The Broad Field of Forensic Pharmacy

What is forensics?

Forensics is quite popular now in the general population. Television shows like CSI, NCIS, Bones, Crossing Jordan, and so on have forensics as the major theme. In the late 1970s and early 1980s, we had the show Quincy, M.E. One of the first things that happens when a person dies on television or in the movies is that forensics is called. This leads to the common misconception that “forensic” means death. While crime scene management and conducting autopsies for medicolegal purposes is certainly within the broad field of forensics, there are many other areas of forensics including forensic toxicology, forensic chemistry, document examination, handwriting analysis, forensic psychology, fraud examination, criminalistics (the scientific collection and examination of physical evidence as it relates to crime), forensic serology (the study of blood and other body fluids as evidence to help reconstruct a crime or accident), forensic geology, forensic photography, forensic meteorology, dactylocsopy (fingerprints), forensic dentistry, forensic engineering, forensic nursing, polygraph examination (the lie detector), forensic medicine, forensic pathology, death investigation, computer forensics, forensic audiology, forensic optometry, recorded evidence, forensic economics, accident reconstruction, forensic anthropology, and of course forensic pharmacy. Nonscientific disciplines, such as accounting, have forensic applications, that is forensic accounting. In fact, almost every profession has a forensic application.

Unnatural death can involve criminal wrongdoing or civil liability. Forensics is important to death investigation. Dictionaries define forensic as “applied to law” or as “science applied to law.” Forensics is not to be confused with thanatology, the study of death. A funeral director or embalmer is not a forensic specialist. An autopsy conducted in medical school for teaching purposes is not a forensic procedure. However, an autopsy conducted to determine whether a crime was committed is a forensic procedure.

What is Forensic Pharmacy?

Pharmacists are experts in the science of drugs. Forensic pharmacy is the application of the drug sciences to legal issues. ^1,2 Forensic pharmacists engage in professional work relating to litigation, the regulatory process, or the criminal justice system. ^1,2 The domain of forensic pharmacy includes the clinical, distributive, administrative aspects of pharmacy, and the basic pharmaceutical sciences. As stated above, almost every profession has a forensic application. It can also be said that almost every specialty of a profession has a forensic application. For example, one could be a forensic psychiatric pharmacist, a forensic clinical pharmacist, a forensic oncology pharmacist, and so on.

Many readers of this article may be thinking that forensic pharmacy is a new and/or exotic field. The only aspect of forensic pharmacy that is new is the terminology. Pharmacists have been doing medicolegal work and law enforcement work for years. Pharmacists have been involved in a variety of leadership roles in the field of forensics. The second person to serve as Commissioner of the Federal Bureau of Narcotics (a predecessor of the Drug Enforcement Administration [DEA]), Henry Giordano was a pharmacist. ³ Mr Giordano was the Commissioner from 1962 to 1968. Prior to, Mr Giordano was a Deputy Commissioner and a special agent with the bureau. Daniel J. Fischer, RPh, DABFE, FACFE, served as Coroner of Marion County, Illinois, for 20 years before retiring in 1996. ⁴

Forensic pharmacy is not an exotic field. Many issues concerning society are relevant to forensic pharmacy including substance abuse control, impaired driving, crime, fraud, date rape, and employment testing for drugs. Pharmacists may provide valuable testimony in cases involving drunk driving, homicide, suicide, malpractice, child abuse, personal injury cases, patents, and so on.

Almost every pharmacist does some type of forensic work whether he or she realizes it or not. A community pharmacist needs to scrutinize a prescription for possible forgery. A hospital pharmacist develops systems to detect and prevent drug diversion. A psychiatric pharmacist may monitor patients for signs of substance abuse. A pediatric pharmacist may watch for signs of child abuse. Pharmacists in drug utilization review programs for state Medicaid programs have fraud detection responsibilities. Drug information specialists are asked questions about urine drug testing. Pharmacists in most practice settings may answer questions on the effects of medication on driving. Nuclear pharmacists may serve as radiation safety officers for their organizations. Pharmacists in hospitals and academia may serve on Institutional Review Boards which protect the rights of human subjects. Many pharmacists give presentations about drugs of abuse to elementary and high school students with the intent of discouraging illegal use of drugs. Kelly M. Smith, PharmD, encourages pharmacists to educate others about the potential risks of drug-assisted acquaintance rape. ⁵ Dr Smith also states “the pharmacist’s professional knowledge may also be of value to law enforcement officials, rape counselors, or other health care professionals who deal with potential acquaintance rape victims.” ⁵

