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Have an awareness of Controlled Drug (CD) Schedules and their impact on practice
Be able to check that prescriptions for CDs meet all the legal requirements
Know the records which must be kept in relation to the receipt and supply of CDs
Know the storage requirements for CDs
Have an understanding of the rules relating to the destruction of CDs
Upon completion of this module, you should be confident that you are working within the regulations for CDs and will know your own role and responsibilities, as well as those of the prescriber.
Course
What is a controlled drug?
Controlled drugs (CDs) are medicines that may cause addiction and harm if not used properly. Sometimes people use these medicines illegally for reasons that are not medical (e.g., drug misuse). As such, they are subject to stringent controls to ensure that they are prescribed, supplied, used and stored safely and legally.1
The Care Quality Commission (CQC) oversees the management of controlled drugs.2
The Misuse of Drugs Regulations 2001 classify CDs into five schedules according to the different levels of control that are required.3
The primary purpose of the Misuse of Drugs Act 1971 is to prevent the misuse of CDs. It does this by prohibiting the possession, supply, manufacture, import and export of CDs except as allowed by the 2001 regulations or by licence from the Secretary of State.3
Useful links
The Medicines Ethics and Practice Guide (MEP) – detailed information on the management of CDs in pharmacies, much of which applies to dispensing practices. In addition to stating the requirements specified in the Regulations it also contains useful summary tables.4
NICE states the Health Act 2006 requires each healthcare organisation to appoint an Accountable Officer, responsible for the safe and effective management of CDs in their organisation.3
According to the CQC each practice should have Standard Operating Procedures (SOPs) for the use and management of CDs.6
SOPs give detailed instructions on how to perform a task or tasks. In addition, they often contain details of who may, or may not, perform certain activities. This supports teamwork and clinical governance, as every member of the team knows who may carry out each task, which helps to manage the risks associated with that activity or process.6
The Dispensing Doctor’s Association (DDA) expects SOPs to be reviewed annually and whenever dispensing procedures are amended.7 If an error is identified or the SOP needs amending because systems or procedures have changed, notify your manager.
Whilst studying this module you must ensure you locate and read the SOPs that are relevant to your role and practice, as staff must abide by them at all times.
There are likely to be several to read as all healthcare providers who hold stocks of CDs must have up to date SOPs regarding:6
Ordering
Administration
Storage
Disposal and destruction
Record keeping
Before you read the next section – what do you think you know about CDs schedules?
Drag the Schedule tiles below to match these with the correct statements.
Click submit to see the answers.
Schedule 1
Schedule 2
Schedule 3
Schedule 4
Schedule 5
Low strength products
Opiates and major stimulants
Hallucinogenics, ecstasy-based drugs and cannabis
Benzodiazepines and steroids
Minor stimulants
Reset
Controlled drug schedules
The designations in brackets are the legal classifications used in the Alphabetical List of Medicines for Human Use in the Medicines Ethics and Practice Guide (MEP).5 The full list of drugs included in the schedules can be found in the Appendix.
Schedule 1 drugs3 (CDs Lic)
Includes drugs which are not used medically, for example, hallucinogenic drugs, ecstasy-type substances, raw opium and cannabis.
Production, supply or possession of these drugs is unlawful without a special licence from the Home Office.
Strict records of the receipt and supply of these must be kept.
They must be stored securely.
Schedule 2 drugs3 (CDs POM)
Includes the opiates, the major stimulants, cocaine, ketamine, and cannabis-based products for medicinal use in humans and quinalbarbitone (secobarbital).
Drugs in this schedule must meet the full CDs prescription requirements.
Strict records of the receipt and supply of these must be kept.
They must be stored securely.
Possession, supply and procurement is authorised for pharmacists and other classes of persons named in the 2001 regulations.
Schedule 3 drugs3 (CDs No Register POM)
Includes the barbiturates and are subject to the special prescription requirements. Records in registers do not need to be kept (although there are requirements for the retention of invoices for 2 years).
Schedule 4 drugs3 (CDs Benz POM or CDs Anab POM)
Split into two parts:
Part I (CDs Benz POM) includes but not limited to most of the benzodiazepines
Part II (CDs Anab POM) includes but not limited to most of the anabolic and androgenic steroids
Controlled drug prescription requirements do not apply and are not subject to safe custody requirements.
There is no register recording requirements (except Sativex®).
Schedule 5 drugs3 (CDs Inv P or CDs Inv POM)
Contains preparations of certain CDs which are exempt from full control when they are present in medicinal products of low strength.
Retention of invoices must be kept for two years.
Safe storage of CDs
The Regulations state that CDs in Schedules 1, 2 and 3, must be kept in safe custody.3
Quinalbarbitone (Schedule 2) is exempt from the safe custody requirements3 (although we recommend that it is stored securely as reminder that it still needs to meet the additional prescription requirements, and its records need to be kept regarding receipt and supply).
