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The pharmacoeconomics of high-cost biotechnology products.

Biotechnology products have created therapy options in areas that have been historically limited. These improvements in patient care have resulted in a reappraisal of the emphasis placed on product acquisition costs and a movement toward evaluating the impact of the product on the entire health care system. Strategic planning for biotechnology products allows pharmacists to partner with the medical staff and financial/administrative representatives of the institution to measure clinical outcomes, estimate cost and revenue impact, document utilization, and promote cost-effective use of these new therapies to generate the maximum benefit for dollars expended.

Biotechnology↗

A survey of drug and therapeutics committees operating in Ireland.

A survey of the number and characteristics of Drug and Therapeutics Committees (DTCs) operating in hospitals in Ireland was conducted in 1984. Just under half of the hospitals surveyed had a DTC and half of those had been formed after 1981. Pharmacists and consultant medical staff were present on every DTC and the latter also chaired most DTCs. Formularies or limited lists had been drawn up by half the DTCs identified and the most frequently discussed topics at DTC meetings were concerned with expenditure control. These findings are discussed and compared with the experience of DTC formation and operation in other countries.

Formularies, Hospital as Topic↗

The evolution of an effective P & T Committee: advice from the chairman.

In an exclusive Hospital Formulary interview, Dr. Roger Williams, Chairman of the University Hospitals P & T Committee, identifies factors that have contributed to the success of their P & T Committee. Policies for evaluating drugs for formulary inclusion, the use and availability of nonformulary drugs, and efforts in improving adverse drug reaction reporting by clinicians are a few of the topics discussed. Dr. Williams' committee supports the concept of a closed, rather rigid formulary, but contends that mechanisms must be available for easy acquisition of nonformulary drugs. Dr. Williams also comments on the clinical benefits derived from participation on a P & T Committee.

Formularies, Hospital as Topic↗

Drug and Therapeutics (D & T) committees in Dutch hospitals: a nation-wide survey of structure, activities, and drug selection procedures.

AIMS: To determine structure, activities and drug selection processes used by Dutch hospital drug and therapeutics (D & T) committees. METHODS: A pretested structured survey questionnaire based on the Australian process and impact indicators, previous research, and consultation of professionals was developed. Subsequently, D & T committees that met predefined selection criteria were asked to participate. RESULTS: The overall response rate was 70% (38/54). D & T committees varied considerably in size and representation of clinical expertise. Although responsibilities were theoretically alike, actual responsibilities were frequently passed on to other authorities, such as pharmacy staff. Few committees used detailed guidelines or decision supportive matrices to establish transparency in drug selection. With respect to drug selection, the value scores on the information resources used, the factors involved, and the selection criteria used varied. Hospital pharmacists were likely to be most involved and to have the greatest impact. A consensus was most difficult to achieve for drugs used in cardiology, oncology, and psychiatry. Interference of industrial marketing strategies on drug selection was recognized and identified. CONCLUSIONS: Our results indicate that Dutch hospital D & T committees differ with respect to their clinical expertise and their activities, a situation comparable with that observed in other countries. Furthermore, the lack of transparency in drug selection was considerable. These findings clarify the differences previously found between Dutch hospital drug formularies.

Data Collection↗

Role of clinical, patient-reported outcome and medico-economic studies in the public hospital drug formulary decision-making process: results of a European survey.

CONTEXT: Over the past 20 years, drug information has grown rapidly, but little is known of its actual use in hospital decision-making. OBJECTIVE: To describe the role of clinical studies (CS), patient-reported outcome studies (PROS) and medico-economic studies (MES) in public hospital drug formulary decision-making. METHODS: A postal survey was conducted in 400 randomly selected public hospitals stratified by country (France, Germany, The Netherlands and the United Kingdom) and profession (doctor or pharmacist). RESULTS: The participation rate was 78% (143 doctors and 169 pharmacists), and the response rate 44%. Responders were generally interested in CS (86%), PROS (71%) and MES (71%). They reported high but unmet expectations concerning information available on PROS and MES, the methodology of these studies and interpretation of the results. CONCLUSIONS: To increase the impact of PROS and MES, we suggest training decision-makers in the study methodology and provide them with support of health and economic experts.

Clinical Trials as Topic↗

Results of our national survey. Current formulary decision-making strategies and new factors influencing the process.

Formulary recently conducted a survey of 2,000 of its readers to uncover what forces are at play in their formulary decision-making processes. Topics included general philosophies toward formulary decision making, philosophies toward adding and deleting products, influences on the process, trends related to product reviews, formulary management strategies, drug information educational strategies, and new approaches to the formulary decision-making process. Some 295 surveys (14.75%) were returned. Highlights and analyses of the survey findings are presented for your review and comparison with your practice setting's approaches.

Attitude of Health Personnel↗

Setting standards--antibiotic policies.

It is important to choose appropriate topics for audit in order to produce satisfactory results and maintain interest and enthusiasm. A trail of incomplete audit cycles is unhelpful and demoralizing. The audit should be carefully designed and a vital stage is choosing appropriate standards upon which to measure current performance. An agreed policy provides a practical standard against which to audit the use of antibiotics.

Anti-Bacterial Agents↗

Developing and implementing a statewide formulary system: one state's experience.

