Forensic pharmacology: An important and evolving subspecialty needs recognition in India

Abstract

With training in pharmacology, a pharmacologist has an expert knowledge as well as working experience in the subjects of therapeutics, pharmacokinetics, and toxicology along with exposure to subjects such as forensic medicine during the medical education. All these knowledge domains can be applied and act as an interface to the forensic situations. The skills and expertise of a forensic pharmacologist can be useful in a large and diverse number of legal cases. With an ever increasing incidence of criminal and civil cases in India, the development and inclusion of forensic pharmacologist in the judicial system of India are the need of the hour. The research in pharmacology has witnessed great technological advancement that allows it to expand its scope beyond the domain of therapeutics, thus enabling Indian pharmacologists to explore the niche area of Forensic Pharmacology. Differing pharmacokinetics and pharmacodynamics of drugs in living and dead, drug interactions, abuse of drugs, personal injury or death due to drug exposure leading to medico-legal issues, environmental exposure to chemicals, and doping and forensic pharmacovigilance are the diverse aspects of Forensic Pharmacology.

In many countries, forensic pharmacologists have been a valuable resource in different criminal and civil cases. They apply their knowledge of pharmacology to civil/legal issues such as resolving litigations, drug regulatory process, and the criminal justice system.[1]

It has been proven through different research studies and case studies that comprehensive investigation plays an unflinching role in the determination of the cause of death in crime scenes with positive drug screens.[2] Even the general public is aware of the role of forensic sciences in the legal system of justice. With increased exposure to the work of the forensic scientists, there has been an increased enrollment in criminal justice system and forensic science courses in schools and colleges in countries like United States of America and Australia.[3] Forensic sciences encompasses the broader application of different branches of science to legal matters. The domain of Forensic Pharmacology focuses on the knowledge of action and interaction of different chemicals in the living beings and its application to legal matters.[4]

Role of Forensic Pharmacologist

Forensic Pharmacology answers the questions of association of chemicals with an individual's behavior, illness, injury, or death.[3] It can be described as the interpretation of the effects of drugs and their duration of action with the purpose of facilitating a medico-legal process.[5]

The pharmacologist conducts an analysis of the body fluids and tissues and interprets the chemical data to help the attorneys in assessing the role of a drug or specific chemical in the behavior, illness, injury, or death of an individual. The forensic pharmacologist can be of great help in both criminal and civil cases. The exact role of a pharmacologist in forensic sciences is to analyze, assess, review, and support the attorney's position. He may be asked to provide a written report if his review positively supports the attorney's case. In the case of a trial, the forensic pharmacologist may be needed to testify and clearly explain the findings in the court. The role of a forensic pharmacologist also involves helping the attorney in preparing a cross-examination of the expert on the opposite side.[3]

Forensic Pharmacologist and Toxicologist

Many a time, a forensic pharmacologist and forensic toxicologist are considered to be the same. The forensic toxicologist is also involved in drug testing and in testifying for the attorney in criminal cases, but a forensic pharmacologist is engaged in forensics in a much broader way.[3] His area of expertise includes a much broader range of cases such as adverse drug reactions to medicines, overdose of medicines, drug interactions, and personal injury resulting from an exposure to medicines, effects from drug abuse or industrial chemicals, and induction of cancer by chemicals.[3]

Forensic Pharmacology: Need of the Hour

Forensic Pharmacology is not a new subspecialty. The only thing new about it is probably the use of the terminology “Forensic Pharmacology” to define a subspecialty of pharmacology that focuses on the legal application of the knowledge that a pharmacologist already possesses. And thus, such subspecialty needs recognition among the Indian pharmacologists.

