In June 2011, RPS released their guidance document “Pharmaceutical Issues when Crushing, Opening or Splitting Oral Dosage Forms” along with an update on “GOOD PRACTICE GUIDANCE ON: The Procurement and Supply of Pharmaceutical Specials” relating to their “Dealing with Specials” featurette. The full guidance can be found on the RPS Website.
IPS Specials has identified the main concerns regarding crushing, splitting and opening capsules from the guidance as:
- Healthcare professionals or carers being exposed to health risks through powder aerosolisation
- 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 underdosing or adverse effects
- May cause oesophageal or stomach irritation or ulceration if tablets are crushed or capsules opened
- Refusal of taking 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
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**
Above all else, it is imperative that Pharmacists make the CARE OF PATIENTS YOUR PRIMARY CONCERN. Of course, IPS Specials takes this very seriously and all of our Specials are manufactured in our cGMP-compliant and MHRA-licenced facility, each accompanied with a Certificate of Compliance. If an imported licenced product is ordered, we will source this from an MHRA recognised authority such as Europe, USA, Canada or Australia though our comprehensive supply chain.
All information has been extracted from the RPS documents mentioned above and are meant as a condensed summary of concerns raised by the RPS - we strongly advise full reading of the documents, including the case studies contained within, which can be obtained by visiting www.rpharms.com/best-practice/specials.asp. The RPS does not recommend or endorse any company and has not endorsed IPS Specials for this article.
**Look for the Specials and NPA Insurance document (January 2011) in the NPA Member’s area www.npa.co.uk/Resources/