General practitioners and laboratories criticize the planned pharmaceutical reform

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Written By Kampretz Bianca

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Berlin – The Federal Ministry of Health (BMG) the planned pharmaceutical reform not only encounters massive resistance from pharmacists, but also clear criticism from the German Association of General Practitioners (HÄV), as well as accredited medical laboratories (ALM).

The pharmaceutical reform bill (ApoRG), which German medical journal In addition to many regulatory innovations and fee changes, it also provides for granting pharmacies the right to carry out a range of vaccinations and tests.

By adapting Section 20c of the Infection Protection Act (IfSG), pharmacists should be authorized to carry out vaccinations with inactivated vaccines, i.e. those without pathogens capable of replication.

Furthermore, with an amendment to Article 24 of the IfSG, the doctor’s reservation contained therein when carrying out patient-oriented rapid tests in pharmacies should be lifted. An adjustment to the Medicines Advertising Act (HWG) is also expected to expand advertising of in vitro diagnostics for personal use and allow pharmacies outside specialist circles to advertise tests.

“The fact that pharmacies can offer all possible vaccines in the future – from tetanus vaccination to TBE vaccination – is a dead end and will not lead to an increase in vaccination rates”, criticizes the federal president of the Association of General Practitioners, Nicola Buhlinger-Göpfarth and Mark Beier.

The very small number of vaccinations against coronavirus and flu that have been carried out in pharmacies in recent years, despite massive publicity, would show that this calculation does not add up. “Instead of drawing the correct conclusions from these facts, the legislator now plans to massively expand the range of vaccines available in pharmacies”, explain Buhlinger-Göpfarth and Beier.

There is no shortage of vaccination offers in practices. The problem is that there are often no clear responsibilities, which is why the association has always advocated a closer aggregation of vaccines in general practitioner practices. This can ensure that someone has an overview of required or missing vaccines.

Figures for family doctor-centered care (HZV) would show that this aggregation of responsibilities works. According to health insurance surveys, vaccination rates in HZV are ten percent higher than in standard care.

Instead of the planned new regulations, the association suggests greater use of pharmacies’ advisory skills and the establishment of a fixed process through which vaccination gaps can also be identified by pharmacies in order to direct affected people to practices in a structured way. “This would be a much more effective approach and, at the same time, would reduce the administrative effort for pharmacies”, emphasize Buhlinger-Göpfarth and Beier.

Accredited laboratories, in turn, oppose plans to increase testing authority. In the future, they will be authorized to offer the use of patient-based rapid in vitro diagnostic tests (POCT) for the detection of adenovirus, influenza virus, norovirus, RSV and rotavirus.

“According to the minister, should patients go to the pharmacy with stool samples, which will then carry out rapid tests on the liquid stool and then also carry out the PCR? Should pharmacies also be allowed to advertise this? “You can’t seriously want this”, criticizes ALM president Michael Müller.

Not only are the rapid tests available today not suitable for making a diagnosis due to their insufficient diagnostic sensitivity, i.e. sensitivity. On the contrary, the indication for diagnosis must be made by a doctor. There are good reasons to forego diagnosis in individual cases.

Furthermore, it is necessary to record and assess the risk of infectious disease outbreaks. “These are things that cannot be done in a pharmacy,” says Müller. The pharmacist also cannot provide medical advice and clinical examinations, which are always part of the indication for laboratory tests.

“Pharmacies are not laboratories; In vitro laboratory diagnosis to detect infectious diseases is in the hands of doctors”, emphasizes Müller. “An expansion of the physician requirement to diagnose infectious diseases must therefore be rejected in the interest of providing the best possible quality of care.”

The two associations are not alone in rejecting the project. For other reasons, the Federal Association of Pharmacists’ Associations (FROM THERE) strictly against the project. The bill proposes to increase packaging-related surcharges for emergency services compensation by about 30 percent, from 21 cents to 28 cents per package of prescription medication.

In the future, around 50 million additional euros would be available to pay for the emergency services provided. For each complete emergency service provided, a pharmacy would then receive a flat fee of around 550 euros. Furthermore, the pharmacy’s remuneration percentage will be gradually reduced from three to two percent, but the funds released as a result will at the same time flow towards an increase in the fixed salary.

“In this way, the uneven distribution of package fees between pharmacies due to sharp increases in drug prices in some drug segments will be balanced, while coverage of price-related costs will continue to be maintained,” the project says. This change will particularly strengthen primary care pharmacies in the area.

From 2027 onwards, the value of the fixed salary must then be defined by agreement. To date, the remuneration of pharmacies regulated in the Medicines Price Ordinance has been readjusted through the ordinance amendment procedure. With effect from January 1, 2027, pharmacists’ associations must then begin with the National Association of Statutory Health Insurance Funds negotiate a new fixed rate.

However, ABDA’s criticisms relate to the second pillar of the law, namely the structural adjustments to the requirements for opening and operating pharmacies. Among other things, they provide for more flexible opening hours, as well as easier establishment of pharmacy branches and greater flexibility in establishing pharmacy branches.

In particular, it should be possible for pharmacies to open differently than before if no licensed pharmacist is present. The presence of experienced pharmaceutical technical assistants (PTA) is then sufficient, as long as telepharmaceutical connection to pharmacists in the branch network is ensured and that the pharmacy management is personally present for at least eight hours per week.

“This is a serious breach of taboo”, criticizes the president of ABDA, Gabriele Regina Overwiening. “Establishments without pharmacists are not pharmacies. It doesn’t help if a pharmacist spends a few hours a week.”

These would be “lower-level dispensing points” that would trivialize and devalue care and create unacceptable risks for patients.

Remuneration will also be restructured, “but it is unlikely that more money will enter the system of supplying medicines through local pharmacies, which has been underfunded for years”, explained Overwiening. “There is a lack of any quick support here.” The project is not, therefore, a greater development of pharmaceutical work in local pharmacies, “but it amounts to a Trojan horse”. © lau/aerzteblatt.de

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