Controlled Drugs National Group Sub-Groups Newsletter Number 1

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Controlled Drugs National Group 

Joint Sub-Groups Newsletter - September 2017. Number 1

CDAR 2016

Latest news from CQC

Controlled Drugs Annual Report 2016

Our update for 2016 highlights CQC’s activity in relation to our controlled drug responsibilities, including our role with controlled drug local intelligence networks (CDLINs), the National Group on Controlled Drugs and the Cross-Border Group for safer management of controlled drugs.

It sets out key changes to legislation, provides an overview of prescribing data and prescribing trends for controlled drugs across England in the primary care sector and we make three recommendations to strengthen existing arrangements.

The annex reports on activity in 2016 from partner organisations of the controlled drugs national group and cross-border group.

News from the Policy Sub-Group

Human Fertilisation and Embryology Authority (HFEA) and CDAOs

There are a number of organisations fitting the CDAO requirements that are registered with the Human Fertilisation and Embryology Authority (HFEA) and not with the CQC. CQC and HFEA are currently working together to develop a parallel HFEA CDAO register and we will provide an update in a future edition.  

Controlled Drugs (Supervision of Management and Use) Regulations 2013

The Department of Health are reviewing the Controlled Drugs (Supervision of Management and Use) Regulations 2013. An initial meeting was held during the autumn of 2016 to consider the effectiveness of the regulations and potential areas to include as part of the review. The Department is in the processes of planning the next stages of the review. 

The review of the Safe Custody Regulations 1973

The Home Office held the first round of meetings to review the 1973 Regulations in early 2017. Meetings have been held with representatives from both the healthcare and non-healthcare (i.e. museums and universities) sectors. A set of targeted meetings took place in August 2017 to drill down into some of the specific issues such as new technology and exemption certificates. 

Diversion from the legal supply chain

MHRA's on-going investigation into diversion of  “z drugs and diazepam ” has now identified around 130 million tablets that have been diverted from the UK authorised supply chain to the criminal market. Around 40 businesses (wholesale suppliers and pharmacies) have been identified as being involved and a number of arrests have been made. 

Launch of new reporting site for harms associated with illicit drugs

In March 2017, Public Health England and MHRA launched a new national system for reporting the effects of new psychoactive substances (NPS) and other illicit drugs, in a similar way to how adverse effects of pharmaceutical drugs are reported using the MHRA’s Yellow Card Scheme. This system is being piloted in order to collect more information about the harms of new drugs, many of which are poorly understood. 

Report Illicit Drug Reaction (RIDR) enables health professionals to report adverse effects of NPS (or any illicit drug) that they encounter with patients through a quick and easy to use website and further Information is also available on the RIDR website including summary reports and publications.

News from the Patient Safety Sub-Group 

Pain assessment in people with cognitive impairment

Pain can be difficult to assess in cognitively impaired individuals because their self-report of pain can be inaccurate or difficult to obtain. Hence behavioral and observation–based assessment is required in these patients. Common pain behaviors include: -

  • Facial expressions: Frowning, grimacing, distorted expression, rapid blinking 
  • Verbalizations/vocalizations: Sighing, moaning, calling out, asking for help, verbal abuse 
  • Body movements: Rigid, tense, guarding, fidgeting, increased pacing/rocking, mobility changes such as inactivity or motor restlessness 
  • Changes in interpersonal interactions: Aggressive, resisting care, disruptive, withdrawn 
  • Changes in activity patterns: Appetite change, sleep change, sudden cessation of common routines 
  • Mental status change: Crying, increased confusion, irritability, distress

Pain can also cause physiological changes such as: -

  • Increased heart rate 
  • Increased blood pressure 
  • Increased respiratory rate 
  • Pupil dilatation

Pain assessment tools that combine behavioral and physiological domains for assessment of pain in patients with cognitive impairment: -

  • Pain Assessment in Advanced Dementia Scale (PAINAD) - is a pain scale developed by Victoria Warden, Ann C. Hurley, and Ladislav Volicer to provide a universal method of analysing the pain experienced by patients in late-stage dementia.
  • Doloplus 2 - is a behavioural pain assessment tool used in elderly patients with limited verbal ability.
  • The Abbey Pain Scale - is an is an instrument designed to assist in the assessment of pain in patients who are unable to clearly articulate their needs.

