Latest news from CQC
Can we please take this opportunity to remind all Controlled Drugs Accountable Officers (CDAOs) to ensure that your contact details are correctly shown on the published CDAO Register. This is important because NHS England Lead CDAOs use the register to update mailing lists for circulation of controlled drugs local intelligence meeting invites, network papers and alerts. The CDAO Register can be found on our website here.
Please note that if you have not notified the CQC of your appointment you will not be entered onto the CDAO Register. To notify us please complete a CDAO notification. Our on-line CDAO notification form along with further information can be found on our website here.
News from the Policy Sub-Group
T-28 Exemption
Certificates- A reminder
Recent
inspections by the CQC have highlighted that some providers are not aware they
need to have an Environment Agency issued T-28 Exemption Certificate to dispose
of CDs. The exemption is free of charge and allows pharmacies and other similar
places, including healthcare settings, to comply with the requirements of the
Misuse of Drugs Regulations 2001 by denaturing controlled drugs (making them
unsuitable for consumption).
The
information about this waste exemption, including how to apply for it, can be
found here. Please also note
that the exemption only lasts 3 years so after this period the exemption needs
to be renewed.
Controlled Drugs (Supervision of Management and
Use) Regulations 2013
The
Department of Health are continuing to review 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 and the Home
Office are about to send out a questionnaire to form the basis for their impact
assessment.
Home
Office pregabalin and gabapentin consultation
This consultation seeks views on options whether, and
how, to schedule pregabalin and gabapentin under the Misuse of Drugs
Regulations 2001 following the recommendation by the Advisory Council on the Misuse of Drugs (ACMD) that these 2 drugs should be controlled as Class C drugs under the Misuse
of Drugs Act 1971 (‘the 1971 Act’) and placed in Schedule 3 to the Misuse of
Drugs Regulations 2001.
The consultation is aimed at members of the public,
healthcare professionals, institutions, all sectors within the supply chain
including the pharmaceutical industry, wholesalers and community pharmacies in
the UK. The consultation opened from 13th November 2017 and runs
until 22nd January 2018.
https://www.gov.uk/government/consultations/pregabalin-and-gabapentin-proposal-to-schedule-under-the-misuse-of-drugs-regulations-2001.
News from the Patient Safety Sub-Group
One of the issues that is frequently raised at the Patient Safety sub-group is that of patients going home without some
of their medicines because they are stored in a different place such as the
controlled drugs cupboard or the medicines fridge. One way of helping to
reduce this risk is by using a discharge check list such as the one below and by adding coloured notes
to the drug chart:
 Medicines discharge checklist
 There have also been
some initiatives to encourage reporting of and learning from controlled
drug related incidents:
The
Community Pharmacy Patient Safety Group is made up of passionate community
pharmacy Medication Safety Officers (MSOs) from across the sector, with
representation from all community pharmacy chains with over 50 branches, as
well as the National Pharmacy Association to represent independent pharmacies.
It provides a forum for these community pharmacy organisations to openly share
and learn from each other when things go wrong, as well as from other sectors
and industries, so that they can collectively improve patient care and reduce
harm.
They’re
coming up to their third year of collaborative sharing and learning now, and
are looking to make their work more accessible and transparent to anyone who is
interested! In this spirit, they have just published their priorities for
2018 at www.pharmacysafety.org/2018-priorities.
Further
information about the Group and their resources
can be found on the website.
