Automatic substitution of biological medicines would be possible if carefully planned and gradually implemented
Fimea has surveyed the views of Finnish pharmaceutical operators and patient organisations on the automatic substitution of the biological medicines used in ambulatory care from the point of view of safeguarding medication safety. Based on the survey, automatic substitution of biological medicines would be possible if it is planned carefully and implemented gradually.
An implementation model for the automatic substitution of biological medicines should be prepared in extensive collaboration with stakeholders. It should be piloted in operating environments where the cooperation between pharmacies and other health care services is as seamless as possible. Medication safety should be safeguarded in a way that would not unnecessarily burden the parties involved in the substitution, but would allow for cost-effective medicinal treatment from an individual and societal point of view without compromising the effectiveness of the patient's medicinal treatment.
The automatic substitution of biological medicines at pharmacies would be possible subject to the following conditions:
Fimea would determine the clinical and practical interchangeability of biological medicines. This would also include an assessment of the functional similarity of the administration devices.
The substitution would be carried out at pharmacies. The pharmacies would comply with their existing statutory obligation to provide the customer with pharmaceutical advice when any biological medicinal product is dispensed. This obligation would also pertain to guidance on the correct and safe use of the administration device of the medicinal product concerned. The expertise of pharmacy personnel would be supported by means of new tools and systems that guide the safe implementation of the substitution.
The substitution would be carried out at pharmacies upon commencement of a biological medicinal treatment when the prescription is dispensed for the first time. For an existing medicinal treatment, the medically justifiable substitution interval could be one year, for example. The prescriber could forbid automatic substitution at a pharmacy for medical or therapeutic reasons.
The correct and safe use of the administration device would also be ensured at pharmacies if the medicine is collected on the patient’s behalf by someone else or ordered online.
The pharmacy and other health care units would cooperate to ensure that the patient is provided with consistent medicines information and guidance in the use of the administration device for the products the patient will use.
The flow of information between the parties involved in medicinal treatment (doctor, nurse, pharmacy personnel) would be more effective and structured than at present.
Biosimilar competence of all those who are involved in medicinal treatment (doctor, nurse, pharmacy personnel) would be developed by ensuring the availability of, and access to, objective biosimilar information by means of both basic and supplementary education and training. Administration device competence would also be ensured.
Use of biosimilars would have implications on the national economy
The use of biological medicines has become increasingly common over the past decade in the treatment of many diseases that are of significance for public health and economy. In 2017, there were eight biological medicines among the ten best-selling medicinal products in Finland, measured in euros, with total sales exceeding EUR 256 million. The costs of biological medicines are expected to increase rapidly in the next few years.
For the most of biological products, there are copies available that are also known as biosimilars, which have been proven to be comparable with their reference medicines as far as their quality, efficacy and safety are concerned. However, the uptake of biosimilars in ambulatory care has remained sparse. A more extensive use of biosimilars would initiate price competition between biological preparations, which would have significant implications on the national economy.
Automatic substitution at pharmacies is not currently applied to biological medicines, but Fimea, along with a number of other European medicinal authorities, has found biosimilars interchangeable.
Background to the survey
The views of Finnish pharmaceutical operators and patient organisations on the automatic substitution of the biological medicines used in ambulatory care were studied with semi-structured interviews conducted in the autumn of 2018. 32 individual, pair or group interviews with a total of 62 people participating in them were conducted for the survey. In the analysis, factors that need to be taken into account if the automatic substitution of biological medicinal products at pharmacies would be considered to be implemented were identified from the material.
In a separate study, Fimea has investigated the attitudes of physicians who prescribe biological medicines on the uptake of biosimilars and their views on the factors that promote and prevent the uptake of biosimilars. The study was published on 15 May 2019.
Automatic substitution of biological medicines at pharmacies. Views on potential automatic substitution and the related medication safety aspects. Serial Publication Fimea Develops, Assesses and Informs 5/2019 (pdf)
- Eija Pelkonen, Director-General +358 29 522 3100
- Päivi Ruokoniemi, Senior Medical Officer, tel. +358 29 522 3422
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