Improving visibility of fentanyl patches

In recent years reports of accidental overdose and unintended transfer of fentanyl patches have been received by the MHRA through their Yellow Card Scheme. Regulatory action was taken in 2016 to improve visibility of Durogesic DTrans patches by insertion of a coloured border around the edge of the patch with different colours to denote the different strengths available. If you are aware of safety incidents relating to accidental overdose of fentanyl please continue to report them to the MHRA; the easiest way to do so is online ( or through the Yellow Card app.

Safe use of Alfentanil injection

With thanks to the London Opioid Safety & Improvement Group (LOSIG) for providing this information.

Alfentanil is an injectable strong opioid used for pain in patients with severe renal failure (e.g. eGFR <30).

It is administered as single subcutaneous injections, or as a continuous subcutaneous infusion via a syringe pump. It can be prescribed over a wide dose range.

Practice points. 


  • Two strengths of injection are available: 500 micrograms / mL and 5 mg / mL (10 x stronger). 
  • Different strengths can be packaged in similar looking boxes.If the wrong box is chosen it can lead to the wrong dose being given. 
  • When medicines boxes look similar, stop and check the box you pick up is: the right medicine, and the right strength where more than one strength exists.


  • The wide dose range of Alfentanil means that doses can be written in MICROgrams or MILLIgrams (mg).
  • If the difference between micrograms and milligrams is not understood it can lead to the wrong calculation results e.g. the volume of the injection to be administered.
  • Micrograms are 1000 times smaller than milligrams i.e. 1000 micrograms equals 1 milligram.
  • Do not abbreviate micrograms due to the risk of misreading. 

Medicines for children

Medicines for Children is a joint project between the Royal College of Paediatrics and Child Health(RCPCH), Neonatal and Paediatric Pharmacist Group (NPPG) and Wellchild which aims to provide reliable practical advice for parents administering medicines to children.  The website contains about 200 leaflets and instructional videos. All information is carefully quality controlled and maintained. We encourage you to look at this helpful website and to forward the link below to your interested colleagues, parents and professionals


Improving visibility of fentanyl patches

In recent years reports of accidental overdose and unintended transfer of fentanyl patches have been received by the MHRA through their Yellow Card Scheme. Regulatory action was taken in 2016 to improve visibility of Durogesic DTrans patches by insertion of a coloured border around the edge of the patch with different colours to denote the different strengths available. If you are aware of safety incidents relating to accidental overdose of fentanyl please continue to report them to the MHRA; the easiest way to do so is online ( or through the Yellow Card app.

Morphine Oral Solution

News from the Prescribing Sub-Group 

High volume prescribing of morphine sulfate oral solution 

It has come to light through the work of the prescribing sub-group that some patients are prescribed very large doses of controlled drugs to manage their pain. In particular we have seen volumes of morphine sulfate oral solution 10mg /5ml prescribed that exceeds six litres on a single prescription. While this may be clinically appropriate for some patients, others may benefit from a review of the medicines they take and a slow release preparation considered instead. We highlighted the importance of ongoing review in our recent annual report and make a recommendation to ensure that the preparation prescribed and the length of treatment is the most appropriate and effective for the patient to reduce opportunities for over prescribing and diversion. NHS England CDAOs will be following this up further in their areas.

Faye's Story: 

This is a sad story that  emphasises important lessons when prescribing for pain.  Persistent pain is often complex in origin and a full understanding of a patient's physical and emotional health underpins good prescribing.  Long term prescribing for pain should always be collaborative between the patient, the GP and specialists involved and clinicians must be mindful of the need for close monitoring and adherence to the treatment plan.  Opioid medicines should always be used as part of a broader therapeutic package using non-pharmacological measures to support the patient in improving their quality of life despite ongoing pain.


News from the Vigilance Sub-Group 

Good practice points to consider when using the services of bank & agency staff and advice for lone prescribers

This is an on-going issue that has been raised by members of the sub-group; 

Bank/Agency staff

  • Check the relevant register i.e. GPhC, GMC, NMC and so on for any conditions on their registration 
  • Check their PIN number and identity
  • Ask for references 
  • Where possible, interview them prior to appointment 
  • If required, request a DBS check. 
  • Do not rely on verbal assurances from a locum agency.
  • Take the time to feedback to the employment agency if they perform poorly
  • Consider whether the locum/bank member needs to have access to controlled drugs

Beware that those minded to obtain controlled drugs i.e. for diversion or for their own use can and do apply for jobs in both the health and care sector. 

