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The pharmacy operating regulations regulate the safe and high-quality supply of pharmaceuticals by pharmacies. This includes the manufacture, testing and storage of drugs, but also their dispensing and advice and information for patients.
On June 12, 2012, the fourth ordinance amending the pharmacy operating regulations (ApBetrO) came into force. The pharmacy operating regulations from 1987, which were valid up to this date, have only been changed slightly so far. An amendment to the ordinance had become necessary in order to adapt it to new developments and practical experience.
The main goals of the revision were to improve drug safety, especially in drug manufacture and in information and advice. Outdated and no longer justified regulations were abolished in order to reduce bureaucracy.
Major changes and innovations:
Like all pharmaceutical manufacturers or wholesalers, pharmacies must now operate a quality management system with which the operational processes, as far as pharmaceutical activities are concerned, are to be optimized. The focus is on the manufacture, testing and storage of drugs in the pharmacy, but also on advice.
The changes made essentially relate to specifications for drug production, in particular for prescription drugs to be manufactured individually for each patient, as well as for their documentation. A plausibility check must be carried out before the start of every formulation drug production, i. That is, a pharmaceutical assessment, especially whether the prescription for the formulation production is suitable to produce a drug with sufficient quality and stability. This regulation is linked to the expectation that the quality of these drugs will increase and z. B. no ineffective drugs are produced. With the mandatory documentation of every prescription drug production, the traceability of the actual drug production is made possible.
For the first time, the ordinance also contains detailed regulations for special and particularly critical drug production in pharmacies. This applies to the production of sterile infusion solutions or the individual patient blister packs.
The regulations for information and advice in pharmacies have been clarified. The pharmacies must z. B. ensure that confidentiality is better guaranteed when advising customers.
The previous detailed requirements with regard to the laboratory equipment of pharmacies and the scientific literature have been deleted. The specific equipment of the pharmacy is now left to the responsibility of the pharmacy manager.
Particularly noteworthy are the regulations on the changed inventory of narcotics in pharmacies. They represent an essential contribution to the improvement of outpatient palliative care and are to be seen in connection with the introduction of a narrowly limited exception regulation in the narcotics law, with which doctors are allowed to provide outpatient palliative care patients with narcotics directly on site in certain cases.
With the regulation that pharmacies should now generally have barrier-free access for patients, the concerns of disabled people are taken into account in particular.
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