The pharmacist’s role in substitution

The Swedish MPA decides which drugs will be substitutable. When assessing substitutability, the Swedish MPA endeavours, as far as possible, to identify any problems that could arise for the patient group as a whole because of the substitution.

Comparison is made at the point of dispensing

In some situations, while the prescriber may find no medical reason to refuse a substitution, it may be considered inappropriate by the pharmacy. This may be explained by the fact that specific properties of a prescribed medicine may only be compared with those of product‍-‍of‍-‍the‍-‍month at the time of dispensing, e.g. looking at whether the drug is available in blister or bottle packaging, whether the packaging had a unit‍-‍dose calendar or not, etc.

This means that the pharmacist may refuse to substitute a drug if the design of its packaging or administration, or the substitution itself, may be assumed to lead to significant inconvenience in the form of impaired drug use or any other risk to the patient’s health.

Dialoguing with the customer

In general, a working dialogue between the pharmacist and the customer about substitution forms an important part of successful medicinal treatment. For most people, generic drug substitution works well, provided helpful information is supplied by prescribers and pharmacists.

The dispensing pharmacist is required to inform the customer that he/she should consider substitution and offer him/her product‍-‍of‍-‍the‍-‍month. As regards dispensing, the pharmacist should also, as far as possible, ensure that the customer is familiar with how to use his/her medicines.

The information the pharmacist provides about substitution is important because it may affect both the customer’s compliance with the prescription and prevent anxiety, misunderstandings, or uncertainty.

The customer may refuse

While pharmacies are required to offer substitute drugs, customers are entitled to refuse. Aided by customised information, the customer can judge for him/herself whether to accept or refuse the substitute offered.
One important task for the pharmacist is to identify customers who need further contact with their prescriber, e.g. when a substitution is inappropriate because of allergy to an excipient. Another example is when, on occasion, the pharmacist refuses to substitute a drug because he/she reasonably believes that the customer should not continue to receive a substitution for the subscribed drug. In such a case, the prescriber should be informed of the situation so that the patient receives a new prescription where the prescriber refuses substitution.

The high-cost threshold applies

When the pharmacist refuses substitution, the prescribed drug should be handed out and the entire cost will be covered by the reimbursement system.

The following are some example situations where the pharmacist is required to refuse substitution:

• The prescriber has indicated that the drug should be taken in the form of divided tablets, but product‍-‍of‍-‍the‍-‍month cannot be divided into equal doses. For information on divisibility, see section 3 of the Summary of Product Characteristics.
• The substitution complicates use so much that it may involve a risk of the customer confusing their drugs, e.g. because he/she takes multiple prescription drugs.
• Despite information from the pharmacist, the customer is worried about differences in the information provided on the package leaflets, which may lead him/her to depart from the intended regimen.
• When assessing substitutability, the Swedish MPA does not take packaging into account. For example, this means that complete packaging and refill packaging are substitutable, meaning that the pharmacist needs to find out what the customer needs. Blisters and bottles are substitutable, too, but some individuals may, because of issues with hand strength or mobility, have such difficulty opening either packaging that the swap cannot be justified.

When the pharmacist refuses to substitute a drug, he/she must record the reason for doing so in the dispensing record.

Regulations

• Läkemedelsverkets föreskrifter (HSLF‍‍-‍‍FS 2019:32) om förordnande och utlämnande av läkemedel och teknisk sprit.
• Vägledning till Läkemedelsverkets föreskrifter (HSLF‍-‍FS 2019:32) om förordnande och utlämnande av läkemedel och teknisk sprit.