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Wednesday, May 3, 2023

Regulation of therapeutic goods

From Wikipedia, the free encyclopedia
https://en.wikipedia.org/wiki/Regulation_of_therapeutic_goods
 
Methylphenidate, in the form of Ritalin pills

The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.

The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be sold. There is usually some degree of restriction on the availability of certain therapeutic goods, depending on their risk to consumers.

History

Modern drug regulation has historical roots in the response to the proliferation of universal antidotes which appeared in the wake of Mithridates' death. Mithridates had brought together physicians, scientists, and shamans to concoct a potion that would make him immune to poisons. Following his death, the Romans became keen on further developing the Mithridates potion's recipe. Mithridatium re-entered western society through multiple means. The first was through the Leechbook of the Bald (Bald's Leechbook), written somewhere between 900 and 950, which contained a formula for various remedies, including for a theriac. Additionally, theriac became a commercial good traded throughout Europe based on the works of Greek and Roman physicians.

The resulting proliferation of various recipes needed to be curtailed in order to ensure that people were not passing off fake antidotes, which led to the development of government involvement and regulation. Additionally, the creation of these concoctions took on ritualistic form and were often created in public and the process was observed and recorded. It was believed that if the concoction proved unsuccessful, it was due to the apothecaries' process of making them and they could be held accountable because of the public nature of the creation.

In the ninth century, many Muslim countries established an office of the hisba, which in addition to regulating compliance to Islamic principles and values took on the role of regulating other aspects of social and economic life, including the regulation of medicines. Inspectors were appointed to employ oversight on those who were involved in the process of medicine creation and were given a lot of leeway to ensure compliance and punishments were stringent. The first official 'act', the 'Apothecary Wares, Drugs and Stuffs' Act (also sometimes referred to as the 'Pharmacy Wares, Drugs and Stuffs' Act) was passed in 1540 by Henry VIII and set the foundation for others. Through this act, he encouraged physicians in his College of Physicians (founded by him in 1518) to appoint four people dedicated to consistently inspecting what was being sold in apothecary shops. In conjunction with this first piece of legislation, there was an emergence of standard formulas for the creation of certain 'drugs' and 'antidotes' through Pharmacopoeias which first appeared in the form of a decree from Frederick II of Sicily in 1240 to use consistent and standard formulas. The first modern pharmacopoeias were the Florence Pharmacopoeia published in 1498, the Spanish Pharmacopoeia published in 1581 and the London Pharmacopoeia published in 1618.

Various other events throughout history have demonstrated the importance of drug and medicine regulation keeping up with scientific advances. In 2006, the challenges associated with TGN 1412 highlighted the shortcomings of animal models and paved the way for further advances in regulation and development for biological products. Rofecoxib represents a drug that was on the market that had not clearly represent the risks associated with the use drug which led to the concept of 'risk management planning' within the field of regulation by introducing the need to understand how various safety concerns would be managed. Various cases over recent years have demonstrated the need for regulation to keep up with scientific advances that have implications for people's health.

United States

In the United States, regulation of drugs was originally a state right, as opposed to federal right. But with the increase in fraudulent practices due to private incentives to maximize profits and poor enforcement of state laws, the need for stronger federal regulation increased. In 1906 President Roosevelt signed the Federal Food and Drug Act (FFDA) which both established stricter national standards for drug manufacture and sales, and also established the Federal government as the regulating authority over the US drug industry. A 1911 Supreme Court decision, United States vs. Johnson, established that misleading statements were not covered under the FFDA. This directly led to Congress passing the Sherley Amendment which established a clearer definition of 'drug marketing requirements'.

More catalysts for advances in drug regulation in the US were certain catastrophes that served as calls to the US government to step in and impose regulations that would prevent repeats of those instances. One such instance occurred in 1937 when more than a hundred people died from using sulfanilamide elixir which had not gone through any safety testing. This directly led to the passing of the Federal, Food, Drug, and Cosmetic Act in 1938. One other major catastrophe occurred in the late 1950s when Thalidomide, which was originally sold in Germany (introduced into a virtually unregulated market) and eventually sold around the world, led to approximately 100,000 babies being born with various deformities. In 1962 the United States Congress passed the Drug Amendments Act of 1962. The Drug Amendments Act required the FDA to ensure that new drugs being introduced to the market had passed certain tests and standards.

United Kingdom

The UK's Chief Medical Officer had established a group to look into safety of drugs on the market in 1959 prior to the crisis and was moving in the direction of address the problem of unregulated drugs entering the market. The crisis created a greater sense of emergency to establish safety and efficacy standards around the world. The UK started a temporary Committee on Safety of Drugs while they attempted to pass more comprehensive legislation. Though compliance and submission of drugs to the Committee on Safety of Drugs was not mandatory immediately after, the pharmaceutical industry later complied due to the thalidomide situation.

European Economic Union

The European Economic Commission also passed a directive in 1965 in order to impose greater efficacy standards before marketing a drug. Drug legislation in both the EU and US were passed in order to assure drug safety and efficacy. Of note, increased regulations and standards for testing actually led to greater innovation in pharmaceutical research in the 1960s, despite greater preclinical and clinical standards. In 1989, the International Conference of Drug Regulatory Authorities organized by the WHO, officials from around the world discussed the necessity for streamlined processes for global drug approval.

Regulatory authorities and key legislation by country

Australia

Therapeutic goods in Australia are regulated by the Therapeutic Goods Administration (TGA), that was created by the Therapeutic Goods Act 1989. The availability of drugs and poisons is regulated by scheduling under individual state legislation, but is generally under the guidance of the national Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).

Under the SUSDP, medicinal agents generally belong to one of five categories:

  • Unscheduled/exempt
  • Schedule 1 (S1) - Over the counter Medicines (Generally is not used)
  • Schedule 2 (S2) - Pharmacy Medicines
  • Schedule 3 (S3) - Pharmacist Only Medicines
  • Schedule 4 (S4) - Prescription Only Medicines
  • Schedule 5 (S5) - Poison
  • Schedule 6 (S6) - Caution/Poison
  • Schedule 7 (S7) - Dangerous/Poison
  • Schedule 8 (S8) - Controlled Drug
  • Schedule 9 (S9) - Prohibited Drug
  • Schedule 10 (S10) - Prohibited Substance

Brazil

Main article: Brazilian Controlled Drugs and Substances Act

Therapeutic goods in Brazil are regulated by the Ministry of Health of Brazil, through its Brazilian Health Regulatory Agency (Anvisa), equivalent to the US Food and Drug Administration. There are six main categories:

