Drug delivery

from Wikipedia, the free encyclopedia

Medication delivery is the sale or other delivery of medication to others.

Germany

Under German law, the dispensing of medication is the sale or other dispensing of medication so designated by law to others. The sale is a sub-case of placing on the market ( Section 4 (17 ) AMG ). The dispensing of pharmaceuticals is regulated in pharmaceutical law, in particular in §§ 43 ff. Medicines Act (AMG). The key points are the pharmacy and prescription requirements ( § 43 , § 48 AMG).

Sold by companies and wholesalers

The dispensing of pharmaceuticals by pharmaceutical companies and wholesalers is regulated in Section 47 AMG. The group of possible recipients is limited to doctors, hospitals, health authorities, scientific research institutions and universities in Section 47 (1) No. 1–9 AMG, along with other pharmaceutical companies and wholesalers and pharmacies.

Pharmaceutical companies may only give free drug samples for the purpose of information and testing to doctors and training centers, but not to pharmacies according to the final regulation in Section 47 (3) AMG.

The Medicines Trade Ordinance determines more details about the internal operational processes. The requirements are further specified in the EU guidelines for good sales practice for medicinal products .

Delivery in pharmacies

The pharmacies are responsible for the proper supply of medicines to the population ( Section 1 (1) ApoG ). To this end, the pharmaceutical companies and wholesalers must ensure that the pharmacies are supplied continuously and in line with their needs ( Section 52b AMG). The pharmacy operating regulations (ApBetrO) oblige the pharmacies to always have certain drugs available ( § 15 ApBetrO).

Since December 2016, a drug may not be dispensed if it is clear to the pharmacist that a prescription has been made without direct contact with the doctor, for example via an Internet portal ( Section 48 (1) AMG new version). This is intended to comprehensively achieve the protective purpose of the prescription requirement and to supplement the sub-statutory regulations for doctors that are already in force with corresponding specifications for the dispensing of drugs by pharmacists.

Medicines that are intended by the pharmaceutical company exclusively for purposes other than the elimination or alleviation of illnesses, ailments, bodily harm or pathological complaints are not subject to pharmacy obligations. You may acc. Section 44 (1) and (2) AMG can also be dispensed outside of pharmacies, unless they require a prescription or are excluded from circulation outside pharmacies by virtue of a statutory ordinance ( Section 44 (3) AMG). This applies to individual medicinal products which, if used as intended or in a habitual manner, may pose a direct or indirect risk to human or animal health (Section 46 AMG). The pharmaceuticals listed in Sections 7 to 10 of the Ordinance on Pharmacy-Only and Over-the-Counter Drugs, which contain , for example, active ingredients with antibiotic , blood-coagulation-retarding , histamine-resistant , hormone-like or autonomic nervous system properties, are included in the pharmacy obligation by ordinance .

The classification as prescription-only or not serves to implement the EU community code for human medicinal products , which otherwise does not make any specifications with regard to the distribution channel.

Delivery outside of pharmacies

The drugs mentioned in Sections 1 to 6 of the Ordinance on Pharmacy-Only and Over-the-Counter Medicines are approved for use outside pharmacies, for example colds or laxatives . These drugs can also be bought in drugstores, health food stores, discounters or traditional food retailers. The self-service ban from § 17 Paragraph 3 ApBetrO does not apply. However, their trade requires a special certificate of competence and is monitored by the authorities ( § 50 , § 64 ff. AMG).

In 2015, pharmacies and mail order business accounted for more than half of sales (58%) . Over-the-counter drugs account for around 6% of total pharmacy sales.

Only the professional or commercial dispensing of pharmaceuticals that are only available in pharmacies or that have been prescribed by a doctor to end consumers outside of pharmacies is subject to criminal liability according to Section 95 (1) No. 4 and Section 43 (3) sentence 1 AMG.

Delivery by mail order

Since 2004, the mailing of pharmacy-only drugs with official permission has been permitted in Germany .

Delivery of narcotics

The traffic with narcotics is also subject to the special provisions of the narcotics law ( § 12 BtMG , § 12 BtMVV ). The prescription is based on a special narcotic drug prescription , the dispensing is monitored by the Federal Opium Agency .

Dispensing of veterinary drugs

The dispensing of veterinary medicines is done by veterinarians , a veterinary medicine cabinet lead, due to the Dispensierrechts or pharmacist for prescription drugs because of a veterinary prescription.

Austria

Section 2 (11) and (15) of the Austrian Medicines Act (AMG) define the dispensing of medicinal products or active ingredients as a subcategory of placing on the market. With the dispensing, the drug reaches consumers or users who purchase it for their own use. The dispensing generally requires the official approval of the drug by the Federal Office for Safety in Health Care (BASG) (Section 7 AMG).

The dispensing of drugs by manufacturers, wholesalers and pharmacies is in VI. Section of the AMG (Sections 57 to 61 AMG).

Section 59 (1) AMG contains the pharmacy reservation that, unlike in Germany, applies to both prescription and non-prescription drugs ( OTC drugs ). A regulatory review application by a drugstore chain directed against this provision was unsuccessful in 2017 for formal reasons.

With the referendum "SOS Medicine", the Lower Austrian Medical Association also advocated direct sales of medicines by doctors. The Austrian Chamber of Pharmacists feared that this system change would lead to a considerable increase in costs.

Distribution by pharmacies is regulated in the pharmacy operating regulations, distribution outside pharmacies requires regulation by ordinance of the Federal Minister of Health (§ 62 AMG) and approval from the BASG (§ 63 AMG).

