patients.

AIMS AND BACKGROUND: The results of several randomized trials and meta-analyses have been reported on adjuvant treatment for early breast cancer and treatment guidelines have been defined accordingly, but detailed data are lacking on the appropriateness of treatment prescription in clinical practice. METHODS: We performed a prospective, observational, multicenter study to monitor the prescription, delivery and effectiveness of radiotherapy following conservative surgery for early breast cancer; 1610 patients treated with postoperative radiation to the breast in 1997 were entered by 12 centers in Lombardy, Italy. Here we report the results of a secondary analysis focused on the prescription of medical adjuvant treatment (1547 eligible patients). RESULTS: Chemotherapy only was prescribed to 526 patients (33%), hormonal therapy only to 539 (33%), and both treatments to 85 patients (5%); 460 women (29%) received no medical adjuvant treatment. We compared the collected data with guidelines defined in 1995 by the St Gallen Consensus Conference. Undertreatment was most frequent in node-negative patients at intermediate/high risk, no treatment (instead of tamoxifen or chemotherapy) being prescribed in 21-45% of cases. Node-negative patients at low risk, on the other hand, were overtreated with tamoxifen in 31% of cases. In node-positive, premenopausal women compliance with guidelines was far better, with a 91-96% rate of chemotherapy prescription. In node-positive, postmenopausal, estrogen receptor-positive patients chemotherapy was unduly prescribed in as many as 56% of cases. Comparison of clinical practice with the next version of the guidelines (1998) showed a somewhat better compliance. CONCLUSIONS: Despite the availability of official and authoritative guidelines, adjuvant treatment prescription for early breast cancer in Lombardy in 1997 was suboptimal, especially in well-defined subgroups of patients.

Adult↗

A profile of alcohol and prescription drug abuse in a high-risk community-based elderly population.

Substance abuse among the elderly is relatively common but often remains undetected or ignored by health and social workers. Psychosocial and health factors related to the aging process are the major contributors to alcoholism and other drug abuse. It is estimated that between two and ten percent of individuals over the age of 60 suffer from alcoholism. This article profiles alcohol and prescription drug abuse among the geriatric clientele of Elderly Services of Spokane (ESS), a division of the Spokane (Washington) Community Mental Health Center. In addition to traditional channels, ESS uses a unique gatekeeper network to identify high-risk, community-based elderly. Elderly persons referred by gatekeepers are regarded as "hidden" elderly and at highest risk; notably, 37 percent of ESS clients are referred via this mechanism. Case management records of 1668 ESS clients were reviewed for a history of alcoholism, and a total of 161 persons (9.6 percent) were diagnosed with either primary or secondary alcohol abuse. Fifty subjects (about five percent of the average active ESS caseload) were referred for prescription drug abuse. Misused prescription drug classes were sedative-hypnotics, antianxiety agents, and analgesics. Diazepam, codeine, meprobamate, and flurazepam were the top four agents, and 92 percent of the subjects were found to have a duration of prescription drug abuse in excess of five years. A 60 percent correlation between prescription drug abuse and previous or active alcoholism was found. Additional characteristics of the geriatric study population are discussed in detail, including specific psychosocial factors, source of referral, age, gender, living situation, marital status, psychiatric history, and presence of polypharmacy.

Aged↗

Use of prescription medications in an elderly rural population: the MoVIES Project.

OBJECTIVE: To determine the pharmacoepidemiology of prescription drug use in a rural elderly community sample, specifically the numbers and categories of medications taken and the factors associated with them. DESIGN: Cross-sectional community survey. SETTING: The mid-Monongahela Valley of southwestern Pennsylvania. PARTICIPANTS: An age-stratified random sample of 1360 community-dwelling individuals, aged 65 years and older. MEASURES: Self-reported use of prescription drugs demographic characteristics, and use of health services. RESULTS: Nine hundred sixty-seven participants (71%) reported regularly taking at least one prescription medication and 157 (10%) reported taking five or more medications (median 2.0, range 0-13). Women took significantly more medications than men (median 2.0, range 0-13 and median 1.0, range 0-9, respectively; p = 0.01). The use of a greater number of medications was independently and statistically significantly associated with older age, hospitalization within the previous 6 months, home health care in previous year, visit to a physician within the previous year, and insurance coverage for prescription medication. Individuals older than 85 years were significantly more likely to be taking cardiovascular agents, anticoagulants, vasodilating agents, diuretics, and potassium supplements. Significantly more women than men were taking nonsteroidal antiinflammatory drugs, antidepressants, potassium supplements, and thyroid replacement medications. CONCLUSIONS: Both the number and the types of prescription medications vary with age and gender. The demographic and health service use variables associated with greater medication use in the community may help define high-risk groups for polypharmacy and adverse drug reactions. Longitudinal studies are needed.

Age Factors↗

[Surveillance study about the use actual of prescription drugs from the viewpoint of gender].

