Prescription requirement

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Symbol for prescription drugs (also written Rx , from Latin recipe )

The prescription requirement (Germany, Switzerland and South Tyrol ) or prescription requirement (Austria, colloquially also in Germany and Switzerland) is a sales demarcation for drugs and medical products and is one of the routine measures of pharmacovigilance .

Prescription drugs may only be dispensed on presentation of a medical, dental or veterinary prescription. This is to protect patients from excessive side effects from drug use. In the case of new drugs in particular, the side effects are usually not yet fully known; rare side effects of a drug can only be recognized through wide use. The misuse of drugs should also be prevented.

Medicines that can be dispensed without a prescription are colloquially referred to as prescription-free (see OTC medicinal products ).

Germany

Medicines that contain certain medicinal substances in accordance with the Medicinal Prescription Ordinance (AMVV) and medicinal products for animals that are used for food production may only be dispensed on presentation of a medical, dental or veterinary prescription ( prescription ). The legal basis for this is the provision of Section 48 of the German Medicines Act (AMG), which regulates market behavior . The dispensing of prescription drugs without a prescription can also constitute a breach of competition law. § 4 UWG old version.

The dispensing takes place through pharmacies ( pharmacy monopoly ) , apart from appropriately regulated exceptions . In the Federal Institute for Drugs and Medical Devices (BfArM), an expert committee on prescription requirements meets twice a year . It makes recommendations on applications for discharge from or subject to prescription requirements ( switch / re-switch ).

In Germany, prescription drugs are marked on the packaging with the words Prescription Required. Since March 2020 it has been possible to prescribe multiple prescriptions (up to four times within a year), but is not yet practiced.

Since January 1, 2004, the prescription requirement is largely identical to the reimbursement of drugs by the statutory health insurance. Exceptions to this are the drugs listed in the OTC overview of the Federal Joint Committee (G-BA).

The Medical Devices Dispensing Ordinance ( Ordinance on the Regulation of the Dispensing of Medical Devices, MPAV ) contains the medical devices that may only be dispensed on prescription.

The abbreviation RxVV stands for the mail order ban on prescription drugs. A RxVV is required by part of the German pharmacy community, which is directed against the consequences of the ECJ ruling of October 2016. It ruled that fixed prices for prescription drugs did not apply to foreign senders. This is seen as an inequality of competition between the domestic owner-managed pharmacies and foreign mail order companies, which corporations can also support.

Various prescription forms are used in Germany to prescribe prescription drugs, depending on reimbursement ( private / statutory health insurance ) and whether the prescription drugs may require official forms ( narcotic prescription, T-prescription).

Austria

The Austrian Prescription Law stipulates that all medicinal products which can endanger the life or health of humans or animals even when used as intended, are subject to a prescription requirement if they are used without medical or veterinary supervision. This means that the prescription requirement in Austria is handled rather strictly; All drugs that could have dangerous side effects or interactions in the rarest of cases are subject to prescription. In practice, this affects more than 80% of the drugs intended for humans, so that in Austria the proportion of self-medication is rather low. However, in justified cases, the pharmacist can exceptionally dispense a prescription drug using his own expertise. Section 4 (5) of the Prescription Duty Act reads: In special emergencies, the pharmacist is entitled to dispense medicinal products even without a prescription being available; but only in the smallest commercially available package.

Switzerland

Medicines in dispensing categories A and B require a prescription . In category B, it is also possible to dispense the prescribed medication more than once, provided this has been noted on the prescription by the doctor. The prescription requirement is determined by Swissmedic .

France

In France , drugs that can only be dispensed on prescription ( French prescription obligatoire ) are summarized in lists I and II. List I drugs may only be dispensed once, unless the doctor has expressly stated how often the drug may be dispensed to the same person on the same prescription. Some drugs on List I may be subject to further restrictions. You are e.g. B. only approved for use by hospital staff or only for first-time administration in the hospital. There are also drugs according to List I that are only approved for use by certain specialists or under special supervision.

Medicines according to List II may be given to the same recipient several times within a maximum of 12 months, but only in the usual amount that is necessary for a monthly treatment.

Medicines that contain narcotics may only be prescribed on a special, numbered, forgery-proof prescription. This must also indicate the maximum duration of treatment with 7, 14 or 28 days.

See also

Wiktionary: requires a prescription  - explanations of meanings, word origins, synonyms, translations
Wiktionary: subject to prescription  - explanations of meanings, word origins, synonyms, translations

Web links

Individual evidence

  1. ^ § 4 UWG old version (old version) in the version valid before December 10, 2015. buzer.de, accessed on April 5, 2018
  2. Thomas J. Dieckmann: BGH: Selling prescription drugs without a prescription constitutes a competition violation on January 8, 2015
  3. BGH, judgment of January 8, 2015 - I ZR 123/13
  4. ^ Switch website of the Federal Association of Drug Manufacturers , accessed on March 29, 2018
  5. European Commission : A Guideline on Changing the Classification for the Supply of a Medical Product for Human Use "Switch-Guideline", 2006 (English)
  6. DAV: Repeat prescriptions are not billable , Deutsche Apothekerzeitung, March 3, 2020.
  7. Glossary - terms and abbreviations from the pharmaceutical sector, www.pts.eu, accessed on July 29, 2020.
  8. C. Müller: "This competition must be fair" , Pharmazeutische Zeitung, January 17, 2020.
  9. L'ordonnance et les règles de prescription des médicaments
  10. ^ Les médicaments à prescription obligatoire