  • Over-the-counter (OTC) medicines (medicamentos isentos de prescrição or MIPs in Portuguese): cough, cold and fever medicines, antiseptics, vitamins and others. Sold freely in pharmacies.
  • Red stripe medicines: sold only with medical prescription. Anti-allergenics, anti-inflammatories, and other medicines.
  • Red stripe antibiotics: antibiotics are sold only with a "special control" white medical prescription with patient's copy, which is valid for 10 days. The original must be retained by the pharmacist after the sale and the patient keeps the copy.
  • Red stripe psychoactive medicines: sold only with a "special control" white medical prescription with patient's copy, which is valid for 30 days. The original must be retained by the pharmacist after the sale and the patient keeps the copy. Drugs include anti-depressants, anti-convulsants, some sleep aids, anti-psychotics and other non-habit-inducing controlled medicines. Though some consider them habit inducing, anabolic steroids are also regulated under this category.
  • Black stripe medicines: sold only with the "blue B form" medical prescription, which is valid for 30 days and must be retained by the pharmacist after the sale. Includes sedatives (benzodiazepines), some anorexic inducers and other habit-inducing controlled medicines.
  • "Yellow A form" prescription medicines: sold only with the "yellow A form" medical prescription - the most tightly controlled, which is valid for 30 days and must be retained by the pharmacist after the sale. Includes amphetamines and other stimulants (such as methylphenidate), opioids (such as morphine and oxycodone) and other strong habit-forming controlled medicines.

Biological medications are complex molecules of high molecular weight obtained from a biological source or biotechnological procedures and are divided by Anvisa into the following categories:

  • Allergens: substances from animals or plants that can induce an IgE response or a type I hypersensitivity reaction
  • Monoclonal antibodies: immunoglobulins derived from the same B lymphocyte clone, propagated in continuous cell lines
  • Biomedicines: obtained from biological fluids or tissues of animal origin or through biotechnological procedures
  • Blood derivatives: obtained from human plasma, subjected to industrialization and standardization processes
  • Probiotics: preparations containing viable microorganisms in sufficient quantity to change the microbiota
  • Vaccines: immunobiological medications that contain one or more antigenic substances capable of inducing immunity to protect against disease, reduce its severity or fight it

The regulatory status of vaccines, which determines their marketing and distribution, may be one of the following established by Anvisa:

Vaccines can only be administered in public health centers or authorized private vaccination services.

Canada

In Canada, regulation of therapeutic goods are governed by the Food and Drug Act and associated regulations. In addition, the Controlled Drugs and Substances Act specifies additional regulatory requirements for controlled drugs and drug precursors.

In Ontario, the Drug and Pharmacies Regulation Act governs "any substance that is used in the diagnosis, treatment, mitigation or prevention of a disease…in humans, animals or fowl."

China

The regulation of drugs in China is governed by the China Food and Drug Administration.

European Union

The European Union (EU) medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and European Medicines Agency (EMA). EMA and the Member States cooperate and share expertise in the assessment of new medicines and of new safety information. They also rely on each other for exchange of information in the regulation of medicine, for example regarding the reporting of side effects of medicines, the oversight of clinical trials, and the conduct of inspections of medicines' manufacturers and compliance with good clinical practice (GCP), good manufacturing practice (GMP), good distribution practice (GDP), and good pharmacovigilance practice (GVP). EU legislation requires that each Member State operates to the same rules and requirements regarding the authorisation and monitoring of medicines.

Within the EU, EudraLex maintains the collection of rules and regulations governing medicinal products in the European Union, and the European Medicines Agency acts to regulate many of these rules and regulations. Amongst these rules and regulations are:

Germany

Main article: List of German drug laws

German law classifies drugs into

  • Narcotics ("Betäubungsmittel")
  • Research chemicals ("neue psychoaktive Stoffe" – permitted only for industrial and scientific purposes)
  • Prescription drugs ("verschreibungspflichtig" or "rezeptpflichtig")
  • Pharmacy-only drugs ("apothekenpflichtig")
  • General sales list drugs ("freiverkäuflich")
  • Raw materials for synthesizing drugs
    • Kategorie 1 (authorization required)
    • Kategorie 2 (reporting required)
    • Kategorie 3 (export restrictions)

Iceland

Medicines in Iceland are regulated by the Icelandic Medicines Control Agency.

India

Main article: Drug policy of India

Medicines in India are regulated by Central Drugs Standard Control Organization (CDSCO) Under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services, CDSCO regulates pharmaceutical products through Drugs Controller General of India (DCGI) at chair.

Drugs are classified under five headings. Under retail and distribution:

  • Schedule X drugs - narcotics
  • Schedule H and L - injectables, antibiotics, antibacterials
  • Schedule C and C1 - biological products, for example serums and vaccines

Under manufacturing practice:

  • Schedule N - list of the equipment for the efficient running of manufacturing wing, qualified personnel
  • Schedule M

Indonesia

Medicines in Indonesia are regulated by National Agency of Drug and Food Control of Indonesia. Drugs in Indonesia are classified into:

  • Over-the-counter (OTC) drug (Obat bebas), drugs freely available to the public. Marked by green circle with black line.
  • Limited OTC drug (Obat bebas terbatas), drugs available to the public only through pharmacy (apotek) or licensed drug stores. Marked by blue circle with black line.
  • Prescription drug (Obat keras), prescription only medicine. Marked by red circle with letter "K" inside circle and black line.
  • Narcotics and psychoactive drugs (Obat psikotropika dan narkotika). National Narcotics Board perform law enforcement measure at illegal drug abuse and drug trafficking.

Ireland

Medicines in the Ireland are regulated according to the Misuse of Drugs Regulations 1988. Controlled drugs (CDs) are divided into five categories based on their potential for misuse and therapeutic effectiveness.

Myanmar (Burma)

The regulation of drugs in Burma is governed by the Food and Drug Administration (Burma) and Food and Drug Board of Authority.

Norway

Medicines in Norway are divided into five groups:

Class A

Narcotics, sedative-hypnotics, and amphetamines in this class require a special prescription form:

Class B

Restricted substances which easily lead to addiction like:

Class C - All prescription-only substances
Class F - Substances and package-sizes not requiring a prescription
Unclassifieds - Brands and packages not actively marketed in Norway

Philippines

The Food and Drug Administration regulates drugs and medical devices in the Philippines.

Sri Lanka

Prohibited. Brands and packages not actively marketed in Sri Lanka.

Switzerland

Medicines in Switzerland are regulated by Swissmedic. The country is not part of the European Union, and is regarded by many as one of the easiest places to conduct clinical trials on new drug compounds.

There are five categories from A to E to cover different types of delivery category:

  • A: Supply once with a prescription from a doctor or veterinarian
  • B: Supply with a prescription from a doctor or veterinarian
  • C: Supply on technical advice from medical staff
  • D: Supply on technical advice
  • E: Supply without technical advice

United Kingdom

Medicines for Human Use in the United Kingdom are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The availability of drugs is regulated by classification by the MHRA as part of marketing authorisation of a product.