Prior to the Pennsylvania Department of Public Welfare (DPW) implementing a statewide formulary for its 21 mental health hospitals and mental retardation facilities, each facility had its own drug use policy. In many facilities, drugs were ordered with little or no cost-containment or drug-management consideration. To change drug purchasing and usage policies, a task force was created to develop a state formulary system. The task force appointed a formulary subcommittee to research and make recommendations on issues such as drug selections, formulary substitutions, and nonformulary drug use. The step-by-step process of developing and implementing the Pennsylvania DPW state formulary--including pitfalls and successes--is presented.

Drug Costs↗

The role of the clinical pharmacist in the institutional setting.

The role of the clinical pharmacist in the institutional setting has been expanding at an ever increasing rate. His role as a clinical consultant with the rounding team has become firmly established. This is supplemented with rational product selection utilizing a hospital formulary. Both clinical pharmacokinetics and nutrition are services that benefit the patient directly in his inpatient environment. Toxicology and drug information provided directly to the consumer has also become accepted. Services provided to institution-wide committees allow a comprehensive understanding of the selection, delivery, and follow-up of medication administration to the patient. Many of these services described have become reimbursable by third-party carriers and other appropriate agencies. As other services are reimbursed, the role of the clinical pharmacist will expand beyond the limited scopes discussed in this paper.

Drug Information Services↗

Spontaneous reporting of adverse drug reactions to non-steroidal anti-inflammatory drugs. A report from the Spanish System of Pharmacovigilance, including an early analysis of topical and enteric-coated formulations.

Non-steroidal anti-inflammatory drugs (NSAIDs) are the third most commonly prescribed group of drugs in Spain. We present here the profile of adverse drug reactions (ADRs) attributed to them and reported to the Spanish System of Pharmacovigilance (SSPV) between 1983 and 1991, together with a preliminary analysis of topical, slow-release (SR) and enteric-coated (EC) preparations. Out of 18,348 reports of ADRs included in the SSPV database, 1609 (8.8%) implicated an NSAID. NSAIDs ranked second after antibiotics (15.1% of all reports) among the most commonly implicated drugs. Half of the patients were more than 55 years old, and 60% were women. Diclofenac (364 reports), piroxicam (282), indomethacin (197), naproxen (155), and ketoprofen (137) were the most commonly implicated NSAIDs in reports of ADRs. The most commonly reported ADRs were gastrointestinal (39%), cutaneous (20%), and those affecting the central and peripheral nervous system (9%). Seven reactions had a fatal outcome, and 138 were considered life threatening. Forty-nine reports included previously undescribed ADRs. There were 98 reports describing ADRs attributed to topical NSAIDs; 5 of these described 11 general reactions, such as duodenal ulcer, gastrointestinal bleeding, diarrhoea, dyspnoea, facial oedema, aggravation of bronchospasm, and angioedema. One hundred and sixty-eight reports referred to SR and EC preparations. The ratio of gastrointestinal to non-gastrointestinal reactions to SR-EC diclofenac was higher in the case of SR-EC diclofenac than in the case of plain diclofenac (P = 0.037); similarly, the ratio of CNS to non-CNS reactions to SR-EC indomethacin was also higher than the corresponding ratio with plain indomethacin (P = 0.002).(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Cutaneous↗

Health plan budget impact analysis for pimecrolimus.

OBJECTIVE: Budget impact models are useful tools for managed care organizations to make drug formulary decisions. The objective of this study was to estimate the incremental budgetary change in per-member-per-month (PMPM) medical and pharmacy costs for atopic dermatitis (AD) or eczema after the introduction of pimecrolimus cream 1%, a topical calcineurin inhibitor. METHODS: Estimates of the percentage of patients seeking care, treatment patterns, and quantities of medications dispensed for AD were measured using 2001 and 2002 medical and pharmacy records in a proprietary database for health plans distributed throughout the United States. Approximately 2.5 million health plan members had continuous health insurance coverage during the study period. Costs for medications were assigned using the 2003 wholesale acquisition cost, and costs for physician visits were based on average 2003 Medicare reimbursement rates. Efficacy data from clinical trials were used to model the impact of pimecrolimus on subsequent physician visits. Sensitivity analyses were performed to evaluate the impact of varying the percentage of patients seeking care, practice patterns, medication quantities, percentage of pimecrolimus users, and levels of patient cost sharing. RESULTS: The estimated percentage of health plan members seeking care for AD in 2001 was 3.2%. The estimated total cost PMPM for AD treatment prior to introduction of pimecrolimus was 0.362 dollars for all covered lives, assuming no patient cost sharing. In the year after its introduction, 5.2% of the AD population filled a prescription for pimecrolimus. The incremental increase in pharmacy benefit cost was 0.008 dollars PMPM in 2003 dollars, but the total incremental medical and pharmacy cost was 0.002 dollars PMPM after accounting for the projected reduction in physician visit costs, representing a 0.7% increase in all AD-related costs. Based on sensitivity analyses, the incremental total cost PMPM after the introduction of pimecrolimus ranged from -0.004 dollars to 0.026 dollars. CONCLUSION: Using claims data for the medical treatment of AD in 2001-2002 and the utilization of pimecrolimus, the addition of pimecrolimus as a treatment option for AD had a minimal impact on PMPM costs for AD-related care in 2003 dollars. As with all pharmacoeconomic models, health plans should perform their own budget forecasting using assumptions derived from their own pharmacy and medical claims data.

Budgets↗