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PubMed2002

The effect on social welfare of a switch of second-generation antihistamines from prescription to over-the-counter status: a microeconomic analysis.

BACKGROUND: The US Food and Drug Administration (FDA) recently held a meeting to determine whether the status of second-generation antihistamines (SGAs) should be switched from prescription (Rx) to over-the-counter (OTC) status. OBJECTIVE: This article provides a conceptual microeconomic framework for addressing issues regarding the impact of such a switch on social welfare. METHODS: A review of the economic literature on Rx-to-OTC switches was conducted. Relevant articles published in English between 1990 and 2001 were identified through searches of ABI Info, EconLit, PsychInfo, MEDLINE, CANCERLIT, AIDSLINE, and HealthStar, as well as a general Internet search for statements in the press or on the FDA Web site. The search terms used were Rx, prescription, OTC, over-the-counter, second-generation antihistamines, nonsedating antihistamines, first-generation antihistamines, and sedating antihistamines. Microeconomic models focusing on consumer surplus were employed to determine the potential price response and social-welfare implications of a switch of SGAs to OTC status. RESULTS: Unlike the agents involved in previous Rx-to-OTC switches, SGAs are still under patent protection. Economic theory suggests that a firm that is protected by a patent will price aggressively. The market for OTC SGAs is likely to be more elastic due to a lack of insurance coverage for OTC products; hence, drug manufacturers would be likely to charge a lower price if SGAs were sold OTC. However, a lower price does not necessarily guarantee an improvement in social welfare; the net impact is determined by whether the increase in consumer surplus outweighs the deadweight loss (losses of consumer and producer surplus not transferred to other parties). Additionally, the assumption of a price reduction would be called into question if there were inequalities in marginal costs between the Rx and OTC markets. In this situation, the postswitch price might increase or not be reduced significantly. CONCLUSIONS: It is uncertain whether granting OTC status to SGAs would be cost saving to society, particularly as these drugs are patent protected. The social-welfare implications of such a switch would depend heavily on pricing strategies and consumer behavior. Further analyses are needed to determine how both factors influence social welfare; only then can the costs and benefits of a switch be understood completely.

Drug Industry↗

PubMed2004

A retrospective data analysis of the impact of the New York triplicate prescription program on benzodiazepine use in medicaid patients with chronic psychiatric and neurologic disorders.

BACKGROUND: Benzodiazepines are treatment mainstays for several disorders, but there is often concern about dependency and addiction. In January 1989, New York implemented regulations requiring physicians to order benzodiazepines using state-monitored triplicate prescription forms. OBJECTIVE: The purpose of this study was to assess the effects of the triplicate prescription program (TPP) on changes in use of benzodiazepines and other psychoactive drugs in clinically vulnerable Medicaid populations. METHODS: Using an interrupted time series with comparison series design, psychoactive medication use was examined in the New York (intervention) and New Jersey (control) Medicaid programs before and after implementation of the New York benzodiazepine TPP among community-dwelling Medicaid beneficiaries aged >/=19 years continuously enrolled from January 1988 through December 1990 in New York or New Jersey with diagnoses of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizoid personality disorder, or schizotypal personality disorder; bipolar disorder; epilepsy; and/or panic disorder, agoraphobia without history of panic disorder, social phobia, or specific phobia. RESULTS: A total of 125,837 New York and 139,405 New Jersey Medicaid beneficiaries were continuously enrolled and met the study inclusion criteria. Of these, there were 6054 Medicaid enrollees in New York and 6875 enrollees in New Jersey who were clinically vulnerable patients with >/=1 of the specified diagnoses. New York Medicaid patients with any of these diagnoses experienced a -48.1% relative change (95% CI, -50.0% to -46.2%) in benzodiazepine use at 6 months after TPP implementation, with no decline in use in New Jersey patients. The largest reduction in benzodiazepine use was seen among patients with seizure disorder (-59.9% at 6 months; 95% CI, -63.9% to -55.9%). Although use of substitute drugs increased slightly in New York after the TPP, it did not offset reductions in benzodiazepine use. The effects of TPP were sustained for 7 years of follow-up and had the greatest impact on nonproblematic benzodiazepine use. CONCLUSIONS: During the time period studied in this analysis, the New York TPP reduced benzodiazepine use among chronically ill patients for whom these agents represent effective treatment. Our findings suggest that many patients previously receiving benzodiazepines did not receive any pharmacologic intervention.

Adult↗

PubMed2004

Drug affordability and prescription noncompliance in the United States: 1997-2002.