Additionally, forensic pharmacy is neither separate nor outside the mainstream forensic fields. Pharmacists hold membership in the American College of Forensic Examiners, American Academy of Forensic Sciences, and the Association of Certified Fraud Examiners. Yale Caplan, former Chief Toxicologist for the Maryland Medical Examiner’s Office, served as President of the American Academy of Forensic Sciences. ⁶ The second person to serve as Chairman of the American College of Forensic Examiners was David E. Rosengard, MD, PhD, MPH, RPh. ⁷ Pascal Kintz, PharmD, PhD, served as a guest editor for a special issue on hair analysis for Forensic Science International. ⁸ Cynthia Morris-Kukoski, PharmD, DABAT, is the Chair, Forensic Special Interest Group with the American Academy of Clinical Toxicology. ⁹ John Harris Trestrail, RPh, DABAT, FAACT, is the Director of the Center for the Study of Criminal Poisoning. ¹⁰ Alton Cantrell is a pharmacist and polygraph examiner. He writes an Internet blog on the effect of medications on the polygraph machine ¹¹ and was the past President of the Alabama Association of Polygraph Examiners.

As previously described, forensic pharmacy is a vast field. The domain of forensic pharmacy overlaps with forensic medicine, forensic psychology, forensic toxicology, forensic accounting, fraud examination, forensic chemistry, forensic document examination, polygraph examination, death investigation, forensic nursing, forensic optometry, and accident reconstruction. Specific issues involving forensic pharmacists include professional malpractice, patient confidentiality, drug diversion, impaired capacity, drug-induced violence, appropriate use of chemical restraints, adverse drug reactions, drug interactions, drugged and drunk driving, product tampering, medication errors, quackery and health care fraud, and poisoning. ^1,2

Many pharmacists do forensic-related work, but I know of only 1 pharmacist who actually had the job title “Forensic Pharmacist.” ¹² Most forensic pharmacists are part-time forensic pharmacists. They either do forensic work as part of their regular job or provide service as part-time work in addition to their full-time job. For example, Mr Fischer served as a Coroner in Illinois, while maintaining his own retail pharmacy. When I worked as the clinical pharmacist at Taunton State Hospital in Taunton, Massachusetts, I served as a toxicology consultant to the Massachusetts Department of Mental Health (DMH) Office of Investigators. Investigators from DHM would consult with me when they investigated incidents involving clients of the DMH. Most of the investigations I was consulted on were deaths where I would interpret the postmortem toxicology tests for the investigators. I also got questions about urine drug testing and also about appropriate use of psychotropic medications. Many of the authors in this issue of the Journal of Pharmacy Practice work as freelance consultants.

Some pharmacists, although rare, are full-time forensic pharmacists that work for the government or serve as forensic toxicologists. Pharmacists hold numerous types of positions with local, state, and federal agencies. ^{1 –3,6,12 –18} Pharmacists with training in criminalistics have worked as criminalists for police departments and crime laboratories. ¹² At the state level, pharmacists have worked as investigators and inspectors for boards of pharmacy, health departments, and narcotic bureaus. ¹⁶ State medical examiners have employed pharmacists with advanced training in toxicology and analytical chemistry in the capacity of forensic toxicologists. ⁶ Many state Medicaid programs and private insurance companies have pharmacists as auditors and investigators. ^16,18 The DEA has employed pharmacists as special agents, diversion investigators, and in administrative positions. ^13,15,16 The Food and Drug Administration (FDA) has pharmacists as consumer safety officers, chemists, pharmacologists, interdisciplinary scientists, compliance officers, and in management positions. ^15,16 Specifically, a pharmacist was Commissioner of the FDA in the early 1980s. Qualified pharmacists can become special agents with the Federal Bureau of Investigation (FBI). A pharmacist friend of mine works as a forensic examiner (support position) in the toxicology laboratory at the FBI in Quantico, Virginia. Pharmacists have testified before Congressional Committees on Government Oversight of the FDA. ¹⁹ Pharmacists have worked as patent examiners for the US Department of Commerce.

