Medicines Commission

from Wikipedia, the free encyclopedia

A drug commission is a body made up of experts that makes recommendations on the use of drugs . In Germany, the drug commissions of the chambers of the medical professions play an important role in pharmacovigilance , among other things , while in Switzerland the Federal Drugs Commission assesses which drugs are on the list of specialties of the drugs that are reimbursable by the health insurers .

In addition, there are often drug commissions in hospitals that determine which drugs should be kept in the clinic by the hospital pharmacy and routinely prescribed by doctors. You can authorize the use of purchased drugs in clinical trials.

Germany

Drugs Commission of the German Medical Association (AkdÄ)

History
The Drug Commission of the German Medical Association (AkdÄ) is a scientific expert committee since 1952 the German Medical Association , but the historical roots date back to the 1911th

Tasks
According to the statute, the "task of the Medicines Commission is to advise the German Medical Association independently on scientific questions relating to the pharmaceutical sector". Drug monitoring (pharmacovigilance) plays a major role in the work of the AkdÄ. The AkdÄ records information from doctors about adverse drug effects of drugs; According to the professional regulations of doctors, they are obliged to report adverse drug reactions to the AkdÄ. The AkdÄ forwards the reports to the competent federal authority in accordance with Section 62 AMG . This then takes the measures required by the step- by- step plan procedure.

Publications
The AkdÄ is the publisher of the drug regulations . In addition to therapy recommendations for various diseases, the AkdÄ also publishes the medication ordinance in practice , which is now published six times a year, and, in cooperation with the National Association of Statutory Health Insurance Physicians, the information sheet for active ingredients on mostly newly introduced drugs .

Board of Directors
Chairman is the Berlin internist, hematologist and oncologist Wolf-Dieter Ludwig, who has held this position since 2007. Deputy: the resident specialist for general medicine Wilhelm Niebling (Titisee-Neustadt). Other members of the board of the AkdÄ: the gastroenterologist Daniel Grandt (Saarbrücken), the clinical pharmacologist Bernd Mühlbauer (Bremen) and (new since December 2015) Ms. Martina Pitzer, specialist in child and adolescent psychiatry and psychotherapy (Karlsruhe).

Drug Commission of the German Pharmacists (AMK)

History
The Drugs Commission of German Pharmacists (AMK) was founded in 1975 as a scientific committee of the ABDA - Federal Association of German Pharmacists' Associations against the background of the impending adoption of the Drugs Act (AMG) of 1976.

Tasks
As a permanent expert committee of the ABDA, the AMK mainly deals with questions of the safety of pharmaceuticals (pharmacovigilance) and primarily performs the tasks for the pharmacists that are specified in the AMG in § 53 (hearing of experts) and in §§ 62 / 63 (pharmacovigilance, step-by-step plan). In the "General Administrative Regulations for the Monitoring, Collection and Evaluation of Drug Risks" (step-by-step plan) according to § 63 AMG, the measures according to danger levels and the cooperation of the responsible authorities and other bodies involved, including the AMK, are regulated.

The AMK also works on subject-specific, medical-pharmacological and toxicological topics from the field of pharmacotherapy. A network of reference pharmacies is available to the AMK for selected questions on drug risks and drug-related problems. The AMK asks the reference pharmacies to provide information on pharmacovigilance and drug therapy safety issues by means of a survey.

Reporting channels for pharmacies
All pharmacists are obliged by the professional regulations of the regional chambers of pharmacies to report drug risks to the AMK immediately. Two forms are available for reporting to the AMK. Regardless of this, pharmacies are obliged to inform their competent authority according to the pharmacy operating regulations (§ 21 ApBetrO) if the assumption is justified that there are quality defects caused by the manufacturer in the case of drugs or raw materials.

Suspicious reports of quality defects from pharmacies to the AMK, which were allegedly caused by the manufacturer or where a risk to patients cannot be ruled out, will be communicated by the AMK to the pharmaceutical company concerned and the responsible supervisory authority of the pharmaceutical company. Reports of side effects (including suspected cases) are immediately forwarded by the AMK to the respective competent higher federal authority (BfArM or PEI) as well as to the pharmaceutical company concerned after receipt and internal assessment.

The competent supervisory authority in the federal states or the higher federal authority then orders the necessary measures. The AMK informs the pharmacies about current problems of drug safety (pharmacovigilance) and risk-minimizing measures (recalls, batch recalls, batch reviews of drugs and medical devices) of the pharmaceutical companies, the competent national authorities as well as the European Medicines Agency (EMA) and the EU Commission .

Publications
The AMK publishes weekly notifications about the risks of drugs and pharmacy-only medical devices as well as measures to minimize risk (e.g. recalls, batch recalls, batch reviews) in the Pharmazeutische Zeitung and Deutsche Apotheker Zeitung as well as on the AMK website.

For particularly urgent reports on drug risks that are associated with an acute hazard potential and are of public interest, a rapid information system is used that the AMK and the PHAGRO-Bundesverband des Pharma Großhandels e. V. has agreed. With AMK-PHAGRO quick information, all public pharmacies and hospital pharmacies in Germany can be informed within a very short time. AMK-PHAGRO quick information is triggered and coordinated by the AMK.

The AMK publishes recommendations for assessing the questionability of prescription drugs in pharmacies and has periodically updated a list of substances / prescription drugs since 2001. However, this list is not a legally binding determination; because the AMK lacks the legal legitimation for this.

The AMK continues to publish its own recommendations for improving drug therapy safety (AMTS) as well as statements from specialist societies.