Toxicology is concerned with the deleterious effects of the drugs and chemical agents on all living systems.[4] Toxicology is included as a part of forensic medicine for medical curriculum in India. It is defined as the science that involves detection of drugs and poisons in biological specimens and its application for medico-legal purposes.[5,6,7] However, it is much different from the interpretation of effects, use or abuse of drugs, and its duration of action for the medico-legal process which is referred to as Forensic Pharmacology.[3] A fine line differentiates “Forensic Pharmacology” from “toxicology.” Some textbooks use term such as “pharmacological toxicology” for assessing the toxicity of therapeutic agents (drugs).[5] Forensic Pharmacology is included as a part of forensic medicine, which discusses toxicities from the drugs in common therapeutic use, commonly abused drugs, drugs having no medicinal value and “street” or “designer drugs.”[6,7]

An important and extensively studied branch of pharmacy curriculum in India is “Forensic Pharmacy” or “Pharmaceutical Jurisprudence,” which deals with various laws pertaining to drugs and pharmaceuticals and profession of pharmacy.[8,9] It includes the knowledge of various acts, rules, and schedules which directly or indirectly influence various operations pertaining to procurement, manufacture, and distribution of drugs. The knowledge of Forensic Pharmacy is essential to understand the legal aspects pertaining to practice of pharmacy. The forensic pharmacist is required to profess and should also be engaged in manufacturing, sale, and distribution of drugs.[9,10] Similarly, Forensic Pharmacology guides us to investigate whether a drug or a chemical was related to an individual's behavior, illness, injury, or death.

With continued new drug developments, there are multiple new drugs hitting the markets every year. Few of them are new molecules in the market and claim to contain “nonillegal” compounds although they may exhibit important psychoactive effects. Such drugs are called as “smart drugs.”[11,12] Also, in addition to new drugs or chemicals, new ways to abuse existing drugs are found, for example, scopolamine has become a drug of abuse for recreational and predatory purposes.[13] Thus, the forensic pharmacologists need to keep themselves updated with the knowledge of new legal and illegal drugs, their pharmacological or toxicological effects and also guide the community and regulatory authorities regarding the possible abuse of such drugs or chemicals to commit the crimes.

Application of the biotechnological advances to pharmacology and toxicology has widely extended our understanding and overall scope of these subjects.[14] Similarly, advances in analytical techniques have made detection of drugs and chemicals much easier which can help resolving medico-legal cases with the guidance from experts such as a forensic pharmacologist. Some drugs can even alter the neurotransmitters and hence lead to a poor impulse control and subsequent aggression in behavior. The role of a forensic pharmacologist becomes significant in this case because he/she is needed to testify the truth of these claims. He/she has to observe, assess, and analyze the violent behavior and use of the drug and determine the likelihood of the relation of impulsive behavior to the drug use.[15]

Pharmacology is evolving as a subject, and Indian pharmacologists need to look at different aspects of pharmacology beyond therapeutics. Forensic Pharmacology offers a unique opportunity to expand the existing knowledge of the drugs, their mechanisms, actions, and its medico-legal impacts. It adds additional dimension to forensic medicine and provides a scope for further research.

The Science of “Drugs and Forensics”

Forensics as a science and profession is considered to be important for the investigation of illness, injury, or deaths. It is defined as the application of the sciences of drugs to the application of legal code of conduct.[5,6,7] The pharmacologist as an expert in the science of drugs and is involved in the clinical, distributive, and administrative aspect of pharmacy.[9,10]

Scope of Forensic Pharmacology

There are many criminal and civil cases involving the use of drugs and other chemicals which come under the forensic law. The forensic pharmacologist needs a specific recognition in his profession because of the highly specific nature of his expertise, skill, and work. Various scenarios where the expertise of a forensic pharmacologist can be useful include:

Drug abuse

A national survey conducted by the Indian Ministry of Social Justice and Empowerment in 2004 has brought forth the fact that drug abuse was quite commonly seen among Indian males aged 12–60 years. The most common abuse was in the use of tobacco (55.8%), alcohol (21.4%), cannabis (3.0%), opiate (0.7%), and sedatives (0.1%).[16]

