Medicines unlicensed

Association of the British Pharmaceutical Industry. The Supply of Unlicensed Medicines. London APBI, 1990. 

This provision allows Member States if they wish (there is no obligation to do so) to make national arrangements for the supply of unlicensed medicines for particular use, but only in the very limited circumstances specified by the Directive. 

The supply of unlicensed medicinal products for individual patients is governed by paragraph 1 of Schedule 1 to the regulations. The text follows the wording of the Directive quite closely, although curiously it omits any reference to the requirement to fulfil special needs ... 

The widest use of unlicensed medicinal products is in the course of clinical trials. It is important to distinguish between clinical trial use and particular patient use, as very different rules govern these different types of use. 

It should be remembered that a practitioner prescribing an unlicensed medicine does so entirely on his own responsibility, carrying the total burden for the patient s welfare and, m the event of an adverse reaction, may be called upon to justify his actions. Under these circumstances it may be advisable for the practitioner to check his position with his medical defence union before prescribing such unlicensed products. 

Where a company suspects that the product is to be used in a way that is not safe for patients, its duty to those patients may involve warning the doctor that it considers the proposed use to be hazardous and, if necessary, refusing or terminating supply. While there is no general obligation to provide product information with unlicensed medicines (and, as noted above, the use of promotional material is prohibited), from a product liability standpoint, the provision of basic safety information about the product is a sensible precaution. 

At the operational level, manufacturers must apply proper care and rigorous quality control during production, to ensure that they supply unlicensed medicinal products of the highest quality. They must also have in place proper systems for dealing with requests for particular patient supply and for keeping all the necessary records. 

In Guidance Note 14, the Medicines and Healthcare Products Regulatory Agency states that hospital trusts, health authorities and independent hospitals should have clear policies on the use of unlicensed medicines, explaining liability considerations and requiring all those involved in the supply chain to ensure that the unlicensed status of a product is commimicated and fully understood. 

Doctors are, of course, under an obligation to inform their patients adequately about proposed treatments, but a company maybe concerned that a patient may not know that he is being treated with an unlicensed medicine. One option would... 

Royal Pharmaceutical Society of Great Britain (RPSGB) (2007) Fitness to Practice and Legal Affairs Directorate Fact Sheet Five. The use of unlicensed medicines in pharmacy. http //www.rpsgb.org/pdfs/factsheet5. pdf [Accessed 4 July 2008],... 

The DDX scheme is a notification procedure for a doctor or dentist plcinning to conduct a clinical trial independently of a commercially interested party and entirely on his or her own responsibility, using an unlicensed medicine or a licensed medicine supplied other them in response to a prescription. The scheme allows a... 

Doctors may prescribe any licensed (i.e. products with a UK marketing authorisation) or unlicensed medicinal product on an NHS prescription form (unless the item is specifically prohibited by the relevant Drug Tariff - see Section 2.6). In addition they may prescribe any licensed or unlicensed product on a private prescription form (see Section 5.1). NHS prescriptions written by doctors for dispensing in the community will usually either be written by general practitioners (GPs) or (less commonly) by hospital doctors. Prescriptions for patients written by hospital doctors that are to be dispensed within the hospital are written on hospital-specific forms (see Section 4.2). 

Dentists are regarded as practitioners and can legally prescribe any licensed or unlicensed medicinal product on a private prescription form (see Section 5.1), although they are ethically expected to limit their prescribing to within their individual area(s) of competence. 

This provision allows Member States if they wish (there is no obligation to do so) to make national arrangements for the supply of unlicensed medicines for particular use, but only in the very limited circumstances specified by the Directive. As part of the 2001 review process, the European Commission recently issued proposals to regulate the compassionate use of medicinal products falling within the scope of Regulation 2309/93/EC (the centralised procedure). However, these proposals are unlikely to come into force for several years. 

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