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.

Constructs underlying community pharmacy dispensing functions relative to Florida pharmacy technicians.

OBJECTIVES: To assess pharmacist and pharmacy technician opinions on functions community pharmacy technicians should perform. DESIGN: Cross-sectional and descriptive. SETTING: Florida community pharmacies during August and September 2004. PARTICIPANTS: Random sample of Florida community pharmacists (n = 2,000) and Certified Pharmacy Technicians (n = 2,000). INTERVENTION: Self-administered mail questionnaire. MAIN OUTCOME MEASURES: Participant attitudes (6-point Likert-type scale: 1, strongly disagree; 6, strongly agree) regarding whether pharmacy technicians should perform 26 community pharmacy dispensing functions. Chi-square difference tests and separate group exploratory factor analyses (EFAs) were conducted. RESULTS: Pharmacists (n = 383) and technicians (n = 579) agreed that technicians should perform 17 of the 26 (65%) functions. The groups differed significantly on eight items that were focused on patient care and beyond technicians' traditional involvement in processing prescriptions, with technicians having a more expansive view of their roles than did pharmacist respondents. Three similar factors were extracted in both groups from the EFAs: functions typical of pharmacy technicians in current practice, clinical pharmacy knowledge functions, and pharmacist-only functions as specified by law. Additionally, general drug knowledge (technician data only) and pharmacy information evaluation and management skills (pharmacist data only) factors were generated. CONCLUSION: Generally, pharmacists and technicians agreed on basic functions involving prescription and claims processing; however, technicians, as compared with pharmacists, supported a more expanded patient care role for themselves.

The "general recognition and acceptance" standard of objectivity for good faith in prescribing: legal and medical implications.

The United States Court of Appeals for the 4th Circuit has ruled that a jury considering charges of drug trafficking against a pain management physician should be instructed that the defendant's good faith is a defense to the charges. The court rejected a subjective standard of good faith, and instead ruled that the good faith of the defendant must be evaluated from an objective perspective. This objective standard requires that the jury determine whether the defendant was practicing in accordance with the standard generally recognized and accepted in the United States. General recognition and acceptance are determined on a case-by-case basis, within the context of a defendant's practice. Simply because a physician's practice is out of the norm for many physicians does not mean it can't be generally recognized and accepted within the standard of medical practice. Expert witness testimony of pain management physicians will assist juries in the application of this standard for good faith in prescribing.

Patient perspectives on criminal prosecutions of pain management practitioners:lessons from the Fisher-Miller case.

The profound effect of the filing of criminal drug trafficking charges against health professionals on the patients are described. Two high profile cases in which a physician, Frank Fisher, and a pharmacist, Stephen Miller, were prosecuted for providing opioid analgesics for pain patients are described. The patients' personal perspectives on their being labeled as drug abusers for using prescribed analgesics that improved their quality of life and the way in which other health professionals and society related to them are described. In spite of the fact that the charges were dismissed, lasting harm to the professionals, their patients and society resulted from this prosecution.

A pharmacist model of perceived responsibility for drug therapy outcomes.

Pharmacists in community and ambulatory care settings are in a unique position to reduce drug-related morbidity and to optimize patient outcomes by identifying, resolving, and preventing drug therapy problems. This particular approach to pharmacy practice expands traditional pharmacist responsibilities of dispensing pharmaceuticals and providing drug information to optimizing patients' drug therapy outcomes. However, pharmacists in general, and community pharmacists in particular, have yet to incorporate this expanded professional role into daily practice. The objective of this study was to examine the validity of a pharmacist model of perceived responsibility for drug therapy outcomes based on the triangle model of responsibility. A survey instrument was tested among community and ambulatory care pharmacists in Florida, USA. The survey instrument contained the following pharmacist-related constructs from the model: clarity of standards, personal control, professional duty, and perceived responsibility for drug therapy outcomes. The model was examined by testing hypothesized relationships between the model constructs and pharmacists' reports of providing pharmaceutical care. The survey response rate was 40.9% (525/1283). All of the study measures exhibited Cronbach alpha values greater than .70. A measurement model was tested using confirmatory factor analysis. The chi2/df ratio (3.02), CFI (.95), and residual (.051) indicated a good fit of the item data to the constructs. According to path analysis, clarity of standards, personal control, and professional duty were significantly related to perceived responsibility for drug therapy outcomes, which in turn, was significantly related to pharmaceutical care provision. Perceived responsibility for drug therapy outcomes acted as a mediator of the effects of clarity of standards, personal control, and professional duty on pharmaceutical care provision. These findings have implications for pharmacy practice and research.

Cancer patient and caregiver experiences: communication and pain management issues.

This study examined facilitators and barriers to effective patient and caregiver communication with providers with emphasis on communication related to cancer pain management. Focus groups and personal interviews were conducted with cancer patients and family caregivers of patients. Communication experiences of subjects as well as suggestions for ways to improve the communication process were elicited. Twenty-two cancer patients and 16 family caregivers participated in the study. Seven themes emerged suggesting improvements that are needed in the communication process. These include: 1) improving the process of information exchange, 2) increasing active participation of patient and caregiver in the care process, 3) improving provider relationship-building skills, 4) overcoming time barriers, 5) addressing fears regarding use of pain management medications, 6) fostering appropriate involvement of family and caregivers in the communication process, and 7) improving coordination of care among providers. Specific suggestions and their practice implications for health care providers are highlighted.

Evaluating promotional claims as false or misleading.

In light of the "false or misleading" standard resulting from the recent legal ruling, it can be concluded that a true claim is one that is both factually and analytically true. Factual truth could be based on the accuracy of the information and the sufficiency of the information. Analytical truth could be based on the scientific foundation for the claim and whether the information within the claim is presented in a balanced way. Regarding the assessment of whether a truthful claim is misleading, the evaluator could consider the relevance, consistency, and context of the information. Standards are important in medication use and medication regulation. Health care professionals who must decide whether a claim is truthful and not misleading will rely on guidance from FDA in determining how to evaluate promotional claims. As the court suggested in the case reviewed here, FDA could take the lead and provide guidance "in differentiating between misleading and false promotion, exaggerations and embellishments, and truthful or non-misleading information." Existing FDA regulations provide a foundation for such guidance. The next step for the agency would be to expand existing guidance to specifically describe how an off-label claim can be identified as either false or misleading.

Legal liability perspectives on abuse-deterrent opioids in the treatment of chronic pain.

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.

Drug enforcement administration liability for false arrest of physician.

Prescribing opioid analgesic medications brings with it a risk of regulatory oversight. A Florida Physician, Dr. Andrew Nguyen, was arrested in 2000 for allegedly violating controlled substance laws. The allegation was that Dr. Nguyen had not conducted a physical examination of a patient for whom controlled substances were prescribed. The allegation was untrue, and the charges against Dr. Nguyen were dismissed. Dr. Nguyen successfully sued the local law enforcement authorities, but a companion lawsuit against the Drug Enforcement Agency (DEA) was dismissed. The United States Court of Appeals has now reinstated Dr. Nguyen's lawsuit against the DEA. The reinstatement of the lawsuit corrects a moral hazard that produces imbalanced regulatory perspectives on the enforcement of controlled substance laws.