Pharmacists may also provide traditional pharmacy services at state forensic psychiatric hospitals. ²⁰ Another aspect of forensic pharmacy is providing pharmaceutical care to inmates at correctional institutions. I heard arguments that pharmacists who work in prisons should not be considered forensic pharmacists. The reason being is that they are not involved with litigation. I disagree with this argument. Pharmacists in prisons have to be more security conscious than most other pharmacists. They are more often involved with interpreting urine drug tests. Pharmacists with the Federal Bureau of Prisons are also correctional officers. ²¹

The majority of forensic pharmacists work as independent consultants. Larger police departments may have pharmacists as consultants or to teach “drug recognition experts.” ¹ Pharmacists have served on the drug testing for collegiate sports and as “technical officers” for the Olympics. ^22,23 The work done by forensic pharmacists can be of great value to attorneys, paralegals, claims adjustors, and forensic specialists. Forensic pharmacists can assist accident reconstructionists by determining the role of drugs or medications as a contributing factor to the accident. ^1–2 Forensic pharmacists can assist fraud examiners and health care administrators in reducing waste and fraud, especially if complex therapeutic issues are involved. ^1,2 Forensic pharmacists can assist true crime writers and nonfiction writers. I provided information and reviewed a case of suspected mercury poisoning for a nonfiction writer. On another occasion, I gave suggestions and described properties of a hypothetical drug that causes violence for a fictional novel with a story of homicide where the person became deranged after abusing drugs.

The most common consulting forensic role for a pharmacist is that of the “forensic litigation consultant.” Pharmacists are a valuable resource to lawyers as consultants or expert witnesses. Consulting activities include reviewing the case and offering an opinion, identifying clinically relevant issues, conducting research and literature reviews, advising on issues to be pursued, interpreting medical records, and suggested questioning for other witnesses. Forensic pharmacists can be of added assistance during the deposition process by providing technical evaluation of the answers given by factual witnesses and expert witnesses. Forensic pharmacists can obtain and review literature to refute the opposing party’s arguments. Forensic pharmacists can assist attorneys during the discovery process by advising them on what information to request. This may include patient records, incident reports, policy and procedures manuals, training guides, and work schedules. Pharmacists have testified as experts in courts of law in two main areas. The original role of the pharmacist was in the area of pharmacy practice. ^24,25 Pharmacists can testify as to whether another pharmacist was negligent in performance of his or her duties. The second type and innovative role of pharmacists as expert witnesses is in the area of therapeutics and human pharmacology. ^24,25 In the 1980s, pharmacists emerged as experts in drug therapy and this has extended to court cases. ²⁵ Certain pharmacists have advanced education in substance abuse or environmental toxicology and thus would be qualified to testify in those areas.

Federal rules of evidence require that an expert has special knowledge, skill, experience, training, and/or education to be qualified as an expert in a court of law. ²⁶ The trial judge has wide discretion as to who may be an expert in a given case based on these guidelines. Pharmacists with their unique education and practical experience in therapeutics and pharmacology have served as expert witnesses in numerous types of civil and criminal cases. Pharmacists have testified in court in matters relating to pharmacy practice, adverse drug reactions, medication errors, personal injury, workmen’s compensation, impaired capacity, driving under the influence (DUI), patents and poisoning.

Pharmacist consultants can be useful in many ways to attorneys. Pharmacists can review and educate the lawyer about medication-related issues. For example, forensic pharmacists can review a personal injury case or malpractice case resulting from an adverse drug reaction. The forensic pharmacist can determine the probability that an adverse drug reaction took place. The pharmacist can educate the attorney about the predictability of the reaction and offer an opinion whether proper monitoring and precautions were followed. The pharmacist can provide literature supporting the attorney’s arguments and refuting the opposition.

Pharmacist Malpractice

Pharmacists have been sued for many reasons including dispensing the wrong medication, compounding errors, failure to detect interactions, failure to contact prescribers about excessive dosages, and failure to warn patients about side effects. Clinical pharmacists can be liable for improperly monitoring drug therapy. Malpractice cases against pharmacists generally require testimony from another pharmacist; the exception being an error that is so obvious that even a layperson can understand it without expert testimony. Most lawyers will not file lawsuits against pharmacists unless an affidavit is obtained from another pharmacist expressing an opinion of negligence. This pharmacist expert witness would express an opinion supporting the allegations of malpractice. The defense may have pharmacists as expert witnesses for rebuttals.

Malpractice Against Other Health Professionals

The forensic pharmacist can assist attorneys regarding malpractice cases of other health professionals, for example physicians and nurses. Generally pharmacists cannot testify as to the professional standards of other professionals. However, if the case involves an adverse drug reaction, the pharmacist can testify about causation. The pharmacist can also testify about alternative therapies with less risk. The role of pharmacist testimony is not limited to adverse drug reactions in these professional malpractice cases. The pharmacist can provide opinions about medications that can prevent disease complications. For example, if a patient develops renal failure from diabetes or hypertension, the pharmacist can discuss medications that would have prevented or reduced the risk of kidney damage.

