Controlled drugs regulation has seen many changes in recent years; from recommendations for best practice following the Shipman enquiry to the introduction of CD prescribing by non-medical prescribers. The safe management of controlled drugs can be a daunting task. The Information Services team regularly take queries from members on a wide range of CD issues, highlighting the difficulties pharmacists face in this field. This CPD article will look at some of the common queries we receive and provide guidance on practice and law surrounding the supply of CDs.

Independent prescribers

Amendments to the misuse of drugs regulations in April 2012 meant that nurse and pharmacist independent prescribers are authorised to prescribe all schedule 2 to 5 controlled drugs for the treatment of organic disease or injury. When prescribing for the treatment of drug addiction diamorphine, cocaine and dipipanone must not be prescribed, however all other drugs (e.g. methadone, buprenorphine) are permitted.

As is the case for all non-medical independent prescribing, practitioners should be fully trained and only prescribe within their areas of competency.

The appropriate date

The appropriate date is either the date of signing or any other date indicated on the prescription by the prescriber, before which they do not want the CD to be supplied. This includes the date of first instalment and dates for subsequent instalments.

Prescriptions for schedule 1, 2, 3 and 4 CDs are valid for 28 days from the appropriate date and prescriptions for schedule 5 drugs are valid for 6 months.

On FP10MDA prescriptions, legally the first instalment must be dispensed within 28 days of the appropriate date. However the nature of instalments overrules this to require that the instalment is dispensed on the actual specified date (which incidentally is also the appropriate date). See "instalment directions" below.

Owing balances

Where you have insufficient stock you are permitted to issue 'owings' for all controlled drugs, including methadone on FP10MDA.

Owing balances for schedule 1 to 4 CDs must be supplied within 28 days of the appropriate date. In most cases this will be the date of signing - although for owings on methadone it will be 28 days from when the instalment was due.

You must ensure that the patient is made aware of the expiry date of the owing balance, if they return after this date then you cannot supply the medication.

Owings must be recorded accurately in the CD register. An entry must be made once for the initial supply and then again for the supply of the remaining balance, once the patient has collected it. Annotate the entry with wording such as "part supply" and "balance fulfilled".

Dosage instructions

It is a legal requirement for all schedule 2 and 3 CD prescriptions to have a clearly defined dose; the prescription cannot be dispensed without one. The dose must state the number of units (i.e. tablets, capsules, patches etc.) to be administered. It cannot be assumed that if no number is stated then it is "one".

In addition it is not sufficient to specify the dose in number of milligrams i.e. MST continus MR tabs 60mg twice daily - would not be acceptable (as this could be achieved using 5mg, 10mg, 20mg, 30mg and 60mg tablets)

Examples of legally acceptable dosage instructions include:
"One as directed"
"One when required"
"One PRN"

Dosages such as "PRN", "when required" or "as directed" without any quantity are not acceptable. Expressions such as "daily" or "weekly" when used alone are also not acceptable, there must be an indication of how many times daily or weekly.

Finally, even though a dose may be legally acceptable that does not imply that it is clinically acceptable. The dose must be clear to allow the patient to take the medication correctly, but the dose must also be checked from a clinical perspective - is it safe or is it appropriate?

Instalment directions

An instalment prescription (FP10MDA or equivalent) must have both a daily dose and an instalment amount stated separately e.g.

"Take 40mls daily, supply 40mls on Friday 18th and 80mls on Saturday 19th."

The instalment direction must include both the quantity of drug per instalment and the interval between each dispensing OR a specified supply date.

Where the prescriber specifies an instalment on a specific date, this over-rides the 28 day validity period. The instalment must only be dispensed on that date unless specified wording is used;

The Home Office has approved specific wordings to allow some flexibility in supply e.g. for bank holidays, pharmacy closed days and missed doses. Although not a legal requirement, the approved wordings (see current MEP 41 p11.) should be used wherever possible. If a prescription is dispensed with alternative wording there will not be the same level of protection from enforcement so the prescriber should be asked to amend the prescription before you begin to dispense it.

