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Prescribing - Unlicensed Medicines

Updated on Thursday, 3 November 2016, 840 views

In theory,  GPs  should nearly always prescribe medication for an indication that is named within the  product licence of  the specific  medicine in question.  Product licences, or marketing authorisations, are granted by the MHRA  (or  at the time of writing in October 2016, by the EMA.)

The term ‘unlicensed medicine’ is used to describe medicines that are used outside the terms of their UK licence or which have no licence for use in the UK.  Unlicensed medicines are in common use especially in paediatrics, psychiatry and palliative care.

It is important to remember that product licences are  brand specific. So, for example,  generic and branded generic producers may therefore have fewer licensed indications than the original branded version of a particular drug. 

In 2013 the GMC produced comprehensive guidance on the prescribing of unlicensed products  http://www.gmc-uk.org/guidance/ethical_guidance/14327.asp , the key paragraph of which reads:

“You may prescribe unlicensed medicines where, on the basis of an assessment of the individual patient, you conclude for medical reasons that it is necessary to do so to meet the specific needs of the patient.”

Paragraphs  69 and 70 of the GMC Guidance  give more detail:

Prescribing unlicensed medicines may be necessary where:

There is no suitably licensed medicine that will meet the patient’s need, for example, where:

i   there is no licensed medicine applicable to the particular patient. For example, if the patient is a child and a medicine licensed only for adult patients would meet the needs of the child; or

ii   a medicine licensed to treat a condition or symptom in children would nonetheless not meet the specific assessed needs of the particular child patient, but a medicine licensed for the same condition or symptom in adults would do so; or

iii  the dosage specified for a licensed medicine would not meet the patient’s need; or

iv   the patient needs a medicine in a formulation that is not specified in an applicable licence.

b.         Or where a suitably licensed medicine that would meet the patient’s need is not available. This may arise where, for example, there is a temporary shortage in supply; or

c.         The prescribing forms part of a properly approved research project.

70        When prescribing an unlicensed medicine you must:

  1. be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy.
  2. take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring, and any follow up treatment, or ensure that arrangements are made for another suitable doctor to do so.
  3. make a clear, accurate and legible record of all medicines prescribed and, where you are not following common practice, your reasons for prescribing an unlicensed medicine.

Because  product licensing does not always match well with actual practice, off-licence use  is  fairly common, for instance

  1. When a generic product is in common use for an indication that evolved after it came off patent – for example, amitriptyline for chronic pain.
  2. When a  branded manufacturer obtains an additional indication on a licence that competitors do not have.
  3. When a new  indication evolves based on  research findings but no manufacturer has  (yet) applied for a licence.
  4. When a product with an adult licence is used for children
  5. When a particular formulation is required that is not specified on the original licence or the patient needs a dose outside the licensed range.

A good rule of thumb is only to prescribe off-licence  either  when it is established practice to do so (amitriptyline for pain), or when specifically advised by a suitable specialist to do so  (though remember that prescribing responsibility falls to you, so be prepared to challenge   recommendations you are unhappy about), when a patient needs a medicine formulated in a specific way and no licensed alternative is available, or when  the CCG  (or its successor)  is recommending a  change to generic or branded generic prescribing and has considered the license implications of this.

Once that decision is made you should, as far as possible, try to

  1. Be aware of the licensed indications for the drugs you prescribe and when you are prescribing outside them.
  2. Remember that product liability now initially falls upon you as the prescriber.
  3. Make sure the patients knows that you  are prescribing off-licence, and why, and agrees to this.
  4. Note that discussion in the medical record.

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