Alternatives to prescribing unlicensed pharmaceutical special-order products (‘specials’) for adults Page 1 of 21 Version 24 – July 2015 This document is regularly reviewed in line with any significant changes Disclaimer The information contained within is intended for use by healthcare professionals within Coastal West Sussex Clinical Commissioning Group (CCG). The decision to alter the formulation of a medicine must be taken by the prescriber, where clinically appropriate for the individual patient concerned as this is usually outside of the terms of the product license. Not all medicines are suitable for crushing/dispersing/opening and it is important to check beforehand for each individual medicine. We have made every effort to check that all information is correct at the time of publication. Coastal West Sussex CCG does not accept any responsibility for loss or damage caused by reliance on this information. Where alternative agents are suggested, therapeutic equivalence is not implied and patients will require monitoring and possible dose titration when switching to a different medicine. The need for a pharmaceutical ‘special’ or crushing tablets or opening capsules should be reviewed regularly. Please note that some of the possible alternatives suggested in this booklet may contain alcohol, sodium, lactose and other excipients that may not be clinically appropriate for all patients. Refer to the medicines’ Summary of Product Characteristics (SPC) or the British National Formulary (BNF). Alternatively, contact the Medicines Management Team should you require further advice. If unsure, please seek further advice from a pharmacist. Please note that when dispensing an unlicensed/special medicine, pharmacists will also bear responsibility for that product. Page 2 of 21 Version 24 – July 2015 This document is regularly reviewed in line with any significant changes Introduction This booklet aims to provide prescribers with alternatives to pharmaceutical special-order products (commonly referred to as ‘specials’). This booklet does not include specific recommendations relating to the suitability of administration via enteral feeding tubes and as such, prescribers are advised to contact the Coastal West Sussex Medicines Management Team, using the contact details listed below, for additional information relating to individual patients where the medication is to be administered via an enteral feeding tube. Definition: Pharmaceutical ‘specials’ are unlicensed medicines that are commercially made-to-order to satisfy an individual patient’s specific clinical need. Pharmaceutical specials are unlicensed medicines that have not been assessed for safety, quality or efficacy by the relevant licensing authorities and are not required to be manufactured to the same standards of Good Manufacturing Practice (GMP) that is normal for pharmaceuticals. The prescriber takes responsibility for the quality of the medicine and any adverse effects experienced by the patient when prescribing 'specials' and they represent a considerable cost to the NHS. Prescribers and pharmacists have a responsibility to ensure that ‘specials’ are only prescribed and dispensed where there is no suitable licensed alternative available. Where appropriate, off-label use of a licensed product (such as crushing tablets or opening capsules) may be preferable to prescribing a wholly unlicensed pharmaceutical 'special'. Some patients, in particular paediatric patients, may require liquid formulations in order to allow a measurable dose to be administered. In such cases, it is not routinely advisable to crush tablets / open capsules or use dispersible formulations with a view to administering a proportion of the dose. Contact details for additional advice If you are looking for a medicine that is not listed in this booklet, require advice on the administration of medicines via enteral feeding tubes, or any additional information, please refer to Coastal West Sussex (CWS) Local Health Economy Formulary (http://www.coastalwestsussexformulary.nhs.uk/). Alternatively, contact CWS Medicines Management Team via [email protected] or by phone: (01903) 707416 Feedback on the Booklet The reviewer of this booklet is keen to have your feedback and would genuinely welcome any comments you may have. In addition, if there are products that you feel should be considered for inclusion when this booklet is next reviewed, please send them at any time to: Coralia Wukovich RegPharmTech Medicines Management Technician E-mail to: [email protected] Page 3 of 21 Version 24 – July 2015 This document is regularly reviewed in line with any significant changes Choosing medicines for patients unable to take solid oral dosage forms A stepwise approach is suggested: STEP 1 I f the medicine is still needed, use a STEP 2 licensed medicine in a suitable Use a licensed medicine in an formulation. unlicensed manner, for example by For example: crushing / dispersing tablets in water STEP 3 Licensed liquid preparation or by opening capsules. Licensed soluble tablets In the few situations where there Licensed powders or granules for suspension Not all medicines are suitable for administration in is no licensed option, consider Licensed patches this way and it is important to check beforehand. See using a ‘special’. overleaf for where to get advice. In order to use a licensed medicine, consider switching to a different agent in the same class, or to As before, consider switching to a different agent or Special-order (‘special’) medicines are a different route of administration. unlicensed and expensive. They should only be route of administration in order to use a licensed used if there is no licensed medicine that meets product. the patient’s needs. In most cases a licensed preparation will be available that meets the patients’ needs. Licensed medicines should be used where possible. Special-order medicines are unlicensed and expensive and should only be used if there is no licensed alternative. Page 4 of 21 Version 24 – July 2015 This document is regularly reviewed in line with any significant changes Sussex Partnership NHS Foundation Trust has developed a ‘Swallowing pills (tablets and capsules) Patient Information Leaflet’ (PIL) which aims to provide some simple techniques to help make swallowing pills easier – available from the links below. Swallowing pills - adults Swallowing pills - children Page 5 of 21 Version 24 – July 2015 This document is regularly reviewed in line with any significant changes Choosing medicines for patients unable to take solid oral dosage forms Practical directions Always check beforehand if a Crushing / dispersing tablets and opening capsules tablet is suitable for For medicines that are suitable for crushing, this should be done by using a pestle and mortar, a tablet crusher or dispersing / crushing, or a between two metal spoons. Tablets should NOT be crushed in plastic containers as the drug may adhere to the plastic. capsule is suitable for opening. The equipment used to crush tablets should be rinsed well and the rinsings administered as well to ensure the entire dose is taken. Only crush/dissolve/disperse medicines one tablet at a time; do NOT mix different medicines together. Care staff may only administer medicines in an unlicensed manner Crushing, dispersal or opening of capsules should only be performed immediately before administration to reduce the on the instruction of the risk of the medicine becoming unstable. prescriber. Patients should be advised to rinse their mouth with water after taking crushed tablets/opened capsules to reduce the risk of any local irritation or anaesthetic effect in the mouth. A written direction to crush or Medicines should only be administered in food with the patient’s knowledge and consent. Hiding medication in food is disperse tablets or to open considered ‘covert administration’ and is only allowed in certain circumstances. capsules must be documented in Tablets/capsule contents/crushed tablets should be dissolved in at least 15-30ml water, unless otherwise stated. the patient’s care plan. The NPC has published ‘Prescribing Specials – Five guiding principles for prescribers’. These principles are based on good prescribing practice and Appendix 2 contains a quick practical checklist for prescribers that can be used as a tool when prescribing. Guidance available at: http://www.npc.nhs.uk/improving_safety/prescribing_specials/ Page 6 of 21 Version 24 – July 2015 This document is regularly reviewed in line with any significant changes The decision to prescribe any medicines is down to the individual prescriber - as is always the case, the prescriber signing the prescription must bear the full responsibility for that treatment. The GMC guidance on good practice in prescribing and managing medicines and devices (2013) states that prescribers should be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy. In addition, the GMC guidance states that when prescribing a medicine that is being used outside the terms of its UK licence or which does not have a license for use in the UK, a practitioner must: a) Be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy; b) 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; c) Make a clear, accurate