Substitutable drugs

Pharmacies are required by law to offer a substitute for a prescribed medicine.

The substitute must be a pharmaceutical equivalent that:

• carries the lowest price tag,
• is available, and
• is covered by the high‍-‍cost threshold.

Roles in the substitution system

• Authorities
  • Läkemedelsverket, the Swedish Medical Products Agency (MPA) decides which drugs are equivalent to each other and interchangeable.
  • TLV, the Dental and Pharmaceutical Benefits Agency, decides which drugs should be covered by the reimbursement system (the high‍-‍cost threshold) and designates the product that will constitute a generic substitute in pharmacies for a particular period of time (‘product‍-‍of‍-‍the‍-‍month’).
  • eHälsomyndigheten, the Swedish eHealth Agency, ensures a functioning technical flow of information on medicines between authorities, pharmacies, and healthcare.
• Prescribers speak to patients and prescribe drugs.
• Pharmacists engage with customers at pharmacies and dispense prescriptions.
• Citizens use the drugs and are responsible for managing their medicinal treatment on a daily basis.

A secure system for users

The Swedish system of substitutable pharmaceuticals includes several check points, with each link increasing customisation to the person who will use the drug. Users are also offered several opportunities to ask questions about drugs and medicinal treatments. The information on substitutes provided by the prescriber and pharmacist is important for appropriate drug use and safe substitution at the pharmacy.

Substitution list

The Swedish MPA decides which drugs are substitutable and publishes a list of substitutable drug groups. Drugs belonging to the same group can be substituted for each other but not for drugs included in other groups. The substitution list is updated regularly, and the current list is published here on the Swedish MPA’s website.

The Swedish MPA takes into account users’ points of view in assessing substitutability with respect to the general patient group, not the individual user. The prescriber and the dispensing pharmacist can assess the individual patient’s needs since they speak to them face to face.

Pharmaceutical equivalence

'Substitutable medicines' means medicines that are pharmaceutically equivalent. When assessing pharmaceutical equivalence, the Swedish MPA consider the efficacy and safety of each individual product.

Substitutable drugs must:

• contain the same active substance of the same strength,
• have the same dosage form,
• be therapeutically equivalent.

In addition to these basic criteria, assessment includes several other aspects, such as the product’s characteristics and the information stated on the package leaflet.

The drugs may have different names and a different appearance. There may also be differences in the product information (the summary of product characteristics and the package leaflet), but they do not imply any differences in the pharmaceutical sense.

Drugs covered by the high‍-‍cost threshold

The Dental and Pharmaceutical Benefits Agency decides which drugs are to be covered by the reimbursement system (the high‍-‍cost threshold), i.e. subsidised, and how much they should cost. For a medicinal product to receive a subsidy, the pharmaceutical company must submit an application for a subsidy to the Dental and Pharmaceutical Benefits Agency.

A drug that is covered by the reimbursement system may be substituted for another substitutable drug that is also covered by the scheme. In some cases, however, a drug that is not covered by the reimbursement system may be substituted for another that does. However, no drug may be substituted for a drug not covered by the reimbursement system. Drugs may be included in the Swedish MPA’s substitution list even if they are not covered by the reimbursement system once the Agency decides on substitutability.
Generic drug substitution applies to medicinal products for humans only, as those intended for use in animals are not covered at all.

Classification by package size

The Dental and Pharmaceutical Benefits Agency divides drugs into groups according to pack size similarity. For example, packs containing 90‍-‍105 tablets are included in the same group. Within each pack size group, the Dental and Pharmaceutical Benefits Agency decides which available medicine has the lowest price, i.e. which one to make 'product‍-‍of‍-‍the‍-‍month'. Product‍-‍of‍-‍the‍-‍month is the substitute that pharmacies are required to offer their customers.

The prescriber assesses whether substitution is appropriate

The prescriber makes a diagnosis and selects the treatment. If the prescriber finds that there are medical reasons why a substitution at a pharmacy would be generally unsuitable for the person in question, he/she may indicate on the prescription that no substitution should be made. In such a case, the pharmacy must dispense the medicine stated on the prescription. Medical reasons may include allergies or medicines needing to look similar to each other from time to time for the person to be able to keep track of the medication he/she is taking.

Medicinal substitution is an active choice

The law requires pharmacies to offer a substitute, but both the pharmacy staff and the individual user may refuse to offer or accept one.
Pharmacy staff may refuse to substitute one drug for another if any difference between product‍-‍of‍-‍the‍-‍month and the drug stated on the prescription is deemed to have an adverse effect on the user. Examples of such an issue may be that product‍-‍of‍-‍the‍-‍month is a refill package where the customer needs a complete package, or the prescriber having expressed the dosage in half-tablet terms where product‍-‍of‍-‍the‍-‍month is indivisible or cannot be prescribed in divided doses.

Parallel import and distribution

Information material

The Swedish MPA and the Dental and Pharmaceutical Benefits Agency have jointly produced information material on the substitution of generic drugs. This material contains in-depth information customised for various target groups and aimed at prescribers, pharmacy staff, and users. It details what everyone can do to make the Swedish system of substitutable pharmaceuticals work optimally. Selected sections have been translated into other languages.

Regulations

• Lagen (2002:160) om läkemedelsförmåner m.m.
• Läkemedelsverkets föreskrifter (HSLF‍‍-‍‍FS 2019:32) om förordnande och utlämnande av läkemedel och teknisk sprit.
• Vägledning till 8 kap. 11 § Läkemedelsverkets föreskrifter (HSLF‍-‍FS 2016:34) om förordnande och utlämnande av läkemedel och teknisk sprit – farmaceuts möjlighet att motsätta sig utbyte av läkemedel.