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Prescription drug

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Photo of the packaging of four medicines registered in the UK, showing their Product Licence Numbers and symbols denoting if they are Prescription Only Medicine (POM) or Pharmacy Medicine (P)

A prescription drug (also prescription medication, prescription medicine or prescription-only medication) is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.

In North America, ℞, usually printed as "Rx", is used as an abbreviation of the word "prescription". It is a contraction of the Latin word "recipe" (an imperative form of "recipere") meaning "take".[1] Prescription drugs are often dispensed together with a monograph (in Europe, a Patient Information Leaflet or PIL) that gives detailed information about the drug.

The use of prescription drugs has been increasing since the 1960s.

Regulation

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Australia

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In Australia, the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) governs the manufacture and supply of drugs with several categories:[2]

  • Schedule 1 – Defunct Drug.
  • Schedule 2 – Pharmacy Medicine
  • Schedule 3 – Pharmacist-Only Medicine
  • Schedule 4 – Prescription-Only Medicine/Prescription Animal Remedy
  • Schedule 5 – Caution/Poison.
  • Schedule 6 – Poison
  • Schedule 7 – Dangerous Poison
  • Schedule 8 – Controlled Drug (Possession without authority illegal)
  • Schedule 9 – Prohibited Substance (Possession illegal without a license legal only for research purposes)
  • Schedule 10 – Controlled Poison.
  • Unscheduled Substances.

As in other developed countries, the person requiring a prescription drug attends the clinic of a qualified health practitioner, such as a physician, who may write the prescription for the required drug.

Many prescriptions issued by health practitioners in Australia are covered by the Pharmaceutical Benefits Scheme, a scheme that provides subsidised prescription drugs to residents of Australia to ensure that all Australians have affordable and reliable access to a wide range of necessary medicines. When purchasing a drug under the PBS, the consumer pays no more than the patient co-payment contribution, which, as of January 1, 2022, is A$42.50 for general patients. Those covered by government entitlements (low-income earners, welfare recipients, Health Care Card holders, etc.) and or under the Repatriation Pharmaceutical Benefits Scheme (RPBS) have a reduced co-payment, which is A$6.80 in 2022.[3] The co-payments are compulsory and can be discounted by pharmacies up to a maximum of A$1.00 at cost to the pharmacy.

United Kingdom

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In the United Kingdom, the Medicines Act 1968 and the Prescription Only Medicines (Human Use) Order 1997 contain regulations that cover the supply of sale, use, prescribing and production of medicines. There are three categories of medicine:[4]

  • Prescription-only medicines (POM), which may be dispensed (sold in the case of a private prescription) by a pharmacist only to those to whom they have been prescribed
  • Pharmacy medicines (P), which may be sold by a pharmacist without a prescription
  • General sales list (GSL) medicines, which may be sold without a prescription in any shop

The simple possession of a prescription-only medicine without a prescription is legal unless it is covered by the Misuse of Drugs Act 1971.[5]

A patient visits a medical practitioner or dentist, who may prescribe drugs and certain other medical items, such as blood glucose-testing equipment for diabetics. Also, qualified and experienced nurses, paramedics and pharmacists may be independent prescribers. Both may prescribe all POMs (including controlled drugs), but may not prescribe Schedule 1 controlled drugs, and 3 listed controlled drugs for the treatment of addiction; which is similar to doctors, who require a special licence from the Home Office to prescribe schedule 1 drugs. Schedule 1 drugs have little or no medical benefit, hence their limitations on prescribing. District nurses and health visitors have had limited prescribing rights since the mid-1990s; until then, prescriptions for dressings and simple medicines had to be signed by a doctor. Once issued, a prescription is taken by the patient to a pharmacy, which dispenses the medicine.

