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SPECIALS


tHE USE of ‘SPECIAlS’ CoStS tHE nHS MIllIonS EACH YEAR. WItH InCREASIng DEMAnDS on tHE nHS BUDgEt, gAREtH MCCABE ConSIDERS HoW tHE MonEY SPEnt on SPECIAlS CoUlD BE BEttER InVEStED In otHER AREAS.


SPECIAlS tHE CASE foR By gareth McCabe A


special preparation is an unlicensed medicine that needs to be specially


manufactured and ordered. they are made to meet the specific needs of an individual patient. the prescribing of unlicensed medication is undertaken in certain clinical situations. this is based on the best available evidence and is judged that a special is in the best interest of the patient.


However, prescribers are advised that they should not continue to use an unlicensed product, unless there is a specific reason, where there is a licensed product available.


Special medications may be prescribed due to a variety of different reasons, the most common of those being¹:


• patient has an allergy to an ingredient used in ‘conventional’ licensed products • patient may have swallowing issues (dysphagia) and cannot take the licensed product • to improve compliance by combining several medications the patient is taking.


A special can be extemporaneously prepared, which is more common option for certain creams and ointments. If it is unfeasible or the pharmacist chooses not to prepare an unlicensed medicine in the pharmacy


48 - PHARMACY In foCUS


then there are laboratories or manufacturers that prepare them for you.


this article relates primarily to those medicines manufactured outside of the dispensary. this usually comes at a much higher price and may incur extra out of pocket fees (eg, handling or delivery fees).


In 2014, approximately £6.4 million was spent on specials in northern Ireland². this is a large amount to spent on medication that in many cases the patients‘ needs could be met with a licensed medicine or a more competitively priced special could have been sourced elsewhere (See table 2).


lEgAl ISSUES: When a prescriber writes a prescription for a licensed product, with the licensed dose and indication, they are protected if any issue regarding adverse effects to a patient occurs. the legal responsibility lies with the pharmaceutical company.


However, for specials, the responsibility lies primarily with the prescriber for any adverse effects to a patient (unless it can be proven that the product was faulty). Pharmacists have a professional responsibility to make prescribers aware of the unlicensed nature of any special before sourcing the product.


As professionals we have an obligation to the care of our patients.


If the special is unsuitable or the directions are off-license (eg, crush tablet, open capsule) and we deem the prescription could adversely affect the patient we have a duty to refuse dispensing. the main issues with crushing a tablet or opening a capsule can be found in the RPS guidance document³:


Healthcare professionals or carers can be exposed to health risks through powder aerosolisation and irritation to the eyes, skin or any mucus membranes if the drug was to come in contact with them. As for the patient themselves, manipulation of a dosage form may cause oesophageal/stomach irritation or ulceration.


Regarding the medication, when altering the dosage form it can lead to less drug being available to produce the desired clinical effect. this can be through powder loss or an uneven split.


there are also changes in the drug pharmacokinetics and bioavailability resulting in underdosing or adverse effects. Conversely there is potential for an unintended large bolus dose being delivered rather than controlled release over an intended timescale resulting in a potentially toxic dose.


And finally, crushing enteric coated tablets may result in the drug being released too early, destroyed by stomach acid, or irritating the stomach lining.


It is important to bear in mind that verbal communication from the prescriber requesting dispensing to go ahead regardless may not remove you from legal liability 4


.


‘Altering a licensed medicine by crushing, suspending or dissolving a tablet or opening a capsule, results in the medicine becoming unlicensed. You may become liable for any harm caused as a result of your actions.’ (the Human Medicines Regulations 2012)


Another key consideration for pharmacists who are being advised to split, crush or opening tablets and capsules, is that most insurance companies do not cover members should there be any adverse effect.


fURtHER REQUIREMEntS WHEn SUPPlYIng UnlICEnSED MEDICInES 5


:


As with any prescription there are certain requirements that need to be made regarding record keeping. Any person selling or supplying a special must:


(a) Keep the following records for at least five years: • the source from which and the date on which the person obtained the product;


• the person to whom and the date on which the sale or supply was made;


• the quantity of the sale or supply; • the batch number of the batch of that product from which the sale or supply was made; and


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