It’s sad and it’s a shame, but it is the direction society and communities are heading, so pharmacists have had to take on a greater role by providing other services which would previously be performed by a nurse or doctor within a health centre. With the ever-changing role of the pharmacist becoming more fragmented within the community, the last thing pharmacists need is more pressure from PCTs regarding their spend on specials, although sadly this has become the case.
In January, the National Pharmacy Association reacted to recent reports from pharmacists regarding the fact that “medicines management teams at some PCTs are recommending the dispensing of crushed/dispersed tablets or opened capsules as part of reducing costs to the PCT of unlicensed specials”. It also went on to remind members that “the responsibility for dispensed products lies ultimately with the dispensing pharmacist” and that the NPA insurance does not cover members “who undertake PCT recommended alternatives to dispensing unlicensed specials – particularly where recommendations result in the integrity of a licensed medicinal product being compromised, eg by crushing, dispersing or breaking open (capsules) or which otherwise interfere with products in any other way.”
The Pharmacists’ Defence Association supports the professional autonomy of pharmacists regarding dispersing tablets/capsules where these are to be administered via crushing, splitting, dispersing or otherwise interfering with the integrity of the dosage unit by publishing a document for their members. It states that citing the PCT or the prescriber’s recommendations as a defence should anything go wrong would not absolve a pharmacist from their own personal professional responsibility towards patient care. After all, patient care is the primary concern of pharmacists, prescribers, PCTs and the NHS.
The reality is that prescribers and pharmacists should be able to make a professional judgement about whether a special is needed. For example, if someone needs to take a tablet, at the whole dose, but has trouble swallowing a whole tablet, then it could be deduced that splitting the tablet in half and taking two halves instead of the whole would work just as well. In some events, this is the case. However, depending on the bioavailability of the drug, its toxicity risk if airborne, as well as other factors such as any loss of the active drug during the splitting process, this may not always be the best option, particularly if advising patients, carers or anyone other than a pharmacist to carry out this process at home.
Crushing, splitting and opening capsules and tablets
The main concerns regarding crushing, splitting and opening capsules and tablets as reported by the Royal Pharmaceutical Society are:
- Healthcare professionals or carers being exposed to health risks through powder aerosolisation;
- Irritation if the drug is inhaled or comes 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 (eg through powder loss or uneven split);
Loss of protection of the drug from the effects of light;
- Changes in the drug pharmacokinetics and bioavailability, resulting in underdosing or adverse effects;
- May cause oesophageal or stomach irritation or ulceration if tablets are crushed or capsules opened;
- Refusal to take the medication due to unpleasant taste;
- Possible anaesthetic effect on the tongue, particularly if sertraline is given in a powdered form;
- Potential for an unintended large bolus dose to be 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.
So what can we do?
Pharmacists must use their professional judgement to decide which dosage form is the safest and most effective route of delivering the medicine to the patient and be completely comfortable with their decision. Understanding the patient’s needs as well as the PCT’s needs to save money will play an important role in the decision making process, but it is ultimately the pharmacist’s decision as they are the ones risking their professional livelihood.
By using a specials manufacturer who is licensed by the MHRA specifi cally to manufacture specials in their Good Manufacturing Practice labs, the pharmacist passes any responsibility for faulty medicines on to the manufacturer. The likelihood of faulty medicines from a specials manufacturer is incredibly low, particularly when the special is made by using the raw active ingredients as opposed to crushing or splitting tablets and capsules, which can still be done safely in some circumstances providing the environment is safe and the drug is stable enough to do so. Another option is to use imported medicines that are licensed outside of the UK and the manufacturer will obtain permission for import and use in the UK from the MHRA. However this is only a realistic choice if the need for the medicine is planned, non-urgent, or the specials supplier has approved stock of the imported product in their warehouse.
Criticism of the specials market
There have been a number of criticisms reported in the media regarding specials and their cost to the NHS, particularly in the face of budget cuts. The reality is that the amount spent on specials in the UK is actually only 1 per cent of the total cost of prescriptions within the UK. These are drugs which serve a specifi c purpose and are often made on demand for a specifi c patient. The prices that specials manufactures charge vary, but with the Drug Tariff soon to include the most popular specials products, there is an increasing standardisation of the industry. This should be viewed as positive news to all reputable specials providers, as the provision of safe, effective, high quality medication to patients must always be our number one concern. Ultimately, it is by pharmacists and specials manufacturers working together that we can ensure a good deal for the NHS, and a good deal for the patients.
Managing director of
1. Specials and NPA Insurance. The National Pharmacy Association www.npa.co.uk/Resources/Member-news/ About-the-Association/Specials-and-NPA-Insurance
2. PDA supports the professional autonomy of pharmacists. The Pharmacists’ Defence Association. www.the-pda.org/newsviews/nv_topical_news1.html?id=2831
3. Guidance on pharmaceutical issues when crushing, opening or Splitting Oral Dosage Forms, Good practice guidance on: the procurement and supply of pharmaceutical specials, and Dealing with specials. The Royal Pharmaceutical Society. www.rpharms.com/best-practice/specials.asp
4. www.acsm.uk.com/about/facts-and-fi gures.aspx