Martha M. Rumore

New York City pharmacists and OBRA '90: one year later.

New York state regulations to implement patient counseling mandated by the Omnibus Budget Reconciliation Act of 1990 took effect in December 1992, yet one year later, little was known about how successfully the counseling mandate was being implemented. To begin assessing the impact, an anonymous questionnaire was distributed to 300 New York City pharmacists and pharmacy interns in the fall of 1993; a 65% (194) response rate was achieved. The opinions of interns and pharmacists differed on whether the counseling requirement had been implemented correctly (p < 0.01). Time, personnel, and expense constraints were most frequently cited as barriers to implementation. Half of the respondents mentioned that patients had to wait for counseling. More often than not, the offer to counsel originated with the pharmacist (51%). Interns (19.5%), technicians (12%), and clerks (17%) offered counseling less frequently. Approximately 35% of patients chose not to supply counseling information. Reasons for not accepting counseling as well as methods for documentation were described and analyzed. A list of items discussed each time a prescription is dispensed revealed little agreement on what constitutes counseling.

Clinical Therapeutics of Endometriosis, Part 2

The 2nd part of a review on medical therapy of endometriosis discusses pseudopregnancy brought on by oral contraceptives, and pseudomenopause induced by Danazol and GnRh agonist therapy. Oral contraceptives are not FDA approved for endometriosis, but many physicians prescribe 1 tablet daily for 2 weeks, then 2 tablets daily for 6-12 months, or higher doses in case of breakthrough bleeding. Pills cause endometrial decidual changes initially then atrophy. Danazol selectively inhibits release of FSH and LH by the pituitary, resulting in anovulation and atrophy of the endometrium. It is currently the preferred and most effective medical therapy for endometriosis, and is approved for this indication. It is used in doses of 200-800 mg in 2 divided doses, or 400-800 mg/day preoperatively. Side effects are androgenic, some of which are not reversible, antiestrogenic, metabolic and nonspecific, i.e., muscle spasms. Drug interactions such as increased insulin requirements have been reported. The GnRH antagonists, nafarelin, buserelin, histrelin and leuprolide must be given subcutaneously or nasally. The anti-ovarian side effects, hot flashes, calcium loss, vaginal dryness and insomnia are more prevalent than the androgenic side effects, weight gain, edema, myalgia, and decreased libido reported with Danazol. Clinical and laparoscopic evidence of improvement is temporary with drug treatment, in contrast to surgery. Infertility is common even with mild endometriosis, and the condition may recur, even after pregnancy.

Fee-For-Service and Cost Justification Activities of Pharmacist-Manned Drug Information Centers in the United States

In the current era of economic constraints, it is becoming increasingly difficult to obtain sufficient funds for drug information services. Many drug information centers (DICs) are becoming less financially secure and so alternative funding sources are becoming essential for maintaining quality services. Additionally, it is becoming more important for centers to provide cost justification data to support their existence There is a paucity of published data concerning cost effectiveness and fund-generating activities of DICs. The purpose of this article is to present an overview of and recommendations for fee-for-service and cost-justification activities of DICs in the United States DICs offer valuable services that can be enhanced through additional revenue gained from fee-for-services activities. To sell drug information services, centers must provide cost-justification data to current and prospective subscribers. In the cost containment world of the 1990s, DICs must be able to prove that they save money by lowering medical costs. Results indicate the need for cost-justification studies and demonstrate the hazards of less than rigorous study. Cost-effectiveness evidence is likely to emerge as the driving force behind DIC funding in the future

Comparison of Drug Information Practice in Hospitals and Industry

To assess the type of information requested of a pharmaceutical manufacturer, requests received over a 12 month period in the Professional Services Department of Sterling Drug Inc were reviewed. To compare drug information services of Sterling Drug with those of pharmacist-operated drug information centers (DICs), requests were classified as to the nature of the question, category of requestor, and patient specificity. Questions regarding dosage or administration, drug identification, and adverse drug events were common in both DICs and industry. At Sterling Drug Inc the largest number of requests were for literature reprints or physician drug samples and dosage or administration. This contrasts with hospital-based DICs, where the largest number of requests pertained to therapeutic use and drug efficacy or adverse drug events. At Sterling and DICs few questions pertained to pharmacology, toxicology or poisoning, and pharmacokinetics. Physicians comprised the largest group of requestors in DICs. Professional and support staffing of DIC and industry drug information practice are compared. Staffing by PharmDs and RPhs was practically identical for drug information services regardless of whether the practice site was industry or DIC.

An Analysis of Class I Recalls: 1982–1996*:

Class I recalls possess the greatest degree of health hazard and are frequently conducted to the consumer or user level. This study analyzes all Class I recalls appearing in the Food and Drug Administration (FDA) Enforcement Reports from 1982–1996. Major causes of Class I recalls over the past 14 years include: drug quality and good manufacturing practices (GMP) violations, mislabeling, and adverse reactions. Class I recalls over this time period are analyzed by reason, brand versus generic company, dosage form (eg, injection, tablet), notification method, and further FDA enforcement action (eg, seizure, injunction, criminal prosecution). Trends are identified. Finally, the effectiveness of Class I recalls to the pharmacy level is assessed.

From Cosmetic to Drug: Crossing the Line

In comparison to drugs, cosmetics are minimally regulated in the United States. However, the statutory definitions of cosmetic and drug are conveniences rather than scientific interpretations and Food and Drug Administration (FDA) classification appears to depend on claims made, the “intended use” doctrine. The cosmetic manufacturer may face legal challenge and the daunting responsibility of compliance to drug regulations when claims make cosmetics “new drugs.” This article explores the history of the drug-cosmetic debate, describes the legal precedents for improper drug claims for cosmetics, and examines recent regulatory interpretations. Also discussed are the intensified drug-cosmetic debate as evidenced by a steady stream of FDA warning letters to cosmetic manufacturers who have “crossed the line” and the growing interest in litigated Lanham Act cosmetic cases.

The Decline in New Drug Development: Liability, cost-containment, and the profit motive have had a major impact on drug development.

The future depends on innovation, not imitation. New drug development can be encouraged in a number of ways (Table 4), and the rewards are great. Who knows what dramatic drug discoveries remain to be found in a new synthetic compound, a fresh soil sample, or a plant obtained from some pristine forest? In any event, let us all hope that the molecular roulette that has governed drug development in the past will be replaced by a more rational, and less empirical, approach.