BACKGROUND: Prescription drug costs have risen rapidly since the mid-1990s. Inability to pay for medications has consequences for population health and health system costs. However, national data on the scope of prescription noncompliance due to cost are surprisingly inconsistent. OBJECTIVE: The goals of this study were to use data from a large, all-ages survey that accurately represents the civilian, noninstitutionalized population to estimate the national prevalence of medication noncompliance due to cost, identify sources of variation in rates of noncompliance due to cost, and assess changes in these rates over a recent 6-year interval (1997-2002). METHODS: We undertook a trend analysis of the National Health Interview Surveys for 1997 through 2002 and detailed subpopulation analysis of the 2002 survey to determine rates of noncompliance due to cost. RESULTS: Our analyses used a total sample size of 276,425 respondents for the 6-year period and a sample size of 43,568 respondents for the year-2002 subpopulation analysis. Self-reported rates of noncompliance due to cost grew from 4.7% in 1997 to 5.9% in 2002. The results of the 2002 survey suggested that noncompliance varied by subpopulation, with relatively high rates (P < 0.001) among working-age adults (ie, aged 18-64 years), women, blacks, Medicaid and Medicare beneficiaries, those with low incomes, and those without health insurance. CONCLUSION: A relatively small but growing proportion of Americans are unable to afford the medications they are prescribed. Cost-associated noncompliance, like other health care access problems, is unevenly distributed in the population.

Adolescent↗

PubMed1998

Regulation of prescription drug promotion: direct-to-consumer advertising.

The US Food and Drug Administration (FDA) is responsible for regulating the information on prescription drugs disseminated by sponsors to health care providers and consumers to ensure that it is truthful and not misleading, and that it presents a fair balance of benefit and risk information. Thus the public health is both protected and promoted by the dissemination of honest, accurate information about regulated products. This paper discusses the regulatory requirements for promotional materials for prescription drugs and the standards used by the FDA to evaluate these materials. It also discusses the agency's views on direct-to-consumer advertising, the enforcement actions that are available to the FDA, the process used by the FDA to determine what action should be taken and when, and what remedies are available.

Advertising↗

PubMed2000

[Quality of antihypertensive drug prescription in a health area].

OBJECTIVE: To find the compliance with previously established criteria on the quality of prescription of medication for hypertension. DESIGN: Retrospective and concurrent evaluation study of scientific and technical quality, with processing data, using as data source the clinical history. SETTING: Primary care teams in a Madrid Health Area. PARTICIPANTS: 873 clinical histories of hyper-intense patients in treatment with diuretics, beta-blockers, ACE inhibitors and/or calcium antagonists were chosen through systematic probabilistic sampling with a randomised start. MEASUREMENTS AND MAIN RESULTS: Data on age, sex, recording of treatment, linked pathologies and situations conditioning the choice of medicine were gathered. Information on the defined use criteria of the various pharmacological groups was also collected. 1145 drugs were used on 873 patients. Most common were the thiazide diuretics (36%), followed by ACE inhibitors (34.4%), calcium antagonists (21%) and beta-blockers (8.6%). 72% of the patients were undergoing one single therapy. 89.7% of the cases (95% CI, 87.43-91.59) had the treatment correctly recorded in the clinical record. Of the 721 hyperintense patients over 59 years old, 70.3% (95% CI, 66.81-73.60) fitted the defined criterion for use of diuretics. 48.7% fitted the ACE inhibitor criteria defined (CI, 43.71-53.78); 85.7% the beta-blocker criteria (CI, 76.85-91.69); and 58.7% the calcium antagonist criteria (95% CI, 52.17-64.9). CONCLUSIONS: The fit of the use of diuretics with the defined quality criterion is acceptable, while in the cases of ACE inhibitors and calcium antagonists the quality of prescription could be improved, while the use of beta-blockers is minimal.

Adult↗

PubMed2003

Understanding US addiction physicians' low rate of naltrexone prescription.