Be particularly alert to de-registered clinicians, those who have been fired from roles in healthcare settings and who may have then gone on to change their name. 

Security of prescription forms issued to lone prescribers;

  • Completed and blank prescription forms should be locked in a drawer or cupboard.
  • Prescription pads must never be left in public view.
  • Completed and blank prescription forms carried on vehicles such as ambulances should be locked in the Trust approved safe. Where vehicles do not have a safe, the prescription pad should be locked in the boot and the alarm should be set. 
  • Where they need to be taken into a patient’s home, only one or two prescription forms should be taken in and these must be locked in a case.

Please see NHS Protect's guidance on security of prescription forms

How to report any unusual behavior that could be due to the misuse of controlled drugs. 

If you have concerns around the theft or misuse of any controlled drugs either by members of staff or by the public you should report it straightaway. Timely reporting of concerns can often prevent other crimes or abuse taking place. There are a number of ways that you can report your concerns:

  • Directly report any unusual activity to the local Controlled Drugs Accountable Officer (CDAO) or NHS England Lead Controlled Drugs Accountable Officer. CQC's CDAO Register
  • Contacting your local Police Force Controlled Drugs Liaison Officer
  • Report any unusual activity by calling National Police reporting on 101 or by  
  • Finding your local police force website and reporting the unusual activity on-line.

Medicines & Healthcare products Regulatory Agency (MHRA)’s EU Common Logo

Falsified medicines are a major threat to public health and safety. Anyone selling medicines to the public via a website must be registered with MHRA and display an EU common logo on every page of the website offering medicines for sale. The EU Common Logo (applicable to all legal retailers of medicines – pharmacies and others) was implemented in UK on 1st July 2015 with the aim of helping members of the public to identify websites that can legally sell medicines.

MHRA is the UK authority with responsibility for registering applicants and compiling a national database with details of suppliers, premises etc. Further information can be found here and the  MHRA press release on selling medicines online 

Storage of controlled drugs in a patient's home

Due to the potent nature of controlled drugs, patients, family members and carers should be given clear instructions on how to store these medicines securely within their own home. Ideally, advice on safe storage should be provided by the practitioner issuing the prescription and the community pharmacist supplying the controlled drug to the patient.

This advice becomes particularly important when young children are living in the home. A number of children in the UK have died or nearly died as a result of adults leaving strong analgesics lying around where children can easily access them. In particular, these medicines can appear very attractive to a young child who will not know the difference between brightly coloured medicines and sweets. Methadone along with other controlled drugs, even in very tiny amounts, can kill a child. 

A safety checklist could include some of the following: 

  • Store controlled drugs & all medicines safely in the home (locked away, out of sight and reach) 
  • Avoid taking medicines in front of children 
  • Advice not to put medicines in bottles without child-resistant lids 
  • Teach children about the dangers of medicines 
  • Never give children medicines to taste 
  • Providing information on safe handling of old or unwanted medicines which includes advice on where to take for safe disposal
  • Providing advice on storing and where to take for disposing of injecting equipment safely


Links to key organisations and relevant Guidance  

CQC is the health and social care services regulator with responsibilities for oversight of safe arrangements for controlled drugs across England. Website

The Department of Health (DH) helps people to live better for longer. They lead, shape and fund health and care in England, making sure people have the support, care and treatment they need, with the compassion, respect and dignity they deserve. Website

The Home Office leads on immigration and passports, drugs policy, crime policy and counter-terrorism and works to ensure visible, responsive and accountable policing in the UK.Website

NHS England leads the National Health Service (NHS) in England. We set the priorities and direction of the NHS and encourage and inform the national debate to improve health and care. Website

The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. Website

NHS Counter Fraud Authority (NHSCFA) (formerly known as NHS Protect  The NHSCFA)began in shadow form in April 2017. It will be established as an independent special health authority in autumn 2017. The NHSCFA will provide a clear focus for both the prevention and investigation of fraud across the health service and will work with NHS England and NHS Improvement to properly uncover fraud and tackle it effectively. Website

Report NHS Fraud online here or by phoning the FCRL on 0800 028 4060

Talk to Frank. Offers an educational and confidential advice service on drugs and legal highs. Details can be found here.