Prescription drug

Regulation in Australia

In Australia the Standard for the Uniform Scheduling of Medicines and Poisons, abbreviated SUSMP, governs the manufacture and supply of drugs:

The categories defined by the SUSMP are:

Similar to the UK, the patient visits a health practitioner, such as a doctor, nurse, dentist, podiatrist, etc., who is able to 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 maximum price a consumer pays is the patient co-payment contribution, which, as of January 1, 2014, is A$36.90 for general patients. Those covered by government entitlements (low-income earners, welfare recipients, Health Care Card holders, etc.) and those covered under the Repatriation Pharmaceutical Benefits Scheme (RPBS) have a reduced co-payment, which is $6.00 in 2014. The table below indicates the changes in co-payments over the years. These co-payments are compulsory and cannot be discounted by pharmacies under any circumstances.

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

Regulation in United Kingdom

In the United Kingdom the Medicines Act 1968 and Prescription Only Medicines (Human Use) Order 1997 contain regulations that cover the supply of sale, use and production of medicines. Prescribing is also covered by this legislation. There are three categories of medicine:

Possession of prescription-only medicines without a prescription is not a criminal offence unless it falls under the Misuse of Drugs Act 1971.

A patient visits a medical practitioner or dentist authorised to 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 can prescribe all POMs but pharmacists are not allowed to prescribe schedule 1 controlled drugs. District nurses and health visitors have had limited prescribing rights since the mid-nineties, before which prescriptions for dressings and simple medicines would have had to have been signed by a doctor. Once issued, a prescription is taken by the patient to a pharmacy, which dispenses the medicine.

Most prescriptions in the UK are NHS prescriptions, subject to a standard charge unrelated to what is dispensed. The NHS prescription fee was increased to £8.40 per item in England on 1 April 2016; prescriptions are free of charge if prescribed and dispensed in Scotland, Wales or Northern Ireland, and for some patients in England, such as inpatients, children, over 60s, those 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 using a prescription payment certificate (informally a "season ticket"), effectively capping costs at £29.10 per month or £104.00 per year.

Outside the NHS, private prescriptions are issued by private medical practitioners, and sometimes under the NHS for medicines not covered by the NHS. 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 due to the cost, a figure which was the same as in 2001.

Regulation in the United States

In the United States, the Federal Food, Drug, and Cosmetic Act defines what substances require a prescription in order 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, an act for which they are issued unique Drug Enforcement Act (DEA) 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.

The Controlled Substances Act (CSA) was enacted into law by the Congress of the United States in 1970. The CSA is the federal U.S. drug law under which the manufacture, importation, possession, use and distribution of certain substances is regulated. The legislation created five schedules (classifications) with varying qualifications for a substance to be included in each.

The safety and effectiveness of prescription drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987. The Food and Drug Administration (FDA) is charged with implementing this 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 fifteen percent of older American adults are at risk of potential major drug-drug interactions.

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 conditions not necessarily requiring care from a healthcare professional and 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, whereas 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 is still available by prescription in doses up to four times the OTC dose for use in cases of severe pain not adequately controlled by the lower, 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; this is known as off-label use. Drug companies, however, are prohibited from marketing their drugs for off-label uses.

Large U.S. 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. 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.

A number of prescription drugs are commonly abused, including fentanyl (Duragesic), hydrocodone (Vicodin), oxycodone (OxyContin), oxymorphone (Opana), propoxyphene (Darvon), hydromorphone (Dilaudid), meperidine (Demerol), and diphenoxylate (Lomotil).

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 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.

The American Medical Association (AMA) 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 (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.

Cost

Prices for 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.

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.

Environment

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