Naltrexone was approved by the US Food and Drug Administration (FDA) in December 1994. Although it is one of only two medications for alcohol rehabilitation approved in the US, naltrexone is not frequently prescribed. This paper examines the factors limiting physicians' use of naltrexone. Data were collected through a survey of US physician members of two addiction medicine professional associations. Logistic regression analysis was conducted with the dependent variable being any prescription of naltrexone. Independent variables consisted of physician practice characteristics, physician ratings of naltrexone's attributes (e.g. efficacy), physicians' patient characteristics, and physicians' exposure to information about naltrexone. On average, addiction medicine physicians prescribed naltrexone to 13% of their alcoholism patients. The two main self-reported reasons why physicians did not prescribe the medication to more patients were that patients refused to take the medication or comply with prescribing regimes (23%), and that patients could not afford the medication (21%). Multivariate results indicated that physician perceptions of naltrexone's effectiveness and safety were significantly associated with prescribing. Physicians who had more exposure to information about the product (e.g. by reading more journal articles about naltrexone) were more likely to prescribe it. In summary, multiple factors are contributing to the relatively low naltexone prescription rate.

Data Collection↗

PubMed1999

Correlation between prescription of various dextropropoxyphene preparations and their involvement in fatal poisonings.

In Sweden, the frequency of fatal poisoning by dextropropoxyphene (DXP) ingestion is constantly high. There are seven preparations containing DXP on the Swedish market; in three of them DXP is the sole analgesic ingredient, while four of them are combinations of analgesics. In an attempt to assess the death rate attributable to each DXP preparation on the basis of toxicological analyses, altogether 834 cases of dextropropoxyphene-related death over a 5-year period (1992-1996) in Sweden have been reviewed. The ratio between number of fatal poisonings and prescription of defined daily dose/1000 inhabitants during a 12-month period (DDD) was determined. The highest ratio, 27, was attributed to unmixed preparations. The ratio for DXP + paracetamol-related deaths was 6.3, and for DXP + phenazone, 6.4, while the lowest ratio, 2, was found among the DXP + chlorzoxazone cases. The unmixed preparations, representing 26% of all DXP prescriptions during the study years, were implicated in 62% of the DXP fatalities, a considerable over-representation. Unmixed preparations, with their higher content of DXP, may be more attractive for many consumers because of their narcotic (euphoric) effects rather than for any analgetic superiority. Another possibility is that unmixed preparations may erroneously have been regarded as safer than when combined with paracetamol, as reports of poisoning with compounds containing DXP + paracetamol have been most frequently reported, probably due to their predominance on the market.

Acetaminophen↗

PubMedDate not supplied

Prescription noncompliance: contribution to emergency department visits and cost.

We randomly surveyed 100 patients in the acute care section of a large urban university hospital Emergency Department (ED) on 6 days with regard to the existence of and reasons for prescription noncompliance. Noncompliance was considered a major factor contributing to the ED visit if: (1) no medications had been taken for at least 48 h before the ED visit; (2) the medications, when previously taken, had routinely controlled the condition for which the patient was presenting to the ED; and (3) no other significant cause or illness was believed to have precipitated the ED visit. ED, admissions, and yearly medication costs were calculated for all patients. Noncompliance was found to be a contributing factor in the cases of 22 patients (22%). The most common medications involved were phenytoin and albuterol. Cost was the most common reason for noncompliance (11 [50%]). The average ED charge per noncompliant patient discharged was $576.61. Six noncompliant patients were admitted at an average cost of $4,834.62. The average cost of a year's medication was $520.72. Noncompliance with drug prescriptions is a significant contributor to ED visits and health care costs.

Adult↗

PubMed1997

Design, development, and evaluation of visual aids for communicating prescription drug instructions to nonliterate patients in rural Cameroon.

In this study, culturally sensitive visual aids designed to help convey drug information to nonliterate female adults who had a prescription for a solid oral dosage form of antibiotic medications were developed and evaluated. The researchers conceptualized the educational messages while a local artist produced the visual aids. Seventy-eight female ambulatory patients were evaluated for comprehension and compliance with antibiotic prescription instructions. The study was conducted in three health centers in Cameroon, West Africa and followed a pre-test, post-test, and follow-up format for three groups: two experimental, and one control. All participants were randomly assigned to either experimental or control groups, 26 patients to each group. Subjects in the experimental groups received visual aids alone or visual aids plus an Advanced Organizer. A comparison of the three groups showed that subjects in the experimental groups scored significantly higher than the control group in both the comprehension and compliance measures.

Adolescent↗

PubMed2000

[The economic impact of inadequate prescriptions].

The impact of antibiotic therapy has gone to considerable expense. The review of literature demonstrates that an optimal use of economical resources can be achieved by an improvement of medical prescriptions. This improvement of prescriptions can be obtained for prophylaxy and for curative therapy. Cost savings can be as high as one-year budget for the recruitment of an infectious diseases consultant.

