Report on generic prescription – advantages and disadvantages

13 December 2006

The aim of this report is to analyse and describe the advantages and disadvantages related to generic prescription. The report is based on a Swedish report on generic prescription (“Generisk förskrivning”), which was drawn up by the Swedish Medicinal Products Agency. Moreover, the report is based on views and comments from external interested parties as well as on a brief review of the conditions in a number of European countries.

It is widely believed that generic prescription entails patient safety advantages in the form of a smaller risk of medication errors and duplication of medication as well as less confusion among medicine users. Generic prescription, and thereby the use of generic medicine names, is not entirely uncomplicated. Some medicinal products have long and difficult generic names or names that can be mistaken for other generic names. Neither the patient safety advantages nor the patient safety disadvantages are scientifically documented.

From the viewpoint of the healthcare system, there may be several advantages related to generic prescription. The prescribing doctor does not need to use time and energy on choosing between different generic medicinal products, and the use of generic names in everyday life may also facilitate the work of foreign doctors working in the Danish healthcare system.

There are no direct economic advantages related to generic prescription. The societal economic benefit, which pertains to the use of inexpensive generics instead of expensive original medicinal products, is already gained via the generic substitution arrangement at pharmacies. However, there are some initial costs involved in the introduction of generic prescription, hereunder in particular the development of IT systems, education and information.

If generic prescription is to be introduced in Denmark , it should be in the form of a voluntary arrangement functioning in combination with generic substitution, and the arrangement should apply to both the primary and the secondary sector.

A concrete decision must be taken to determine which medicinal products that are to be included in the arrangement. The point of departure should be that the same considerations are made as in the current substitution arrangement.

Several of the presumed advantages related to generic prescription – particularly the risk of medication errors and duplication of medication – are linked with and dependent on a changed labelling of medicinal product packages, so that the generic name gets a more prominent place than what is currently the case, since the trade name is dominant. It is, however, doubtful whether the required rules can be established nationally.

The introduction of generic prescription merely at rule level requires an amendment of the Executive Order on prescriptions.

Recommendations of the report

On the current basis, the Danish Medicines Agency does not recommend the introduction of generic prescription. These are main reasons:

  • The patient safety advantages which may stem from generic prescription are not documented. They are assumptions.
  • A significant prerequisite for achieving patient safety advantages is the introduction of more stringent requirements for the indication of the generic name on medicinal product packets. Such stringent requirements can most likely not be introduced under the current EU regulation of the area.
  • Generic prescription will create a better connection between medical scientific literature, the doctor’s working day and the issue of prescriptions. Moreover, generic prescription will facilitate the work of foreign doctors working in Denmark . The actual positive societal effect of this is difficult to quantify.
  • Society – and patients – achieve no direct financial savings. The direct economic and financial savings related to the use of inexpensive generics are already achieved by means of the current substitution arrangement.
  • Significant costs are involved in the introduction of generic prescription, for instance for changing the IT systems of doctors and pharmacies as well as information and education. However, these are primarily non-recurring expenses.

Over the past years, a large number of system changes have been implemented within the pharmaceutical area, and they have had great impact on the everyday life of doctors and at pharmacies, for example several changes of the reimbursement system, changes of the substitution arrangement, changed prescription procedures and the establishment of the Medicine Profile. In the light of this, caution should be exercised with regard to yet another extensive system change, and especially when the positive effect of such a change is uncertain.

If interested parties etc. have a strong and unambiguous wish for the introduction of generic prescription, it may – regardless of the above – be considered to launch a test of voluntary generic prescription. According to the Danish Medicines Agency’s assessment, there are no significant risks involved in such a test. The majority of the interested parties, which the Danish Medicines Agency contacted prior to the drafting of this report, were positive towards generic prescription.

The above initial expenses for the development of IT systems, education and information will, to a great extent, be incurred regardless whether generic prescription is implemented fully or in connection with a limited test.

If generic prescription is introduced, the arrangement should be systematically evaluated after an appropriate period of time.

The entire report is available via the fact box to the right (in Danish only).

The Danish Medicines Agency, 13 December 2006