The Misuse of Drugs Regulations 2001 divide Controlled Drugs (CDs) into five schedules corresponding to their therapeutic usefulness and misuse potential. A number of changes affecting the prescribing, record keeping and destruction of CDs have been introduced as a result of amendments to the Misuse of Drugs Regulations 2001. The Controlled Drugs (Supervision of Management and Use) Regulations 2006 came into effect on 1st January 2007.
Schedule 1 (Controlled Drug licence)
- Have no recognised medicinal use and include cannabis, coca leaf, lysergic acid diethylamide (LSD) and mescaline.
- Production, possession and supply of these drugs are limited to research or other special purposes.
- Practitioners and pharmacists may not lawfully possess Schedule 1 drugs except under licence.
Schedule 2 (Controlled Drugs)
- Includes diamorphine (heroin), morphine, remifentanil, pethidine, secobarbital, glutethimide, amfetamine, and cocaine.
- Are subject to safe custody requirements and so must be stored in a locked receptacle, usually in an appropriate CD cabinet or approved safe, which can only be opened by the person in lawful possession of the CD or a person authorised by that person.
- A licence is required to import or export drugs in Schedule 2.
- The drug may be administered to a patient by a doctor or dentist, or by any person acting in accordance with the directions of a doctor or dentist.
- A register must be kept for Schedule 2 CDs and this register must comply with the relevant regulations.
- The destruction of CDs in Schedule 2 must be appropriately authorised and the person witnessing the destruction must be authorised to do so.
Schedule 3 (Controlled Drugs - no register)
- Includes a small number of minor stimulant drugs and other drugs which are less likely to be misused than the drugs in Schedule 2.
- Examples are the barbiturates (except secobarbital, now Schedule 2), buprenorphine, diethylpropion, mazindol, meprobamate, midazolam, pentazocine, phentermine, and temazepam.
- The government has now placed tramadol in Schedule 3 to the Misuse of Drugs Regulations 2001 but with exemption from the safe custody requirements.
- Are exempt from safe custody requirements and can be stored on the open dispensary shelf except for temazepam, buprenorphine and diethylpropion, which must be stored in a locked CD receptacle.
- Are subject to the same special handwriting requirements as Schedule 2 CDs.
- There is no legal requirement to record transactions in a CD register.
- The requirements relating to destruction do not apply unless the CDs are manufactured by the individual.
- Invoices must be retained for a minimum of two years.
- Are exempt from safe custody requirements, with destruction requirements only applying to importers, exporters and manufacturers.
- Specific CD prescription-writing requirements do not apply.
- CD registers do not need to be kept, although records should be kept if such CDs are produced, or if a licensed person imports or exports such drugs:
- Part 1: benzodiazepines (except temazepam and midazolam, which are in Schedule 3) and zolpidem, which are subject to minimal control:
- Includes most of the benzodiazepines, plus eight other substances including fencamfamin and mesocarb.
- Possession is an offence without an appropriate prescription. Possession by practitioners and pharmacists acting in their professional capacities is authorised.
- Are subject to full import and export control.
- Part 2 includes androgenic and anabolic steroids, clenbuterol, human chorionic gonadotrophin (hCG), non-human chorionic gonadotrophin, somatotropin, somatrem, and somatropin:
- Includes most of the anabolic and androgenic steroids such as testosterone, together with clenbuterol (adrenoreceptor stimulant) and growth hormones.
- There is no restriction on the possession when it is part of a medicinal product.
- A Home Office licence is required for the importation and exportation of substances unless the substance is in the form of a medicinal product and is for self-administration by a person.
- Part 1: benzodiazepines (except temazepam and midazolam, which are in Schedule 3) and zolpidem, which are subject to minimal control:
Schedule 5 (Controlled Drug - invoice)
- Includes preparations of certain controlled drugs (eg, codeine, pholcodine, morphine) which are exempt from full control when present in medicinal products of low strengths, as their risk of misuse is reduced.
- No restriction on the import, export, possession, administration or destruction of these preparations and safe custody regulations do not apply.