Chairman and members of the AMK
The specialist pharmacologist DGPT and specialist pharmacist for drug information Martin Schulz (born 1959) has been chairman of the Drugs Commission of German Pharmacists (AMK) since 2009. The other honorary members of the AMK are experts from the fields of public pharmacy, hospital pharmacy, university (subject areas pharmacology, toxicology, clinical pharmacy, clinical pharmacology, medicine, pharmaceutical technology / biopharmacy, pharmaceutical analysis, pharmaceutical / medicinal chemistry, pharmaceutical biology) and military pharmacy . The members of the AMK support the activities of the office of the AMK, a department of the pharmaceuticals division of the ABDA. The members and the chairman of the AMK are appointed for a period of four years by the executive board of the ABDA.

Austria

According to the law, the Medicines Commission has the following tasks in particular: Creation of a list of medicinal products that are used in the hospital (medicinal product list) and their adaptation. furthermore, the development of guidelines on the procurement and handling of pharmaceuticals. The sponsors of hospitals must ensure that the Medicines Commission takes into account the decisions of the Federal Target Control Commission in matters of the joint Medicines Commission in accordance with Section 13 (2) of the Federal Act on Health Partnership Target Control and in particular the following principles in fulfilling its task. Only the health of the nurses is decisive for the use of the medication. The selection and application of the drugs may only be based on the principles and recognized methods of medical and pharmaceutical science.

When working out guidelines on procurement and handling, the expediency and economic efficiency must also be taken into account, in particular that the most economically advantageous drug is selected from several therapeutically equivalent drugs; if necessary, instead of prescribing drugs at all others, e.g. B. therapeutically equivalent measures that would be more appropriate and economical are taken; When prescribing drugs for the supply after the discharge of several therapeutically equivalent drugs, the economically most favorable one in the case of a paid purchase and, if medically justifiable, the reimbursement code issued by the Main Association of Austrian Social Insurance Institutions and the guidelines contained therein for the economic prescription are taken into account . The state legislation has to oblige the carriers of hospitals to ensure that the drugs contained in the drug list are used in the hospital and that, in the event of a deviation from the drug list, the medical necessity of this deviation is subsequently brought to the attention of the drug commission is justified. The provincial legislation must ensure that the Medicines Commission has a representative from the social security system and that the rules of procedure of the Medicines Commission stipulate that the procedure according to Paragraph 4 No. 3 is to be coordinated with this representative. In addition, the provincial legislation can issue further regulations on the Medicines Commission, in particular its composition, on the rules of procedure, the convening of the Commission, the conduct of negotiations and any control tasks to be carried out by the Commission. The Medicines Commission has to give itself rules of procedure. Furthermore, the state legislation has to ensure that the members of the drug commissions are not subject to any instructions in the exercise of their duties.

Switzerland

The Federal Medicines Commission (EAK) advises the Federal Office of Public Health on the preparation of the list of specialties, a positive list for medicinal products . According to Art. 37e of the Ordinance on Health Insurance, the commission is made up of representatives of the authorities and cantons, the insured, doctors, pharmacists and hospitals, the medical and pharmaceutical faculties and the pharmaceutical industry and is appointed by the Federal Council. In addition to the EAK, there are individual drug commissions at hospitals.

Web links

Individual evidence

  1. ↑ Key data on the historical development on the AkdÄ website
  2. ↑ Drug prescriptions
  3. ↑ Therapy recommendations of the AkdÄ
  4. ↑ Drug Ordinance in Practice (AVP). AkdÄ, accessed April 24, 2019 .
  5. ↑ Active ingredient currently. KBV, AkdÄ, retrieved on June 23, 2010 : "Active ingredient CURRENT is created within the scope of § 73 Par. 8 SGB ​​V by the National Association of Statutory Health Insurance Physicians (KBV) in cooperation with the Drugs Commission of the German Medical Association (AkdÄ)"
  6. ↑ Newly elected board of the Drugs Commission of the German Medical Association (PDF; 38 kB), AkdÄ press release of December 7, 2015, accessed on December 8, 2015
  7. ↑ General administrative regulation for the observation, collection and evaluation of drug risks (step-by-step plan) according to § 63 of the Medicines Act (AMG). Retrieved April 12, 2017
  8. ↑ For more drug safety - AMK information flyer (as of February 2017) ( Memento of the original from April 13, 2017 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. @1@ 2Template: Webachiv / IABot / www.abda.de
  9. ↑ Rules of Procedure of the AMK from June 24, 2014
  10. ^ Pharmaceutical newspaper. Drug Commission: Making drug therapy safer. (PZ No. 47/2010)
  11. ↑ Benzodiazepines and Z-Hypnotics: AMK survey on abuse (PZ No. 20/2013)
  12. ↑ AMK survey: risk of confusion between drugs (PZ No. 19/2016)
  13. ↑ 13. The AMK in numbers: The year 2016
  14. ↑ Report sheet forms of the Drugs Commission of German Pharmacists (AMK)
  15. ↑ News from the Drugs Commission of German Pharmacists (AMK)
  16. ↑ Questionable prescription drugs (AMK, as of May 2015)
  17. ↑ Martin Schulz on the website of the University of Frankfurt
  18. ↑ ABDA appoints chairmen and members of the Drugs Commission of German Pharmacists (AMK) (ABDA press release of March 8, 2017)
  19. ↑ ABDA appoints chairmen and members of the Drugs Commission of German Pharmacists (AMK) (ABDA press release of March 8, 2017)