Patient safety and health

Own material topic
Patient safety and health 

GRI 103-1
Explanation of the material topic and its boundary

Medication errors or reductions in the quality of medications can have serious consequences for a patient’s health. They also pose a risk to the reputation of the companies involved. Digitalisation opens up new opportunities for innovative solutions to improve patient safety. Galenica is committed to ensuring the quality of medicinal products along its entire value chain and takes the appropriate measures in terms of infrastructure, processes, and the training and education of its employees.

GRI 103-2
The management approach and its components

GDP Guidelines

Alloga, Galexis, UFD, Pharmapool, Verfora and the Bichsel Group adhere closely to every aspect of the GDP Guidelines for human medicinal products. On the one hand, these legal requirements are intended to prevent counterfeit drugs from entering legal supply chains. On the other hand, control measures within the distribution chain ensure the quality and integrity of medicinal products. Drug temperature is recorded and analysed in real time throughout the entire life cycle, from production through to delivery to the customer. If there are deviations in temperature, the causes are investigated and suitable measures are taken in accordance with GDP guidelines. In addition to these guidelines, the aforementioned companies apply their own standards and processes in their day-to-day work to ensure the safety of patients at all times.

Galexis, UFD, Pharmapool and the Bichsel Group each operate their own fleet comprising 168 delivery vans (up to 3.5 tonnes) and 5 lorries (14 to 22 tonnes). All vehicles are GDP-compliant and are fitted with an air conditioning system in the loading space, which is mandatory for the transport of pharmaceutical products.

Quality systems

HCI Solutions provides master data for the Swiss healthcare market. The company is also active in the field of e-health with the aim of increasing patient and medication safety in the Swiss healthcare system. With innovative digital solutions such as Documedis®, HCI Solutions makes a significant contribution to safe and efficient healthcare in Switzerland. To guarantee the quality of medication data, HCI Solutions carries out process-integrated checks. The company checks the acquisition of drug data according to the four-eyes principle, while the six-eyes principle applies to sensitive active substances (such as blood thinners). HCI Solutions carries out random quality checks on a daily basis and a more comprehensive inspection every two weeks. Any error discovered is documented and its cause investigated. HCI Solutions is certified to ISO 9001:2015 and ISO 13485:2016.

The QMS of the Service Unit Pharmacies has standard operating procedures (SOPs) for all relevant pharmacy processes. These include the manufacture and dispensing of drugs, data protection, confidentiality, hygiene and the disposal of medications. Galenicare regularly carries out audits to ensure compliance with the SOPs in the individual pharmacies. In addition to these announced audits, anonymous test purchases and phone calls and inspections by cantonal pharmacists take place in all pharmacies. Several times a year, Galenica conducts QMS and legal requirements courses for pharmacy employees. For specific services such as heart checks, allergy checks, diabetes checks and vaccinations, employees complete certified courses and obtain certificates of competence.

As a company specialising in pharmaceutical manufacturing and home care with its own certified general pharmacist, the Bichsel Group places great importance on the quality of its products and services. The company carries out numerous chemical and microbiological analyses on a daily basis to check end products, raw materials and packaging materials and holds manufacturing licenses, EU GMP certificates for medicinal products and EC certificates for medical devices in accordance with Directive 93/42/EEC of the European Council.

The specialty pharmacy Mediservice supports patients with chronic and rare illnesses by providing additional services such as home care and patient events. Mediservice also has a licence to operate as a public pharmacy and a wholesale licence. Accordingly, Mediservice’s QMS meets a wide range of requirements.

You can find further information about certifications and quality systems under Compliance (GRI 419).

