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Background Although Kentucky pharmacists recently gained authority to provide protocol-driven care for 13 conditions, provision of prescription hormonal contraception (HC) services is not currently authorized. A board-approved protocol allowing for provision of nonprescription over-the-counter (OTC) emergency contraception (EC) was recently approved by the Kentucky Board of Pharmacy but has yet to be implemented. Objectives The objectives of this study were (1) to assess Kentucky pharmacists’ interest in providing prescription HC and OTC EC services via protocol and (2) to identify perceived benefits/barriers regarding provision of prescription HC. Methods An online questionnaire was disseminated electronically to a convenience sample of Kentucky pharmacists. The questionnaire collected (1) demographic information, (2) opinions regarding provision of prescription HC and OTC EC, and (3) perceived benefits and barriers regarding provision of prescription HC. For analysis, responses were limited to pharmacists in community-based practice. McNemar’s test was used to identify statistically significant differences in support by dosage form. In addition, a multivariable logistic regression model was used to examine associations between demographic factors and support for pharmacist provision of prescription HC. Results We received 151 responses from community-based pharmacists. Support for provision of prescription HC was highest for oral (61%) and transdermal (54%) forms. We found no statistically significant differences in support among demographic factors other than number of years in practice, with more recent graduates being at higher odds of support. In addition, time, reimbursement, training, and belief in the need for pelvic exams were the most commonly cited barriers to implementation. With regard to OTC EC provision, pharmacists were largely supportive (62%) and confident in their abilities. Conclusions Community-based pharmacists in Kentucky are supportive of provision of oral, vaginal, and transdermal prescription HC as well as OTC EC via protocol. Barriers, including time, reimbursement, training, and belief in the need for pelvic exams, should be addressed to increase support for prescription HC provision.

Pharmacies are a potential site for access to sterile syringes as a means for preventing human immunodeficiency virus (HIV), but the type and extent of their utility is uncertain. To examine pharmacy syringe purchase, we conducted a standardized, multistate study in urban and rural areas of four states in which attempts to purchase syringes were documented. Of 1,600 overall purchase attempts, 35% were refused. Colorado (25%) and Connecticut (28%) had significantly lower rates of refusal than Kentucky (41%) and Missouri (47%). Furthermore, urban settings had higher rates of refusal (40%) than rural settings (31%, P

Objective To examine pharmacists' attitudes and practices surrounding human immunodeficiency virus (HIV) prevention among injection drug users. Design Focus groups. Setting Urban and rural sites in Colorado, Connecticut, Kentucky, and Missouri. Patients or Other Participants: Eight focus groups, with 4 to 11 pharmacists participating in each group. Interventions Transcripts of focus group discussions were evaluated for common themes by the authors and through the use of NUD*IST. Main Outcome Measures Willingness to sell syringes to all customers, views on syringe exchange programs (SEPs), knowledge of laws governing syringe sales and racial, ethnic, or gender biases in syringe selling practices. Results Two pharmacists established their own policies of selling syringes to everyone, and three expressed a willingness to have their pharmacies serve as SEPs. A total of 20% of the pharmacists expressed an interest in learning more about the efficacy of SEPs and distribution of syringes by pharmacists, and were willing to change their views based on this information. Many also indicated a general willingness to work with SEPs or to participate in the effort to curb the spread of HIV. However, a majority of pharmacists opposed having SEPs in their pharmacies and reported selling syringes only within specific limits: to known diabetics, to individuals who looked reasonable, or to individuals who presented a logical explanation. No racial, ethnic, or gender bias was observed. Conclusion Opinions among pharmacists varied across and within sites. While a majority of pharmacists would not establish SEPs in their own pharmacies, nearly all would participate in other HIV-prevention programs. Educational programs for pharmacists may be valuable in HIV-prevention efforts.

