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.

Multiple schedule II prescriptions: the final rule.

Multiple same-day prescriptions for Schedule II medications offer the flexibility to provide continuous access to necessary medication without requiring that stabilized patients unnecessarily visit their prescriber on a monthly basis. The federal Drug Enforcement Administration recently promulgated a new regulation that specifically authorizes the use of multiple prescriptions. This is a change in policy within the agency. Health care professionals must communicate to each other that this useful practice is now recognized as being completely legal.

Should the DEA conduct a "patient impact assessment" when promulgating new restrictions on controlled substance distribution?

The federal notice and comment rulemaking process is described and illustrated with the recent multiple-copy prescription controversy. Impact assessment, balance in controlled substance regulation, and informing balanced decision making are discussed. Examples of regulations that may warrant patient impact assessment scrutiny are provided and the need for caution in applying these is described.

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.

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.

Debunking myths of negligence in pain management practice.

Pain management practitioners must meet the standard of care to avoid liability for malpractice. The Court of Appeals of Florida has recently reversed a jury verdict against a surgeon who provided pain management care to a patient who died after overdosing on opioids obtained from a different physician. The plaintiffs had contended that the surgeon breached the standard of care by failing to perform specific activities that would have prevented the patient from obtaining the drugs that cause her death. The appellate court rejected the plaintiffs' argument because the evidence failed to support malpractice liability of the surgeon.

Pharmacist-physician collaboration in pain management practice.

Pain is one of the most common reasons patients seek out healthcare and management typically requires complex medication regimens. Pharmacists have become increasingly more involved in pain management. Historically, pharmacists and physicians have often had adversarial relationships because of regulatory influence. However, as medication experts, pharmacists can play a key role in optimizing outcomes in the management of pain and can be critical to the success of the medication regimen. Numerous opportunities for collaboration exist for pharmacists and physicians in various settings. One example is the VIGIL process, an effective risk management strategy that requires collaboration between pharmacists and physicians. The success of pharmacist-physician collaboration will depend on numerous factors, including strong physician and administrative support. A clear strategy and stepwise approach to developing a pain management pharmacist-physician collaborative practice is the key to its success. Once the collaboration is formalized, a management strategy should also be defined and should include regular chart review and regular feedback from the physician. Through physician-pharmacist collaboration, pain management outcomes can be optimized and risk can be managed.