Safe custody requirements apply to Schedule 3 drugs except for:3
5,5 disubstituted barbituric acid
Gabapentin
Mazindol
Meprobamate
Midazolam
Pentazocine
Phentermine
Pregabalin
Tramadol hydrochloride
Any stereoisomeric form or salts of the above
What is “safe custody”?
Dispensaries – typically a locked and secured cupboard or cabinet used solely for the purpose of storing CDs. There are detailed specifications which CDs cupboards must meet in order to satisfy the Misuse of Drugs (Safe Custody) Regulations 1973.7
The CDs cupboard must be kept locked when not in use and access must be limited to those with specific authority e.g., GPs and experienced dispensers.7
Doctors visiting patients – when there is a need to carry CDs in a doctor’s case for example whilst visiting patients in their homes – safe custody means a locked bag which the doctor must carry with them.7
The keys should be kept separate from the case, or a more practical option fitted with a digital combination lock.7
The case should only be left unattended in exceptional circumstances and must always be locked when it is. If left unattended in a vehicle, it should be kept out of sight. The vehicle should be locked and any additional security features such as an alarm or immobiliser activated.7
It is advisable to only carry the minimum quantity of CDs required to fulfil emergency treatment needs. To avoid packaging and labelling pitfalls it is better not to carry CDs in any form other than injection ampoules for emergency use and, preferably, in only one strength.7
Ordering CDs from a wholesaler
A requisition in writing must be submitted by a practitioner (who must have a unique prescriber ID) to the wholesaler or registered pharmacies before they obtain any Schedule 2 or 3 CDs.5
Dispensing doctors can order CDs electronically from a wholesaler; however, dispensing doctors must then provide the wholesaler with a requisition upon receipt of the CDs.5
However, a practitioner urgently requesting a drug, who is unable to supply a requisition before delivery, may receive the drug provided they supply a requisition within the next 24 hours. If they do not, they will have committed an offence.5
Any organisation that holds stocks of CDs should keep those levels to a minimum whilst holding sufficient stock to meet patients’ needs.6
Reviewing CDs usage over the previous 2 years can help to ensure current stock holding is appropriate. Requisitions and invoices for CDs should ideally be kept for longer than the mandatory 2 years as cases often come to court at a much later date, by which time any evidence would have been destroyed. The DDA recommends an 11-year retention, a period that also covers product liability issues.7
When receiving a supply of CDs, it is the responsibility of the accountable doctor to ensure that the correct items have been delivered and that all appropriate entries are made in the Controlled Drug Register (CDR) on the day or following day of receipt. The task of completing the CDR can be delegated, but the doctor or pharmacist is ultimately accountable.5
Anyone who receives CDs from the wholesaler other than the accountable doctor or pharmacist should be authorised to do so in writing, in advance, and should sign the supplier’s delivery note at the point of receipt.5
Before you read the next section - When receiving CDs, which three pieces of information do you think must be recorded in the Controlled Drugs Register (CDR)?
A. Date the supply was received
B. Name and address from the wholesaler it was received
C. Whether proof of identity was requested of you (yes or no)
D. Quantity
E. The name of the delivery driver
Controlled Drugs Registers (CDRs)
The following rules must be followed:
Records for Schedule 2 CDs must be kept in a CDs register. This is not a legal requirement for Schedule 3, 4 or 5 CDs.5
Entries must be in chronological sequence so must be made in the order in which they happen.6
A separate register or separate part of the register must be kept for each class of drug.6
A separate page shall be used for each strength and form of drug.6
The name of the drug, its strength and form must be written at the top of the page.6
Entries must be made on the day of the transaction or on the next day (within 24 hours).6
No cancellation, obliteration or alteration may be made; any errors should be marked neatly e.g., with an asterisk* and amendments or corrections must be put in as a footnote and signed and dated.6
Be bound (not loose-leaved) or a computerised system which is in accordance with best practice guidance.6
Entries must be in ink or otherwise indelible or shall be in computerised form.6
Electronic registers need to identify the person making each entry and must prevent entries being altered at a later date.7
The CDR must be kept at the practice and if it is electronic, it must be accessible at the practice it relates to.7
Adequate back-ups must be made of computerised registers.7
Records of the supply and collection of CDs
It is essential to record the supply and collection of CDs
A lot of information relating to the supply of CDs must be recorded in the CDR, including information about who has collected drugs ordered on a requisition or prescription.7
The details required as a minimum are:7
When CDs are obtained
Date of supply obtained
Name and address of person or firm supplied
Quantity obtained
When CDs are supplied
Date supplied
Name and address of person or firm supplied
Quantity
Person collecting the Schedule 2 Controlled Drug (this could be the patient/patient’s representative/healthcare professional; if it is a healthcare professional their name and address)
Details of authority to possess, in other words, the prescriber or licence holder’s details
Whether proof of identity of person collecting was requested (yes or no)
Whether proof of identity of person collecting was provided (yes or no)
Note: Entries relating to the supply of CDs should not be made until the supply has taken place. Frequently the item will be dispensed on a different day to the date of supply.