Continuous monitoring of all products

Product safety is checked and safeguarded at Verfora using a variety of approaches. Verfora checks that contract manufacturers qualify for the necessary processes by carrying out initial and regularly recurring audits. These evaluate compliance with the GMP guidelines and ensure that they are adhered to so that safe products can be manufactured for patients at all times. The audits also take into account environmental, health and safety factors within the partner companies. The products are then carefully examined before being placed on the market to ensure that they have been manufactured and tested in accordance with the GMP guidelines and that they meet all applicable specifications. As with all medications, Verfora products undergo a preclinical and a clinical trial to ensure their safety and efficacy. Once the products are on the market, pharmacovigilance is at the heart of Verfora’s safety efforts, i.e. the continuous monitoring of all products. All new Verfora employees are trained in pharmacovigilance and receive a checklist of steps to be taken in the event of side effects. In addition, pharmacovigilance training is held for all employees every year. The company also systematically checks advertisements and advertising posters for products to ensure they are correct. In parallel to pharmacovigilance, the products are regularly analysed in the laboratory until the end of their life so that any deviations in quality can be identified and remedied at an early stage.

Promote the technical competence of employees

In 2021, around 85 pharmacists attended quality management courses. Quality management and patient safety are also key issues in the basic training of pharmacy assistants working towards their Federal Proficiency Certificate.

Where required, Verfora offers training sessions for pharmacies when new medications are launched in order to promote employees’ skills and ensure patient safety and health. In 2021, Verfora conducted 328 training sessions for a total of 3,050 pharmacy assistants and pharmacists.

Increased patient safety using e-medication solution

Digitalisation is leading to new, innovative ways to improve patient safety. Documedis^® is the process-integrated solution for increased medication and patient safety in the healthcare system. Documedis^® offers specific e-health applications and services relating to the medication process based on INDEX data. HCI Solutions works with various reference communities to make Documedis^® available in the electronic patient record. This will allow more functions to be made available to the various service providers in the future, such as merging several e-mediplans, which will result in an increase in patient safety. Documedis^® is already being implemented in pharmacy, medical and hospital software.

The Documedis^® module Primary Care Algorithms (PCA.CE) provides the option of offering precise identification of health disorders and illnesses using algorithms. In 2021, HCI Solutions implemented 22 additional algorithms, including for diseases such as acne, eczema and shingles. There are now 33 algorithms in total. HCI Solutions is constantly expanding the functionality of Documedis^®_.

Uninterrupted cold chain for medications

All Wholesale & Logistics companies, as well as Medifilm, Mediservice and Bichsel, provide an uninterrupted cold chain for the storage and transport of temperature-sensitive drugs. At Alloga, this also applies to so-called ultra-deep-freeze logistics, in other words, storage and dispatch at -80°C, the required temperature for a new generation of cancer drugs. In preparation for the delivery of COVID-19 vaccines, Alloga further expanded its ultra-deep-freeze logistics in the reporting year. Temperature control is ensured by using dry ice in special containers. Alloga and Galexis also use paraffin-filled cooling elements, which, in contrast to water-based cooling elements, ensure the medicines remain at a more stable temperature. The proportion of transported refrigerated products in the reporting year was 6% for Galexis’ own vehicle fleet and around 31% for third-party transport.

Important contribution to combating the coronavirus

Galenica pharmacies are making an important contribution to combating the coronavirus. From mid-November 2020, the first of them offered both rapid antigen tests and PCR tests for coronavirus, and pharmacies have also been offering COVID-19 vaccinations since 2021. In 2021, the Galenica pharmacies carried out a total of more than 230,000 antigen, PCR and antibody tests and administered around 90,000 COVID-19 vaccinations.

GRI 103-3
Evaluation of the management approach

• Quality management: the QMSs of the companies of the Galenica Group are regularly and systematically audited.
• GDP guidelines: the regional therapeutic products institutes periodically check compliance with the GDP guidelines.
• Pharmacovigilance: at Verfora, all employees are obliged to forward reports of side effects from specialists and patients to the responsible internal office promptly and in full. Information on the duration, progression and impact of the side effect and on the dosage and duration of product use plays a key role in this. Verfora documents and investigates each report, taking appropriate measures where necessary.

Own indicator
Pharmacovigilance: Forwarding reports

In 2021, Verfora employees met the deadline for forwarding reports of side effects in 92% of cases (target: >90%). The authorities or contractual partners were notified within the required period in 100% of cases (target: >90%). The completeness of information on the reported side effects was exemplary at 98% (target: >80%).

Own indicator
QMS training in pharmacies

In the reporting year, 85 pharmacists completed QMS training.