In criminal courts, crimes which are committed by the individuals under the influence of a drug or medication are one of the most frequently reported ones. These crimes could be the results of the effect of medicine resulting in a change in the behavior or thought process of the person.[17] Forensic Pharmacology deals with the study of “drugs of abuse”, examples of which are cannabinoids, central nervous system (CNS) stimulants such as cocaine, heroin, marijuana, tobacco, and amphetamine-related drugs, CNS depressants such as alcohol, benzodiazepines, and opioids, hallucinogens such as lysergic acid diethylamide, mescaline, and phencyclidine, dissociative anesthetics such as ketamine, inhalants such as chloroform and anabolic steroids.[3] Such drugs are often involved in criminal and civil matters concerning personal injury, motor vehicle accidents, drug overdose, and murder. Also, their actions and addiction liability has profound medico-legal implications.[3]

Sports medicine and doping

The identification of androgens as ergogenic or performance enhancing agents dates back to the 1930's.[18] Commonly used ergogenic drugs include anabolic steroids, narcotic analgesics, diuretics, beta blockers, growth hormone, oral peptide hormones, amphetamines, caffeine, cocaine, sympathomimetic agents, and erythropoietin.[19] Several sportsperson have been found guilty of using such ergogenic agents to enhance their performance in sports.[20] World Anti-Doping Agency has stringent guidelines on the use of ergogenic drugs. National Anti-Doping Agency is the national organization responsible for promoting, coordinating, and monitoring the doping control program in sports with a vision of “dope free” sport in India. A forensic pharmacologist can help in achieving this vision with the better use of analytical methods to detect the doping and can also help in avoiding accidental use of ergogenic drugs by athletes. Additionally, they can also advise on the drug interactions and use of drugs for therapeutic purposes in athletes.

Blood levels

The forensic pharmacologist can assess and analyze the blood samples of a person to determine high and borderline doses, signs of toxicity, lack of therapeutic effect, or a suspected case of poor adherence.[21] A pharmacologist is well-versed to detect alterations in postmortem and ante-mortem blood levels. The pharmacologist can also closely monitor the narrow therapeutic range of different drugs such as digoxin, lithium, or theophylline.[22,23]

Drugs, alcohol, and driving

Forensic pharmacologist is armed with the knowledge of pharmacokinetics, pharmacodynamics, drug interactions, and adverse reactions.[24] He is the most well-suited to analyze the data collected and make an informed decision in favor of or against his attorney's case. The forensic pharmacologist can interpret the concentration of alcohol in blood and its typical effects. Pharmacokinetics is employed to measure the blood level of alcohol at the time of the alleged crime. Drug interactions, synergistic or antagonistic effect of different drugs on alcohol absorption or metabolism, and the disease state present in the individual can be easily assessed by the forensic pharmacologist and provide a great help to the medico-legal and judicial system.[25]

Criminal cases

Forensic pharmacologists play an important role in a wide range of criminal cases. There are many cases where a forensic pharmacologist can provide a testimonial such as use of drug or poison as a weapon, mental impairment caused due to the effect of a medication, or the use of a specific drug as the reason for criminal aggression.[26] Drug use and their effect on the victim form a major reason for a large number of criminal events. Drugs are frequently used in suicide attempts and as a tool of homicide or sexual assault.[27,28] The most commonly used date drugs are flunitrazepam, alcohol, gamma-hydroxybutyrate, and ketamine.[12,17,29]

Forensic pharmacovigilance

Commonly encountered problems with the use of medication in clinical practice are adverse drug reactions, drug interactions, systematic medical errors in use, unexpected failures of effectiveness, or quality problems by users. Considering the patient safety, such problems should be reported and scrutinized in detail.