Most prescriptions are NHS prescriptions, subject to a standard charge that is unrelated to what is dispensed. The NHS prescription fee was increased to £9.90 for each item in England in May 2024;[6] prescriptions are free of charge if prescribed and dispensed in Scotland,[7] Wales and Northern Ireland,[8] and for some patients in England, such as inpatients, children, those over 60s or with certain medical conditions, and claimants of certain benefits.[9] The pharmacy charges the NHS the actual cost of the medicine, which may vary from a few pence to hundreds of pounds.[10][11] A patient can consolidate prescription charges by using a prescription payment certificate (informally a "season ticket"), effectively capping costs at £31.25 a quarter or £111.60 for a year.[9]

Outside the NHS, private prescriptions are issued by private medical practitioner and sometimes under the NHS for medicines that are not covered by the NHS.[10][11] A patient pays the pharmacy the normal price for medicine prescribed outside the NHS.

Survey results published by Ipsos MORI in 2008 found that around 800,000 people in England were not collecting prescriptions or getting them dispensed because of the cost, the same as in 2001.[12]

United States

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Regulation of therapeutic goods in the United States
Prescription drugs
Over-the-counter drugs
Law
Government agencies
Process
International coordination
Non-governmental organizations

In the United States, the Federal Food, Drug, and Cosmetic Act defines what substances, known as legend drugs, require a prescription for them to be dispensed by a pharmacy. The federal government authorizes physicians (of any specialty), physician assistants, nurse practitioners and other advanced practice nurses, veterinarians, dentists, and optometrists to prescribe any controlled substance. They are issued unique DEA numbers.[13] Many other mental and physical health technicians, including basic-level registered nurses, medical assistants, emergency medical technicians, most psychologists, and social workers, are not authorized to prescribe legend drugs.[14]

The federal Controlled Substances Act (CSA) was enacted in 1970. It regulates manufacture, importation, possession, use, and distribution of controlled substances, which are drugs with potential for abuse or addiction. The legislation classifies these drugs into five schedules, with varying qualifications for each schedule. The schedules are designated schedule I, schedule II, schedule III, schedule IV, and schedule V. Many drugs other than controlled substances require a prescription.

The safety and the effectiveness of prescription drugs in the US are regulated by the 1987 Prescription Drug Marketing Act (PDMA). The Food and Drug Administration (FDA) is charged with implementing the law.

As a general rule, over-the-counter drugs (OTC) are used to treat a condition that does not need care from a healthcare professional if have been proven to meet higher safety standards for self-medication by patients. Often, a lower strength of a drug will be approved for OTC use, but higher strengths require a prescription to be obtained; a notable case is ibuprofen, which has been widely available as an OTC pain killer since the mid-1980s, but it is available by prescription in doses up to four times the OTC dose for severe pain that is not adequately controlled by the OTC strength.

Herbal preparations, amino acids, vitamins, minerals, and other food supplements are regulated by the FDA as dietary supplements. Because specific health claims cannot be made, the consumer must make informed decisions when purchasing such products.[15]

By law, American pharmacies operated by "membership clubs" such as Costco and Sam's Club must allow non-members to use their pharmacy services and may not charge more for these services than they charge as their members.[citation needed]

Physicians may legally prescribe drugs for uses other than those specified in the FDA approval, known as off-label use.[citation needed] Drug companies, however, are prohibited from marketing their drugs for off-label uses.[citation needed]

Some prescription drugs are commonly abused, particularly those marketed as analgesics, including fentanyl (Duragesic), hydrocodone (Vicodin), oxycodone (OxyContin), oxymorphone (Opana), propoxyphene (Darvon), hydromorphone (Dilaudid), meperidine (Demerol), and diphenoxylate (Lomotil).[16]

Some prescription painkillers have been found to be addictive, and unintentional poisoning deaths in the United States have skyrocketed since the 1990s according to the National Safety Council.[17] Prescriber education guidelines as well as patient education, prescription drug monitoring programs and regulation of pain clinics are regulatory tactics which have been used to curtail opioid use and misuse.[18]

Expiration date

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The expiration date, required in several countries, specifies the date up to which the manufacturer guarantees the full potency and safety of a drug. In the United States, expiration dates are determined by regulations established by the FDA.[19] The FDA advises consumers not to use products after their expiration dates.[20]

