Prescription drug

Last updated on 19 July 2017

A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed. 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.

"Rx" (℞) is often used as a short form for prescription drug in North America- 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. In the U.S., 88% of older adults (62–85 years) use at least 1 prescription drug, while 36% take at least 5 prescription medicines concurrently.[2]

Regulation

Australia

In Australia, the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) governs the manufacture and supply of drugs with several categories:[3]

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

Like in the UK, the patient visits a health practitioner, (doctor, nurse, dentist, podiatrist, etc.,), who may prescribe the 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, 2017, is A$38.80 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 $6.30 in 2017. The co-payments are compulsory and cannot be discounted by pharmacies under any circumstances.

Private prescriptions are issued for medicines that are not covered on the PBS or are used off-label, for indications other than those covered by the PBS. The patient pays the pharmacy for medicines that are privately prescribed.

United Kingdom

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 sold by a pharmacist if they are prescribed by a prescriber
  • 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 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, suitably-qualified and experienced nurses and pharmacists may be independent prescribers. Both may prescribe all POMs, but pharmacists may not prescribe Schedule 1 controlled drugs. 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 £8.60 per item in England on 1 April 2017;[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 £29.10 per quarter or £104.00 per 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] NHS supply beyond three months' worth is not covered and must be purchased privately. 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

In the United States, the Federal Food, Drug, and Cosmetic Act defines what substances require a prescription for them to be dispensed by a pharmacy. The federal government authorizes physicians, psychiatrists, physician assistants, nurse practitioners and other advanced practice nurses, veterinarians, dentists, and optometrists to prescribe any controlled substance. They are then issued unique Drug Enforcement Act numbers; many other mental and physical health technicians, including basic-level registered nurses, medical assistants, emergency medical technicians, most psychologists, and social workers, for example, do not have the authority to prescribe any controlled substance.[13]

The Controlled Substances Act (CSA) was enacted into law by the US Congress of the United States in 1970. It is the federal drug law that regulates manufacture, importation, possession, use, and distribution of certain substances. The legislation classes substances into five schedules, with varying qualifications for each schedule.

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.

Misuse or abuse of prescription drugs can lead to adverse drug events, including those due to dangerous drug interactions. According to one study, as many as 15% of older American adults are at risk of potential major interactions between drugs.[2]

The package insert for a prescription drug contains information about the intended effect of the drug and how it works in the body. It also contains information about side effects, how a patient should take the drug, and cautions for its use, including warnings about allergies.

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.[14]

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.[15]

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

Large US retailers that operate pharmacies and pharmacy chains use inexpensive generic drugs as a way to attract customers into stores. Several chains, including Walmart, Kroger (including subsidiaries such as Dillons), Target, and others, offer $4 monthly prescriptions on select generic drugs as a customer draw.[16] Publix Supermarkets, which has pharmacies in many of their stores, offers free prescriptions on a few older but still effective medications to their customers. The maximum supply is for 30 days.

Many 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).[17]

Prescription painkillers have been found to be extremely addictive, and unintentional poisoning deaths in the United States have skyrocketed since the 1990’s.[18] 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.[19]

Expiration date

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.[20] The FDA advises consumers not to use products after their expiration dates.[21]

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 85% of them were safe and effective as far as 15 years past their expiration date. Joel Davis, a former FDA expiration-date compliance chief, said that with a handful of exceptions—notably nitroglycerin, insulin, some liquid antibiotics; outdated tetracyclines can cause Fanconi syndrome—most expired drugs are probably effective.[22]

The American Medical Association (AMA) 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 (OTC) and dietary (herbal) 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

Prices for prescription drugs vary widely around the world.[26] Prescription costs for biosimilar and generic drugs are usually less than brand names, but the cost is different from one pharmacy to another.[27]

Prescription drug prices including generic prices are rising faster than the average rate of inflation. To subsidize prescription drug costs, some patients have decided to buy medicine online.[28]

Environment

Traces of prescription drugs — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been detected in drinking water.[29][30]

See also

References

  1. ^ Crane, Gregory R. "Perseus 4.0 (Perseus Hopper)". Perseus 4.0 (Perseus Hopper). Retrieved 19 January 2014.
  2. ^ a b Qato, Dima M.; Wilder, Jocelyn; Schumm, L. Philip; Gillet, Victoria; Alexander, G. Caleb (2016-04-01). "Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011". JAMA internal medicine. 176 (4): 473–482. ISSN 2168-6114. PMID 26998708. doi:10.1001/jamainternmed.2015.8581.
  3. ^ "The Poisons Standard (the SUSMP)". Therapeutic Goods Administration. Retrieved 17 September 2011.
  4. ^ "About Registration: Medicines and Prescribing". Health and Care Professions Council. Retrieved 15 February 2015.
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  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. 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
  13. ^ "US Nurse Practitioner Prescribing Law: A State-by-State Summary". Medscape Nurses. 2 November 2010. Retrieved 26 November 2010.
  14. ^ Alexander, GC; O'Connor, AB; Stafford, RS (2011). "Enhancing prescription drug innovation and adoption". Annals of Internal Medicine. 154 (12): 833–837. PMC 4049188Freely accessible. PMID 21690598. doi:10.7326/0003-4819-154-12-201106210-00012.
  15. ^ Strain, Jeffrey (2 February 2015). "Can I Use the Costco Pharmacy Without a Membership?". SavingAdvice.com. Archived from the original on 3 April 2016. Retrieved 28 May 2016.
  16. ^ "$4 Generic Prescription Drugs". HealthHarbor. Archived from the original on 10 February 2010. Retrieved 19 January 2010.
  17. ^ "Prescription Drugs & Cold Medicines". www.drugabuse.gov. National Institute of Health. Retrieved 12 September 2015.
  18. ^ Injury Facts. National Safety Council. 2017. p. 161. ISBN 978-0-87912-357-4.
  19. ^ 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
  20. ^ "Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance - Records and Reports". United States Food and Drug Administration.
  21. ^ "Expiration Dates Matter". United States Food and Drug Administration. 14 July 2015. Retrieved 12 September 2015.
  22. ^ Cohen, Laurie P. (2000-03-28). "Many Medicines Prove Potent for Years Past Their Expiration Dates". The Wall Street Journal. 235 (62). pp. A1.
  23. ^ "Report 1 of the Council on Scientific Affairs (A-01) Full text: Pharmaceutical Expiration Dates". American Medical Association. June 2001.
  24. ^ Drug Expiration Dates - Do They Mean Anything?. Harvard Health Publications. Retrieved on February 15, 2011.
  25. ^ "Drug Expiration Dates - Are They Still Safe to Take?". drugs.com. 10 February 2014. Retrieved 12 September 2015.
  26. ^ [1]. Frontline. Posted April 15, 2008.
  27. ^ [2]. University of Minnesota. March 29, 2013.
  28. ^ [3]
  29. ^ 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.
  30. ^ Gray, Richard (2008-01-13). "Cancer drugs found in tap water". The Sunday Telegraph. Retrieved 2010-01-19.

Further reading

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