The availability of medicines is generally not a problem in Denmark, and it happens rarely that people cannot get the medicine they need from for example a pharmacy.
On the other hand, problems with the supply of medicine are not uncommon. Most often it makes no practical difference to people in Denmark because the pharmacy is able to dispense an alternative product that corresponds to the medicine the doctor prescribed, or it can dispense a different pack size of the medicine. But the price might be higher and sometimes it is necessary to contact the doctor again, which will prolong the process.
That is why the Danish Medicines Agency collaborates on a continuous basis with wholesalers, companies, pharmacies, the regions and other authorities, nationally and internationally, to minimise the risk of supply and delivery problems in pharmacies and hospitals.
In many cases, the pharmacy can deal with the shortage of a particular medicine by dispensing an equivalent alternative. Doctors often also have the possibility of prescribing a usable alternative. And when a product is in scarce supply, doctors and hospital departments can apply to the Danish Medicines Agency for a compassionate use permit for a medicine that is not on the Danish market – either for use in a hospital department or for a patient via a pharmacy.
Why do supply problems occur?
The pharmaceutical companies’ supply of medicines to the Danish market is regulated by several rules and requirements, and price and availability considerations must be balanced.
Like other products such as food and clothes that are produced globally and sold on the Danish market, there could be a number of reasons why a medicine for a period of time cannot be supplied to hospitals or is not available from pharmacies. This could be due to:
- lack of the raw material used in the medicine
- a quality defect in manufacturing
- production failures at a supplier
- the medicine being on back order from a distributor
- the product being sold out at the pharmacy
- a higher demand for the medicine than expected by the pharmaceutical company
- the pharmaceutical company assessing that marketing the medicine is no longer worthwhile
The global development with fewer pharmaceutical manufacturers also makes the supply of medicine more vulnerable in general. This is because the problems that a single company might be facing will affect the supply more compared to if there were many manufacturers. The Danish Medicines Agency is working to prevent this in collaboration with drug regulatory authorities and other partners at international level.
Prevention of and information about supply problems
By law, companies and wholesalers are obliged to ensure appropriate and continuous supply of the medicines they market. This includes prescription-only medicines sold only from pharmacies and vaccines.
The Danish Medicines Agency collaborates with a number of participants and collaboration partners, nationally and internationally, on long-term solutions to best prevent shortages of medicines that are essential to the treatment of patients, and on the strengthening of information about supply failures whenever they occur.
This collaboration has been intensified in response to a growing number of supply problems in 2019. More efforts will be paid to improve information to doctors about which medicines are unavailable so that doctors can take any supply problems into account before the patient arrives at the pharmacy.
The Danish Medicines Agency also works with the availability of medicines on the international scene. The drug regulatory authorities in and outside Europe increasingly work together to prevent medicine shortages and to limit the consequences when supply problems occur by way of:
- collaboration with the pharmaceutical companies to resolve production and distribution problems
- exchange of information with international partners about alternative sources of supply
- development of strategies to prevent problems in the supply chain, for example by preparing guidelines for the companies on the reporting of shortages
- improvement of the exchange of information and best practice among the European drug regulatory authorities
In addition, the Nordic Council’s working party on the exchange of information in the pharmaceutical area has formed a working party which works to find solutions to the existing supply problem challenges, the aim being to strengthen the already high availability of medicines even more.