Controlled Drug’s Bulletin

for

Community Pharmacies

March 2013

Important Legislative changes to Sativex®

The Home Office has confirmed that the statutory instrument (SI) which places Sativex® in Schedule 4 Part I of the Misuse of Drugs Regulations 2001 (as amended) (the 2001 Regulations) has been made. The SI, which applies to Great Britain, comes into force on 10th April 2013.

On 10th April 2013 the Home Office Open General Licence under which Sativex® is currently available to healthcare will be revoked; and will become a Schedule 4 Part I drug and its continued availability for use in healthcare will be enabled under the 2001 Regulations.

In practice:

  • The Misuse of Drugs (Safe Custody) Regulations 1973 does not apply to Sativex®.
  • Regulation 15 which specifies how prescriptions for Schedules 2 and 3 CDs should be written does not apply to Sativex®.
  • FP10PCD requirements do not apply when Sativex® is prescribed privately.
  • The destruction of expired stocks of Sativex® and patient returns by healthcare professionals does not need to be witnessed by an authorised witness.
  • The requirement to keep records does not extend to the use of a CD register. However, the Home Office strongly recommends the use of the CD register, as the most recognised UK CD record keeping document, for records relating to Sativex®.

Following a review of all the CD incidents reported in from community pharmacy to the PCT and all the CD destructionscarried outin the last year we would like toremind you of the following:

CD Incident Reporting

Under the Controlled Drug legislation post –Shipman, Community Pharmacies and GP Surgeries are required to report all CD incidents,near misses and discrepancies to the CD Accountable Officer at the PCT/CCG.The PCT/CCGisrequired to maintain a record of all CD incidents, near misses and discrepancies.

It is essential that they are reported to the Accountable Officer as soon as possible so they can be dealt with appropriately. These reports allow us to review practice and see if there are any lessons to be learnt to stop suchincidents happening in the future.

If you have any concerns with frequent or excess quantities of drugs that are liable for abuse, please do not hesitate to contact the medicines management team.

Sealed Liquids

When dispensing a full and sealed bottle of a liquid CD, it is best practice to re-measure liquid prior to supplying to the patient due to the overage that could potentially be supplied. In the case of methadone, this is much more of a possibility.

Clients on methadone should not be given sealed bottles; instead, the seal should be broken, measured and then dispensed.

A concern was raised where a client was insistent on having their 1820ml fortnightly prescription of methadone in 18 sealed bottles of 100ml. The potential overage would be 180mls, unlawfully supplied.

Methadone Overage

Across a batch of methadone liquid, there is the potential for an overage up to 10%. On your balance checks (frequency dependant on usage, best practice is daily/weekly), you should include the overage in your balance, clearly annotating.

Safe Custody of Dispensed CD’s

Once a controlled drug has been dispensed and is awaiting collection, it should be kept in a locked CD cupboard out of view of customers and under direct supervision of the responsible pharmacist. This also includes methadone and buprenorphine for daily collection.

If a CD is stored on the bench and the pharmacist leaves the dispensary for whatever reason, it is then no longer under the direct supervision of the pharmacist and therefore in breach of the Misuse of Drugs (Safe Custody) Regulations 1973. Please ensure that all controlled drugs are locked in a secure CD cupboard at all times.

It has been reported that several pharmacies are leaving dispensed methadone for daily collection on the dispensary bench in full view of customers. As well as being a safe custody issue, this also raises concerns of patient confidentiality.

SMS Clients

If an SMS client has not picked up for 3 consecutive days, the SMS team should be informed immediately and further doses not dispensed until further notice. This system is in place as the client may need to have their dose altered due to the missing days as the dose originally prescribed may no longer be tolerated and may cause overdose.

Some patients in a ‘shared care’ arrangement may not have their prescription ‘tied’ to a particular pharmacy and may choose where to go. In this case, if you have any concerns about regular clients missing doses, please inform the SMS team.

A prescription may sometimes state that the client is to be breathalysed before their dose is given. This is a requirement asked of you by the SMS, it is not a professional judgement.

An incident was reported where a client had not collected their daily methadone dose for 3 consecutive days, but was dispensed to the client on the 4th day. The patent was also not breathalysed (stated on the prescription) as the pharmacist believed it to be a professional judgement and not a requirement. Training had also not been given on the breathalyser.

We have had several incidents reported where doses of methadone have been issued to a patient without a valid prescription. Please double check the dates on the prescription before issuing,

CD Balance Checking

Don't forget that you must check balances of out of date CDs even if you have no in date stock of that particular CD. We have hadcases wherethey hadn't been checked or destroyed for several years. Ifany had gone missing it wouldhave been impossible to pinpoint a sensible time frame to investigate.

A discrepancy was reported in which 1 tablet was missing from the balance. On investigation, it was discovered that balance checks of this particular drug had not been completed for 2 years prior to identifying a discrepancy.

Ami Luck – Risk Management Technician

East Sussex PCT’s