|
Project managing a named-patient programme can be time-consuming and complex. Many pharmaceutical companies choose to outsource the management of the supply of their drug to a specialist third party company who are considered experts in controlling the supply of medicines on a named-patient basis.
Maintaining control of the programme
There are several important elements to consider in any named-patient management programme.
1. Use pharmacovigilance:
- If your drug is to be used prior to launch, a system must be in place to capture any patients who experience adverse effects, in order to manage a recall and for quality assurance purposes. A screening process between the pharmaceutical company's internal medical department and the physician should be implemented prior to supply of the medicine. Close monitoring of the use of the drug enables the company to capture response and side-effect data for future use. This would be equivalent to the ‘Yellow Card’ system.
2. Maintain traceability and manage counterfeit concerns:
- It is important to inform and advise physicians how to use the drug correctly and also to remember that unlicensed drugs need to have appropriate labeling and packaging.
3. Involve pharmacists:
- The prescribing physician makes the decision whether to use an unlicensed drug. However, the dispensing pharmacist also has a duty of care when dispensing the requested medicine. Successfully managed named-patient programs will ensure the drug is being used correctly and the access to it is controlled appropriately.
Managing global demand
The drug that is currently undergoing regulatory approval in any particular jurisdiction may have already been launched elsewhere in the world; some the key physicians may already be using it in other countries. It is important therefore, to discuss internally the potential global demand for the product and devise a global strategy. For example, launching the drug in some European countries and/or USA but only making it available on a named-patient basis in other countries. Managing the demand from different markets can be complex and involves dealing with different languages, cultures, currencies and time zones.
Adhering to EU regulations
When launching a product within Europe, not all markets will gain approval or will have the product available at the same time. In some EU markets as well as emerging markets including Brazil, the commercial size of the market could exclude the potential for a drug to become licensed.
The current EU regulations state that "No medicinal product appearing in the Annex may be placed on the market within the Community unless a marketing authorisation has been granted by the Community in accordance with the provisions of this Regulation." However, there is an exemption order that allows the supply and use of unlicensed medicines (that is, those medicines which do not yet have a marketing authorization) on a named-patient basis.
European guidelines do not allow the promotion of a drug pre-launch. However, pharmaceutical companies can respond to requests directly from physicians without actively promoting the drug.
Similar regulations exist for the USA and Canada as well most of the developed as well as emerging countries.
Obtaining market intelligence
Running a named-patient programe can provide you with important market intelligence, as well as providing you with a commercial opportunity to increase access to your medicines prior to launch and help to uplift sales at launch. The feedback gained from patients and physicians can provide useful pre-marketing data to support approval of the drug. Information, such as the prescribing physician and the number of patients treated, can assist with early-stage brand advocacy development in the lead up to launch.
|
