Call for evidence: Extemporaneous methadone
Questions for other healthcare professionals, patients and other interested parties
4. Awareness
4.1 Did you know that pharmacists can supply either a licensed methadone liquid or a methadone liquid that they have prepared themselves?
Yes, the Accountable Officers of Scotland’s NHS Boards are aware of this.
4.2 If you are a patient that receives methadone liquid, do you know which preparation you receive? Does it matter to you which preparation you receive?
N/A
4.3 If you prescribe methadone liquid, or are involved in methadone treatment programmes, do you know which methadone liquid preparation your patients receive? Does it matter to you which preparation is supplied?
The MHRA have advised that a licensed medicines should always be used in preference to an unlicensed product when both are available and the clinical outcome would be the same. It is difficult to see why this exemption should exist. In our experience it is very unlikely that the patients or prescribers have been told that the methadone is prepared in this way. The prescriber will be of the opinion that they have ordered a licensed product.
4.4 Do you have any concerns about the safety of extemporaneous preparation of methadone in pharmacy? If so, are you able to provide any evidence or specific examples where this practice has, or has had the potential, to put patients at risk?
Yes. There are safety concerns around the preparation. Stock methadone that is unusable must be destroyed in the presence of an authorised witness. There are regular requests for authorised witnesses to attend the destruction of faulty batches of methadone. This raises concerns about the processes used in some community pharmacies. Inspection reports on pharmacy premises from the GPhC suggest that there any a significant number where the standard operating procedures are not robust or not being adhered to.
There have been a number of incidents of errors over the years. One of the most serious in around 2005 resulted in patients being given a five-fold overdose and twenty patients had to be reviewed in hospital. There have also been cases of surgical spirit being used as a diluent by mistake and patients receiving the diluent alone which did not contain any methadone.
5. Impact
5.1 Do you support or oppose the exemption in standards to allow extemporaneous preparation of methadone?
Oppose.
The argument for the use of this product is that there may be restrictions on space available in suitable Controlled Drug cabinets. The pharmacists are paid to provide a professional service and so the funding received should be used to ensure that the facilities are adequate whether that includes additional staff or additional resources such as cabinets. Most pharmacies will receive at least once daily deliveries and so it is not necessary to hold large quantities of stock.
The other argument is for easier transportation of large quantities, especially in rural areas. However, there are a significant number of liquid products which are relatively high use and so also need to be transported over these distances.
This concern over extemporaneous methadone extends to other care providers as well as pharmacy. In rural areas there is an increasing presure for dispensing doctors to supply methadone, and where the extemporaneous preparation is assembled, without the supervision of a pharmacist or technician the risks of errors are compounded. Should the components of the extemporaneous preparation not be available then this risk would be removed.
5.2 Do you believe that supplying methadone liquid prepared extemporaneously has a neutral, positive or negative effect on substance misuse services?
Negative.
This is inherently a greater risk than the supply of a licensed alternative.
5.3 If methadone liquid could not be prepared extemporaneously, would this have a neutral, positive or negative effect on substance misuse services in particular the services to patients?
Positive.
There would be reduced risks to patients as the supply of a licensed product minimises the risks of products not being of the required quality.
5.4 If methadone liquid could not be prepared extemporaneously, do you think this would have a neutral, positive or negative effect, including any additional financial or other burden, on the supplying pharmacy?
Preparation of extemporaneous methadone is financially attractive as it is significantly cheaper than the licensed product, but reimbursement will be at Drug Tariff price. This means that the NHS is funding the supply of the licensed product but this is not always being used. It is not appropriate for this to continue.
6. Feedback, complaints or concerns
6.1 Have you ever had a cause for concern or made a complaint about the methadone liquid that a pharmacist has supplied?
Yes, see 4.4