Both prescribers and pharmacists have a responsibility to make sure that, where unlicensed medicines (‘Specials’) are prescribed, they are the most appropriate choice and patients are supported to use them effectively.

In their report, ‘Professional Guidance for the Procurement and Supply of Specials, December 2015’, The Royal Pharmaceutical Society stated that, ‘When procuring and supplying a Special, pharmacists must ensure that patients receive medicine that is of appropriate quality, is appropriate for the patient’s condition and personal circumstances, with minimal clinical risk.’

Employing the services of a reputable unlicensed medicine manufacturer will help to ensure pharmacists comply with this guidance.


There are potentially hazardous outcomes that may result from splitting, crushing and opening presentations of licensed medicines that can be avoided by using an unlicensed medicines (Specials) manufacturer to prepare a patient-specific presentation.

The potential consequences can include:

  • Healthcare professionals or carers being exposed to health risks through powder aerosolization;

  • Irritation if the drug was inhaled or came into contact with eyes, skin or other mucous membranes and, in some cases, causing skin toxicity;

  • Negative impact on the stability of the drug substance;

  • Less drug available to produce the desired clinical effect (e.g. through powder loss or uneven split);

  • Loss of protection of the drug from the effects of light;

  • Changes in the drug pharmacokinetics & bioavailability resulting in under-dosing or adverse effects;

  • May cause oesophageal or stomach irritation or ulceration if tablets are crushed or capsules opened;

  • Reduction in compliance as the patient may refuse to take the medication due to unpleasant taste;

  • Possible anaesthetic effect on the tongue, particularly if sertraline is given in a powdered form;

  • Potential of an unintended large bolus dose being delivered rather than controlled release over the intended timescale resulting in a potentially toxic dose with an increased risk of adverse effects;

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

This list is a summary of concerns raised by the Royal Pharmaceutical Society in the document, “Pharmaceutical Issues when Crushing, Opening or Splitting Oral Dosage Forms”. We strongly advise a full reading of all Specials related documentation. This can be found at:


Another key consideration for Pharmacists who are being advised to split, crush or opening tablets and capsules is that the NPA Insurance does not cover members should there be any adverse effects. For full details, we urge you to look for the Specials and NPA Insurance document (January 2011) in the NPA Member’s area

IPS Pharma manufactures all unlicensed medicines (Specials) in our cGMP-compliant and MHRA licensed facility and a Certificate of Compliance accompanies each one – providing peace of mind for prescriber and pharmacist while fulfilling the unmet medical needs of individual patients in a safe, ethical and compliant manner.

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