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Pharmaceutical Services Negotiating Committee

Controlled Drugs

Dispensing Controlled Drugs

In recent years, there have been a substantial number of changes made to systems used for the safe management of Controlled Drugs (CDs). Key requirements are summarised in the following guidance.

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Prescription Form and Owing Note Validity

 Computer Generation: Prescribers can now issue computer-generated prescriptions for all CDs including Schedule 2 and 3 CDs; all details except the signature can be computer-generated. The requirement that CD prescriptions should be written in the prescriber’s own handwriting was removed in November 2005.

Validity of Form: Prescriptions for Schedule 2, 3 and 4 CDs are only valid for 28 days. The 28 day period of validity runs from the date the prescription was signed unless the prescriber has specified a start date on the prescription. For instalment dispensing prescriptions, the first supply must be made within 28 days of the appropriate date and the remainder of the instalments must be dispensed only in accordance with the directions on the prescription.

Repeat Dispensing: Schedule 2 and 3 CDs can not be prescribed on repeat dispensing prescriptions. Repeat dispensing prescriptions for Schedule 4 CDs must be dispensed for the first time within 28 days of the appropriate date. After the first dispensing the repeats are legally valid within the normal periods of validity of the repeatable prescription. Repeat prescriptions for Schedule 5 CDs must be dispensed for the first time within six months of the appropriate date. After the first dispensing the repeats are legally valid within the normal periods of validity of the repeatable prescription.

Owings: In the case of owings, the owing balance of prescriptions for Schedule 2, 3 or 4 CDs cannot be dispensed later than 28 days after the appropriate date on the prescription. It is good practice for the pharmacist to make the patient or their representative aware at the outset that they will not be able to collect the balance of a Schedule 2, 3 or 4 CD after the 28 day period has elapsed. For prescriptions for Schedule 5 CDs, the balance of an owing cannot be collected more than 6 months after the appropriate date.

Length of Treatment: There is a good practice requirement that the quantity of Schedule 2, 3 and 4 Controlled Drugs be limited to a quantity for up to 30 days treatment. In cases where the prescriber believes that a prescription should be issued for a longer period he may do so but will need to be able to justify that there is a clinical need and that it would not cause an unacceptable risk to patient safety. Pharmacists are able to dispense Schedule 2, 3 and 4 CD prescriptions ordering a supply of more than 30 days supply.

Prescription Writing Requirements: To be valid, on top of the normal prescription requirements for prescription only medicines, prescriptions for Schedule 2 and 3 Controlled Drugs (excluding Temazepam) must meet certain prescription writing requirements. In summary, these prescriptions must contain the dose, form, strength (where appropriate) and a total quantity of the preparation in both words and figures. Medicines Ethics and Practice, published annually by the RPSGB provides more detailed guidance on these requirements.


Amending Typographical Errors

Pharmacists are able to amend prescriptions for Schedule 2 and 3 Controlled Drugs where the prescription does not comply with the CD prescription requirements. The only changes that pharmacists can make are:

  • Minor spelling mistakes
  • Minor typographical mistakes (this may include, for example, a number being substituted for a letter or two letters being inverted but where the prescriber’s intention is still clear)
  • Where the total quantity of the CD/number of dosage units is specified in either words or figures but not both, a pharmacist can add either the missing words or figures as required (but not both)

In doing this, pharmacist must exercise due diligence and be satisfied that the prescription is genuine and the CD is being supplied in accordance with the intention of the prescriber. The prescription must be amended in ink or otherwise indelibly and the pharmacist must mark the prescription so that the amendment is attributable to him or her, for example by signing the amendment. If there is more than one amendment on the same prescription, each amendment must be marked.

Where an amendment is made by one pharmacist and another pharmacist makes the supply, the Home Office has advised that the second pharmacist should also mark the amendment to indicate that he is also satisfied and it is attributable to him as well.


Instalment Dispensing

NHS Prescription Services has published detailed guidance (currently not available as this is being updated - see link to page discussing the Drug Tariff changes for July below) on the dispensing, endorsement and reimbursement arrangements for FP10MDA Instalment dispensing prescription forms. The Welsh Assembly Government has confirmed that this applies in principle in Wales.

 In England, only Schedule 2 CDs plus buprenorphine, Buprenorphine/Naloxone (Suboxone) and diazepam can be supplied in instalments against Form FP10MDA. In Wales, Schedule 2, 3, 4 and 5 Controlled Drugs can be supplied in instalments on Form WP10MDA. In both cases, the period of treatment must not exceed 14 days. The prescriber must specify the number of instalments to be dispensed and the interval between each instalment.

 
 

Identity Checks / Collection of Prescriptions for CDs

Signing the Back of the Prescription Form: It is good practice to ask individuals, at the point that Schedule 2 or 3 CDs are handed to them, to sign the back of the prescription form as confirmation of collection. Where the person collecting the CDs does not agree to sign the back of the form, pharmacists may apply their discretion on whether or not to supply the CDs.

Identity Checks: There is a legal requirement for pharmacists to establish whether a person collecting a Schedule 2 CD is the patient, the patient’s representative or a health care professional acting within their professional capacity. This only applies to Schedule 2 CDs.