The United Kingdom has a three-tiered classification system:

  • General Sale List (GSL)
  • Pharmacy medicines (P)
  • Prescription Only Medicines (POM)

Within POM, certain agents with a high abuse/addiction liability are also separately scheduled under the Misuse of Drugs Act 1971 (amended with the Misuse of Drugs Regulations 2001); and are commonly known as Controlled Drugs (CD).

United States

Therapeutic goods in the United States are regulated by the U.S. Food and Drug Administration (FDA), which makes some drugs available over the counter (OTC) at retail outlets and others by prescription only.

The prescription or possession of some substances is controlled or prohibited by the Controlled Substances Act, under the FDA and the Drug Enforcement Administration (DEA). Some US states apply more stringent limits on the prescription of certain controlled substances C-V and BTC (behind the counter) drugs such as pseudoephedrine. Three primary branches of pharmacovigilance in the U.S. include the FDA, the pharmaceutical manufacturers, and the academic/non-profit organizations (such as RADAR and Public Citizen).

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Self-medication

From Wikipedia, the free encyclopedia
https://en.wikipedia.org/wiki/Self-medication

Self-medication is a human behavior in which an individual uses a substance or any exogenous influence to self-administer treatment for physical or psychological conditions: for example headaches or fatigue.

The substances most widely used in self-medication are over-the-counter drugs and dietary supplements, which are used to treat common health issues at home. These do not require a doctor's prescription to obtain and, in some countries, are available in supermarkets and convenience stores.

The field of psychology surrounding the use of psychoactive drugs is often specifically in relation to the use of recreational drugs, alcohol, comfort food, and other forms of behavior to alleviate symptoms of mental distress, stress and anxiety, including mental illnesses or psychological trauma, is particularly unique. Such treatment may cause serious detriment to physical and mental health if motivated by addictive mechanisms. In postsecondary (university and college) students, self-medication with "study drugs" such as Adderall, Ritalin, and Concerta has been widely reported and discussed in literature.

Products are marketed by manufacturers as useful for self-medication, sometimes on the basis of questionable evidence. Claims that nicotine has medicinal value have been used to market cigarettes as self-administered medicines. These claims have been criticized as inaccurate by independent researchers. Unverified and unregulated third-party health claims are used to market dietary supplements.

Self-medication is often seen as gaining personal independence from established medicine, and it can be seen as a human right, implicit in, or closely related to the right to refuse professional medical treatment. Self-medication can cause unintentional self-harm. Self-medication with antibiotics has been identified as one of the primary reasons for the evolution of antimicrobial resistance.

Definition

Generally speaking, self-medication is defined as "the use of drugs to treat self-diagnosed disorders or symptoms, or the intermittent or continued use of a prescribed drug for chronic or recurrent disease or symptoms".

Self-medication can be defined as the use of drugs to treat an illness or symptom when the user is not a medically qualified professional. The term is also used to include the use of drugs outside their license or off-label.

Psychology and psychiatry

Self-medication hypothesis

As different drugs have different effects, they may be used for different reasons. According to the self-medication hypothesis (SMH), the individuals' choice of a particular drug is not accidental or coincidental, but instead, a result of the individuals' psychological condition, as the drug of choice provides relief to the user specific to his or her condition. Specifically, addiction is hypothesized to function as a compensatory means to modulate effects and treat distressful psychological states, whereby individuals choose the drug that will most appropriately manage their specific type of psychiatric distress and help them achieve emotional stability.

The self-medication hypothesis (SMH) originated in papers by Edward Khantzian, Mack and Schatzberg, David F. Duncan, and a response to Khantzian by Duncan. The SMH initially focused on heroin use, but a follow-up paper added cocaine. The SMH was later expanded to include alcohol, and finally all drugs of addiction.

According to Khantzian's view of addiction, drug users compensate for deficient ego function by using a drug as an "ego solvent", which acts on parts of the self that are cut off from consciousness by defense mechanisms. According to Khantzian, drug dependent individuals generally experience more psychiatric distress than non-drug dependent individuals, and the development of drug dependence involves the gradual incorporation of the drug effects and the need to sustain these effects into the defensive structure-building activity of the ego itself. The addict's choice of drug is a result of the interaction between the psychopharmacologic properties of the drug and the affective states from which the addict was seeking relief. The drug's effects substitute for defective or non-existent ego mechanisms of defense. The addict's drug of choice, therefore, is not random.

While Khantzian takes a psychodynamic approach to self-medication, Duncan's model focuses on behavioral factors. Duncan described the nature of positive reinforcement (e.g., the "high feeling", approval from peers), negative reinforcement (e.g. reduction of negative affect) and avoidance of withdrawal symptoms, all of which are seen in those who develop problematic drug use, but are not all found in all recreational drug users. While earlier behavioral formulations of drug dependence using operant conditioning maintained that positive and negative reinforcement were necessary for drug dependence, Duncan maintained that drug dependence was not maintained by positive reinforcement, but rather by negative reinforcement. Duncan applied a public health model to drug dependence, where the agent (the drug of choice) infects the host (the drug user) through a vector (e.g., peers), while the environment supports the disease process, through stressors and lack of support.

Khantzian revisited the SMH, suggesting there is more evidence that psychiatric symptoms, rather than personality styles, lie at the heart of drug use disorders. Khantzian specified that the two crucial aspects of the SMH were that (1) drugs of abuse produce a relief from psychological suffering and (2) the individual's preference for a particular drug is based on its psychopharmacological properties. The individual's drug of choice is determined through experimentation, whereby the interaction of the main effects of the drug, the individual's inner psychological turmoil, and underlying personality traits identify the drug that produces the desired effects.

Meanwhile, Duncan's work focuses on the difference between recreational and problematic drug use. Data obtained in the Epidemiologic Catchment Area Study demonstrated that only 20% of drug users ever experience an episode of drug abuse (Anthony & Helzer, 1991), while data obtained from the National Comorbidity Study demonstrated that only 15% of alcohol users and 15% of illicit drug users ever become dependent. A crucial determinant of whether a drug user develops drug abuse is the presence or absence of negative reinforcement, which is experienced by problematic users, but not by recreational users. According to Duncan, drug dependence is an avoidance behavior, where an individual finds a drug that produces a temporary escape from a problem, and taking the drug is reinforced as an operant behavior.

Specific mechanisms

Some people who have a mental illness attempt to correct their illnesses by using certain drugs. Depression is often self-medicated by the use of alcohol, tobacco, cannabis, or other mind-altering drugs. While this may provide immediate relief of some symptoms such as anxiety, it may evoke and/or exacerbate some symptoms of several kinds of mental illnesses that are already latently present, and may lead to addiction or physical dependency, among other side effects of long-term use of the drug. This does not differ significantly from the potential effects of drugs provided by physicians, which are equally capable of producing dependency and/or addiction and also have side effects arising from long-term use.

People with posttraumatic stress disorder have been known to self-medicate, as well as many individuals without this diagnosis who have experienced psychological trauma.

