David B. Brushwood

Update on Prescription Monitoring in Clinical Practice: A Survey Study of Prescription Monitoring Program Administrators

OBJECTIVE Prescription drug abuse and undertreatment of pain are public health priorities in the United States. Few options to manage these problems are balanced, in simultaneously supporting pain relief and deterring prescription drug abuse. Prescription monitoring programs (PMPs) potentially offer a balanced approach; however, the medical/scientific communities are not well informed about their current status and potential risks/benefits. The purpose of this study was to provide a benchmark of the current status of PMPs for healthcare providers upon which to engage PMP administrators. DESIGN A Web survey of current PMP directors with a telephone follow-up conducted in June-July 2006 regarding goals, data captured, data sharing procedures, healthcare provider training, and evaluation efforts. RESULTS Eighteen of 23 states with operating PMPs at that time participated. Eleven programs allowed physician access to PMP data. Data were delivered by mail (N = 6), fax (N = 8), e-mail (N = 1), and Websites (N = 8). Eight programs provided data to providers within 1 hour. Three states have developed provider PMP usage guidelines. Eight states developed or are developing educational programs. Two states completed or are conducting evaluations of the public health impact of PMP implementation. Five states have begun utilizing PMP data as an epidemiological tool. CONCLUSIONS Initial public safety orientation of PMPs is evolving to include improving public health and patient care. Beginning with efforts to engage healthcare providers through data sharing and education, and progressively including program evaluation on public health and patient care, our results suggest a rapid movement in the direction of utilization of PMPs to improve health care.

From confrontation to collaboration: collegial accountability and the expanding role of pharmacists in the management of chronic pain.

The war on drugs has created an environment where both physicians and pharmacists are afraid to aggressively manage pain - which, for many patients, means horrific unrelieved suffering. Although the policy-on-paper, as the author calls it, regarding controlled substances has eased, the policy-in-practice has not, and physicians and pharmacists are still fearful of prosecution or other disciplinary action. As a solution, the author proposes and discusses in detail collaborative drug therapy management for chronic pain.

Legal Liability Perspectives on Abuse-Deterrent Opioids in the Treatment of Chronic Pain

ABSTRACT Abuse-deterrent opioid analgesic formulations can help reduce the risk of opioid diversion and abuse. Not all opioid analgesics are available as both extended- and immediate-release dosage forms in abuse-deterrent formulations. Clinicians may have to balance the clinical benefit of a product that does not use abuse-deterrent technology versus the regulatory benefit of using a product with this technology. There is the possibility that a health care professional may be held legally liable when a product without abuse-deterrent qualities is used and a person suffers harm that would not have occurred had an abuse-deterrent formulation been provided. This article reviews legal precedents that inform an understanding of the need to reduce malpractice exposure by identifying patients who are at high risk of opioid diversion and/or abuse and considering the use of an abuse-deterrent formulation for these patients.

RESEARCH: Media Coverage of Controlled Substance Diversion Through Theft or Loss

OBJECTIVES To determine the frequency of media reports of controlled substance diversion. DESIGN Quantitative search of news articles from LexisNexis Academic, using search strings related to four different types of controlled substance diversion. SETTING Not applicable. PATIENTS OR PARTICIPANTS Not applicable. MAIN OUTCOME MEASURES Number of media reports about diversion of controlled substances at the prescriber or dispenser levels, through pharmacy robberies or thefts, and through hijackings or robberies of shipments. RESULTS Media reports of controlled substance diversion indicate that theft and loss are important problems and that inappropriate prescribing and dispensing are substantial problems as well. Leaks of controlled substances from the closed system of distribution seem to be increasing as rapidly through theft and loss as through inappropriate prescribing and dispensing. During the five biennia between 1993 and 2002, these percentage increases in media reports were observed for the different types of diversion: 200% for prescribers; 350% for dispensers; 133% for pharmacy robberies and thefts; and 1,800% for thefts from shipping channels. CONCLUSION A balanced approach to the prevention of controlled substance diversion, aimed at reducing illicit acquisition of drugs from theft and loss as well as from prescribing and dispensing, may produce the greatest success without adversely affecting the quality of patient care.

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.

The Duty to Counsel: Reviewing a Decade of Litigation

Twenty-three legal cases from the 1980s were studied. The allegation in each of these cases was that the defendant pharmacist should have done something more than correctly process a prescription to prevent harm to the patient from drug use. Four theoretical models of pharmacist legal responsibility are considered: (1) the policy-analysis model, (2) the professional-standards model, (3) the consumer-expectation model, and (4) the power model. It is concluded that the power model, based on superior knowledge and reasonable foreseeability of harm, best defines the pharmacists legal responsibility, consistent with established legal precedents.

Hospital liability for accuracy of pharmacist consultations

Pharmacists regularly provide consultations to prescribers regarding the appropriateness of drugs, doses, dosage forms, and other aspects of drug therapy. These consultations may be provided by a pharmacist who functions primarily in a dispensing role and whose screening of drug orders results in

A third class of drugs: an overview.

Drug distribution in the U.S. allows certain products to be used only under the supervision of a physician or dentist. The distribution of other products is underrestricted, such that they may be used by consumers without any supervision. This article discusses the possibility of establishing a third class of drugs that would be available without a prescription but could be purchased only from a pharmacist. The current prescription-to-OTC switch process may provide an excellent opportunity to establish a third class of drugs. However, significant obstacles exist to such a move. For there to be sufficient public policy justification for a third class of drugs, it must be shown that the public will benefit through increased quality of health care and that the economic consequences will not be prohibitive.

Extended consequences of pharmacy error

David B. Brushwood Patient safety is as critical in pharmacy as it is in any other health profession. Pharmacists take seriously their responsibility to develop pharmacy practice systems that detect and counteract inevitable human errors so that the harm caused by these errors can be minimized, if not eliminated. When an error is not corrected and causes harm, there are consequences for the harmed patient as well as for the pharmacist responsible for the error.

Investigation of the Potential Effects of Registration Requirements on Florida Pharmacy Technician Credentials

Background: On June 23, 2008, Florida adopted regulations mandating credentialing requirements for pharmacy technicians. Objective: To investigate the Pharmacy Technician Certification Board (PTCB) certified pharmacy technician self-report and pharmacist report of work experience, education, training, and non-PTCB certification credentials of Florida community pharmacy technicians prior to the adoption of registration requirements in that state and to predict the effects of the requirements on Florida pharmacy technicians. Methods: A self-administered questionnaire was mailed to 2000 Florida pharmacists and 2000 Florida PTCB Certified Pharmacy Technicians (CPhTs) in 2004. Results: Of the 1230 returned questionnaires, 571 (46%) were from pharmacists and 659 (54%) were from technicians. Most of the pharmacists in the sample reported that they had supervised a CPhT, while few had supervised a technician with an AA in Pharmacy Technician Sciences. Most of the technicians sampled reported having some higher education. Less than half reported having formal technician training. Few reported having non-PTCB pharmacy technician certificates. Conclusions: Florida pharmacy technicians had some higher education or technician training credentialing, despite its not being mandatory. Pharmacists may not always be aware of the education and credentials of the technicians they supervise. The new registration requirements will most likely have little effect on existing Florida pharmacy technicians who register before January 1, 2011. Those who are CPhTs will have to complete types of continuing education that are different from those that they were required to complete for certification. Those who are not CPhTs will have to complete continuing education programs.