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Pharmacovigilance at Orion

Pharmacovigilance is a science and activities relating to the detection, assessment, understanding and prevention of adverse drug reactions or any other drug-related problems. Our duty is to monitor the safety of our products throughout their life-cycles ever since the early R&D phases until the product is no more available on the market.

Several functions of the company are involved in the pharmacovigilance processes coordinated by the Global Drug Safety organisation, which is a Headquarter function in Espoo Finland. Appropriately, qualified and trained experts are responsible for the assessment and activities related to the management of benefit/risk balance of the products. Our pharmacovigilance operations and Quality Management System are compliant with international regulatory requirements and guidelines.

Locally in Orion subsidiaries and sales offices the data is handled by local pharmacovigilance responsible personnel. All global safety data from all sites are collected into a single point by Global Drug Safety (Espoo Finland) for assessment, continuous monitoring and reporting. Safety data that is collected include e.g. information about suspected adverse reactions, lack of efficacy, medication errors, interactions, exposure during pregnancy and over-doses. Information is received from clinical trials and as spontaneous reports e.g. from healthcare professionals, regulatory authorities, patients, relatives and scientific literature.

Orion collects safety information globally and these are reported to the regulatory authorities worldwide in line with the local legislation (e.g. to European Medicines Agency/EudraVigilance, US FDA, National Competent Authorities in EU and other countries outside EU). Data is shared as well with licensing partners according to Safety Data Exchange Agreements concerning the products. Orion and its licensing partners as well as regulatory authorities continuously evaluate the information to detect safety signals that might affect the benefit-risk balance of the products to early identify any emerging safety issues. In addition to continuous signal detection procedures, Orion reviews the cumulative data periodically. Periodic Safety Update Reports (PSURs) are prepared and submitted to the regulatory authorities. In the PSUR all available safety information and the benefit-risk profile of the product is thoroughly evaluated and e.g. changes to the product information or other risk minimisation actions will be proposed if necessary. PSURs are shared with licensing partners as well.

We work in continuous collaboration with authorities in the evaluation of the safety of our products and the balance between risks and benefits. When necessary, we undertake actions to ensure patient safety and the correct and safe use of our products. Such actions may include, for example, updating of the information provided in the Summary of Product Characteristics and the Package Leaflet, communicating information to or training of healthcare professionals, adding, e.g., contraindications or precautions and warnings to the medicines, or discontinuation of sales. The possible actions are always taken in a controlled manner in collaboration with healthcare authorities.

All data, documents and records related to pharmacovigilance are physically and electronically stored in designated access controlled archives and databases, and retained in accordance with the relevant legislation and requirements.

Some global or local pharmacovigilance tasks can be subcontracted. The subcontracting of Orion pharmacovigilance tasks is done in accordance with the requirements of the Orion quality management system. Orion retains responsibility for the pharmacovigilance tasks that have been subcontracted and performs regular audits of subcontractors.