Anti-Bacterial Agents↗

PubMed2002

Pain management and prescription monitoring.

Preventing diversion and abuse of prescription controlled substances while ensuring their availability for legitimate medical use is an important public health goal in the United States. In one approach to preventing and identifying drug diversion, 17 states have implemented prescription monitoring programs (PMPs) to monitor the prescribing of certain controlled substances. While PMPs are not intended to interfere with legitimate prescribing, some in the pain management community feel that they negatively affect prescribing for pain management. This article describes a collaborative project initiated by the Pain & Policy Studies Group that brought together regulatory and pain management representatives twice in 1998 to share perspectives and reconcile differing views on the effects of PMPs. The ultimate goals of this project are to provide accurate information to healthcare clinicians about PMPs, better define the balance between preventing drug diversion and providing pain management, and promote continued dialog and cooperation among the groups.

Drug Monitoring↗

PubMed1999

Cardiovascular drug prescriptions and risk of depression in diabetic patients.

Our aim was to investigate the association of calcium channel blocker (CCB), beta-blocker, and ACE inhibitor medications with the risk of depression in diabetic patients. A case-control study was performed using an automated database (MediPlus, IMS) of 400 primary care practices in Germany including 972 diabetic cases with newly diagnosed depression in 1996 (index date) and 972 diabetic controls, matched for age, sex, and index date. The odds ratios (95%-confidence intervals) for depression, adjusted for type of practice, number of visits and prescriptions, hospitalization, cardiovascular diagnoses, and renal failure, were 2.2 (95% CI: 1.2-4.2) for exposure to CCB 6 months prior to index date, 2.6 (95% CI: 1.1-7.0) for beta-blockers, and 1.3 (95% CI: 0.8-2.2) for ACE inhibitors, respectively. Adjusted odds ratio for CCB (4.3; 95% CI: 1.7-13.5) and beta-blockers (4.5; 95% CI: 1.2-29.5) were higher with daily dosages above the median. Prescriptions of CCB and beta-blockers among diabetic patients may increase the risk of depression. Because this association may alternatively be explained by cardiovascular comorbidity, further studies will be necessary to investigate the link between these cardiovascular medications and depression.

Adrenergic beta-Antagonists↗

PubMed1997

The use of an enteral expert system in the prescription of enteral formulas in a university hospital.

A personal computer-based expert system has been developed for the prescription of enteral formulas based on patient-need characteristics. Two hundred twelve inpatients in a university hospital setting were prospectively evaluated to compare the identity and cost of the enteral formula prescribed by the expert system with the identity and cost of the enteral formula prescribed by the ward team. Two hundred seven patients had complete data to allow analysis. There was a mean cost savings (+/-SD) of $1.18 +/- 7.69/d for each patient using the expert system compared with the MD-prescribed formula (P = 0.023). We project that the use of this program would save $27,564/y in our hospital (an average of 23,360 patient/days of enteral feeding per year). We conclude that the use of an expert system can be cost-effective in the prescription of enteral formulas for hospitalized patients.

Adult↗

PubMed2003

A multi-agent system approach for monitoring the prescription of restricted use antibiotics.

Hospitals have a specified set of antibiotics for restricted use (ARU), very expensive, which are only recommended for special pathologies. The pharmacy department daily checks the prescription of this kind of antibiotics since it is often the case that, after a careful analysis, one can get the same therapeutic effects by using normal antibiotics which are much cheaper and usually less aggressive. In this paper, we describe a multi-agent system to help in the revision of medical prescriptions containing antibiotics of restricted use. The proposed approach attaches an agent to each patient which is responsible of checking different medical aspects related to his/her prescribed therapy. A pharmacy agent is responsible for analyzing it and suggesting alternative antibiotic treatments. All these agents are integrated in a hospital distributed scenario composed by many different kinds of software and human agents. This patient-centered multi-agent scenario is specified using the design methodology of Electronic Institutions.

Anti-Bacterial Agents↗

PubMed1996

Satisfaction with prescriptive authority protocols.