A study conducted by the U.S. Food and Drug Administration covered over 100 drugs, prescription and over-the-counter. The results showed that about 90% of them were safe and effective far past their original expiration date. At least one drug worked 15 years after its expiration date.[21] Joel Davis, a former FDA expiration-date compliance chief, said that with a handful of exceptions—notably nitroglycerin, insulin, and some liquid antibiotics (outdated tetracyclines can cause Fanconi syndrome)—most expired drugs are probably effective.[22]

The American Medical Association issued a report and statement on Pharmaceutical Expiration Dates.[23] The Harvard Medical School Family Health Guide notes that, with rare exceptions, "it's true the effectiveness of a drug may decrease over time, but much of the original potency still remains even a decade after the expiration date".[24]

The expiration date is the final day that the manufacturer guarantees the full potency and safety of a medication. Drug expiration dates exist on most medication labels, including prescription, over-the-counter and dietary supplements. U.S. pharmaceutical manufacturers are required by law to place expiration dates on prescription products prior to marketing. For legal and liability reasons, manufacturers will not make recommendations about the stability of drugs past the original expiration date.[25]

Cost

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Prices of prescription drugs vary widely around the world. Prescription costs for biosimilar and generic drugs are usually less than brand names, but the cost is different from one pharmacy to another.

To lower prescription drug costs, some U.S. states have sought federal approval to buy drugs in Canada, as of 2022.[26]

Generics undergo strict scrutiny to meet the equal efficacy, safety, dosage, strength, stability, and quality of brand name drugs.[27] Generics are developed after the brand name has already been established, and so generic drug approval in many aspects has a shortened approval process because it replicates the brand name drug.[27]

Brand name drugs cost more due to time, money, and resources that drug companies invest in them to conduct development, including clinical trials that the FDA requires for the drug to be marketed.[28] Because drug companies have to invest more in research costs to do this, brand name drug prices are much higher when sold to consumers.[28]

When the patent expires for a brand name drug, generic versions of that drug are produced by other companies and are sold for lower price. By switching to generic prescription drugs, patients can save significant amounts of money: e.g. one study by the FDA showed an example with more than 52% savings of a consumer's overall costs of their prescription drugs.[29]

Strategies to limit drug prices in the United States

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In the United States there are many resources available to patients to lower the costs of medication. These include copayments, coinsurance, and deductibles.[neutrality is disputed] The Medicaid Drug Rebate Program is another example.[30]

Generic drug programs lower the amount of money patients have to pay when picking up their prescription at the pharmacy. As their name implies, they only cover generic drugs.[31]

Co-pay assistance programs are programs that help patients lower the costs of specialty medications; i.e., medications that are on restricted formularies, have limited distribution, and/or have no generic version available. These medications can include drugs for HIV, hepatitis C, and multiple sclerosis. Patient Assistance Program Center (RxAssist) has a list of foundations that provide co-pay assistance programs. Co-pay assistance programs are for under-insured patients. Patients without insurance are not eligible for this resource; however, they may be eligible for patient assistance programs.

Patient assistance programs are funded by the manufacturer of the medication. Patients can often apply to these programs through the manufacturer's website. This type of assistance program is one of the few options available to uninsured patients.

The out-of-pocket cost for patients enrolled in co-pay assistance or patient assistance programs is $0. It is a major resource to help lower costs of medications—however, many providers and patients are not aware of these resources.

Environment

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Traces of prescription drugs—including antibiotics, anti-convulsants, mood stabilizers and sex hormones—have been detected in drinking water.[32][33] Pharmaceutically active compounds (PhACs) discarded from human therapy and their metabolites may not be eliminated entirely by sewage treatment plants and have been detected at low concentrations in surface waters downstream from those plants.[34] The continuous discarding of incompletely treated water may interact with other environmental chemicals and lead to uncertain ecological effects.[35] Due to most pharmaceuticals being highly soluble, fish and other aquatic organisms are susceptible to their effects.[34] The long-term effects of pharmaceuticals in the environment may affect survival and reproduction of such organisms.[34] However, levels of medical drug waste in the water is at a low enough level that it is not a direct concern to human health. However, processes, such as biomagnification, are potential human health concerns.[36]

