Australia In
Australia, the
Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) governs the manufacture and supply of drugs with several categories: • 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. 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 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: • 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. 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; prescriptions are free of charge if prescribed and dispensed in
Scotland,
Wales and
Northern Ireland, and for some patients in England, such as inpatients, children, those over 60s or with certain medical conditions, and claimants of certain benefits. The pharmacy charges the NHS the actual cost of the medicine, which may vary from a few pence to hundreds of pounds. 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.
United States 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. 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. 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. 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. 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. 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). 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. 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.
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. The FDA advises consumers not to use products after their expiration dates. 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. 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. The
American Medical Association issued a report and statement on Pharmaceutical Expiration Dates. 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". 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. ==Cost==