Blood Levels

Certain drugs have a narrow therapeutic range and need to be closely monitored (eg digoxin, theophylline, lithium, etc). Clinical reasons for which to draw blood samples include high doses and borderline doses, signs of toxicity occurring, lack of a therapeutic effect, or suspected poor adherence. ²⁷ Toxicology analysis is a common part of the forensic autopsy and often forensic pharmacists are consulted to interpret drug levels. Numerous changes occur postmortem that may increase or decrease the blood level detected at autopsy. ^28,29 The postmortem blood level may not reflect an antemortem blood level.

Drugs, Alcohol, and Driving

Pharmacists have numerous skills that are useful in DUI cases. ³⁰ The forensic pharmacist can interpret the levels of blood alcohol and discuss the typical effects from different alcohol levels. Pharmacists can apply pharmacokinetics to estimate the level of alcohol at the time of the alleged event. Pharmacokinetics calculations can especially be helpful if an extended time period exists between the incident and time of collection. Drug interactions can be relevant to DUI cases. ^31,32 Certain medications can have additive effects with ethanol, that is lower levels of ethanol will produce greater effects. Other medications can alter the absorption or metabolism of ethanol. Certain disease states may make a person susceptible to the effects of ethanol. Pharmacists can provide input regarding these other factors relating to alcohol consumption such as personal injury cases.

Criminal Cases

The work of forensic pharmacists may be needed in various types of criminal cases. This includes cases where the drug or poison was used as a weapon, or where medications impair the mental capacity of the defendant or victim. Drugs as a causative factor for aggression have been used as a criminal defense. ³³ This defense is more likely to be successful if the drug is a prescribed medication rather than a substance of abuse. This defense is more likely to be accepted with involuntary ingestion rather than voluntary intoxication. Medication effects can be an issue in determining whether a defendant is competent to stand trial. ²

The effects of drugs on victims are often related to criminal cases. ³⁴ Medications are often used as agents for suicide and in suicide attempts. Drugs and poisons have been used as tools of homicide. ³⁵ Drugs have been used to facilitate sexual assault, especially in dating situations. The most well-known date rape drug is flunitrazepam (Rohypnol), ³⁶ although alcohol is the most common agent. Other well-known date rape drugs include gamma-hydroxybutyrate (GHB) and ketamine. ² In theory, any drug that has sedating, mind alerting effects, or impairs memory could be used to facilitate a sexual assault. Chemical weapons have been used in terrorism and continue to be risk to this day. ³⁷

Off-Label Drug Use

Forensic pharmacist can review insurance claims relating to medication therapy, especially where new and unusual uses of medications are prescribed. A pharmaceutical manufacturer, before marketing a drug, has to obtain approval from the FDA. The product’s labeling is part of this application process. A pharmaceutical company may only market the drug for conditions that the FDA has approved. However, health care providers may prescribe marketed medications for uses other than FDA-approved uses. These are referred to as “unlabeled” or “off-label” uses. ³⁷ Patients, medical professionals, and health care organizations often submit claims to insurance companies, seeking payment for unlabeled uses. This may raise “red flags” with the insurance company. A forensic pharmacist can review such claims and offer an opinion whether the use is reasonable and common practice. Off-label use may be brought up in malpractice lawsuits as a standard of care issue. ³⁸ Prescribing off-label medications is in itself not malpractice. Many off-label uses of medications are appropriate and medically necessary. The forensic pharmacist may offer testimony about the need for unlabeled indications and provide insight into appropriate use of that medication. ²

Fraud and White-Collar Crime

The Association of Certified Fraud Examiners defines fraud as any intentional or deliberate act to deprive another money or property by means of deception. ³⁹ Types of fraud related to forensic pharmacy include ² :

Overlap exists in the above areas. For example, diverting a controlled substance that was intended to be administered to a Medicaid patient and subsequently billed to Medicaid is both drug diversion and Medicaid fraud. Case reports suggest that some cases of financial fraud may be due to the need to purchase illegal drugs. ³⁹

Conclusion

Pharmacists have training in therapeutics, chemistry, pharmacology, pharmacokinetics, and toxicology. All of these areas can be applied to a variety of forensic siutations. The skills of pharmacists can be useful in legal cases involving malpractice, personal injury, drunk and drugged driving, fraud, criminal poisoning, date rape, and worker’s compensation.