Due to the different effects of the different classes of drugs, the SMH postulates that the appeal of a specific class of drugs differs from person to person. In fact, some drugs may be aversive for individuals for whom the effects could worsen affective deficits.

CNS depressants

Alcohol and sedative/hypnotic drugs, such as barbiturates and benzodiazepines, are central nervous system (CNS) depressants that lower inhibitions via anxiolysis. Depressants produce feelings of relaxation and sedation, while relieving feelings of depression and anxiety. Though they are generally ineffective antidepressants, as most are short-acting, the rapid onset of alcohol and sedative/hypnotics softens rigid defenses and, in low to moderate doses, provides relief from depressive affect and anxiety. As alcohol also lowers inhibitions, alcohol is also hypothesized to be used by those who normally constrain emotions by attenuating intense emotions in high or obliterating doses, which allows them to express feelings of affection, aggression and closeness. Most patients that have been hospitalized for substance use or alcohol dependence reported using drugs in response to depressive symptoms. This type of misuse is more likely in men than in women. This makes diagnosing a psychiatric disorder very difficult in substance abusers, because of self medicating. People with social anxiety disorder commonly use these drugs to overcome their highly set inhibitions.

Psychostimulants

Psychostimulants, such as cocaine, amphetamines, methylphenidate, caffeine, and nicotine, produce improvements in physical and mental functioning, including increased energy and alertness. Stimulants tend to be most widely used by people with ADHD, which can either be diagnosed or undiagnosed. Because a significant portion of people with ADHD have not been diagnosed they are more prone to using stimulants like caffeine, nicotine or pseudoephedrine to mitigate their symptoms. It's worth noting that the unawareness concerning the effects of illicit substances such as cocaine, methamphetamine or mephedrone can result in self-medication with these drugs by individuals affected with ADHD symptoms. This self medication can effectively prevent them from getting diagnosed with ADHD and receiving treatment with stimulants like methylphenidate and amphetamines.

Stimulants also can be beneficial for individuals who experience depression, to reduce anhedonia and increase self-esteem., however in some cases depression may occur as a comorbid condition originating from the prolonged presence of negative symptoms of undiagnosed ADHD, which can impair executive functions, resulting in lack of motivation, focus and contentment with one's life, so stimulants may be useful for treating treatment-resistant depression, especially in individuals thought to have ADHD. The SMH also hypothesizes that hyperactive and hypomanic individuals use stimulants to maintain their restlessness and heighten euphoria. Additionally, stimulants are useful to individuals with social anxiety by helping individuals break through their inhibitions. Some reviews suggest that students use psychostimulants to self medicate for underlying conditions, such as ADHD, depression or anxiety.

Opiates

Opiates, such as heroin and morphine, function as an analgesic by binding to opioid receptors in the brain and gastrointestinal tract. This binding reduces the perception of and reaction to pain, while also increasing pain tolerance. Opiates are hypothesized to be used as self-medication for aggression and rage. Opiates are effective anxiolytics, mood stabilizers, and anti-depressants, however, people tend to self-medicate anxiety and depression with depressants and stimulants respectively, though this is by no means an absolute analysis.

Modern research into novel antidepressants targeting opioid receptors suggests that endogenous opioid dysregulation may play a role in medical conditions including anxiety disorders, clinical depression, and borderline personality disorder. BPD is typically characterized by sensitivity to rejection, isolation, and perceived failure, all of which are forms of psychological pain. As research suggests that psychological pain and physiological pain both share the same underlying mechanism, it is likely that under the self-medication hypothesis some or most recreational opioid users are attempting to alleviate psychological pain with opioids in the same way opioids are used to treat physiological pain.

Cannabis

Cannabis is paradoxical in that it simultaneously produces stimulating, sedating and mildly psychedelic properties and both anxiolytic or anxiogenic properties, depending on the individual and circumstances of use. Depressant properties are more obvious in occasional users, and stimulating properties are more common in chronic users. Khantzian noted that research had not sufficiently addressed a theoretical mechanism for cannabis, and therefore did not include it in the SMH.

Effectiveness

Self-medicating excessively for prolonged periods of time with benzodiazepines or alcohol often makes the symptoms of anxiety or depression worse. This is believed to occur as a result of the changes in brain chemistry from long-term use. Of those who seek help from mental health services for conditions including anxiety disorders such as panic disorder or social phobia, approximately half have alcohol or benzodiazepine dependence issues.

Sometimes anxiety precedes alcohol or benzodiazepine dependence but the alcohol or benzodiazepine dependence acts to keep the anxiety disorders going, often progressively making them worse. However, some people addicted to alcohol or benzodiazepines, when it is explained to them that they have a choice between ongoing poor mental health or quitting and recovering from their symptoms, decide on quitting alcohol or benzodiazepines or both. It has been noted that every individual has an individual sensitivity level to alcohol or sedative hypnotic drugs, and what one person can tolerate without ill health, may cause another to experience very ill health, and even moderate drinking can cause rebound anxiety syndrome and sleep disorders. A person experiencing the toxic effects of alcohol will not benefit from other therapies or medications, as these do not address the root cause of the symptoms.

Nicotine addiction seems to worsen mental health problems. Nicotine withdrawal depresses mood, increases anxiety and stress, and disrupts sleep. Although nicotine products temporarily relieve their nicotine withdrawal symptoms, an addiction causes stress and mood to be worse on average, due to mild withdrawal symptoms between hits. Nicotine addicts need the nicotine to temporarily feel normal. Nicotine industry marketing has claimed that nicotine is both less harmful and therapeutic for people with mental illness, and is a form of self-medication. This claim has been criticised by independent researchers.

Self medicating is a very common precursor to full addictions and the habitual use of any addictive drug has been demonstrated to greatly increase the risk of addiction to additional substances due to long-term neuronal changes. Addiction to any/every drug of abuse tested so far has been correlated with an enduring reduction in the expression of GLT1 (EAAT2) in the nucleus accumbens and is implicated in the drug-seeking behavior expressed nearly universally across all documented addiction syndromes. This long-term dysregulation of glutamate transmission is associated with an increase in vulnerability to both relapse-events after re-exposure to drug-use triggers as well as an overall increase in the likelihood of developing addiction to other reinforcing drugs. Drugs which help to re-stabilize the glutamate system such as N-acetylcysteine have been proposed for the treatment of addiction to cocaine, nicotine, and alcohol.

Infectious diseases

In 89% of countries, antibiotics can be prescribed only by a doctor and supplied only by a pharmacy. Self-medication with antibiotics is defined as "the taking of medicines on one's own initiative or on another person's suggestion, who is not a certified medical professional". It has been identified as one of the primary reasons for the evolution of antimicrobial resistance.