- A practitioner, pharmacist or a person holding an appropriate licence may manufacture or compound any CD in Schedule 5.
- Therefore exempt from virtually all CD requirements other than that invoices must be kept for a minimum of two years.
Standard operating procedures
Regulations made under the Health Act 2006 require each healthcare organisation to appoint an Accountable Officer, responsible for the safe and effective use of CDs in their organisation. The Regulations also introduce standard operating procedures (SOPs) for the use and management of CDs. GP practices will need to have an appropriate process in place to agree and adopt SOPs for their use.
- An SOP is a document that describes the responsibilities and the procedures, including audit, necessary to manage CDs safely and accountably. The SOPs must include:
- Ordering and receipt of CDs.
- Assigning responsibilities.
- Where the CDs are stored.
- Who has access to the CDs.
- Security in the storage and transportation of CDs as required by misuse of drugs legislation.
- Disposal and destruction of CDs.
- The person who is to be alerted if complications arise.
- Record keeping, including:
- Maintaining relevant CD registers under misuse of drugs legislation
- Maintaining a record of the CDs specified in Schedule 2 to the Misuse of Drugs Regulations 2001 that have been returned by patients
- The practice SOP should also include:
- Responsibilities within the practice team.
- Validation by clinical commissioning group (CCG) and date.
- Review period - eg, one, two or three years.
- Lead author and named people contributing to the SOP.
Prescriptions for Controlled Drugs
- The amendments to the Misuse of Drugs Regulations 2001 that came into force in November 2005 removed the requirement that CD prescriptions should be written in the prescriber's own handwriting. This means that CD prescriptions can be typewritten, handwritten or computer printed. Only the signature of the prescriber has to be handwritten.
- Further changes following amendments to the Misuse of Drugs Regulations came into force in July 2006. These include:
- A new requirement that patients or other people collecting medicines on their behalf must sign for them.
- Validity of any prescription for Schedule 2, 3 and 4 CDs to be restricted to 28 days.
- Strong recommendation that the maximum quantity be limited to 30 days for prescriptions of Schedule 2, 3 and 4 CDs.
- Re-emphasis of professional guidance that doctors should prescribe CDs for themselves or family members only in exceptional circumstances.
- Doctors are only able to prescribe diamorphine, dipipanone and cocaine to substance misusers for the treatment of addiction if they hold a licence issued by the Home Office. All doctors may prescribe such drugs for patients, including substance misusers, for the relief of pain due to organic disease or injury, without a specific licence.
- Prescriptions for Schedule 4 and 5 CDs are exempt from the specific prescription requirements of the Misuse of Drugs Regulations 2001. However, they must still comply with the general prescription requirements as specified under the Medicines Act.
- Emergency supplies of Schedule 2 and 3 CDs, for a specific patient, are not permitted either at the request of the patient or a practitioner. The only exception to this rule is phenobarbital for the treatment of epilepsy.
NHS prescription form
- FP10 prescription forms now include a box on the back of the prescription where the signature of the patient or other person collecting a Schedule 2 or 3 CD must be recorded.
- The prescriber should include the patient's NHS number on the prescription form.
- The prescriber should sign any script changes. The prescription must contain the following details:
- The patient's full name, address and, where appropriate, age.
- The name and form of the drug, even if only one form exists.
- The strength of the preparation, where appropriate.
- The dose to be taken.
- The total quantity of the preparation, or the number of dose units, to be supplied in both words and figures.
- Form FP10MDA-S is used for prescribing CDs (mainly methadone) to addicts. It is twice the size of the standard FP10 because it contains space for the pharmacist to record each time an instalment is supplied.
- FP10SS forms are designed for use with the prescriber's computer system. FP10NC are for handwritten prescriptions.
Private prescription form
- A special form (FP10PCD) has been introduced for any private prescription of schedule 2 and 3 CDs which will be dispensed in the community.
- The prescriber should obtain the patient's NHS number if possible and enter this number on the prescription form.
- The private prescription form includes space for the person collecting the CD to sign the back of the form. Any person collecting Schedule 2 and 3 CDs will be asked to sign the back of the prescription form.
