The Controlled Drugs National Group Sub-Group Newsletter

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The Controlled Drugs National Group Newsletter

Produced by the Care Quality Commission (CQC) National Controlled Drugs Group's Sub-Groups' Date; May 2018

Update from the CQC 

Human Fertilisation and Embryology Authority (HFEA) Controlled Drug Accountable Offcier (CDAO) Register 

In March 2018, the HFEA published a register of CDAOs where the organisation is  solely registered with the Human Fertilisation and Embryology Authority (HFEA) and not with CQC – albeit there is only a very small number.
We also include a link on our controlled drug pages:

    The state of care in independent online primary health services

    CQC’s publication of the findings from our programme of inspections of primary health care services provided online in the independent sector has now been published:

      Regs 2013

      News from the Controlled Drugs Policy Sub-Group

      Controlled Drugs (Supervision of Management and Use) Regulations 2013

      The Department of Health and Social Care continues to review The Controlled Drugs (Supervision of Management and Use) Regulations 2013. A questionnaire was circulated to stakeholders during May 2018 to gather views and evidence to underpin the review.  DHSC will be analysing the responses with a view to publishing a Post Implementation Review report in the summer.

      CBD (Cannabidiol) containing products

      This remains an area of much activity for the Home Office, in collaboration with MHRA and the Food Standards Agency (FSA). Whilst pure CBD is not a controlled substances under the Misuse of Drugs Act 1971, analysis to date suggests it is found in products containing controlled cannabinoids, such as  tetrahydrocannabinol (THC), and therefore is a controlled substance under Schedule 1. As such there would not be a licensing route, other than via bona-fide research with a view to ‘accreditation’ as a medicine. The Home Office have recently published a factsheet covering these issues available at:

      Pregabalin and Gabapentin Consultation  

      The Home Office's consultation ran until 22 January and they are currently working through the responses. We are awaiting a further update in the coming months. 

      Safe Custody Regulations

      The Home Office is reviewing the Safe Custody Regulations. A recent preliminary questionnaire designed to inform their impact assessment highlighted concerns that the current regulations are outdated, complex and inflexible. A full Government consultation will be carried out in the coming months giving stakeholders another opportunity to comment on the proposals. 

      News from the Patient Safety Sub-Group

      The Importance of transferring complete and accurate information across the interface 

      contributed by Tania Carruthers, Clinical Director of Pharmacy Heart of England NHSFT

      Medicines reconciliation, as defined by the Institute for Healthcare Improvement, is the process of identifying an accurate list of a person's current medicines and comparing them with the current list in use, recognising any discrepancies, and documenting any changes, thereby resulting in a complete list of medicines, accurately communicated. 
      The medicines reconciliation process will vary depending on the care setting that the person has just moved into – for example, from primary care into hospital, or from hospital to a care home or hospice.

      Here is an example to illustrate the importance of undertaking robust medicines reconciliation as individuals move across different interfaces.

      A patient was admitted to a hospice from a hospital ward. During medicines reconciliation, they were found to have a fentanyl patch 75 microg/hr in situ. The discharge letter stated that the patient was discharged on fentanyl patch 50 microg/hr. How did this discrepancy arise?

      The investigation identified that the patient was admitted to the hospital on fentanyl patch 50 microg/hr and was clearly documented in the medicines management notes by the ward based technician. It was also documented that the dose had been increased on admission to 75 microg/hr to manage the pain. However, on the day of discharge (two days later), the consultant reduced the dose back to 50 microg/hr due to side-effects. Whilst the ward staff waited for a supply of fentanyl 50 microg/hr patches to arrive to change the patch, the patient was discharged with the 75 microg/hr patch in situ.

      The learning included stating more clearly the date the patch was applied, and the date/time for its removal, improving transfer of prescription information including a robust handover to the receiving organisation.


      Potential for therapeutic duplication in patients using syringe drivers/PCA 

      contributed by Devina Halsall NHS England CDAO, Cheshire and Merseyside

      A number of patients in a variety of organisations have continued on their usual CD medicines whilst a syringe driver or PCA was started. 