Self-medication with antibiotics is an unsuitable way of using them but a common practice in developing countries. Many people resort to that out of necessity when access to a physician is unavailable because of lockdowns and GP surgery closures, or when the patients have a limited amount of time or money to see a prescribing doctor.  While being cited as an important alternative to a formal healthcare system where it may be lacking, self-medication can pose a risk to both the patient and community as a whole. The reasons behind self-medication are unique to each region and can relate to health system, societal, economic, health factors, gender, and age. Risks include allergies, lack of cure, and even death.

Besides developing countries, self-medication with antibiotics is also a problem for higher-income countries. In the European Union the average prevalence was 7% in 2016 with the highest rates in southern countries. There are high rates of self-medication with antibiotics in Russia (83%), Central America (19%) and Latin America (14-26%) too.

Two significant issues with self-medication are the lack of knowledge of the public on, firstly, the dangerous effects of certain antimicrobials (for example, ciprofloxacin, which can cause tendonitis, tendon rupture and aortic dissection) and, secondly, broad microbial resistance and when to seek medical care if the infection is not clearing.

Also inappropriate use of over-the-counter ibuprofen or other nonsteroidal anti-inflammatory drugs during winter influenza outbreaks can lead to death, e.g. due to haemorrhagic duodenitis induced by ibuprofen, or the consequences of exceeding the recommended doses of paracetamol by combining doses of the generic product with proprietary flu-remedies and Tylex (paracetamol and codeine).

In a questionnaire designed to evaluate self-medication rates amongst the population of Khartoum, Sudan, 48.1% of respondents reported self-medicating with antibiotics within the past 30 days, whereas 43.4% reported self-medicating with antimalarials, and 17.5% reported self-medicating with both. Overall, the total prevalence of reported self-medication with one or both classes of anti-infective agents within the past month was 73.9%. Furthermore, according to the associated study, data indicated that self-medication "varies significantly with a number of socio-economic characteristics" and the "main reason that was indicated for the self-medication was financial constraints".

Similarly, in a survey of university students in southern China, 47.8% of respondents reported self-medicating with antibiotics.

Physicians and medical students

In a survey of West Bengal, India undergraduate medical school students, 57% reported self-medicating. The type of drugs most frequently used for self-medication were antibiotics (31%), analgesics (23%), antipyretics (18%), antiulcerics (9%), cough suppressants (8%), multivitamins (6%), and anthelmintics (4%).

Another study indicated that 53% of physicians in Karnataka, India reported self-administration of antibiotics.

Children

A study of Luo children in western Kenya found that 19% reported engaging in self-treatment with either herbal or pharmaceutical medicine. Proportionally, boys were much more likely to self-medicate using conventional medicine than herbal medicine as compared with girls, a phenomenon which was theorized to be influenced by their relative earning potential.

Regulation

Main article: Regulation of therapeutic goods

Self-medication is highly regulated in much of the world and many classes of drugs are available for administration only upon prescription by licensed medical personnel. Safety, social order, commercialization, and religion have historically been among the prevailing factors that lead to such prohibition.

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Substance dependence

From Wikipedia, the free encyclopedia
https://en.wikipedia.org/wiki/Substance_dependence
 
Substance dependence
Other namesDrug dependence
SpecialtyPsychiatry

Substance dependence, also known as drug dependence, is a biopsychological situation whereby an individual's functionality is dependent on the necessitated re-consumption of a psychoactive substance because of an adaptive state that has developed within the individual from psychoactive substance consumption that results in the experience of withdrawal and that necessitates the re-consumption of the drug. A drug addiction, a distinct concept from substance dependence, is defined as compulsive, out-of-control drug use, despite negative consequences. An addictive drug is a drug which is both rewarding and reinforcing. ΔFosB, a gene transcription factor, is now known to be a critical component and common factor in the development of virtually all forms of behavioral and drug addictions, but not dependence.

The International Classification of Diseases classifies substance dependence as a mental and behavioural disorder. Within the framework of the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), substance dependence is redefined as a drug addiction, and can be diagnosed without the occurrence of a withdrawal syndrome. It was described accordingly: "When an individual persists in use of alcohol or other drugs despite problems related to use of the substance, substance dependence may be diagnosed. Compulsive and repetitive use may result in tolerance to the effect of the drug and withdrawal symptoms when use is reduced or stopped. This, along with Substance Abuse are considered Substance Use Disorders." In the DSM-5 (released in 2013), substance abuse and substance dependence have been merged into the category of substance use disorders and they no longer exist as individual diagnoses.

Addiction and dependence glossary
  • addiction – a biopsychosocial disorder characterized by persistent use of drugs (including alcohol) despite substantial harm and adverse consequences
  • addictive drug – psychoactive substances that with repeated use are associated with significantly higher rates of substance use disorders, due in large part to the drug's effect on brain reward systems
  • dependence – an adaptive state associated with a withdrawal syndrome upon cessation of repeated exposure to a stimulus (e.g., drug intake)
  • drug sensitization or reverse tolerance – the escalating effect of a drug resulting from repeated administration at a given dose
  • drug withdrawal – symptoms that occur upon cessation of repeated drug use
  • physical dependence – dependence that involves persistent physical–somatic withdrawal symptoms (e.g., fatigue and delirium tremens)
  • psychological dependence – dependence that involves emotional–motivational withdrawal symptoms (e.g., dysphoria and anhedonia)
  • reinforcing stimuli – stimuli that increase the probability of repeating behaviors paired with them
  • rewarding stimuli – stimuli that the brain interprets as intrinsically positive and desirable or as something to approach
  • sensitization – an amplified response to a stimulus resulting from repeated exposure to it
  • substance use disorder – a condition in which the use of substances leads to clinically and functionally significant impairment or distress
  • tolerance – the diminishing effect of a drug resulting from repeated administration at a given dose

Withdrawal

Main article: Drug withdrawal

Withdrawal is the body's reaction to abstaining from a substance upon which a person has developed a dependence syndrome. When dependence has developed, cessation of substance-use produces an unpleasant state, which promotes continued drug use through negative reinforcement; i.e., the drug is used to escape or avoid re-entering the associated withdrawal state. The withdrawal state may include physical-somatic symptoms (physical dependence), emotional-motivational symptoms (psychological dependence), or both. Chemical and hormonal imbalances may arise if the substance is not re-introduced. Psychological stress may also result if the substance is not re-introduced.

Infants also experience substance withdrawal, known as neonatal abstinence syndrome (NAS), which can have severe and life-threatening effects. Addiction to drugs such as alcohol in expectant mothers not only causes NAS, but also an array of other issues which can continually affect the infant throughout their lifetime.

Risk factors

Mental health as a risk factor for illicit drug dependency or abuse.

Dependence potential

The dependence potential of a drug varies from substance to substance, and from individual to individual. Dose, frequency, pharmacokinetics of a particular substance, route of administration, and time are critical factors for developing a drug dependence.

