Controlled drugs Guidance for GP practices

• Key Recommendations
• The controlled drugs register
  • Drugs received
  • Drugs supplied
  • Supplies to replace items used by GPs
  • Stock check
• Safe custody requirements of controlled drugs
• Prescribing requirements for controlled drugs
  • Prescribing in instalments: form FP10 (MDA)
  • The date on the CD prescription
  • Phenobarbitone
• Invoice requirements for controlled drugs
• Destruction of controlled drugs
  • Stock drugs
  • Drugs returned by patients/patients representatives
• Appendix 1 - The controlled drug schedules

Key Recommendations

• On any CD entry, two members of staff initial the register, one of which would be a witness
• Within the bound book, a separate page be used for each form and strength of each drug. This allows the users to keep a running stock level for each item, which can help to identify any discrepancies.
• Two members of staff (not the GP involved) supply the item, make appropriate entries in the register and sign to say they have supplied and witnessed the transfer. The GP should make the appropriate entry in their CD register for their bag.
• All invoices for all controlled drugs be retained for two years.
• Schedule 3 drugs should be destroyed in the same way, although this is not a legal requirement.
• Where appropriate, patients should be encouraged to return all drugs for disposal to their local community pharmacy.
• A separate record book should be used to audit the return and destruction of prescribed controlled drugs of schedule 2 and 3.

The controlled drugs register

The Health Authority Medical Advisor has authority to inspect the register, the premises, and the general drug control procedures in practices.

Every transaction for a Schedule 2 drug (and their salt preparations) must be recorded in the controlled drugs register - see appendix 1.

• If controlled drugs are kept on the premises, a register must be kept for each premises (not simply the main surgery)
• A register should also be kept in relation to each doctor's bag

Drugs received

The entries must

• show the date received
• show the name and address of the person or firm from whom they are received show the amount received show the form and strength in which supplied

Recommendation

• two members of staff initial the register, one of which would be a witness

Drugs supplied

The entries must

• show the date on which the supply was made
• give the name and address of the person for whom it was prescribed
• give particulars regarding the authority of person who prescribed the item (or if supplying for a GPs bag — the person in possession of the item)
• record the amount supplied
• show the form and strength in which supplied

Recommendation

• two members of staff initial the register, one of which would be a witness

Both register entries must

• be in a bound register with appropriately ruled and headed columns (there are commercially printed registers available of varying standards.
  • Recommendation - do not use a looseleaf version.
• be written in indelible ink
• be in chronological order
• have separate sections for each class of drug; separate sections are required for amphetamines (which include dexamphetamine) and methylamphetamine if held
• show the class of drug at the head of each page
• be made on the day of transaction or on the following day
• have no cancellations or obliterations or alterations (corrections must be made in indelible ink in the margin or as a footnote and must be signed and dated)
• be kept on the premises to which the register relates and be available for inspection at any time
• be kept safe for 2 years from the date of the last entry

Recommendation

• within the bound book, a separate page be used for each form and strength of each drug. This allows the users to keep a running stock level for each item, which can help to identify any discrepancies.

Supplies to replace items used by GPs

If a schedule 2 item has been used by a GP, the GP should write a prescription for the item used and present this to the staff to obtain a replacement.

Recommendation

• two members of staff (not the GP involved) supply the item, make appropriate entries in the register and sign to say they have supplied and witnessed the transfer. The GP should make the appropriate entry in their CD register for their bag.

Should a GP require a new item, the practice CD register should be completed as above by two other members of staff. This entry should indicate that the item is for the GPs bag. The GP should make the appropriate entries in their own CD register for their bag.

The GPs are responsible for keeping their registers up to date and they should participate in a monthly stock check. The GP should register the administration of controlled drugs to a patient from their bag in their own CD register for their bag.

If no controlled drugs are held centrally on practice premises then a personal register relating to the controlled drugs held in each GPs bag only is required. However, when recording drugs received and supplied, it may be prudent if the above approach is taken, that is, another senior member of the primary health care team initialling the entry.