      For example: 

      • Oxycodone MR 5mg po alongside a newly prescribed syringe driver containing oxycodone and midazolam 

      Oxycodone MR 40mg po alongside alfentanil via syringe driver
      Recommendations for prescribers, pharmacists and nursing teams include: 

      1. Check MAR/charts/electronic prescribing systems for concomitant medicines prescribed and worn (eg patches when starting PCAs or syringe drivers.
      2. Note the use of syringe driver or PCA, along with contents, on the drug chart or electronic prescribing system.
      3. Be aware of the risk of therapeutic duplication (eg respiratory depression) if the medicines history is not checked / reconciled when starting PCAs or syringe drivers.
      4. Ensure patients and their carers’ are clear about which medicines to stop and which to continue with.
      5. Educate patients and carers’ on what to do with obsolete medicines (eg in the home setting, they can return to any pharmacy for safe disposal). 

      Responsibility for prescribing between primary and secondary / tertiary care 

      In March 2018, NHS England published guidance that aims to provide clarity on the responsibilities of all professionals involved in commissioning and prescribing across primary, secondary and tertiary care, and to provide support in developing shared care agreements and in the transfer of care. A link to this guidance can be found:

        Availability of diamorphine (5mg and 10mg) 

        We have been made aware of some supply issues: 
        Wockhardt (a main supplier) have had manufacturing issues with their 5mg and 10mg strengths since January 2018.
        In the interim period, another supplier, Accord, has been able to fast-track and upscale their supplies- they brought in lots of extra stock of the 5mg and 10mg during. We encouraged wholesalers to order from Accord during this time, but there may have been local issues and some constraints in the market early/mid Feb  whilst Accord responded etc.
        Wockhardt  now have stock again are now able to meet their normal demand again and don’t foresee any issues going forward
        Accord also have good supplies of the 5mg and 10mg available
        The Department of Health and Social Care are keeping in contact with both suppliers and will continue to monitor 
        All other strengths (30mg , 100mg) have not been affected by the recent issues, so supplies have been available.
        In summary, there have been recent constraints affecting the 5mg and 10mg strengths, but supplies have continued to remain available. The issues should now be resolved as both manufacturers are currently back to their normal supply position but we are continuing to monitor.

        Quarterly CD occurrence reports and their merits – a reminder from NHS England lead CDAOs,

        Quarterly CD occurrence reports (ORs) are mandatory for all controlled designated bodies and are useful for both the organisation and the wider system. 

        They provide a framework for the designated body CDAO to quantify and identify themes from their  CD incidents and concerns so that they can:

        Take action on preventable causes of harm
        Share learning to reduce the likelihood of recurrence 
        Provide assurance to NHS England that the designated body has systems that are effective in reducing risks related to controlled drugs.

        They also enable NHS England Lead CDAOs to:

        Publicise concerns, successes and lessons  learned across their CDLINs and the wider system 
        Provide assurance  to the Secretary of State for Health, via CQC, that CDs are being used and managed in a safe and effective way across health care settings.


        Potential confusion between opioid transdermal patches (fentanyl / buprenorphine) and wound dressings. 

        NHS Improvement has been made aware of a potential confusion between opioid transdermal patches (fentanyl / buprenorphine) and wound dressings. A typical case involved a patient/carer or healthcare professional inadvertently applying an opioid patch instead of a wound dressing. Possible contributory factors to this type of error include supply of wound dressings alongside other prescribed medicines, including opioid patches, in TTA bags from hospital and Community Pharmacy bags or supply of opioid patches in dressing bags. The application of clear dressings on top of opioid patches to prevent them falling off may also increase similarities between opioid patches and wound dressings. Information to Patients / Carers should be that they read the labels of all prescribed products to reduce this risk and if possible supply of wound dressings in a separate bag to other prescribed medicines.