An article in The Lancet compared the harm and dependence liability of 20 drugs, using a scale from zero to three for physical dependence, psychological dependence, and pleasure to create a mean score for dependence. Selected results can be seen in the chart below.

Drug Mean Pleasure Psychological dependence Physical dependence
Heroin/Morphine 3.00 3.0 3.0 3.0
Cocaine 2.39 3.0 2.8 1.3
Tobacco 2.21 2.3 2.6 1.8
Barbiturates 2.01 2.0 2.2 1.8
Alcohol 1.93 2.3 1.9 1.6
Benzodiazepines 1.83 1.7 2.1 1.8
Amphetamine 1.67 2.0 1.9 1.1
Cannabis 1.51 1.9 1.7 0.8
Ecstasy 1.13 1.5 1.2 0.7

Capture rates

Capture rates enumerate the percentage of users who reported that they had become dependent to their respective drug at some point.

Drug % of users
Cannabis 9%
Alcohol 15.4%
Cocaine 16.7%
Heroin 23.1%
Tobacco 31.9%

Biomolecular mechanisms

Psychological dependence

Two factors have been identified as playing pivotal roles in psychological dependence: the neuropeptide "corticotropin-releasing factor" (CRF) and the gene transcription factor "cAMP response element binding protein" (CREB). The nucleus accumbens (NAcc) is one brain structure that has been implicated in the psychological component of drug dependence. In the NAcc, CREB is activated by cyclic adenosine monophosphate (cAMP) immediately after a high and triggers changes in gene expression that affect proteins such as dynorphin; dynorphin peptides reduce dopamine release into the NAcc by temporarily inhibiting the reward pathway. A sustained activation of CREB thus forces a larger dose to be taken to reach the same effect. In addition, it leaves the user feeling generally depressed and dissatisfied, and unable to find pleasure in previously enjoyable activities, often leading to a return to the drug for another dose.

In addition to CREB, it is hypothesized that stress mechanisms play a role in dependence. Koob and Kreek have hypothesized that during drug use, CRF activates the hypothalamic–pituitary–adrenal axis (HPA axis) and other stress systems in the extended amygdala. This activation influences the dysregulated emotional state associated with psychological dependence. They found that as drug use escalates, so does the presence of CRF in human cerebrospinal fluid. In rat models, the separate use of CRF inhibitors and CRF receptor antagonists both decreased self-administration of the drug of study. Other studies in this review showed dysregulation of other neuropeptides that affect the HPA axis, including enkephalin which is an endogenous opioid peptide that regulates pain. It also appears that µ-opioid receptors, which enkephalin acts upon, is influential in the reward system and can regulate the expression of stress hormones.

Increased expression of AMPA receptors in nucleus accumbens MSNs is a potential mechanism of aversion produced by drug withdrawal.

Physical dependence

Upregulation of the cAMP signal transduction pathway in the locus coeruleus by CREB has been implicated as the mechanism responsible for certain aspects of opioid-induced physical dependence. The temporal course of withdrawal correlates with LC firing, and administration of α2 agonists into the locus coeruleus leads to a decrease in LC firing and norepinephrine release during withdrawal. A possible mechanism involves upregulation of NMDA receptors, which is supported by the attenuation of withdraw by NMDA receptor antagonists. Physical dependence on opioids has been observed to produce an elevation of extracellular glutamate, an increase in NMDA receptor subunits NR1 and NR2A, phosphorylated CaMKII, and c-fos. Expression of CaMKII and c-fos is attenuated by NMDA receptor antagonists, which is associated with blunted withdrawal in adult rats, but not neonatal rats While acute administration of opioids decreases AMPA receptor expression and depresses both NMDA and non-NMDA excitatory postsynaptic potentials in the NAC, withdrawal involves a lowered threshold for LTP and an increase in spontaneous firing in the NAc.

Diagnosis

DSM classification

"Substance dependence", as defined in the DSM-IV, can be diagnosed with physiological dependence, evidence of tolerance or withdrawal, or without physiological dependence. DSM-IV substance dependencies include:

Management

Addiction is a complex but treatable condition. It is characterized by compulsive drug craving, seeking, and use that persists even if the user is aware of severe adverse consequences. For some people, addiction becomes chronic, with periodic relapses even after long periods of abstinence. As a chronic, relapsing disease, addiction may require continued treatments to increase the intervals between relapses and diminish their intensity. While some with substance issues recover and lead fulfilling lives, others require ongoing additional support. The ultimate goal of addiction treatment is to enable an individual to manage their substance misuse; for some this may mean abstinence. Immediate goals are often to reduce substance abuse, improve the patient's ability to function, and minimize the medical and social complications of substance abuse and their addiction; this is called "harm reduction".

Treatments for addiction vary widely according to the types of drugs involved, amount of drugs used, duration of the drug addiction, medical complications and the social needs of the individual. Determining the best type of recovery program for an addicted person depends on a number of factors, including: personality, drugs of choice, concept of spirituality or religion, mental or physical illness, and local availability and affordability of programs.

Many different ideas circulate regarding what is considered a successful outcome in the recovery from addiction. Programs that emphasize controlled drinking exist for alcohol addiction. Opiate replacement therapy has been a medical standard of treatment for opioid addiction for many years.

Treatments and attitudes toward addiction vary widely among different countries. In the US and developing countries, the goal of commissioners of treatment for drug dependence is generally total abstinence from all drugs. Other countries, particularly in Europe, argue the aims of treatment for drug dependence are more complex, with treatment aims including reduction in use to the point that drug use no longer interferes with normal activities such as work and family commitments; shifting the addict away from more dangerous routes of drug administration such as injecting to safer routes such as oral administration; reduction in crime committed by drug addicts; and treatment of other comorbid conditions such as AIDS, hepatitis and mental health disorders. These kinds of outcomes can be achieved without eliminating drug use completely. Drug treatment programs in Europe often report more favorable outcomes than those in the US because the criteria for measuring success are functional rather than abstinence-based. The supporters of programs with total abstinence from drugs as a goal believe that enabling further drug use means prolonged drug use and risks an increase in addiction and complications from addiction.

Residential

Residential drug treatment can be broadly divided into two camps: 12-step programs and therapeutic communities. 12-step programs are a nonclinical support-group and spiritual-based approach to treating addiction. Therapy typically involves the use of cognitive-behavioral therapy, an approach that looks at the relationship between thoughts, feelings and behaviors, addressing the root cause of maladaptive behavior. Cognitive-behavioral therapy treats addiction as a behavior rather than a disease, and so is subsequently curable, or rather, unlearnable. Cognitive-behavioral therapy programs recognize that, for some individuals, controlled use is a more realistic possibility.