On the other hand, there is clear evidence of harm to aquatic animals and fauna. Recent advancements in technology have allowed scientists to detect smaller, trace quantities of pharmaceuticals in the ng/ml range.[37] Despite being found at low concentrations, female hormonal contraceptives may cause feminizing effects on male vertebrate species, such as fish, frogs and crocodiles.[37]

The FDA established guidelines in 2007 to inform consumers should dispose of prescription drugs.[38] When medications do not include specific disposal instructions, patients should not flush medications in the toilet, but instead use medication take-back programs to reduce the amount of pharmaceutical waste in sewage and landfills.[39] If no take-back programs are available, prescription drugs can be discarded in household trash after they are crushed or dissolved and then mixed in a separate container or sealable bag with undesirable substances like cat litter or other unappealing material (to discourage consumption).[39]

See also

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References

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  1. ^ "Rx". Merriam Webster Dictionary. Archived from the original on 22 April 2021. Retrieved 16 April 2021.
  2. ^ "The Poisons Standard (the SUSMP)". Therapeutic Goods Administration. Archived from the original on 5 October 2014. Retrieved 17 September 2011.
  3. ^ "About the PBS". Pharmaceutical Benefits Scheme. Archived from the original on 26 September 2022. Retrieved 26 September 2022.
  4. ^ "About Registration: Medicines and Prescribing". Health and Care Professions Council. Archived from the original on 13 January 2016. Retrieved 15 February 2015.
  5. ^ "Other drug laws". Home Office. Archived from the original on 19 April 2010.
  6. ^ "How Much is the NHS Prescription Charge?". NHS Choices. Archived from the original on 2 December 2020. Retrieved 15 June 2020.
  7. ^ "Staged end to prescription charge". BBC News. 5 December 2007. Archived from the original on 23 January 2009. Retrieved 10 March 2008.
  8. ^ "[NI] Prescription charges". NI Direct. Archived from the original on 29 August 2011. Retrieved 12 July 2011.
  9. ^ a b "NHS in England - help with health costs". nhs.uk. NHS. NHS Choices. Archived from the original on 27 July 2017. Retrieved 15 February 2017.
  10. ^ a b "Patients and prescribing: rights and responsibilities". British Medical Association. 23 March 2006. Archived from the original on 9 January 2009. Retrieved 18 April 2010.
  11. ^ a b "Information and guidance on prescribing in general practice" (PDF). British Medical Association. September 2004. Archived from the original (PDF) on 2012-06-07.
  12. ^ "Ipsos MORI:Prescription Costs A Barrier To Healthcare, 27 February 2008". Archived from the original on 5 March 2016. Retrieved 26 June 2014.
  13. ^ "Registration". DEA Diversion Control Division. 2017-07-14. Archived from the original on 2021-09-07. Retrieved 2021-09-14.
  14. ^ "US Nurse Practitioner Prescribing Law: A State-by-State Summary". Medscape Nurses. 2 November 2010. Archived from the original on 18 September 2017. Retrieved 26 November 2010.
  15. ^ Alexander, GC; O'Connor, AB; Stafford, RS (2011). "Enhancing prescription drug innovation and adoption". Annals of Internal Medicine. 154 (12): 833–837. doi:10.7326/0003-4819-154-12-201106210-00012. PMC 4049188. PMID 21690598.
  16. ^ "Prescription Drugs & Cold Medicines". www.drugabuse.gov. National Institute of Health. Archived from the original on 30 January 2018. Retrieved 12 September 2015.
  17. ^ Injury Facts. National Safety Council. 2017. p. 161. ISBN 978-0-87912-357-4.
  18. ^ National Safety Council (2017). The State of Safety - A State-by-State Report. Itasca, IL. Pg. 30-31. accessed at: http://www.nsc.org/NSCDocuments_Advocacy/State-of-Safety/State-Report.pdf Archived 2017-07-28 at the Wayback Machine