In recent years, the concept of gender-specific medicine has become generalized in Japan. We need to understand gender differences in the pattern of use prescription drugs for the appropriate use of medications. We therefore investigated gender differences in the use of prescription drugs based on data form nine hospitals in Japan. The data were extracted from their drug ordering systems in the month from March 1 to 31, 2003. We analyzed the data from the viewpoints of sex and age. The frequency of prescriptions for central nervous system drugs and Kampo medicines was higher for women than for men. The same trend was seen for hormones and vitamins. On the other hand, the frequency of prescriptions for cardiovascular drugs for men was higher than that for women. The same trend was found for unclassified metabolic drugs such as arthrifuges. As a result of detailed analysis by age-group, it is suggested that a correlation exists between the age specificity of prescription drugs and gender differences in disease occurrence. This information had not previously been investigated in Japan. Since the results appear useful, we to improve perform more detailed analyses and accumulate evidence to improve drug therapy.

Adolescent↗

Prescription drug abuse among ecstasy users in Miami.

This study examines the nature, extent and consequences of prescription drug abuse among 143 ecstasy users in Miami. Participants were recruited through nightclub and college campus outreach, and through respondent referrals. Instrumentation included the Risk Behavior Assessment, Substance Abuse Module and Center for Epidemiological Studies Depression Scale. Median age was 23, 42% were female and 50% Hispanic. An arrest history was reported by 44%, and 33% reported prior drug/alcohol treatment. Prescription drug abuse was reported by 87%; alprazolam (57%), oxycodone (36%), hydrocodone (32%) and diazepam (30%) were cited most often. Prescription drug abusers were more likely to report polydrug use, drug treatment histories, risky drug use behaviors, and symptoms of depression. They also reported numerous physical, psychological and social consequences of prescription drug abuse. Additional studies among larger samples are needed to understand the processes of prescription drug access and the extent of integration in club drug using cultures.

Adolescent↗

Pharmacist support for selling syringes without a prescription to injection drug users in Rhode Island.

OBJECTIVE: To examine pharmacists' attitudes and obstacles to syringe sales to IDUs without prescriptions in Rhode Island, around the time that such sales became legal in the state. DESIGN: Self-administered written survey. SETTING: Rhode Island. PARTICIPANTS: 400 randomly selected pharmacist members of the Rhode Island Pharmacists Association. MAIN OUTCOME MEASURES: Responses to survey items. RESULTS: Of the 400 pharmacists contacted, 131 (33%) completed and returned the survey; of these, 101 (77%) were pharmacists who worked in stores that provided direct nonprescription syringe sales to the public. The majority of these 101 pharmacists were willing to sell syringes to a suspected IDU without a prescription (65%), favored providing free sharps containers for disposal (68%), and supported providing pamphlets on safer injection practices (88%). Willingness to sell syringes to IDUs without a prescription was significantly correlated with various beliefs about possible consequences of sales. CONCLUSION: The high level of support for nonprescription syringe sales to IDUs is promising. The correlation between the willingness to sell syringes to IDUs without a prescription and various beliefs suggests that future educational interventions might encourage pharmacists to sell syringes to this population without a prescription to decrease HIV and hepatitis transmission.

Adult↗

National observational study of prescription dispensing accuracy and safety in 50 pharmacies.

OBJECTIVES: To measure dispensing accuracy rates in 50 pharmacies located in 6 cities across the United States and describe the nature and frequency of the errors detected. DESIGN: Cross-sectional descriptive study. SETTINGS: Chain, independent, and health-system pharmacies (located in hospitals or managed care organizations). PARTICIPANTS: Pharmacy staff at randomly selected pharmacies in each city who accepted an invitation to participate. INTERVENTION: Observation by a pharmacist in each pharmacy for 1 day, with a goal of inspecting 100 prescriptions for dispensing errors (defined as any deviation from the prescriber's order). MAIN OUTCOME MEASURE: Dispensing errors on new and refill prescriptions. RESULTS: Data were collected between July 2000 and April 2001. The overall dispensing accuracy rate was 98.3% (77 errors among 4,481 prescriptions; range, 87.2%-100.0%; 95.0% confidence interval, +/- 0.4%). Accuracy rates did not differ significantly by pharmacy type or city. Of the 77 identified errors, 5 (6.5%) were judged to be clinically important. CONCLUSION: Dispensing errors are a problem on a national level, at a rate of about 4 errors per day in a pharmacy filling 250 prescriptions daily. An estimated 51.5 million errors occur during the filling of 3 billion prescriptions each year.

Drug Labeling↗

Medication use patterns and health outcomes among patients using a subsidized prescription drug program.