One of many recovery methods are 12-step recovery programs, with prominent examples including Alcoholics Anonymous, Narcotics Anonymous, and Pills Anonymous. They are commonly known and used for a variety of addictions for the individual addicted and the family of the individual. Substance-abuse rehabilitation (rehab) centers offer a residential treatment program for some of the more seriously addicted, in order to isolate the patient from drugs and interactions with other users and dealers. Outpatient clinics usually offer a combination of individual counseling and group counseling. Frequently, a physician or psychiatrist will prescribe medications in order to help patients cope with the side effects of their addiction. Medications can help immensely with anxiety and insomnia, can treat underlying mental disorders (cf. self-medication hypothesis, Khantzian 1997) such as depression, and can help reduce or eliminate withdrawal symptomology when withdrawing from physiologically addictive drugs. Some examples are using benzodiazepines for alcohol detoxification, which prevents delirium tremens and complications; using a slow taper of benzodiazepines or a taper of phenobarbital, sometimes including another antiepileptic agent such as gabapentin, pregabalin, or valproate, for withdrawal from barbiturates or benzodiazepines; using drugs such as baclofen to reduce cravings and propensity for relapse amongst addicts to any drug, especially effective in stimulant users, and alcoholics (in which it is nearly as effective as benzodiazepines in preventing complications); using clonidine, an alpha-agonist, and loperamide for opioid detoxification, for first-time users or those who wish to attempt an abstinence-based recovery (90% of opioid users relapse to active addiction within eight months or are multiple relapse patients); or replacing an opioid that is interfering with or destructive to a user's life, such as illicitly-obtained heroin, dilaudid, or oxycodone, with an opioid that can be administered legally, reduces or eliminates drug cravings, and does not produce a high, such as methadone or buprenorphine – opioid replacement therapy – which is the gold standard for treatment of opioid dependence in developed countries, reducing the risk and cost to both user and society more effectively than any other treatment modality (for opioid dependence), and shows the best short-term and long-term gains for the user, with the greatest longevity, least risk of fatality, greatest quality of life, and lowest risk of relapse and legal issues including arrest and incarceration.

In a survey of treatment providers from three separate institutions, the National Association of Alcoholism and Drug Abuse Counselors, Rational Recovery Systems and the Society of Psychologists in Addictive Behaviors, measuring the treatment provider's responses on the "Spiritual Belief Scale" (a scale measuring belief in the four spiritual characteristics of AA identified by Ernest Kurtz); the scores were found to explain 41% of the variance in the treatment provider's responses on the "Addiction Belief Scale" (a scale measuring adherence to the disease model or the free-will model of addiction).

Behavioral programming

Behavioral programming is considered critical in helping those with addictions achieve abstinence. From the applied behavior analysis literature and the behavioral psychology literature, several evidence based intervention programs have emerged: (1) behavioral marital therapy; (2) community reinforcement approach; (3) cue exposure therapy; and (4) contingency management strategies. In addition, the same author suggests that social skills training adjunctive to inpatient treatment of alcohol dependence is probably efficacious. Community reinforcement has both efficacy and effectiveness data. In addition, behavioral treatment such as community reinforcement and family training (CRAFT) have helped family members to get their loved ones into treatment. Motivational intervention has also shown to be an effective treatment for substance dependence.

Alternative therapies

Alternative therapies, such as acupuncture, are used by some practitioners to alleviate the symptoms of drug addiction. In 1997, the American Medical Association (AMA) adopted, as policy, the following statement after a report on a number of alternative therapies including acupuncture:

There is little evidence to confirm the safety or efficacy of most alternative therapies. Much of the information currently known about these therapies makes it clear that many have not been shown to be efficacious. Well-designed, stringently controlled research should be done to evaluate the efficacy of alternative therapies.

Treatment and issues

Medical professionals need to apply many techniques and approaches to help patients with substance related disorders. Using a psychodynamic approach is one of the techniques that psychologists use to solve addiction problems. In psychodynamic therapy, psychologists need to understand the conflicts and the needs of the addicted person, and also need to locate the defects of their ego and defense mechanisms. Using this approach alone has proven to be ineffective in solving addiction problems. Cognitive and behavioral techniques should be integrated with psychodynamic approaches to achieve effective treatment for substance related disorders. Cognitive treatment requires psychologists to think deeply about what is happening in the brain of an addicted person. Cognitive psychologists should zoom in to neural functions of the brain and understand that drugs have been manipulating the dopamine reward center of the brain. From this particular state of thinking, cognitive psychologists need to find ways to change the thought process of the addicted person.

Cognitive approach

There are two routes typically applied to a cognitive approach to substance abuse: tracking the thoughts that pull patients to addiction and tracking the thoughts that prevent them if so from relapsing. Behavioral techniques have the widest application in treating substance related disorders. Behavioral psychologists can use the techniques of "aversion therapy", based on the findings of Pavlov's classical conditioning. It uses the principle of pairing abused substances with unpleasant stimuli or conditions; for example, pairing pain, electrical shock, or nausea with alcohol consumption. The use of medications may also be used in this approach, such as using disulfiram to pair unpleasant effects with the thought of alcohol use. Psychologists tend to use an integration of all these approaches to produce reliable and effective treatment. With the advanced clinical use of medications, biological treatment is now considered to be one of the most efficient interventions that psychologists may use as treatment for those with substance dependence.

Medicinal approach

Another approach is to use medicines that interfere with the functions of the drugs in the brain. Similarly, one can also substitute the misused substance with a weaker, safer version to slowly taper the patient off of their dependence. Such is the case with Suboxone in the context of opioid dependence. These approaches are aimed at the process of detoxification. Medical professionals weigh the consequences of withdrawal symptoms against the risk of staying dependent on these substances. These withdrawal symptoms can be very difficult and painful times for patients. Most will have steps in place to handle severe withdrawal symptoms, either through behavioral therapy or other medications. Biological intervention should be combined with behavioral therapy approaches and other non-pharmacological techniques. Group therapies including anonymity, teamwork and sharing concerns of daily life among people who also have substance dependence issues can have a great impact on outcomes. However, these programs proved to be more effective and influential on persons who did not reach levels of serious dependence.

Vaccines

  • TA-CD is an active vaccine developed by the Xenova Group which is used to negate the effects of cocaine, making it suitable for use in treatment of addiction. It is created by combining norcocaine with inactivated cholera toxin.
  • TA-NIC is a proprietary vaccine in development similar to TA-CD but being used to create human anti-nicotine antibodies in a person to destroy nicotine in the human body so that it is no longer effective.

History

The phenomenon of drug addiction has occurred to some degree throughout recorded history (see "Opium"). Modern agricultural practices, improvements in access to drugs, advancements in biochemistry, and dramatic increases in the recommendation of drug usage by clinical practitioners have exacerbated the problem significantly in the 20th century. Improved means of active biological agent manufacture and the introduction of synthetic compounds, such as fentanyl and methamphetamine, are also factors contributing to drug addiction.

For the entirety of US history, drugs have been used by some members of the population. In the country's early years, most drug use by the settlers was of alcohol or tobacco.

