Annual report 2018

Galenica annual report 2018 | 35 Sustainability coverage Implementation of the Falsified Medicines Directive in Switzerland Based on EU Directive 2011/62/EU, Switzerland has supplemented the Therapeutic Products Act (TPA) with provisions on safety features (Article 17a). Swiss manu- facturers, wholesalers and persons licensed to dispense medicines can implement the new TPA article voluntarily. The Federal Council may, however, declare the article mandatory at any time. By founding the Swiss Medicines Verification Organisation (SMVO), the players in the healthcare sector have joined forces to implement the EU directive on a voluntary basis and to further improve patient protection. The Swiss Medicines Verification Sys- tem (SMVS GmbH) has therefore been set up to ensure operational implementation of medicine verification in Switzerland and manage the Swiss database. The inter- ests of Galenica are represented by various associations, which in turn are members of the SMVO. Continuous monitoring of medication effects Verfora’s quality management system ensures that no falsi- fied medicines enter the supply chain. Any suspected cases are thoroughly investigated and documented. “Although we don’t sell products that are traditionally targets for falsifica- tion, we will implement the required measures to protect against falsification as soon as the EU directive is legally binding in Switzerland. Only one of our products would be affected at present: Algifor ® Junior, which requires a prescription,” explains Daniel Steck, Relationship Manager Consumer Healthcare at Verfora. Maximum safety when dispensing medicines Pharmacies play a key role in patient safety and therefore in implementing FMD. According to the directive, all prescrip- tion medicines must be scanned and their authenticity checked by the pharmacist before they are dispensed to the patient. A visual inspection of the tamper-evident closure is also required. Galenica pharmacies are already subject to strict inspection guidelines. “The product number and expiry date of all medicines are checked on delivery and before they are dispensed to the patient. We also check the com- pleteness and integrity of the packaging. If a pack had already been opened, it would be noticed immediately,” explains Daniel Hugentobler, Head of Quality at Galenicare. To further improve safety, Galenica pharmacies are also implementing the EU Falsified Medicines Directive. Daniel Hugentobler explains: “We are currently procuring new scanners for all pharmacies, making the necessary adjust- ments to our quality management system and training our employees.” HCI Solutions has also integrated new func- tionalities into the Triapharm ® pharmacy software to ensure technical compatibility with the national database. To guar- antee data protection, only information from the Datamatrix code is sent to the national database. Patient data are only stored locally. Eric Rochat, Process and Security Specialist at HCI Solutions, confirms that data privacy is fully assured with the implementation of the EU directive. Significant improvement in patient safety Daniel Hugentobler also points out that in June 2019, all Galenica pharmacies will be ready to check the authenticity of prescription medicines in accordance with the EU direc- tive. But what happens if the authenticity of the medicine is not confirmed during a check? “In this case, of course, the medicines will not be dispensed, and the internal quality unit will be informed so that it can establish the facts,” says Hugentobler. “Although checking every pack on delivery means additional work for our employees, this significantly improves patient safety. Because it is not just the authentic- ity of the drug that is checked by scanning the two-dimen- sional code. The expiration date and the batch number are checked too – and it was previously only possible to do that visually,” says Hugentobler. Galenica