Private prescriptions

Private prescriptions for all schedule 2 and 3 CDs (including temazepam) MUST be written on the appropriate standardised private prescription form:

• England - FP10PCD
• Wales - WP10PCD
• Scotland - PPCD(1)
• Northern Ireland - HS21S

In addition, this form MUST contain the prescriber's unique six-digit CD identification number; this is not the same as the prescriber's professional registration number (e.g. GMC no.), it is a number issued by NHS agencies and can be obtained from the Local NHS England team.

Once the supply is complete, the original private prescription form must be submitted to the relevant pricing authority (e.g. NHSBSA). In England and Wales a special submission form FP34PCD must be used and the pharmacy also requires a unique submission code (issued by the Local NHS England team). The form can be downloaded from http://www.nhsbsa.nhs.uk/2473.aspx.

Private prescriptions for schedule 1-4 CDs are valid for 28 days from the appropriate date and schedule 5 CDs are valid for 6 months. Prescriptions for schedule 1-3 controlled drugs are not permitted to be repeated.

CD requisitions (signed orders)

It is mandatory for requisitions for all schedule 1, 2 and 3 CDs to be written on the standardised requisition form:

• England - FP10CDF
• Wales - WP10CDF
• Scotland - GP10A
• Northern Ireland - HS21S

Hospices and prisons are exempt from the requirement to use the approved form.

The mandatory form can be obtained online from NHSBSA website (www.nhsbsa.nhs.uk). They can be downloaded, completed online, printed and signed in wet ink.

In an emergency, a doctor or dentist can be supplied with a schedule 2 or 3 CD upon affirmation that a requisition will be provided within 24 hours. Failure to do so would be an offence on the part of the doctor or dentist.

Once the supply of a schedule 2 CD has been made an entry must be made in the relevant section of the CD register, it is good practice to also record the supply in the private prescription register. Supplies of schedule 3 CDs must be recorded in the private prescription register. The requisition form should be indelibly marked with the pharmacy name and address, where a stamp is used this must be legible. A copy of the requisition must be kept for two years from the date of supply and the original must be submitted on form FP34PCD as per private prescriptions

Record-keeping of branded generics

Increasingly, manufacturers of generic products are using a 'brand name' to identify their product - these have become known as 'branded generics'. Because these generics are easily distinguishable, and can be described by the brand name, it would be considered good practice to use a separate register for each branded generic. Alternatively a single 'generic' register could be used.

The decision as to whether to enter details of all generic products of the same description into a single register or to use multiple registers (one for each manufacturer) is a professional decision for the pharmacist/superintendent.

In order to aid this decision, the following practice issues should be taken into consideration. The likelihood is that a different decision may be taken for different controlled drug presentations. There is no 'one size fits all' policy.

1. Running balances - care must be taken to ensure that running balances recorded in each register are accurate. If multiple registers are used there is a risk that a generic product will be entered in the wrong register (if considered simply to be 'generic') leading to balance discrepancies.
2. Drug recalls - if a recall is issued for a specific branded generic it will be easier to identify if any has been dispensed when multiple registers are used. If a single 'generic' register is used it will be difficult to determine if any of the affected brand has been dispensed.
3. Audits/inspections - the use of multiple registers will facilitate the auditing of controlled drugs by GPhC inspectors, Accountable Officers and by pharmacy staff.
4. Prescribing issues - in some cases prescribers may specify a particular branded generic, or they may specify a variable characteristic of the product unaffected by the generic description. An example of this is with fentanyl patches where both matrix and reservoir patches are available. Legally, either type of patch meets the generic prescription, however clinically there are differences. The prescriber may specify which type of patch to use. Where a single register is used there may be issues with running balances. We recommend either using a separate register for each branded generic patch or a separate register for generic matrix and generic reservoir patches.
5. Space constraints and ordering restrictions - where there are several branded generics available the situation could arise where there are a large number of registers, essentially for the same product, each with low stock levels recorded. This problem is compounded by pharmacists having little or no control over which branded generic is received from the wholesaler.
6. Communication - it must be made clear to staff what the policy is surrounding which CD registers to use. The SOP relating to CD stock control and record keeping should be amended to reflect the individual pharmacy policy and to specify which registers to use for each controlled drug.

The above regulation and practice guidance can be found, along with all the other information you require for the safe management of controlled drugs, in Numark's template SOPs, available to download from NumarkNet.

The Information Services team is also available to take your calls on 0800 783 5709 option 2.