Stock check

Stock levels should be checked once a month

• comparing the actual stock with the register (and the computer if this is appropriate) within each premises
• comparing the actual stock with each GP against their individual register

An authorised person (including Home Office Drugs Inspectors) can request a viewing of the particulars of stock receipt and supply, at any time.

Safe custody requirements of controlled drugs

The Misuse of Drugs Act 1971 and subsequent Regulations (Safe Custody) 1973 and 1985, lay down the rules for safe custody of controlled drugs (particularly those in Schedule 2 — see BNF edition 49, page 7 - 9, for details of scheduling).

Home Office recommendations include: -

If drugs are stored on surgery premises:

• drugs requiring safe custody should be stored under lock and key in a safe/cabinet
• a locked safe/cabinet preferably of steel, with suitable hinges, fixed to a wall or the floor with rag bolts (these bolts should not be accessible from outside the cabinet). Ideally the safe/cabinet should be within a cupboard or some other position to avoid easy detection by intruders the room containing the safe/cabinet should be lockable and tidy around the safe/cabinet area to avoid drugs being misplaced
• walls of the room should be constructed to a suitable thickness using suitable materials
• a locked receptacle is necessary for drugs in transit
• stock should be kept to a minimum and nothing should be displayed outside to indicate that controlled drugs are kept within that receptacle

A GP's BAG IS REGARDED, ONCE LOCKED, AS A SUITABLE 'LOCKED RECEPTACLE' ALTHOUGH A LOCKED CAR IS NOT - (RAO v WYLES, 1949).

Regulations also cover security measures to prevent users unlawfully obtaining supplies of drugs and syringes, prescription pads and headed notepaper from surgeries.

Practice staff should be aware of security:

• do not leave blank prescription pads 'lying around', especially in the reception area
• make sure that blank pads are not left unattended on a GP's desk
• blank prescriptions must NEVER be signed
• pads should be locked away at night, in case of unlawful entry
• discourage GPs from using them as 'spare notepads' in pockets

All practice staff should apply strict security at all times in dispensing practices. It makes sense to lock ALL Schedule 3 drugs (with Schedule 2) in the CD cabinet. Drugs in Schedules 4 and 5 are also the targets of addicts, and if they are kept on the shelves, then the dispensary itself should have barred windows, good locks and infra- red alarms.

Prescribing requirements for controlled drugs

When prescribing drugs listed in Schedules 2 or 3, (with the exception of phenobarbitone, phenobarbitone sodium and preparations containing them) the prescription, under the Misuse of Drugs Regulations (1985), is subject to the following requirements:

• show the doctor's full name and prescribing registration number, address, telephone number and Health Authority (this is pre-printed on the prescription)
• written in indelible ink BY THE GP and SIGNED and DATED by that GP (not computer generated) and clearly stating
  • the patient's full name, address and age where appropriate
  • the name and form of the drug (e.g. tablets, even if only one form exists)
  • the strength of a preparation (where appropriate)
  • the dose to be taken
  • the total quantity to be supplied in words and figures
• prescriptions for controlled drugs are valid for 13 (thirteen) weeks

Prescribing in instalments: form FP10 (MDA)

Terms of Service for Doctors in General Practice (item 36 [2A]) state that if a prescription is to be dispensed in instalments then the prescription must specify the following (in the prescribers own handwriting):

• Number of instalments
• The intervals to be observed between instalments (if necessary, include instructions for supplies at weekends or bank holidays)
• The quantity to be supplied in each instalment
• These prescriptions are valid only for the instalment dates specified on the form

These prescription forms exist to allow daily dispensing (instalments) from one form. Their use is limited to certain controlled drugs and for a maximum of 14 days per form. It is not permitted to prescribe controlled drugs by the 'repeat' method, as used in some private prescribing. This also applies to private prescribing of controlled drugs.

CD prescription (schedules 2 and 3) must: -

• Be hand-written by the GP (except phenobarbitone and temazepam)
• Have the total quantity or number of dosage units written in words and figures
• Satisfy ALL the requirements: it is an offence not to do so

While CD prescription forms cannot be generated by computers, the computer system is recommended as a method by which to record and audit the prescribing of controlled drugs.

