Forensic Pharmacist Report in a Coumadin Death Case

James O’Donnell

THIS ARTICLE. AS part of the Forensic Pharmacist issue, presents a series of reports of opinions, case summary, citations to standards of practice, and pharmacy rules and regulations, as applied and utilized in a forensic evaluation by this author in a death caused hy a Coumadin dispensing error; Cogentin had been prescribed. An interesting part of the case was the deception by the defendant pharmacist, who denied knowledge of the error when the death was investigated by the hospital treating the patient as well as by the Board of Pharmacy investigators.

The case is made interesting further because, in Pennsylvania, the state in which the error occurred and the suit was brought, experts must express complete reports, and depositions of experts are, by custom, not taken. All of the experts’ opinions must be fully expressed in reports, or they will be precluded in trial. Because Coumadin errors are the mosr frequent cause of lawsuits against pharmacists …

Forensic Pharmacist Report in a Coumadin Death Case (Full Article – PDF)

Alcohol: Gastrointestinal and Other Toxicities

This article will focus on the two areas of alcohol injury: first, the gastrointestinal system, primarily liver toxicity and cirrhosis, and second, the human toll in injury, examining injury epidemiology information that estimates alcohol’s involvement in trauma. Any pharmacist consulting in any capacity, especially related to gastrointestinal disorders, will need to understand the significant sociological, pathological, pharmacological, and psychological impact of alcohol.

Pharmacists providing care, including dispensing many different drugs to patients, should be cognizant of the interacting effects of alcohol and the need to warn patients. Finally, the reader will Jearn of a case in which a pharmacist was sued for not warning about the use of alcohol with a central nervous system depressant, and the resultant litigation after that lawsuit.

Alcohol: Gastrointestinal and Other Toxicities – Full Article (PDF)

Forensic Drug Testing and Drug Testing in the Workplace

Excerpted Chapters from Drug Injury: Liability, Analysis and PreventionChapter 43 – Forensic Drug Testing — Chapter 44 – Drug Testing in the Workplace (PDF – Full chapters)

43.1 Introduction
Review of this chapter will assist counsel in understanding
the tests, in communicating with their own experts, and also
in cross-examining opposing experts.

In order for a scientist, toxicologist, pharmacologist,
pharmacist, or pathologist to correlate drug action or effects
with the drug found in the body, the concentration found in
the body must be sufficient to cause the adverse reaction or
be beyond the expected therapeutic dose. In addition, the
type of specimen collected must be one that will properly
reflect the drug concentration in the body at the time of the
incident/death. For these reasons, the interpretation of the
drug’s reaction for the purposes of determination of cause
and effect can be problematic. The method of sample analysis
and a review of the laboratory data are of key importance.
Test results have the potential for error, and may need to be
critiqued by a qualified expert.

Drug Injury: Liability, Analysis and Prevention,  Chapters 43, 44 (PDF)

Policies and Procedures – Enhancing Pharmacy Practice and Limiting Risk

James O’Donnell, PharmD, MS; and F. Randy Vogenberg, RPh, PhD


Let’s face it—health care settings, including pharmacies, can be legal land mines because patients and the public can and do get hurt. As a policy-recommending body to the medical and administrative staff in health care organizations, P&T committees have a primary
role of maintaining a limited list (formulary) of medications approved for use that meet the needs of clinicians and their patients as well as those of the organization. 1 Because most members of P&T committees are not pharmacists, a primer on policies and procedures (P&Ps), including an emphasis on their importance for pharmacists, may be helpful for P&T
committees in executing their duties.

Read the rest of  Policies and Procedures – Enhancing Pharmacy Practice and Limiting Risk (pdf).

Drug Shortages Pose Problems for P&T Committees in Accountable Care Organizations


For more than a decade, drug short¬ages have made headlines. Shortages also have forced P&T committees in many hospitals and health care delivery organizations to make contingency plans for providing safe and effective therapies when conventional and preferred drugs are not available. An article published in P&T in 2011 described several concerns associated with drug shortages and substitutions, including safety risks, cost implications, and the domino effect that shortages can have when the inability to acquire one agent leads to unexpected demand for another.

The passage of health care reform legislation …continued (PDF)

Preface to “Drug Injury, Liability, Analysis and Prevention. Third Edition.”

Drug Injury, Liability, Analysis, and Prevention, Third Edition (2012) was designed to serve as a reference for attorneys, pharmacists, physicians, risk managers, nurses, drug manufacturers, and regulators—as well as anyone with any interest in drug use and drug injury. It summarizes the FDA’s responsibility in monitoring dr ug development and safety. It reviews current drug-product-related liability issues that focus on the manufacturer’s role in providing for drug safety. The book identifies important roles that pharmacists play in enhancing medication safety and effectiveness, and demonstrates what can happen when pharmacists and other practitioners and healthcare institutions do not perform adequately. By focusing on the most dangerous drugs, the reader can learn from the tragedies and mistakes of others, look at their own practice settings, and avoid making similar mistakes.

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