Obligation to QMS pragmatically solved

The revised Therapeutic Products Act has been in force in Switzerland since 1 January 2020. The topic of "pecuniary advantages in the healthcare sector" was the subject of most discussion in the run-up: in the past, doctors were allegedly too often persuaded by the pharmaceutical industry to give preference to certain medicines to patients by means of a wide variety of incentives. The new legal regulations now ensure that financial incentives no longer influence the prescription of medicines. Another important element of the revised Therapeutic Products Act is transparency. For example, discounts or reimbursements granted when purchasing medicines must now be disclosed at the request of the FOPH.

Cantonal enforcement

The regulations governing the distribution, dispensing and prescription of medicinal products were also changed or standardised. Much of this was previously regulated differently at the cantonal level. Anyone dispensing medicines still requires a cantonal licence. In order to obtain this licence, the Therapeutic Products Act now stipulates at the national level that "a suitable quality assurance system adapted to the type and size of the establishment must be in place" (HMG Art. 30, No. 2). Quality assurance is now given greater importance, especially as the cantons can stipulate further conditions for the granting of licences and must carry out periodic inspections. In some cantons, pharmacies were already required to have a QMS before January 2020. And large pharmacy chains such as Toppharm or Amavita already have their own quality management systems.

"You have to live quality"

Continuously reviewing quality and making improvements where necessary are core tasks of every pharmacy anyway, according to pharmaSuisse, the umbrella organisation for pharmacists. This is also confirmed by pharmacist Claudia Meier-Uffer. She is the manager and owner of the pharmacy in Gossau SG. "You have to live quality; a quality management system is only as good as you live it yourself," she stresses. The fact that the revised Therapeutic Products Act now prescribes a QMS throughout Switzerland is therefore not "new territory" for the pharmacist from eastern Switzerland. But nevertheless, other small, independent pharmacies are likely to face the challenge: What is a "suitable QMS adapted to the type and size of the business"? How does one find such a suitable quality management system? And how much effort does it require? The cantonal pharmacists defined the requirements for quality assurance in a position paper back in 2015. It lists in nine chapters what a quality assurance system must contain and which points a pharmacy must fulfil. The ISO 9001 QMS Pharma solution developed by the pharmaSuisse industry association is also based on these specifications. It is an industry solution based on the globally recognized ISO 9001 standard, which means that the quality requirements focus explicitly on the day-to-day operations of a pharmacy and its areas of activity. According to pharmaSuisse, ISO 9001 QMS Pharma is suitable for every pharmacy, regardless of its profile. Nevertheless, all the requirements of ISO 9001 are covered in it. "A total of 570 pharmacies have been following this programme since 2015," explains Eva von Wartburg, product manager ISO 9001 QMS Pharma at pharmaSuisse. "It is not yet possible to say how many pharmacies will now be added explicitly due to the amendment to the Therapeutic Products Act. The registration period runs until 31 March 2020", Eva von Wartburg continues.

Manageable effort

Often enough, a QMS is associated with a large administrative effort. Many pharmacies also ask themselves the question: How much time do pharmacists have to invest in this? A closer look at pharmaSuisse's internal association information shows that the effort is manageable, even when viewed from the outside. This also corresponds to the experience of Claudia Meier-Uffer, who has been implementing the ISO 9001 QMS Pharma programme in her pharmacy since 2017. Because the introduction of the QMS takes place gradually, spread over a year. Pharmacies that opt for the ISO 9001 QMS Pharma receive monthly documents and instructions on how to put the specifications into practice. "We, too, were given tasks to complete in tidbits, so to speak. Much of this was already a matter of course for us anyway," recalls Claudia Meier-Uffer. The documents are designed as ready-to-use documents, so they don't require any additional effort. Most of the work is done online, and the pharmacies are given personal access to the QMS website. pharmaSuisse has also set up a hotline for questions. Overall, the industry association estimates that the introduction of the QMS will take about one day per month in the first year. After one year, the pharmacy receives an individual ISO 9001 QMS Pharma certification. This is awarded by the external certification body Bureau Veritas Certification. With this certification, the pharmacy confirms its commitment to continuous improvement processes.

External audits by sample

A special feature of ISO 9001 QMS Pharma is the collective approach. This means that the pharmacies involved improve their quality "in step", as it were. The ISO 9001 standard allows certification in a sampling procedure for such systems: Only a certain number of pharmacies are audited externally, but all integrated businesses then receive the certificate. QMS auditors from pharmaSuisse, however, also carry out audits of all member pharmacies in a three-year cycle. Thus, all affiliated pharmacies are audited once within three years. "For this purpose, we have 20 of our own auditors on duty," explains Eva von Wartburg. These are pharmacists who have been specially trained for this purpose and now perform the audit tasks on a part-time basis.

Attractive overall package

ISO 9001 QMS Pharma is not free of charge, but comparatively inexpensive. Members of pharmaSuisse pay CHF 995 per year (excluding VAT), non-members CHF 1990. For comparison: According to SQS, an equivalent ISO 9001 system costs around CHF 3500 per year. Assuming that member pharmacies can also subscribe to a document management system for CHF 120, this overall package is indeed very attractive. And it seems to be going down well with the pharmacies. "We receive almost only positive feedback from the pharmacies. Above all, the support for the introduction of the QMS is very much appreciated," says Eva von Wartburg. And it is also simple: "Due to the excellent documentation of ISO 9001 QMS Pharma, quality management can in principle even be delegated to pharmaceutical assistants," says Claudia Meier-Uffer. The renewal rate of 92 percent indicates that ISO 9001 QMS Pharma is probably without alternative for most pharmacies. The example of pharmaSuisse's solution can also be seen as an example of how an industry can implement new legal regulations pragmatically and relatively cost-effectively.