The 19th century saw opium usage in the US become much more common and popular. Morphine was isolated in the early 19th century, and came to be prescribed commonly by doctors, both as a painkiller and as an intended cure for opium addiction. At the time, the prevailing medical opinion was that the addiction process occurred in the stomach, and thus it was hypothesized that patients would not become addicted to morphine if it was injected into them via a hypodermic needle, and it was further hypothesized that this might potentially be able to cure opium addiction. However, many people did become addicted to morphine. In particular, addiction to opium became widespread among soldiers fighting in the Civil War, who very often required painkillers and thus were very often prescribed morphine. Women were also very frequently prescribed opiates, and opiates were advertised as being able to relieve "female troubles".

Many soldiers in the Vietnam War were introduced to heroin and developed a dependency on the substance which survived even when they returned to the US. Technological advances in travel meant that this increased demand for heroin in the US could now be met. Furthermore, as technology advanced, more drugs were synthesized and discovered, opening up new avenues to substance dependency.

Society and culture

Demographics

Internationally, the U.S. and Eastern Europe contain the countries with the highest substance abuse disorder occurrence (5-6%). Africa, Asia, and the Middle East contain countries with the lowest worldwide occurrence (1-2%). Across the globe, those that tended to have a higher prevalence of substance dependence were in their twenties, unemployed, and men. The National Survey on Drug Use and Health (NSDUH) reports on substance dependence/abuse rates in various population demographics across the U.S. When surveying populations based on race and ethnicity in those ages 12 and older, it was observed that American Indian/Alaskan Natives were among the highest rates and Asians were among the lowest rates in comparison to other racial/ethnic groups.

Substance Use in Racial/Ethnic Groups
Race/Ethnicity Dependence/Abuse Rate
Asian 4.6%
Black 7.4%
White 8.4%
Hispanic 8.6%
Mixed race 10.9%
Native Hawaiian/

Pacific Islander

11.3%
American Indian/

Alaskan Native

14.9%

When surveying populations based on gender in those ages 12 and older, it was observed that males had a higher substance dependence rate than females. However, the difference in the rates are not apparent until after age 17.Drug and Alcohol Dependence reports that older adults abuse drugs including alcohol at a rate of 15-20%. It's estimated that 52 million Americans beyond 12 years old have abused a substance.

Substance Use in Different Genders w/ Respect to Age
Age Male Female
12 and older 10.8% 5.8%
12-17 5.3% 5.2%
18 or older 11.4% 5.8%

Alcohol dependence or abuse rates were shown to have no correspondence with any person's education level when populations were surveyed in varying degrees of education from ages 26 and older. However, when it came to illicit drug use there was a correlation, in which those that graduated from college had the lowest rates. Furthermore, dependence rates were greater in unemployed populations ages 18 and older and in metropolitan-residing populations ages 12 and older.

Illicit Drug Dependence Demographics (Education, Employment, and Regional)
Education level Rates Employment status Rates Region Rates
high school 2.5% un-employed 15.2% large metropolitan 8.6%
no-degree, college 2.1% part-time 9.3% small metropolitan 8.4%
college graduate 0.9% full-time 9.5% non-metropolitan 6.6%

The National Opinion Research Center at the University of Chicago reported an analysis on disparities within admissions for substance abuse treatment in the Appalachian region, which comprises 13 states and 410 counties in the Eastern part of the U.S. While their findings for most demographic categories were similar to the national findings by NSDUH, they had different results for racial/ethnic groups which varied by sub-regions. Overall, Whites were the demographic with the largest admission rate (83%), while Alaskan Native, American Indian, Pacific Islander, and Asian populations had the lowest admissions (1.8%).

Legislation

Depending on the jurisdiction, addictive drugs may be legal, legal only as part of a government sponsored study, illegal to use for any purpose, illegal to sell, or even illegal to merely possess.

Most countries have legislation which brings various drugs and drug-like substances under the control of licensing systems. Typically this legislation covers any or all of the opiates, amphetamines, cannabinoids, cocaine, barbiturates, benzodiazepines, anesthetics, hallucinogenics, derivatives and a variety of more modern synthetic drugs. Unlicensed production, supply or possession is a criminal offence.

Usually, however, drug classification under such legislation is not related simply to addictiveness. The substances covered often have very different addictive properties. Some are highly prone to cause physical dependency, while others rarely cause any form of compulsive need whatsoever. Also, under legislation specifically about drugs, alcohol and nicotine are not usually included.

Although the legislation may be justifiable on moral or public health grounds, it can make addiction or dependency a much more serious issue for the individual: reliable supplies of a drug become difficult to secure, and the individual becomes vulnerable to both criminal abuse and legal punishment.

It is unclear whether laws against illegal drug use do anything to stem usage and dependency. In jurisdictions where addictive drugs are illegal, they are generally supplied by drug dealers, who are often involved with organized crime. Even though the cost of producing most illegal addictive substances is very low, their illegality combined with the addict's need permits the seller to command a premium price, often hundreds of times the production cost. As a result, addicts sometimes turn to crime to support their habit.

United States

In the United States, drug policy is primarily controlled by the federal government. The Department of Justice's Drug Enforcement Administration (DEA) enforces controlled substances laws and regulations. The Department of Health and Human Services' Food and Drug Administration (FDA) serve to protect and promote public health by controlling the manufacturing, marketing, and distribution of products, like medications.

The United States' approach to substance abuse has shifted over the last decade, and is continuing to change. The federal government was minimally involved in the 19th century. The federal government transitioned from using taxation of drugs in the early 20th century to criminalizing drug abuse with legislations and agencies like the Federal Bureau of Narcotics (FBN) mid-20th century in response to the nation's growing substance abuse issue. These strict punishments for drug offenses shined light on the fact that drug abuse was a multi-faceted problem. The President's Advisory Commission on Narcotics and Drug Abuse of 1963 addressed the need for a medical solution to drug abuse. However, drug abuse continued to be enforced by the federal government through agencies such as the DEA and further legislations such as The Controlled Substances Act (CSA), the Comprehensive Crime Control Act of 1984, and Anti-Drug Abuse Acts.

In the past decade, there have been growing efforts through state and local legislations to shift from criminalizing drug abuse to treating it as a health condition requiring medical intervention. 28 states currently allow for the establishment of needle exchanges. Florida, Iowa, Missouri and Arizona all introduced bills to allow for the establishment of needle exchanges in 2019. These bills have grown in popularity across party lines since needle exchanges were first introduced in Amsterdam in 1983. In addition, AB-186 Controlled substances: overdose prevention program was introduced to operate safe injection sites in the City and County of San Francisco. The bill was vetoed on September 30, 2018, by California Governor Jerry Brown. The legality of these sites are still in discussion, so there are no such sites in the United States yet. However, there is growing international evidence for successful safe injection facilities.

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