The role of pharmacies in the substitution scheme

The pharmacy suggests substitution and informs the patient 

The pharmacy must offer the cheapest medicine when there are multiple equivalent brands on the substitution list. It is important that the patient receives sufficient information to evaluate a potential substitution. 

Feel free to use our patient brochure on medicine substitution in pharmacies. 

If patients still choose not to substitute, they must pay the price difference between the medicine offered and the one prescribed by the physician. If the medicine is prescribed at the expense of public health insurance, the price difference should not be recorded as a co-payment. 

If the physician has reserved against substitution on the prescription, substitution should not be offered. For medicines with limited substitution, substitution should only be offered if it is the first time the patient is collecting the medicine. If a medicine has a patent-protected indication, it is not substitutable for that indication. NOMA informs pharmacies about patent-protected indications through a substitution note in FEST (Norwegian Electronic Prescription Support System). 

Pharmacies' delivery obligations 

For substitutable medicines with a set tiered price, pharmacies are required to stock at least one medicine within each substitution group. It is up to each pharmacy to decide which brands they stock at the tiered price. You can read more about the tiered pricing system here. 

Even though the pharmacy offers medicine substitution, it is obligated to dispense the brand requested by the physician or the patient. 

When medicines are collected by others or are delivered 

When someone other than the patient collects the medicines, the person collecting must receive sufficient information to evaluate the substitution on behalf of the patient. Information about the substitution must be conveyed to the patient. 

When medicines are delivered to the patient, it is assumed that the patient has been informed and has consented to the substitution. 

Presrcibing the active ingredient – guidance for pharmacies 

Substitutable medicines are those listed on the substitution list, according to the Regulation on the prescription and dispensing of medicines, § 10-7. The regulation's § 5-5 also states that the prescription must include sufficient information about the medicine for correct dispensing: dosage form, strength or composition, and quantity. Instead of quantity, dosage and treatment duration can be specified. 

The pharmacy must dispense enough medicine to ensure the patient's treatment plan is maintained. When dispensing a larger quantity of medicine than specified on the prescription, the pharmacy must inform the patient that any remaining medicine after the treatment period should not be used. 

Prescribers use various systems for prescribing. Some systems support active ingredient prescribing as the default, while others do not. If the pharmacy receives a prescription based on the active ingredient, the pharmacy must choose which medicine to dispense. There are several options for selecting a product, and medicines with the same substitution group code are substitutable with each other. 

For active ingredient prescribing, the quantity prescribed may not always match the available marketed package sizes. This is because the prescriber's system calculates the quantity based on dosage and treatment duration. System support has been developed in pharmacy data systems to facilitate active ingredient prescribing. 

If prescribed quantities do not match the available marketed package sizes, the following is recommended: 

• Packages closest to the prescribed quantity should be dispensed. 
• Pharmacies must be particularly cautious when small quantities of A and B preparations are prescribed and may assess whether a partial package is necessary. 
• For chronic conditions, no less than a three-month supply should be dispensed. 
• Sufficient quantities should be dispensed to complete the prescribed treatment. 
• Active ingredient prescribing should not result in more frequent partial packaging than when prescribing branded medicines, but partial packaging should still be carried out when deemed necessary. 
• Use pharmaceutical judgement. 

The substitution scheme does not apply to medicines for animals 

The substitution scheme in pharmacies does not apply to medicines for animals. For medicines for animals, the brand name must be stated on the prescription, and the pharmacy must dispense the medicine specified on the prescription. The pharmacy must contact the veterinarian to obtain permission for any substitution. 

About substitution of parallel-imported medicines 

Both physicians and patients can reserve against substitution, including for parallel-imported medicines. 

Parallel-imported medicines are produced by the same pharmaceutical company as the original medicine in Norway and are imported from countries with lower medicine prices. Parallel-imported medicines may have a different form, color, and product name than the original medicine and can differ as much as various brands of the same medicine. Therefore, reservations against substitution also apply to parallel-imported medicines. 

However, in practice, a parallel-imported medicine that is identical to the original medicine can be substituted in pharmacies, despite a physician's reservation. The substitution scheme must be practiced in a way that ensures patient safety, and the pharmacy must assess which packages of parallel-imported medicines are similar enough to be substituted. 

Parallel-imported medicines with limited substitution 

Some medicines have limited substitution because the consequences of misuse and/or small differences in bioavailability can be particularly problematic. Pharmacies should therefore exercise special caution when offering substitution for medicines with limited substitution, even when there is no physician's reservation. 

Even if the tablets are identical in composition and appearance, they are often repackaged, leading to differences in the packaging's appearance. This must be considered for medicines with limited substitution and the patient's understanding and adherence to the treatment.