 Another initiative, shared at
The Berkshire CD LIN:
Reading Public Health renewed the contracts
with Pharmacies for Supervised Consumption in 2017/18. A requirement of the
contract is to record
patient safety incidents. Since 2005, pharmacies have been required to record
patient safety incidents in an incident log and report these to the National
Reporting and Learning Service (NRLS). The Reading Public Health Supervised
Consumption Contract also requires pharmacists to report the CD incident to the
CDAO via the NHS England CD reporting tool at www.cdreporting.co.uk
News from the Prescribing Sub-Group
Prescribing of Diconal
The prescribing sub-group have been keeping an
overview of diconal prescribing across England over the past year and are pleased to report that overall
prescribing is going down and new patients are not being started on it:
Dipipanone is
a strong opioid analgesic drug, used for very severe pain. The main preparation of
the drug commercially available is mixed with cyclizine (Diconal®) which
has the advantage of reducing nausea, vomiting and histamine release associated
with strong opioid therapy. As of November 2011 Amdipharm stopped making the
Diconal brand tablets for the UK due to undisclosed commercial reasons.
Prescribing of dipipanone is discouraged apart
from in exceptional circumstances, because of the perceived risk of abuse - the
BNF marks the substance as "less suitable for prescribing" along with
other older compounds such as pethidine and pentazocine with unusual abuse
patterns. The combination with cyclizine leads to a very strong
"rush" if the drug is injected. During the late 1970s to early 1980s
in the UK, many deaths were blamed on misuse of this preparation.
The number of NHS prescriptions for
dipipanone/cyclizine has reduced dramatically in the UK in recent years, which
is great news for patients. Safer, more effective treatments are being used
instead where there is a clear indication for treatment, and those patients
with dependence and addiction problems (and no clear indication) have been
offered support or treatment for their addiction
Prescribing of oral morphine solution 10mg/5ml
We have also continued to monitor the
prescribing of oral morphine solution 10mg/5ml since we reported on high
volume prescribing in our 2016 Controlled Drugs Annual Report:
Morphine sulfate 10mg/5ml oral solution
(commonly known by the brand name Oramorph®) is a short acting
preparation of the strong opiate morphine, and is used for breakthrough
analgesia in chronic pain, or sometimes for short term pain relief in acute pain.
The concentration of morphine in this preparation is relatively low, and
as a result the preparation is only listed as a Controlled Drug in schedule 5
of the Misuse of Drugs Regulations 2001. Schedule 5 CDs have the least
regulation of all controlled drugs and consequently morphine sulfate 10mg/5ml
oral solution is perceived as being easier to obtain inappropriately. A large
number of incidents take place each year in which the preparation is stolen or
diverted, and furthermore the prescribing is less closely monitored as a result
of its scheduling. People who obtain even small volumes of the preparation will
still be able to consume a significant amount of morphine in order to
experience a high; morphine is a highly addictive substance.
In recent months the Controlled Drugs Accountable Officers (CDAOs) have
taken a renewed interest in the prescribing trends for this preparation and
have worked with the CQC and NHSBSA to benchmark prescribing data. From this
work it became evident that huge volumes of the preparation are prescribed on
individual prescriptions – sometimes as much as 10litres on a single
prescription. This makes clear the huge quantities of morphine sulfate that are
being dispensed and in the possession of patients, and clearly demonstrates a
significant risk. CDAOs are working with individual practices and CCG
colleagues to challenge risky prescribing and identify forged prescriptions.
This will provide assurance that the risks of harm are being mitigated.
News
from the Vigilance Sub-Group
Pharmacy delivery
driver errors.
We
would like to highlight a recent coroner’s inquest that involved the use of a community
pharmacy delivery driver. In summary, a
prescription for morphine sulfate capsules, intended for another person living close to the
deceased at a similar address, and with an almost identical name was delivered
in error alongside other medicines which were correctly prescribed and intended
for the deceased. Unfortunately the patient who received the morphine sulfate capsules was
partially sighted and took it with fatal consequences. The findings were that the
checks that should have been undertaken on the name and address and the
obtaining of a signature as set out in the standard operating procedure for delivery
of controlled drugs were not followed.
With
this in mind we would like to share some guidance which gives practical
information around the use of delivery drivers.
https://www.chemistanddruggist.co.uk/news/death-and-delays-in-review-of-multiples-medicine-deliveries.
and:
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
and guidance on Security
of Prescription Forms - August 2015
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
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