Understanding Changes in How Unlicensed Medication Is Prescribed

A valuable role that has been exploited?

Unlicensed medication - also known as ‘off-label’ medication - is commonly used to treat patients around the world. In most cases it is only used when normal licensed medicine cannot be used. For example if a patient could not swallow tablets or were allergic to an ingredient in the licensed medicine. Therefore liquid medicine specialists such as Rosemont Pharmaceuticals  and other drug companies such as Pfizer provide an important service to those who suffer with dysphagia who may have to be prescribed unlicensed medication as an alternative to solid medication.

According to NICE unlicensed medication has a ‘valuable role to play’ when it comes to caring for patients when there are no licensed medication available to treat their symptoms. However, they also mention that ‘..information for healthcare professionals and patients to decide whether these medicines are safe and effective, and when they are most likely to yield good patient outcomes, can be difficult to find’ With this in mind it has been of little surprise that there has been an outcry when unlicensed medication has had serious side effects on patients and to make matters worse, may have not been administered for the correct reasons.

One example of off label medication usage is when medication licensed for one condition gets used to treat another condition it is not licensed for. This is not uncommon, however in light of the lack of information available on the dangers unlicensed medications can pose to a person’s health, the reason for choosing the off label medication has to be seen as sound and in the patients best interests. In fact, the MHRA advice to prescribers several criteria should be taken into consideration before prescribing an unlicensed medicine. These include being satisfied that:

• an alternative, licensed medicine would not meet the patient’s needs
• such use would better serve the patient’s needs than an appropriately licensed alternative
• there is a sufficient evidence base and/or experience of using the medicine to show its safety and efficacy

Serious side effects from unlicensed use of Avastin

However concerns have been raised over the last few years about the usage of such unlicensed medication and the reasons as to why this was used. One of the cases that caused much controversy was when a precautionary recall of 27 Avastin batches occurred in the US. This was as a result of reports that many users had developed an in inflammatory condition of the internal coats of the eye called endophthalmitis and in fact in some cases, patients lost all remaining vision in their eyes. Avastin is licenced for use as a cancer drug but has been used off label for the treatment of wet ADM. The actual licensed drug for the treatment for wet AMD is Lucentis (ranibizumab). However, the reason doctors used the unlicensed Avastin is because it was notably cheaper- around $50 per injection compared to the $2,000 of Lucentis.

The outfall from this was dramatic and triggered a series of events around the safety concerns of using unlicensed medicines. . In 2012, Jim Thomson, chair of the European Alliance for Access to Safe Medicines (EAASM), said "We are not just heading for a healthcare system where economic factors are placed before patient safety and choice - we are already there," and ‘…this is about money, pure and simple, but at what price? Patient safety? What price is a patient's sight worth?"

What became even more concerning to patient representatives, was that despite the safety concerns, the GMC had drafted proposals back in 2011 considering altering guidelines that actually allowed doctors to make decisions based on cost. They even suggested that doctors would not have to tell patients if they intended to treat them with an unlicensed medicine.

However the GMC has now published their updated guidelines (February 2013) and rather than cost playing a major factor in choice between licensed or unlicensed medication, the guidance now highlights that patient ‘needs’ should be at the heart of the service. Also, it states to medical practitioners that ‘ you must give patients (or their parents or carers) sufficient information about the medicines you propose to prescribe to allow them to make an informed decision’

Hopefully, now that patient needs are always going to be at the heart of a clinical decision of what medication should be prescribed, scenarios like the Avastin fiasco will be avoided and unlicensed medication will not be singed in the media spotlight. Eventually it may be given more publicity for positives such as benefiting areas such as paediatrics where difficulties in developing age appropriate formulae mean that children are often given off label medication and for cases of rare diseases where unlicensed medication may be a persons only hope.

Resources

http://www.pharmatimes.com/Article/11-09-22/Calls_for_Europe_to_curb_and_control_off-label_use.aspx
http://www.pharmatimes.com/Article/11-10-06/Govt_moves_on_evidence_base_for_off-label_Rxing.aspx
http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/DrugAlerts/Company-ledrecalls/CON146660
www.gmc-uk.org/Good_practice_prescribing_consultation_draft_FINAL.pdf_40006888.pdf
http://www.pinsentmasons.com/en/media/legal-updates/updated-guidance-from-gmc-on-using-unlicensed-medicines-/
http://www.gmc-uk.org/guidance/ethical_guidance/14316.asp
http://www.gmc-uk.org/Prescribing_Guidance__2013__50955425.pdf
http://www.gmc-uk.org/guidance/ethical_guidance/14316.asp
http://www.pinsentmasons.com/PDF/LifeSciencesLegalOutlook.pdf
http://www.gmc-uk.org/guidance/ethical_guidance/14327.asp
http://www.rosemontpharma.com/
http://www.pharmatimes.com/Article/11-09-01/Off-label_Avastin_use_linked_to_eye_infections.aspx