Pharmacovigilance is the well-known science related to the adverse effects or any other drug-related problems.[30,31] It helps in improving patient safety in therapeutics by detection, warning, management, and advice which can reduce the harm and benefit in practice. Pharmacovigilance can also be used as an important medical discipline in forensic cases in a variety of ways, e.g., establishing the effects of the drugs leading to crime, e.g., could this drug (or chemical) have caused this harmful effect in the person and did it really cause the effect either (criminal case)?[30,31] Any injury or death in the form of adverse drug reactions that are caused by counterfeit, contamination, adulteration, or other substandard medicinal products which is identified by application of standard pharmacovigilance procedure is termed as “forensic pharmacovigilance” and it forms an integral part of Forensic Pharmacology.[32]

In context of civil cases, Forensic Pharmacovigilance can play an important role when some previously unsuspected class effect emerges when the drug is available in public domain after licensing, as compared to the use in restricted group who took part in its clinical trials. The teratogenicity with Thalidomide is the classic example.[31] Recently, there were concerns of bladder cancer with use of anti-diabetic medication Pioglitazone, and it was banned in India for a brief period. It differs from Pharmacovigilance as it considers the medico-legal implications as well.

Off-label drug use

Forensic pharmacologist also plays a significant role in civil cases which involve review of insurance claims. Forensic pharmacologist can review the use of “off-label” use of a drug and enable the initiation of a malpractice law suit. The forensic pharmacologist can testify about the appropriateness and urgency of the unlabeled use of a drug.[1]

Environmental toxicology and ecotoxicology

Due to increased urbanization and industrialization, we currently inhale, ingest, or absorb several different chemicals, which at certain dosage or durations of time can lead to subsequent morbidities or mortalities. Dr. Dewan highlighted the importance of teaching regarding prevention, monitoring, evaluation, diagnosis, and treatment of toxic exposures including intentional, unintentional, occupational, and environmental exposures.[33] A forensic pharmacologist can play an important role in spreading the awareness about evaluation, diagnosis, treatment, and prevention of toxic exposures and also help in resolving the medico-legal issues surrounding it.

Career Path of a Forensic Pharmacologist

The forensic pharmacologist should be able to isolate, identify and quantify drugs, and chemicals in biological materials. Also, the forensic expert is also expected to be trained in following court decorum and remaining unaffected by the witness stand. He should also have excellent communication skills. A forensic pharmacologist who has to testify should be an expert in all drug-related topics which may include:[34]

• Prescription or dispensation of the wrong drug

• Use of counterfeit drugs

• Incorrect storage of drugs

• Incorrect calculation of dosage

• Administration of a wrong dose

• Harmful drug interactions

• Adverse events related to drug use

• Adverse drug reactions.

It can be said that the forensic pharmacologist will review a case akin to a clinical pharmacologist or assess an administrative problem or a clinical challenge but with his focus on the specific legal issue involved. A forensic pharmacologist can be a part-time forensic scientist or do a regular job in the domain of forensic practices.[1,35]

Services Provided by Forensic Pharmacologist

The services provided by a forensic pharmacologist can be classified as administrative, clinical evaluation, and distributive. The administrative role includes employment testing, patents, or scientific fraud. Clinical evaluations involve the inappropriate use of chemical agents, adverse drug reactions, date rape drugs, drugged and drunk driving, drug-induced violence, drug interactions, impaired capacity, medication errors, poisoning, or substance abuse. The distributive role of a forensic pharmacologist is related to adulteration or contamination of drugs and use of counterfeit drugs.[36]

Status of Forensic Medicine and Forensic Pharmacology in India

In the Indian perspective, the clinical forensic medicine with special medico-legal training is neither well-developed nor implemented correctly. Some cities such as Mumbai have a police surgeon functioning both at forensic as well as therapeutic level. However, this is inadequate in providing proper medico-legal examination, accurate analysis, and appropriate documentation.[37] While the forensic medical techniques are an integral part of the medico-legal system in countries such as Latin America, Australia, Europe, and many Asian Countries, India is still lagging behind.[38,39] There is no clear delineation of the knowledge, skill, and hence work of the specialty or subspecialty.[37]

Forensic Pharmacology forms an interface between forensic medicine, toxicology, and pharmacology. Its overall scope is summarized in Figure 1. Though it is an important subspecialty, it is often neglected by pharmacologists fraternity in India and not well recognized or developed in our country. It is the need of the hour to discuss the comprehensive information on use or abuse of drugs/chemicals and their medico-legal implications. Globally several teaching institutes and universities have dedicated centers “that teach Forensic Pharmacology,” for example, American Institute of Pharmaceutical Sciences has a dedicated “Center for Forensic Pharmacology.”[39] South Dakota State University and the City University of New York also offer courses of Forensic Pharmacology. Adding Forensic Pharmacology as a specialization in India or focusing on the legal aspects of the drugs while studying pharmacology will certainly help the medical students.