The illegal dispensing of drugs is acc. Section 83 (1) no. 5 AMG is punishable by a fine as an administrative offense. The drug counterfeiting is a criminal offense (§ 82b AMG).

Switzerland

The dispensing of medication has always been part of the medical profession. Every doctor's practice is therefore equipped with a drug store and drugs for direct use in the practice and for emergency dispensing (so-called self-dispensation , abbreviated to SD ).

The Swiss health care system also allows in Art. 37 Para. 3 KVG to equate the doctors running a pharmacy with the licensed pharmacists through cantonal regulations. The legal situation in the cantons is very different: In 14 cantons, mainly in the German-speaking part of Switzerland (AI, AR, BL, GL, LU, NW, OW, SG, SO, SZ, TG, UR, ZG, ZH), doctors are allowed to sell drugs to their patients. The cantons of Basel-Landschaft and Appenzell Ausserrhoden had the highest density in 2016 .

More than a third of the practicing resident physicians from all disciplines in Switzerland have a patient pharmacy. About 24% of the medicines dispensed in Switzerland are sold by doctors in home pharmacies, 53% in pharmacies.

The individual drugs are divided into dispensing categories. These determine whether a drug requires a prescription.

literature

Individual evidence

  1. ↑ Kloesel, Cyran: Pharmaceutical Law , § 47 Note 52; Miller, in: Kügel, Müller, Hofmann: AMG , 2012, § 47 Rn. 65
  2. ↑ Hanseatisches Oberlandesgericht Hamburg, order of February 10, 2015, 3 U 16/13
  3. ↑ Hermann-Josef Omsels: § 47 AMG drug sample online commentary on the UWG, accessed on March 28, 2018
  4. ^ Text of the drug trade regulation
  5. ↑ Helga Blasius: From the manufacturer to the patient. Distribution of pharmaceuticals and distribution demarcation Deutsche Apotheker-Zeitung , 2014
  6. ↑ Fourth law amending pharmaceutical law and other provisions of December 20, 2016 , Federal Law Gazette I p. 3048
  7. ^ Draft law of the federal government of a fourth law to change pharmaceutical law and other regulations BR-Drs. 120/16 of March 11, 2016, pp. 42/43
  8. ↑ Art. 70-75 of Directive 2001/83 / EC of the European Parliament and of the Council of 6 November 2001 on the creation of a Community code for medicinal products for human use (PDF) OJ. L 311 of November 28, 2001, p. 67
  9. ↑ Helga Blasius: From the manufacturer to the patient. Distribution of pharmaceuticals and distribution demarcation Deutsche Apotheker-Zeitung , 2014
  10. ↑ BVerwG, judgment of October 18, 2012 - 3 C November 25
  11. ↑ cf. for example retail sales of pharmaceuticals outside of pharmacies. Announcement of the Bavarian State Ministry for Labor and Social Affairs, Family, Women and Health dated August 11, 1997 Az .: VII 6 / 8622-9 / 4/97
  12. ^ The pharmaceutical market in Germany. Facts and figures Federal Association of Drug Manufacturers , editorial deadline: April 2016, p. 21
  13. ↑ Claudia Korf, Eckart Bauer: Apothekenwirtschaftsbericht 2017 p. 31
  14. ↑ Unauthorized delivery of drugs rechtslupe.de to Stuttgart Higher Regional Court, decision of 18 January 2012 - Az. 4 Ss 664/11 , 8 February 2012
  15. ↑ Federal Ministry of Food and Agriculture : Veterinary Medicines: Dispensing, Application and Mail Order Website accessed on April 5, 2018
  16. ↑ Federal Act of March 2, 1983 on the Production and Marketing of Medicinal Products (Medicines Act - AMG) Federal Law Gazette No. 185/1983. RIS , accessed April 6, 2018
  17. ^ Decision of the Constitutional Court of 25 September 2017 - G 8 / 2017-11, G 10-11 / 2017-11, V 6-8 / 2017-11
  18. ↑ Christine Ahlheim: Austria: drugstore chain fights for OTC deregulation Deutsche Apothekerzeitung , January 18, 2018
  19. ↑ Direct dispensing of medication by doctors in individual cases has many advantages Website sos-medizin.at, accessed on April 7, 2018
  20. ↑ Referendum "SOS Medicine": First hurdle passed. Preliminary result of the introductory procedure: 26,811 declarations of support Website of the Medical Association for Lower Austria, March 8, 2017
  21. ↑ A doctor must remain a doctor and a pharmacist must remain a pharmacist! Patients don't need a dispute between the health professions Press release of the Austrian Chamber of Pharmacists , March 15, 2014
  22. ↑ Ordinance of the Federal Minister for Health and Women on the operation of pharmacies and medical and veterinary house pharmacies (Apothekenbetriebsordnung 2005 - ABO 2005) BGBl. II No. 65/2005. RIS , accessed April 6, 2018
  23. ↑ Thomas Bergmair: Self- dispensation in Switzerland Journal for Health Policy 2016, pp. 99–115, 105
  24. ↑ Position paper on medical drug dispensing (self-dispensation) FMH , February 27, 2012
  25. ↑ Different densities of SD doctors and pharmacies in the cantons Interpharma website , accessed on April 9, 2018
  26. ↑ Thomas Bergmair: Self- dispensation in Switzerland Journal for Health Policy 2016, pp. 99–115, 106
  27. ↑ Dispensing of pharmaceuticals ( Memento of the original from April 9, 2018 in the Internet Archive ) Info: The archive link has been inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. Website of the Federal Office of Public Health , December 2, 2016 @1@ 2Template: Webachiv / IABot / www.bag.admin.ch