- There are two kinds of forms available, personalised (FP10PCDNC) and non-personalised (FP10PCDSS). Personalised forms contain the prescriber's details already printed.
Prescribing in instalments
- Some CDs can be dispensed to substance misusers in instalments, providing they are prescribed using specific NHS prescription forms.
- In England, GPs must use the form FP10MDA-S to prescribe in instalments Schedule 2 CDs, buprenorphine (Schedule 3) or diazepam (Schedule 4) for drug addiction. This form must not be used for any other purpose.
- The prescription must be dispensed on the date on which it is due. If the client does not collect an instalment when it is due, that supply is no longer valid. The client cannot collect that supply the following day.
- If a CD prescription is to be dispensed in instalments (eg, daily) then the FP10MDA-S must specify:
- The number of instalments.
- The intervals to be observed between instalments (if necessary, instructions for supplies at weekends or bank holidays should be included).
- The total quantity of CD that will provide treatment for a period not exceeding 14 days.
- The quantity to be supplied in each instalment.
- Current legislation does not allow Schedule 2 and 3 CDs to be prescribed as repeat prescriptions (ie to be part of the repeat prescribing or dispensing system)
Ordering, possessing and supplying Controlled Drugs
- Doctors, dentists and pharmacists are authorised under the Misuse of Drugs Regulations 2001 to possess, supply and compound CDs in Schedules 2, 3, 4 and 5. They may only supply CDs to those who may lawfully possess them, including patients for whom a drug is prescribed.
- Paramedics have more recently been authorised to possess and administer controlled drugs.
- Practitioners must not use patient-specific CD prescriptions to replace or top up their bags or practice stock, even if the stock was used for that patient initially.
- Practitioners may obtain Schedule 2 and 3 CDs from pharmacies or wholesalers for practice use or stock upon the production of a written requisition.The requisitions must be:
- Signed by the prescriber.
- State the prescriber's name and address, and their profession or occupation.
- Specify the total quantity of the drug (this does not have to be in words and figures).
- Specify the purpose for which it is required - eg, for practice use.
- Suppliers must keep all requisitions for a minimum of two years. A requisition is not required before supplying or obtaining Schedule 4 or 5 CDs.
- A practitioner who requires a Schedule 2 or 3 CD urgently and who is unable to supply a signed order can request the drugs to be supplied in an emergency. The practitioner may be supplied with the CD provided he or she gives an undertaking to supply a written, signed requisition within 24 hours. Failure to do this is a criminal offence on the part of the practitioner.
- It is the responsibility of the pharmacist or doctor, when receiving a supply of CDs from the wholesaler, to ensure that the correct item is delivered and that all appropriate entries are made in the CD register on the day of supply, or the day following the day of supply.
- There is now a requirement for persons asked to supply Schedule 2 CDs on prescription to seek to establish whether the person collecting the drug is the patient, the patient's representative or a healthcare professional acting in his/her professional capacity on behalf of the patient.
- Where the person is the patient or the patient's representative (eg, a friend, or a neighbour) the dispenser:
- May request evidence of that person's identity; and
- May refuse to supply the drug if he/she is not satisfied as to the identity of that person.
- Where the person collecting the prescription is a healthcare professional acting in his/her professional capacity on behalf of the patient, the dispenser:
- Must obtain that person's name and address.
- Must, unless he/she is acquainted with that person, request evidence of that person's identity; but
- May supply the drug even if he/she is not satisfied as to the identity of that person.
- The new regulations do allow discretion not to ask patients or patient representatives for proof of identity if, for example, they have concerns that to do so may compromise patient confidentiality or deter patients from having their medicine dispensed.
Keeping and storage of Schedule 2 Controlled Drugs and buprenorphine
- These CDs must be kept in a locked receptacle. This can be a doctor's bag with a lock and, if the bag is transported in the doctor's car, it must be locked and placed in a locked boot. A locked car is not adequate security; the bag must also be locked.
- In the surgery, a locked cabinet should ideally be secured to the wall of a room and only opened by the GP or someone authorised by the GP.
