Medication is any substance, other than food, used to prevent, diagnose, treat, or alleviate the symptoms of an abnormal disease or condition. According to the WHO, a drug is defined as a compound intended to affect the structure or function of the body, often for the diagnosis, treatment, or prevention of disease. The function and intended use of a drug are central to its classification and regulatory review. Drugs can also affect the functioning of the brain and the rest of the body, causing changes in mood, consciousness, thoughts, feelings, or behavior.
Drugs and substances are classified into different schedules based on their medical use, abuse potential, and dependency risks, as outlined by law. Examples include heroin (Schedule I), cocaine (Schedule II), marijuana (Schedule I), and ketamine (Schedule III). This classification system helps regulate the production, distribution, and use of controlled substances.
Traditional drugs are typically produced through a chemical process, while biologics are derived from living organisms through a biological process. Both drugs and biologics are generally covered under the same laws and regulations by the FDA, but differences in manufacturing require tailored guidance.
Medicines are sold and purchased through legal channels, often requiring a doctor's prescription, to ensure patient safety and regulatory compliance. Regulatory oversight relies on data and additional information to demonstrate the safety, effectiveness, and pharmacology of drugs for approval and market access.
Introduction to the World Health Organization
The World Health Organization (WHO) stands at the forefront of global health, playing a pivotal role in the regulation and oversight of psychoactive drugs, controlled substances, and medicines. As a specialized agency of the United Nations, the WHO is dedicated to promoting health, ensuring safety, and protecting vulnerable populations around the world. Its influence extends across a wide range of health-related areas, from setting international drug laws and standards for psychoactive substances to guiding the safe use of vaccines, blood components, and biologics.
A core part of the WHO’s mission is to collaborate with countries to strengthen their drug regulations and manufacturing processes. This includes providing technical guidance on good manufacturing practices, quality control, and the safe production of medicines and vaccines. By helping countries develop robust systems for the control and distribution of pharmaceuticals, the WHO ensures that patients everywhere have access to safe, effective, and high-quality treatments. For example, the organization works closely with national authorities to ensure that controlled substances are dispensed only with a doctor’s prescription and that strict regulations are in place to prevent abuse and diversion.
The WHO also recognizes that key differences exist between drugs and biologics. While drugs are generally synthesized through chemical processes, biologics—such as vaccines and certain blood products—are derived from living organisms and require specialized manufacturing and quality assurance protocols. These differences in structure and production mean that biologics and drugs are subject to distinct regulatory requirements, and the WHO provides tailored guidance to address these unique challenges.
In the realm of addiction and substance use disorders, the WHO offers evidence-based recommendations for the treatment and prevention of drug and alcohol addiction. The organization supports harm reduction strategies and symptom management approaches to minimize the risks associated with psychoactive drug use. By promoting public awareness and providing technical assistance, the WHO helps countries develop effective laws and regulations to control narcotics, prevent abuse, and ensure the safe storage and disposal of controlled substances.
Beyond medicines and controlled substances, the WHO’s regulatory oversight extends to food and cosmetic products. The organization works to ensure that these products are safe for human use, free from contamination, and manufactured according to international standards. This comprehensive approach to regulation helps protect public health on a global scale.
Through its leadership, technical expertise, and commitment to evidence-based policy, the World Health Organization plays a critical role in shaping drug laws, improving access to essential medicines, and safeguarding the health and well-being of people worldwide.
Psychopharmaceuticals and psychoactive drugs
are substances that, when ingested or administered into the system, affect mental processes such as perception, awareness, cognition or mood and emotions. Psychoactive drugs belong to a broader category of psychoactive substances that also include alcohol and nicotine. The use of psychotropic drugs without medical supervision is associated with significant health risks and can lead to the development of drug use disorders.
These disorders, especially when left untreated, increase morbidity and mortality risks for individuals and can cause significant suffering and deficiencies in personal, family, social, educational, occupational, or other important areas of functioning. Drug use disorders are associated with significant costs to society due to lost productivity, premature mortality, increased health care spending, and costs related to criminal justice, social welfare and other social consequences. A study to prevent deaths from opioid overdose shows promising results and improving prevention and treatment of drug use disorders was discussed at the Third WHO Forum on Alcohol, Drugs and Addictive Behaviors (FADAB) Meeting of Technical Experts on Public Health Responses to Cannabis Use. The revised edition incorporates the results of field tests. The drug definition for children (entry 2 of the medical definition of medication) is also included. A drug, or pharmaceutical product, is a substance used to prevent or cure a disease or condition or to alleviate its symptoms.
In the United States, medications can be taken orally, through a skin patch, by injection, or through an inhaler. A drug can also refer to an illegal or restricted substance that people use for recreational purposes or to get high. The development of new and improved drugs is a complex and expensive business in the United States. Some of the largest U. S.
corporations such as Johnson & Johnson, Pfizer, Merck and Eli Lilly are dedicated to researching, testing, manufacturing and marketing new drugs. In addition, biotechnology has evolved in recent years as an important new branch of the drug business. Biotechnology companies focus on research and development (R&D) of new cures based on genetic manipulation. Major players in the field include Amgen, Gilead Sciences and Celgene Corp. In the United States prescription drugs must be approved by the Food and Drug Administration (FDA).
The agency's Drug Evaluation and Research Center (CDER) acts as a consumer watchdog. In the development and discovery phase researchers explore new possibilities. They can investigate the unexpected effects of existing drugs; test new molecular compounds; or create new technologies that allow drugs to act differently in the body. In the preclinical research phase when a potential new drug is identified researchers determine the correct doses and methods of administration; side effects; interactions with other drugs; and efficacy. They also study the absorption; metabolism; and excretion characteristics of the drug. In the clinical research phase; the company first analyzes the substance in the laboratory or in vitro; and sometimes on animals or in vivo.
Depending on the result; the drug can be tested on human subjects in clinical trials to determine if it is safe and effective. The phase 1 clinical trial or study is the first phase of the long and exhausting drug approval process. While its main objective is to establish the safety profile of the investigational drug; these studies also allow for collection of vital information about its effects; chemistry; doses; methods of administration; side effects; interactions with other drugs; efficacy; absorption; metabolism; excretion characteristics; etc. Phase 2 focuses on drug efficacy while phase 3 trials are used to compare treatment with established treatments for a medical problem. A phase 4 follow-up that analyzes effects on population can be carried out once it has been approved by FDA. All phases only begin after pharmaceutical companies' extensive research & development phase (R&D); which can be lengthy & costly. A drug that overcomes this obstacle is sent to CDER for review.
The agency employs pharmacologists; chemists; statisticians; doctors & other scientists who carry out an independent & impartial review of drug & documentation submitted with it. This process usually takes 6-10 months to complete & if CDER determines that benefits outweigh risks then company may sell drug & is responsible for monitoring reports on drug efficacy & unforeseen side effects. A brand-name drug can be patented for 20 years after its discovery/invention & once patent expires other manufacturers can produce & market generic equivalents. Generic equivalents are increasingly being prescribed as they become available in US due to their relatively low cost. Generics must have same medicinal ingredients & therefore same therapeutic effects to receive FDA approval for sale as substitutes. The price of prescription drugs is a source of great financial stress for many Americans & has become one of biggest political problems today. Health insurance prevents many Americans from burdening most retail drug prices although coverage varies widely. In any case drug costs are major factor in increase in health insurance premiums & it is important for people to understand how drugs are developed & approved before they are available for sale.
