Responsive regulation of Internet pharmacy practice.

Professor Brushwood discusses the effectiveness of the Internet as a medium for carrying out pharmaceutical care. A proponent of Internet pharmacy, Professor Brushwood argues that pharmacy regulators could best protect and promote public health through responsive Internet regulation. Wary of state paternalism, the article advocates the Verified Internet Pharmacy Practice Site program of the National Association of Boards of Pharmacy as a model method for regulating pharmacy practices over the Internet.

Adverse drug reactions in elderly patients: alternative approaches to postmarket surveillance.

In the last three years, the Food and Drug Administration has withdrawn seven prescription drugs from the market, and it has required intensified warnings for a number of others, all due to the discovery of previously unforeseen side effects associated with their use. Adverse drug reactions are a leading cause of death in the United States. For a variety of physiological and socio-medical reasons, the elderly are particularly susceptible to adverse drug reactions. Because the pre-approval process cannot expose all potential risks associated with a drug, the authors assert that policymakers should consider implementing a more extensive, and more integrated, post-approval surveillance and testing system. They conclude that the recent cluster of drug withdrawals due to safety problems raises legitimate questions about the rigor and effectiveness of the post-approval monitoring system for new drugs, and these questions extend beyond the obvious difficulties associated with the collection and analysis of risk data. Traditionally viewed as a regulatory problem for the FDA, the problem of adverse drug reactions implicates patient welfare and the provision of medical care more broadly, and a purely regulatory mind set unnecessarily constrains thinking about possible approaches to improving drug safety. Possible solutions to the problem ought to contemplate more formalized involvement of the medical community, pharmacists, and patients. This Article introduces a proposed systems approach to detecting and preventing adverse drug reactions, and discusses several other incremental reforms to existing systems that may help the medical community to improve the overall safety of prescription drug therapy for the elderly, and ultimately for all patients.

State pharmacy regulators' opinions on regulating pharmaceutical care outcomes.

OBJECTIVE: To examine the opinions of state pharmacy regulators regarding responsibility for the outcomes of drug therapy, and approaches that might be taken to regulate for pharmaceutical care outcomes. DESIGN: Surveys were sent to the executive secretaries of state pharmacy boards. The executive secretaries were encouraged to seek input from other board staff and board members in formulating a response. Reminder postcards were sent to all subjects 1 week after the initial mailing. MEASURES: The survey instrument was divided into three sections. The first section identified 10 approaches that state boards could use to regulate for outcomes and asked subjects to indicate the utility of each. The second and third sections asked the subjects to determine the extent to which pharmacies and pharmacists, respectively, should be responsible for outcomes potentially related to pharmaceutical care. RESULTS: Forty-one usable surveys were returned. All approaches to regulation were viewed as potentially useful, and scores for three approaches indicated that they would be consistently helpful for effective regulation of pharmaceutical care outcomes. The pharmacy was viewed as solely responsible for poor outcomes related to systems deficiencies, a lack of self-assessment, inadequate references, equipment, and technician support. Pharmacists were assigned greatest responsibility for outcomes related to prescription filling, and less responsibility for outcomes related to patient care. However, there was considerable variation in responses to many of the items, reflecting the diverse opinions of pharmacy regulators on these issues. CONCLUSIONS: While pharmacy regulators appear open to some outcomes-oriented approaches to regulation, there is no clear consensus on responsibility for pharmaceutical care outcomes.

Conscientious objection to assisted death: can pharmacy address this in a systematic fashion?

OBJECTIVE: To describe a legal structure for the accommodation of pharmacists' rights of conscience in the dispensing of drugs for pharmaceutically assisted death. BACKGROUND: Pharmacists have indicated that there is disagreement in the profession regarding the appropriateness of a practice known as "pharmaceutically assisted death," in which lethal medications are prescribed for terminally ill patients who want to end their lives. Pharmacists who object to pharmaceutically assisted death may be asserting a conscientious objection that threatens to create a conflict with their employers. In addition, pharmacists who support pharmaceutically assisted death, but whose employers forbid the dispensing of medications for this purpose, may face a similar conflict. Current laws and principles of professional ethics fail to adequately address the resolution of either of these conflicts. DISCUSSION: We propose a system within which the pharmacy profession could accommodate the right to conscientious objection without sacrificing the quality of patient care. At the heart of our proposal is the understanding that employers must respect an employee's right to beliefs that differ from those of the employer and, correspondingly, the understanding that employees must respect the employer's duty to provide products and services to those who seek them from the employer. CONCLUSIONS: Pharmacy associations can adopt policies for conscientious objection and have those policies become law through action of the state legislature or the state board of pharmacy. This approach could lead to the development of a clear policy and procedure for resolving the issue of conscientious objection within the pharmacy community, making it far less likely that institutions outside pharmacy would be required to develop a solution for pharmacy.