The physicians role in the substitution scheme

The physician must inform 

While NOMA and pharmacies have the primary responsibility for implementing the substitution scheme, the physician plays an important role in ensuring safe medicine substitution. The physician must: 

• Inform the patient that the pharmacy may dispense a different brand than the one stated on the prescription, but that the medicine has the same effect. 
• Keep the medication list updated for all patients using regular medicines and, if necessary, provide a printed copy. 
• Reserve prescriptions against substitution if there are compelling medical reasons for doing so. 

In cases of active ingredient prescribing, the prescriber does not specify a brand on the prescription, which simplifies substitution, makes it easier to understand, and improves adherence for the patient. However, the fact that a medicine can be prescribed by active ingredient does not necessarily mean it is substitutable at the pharmacy. This depends on whether a marketed generic or biosimilar substitutable medicine exists. 

NOMA can override whether a medicine can be prescribed by active ingredient. This may be relevant, for example, when medicines in the same active ingredient group belong to different substitution groups. It can still happen that certain medicines, which must be prescribed under a brand name, are listed on the substitution list and are therefore substitutable at the pharmacy. 

Written patient information can also be used when the physician deems it necessary. Click here to download a brochure. 

Reservation Against Substitution 

The physician can reserve against medicine substitution if there are compelling medical reasons. The physician must evaluate all prescriptions individually, even when another physician has previously reserved against substitution. The physician must always document the medical reason for the reservation in the patient’s medical record. 

Compelling medical reasons include: 

• Significant issues with misuse or non-adherence, for example, in cases of cognitive impairment, visual impairment, mental illness, or polypharmacy. 
• Significant challenges with handling the substitution of administration equipment, such as differences in injection devices. 
• Severe problems with excipients, including previous serious allergic reactions to excipients. 
• Pronounced side effects from previous substitutions of the same active ingredient. 

It is up to the physician to assess whether there are compelling medical reasons to reserve against substitution. A single negative experience with substitution cannot justify a reservation against substitution of other types of medicines in the future. The physician also cannot reserve against substitution based on general skepticism about the substitution scheme or because the physician or patient assumes that the medicines are not equivalent. 

If the conditions for a reservation by the physician are not met, the patient can choose to reserve against substitution at the pharmacy. In such cases, the patient must pay any price difference themselves. 

NOMA does not assess what constitutes compelling medical reasons in individual cases. 

Medicines with particularly high reservation rates 

In general, physicians follow the guidelines for reserving against substitution appropriately. On average, physicians reserve against substitution for 4% of prescriptions in pharmacies. However, for certain medicines, the reservation rate is significantly higher. This applies particularly to the medicines Nexium, Zyrtec, and Lipitor, where the reservation rates in 2021 were 21%, 9%, and 7%, respectively. 

These three medicines account for approximately one-third of the total cost of physicians’ reservations against substitution. NOMA does not see additional challenges related to adherence, excipients, administration equipment, or side effects with these medicines that would explain the high reservation rates. 

If the reservation rates for Nexium, Zyrtec, and Lipitor were at the “normal” level of approximately 4%, public health insurance would save approximately 60 million NOK annually. 

Notes 

1. Farmalogg’s Medicine Statistics: Percentage of all sold packages dispensed from pharmacies on blue prescriptions with a physician’s reservation. 
2. Total cost of the 25 active ingredients with the highest estimated additional cost due to physician reservations in 2021.