Figure 1.

Scope of forensic pharmacology

At present, a medical student pursuing MBBS degree in India studies various subjects. These include pharmacology, which deals with what different drugs; their therapeutic effects and uses, as well as forensic medicine which deals with the legal implications of behavior, injury and illnesses. The student also learns about the clinical implications of drugs as the part of internal medicine. However, there is no integrated course that focuses on Forensic Pharmacology as a specialized subject. In today's perspective, it is essential that Forensic Pharmacology is developed as a subspecialty to pave way for high quality and fast paced medico-legal service in India. The lack of a proper subspecialty of Forensic Pharmacology in India can be cited as a deficiency which needs to be recognized and rectified.[37] An evolved system of Forensic Pharmacology is needed to accurately document and analyze the drug or chemical related injuries of the victim and his or her body fluid samples. It can minimize the common forensic errors occurring in emergency departments and hospitals. With the specialized workforce, errors in recognizing, collecting or preserving evidential material,[38,39,40] incorrect interpretations, and lack of knowledge of policing or methods of investigation can be corrected.[41,42]

There has been a continuous rise in the medico-legal cases related to the use of drugs. The advent of new drugs in the market has also added to the complications associated with the use of these drugs. The poisoning incidents which arise from the use of toxicological agents are also increasing. This gives rise to various questions pertaining to the accuracy of the results obtained from the samples collected, the possibility of the extrapolation of these results to the living to obtain the exact amount present at the time of death, the effect on the results due to the time period lapsed since the death or the correlation of the results obtained from blood and different organs. This forms the basis of the involvement of the expertise of forensic pharmacologist in the drug-related medico-legal cases. The forensic pharmacologist is the right person to provide an accurate correlation between the drug level in the body and associated postmortem changes.[41,43]

An expert providing evidence in a court of law must possess special knowledge, skills, experience, training, and even education to achieve the qualification which enables him to give an expert opinion in a court of law. The trial judge practices discretion about allowing someone to be an expert or not. Pharmacologists have education and experience in pharmacology which allows them to serve as expert witnesses in various civil and criminal cases. They are, therefore, needed to testify in court matters on different topics related to adverse drug reactions, medication errors, personal injury, drug testing, workman's compensation, impaired capacity, and driving under the influence of alcohol and poisoning.[3]

Conclusions

In cases where validation cannot be made between the uses of a drug with a specific associated outcome, it becomes difficult for a judiciary to offer radical explanation. In such cases, a forensic pharmacologist can make a useful contribution by utilizing his or her knowledge of drug-related problems and pharmacology to provide relevant results and data which is helpful in assisting the legal system to take the right decision. Medical education in India needs to focus on developing Forensic Pharmacology as a subspecialty.

The author has completed M. D. Pharmacology and Therapeutics from Seth G. S. Medical College and K.E.M. Hospital, Parel, Mumbai. Prior to that he has worked at Department of Forensic Medicine and Toxicology, B. J. Medical College and Sassoon Hospitals, Pune, for 1 year, where he worked on various medico-legal cases extensively and had significant exposure to Forensic Medicine. With this exposure he developed keen interest in Forensic Pharmacology.

Financial support and sponsorship

Nil.

Conflicts of interest

The author has completed M. D. Pharmacology and Therapeutics from Seth G. S. Medical College and K.E.M. Hospital, Parel, Mumbai. Prior to that he has worked at Department of Forensic Medicine and Toxicology, B. J. Medical College and Sassoon Hospitals, Pune, for 1 year, where he worked on various medicolegal cases extensively and had significant exposure to Forensic Medicine. With this exposure he developed keen interest in Forensic Pharmacology.