OBJECTIVE: To evaluate medication adherence, medication safety, health care utilization, and health outcomes among patients enrolled in a subsidized prescription program. DESIGN: Cross-sectional study. SETTING: Conducted as part of the Prescription Access program, a subsidized prescription program serving indigent patients residing in Franklin County, Ohio. PATIENTS: Patients qualifying for enrollment in the program were uninsured and had a household income of 200% or less of federal poverty level. Approximately 5% of the 2,500 patients (mean age, 70.6 years) enrolled in the program were systematically selected from a computer-generated patient enrollment report. INTERVENTION: Telephone interviews conducted by a pharmacist or advanced student pharmacist between January and September 2002. MAIN OUTCOME MEASURES: Patterns of medication use and safety, level of health care utilization, and health outcomes. RESULTS: A total of 104 patients reported taking a mean (+/- SD) of 6.7 +/- 3.8 medications. A total of 72 (69%) patients reported taking their medications correctly, and 90 (87%) reported finishing their medication course as prescribed. Medication refills were obtained by 75 (72%) patients, but of these patients, only 55 (73%) indicated that they obtained their refills on time. Adverse effects occurred in 25 (24%) patients, and 2 patients reported an allergic reaction. A total of 51 (49%) patients made unscheduled visits to their primary care physician, another health care facility, an emergency department, and/or were admitted to a hospital. Unscheduled visits occurred more often among nonadherent patients (59%) than adherent patients (44%), but not significantly so. In addition, 82 (79%) patients reported an improvement in health-related quality of life (QOL); 90 (87%) had a means of transportation to obtain medications; and 93 (89%) indicated that they would have to skip medications or give up necessities, if they were not enrolled in a subsidized prescription program. CONCLUSION: An improvement in self-reported QOL and a high rate of medication adherence demonstrate support for the benefits of this and similar subsidized prescription drug programs. A high rate of additional health care utilization, especially among nonadherent patients, indicates an area for further analysis, program revisions, and/or patient education.

Aged↗

Common prescriptions in ambulatory care in Lebanon.

OBJECTIVE: To describe prescribing practices of family physicians in a staff model health maintenance organization at a university health center in Lebanon and estimate costs of such practices for common diseases. METHODS: All prescriptions issued between July 1, 1997, and June 30, 1998, were prospectively collected. The diagnoses made by physicians at each encounter were recorded, and the total price of medications prescribed was calculated. The core prescribing indicators as defined by the World Health Organization and the mean annual prescription price per person for the 25 most common diagnoses were calculated. RESULTS: Prescribing occurred in 27.1% of encounters, with a mean of 1.6 medications per encounter; 17.5% of all prescriptions included an antibiotic. Generic drugs and essential drugs each accounted for 2.9% of all medications. Approximately 50% of the consultations for either respiratory or ear infections resulted in a prescription. Cervical spine syndromes and lipid metabolism disorders cost most among recorded diagnoses, with mean annual prescription prices per person of US $2016 and $1128, respectively. CONCLUSIONS: The low rate of generic and essential drug prescribing, as well as the frequency of prescribing in respiratory infections, highlight the need for initiatives to help rationalize prescribing in primary care in Lebanon. Together with the diagnostic categories incurring high cost per person, these issues can be part of physician education or treatment guideline development. These measures may aid the government in its subsidy of primary health care centers.

Academic Medical Centers↗

Why aren't lower, effective, OTC doses available earlier by prescription?

BACKGROUND: Many popular oral over-the-counter (OTC) drugs were originally available only by prescription, but not at the low doses contained in their OTC counterparts. Yet, if OTC doses are effective for treating mild symptoms, why weren't these low, often safer doses made available at least by prescription when the drugs were first approved? OBJECTIVE: To examine issues surrounding the delayed approval of OTC doses by the Food and Drug Administration (FDA). METHODS: Information reviewed included package inserts, data obtained from manufacturers, and articles published in MEDLINE (1966 to December 2001). Medications examined included presently available and potentially approved OTC antiinflammatory, gastrointestinal, and antihistamine drugs. RESULTS: Considerable data demonstrate the effectiveness of ibuprofen, naproxen, ranitidine, famotidine, nizatidine, diphenhydramine, and clemastine at OTC doses. Published studies also show the effectiveness of celecoxib, omeprazole, and fexofenadine at doses 33-50% lower than currently recommended for prescription use. CONCLUSIONS: OTC doses are effective for many patients with mild symptoms and for some with serious symptoms. However, OTC-like doses are usually not offered when drugs are approved for prescription use because new drugs are usually studied in patients with serious conditions requiring higher doses; manufacturers and the FDA seem to prefer a middle-dose approach; >75% of subjects in premarketing dose studies are male; and averaging the responses of study subjects may obscure a wide range of interindividual variation in drug response. Simplistic dosage guidelines make therapeutic decisions easier. Because dose-related adverse effects frequently diminish quality-of-life and reduce adherence, the early availability of OTC-like doses, at least by prescription, would allow healthcare professionals greater flexibility in matching medication doses to patients' widely differing needs.

Anti-Inflammatory Agents, Non-Steroidal↗