The date on the CD prescription

Some confusion exists here.

• Schedules 2 & 3 prescriptions cannot be printed on computer
• The Misuse of Drugs Regulations, 1985 (Schedule 3: 6.3.86) say that 'a stamp may be used for the date' when referring to Schedule 2 drugs
• Prescriptions for schedules 2 & 3 drugs (apart from phenobarbitone and temazepam) must be hand-written by the GP, and for security, we also recommend that GPs write the date in their own handwriting rather than use a date stamp.

N.B. - A prescription for a controlled drug included in schedules 2 and 3 of the Misuse of Drugs Regulations (1985), may not be dispensed unless the prescribing meets the requirements of regulation 15 of the Misuse of Drugs Regulations. Such regulations should apply to pharmacy dispensing and dispensing GP practices.

Pharmacists cannot dispense incomplete prescriptions. Incomplete prescriptions (e.g. with no stated dosage or with any other omission) should be referred back to the GP, usually via the patient or by telephone. The Pharmacist should only retain the prescription if it is a suspected forgery.

Any part of the prescription that has not been written upon should be blanked off to reduce the opportunity for fraud.

Phenobarbitone

A member of staff may write a prescription for PHENOBARBITONE (schedule 3) provided both the quantity and strength are written in words and figures. The date must be handwritten.

Invoice requirements for controlled drugs

The invoices for Schedule 3 and 5 controlled drugs must be retained for two years.

Recommendation - that all invoices for all controlled drugs be retained for two years.

The CD register

• Should be a bound book (not loose leaf or card-index)
• Must have the drugs to which the entries relate specified at The head of the page
• Must show drugs obtained and drugs supplied
• Must be kept on the premises
• Be available for inspection
• Be kept for two years from the date of the last entry (dangerous drugs (misuse of drugs) regs 1973).

Police

• Police have the right of entry to pharmacies but not to GP surgeries – although obviously GPs would offer help wherever possible.

Destruction of controlled drugs

Stock drugs

Regulation 26 of the Misuse of Drugs Act (1973), states that in Pharmacies and Dispensing Practices, controlled drugs in Schedules 1 or 2 may only be destroyed in the presence of a person authorised by the Secretary of State, e.g.: - Any Police Officer Health Authority Medical and Pharmaceutical Advisors Home Office Inspector

Such an authorised person would be required to be present for the destruction of out of date stock items from schedule 1 or 2. Details of the drug being destroyed must be entered in the controlled drugs register, including the drug name, form, strength and quantity as well as the date of destruction and the signature of the person in whose presence the drug was destroyed. Failure to do so would make the GP guilty of a misdemeanour.

Recommendation Schedule 3 drugs should be destroyed in the same way, although this is not a legal requirement.

Drugs returned by patients/patients representatives

The above regulation does not apply to controlled drugs returned to a practice or community pharmacist by a patient because the audit trail stops once the drugs have been dispensed. The practice or community pharmacist should destroy these drugs by an appropriate method (preferably within a short space of time). Hoarding of significant quantities of returned drugs is not best practice. Such supplies are at risk of being mislaid or stolen.

Recommendation where appropriate, patients should be encouraged to return all drugs for disposal to their local community pharmacy.

Future local campaigns will encourage patients to return unwanted drugs to pharmacies.

• These returned drugs should not be entered in the practice controlled drugs register
• These drugs must not be re-issued

Recommendation

• A separate record book should be used to audit the return and destruction of prescribed controlled drugs of schedule 2 and 3.

This book should be used in the form of a continuous list and should record the following information:

• date of return
• each item returned including drug name, form, strength and quantity
• the name of the patient they were prescribed to
• the signatures of the accepting member of staff and the patient or patient's representative (not staff)

At a suitable time, a practice partner plus another member of staff should destroy these returned items, with both signing next to the above entry to state that the drugs have been destroyed.

Appendix 1- controlled drug schedules

The lists set out in this appendix are not comprehensive.