Access to medication and drug company sales practices: setting priorities for critique and advocacy.
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To improve the cost-effectiveness of psychotropic medications, a process was established to involve all stakeholders in a seven-county public-sector behavioral health managed care plan in the development of formulary guidelines. After delineation of the issues and of possible strategies, proposed formulary guidelines were drafted and presented to the stakeholders in a series of meetings. The stakeholders were also educated about pharmacy cost management issues and possible strategies. The guidelines were modified on the basis of the feedback obtained from stakeholders, and the consensus formulary guidelines were adopted. Within ten weeks of implementation of the guidelines, monthly medication costs had declined by 3 percent from baseline, although the number of medication users increased by 3 percent over the same period. There were few complaints about the guidelines. Effective, consensus-driven, medication cost-containment strategies can be implemented through a process of engagement and education of stakeholders in a community mental health plan.
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A recent Audit Commission report into general practice prescribing identifies areas where general practitioner and pharmacist collaboration could be beneficial. Two such areas are formulary development and repeat prescribing review. Increased generic prescribing is encouraged in the report and in central priorities for Scottish Health Boards. This study was designed to develop and assess the effects on prescribing, of a practice formulary and a procedure for change to generic name prescribing. A practice formulary, standards for generic name prescribing and an approach to prescribing review were agreed, developed and implemented. Formulary compliance and the extent of prescribing generically and of changes to generic prescriptions were assessed by prospective prescription monitoring. Consultations resulting in a prescription reduced from 69% to 59% and 80% of acute prescribing events were met from 144 formulary medicines. Rapid change to generic name prescriptions was achieved without patient complaints and the overall generic prescribing level increased from 57% to 68%. Eighty percent of all new prescriptions were generic.
Personalized medicine considers factors unique and specific to each patient to make clinical decisions, including selecting pharmacotherapy. Drug formularies, including those available to enrollees in Medicare Part D, are based on group characteristics and financial considerations. Consequently, an appeal of a formulary's preferred drug selection may be necessary to ensure the best care of the patient. Consideration of basic principles of clinical pharmacology can be used to decide whether an exemption should be considered and to document specific reasons for the request.
Part of the impact of the war in ex-Yugoslavia and especially Bosnia and Herzegovina was to limit the supply of therapeutic drugs they had used before the war. The difficulties encountered made the health care system temporarily dependent on humanitarian assistance agencies which applied the concept of essential drugs; and, after initial difficulties, national health staff adapted to the need to prescribe from a very limited range of drugs. Meanwhile, national drug policy and procurement and prescribing practices were reviewed by working groups and a national List of Essential Drugs was drawn up by national experts with international support. This list has now been passed into legislation.
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High doses of antidepressants are often used for treatment-resistant depression. Venlafaxine, a dual serotonin and noradrenaline reuptake inhibitor, has been shown to have a tolerable side-effect profile in previous studies using doses of up to 375 mg/day. We investigated the tolerability of higher than currently recommended doses of venlafaxine using the UKU side-effect rating scale. Seventy outpatients fulfilling DSM-IV criteria for major depressive disorder were recruited into two demographically matched groups according to their daily dosage of venlafaxine: high dose n = 35 (> or = 375 mg/day, range 375-600 mg, average 437 mg/day) or standard dose n = 35 (< 375 mg/day, range 75-300 mg, average 195 mg/day. Clinical characteristics were noted and the UKU side-effect rating scale was administered to a subsample of patients. The most frequently reported complaints in both groups were increased fatigue (48%), concentration difficulties (48%), sleepiness/sedation (37%), failing memory (44.4%) and weight gain (29.6%). Apart from weight gain, the complaints were found to be experienced significantly more severely by the high-dose group. Six patients discontinued venlafaxine due to intolerable side-effects but only two of these patients were on a high dose. There was a tendency for mildly raised blood pressure in 10% of patients on an average dose of 342 mg/day. However, no difference between the two groups was found. This preliminary open study demonstrates that venlafaxine is tolerated at higher than British National Formulary recommended doses (i.e. up to 600 mg daily). However, increased frequency and severity of reported side-effects in the high-dose group are not associated with increased rates of discontinuation.
PURPOSE: Under the Medicare Prescription Drug Improvement and Modernization Act, beneficiaries remaining in the traditional fee-for-service plan will face a variety of drug benefit options provided by private stand-alone prescription drug plans. Although these plans likely will differ with regard to a number of important attributes, little is known about older adults' judgment processes in this context. The objectives of this study were to 1) better understand the manner in which drug insurance attributes are weighted in older adults' judgments of drug benefit suitability, 2) explore variability in judgment strategies among seniors, and 3) assess seniors' insight into their judgment policies. METHODS: Three focus groups were conducted with 19 older adults to elicit important drug plan attributes. A policy-capturing study with 32 seniors, none of whom had participated in the focus groups, then was employed to quantify the impacts of these attributes on judgments of plan suitability. RESULTS: Focus group participants reported that copayment, monthly premium, deductible, formulary use, and mail-order pharmacy use were important drug insurance attributes. The policy-capturing study showed that deductibles and premiums were weighted most heavily in judgment formation. However, significant variability in judgment policies was apparent, with 3 distinct groups emerging from cluster analysis. The first emphasized deductibles and copayments, the second premiums and deductibles, and the third use of a mail-order pharmacy and deductibles. Study volunteers exhibited insight into the role of some plan attributes in their judgments, but not others. CONCLUSIONS: Cost-sharing provisions appear to be most important in older adults' evaluations of drug benefit plans. However, significant heterogeneity in attribute preferences also was apparent in this study. Older adults may not be cognizant of the manner in which some plan attributes affect their evaluations, suggesting a role for decision aids in this process.