Objective To examine injection drug users (IDUs) opinions and behavior regarding purchase of sterile syringes from pharmacies. Design Focus groups. Setting Urban and rural sites in Colorado, Connecticut, Kentucky, and Missouri. Patients or Other Participants: Eight focus groups, with 4 to 15 IDU participants per group. Interventions Transcripts of focus group discussions were evaluated for common themes by the authors and through the use of the software program NUD*IST. Main Outcome Measures Knowledge of human immunodeficiency virus (HIV), pharmacy use, barriers to access from pharmacies, high-risk and risk-reducing behavior, and rural/urban difference. Results Almost all participants knew the importance of using sterile syringes for disease prevention and reported buying syringes from pharmacies more than from any other source. Two IDUs believed pharmacists knew the syringes were being used for injecting drugs and perceived pharmacists' sales of syringes to be an attempt to contribute to HIV prevention. Most IDUs reported that sterile syringes were relativity easy to buy from pharmacies, but most also reported barriers to access, such as having to buy in packs of 50 or 100, being made to sign a book, having to make up a story about being diabetic, or having the feeling that the pharmacists were demeaning them. While the majority of IDUs reported properly cleaning or not sharing syringes and safely disposing of them, others reported inadequate cleaning of syringes and instances of sharing syringes or of improper disposal. There were few differences in IDUs' reported ability to buy syringes among states or between urban and rural sites, although the data suggest that IDUs could buy syringes more easily in the urban settings. Conclusion For the most part, participants understood the need for sterile syringes in order to protect themselves from HIV, hepatitis B virus, and hepatitis C virus and saw pharmacies as the best source of sterile syringes. Although these data are not generalizable, they suggest that pharmacists can and do serve as HIV-prevention service providers in their communities.

In the United States, up to 80% of prescription drugs are prescribed for indications not approved by the Food and Drug Administration (FDA).[1][1] Unlabeled use is often the mainstay of therapy in patient populations for whom less conclusive evidence is available, such as pediatric,[2][2] oncology,[

The law regarding refusal of psychiatric patients to take psychotropic medication is reviewed. The law in this area is traced through its evolution beginning in the 1960s when failure to administer medication to psychiatric patients was considered mistreatment of the patient. The legal basis for forcible administration of drugs is reviewed, and a discussion of cases in which patients refused to accept treatment on religious grounds is presented. When children are involved, the courts are generally in accord that the parents' right to freedom of religion ends where the child's right to life begins or when there is a threat to public health and safety. In cases involving adults, without a threat to public health or safety, relevant opinions rule that medical treatment should not be ordered against the patient's religious beliefs because it would constitute a violation of the First Amendment. Two leading cases involving the forcible administration of medication, Rennie v. Klein and Rogers v. Okin, held that administration should be limited to emergency situations when there is substantial risk of injury to the patient or others in the hospital. The Supreme Court made it clear that the right to refuse must be derived from state law, not from the federal Constitution, apparently giving health-care professionals broad leeway in exercising professional judgment in this area.

Tax issues related to sales of medications to outpatients by pharmacies in nonprofit hospitals are described. Hospitals are increasing their emphasis on development of ambulatory-care programs. Two aspects of the tax implications of such services are (1) whether revenue from sales of medications to ambulatory patients constitutes "unrelated business income" for the nonprofit hospital and thus is taxable and (2) whether engaging in dispensing of medications to ambulatory patients might jeopardize the tax-exempt status of the hospital. Various rulings from the Internal Revenue Service and court cases are reviewed. Sales of medications to members of the general public who are unrelated to the hospital are taxable. Sales of medications for the convenience of hospital patients, and irregular and intermittent sales to the public by a pharmacy that normally serves only "patients," are tax exempt. Sales of medications to the public probably do not jeopardize the tax-exempt status of a hospital so long as the primary purpose of the hospital is consistent with permissible tax-exempt purposes.

The potential for clinical pharmacy services to reduce the liability of institutions and the personnel who practice in them is presented. Several studies are reviewed that identify the characteristics of patients who are at a high risk of developing complications. Based on these data and data gathered on drug-related malpractice claims, pharmacists can concentrate their efforts on those patients who have the greatest liability implications to the institution. Pharmacists' efforts to reduce the liability of their institutions can also provide a justification for their clinical services.

As the pharmacist's clinical role expands he is confronted with legal questions concerning actual or proposed activities. A number of papers have appeared in the literature of pharmacy which address the potential legal liability of the pharmacist who engages in clinical activity but most are written in terms of general principles of law with few specific circumstances addressed. In this article, legal questions raised by clinical pharmacists in the course of their everyday practices are evaluated and discussed. Among the issues presented are use of an FDA-approved drug for an unapproved use, informed consent in administration of unapproved drugs, the role of the pharmacist in managing hypertensive patients visiting a hospital-based clinic, the legality of a pharmacist administering injectible drugs, the legality of permitting Pharm.D. students to draw blood, and the application of the Federal Food, Drug and Cosmetic Act to the preparation of aluminum hydroxide cookies for dialysis patients. The specific questions are answered and the legal standard of care expected of pharmacists performing clinical functions is discussed. While no cases have been decided yet concerning newer clinical activities, some precedent can be found in past cases. Approaches to handling these questions should be of value in addressing future legal issues presented as pharmacists further seek to better utilize their knowledge.