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.

The third edition contains forty-eight chapters, contributed by 45 authors, eleven of which are attorneys who practice at the FDA, healthcare, regulatory law, malpractice defense, and the prosecution of product liability and medical malpractice. The remaining majority of chapters are contributed by accomplished physicians, pharmacologists, pharmacists, nurses, and other scientists, as well as one business executive.

The Book is divided into four sections:

I. The Pharmaceutical Process: How are drugs developed?
II. High Risk Drug Therapies Resulting in Injury and Litigation: What drugs cause the most injury?
III. Pharmacists, Pharmacy, and Pharmacy Practice: What can Pharmacists and health systems do to minimize risk and improve drug safety?
IV Forensic and Toxicology Issues: Recreational drugs, Drug Testing, and Pain Equipotency

Most of the chapters are either new (14) or extensively revised since publication of the second edition of this book. Five chapters that have not been updated contain information that remains timely – Blood Factor Products Holocaust, The E-Ferol Tragedy, Failed Drug Warnings, Drug Product Identification, and the NABP paper on the use of pharmacy technicians. Several chapters have been deleted, usually representing major drug litigation (Fen- Phen, Oxycontin, Rezulin, Baycol, Ephedra-Metabolide, PPA, anabolic steroids,) that have now been resolved through global settlements, market withdrawal, product reformulation, or more restrictive regulation. Chapters new to the Second Edition include allergic drug risks, anticoagulants and the risk for Heparin-Induced Thrombocytopenia (HIT), Critical Care Drug Toxicity, General Principles of Pharmacology, Postmortem Distribution, Pharmacy Malpractice, Non-drug marketplace (dietary supplements), Drug Litigation History – Lessons Learned, FDA MedWatch System Use and Analysis, Counterfeit Drugs, Prescription Drug Revolution and Drug Discovery, After Hours Pharmacy services, Dangers of Opiates, Fetal Drug Toxicity, and HIV drug toxicity.

I believe that the pharmacist’s most important responsibility is to ensure that drugs are used safely and effectively. We have included updated chapters on many of the specialized pharmacist chapters from the Second Edition, and have recruited contributions in the areas of acute, care, emergency-department care, the identification of drug dosage forms, the appropriate use of intravenous medications, the role of the pharmacoepidemiologist, and a new chapter on pharmacy malpractice. We are fortunate to have a updated compiled Pharmacy Case-Law Update by Morris and Stilling – both pharmacist/attorneys—adapted from a very popular presentation at the 2010 Annual Meeting of the American Society of Pharmacy Law.

A revised chapter by medical malpractice defense attorneys Barkus and Derian discusses the defense of physicians and hospitals in drug and medical device litigation. The medication error chapters have been consolidated from three to one, with extensive revisions. The 1999 Institute of Medicine (IOM) report, To Error Is Human, was updated by the IOM in 2006. Similar problems continued to be reported, and therefore the following is worth repeating. According to the Institute of Medicine’s (IOM) report “To Err is Human,” originally published in 1999, between 44,000 and 98,000 people die every year from medical errors that occur in hospitals. About 7,000 of these
were attributable to medication errors in 1993—comprising one out of every 131 outpatient deaths and one out of every 854 inpatient deaths. This problem is not limited to hospital patients either. In fact, hospitalized patients represent only a small number out of the total population at risk of experiencing a medication-related error. “Numerous studies document errors in prescribing medications, dispensing by pharmacists, and unintentional non- adherence on the part of the patient,” reads the IOM report. “Medication errors have the potential to increase as a major contributor to avoidable morbidity and mortality as new medications are introduced for a wider range of indications.” A JAMA article described the enormity of drug-related deaths as the equivalent of two 747s crashing every week. Of course, where there is injury, there may be litigation. When education and safe healthcare practitioners’ practice fail, affected patients have a right to investigate and seek damages for their injuries. Many times, that is all that they can do, because their injuries are permanent or fatal.

Because drugs are ubiquitous, and because drugs affect people’s lives and practice outside the walls of the hospital and drugstore, we again include chapters on Recreational Drugs and the Forensic Pharmacist. As stated earlier, a focused audience of the Book is attorneys, who usually have no training in FDA, pharmacy, or regulatory law, and who certainly have no training in pharmacology or the pathology of drugs. Yet, in a wide spectrum of practices, attorneys must master these complex topics to represent their clients. To assist in the apparently daunting learning curve facing the non-clinician in assessing drug injury matters, we have included an extensive review of the Basic Principles of Pharmacology (Chapter 10), which contains principles applicable to all drugs. The First and Second Editions of Drug Injury were well received by legal, medical, pharmacy, and nursing practitioners and scholars. The First and Second Editions of Drug Injury have been used as text and reference books in several universities, and can be found in numerous medical, pharmacy, manufacturer, and law libraries, the FDA library, and in private law offices throughout the United States.

Summary

In closing, Drug Injury, Third Edition is intended to serve as a broad and deep reference for anyone with a professional or personal interest in drug use, development, testing, and the dangers of drug injury. The Book shows how pharmacists play pivotal roles in the proper administration and use of prescription medications, and clearly highlights the perils of untrained or careless practitioners. I and all of the contributors to Drug Injury sincerely hope that readers will learn from the lessons contained within this text, collaborating together to create a safer future for all of us. Without these contributors, there would be no book!

On a personal note, it gives me great pride to include contributions by my children, Kimberly, who, while completing requirements for her MBA at the Kellogg Business School, investigated and reported on the (continuing) problem of counterfeit drugs, and my son Jim, who just completed his PhD In Pharmacology, contributed to the chapter on General Principles in Pharmacology.
James O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph. Associate Professor of Pharmacology,
Rush University Medical Center, Chicago, IL President, Pharmaconsultant Inc., Barrington, IL

(L&J Publications, 2012).