In dispensing practices, often two members of staff will initial the register when making an entry, this includes when the supply is to a doctor’s bag and the doctor is present. In other words, one member of staff supplies the item and makes the entry in the register while the second witnesses the transfer. Both initial the register to confirm the transfer has taken place.7
The GP then makes the entry in the CDs register for the bag.7
Prescribing CDs
Following a change in legislation in 2015, schedule 2 and 3 CDs prescriptions can be sent electronically via the Electronic Prescription Service (EPS) or handwritten.6
It is good practice to limit prescription to provide sufficient supply for a patient for 30 days. There are some circumstances where this can be extended i.e., clinical indication and where the risk / benefit ratio has been assessed as acceptable – the prescriber should be prepared to justify the decision if later challenged.6
The decision for extending the supply beyond 30 days should be recorded in the patient’s record.6
Example of a prescription form for schedule 2 and 3 CDs
This form contains fictitious patient information for illustrative purposes only.
What has gone wrong?
This form contains fictitious patient information for illustrative purposes only. Review the below form and click ‘next’ to see what has gone wrong.
Did you spot the errors?
This form contains fictitious patient information for illustrative purposes only.
Private prescriptions
Private prescriptions for CDs in Schedules 2 and 3 must be on specific forms (FP10PCDs in England, PPCDs in Scotland, W10PCDs in Wales, PCD1 in Northern Ireland).7
Prescriptions must include the prescriber’s identification number (NHS prescriber code in Scotland). This is not the same as the professional registration number.7
The original prescription forms must be sent to the relevant NHS Agency, as is the case for the standardised CDs requisitions.7
Dispensing prescriptions for CDs
Legally a dispensing doctor may delegate the task of dispensing medicines for their patients to their employees. The practice (and partners) are liable for any errors made or for any breach of the law. However, accountability remains with the dispensing doctor.5
A dispenser would not normally be expected to supply a prescribed Schedule 2 or 3 CDs without first checking the dispensed items with a doctor.5
In addition, as part of a risk management strategy, other than in exceptional circumstances, the prescriber of CDs should ideally not dispense, transport and administer the medication prescribed, in other words, at least one other suitably trained person should be involved in the process.5
Checking dispensed prescriptions
Robust checking protocols should be in place and staff involved in checking should have consistently demonstrated their competence before being allowed to check dispensed items. In each case, the checker must check the prescription is legal and complete, and then use the prescription to check:
The Dispensing Label7
name of the patient
name and address of the dispensing practice
date of dispensing
name of the medicine
directions for use of the medicine
precautions relating to the use of the medicine
‘Keep out of the sight and reach of children’
The Dispensed Item
Drug name, strength, form, quantity, expiry date, PIL and sundry items.7
Where possible, when dispensing CDs, the quantity/volume and strength should be verified by a second person.7
Destruction of CDs
CDs requiring destruction will either be part of the dispensary’s stock or stock from the GP’s bag, for example, when a drug has passed its expiry date, or drugs which have been dispensed for a patient and have now been returned for safe destruction.8
Storage of items awaiting destruction9
Drugs which would normally require safe custody, continue to do so whilst awaiting destruction. This affects both stock and patient returns. It is therefore extremely important that the items are clearly marked and kept as separate as possible from the stock of CDs to prevent them being selected and dispensed by accident.