  19. ^ "Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance - Records and Reports". United States Food and Drug Administration. 8 February 2019. Archived from the original on 23 April 2019. Retrieved 16 December 2019.
  20. ^ "Expiration Dates Matter". United States Food and Drug Administration. 14 July 2015. Archived from the original on 29 June 2017. Retrieved 12 September 2015.
  21. ^ "Proceedings". Baylor Univ. Medical CTR. 13: 309.
  22. ^ Cohen, Laurie P. (2000-03-28). "Many Medicines Prove Potent for Years Past Their Expiration Dates". The Wall Street Journal. Vol. 235, no. 62. pp. A1.
  23. ^ "Report 1 of the Council on Scientific Affairs (A-01) Full text: Pharmaceutical Expiration Dates". American Medical Association. June 2001. Archived from the original on 2011-02-01. Retrieved 2010-04-19.
  24. ^ "Drug Expiration Dates — Do They Mean Anything?". Harvard Health. 2003-11-01. Retrieved 2024-09-01.
  25. ^ "Drug Expiration Dates - Are Expired Drugs Still Safe to Take?". Drugs.com. 20 July 2020. Archived from the original on 15 April 2021. Retrieved 28 July 2023.
  26. ^ Phil Galewitz (14 December 2022). "States challenge Biden to lower drug prices by allowing imports from Canada". CBS News. Archived from the original on 28 July 2023. Retrieved 28 July 2023.
  27. ^ a b Research, Center for Drug Evaluation and. "Questions & Answers - Generic Drugs: Questions & Answers". www.fda.gov. Archived from the original on 2019-04-23. Retrieved 2017-10-31.
  28. ^ a b "Generic Drugs". US Food and Drug Administration. 1 November 2021. Archived from the original on 28 July 2023. Retrieved 28 July 2023.
  29. ^ "Savings From Generic Drugs Purchased at Retail Pharmacies". US Food and Drug Administration. 6 May 2016. Archived from the original on 26 April 2019. Retrieved 28 July 2023.
  30. ^ "Cost Sharing Out of Pocket Costs". Medicaid.gov. Archived from the original on 25 November 2019. Retrieved 12 June 2018.
  31. ^ "Generic Drug Facts". FDA. Archived from the original on 23 April 2019. Retrieved 12 June 2018.
  32. ^ Jeff Donn; Martha Mendoza; Justin Pritchard (2008-03-10). "Drugs found in drinking water". USA Today. Associated Press. Archived from the original on 2008-03-13. Retrieved 2011-02-15.
  33. ^ Gray, Richard (2008-01-13). "Cancer drugs found in tap water". The Sunday Telegraph. Archived from the original on 2009-03-17. Retrieved 2010-01-19.
  34. ^ a b c Li, W. C. (2014-04-01). "Occurrence, sources, and fate of pharmaceuticals in aquatic environment and soil". Environmental Pollution. 187 (Supplement C): 193–201. Bibcode:2014EPoll.187..193L. doi:10.1016/j.envpol.2014.01.015. PMID 24521932.
  35. ^ Heberer, Thomas (2002-05-10). "Occurrence, fate, and removal of pharmaceutical residues in the aquatic environment: a review of recent research data". Toxicology Letters. 131 (1): 5–17. doi:10.1016/S0378-4274(02)00041-3. PMID 11988354.
  36. ^ Boxall, Alistair B.A. (December 2004). "The environmental side effects of medication". EMBO Reports. 5 (12): 1110–1116. doi:10.1038/sj.embor.7400307. ISSN 1469-221X. PMC 1299201. PMID 15577922.
  37. ^ a b Fabbri, Elena (March 2015). "Pharmaceuticals in the environment: expected and unexpected effects on aquatic fauna". Annals of the New York Academy of Sciences. 1340 (1): 20–28. Bibcode:2015NYASA1340...20F. doi:10.1111/nyas.12605. hdl:11585/556827. ISSN 1749-6632. PMID 25557669. S2CID 2567919.
  38. ^ "External Medicine: Discarded Drugs May Contaminate 40 Million Americans' Drinking Water". Scientific American. Archived from the original on 2021-04-15. Retrieved 2017-11-15.
  39. ^ a b Lubick, Naomi (May 2010). "Drugs in the Environment: Do Pharmaceutical Take-Back Programs Make a Difference?". Environmental Health Perspectives. 118 (5): A210–A214. doi:10.1289/ehp.118-a210. ISSN 0091-6765. PMC 2866706. PMID 20435558.
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