        News from the Prescribing Sub-Group

        The prescribing sub-group have been looking at MDA (instalment) prescriptions at practice level for all schedules of CDs and have found CDs included in the data that you would not expect to be prescribed in instalments for the management of substance misuse, fentanyl for example. The NHS England CDAOs are now looking at the data across their areas and we will be following up on their findings over the coming months

        News from the Vigilance Sub-Group

        What should you do if illicit substances are found in the possession of a patient in a clinical setting

        - in order to protect public safety, the safety of staff and the safety of the patient

        The substance should be taken into possession of the organisation and placed in the CD cabinet and recorded in the CD register. To protect the healthcare professional, there should be a witness signature by two members of staff.  The substance should not to be returned to the patient, their family or a representative as that would qualify as an unlawful supply of the (suspected) controlled substance. However, in order to maintain trust and to protect patient confidentiality, the patient’s details do not need to be notified to the police unless there are concerns. If the patient refuses to hand over the substance, the local police should be called and the patient advised accordingly. The organisation’s CDAO should be informed. If the quantity is small (i.e. for personal use), then the substance can be destroyed according to the organisation’s CD destruction SOP as an unknown substance. Where the quantity is larger, potentially for dealing purposes, the police should be contacted for advice and destruction. 


        Tips for Keeping Controlled Drugs (CDs) Secure, out of hours and when contractors are on site 

        contributed by Devina Halsall NHS England CDAO, Cheshire and Merseyside; and John Pickering, CDAO and Director, Nuffield Health The Grosvenor Hospital Chester

        Preventative measures
        1. Relocate CDs from less secure areas to more secure areas overnight.  
        2. Implement a thorough protocol for night time lock-up in vulnerable departments 
        3. Ensure staff know how to report damage to premises/security accurately and quickly 
        4. Ensure repairs are dealt with in appropriate timescale 
        5. When construction is planned in areas where CDs are stored or used, the CDAO and estates managers should work together to ensure risk of CD diversion is minimised. 
        6. Raise general awareness of all staff 

        Actions following a theft 
        1. Notify all relevant bodies (police, CDAO via plus phone call follow-up, as well as CCG, CQC, etc.) on the day the theft is discovered 
        2. Notify your local CDLO or police authority according to your local CDLIN arrangements for contacting police 
        3. Ensure you receive and note the crime reference number (as this will support investigating officers and CDAO at the designated body/organisation) 
        4. Escalate within the organisation, investigate and identify next steps.
        5. Review and amend local policy and security arrangements 
        6. Inform staff and provide support

        Reporting on underfill of controlled drug preparations

        We have been made aware of an underfill issue with a batch of methylphenidate tablets which we have reported to the MHRA. They advise that any concerns like this should be  reported via a Yellow Card:

        Mistaken identity errors in pharmacies

        contributed by Darren Barnett, Deputy Head of Pharmacy, NHS England South, South West

        The supply of medicines to the wrong patient continues to be a commonly reported error and many of the reported incidents have involved the supply of methadone to the wrong patient. These have occurred because proper checks of the dispensed medicine, the prescription, and the identity of the patient were not carried out.
        Even when a patient is known to you, it is still important to adhere to your hand out SOPs. These will normally instruct you to check the patient’s name, address and/or date of birth every time before administering or handing out medicines. These checks should be made with reference to the prescription form, with a re-check of the labels of the dispensed medicines for the name and quantity before hand out. When supplying medication to treat substance misuse, it is also good practice to ask the patient what dose or quantity they are expecting as an additional check.

        If the wrong patient’s medication is handed out, there could be serious consequences for both the patient and pharmacist.
        Local Police CD Liaison Officers have advised that if someone else’s methadone is administered or supplied to a patient resulting in an overdose and the prescribing team is not available or able to locate the patient for assessment, then the police should be involved to check the welfare of the patient.


        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. 

        The Department of Health and Social Care (DHSC) 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

        MHRA report product defects to them using the Yellow Card scheme:

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

        NICE guidance (NG46) on Controlled Drugs: Safe Management and Use 

        NHS Counter Fraud Authority (NHSCFA) updated their guidance on prescription form security in March 2018:

        Public Health England’s advice for local authorities and local partners on widening the availability of naloxone to reduce overdose deaths from heroin and other opiate drugs.

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