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Earn up to 8 hours of pharmacist CE with Regulatory and Risk Management Essentials for Institutional Pharmacy Leadership, a MasteryRx course on the pharmacy law and compliance issues hospital and health-system pharmacists face, from documentation liability to controlled substance diversion.
Institutional pharmacy practice presents complex legal, ethical, and regulatory challenges that extend across nearly every aspect of medication management. Pharmacy professionals must not only provide safe and effective care, but also understand how their decisions, documentation, and operational practices can create or mitigate risk for patients and their organizations.
This comprehensive series examines legal and professional responsibilities through real-world cases and issues relevant to hospital and health-system pharmacy practice. Topics include medication order processing and documentation, controlled substance diversion, compounding errors, Joint Commission standards, fraud, waste and abuse, unapproved and scientifically unsupported drug use, employer-employee relationships, and the boundaries between innovative therapy and clinical research.
Throughout the series, participants will examine how laws, regulations, professional standards, and ethical principles intersect with everyday pharmacy practice and identify strategies to strengthen compliance, reduce institutional liability, and support safe, evidence-based patient care.
In an institutional practice setting pharmacists have a responsibility to monitor each patient’s drug therapy and to consult with prescribers when there is a potential problem with a patient’s pharmaceutical care. Pharmacists have a responsibility to correct prescribing errors and to develop policies and procedures that are designed to promote effective teamwork between pharmacy and nursing. This program focuses on lawsuits in which a hospital has been sued by a patient following the prescribing, dispensing, and administration of an allegedly inappropriate medication. This monograph reviews allegations that a hospital pharmacist’s failure to consult with the prescriber, as evidenced by the absence of documentation, fell below the standard of care of a reasonable and prudent pharmacist, and that the failure to consult was a cause of the harm suffered by the patient. Legally acceptable strategies to document pharmacist consultations with prescribers and with nursing are discussed, without resort to the impractical advice to “document everything,” and rejecting the untruthful cliché that “if it isn’t documented, then it didn’t happen.” Two additional legal case studies are reviewed to demonstrate other legal issues regarding liabilities that may arise in the documentation of patient care activities.
The Joint Commission (TJC), also referred to simply as “The Joint,” is a private, non-profit, quasi-legal organization that is dedicated to quality improvement and patient safety in healthcare institutions. TJC has established standards for institutional structures, processes, and outcomes. According to TJC, the pharmacy department is responsible for compliance with standards for medication use throughout the institution. Compliance with TJC standards is an administrative responsibility rather than a legal responsibility, although there are potential legal consequences of noncompliance. This program considers the legal significance of TJC standards. Are aspirational TJC standards different from minimal or optimal standards that may be recognized in litigation by a patient against a healthcare institution following an alleged medication error? What is the legal significance of any deficiencies found at an institution by TJC during a survey? How quickly must a corrective action plan be developed following a determination of unsafe pharmacy practices at an institution? This program discusses the implications of TJC standards and TJC survey results for legal liability of the pharmacy department.
The federal Drug Enforcement Administration (DEA) has established what has been referred to as a “cradle to grave” closed system of distribution for pharmaceutical products that have an accepted medical use and a potential for abuse. The closed system places DEA regulated drugs into one of five schedules. The DEA system requires registration of professional individuals and institutions that may provide patient access to scheduled drugs, and it requires extensive record keeping to facilitate monitoring of controlled substance receipt, possession, and distribution. This monograph describes the responsibility of institutional pharmacies to control access to DEA scheduled drugs. Any leak from the closed system at an institutional practice site is classified as a “diversion” and it is considered unlawful.
There is a long history of extemporaneous compounding in the pharmacy profession. The pharmacy team is committed to providing patients with necessary unique medications in both the community practice setting and the institutional practice setting. Patients often require medications in a strength or dosage form that is unavailable with pre-manufactured products. They may require an admixture that is commercially unavailable. This program examines the potential legal liabilities related to extemporaneous compounding by the pharmacy team at institutional pharmacies. The legal consequences of the New England Compounding Center disaster are discussed. Using the legal case study method, this program evaluates legal requirements in pharmacy for attentiveness to standards in the preparation of compounded medications. The program includes consideration of the legal liabilities that can result from inadequate preceptor supervision of compounding by student pharmacists. Strategies for systematic quality improvement to reduce liability exposure from improperly compounded medications are discussed.
Institutional pharmacy departments have a legal responsibility to assure that medications used in the institution are ordered and administered in accordance with institution policies and relevant professional standards of care. This monograph focuses on three legal cases of ivermectin refusal by healthcare institutions following a hospitalized patient’s demand that the drug be used in treatment for COVID-19. The legal issues addressed by the courts in these appellate cases are reviewed, and the broader implications of the courts’ rulings are examined. The principles of law established by these legal cases provide important interpretations of longstanding legal issues regarding the responsibility of healthcare institutions to decline the use of medications when the proposed use is not evidence-based, despite demands by admitted patients that the medications be used in their care. These basic principles of law have seldom been explicitly stated and were brought to the forefront by the COVID-19 global pandemic. The monograph considers the appropriate use of the power to decline medications requested by patients. Strategies for the development and use of policies and procedures for managing patient demands for unscientific medication use are explored.
Pharmacists and other pharmacy team members who practice in an institutional setting are often classified as “at will” employees with no specific contractual rights. Nevertheless, under the law, employees have recognized non-contractual rights and responsibilities, and employers also have rights and responsibilities. Employment brings with it a mutuality of obligations. This monograph explores legal requirements that apply to both institutional pharmacy practice site employees and to healthcare institution employers. While the law generally allows employers to manage their business as they wish, there are a number of situations in which the law provides protection for pharmacy team members when adverse employment actions have been taken by employers. The legal case study method is used to analyze claims by employers that their employees have not met expectations and claims by employees that they have been treated unlawfully by their employers. The program explains how preventable communication breakdowns may lead to legal disputes between pharmacy employees and employers.
This monograph examines the challenges for institutional pharmacists due to the marketing of unapproved drugs. The FDA estimates that there are over 1,000 unapproved drugs in the pharmaceutical supply chain. While these unapproved drugs may be safe, and they may be effective, the lack of FDA approval creates a situation in which a responsibility falls on the department of pharmacy to protect patients from potential toxicity and lack of efficacy. The monograph reviews the basic principles of new drug approval under the Food, Drug, and Cosmetic Act, including the classification of some unapproved drugs as new drugs. The legal case study method is used to examine situations in which the legality of unapproved drugs has been determined by courts of law. The significant role of pharmacists in the evaluation of medication use, and the identification of harm from unapproved drugs, is considered.
Legal requirements and ethical traditions in pharmacy combine to create identifiable responsibilities that protect patients and that guide pharmacy team members in the appropriate management of pharmaceutical care. Two of the most important principles of pharmacy ethics are informed consent and the protection of subjects in clinical research. This monograph focuses on those two foundational principles of ethics and on the regulatory enforcement mechanisms that assure adherence to them in pharmaceutical care. The legal case study method is used to distinguish between clinical research and innovative drug therapy. Examples are provided of clinical care that requires patient participation in decisions about drug therapy to demonstrate respect for patient autonomy and to reduce institutional exposure to legal liability.
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$149.00
$149.00
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