- Records for Schedule 2 but not Schedules 3, 4 or 5 CDs must be kept in a CD register. All healthcare professionals must keep their own CD register. GPs, pharmacists or other healthcare professionals are personally responsible for keeping the relevant CD registers up-to-date.
Requirements for records
- Records for Schedule 2 CDs must be kept in a CD register. This is not a legal requirement for Schedule 3, 4 or 5 CDs.
- All healthcare professionals who hold personal CD stock must keep their own CD register, and they are personally responsible for keeping this accurate and up-to-date.
- The register must:
- Be bound (not loose-leaved) or a computerised system which is in accordance with best practice guidance.
- Contain class sections for each individual drug.
- Have the name of the drug specified at the top of each page.
- Have the entries in chronological order and made on the day of the transaction or the next day.
- Have the entries made in ink or otherwise so as to be indelible or in a computerised form in which every such entry is attributable and capable of being audited.
- Not have cancellations, obliterations or alterations; corrections must be made by a signed and dated entry in the margin or at the bottom of the page.
- Be kept at the premises to which it relates and be available for inspection at any time. A separate register must be kept for each set of premises (eg, at each branch surgery).
- Be kept for a minimum of two years after the date of the last entry, once completed.
- Not be used for any other purpose.
- For CDs received into stock, the following details must be recorded in the CD register:
- The date on which the CD was received.
- The name and address of the supplier - eg, wholesaler, pharmacy.
- The quantity received.
- The name, form and strength of the CD.
- For CDs supplied to patients (via prescriptions), or to practitioners (via requisitions), the following details must be recorded in the CD register:
- The date on which the supply was made.
- The name and address of the patient or practitioner receiving the CD.
- Particulars of the authority of the person who prescribed or ordered the CD.
- The quantity supplied.
- The name, form and strength in which the CD was supplied.
- The Secretary of State for Health can authorise the medical adviser of the CCG or other appointed doctor to ask GPs to produce records and to view stocks. Failure to comply is an offence.
- Where a practitioner carries a bag for home visits, etc, containing CDs, a separate CD register should be kept for the CD stock held within that bag. Each doctor is responsible for the receipt and supply of CDs from their own bag.
- Restocking of a bag for home visits, etc, from practice stock should be witnessed by another member of the practice staff, as should the appropriate entries into the practice's CD register.
- Where a prescription is written by a doctor following the administration of a CD to a patient, the doctor should endorse the prescription form with the word 'administered' and then date it.
- Information should also be entered into the patient's record as soon as practicable.
Destroying Controlled Drugs
- NB: professional guidance strongly recommends that any medication returned from patient stocks should not be re-issued or used to treat other patients.
- There is no current legal requirement that 'patient-returned' Schedule 2 and 3 CDs should be destroyed in the presence of an authorised witness, but it is strongly recommended that doctors and pharmacists have the destruction of these returns witnessed by another member of staff (preferably by a registered healthcare professional) and make a record of the destruction in a separate book set aside for this purpose.
- Those healthcare professionals and service providers required by law to maintain a CD register are not allowed to destroy expired Schedule 2 (or 1) CDs from their stock without destruction being witnessed by an authorised person.
- When a CD is destroyed, details of the drug must be entered into the CD register. This should include: the name of the drug, form, strength and quantity, the date it was destroyed, and the signature of the authorised person who witnessed the destruction and that of the professional destroying it (ie two signatures).
- The list of those authorised to witness the destruction of CDs includes:
- A CCG chief pharmacist or pharmaceutical prescribing adviser who reports directly to the chief executive or to a director of the CCG.
- A registered medical practitioner who has been appointed to the CCG Professional Executive Committee or equivalent.
- The CCG board executive member with responsibility for clinical governance or risk management.
- Medical director of a CCG.
Further reading and references
; NICE Guidelines (April 2016)
; Dept of Health, February 2013
; Home Office
; Public Health England
; Home Office, March 2014
; National Prescribing Centre, December 2009
; National Prescribing Centre, February 2012
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