Potassium clavulanate is a novel beta-lactamase inhibitor, which, in combination, expands the spectrum of amoxicillin to include many amoxicillin-resistant organisms. Potassium clavulanate is excreted 30-50 percent unchanged renally and its plasma time-course parallels that of amoxicillin. Several studies suggest that an increased incidence of gastrointestinal side effects may occur with this combination. In the current oral formulation, its greatest utility may be in pediatric infections due to beta-lactamase-producing Haemophilus influenzae and B. cattarhalis. In adults, the combination has not been adequately studied against other effective antibiotics.
The orphan drug pimozide was recently approved for marketing in the U.S. for the treatment of Tourette's syndrome (TS). TS is characterized by recurrent, involuntary motor movements and vocal tics, and is believed to be due to neurochemical dysfunction. Pimozide's receptor selectivity differs from that of haloperidol, the standard agent used for TS. Clinical trials with pimozide demonstrate a positive response for many patients, although superiority over haloperidol has not been demonstrated in general. Pimozide causes annoying side effects in a large percentage of patients and may cause severe side effects (e.g., tardive dyskinesia, cardiovascular toxicity) with prolonged use and/or at higher doses. The long half-life of pimozide allows for once-daily dosing. Pimozide should be reserved for treatment of patients with TS who have not responded to haloperidol or who cannot tolerate haloperidol's adverse effects.
The chemistry, in vitro activity, adverse effects, and clinical indications for the new third-generation cephalosporin, ceftazidime, are reviewed. Ceftazidime appears to have a unique place among the third-generation agents in the treatment of some infectious processes caused by Pseudomonas aeruginosa. It does not demonstrate superiority to other third-generation drugs against Enterobacteriaceae, aerobic gram-positive cocci, or anaerobes. It is eliminated renally and is similar to ceftizoxime, cefoperazone, and moxalactam in half-life. Ceftazidime shares the safety profile of most of the cephalosporins, and has not been shown to have an effect on prothrombin or produce the disulfuram reaction seen with moxalactam and cefoperazone. Specific indications for its use are discussed.
Iohexol and iopamidol are new second-generation nonionic contrast media. We review their physical/chemical properties and describe the improvements made over the first-generation nonionic prototype, metrizamide, and conventional ionic contrast media. The significance of low osmolar solutions is discussed and the relationship between osmolality and adverse reactions is emphasized. The convenience of a ready-to-use stable solution that offers an advantage over the lyophilized metrizamide in practical application is suggested. Clinical studies using randomized, double-blind comparison techniques are cited. An attempt is made to define the exact role for iohexol and iopamidol.
Buspirone is a member of a new class of agents known as azaspirodecanediones, and represents the first nonbenzodiazepine anxiolytic to be introduced in the U.S. in recent years. It does not resemble the benzodiazepines or older anxiolytics such as meprobamate and the barbiturates in pharmacologic profile. Buspirone lacks anticonvulsant activity, interacts minimally with central nervous system depressants such as alcohol, and does not cause muscle relaxation. The drug is reported to have minimal sedating effect, to cause no impairment of driving-related skills, and to have no euphoriant effect or addictive potential. With this low side-effect profile, buspirone should not require Drug Enforcement Agency scheduling controls. Clinical trials indicate buspirone is efficacious in the treatment of mild to moderate anxiety disorders. Answers to questions of possible side effects related to dopaminergic intractions must await post-marketing experience. Buspirone is a suitable addition to drug formularies as its pre-marketing data suggest several advantages compared with anxiolytics currently available.
Alfentanil is a tetrazole derivative of fentanyl. Many of the pharmacologic effects of alfentanil are similar to those of fentanyl and sufentanil, but of quicker onset than those of fentanyl and of shorter duration than those of fentanyl and sufentanil. Alfentanil may cause less intense respiratory depression than equianalgesic doses of fentanyl. Alfentanil has a lower total body clearance, smaller volume of distribution, and shorter half-life than fentanyl and sufentanil. Clinical trials indicate alfentanil can be used effectively as an analgesic, an analgesic supplement to anesthesia, an anesthetic induction agent, and as the major component of a general anesthetic. Its short duration of effect makes it attractive as an analgesic supplement for short ambulatory surgical procedures. Alfentanil is recommended for addition to drug formularies, but its use should be restricted to anesthesia personnel.
Health maintenance organizations (HMO) are growing in number as a cost-effective way of providing health care. In some, stringent formulary management policies including programs authorizing therapeutic substitution are practiced. Under this concept a drug that has been previously determined to be therapeutically equivalent to a second drug, even though it is not chemically equivalent to the prescribed drug, is automatically dispensed without contacting the prescriber. This study was undertaken to learn the extent and conditions under which therapeutic substitution is being practiced in the HMO setting. A survey was sent to all HMO in the U.S. inquiring into the operation of the pharmacy services. Specific focus was on the operation of the formulary and the policies and procedures being followed. The main goal was to learn how many programs authorize therapeutic substitution, what drugs are allowed, and what procedures are followed once the substitution is made. Of the 481 surveys sent out, 192 (40 percent) usable responses were received. Results indicate that 30.5 percent of HMO pharmacy plans allow therapeutic substitution. These programs were most likely to be of the staff-model or the group-model and least likely to be of the independent practice association type. HMO with an inhouse pharmacy more frequently had policies allowing therapeutic substitution than those using outside pharmacy services.