Obsolete, expired and unwanted stock of CDs
The destruction of these CDs must be witnessed by a person authorised by the Secretary of State. There are a number of different people who can act as witnesses for the destruction of stock, including police officers who are CDs liaison officers.5
The destruction of stocks of Schedule 3 and 4 CDs does not need to be witnessed by an authorised person.5
Expired Schedule 5 preparations can be destroyed without an authorised witness.8
Stock waiting to be destroyed must be included in the running balance in the CDR until it is destroyed. The destruction must be appropriately noted in the register and the authorised witness should sign the entry.9
Destruction of patient returned medicines
Currently a doctor or pharmacist may destroy schedule 2 and schedule 3 CDs returned by a patient or their representative without the presence of an authorised person. However, it is good practice and strongly recommended that they do so in the presence of another member of staff, preferably another registered healthcare professional.5
It is good practice to keep a record of patient returned Schedule 2 CDs and their destruction. CDs which have been returned by patients should not be entered into the CDR and therefore will not be part of the running balance.9
It is recommended that the following details are recorded and that the records are kept for at least 7 years:5
Date of return of the CD
Name, quantity, strength and form of the CD
The role of the person returning the CDs (if possible)
The name and signature of the person who received the CD
The names, positions and signatures of the staff who destroyed the CDs and witnessed the destruction
Destruction of CDs
All CDs in Schedules 2, 3 and 4 (Part I) must be denatured so that the drug is irretrievable before being placed into waste containers.8
Wherever possible it is best to use commercially available denaturing kits.8
The table below gives detailed information on the way in which different formulations should be denatured.9
Preparation
Notes on denaturing
Tablets and Capsules
Remove the tablets or capsules from outer packaging and blister packaging and place in a CDs denaturing kit. This will ensure the whole tablets or capsules are not readily recoverable. Alternatively, crush or grind the tablets/capsules and place in hot soapy water ensuring the drug is dissolved or dispersed. Then put the mixture in the waste disposal container
Controlled Drug Liquids
Add liquids to the normal denaturing kit they will mix with the other waste material and be irretrievable. Alternatively, add them to an appropriate quantity of cat litter and once absorbed, dispose of the litter via the usual waste disposal method
Fentanyl or buprenorphine patches
Remove the backing and fold the patch upon itself and place in the waste disposal bin or preferably in CDs denaturing kit
Ampoules
Open the ampoules and pour the contents on to the denaturing kit and put the ampoule in the sharps bin. Any ampoules containing powder should have water added and then the solution be poured into the kit
Aerosols
Expel the contents into water and dispose of the mixture in the same way for CDs Liquids
Useful links
The Medicines Ethics and Practice Guide (MEP) – detailed information on the management of CDs in pharmacy, much of which applies to dispensing practices. In addition to stating the requirements specified in the Regulations it also contains useful summary tables
List of most common CDs – a list of the most commonly encountered drugs currently controlled under the misuse of drugs legislation showing their respective classifications under both the Misuse of Drugs Act 1971 (MDA) and the Misuse of Drugs Regulations 2001 (MDR)
References
1. National Institute for Health and Care Excellence (NICE) ‘Controlled drugs: safe use and management’ NICE Guideline [NG46], Published April 2016 Last Accessed July 2021
2. Care Quality Commission ‘Controlled Drugs’, Last updated 12 July 2017 Last Accessed July 2021
3. National Institute for Health and Care Excellence (NICE) British National Formulary (BNF) ‘Controlled drugs and drug dependence: Regulations and classification’ Last Accessed July 2021
4. The Medicines Ethics and Practice Guide (MEP) (Access is for members of the Royal Pharmaceutical Society only)
5. The National Prescribing Centre ‘A guide to good practice in the management of CDs in primary care in England’, Third Edition, Published December 2009 Last Accessed July 2021
6. Care Quality Commission ‘GP mythbuster 28: Management of controlled drugs’, Last Updated 28 April 2021 Last Accessed July 2021
7. Dispensing Doctors Association (DDA) Dispensing Guidance, Eighth Edition, Published 2019 Last Accessed July 2021
8. Pharmaceutical Services Negotiating Committee (PSNC) ‘Controlled Drugs regulations’ Last Accessed September 2021
9. NHS England ‘NHS England BGSW Area Team Controlled Drug Management: Standard Operating Procedures’, Published October 2014 Last Accessed July 2021
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Exam
The Health Act 2006 requires each organisation to appoint an…
(Select one)
Accountable Officer
Accountable Executive
Accountable Manager
Accountable Supervisor
How often do the Dispensing Doctors Association (DDA) expect Standard Operating Procedures (SOPs) to be reviewed?
(Select one)
Quarterly
Bi-Monthly
Annually
Every two years
Which schedule covers opiates and major stimulants?
(Select one)
1
2
3
5
When visiting patients in their homes, CDs should be kept in?
(Select one)
The doctor’s pocket
They are not permitted to leave the dispensary
Any receptacle, as long as it stays with the doctor
A locked bag
When ordering CDs from a wholesaler who is responsible for ensuring that the correct items have been delivered?
(Select one)
The delivery driver
The accountable doctor
The Accountable Officer
Anyone on the dispensing team
When entering CDs in the Controlled Drug Register (CDR) in what time frame should they be entered?
(Select one)
Within 2 hours
The same day or following day of receipt
Within 48 hours
Within one week
What should be included on a private prescription?
(Select one)
Prescriber identification number (or prescriber code in Scotland)
Professional registration number
The patient’s ethnicity
The GP practice code
Which of the below are recommended to be recorded when destroying patient returned medicines?
(Select all that apply)
Date of return of the CD
The role of the person returning the CDs
Name, quantity, and strength of the CD
The name and signature of the person who received the CD
1/3 attempts
Sorry, you only scored 3/5. You must score 5 to pass this exam.
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