OBJECTIVES: The use of prescriptive authority protocols by pharmacists and physicians in Washington was described as to: (1) types of decisions made, frequency of use, and nature of working arrangements among participants; (2) their perceived impact on professional practice and care rendered to patients; and (3) their satisfaction with the protocol arrangements. DESIGN: A mail survey of participants currently engaged in prescriptive authority was conducted. RESULTS: Responses were received from participants in 44 of 57 protocols. A total of 135 prescribers and 84 pharmacists responded. On average, 7 pharmacists and 27 prescribers were involved in each protocol, and had been involved for 6 years or more. It was estimated that approximately 10% of all active practitioners participated in protocols. Most protocols involved continuation of drug therapy or authorizing renewals. Modification of therapy (usually involving dosage or dose from changes) was practiced in two-thirds of the protocols, and initiation of therapy in about half of them. Most existed within managed care and group practice settings. Most prescribers (98%) and pharmacists (95%) were satisfied with protocol arrangements. Additionally, they generally agreed that the protocols increase patient convenience and increase the quality of patient care, and they encouraged their colleagues to use prescribing protocols. CONCLUSIONS: Protocol arrangements appear to be working well from the perspective of participants. Based on this experience, the authors encourage the development of similar protocol arrangements in other states.

Clinical Protocols↗

PubMedDate not supplied

[Prescription and preparation of parenteral nutrition at Spanish hospitals].

OBJECTIVE: To identify habits related to prescription and preparation of parenteral nutrition in Spain and their adequacy to current recommendations. METHOD: A questionnaire was administered in order to collect information about the characteristics of diets used at each hospital and the way they were prepared. The questionnaire was available through the web page of the Spanish Society of Hospital Pharmacy. RESULTS: Forty five hospitals answered the questionnaire. More than 90% of the hospitals reported that they used diets with a fixed or standard composition and 66.6% reported that they bought diets available in the market with a defined composition. Fifty seven point five per cent of the hospitals always prepared "all in one" parenteral nutrition and 37.5% prepared them only for adults. A 5% provided the lipids separately, both for adults and for children. Forty five per cent of the hospitals reported that they did not use organophosphates as source of phosphate. Almost 60% alternate the introduction of vitamins and trace elements. Differences were also found regarding the type of lipids provided and the use of filters. Most hospitals used multi-layer bags and photoprotection. CONCLUSIONS: There is quite a lot of diversity in the patterns of prescription and preparation of parenteral nutrition in our country. Further consensus documents should be written about these topics.

Hospitals↗

PubMed2005

Patterns of prescription of hypoglycaemic drugs in Gran Canaria (Canary islands, Spain) and estimation of the prevalence of diabetes mellitus.

OBJECTIVE: To study the patterns of hypoglycaemic treatment in our community and to estimate the prevalence of known and drug-treated diabetes mellitus. METHODS: From all the diabetic patients who attended the Healthcare Centers of the National Health Service in Gran Canaria in 1999, a random sample of 2924 diabetic patients > 20 years old was selected. Data on age, gender, clinical onset of diabetes, and hypoglycaemic treatment were obtained. Data on drug consumption were supplied by the National Health Service. RESULTS: Of the DM-2 patients 4.4% (3.65-5.14) 84.2% (82.7785.42), 9.4% (8.34-10.45) and 2.1% (1.58-2.61) received diet only, oral drugs, insulin or combination. The duration of DM-2 was associated with more oral drugs and more insulin treatment, but the duration of DM-1 was not associated with intensive insulin therapy;<50% of the type 1 patients had >or=3 daily injections. The prescriptions of biguanides were scarce; over 1/3 of them were of buformin. DM-1 and DM-2 patients were treated with similar doses of insulin, but DM-1 patients had more insulin injections (2.56 vs 2.07, P<0.001), and more fast-acting insulins (65.2% vs 38.0%, P<0.001). The estimated prevalences of known and drug-treated diabetes in the Gran Canaria island were 5.95% (95% CI: 5.096.80%) and 5.73% (4.88-6.57%). CONCLUSIONS: Our prevalences of known and drug-treated diabetes is among the highest reported in European populations. The prescriptions of metformin and of combined therapy in DM-2, and of intensive insulin therapy in DM-1 are less frequent than expected, but nonetheless insulin therapy in DM-1 is more intensive and uses more fast-acting insulin than in DM-2.

Adult↗

PubMed1995

Pharmaceutical prescriptions in Italy.

Pharmaceutical prescriptions are quite different in four European countries: Italy, France, Germany, and the United Kingdom. In particular, in 1992, among the 50 most sold products by value, only seven active principles are common to these four countries. In Italy, in 1994, there has been a substantial change in pharmaceutical prescriptions, since, for the first time, drugs have been reimbursed by the National Health System (NHS) on the basis of efficacy. As a result of this new policy, the 50 most-sold products by value have changed dramatically in the first five months of 1994. The pharmacologic and economic implications of this change are discussed.

Drug Prescriptions↗