Where the person collecting the Schedule 2 CD is the patient or the patient’s representative, the pharmacist should ask for proof of identity, for example, ask to see photo-ID or a credit or debit card. Pharmacists have the discretion to decide whether to ask for proof of identity and also whether to supply the CD. Where the person collecting the Schedule 2 CD is a health care professional, the pharmacist must obtain the person’s name and address and must ask for proof of identity unless the health professional is known to them. The pharmacist may still supply the CD even if ID is not provided.


Record Keeping Requirements

Running Balances: As a matter of good practice pharmacists who supply CDs should maintain a running balance of stock in their Controlled Drug Register (CDRs). This is expected to become a mandatory requirement once electronic registers are in common use. Further guidance on the maintenance of a running balance in the CDR is available on the RPSGB Website.

Controlled Drug Registers: From 1st February 2008 the requirement to maintain a Controlled Drug Register (CDR) in its prescribed form as was set out in schedule 6 of the 2001 regulations was removed and replaced with a requirement for specific headings/fields in the CDR. The regulations now also require that additional information should be recorded in the CDR in relation to the identity of the person collecting a schedule 2 CD supplied on prescription.

The regulations allow the following information to be recorded in the CDR, under the following specific headings, when CDs are obtained:

  • Date supply obtained
  • Name and address from whom obtained (e.g. wholesaler, pharmacy)
  • Quantity obtained

When CDs are supplied, the regulations require information to be recorded in the CDR, under the following specifc headings:

  • Date supplied
  • Name and address of person or firm supplied
  • Details of authority to possess-prescriber or license holder details
  • Quantity supplied
  • Whether the person who collected the drug was the patient, the patient's representative or a healthcare professional acting on behalf of the patient;
  • If the person who collected the drug was a healthcare professional acting on behalf of the patient, that person's name and address;
  • If the person who collected the drug was the patient or the patient’s representative, whether evidence of identity was requested of that person (yes/no);And whether evidence of identity was provided by the person collecting the drug (yes/no).

Further guidance on the changes to record keeping requirements for controlled drugs can be found on the Department of Health website.

Electronic Controlled Drug Registers: Pharmacists are allowed legally to keep CDRs electronically if they wish to do so providing they comply with the legislation. The Regulations require that every computerised entry must be attributable and capable of being audited. The computerised register must be accessible from the premises to which it relates and persons authorised by the Secretary of State (e.g., the Society’s inspectors) are able to request that a copy of the register, in its computerised or other specified form, be sent to them.

Pharmacists are advised that CD registers may only be held in a computerised form if safeguards are incorporated into the software to ensure all of the following:

  • The author of each entry is identifiable
  • Entries cannot be altered at a later date
  • A log of all data entered is kept and can be recalled for audit purposes

Access control systems should be in place to minimise the risk of unauthorised or unnecessary access to the data and adequate backups must be made. Pharmacists are also advised that arrangements must be made so that inspectors can examine computerised records during a visit with minimum disruption to the dispensing process. A number of pharmacy system suppliers have now integrated electronic registers into their dispensing systems.


Destruction of Patient Returned and Stock Controlled Drugs

Pharmacy contractors must have appropriate arrangements in place for securing the safe destruction and disposal of CDs. All CDs in Schedule 2 and those CDs in Schedule 3 that are subject to safe custody requirements should be placed into waste containers only after the controlled drug has been rendered irretrievable (i.e. by denaturing). Where practicable pharmacists should use CD denaturing kits in order to denature CDs, these can be obtained from some PCOs, waste contractors and the NPA. Where this is not possible other methods of denaturing may be used for example adsorbing onto cat litter, provided that there are no risks to human health or the environment. Detailed guidance on the disposal of unwanted medicines can be found in the waste section of this website.

Patient returned CDs: Pharmacies can accept CDs returned by patients from their own homes and from care homes providing personal care for safe destruction and onward disposal. Pharmacies in England and Wales are not able to accept waste medicines, including CDs, from care homes which provide nursing care. Pharmacists must make a record of patient returned Schedule 2 CDs, and their destruction, and to ensure another member of staff, preferably a pharmacist or pharmacy technician if available, witness the destruction. There is currently no requirement for the destruction of patient returned CDs to be destroyed by an authorised witness. The record of the destruction should be made somewhere other than the CD register.

Date expired pharmacy stock: It is a legal requirement for pharmacy contractors to have stocks of obsolete, expired and unwanted Schedule 1 and 2 CDs destroyed in the presence of an authorised witness.

An amendment to the Misuse of Drugs Regulations 2001 which came into force on the 16th August 2007 allows Accountable Officers to authorise people or groups of people to witness the destruction of controlled drugs to render them irretrievable. Previously the witnessing of destruction of controlled drugs was undertaken by the police chemist inspection officers, the Royal Pharmaceutical Society inspectors, and the Home Office inspectors.

Any person authorised to witness destruction of controlled drugs by the accountable officer should have the appropriate training and will be accountable for this directly to the accountable officer.

A record of the date of destruction, quantity of product destroyed and a signature of the witness should be entered into the CDR. The disposal of date-expired medicines in Schedules 3,4 and 5 does not need to be witnessed or recorded.


Requisitions for Schedule 1,2 and 3 Controlled Drugs

The regulations for requisitions for Schedule 1,2 and 3 Controlled Drugs changed on 1st January 2008.

The changes apply to requisitions used for the supply of schedule 1, 2 and 3 CDs by authorised practitioners working in any health care setting in the community, for the purpose of treating patients. Authorised practitioners include pharmacists working in community pharmacies. The new requisition form should not be used when supplies are made from other settings, for example: NHS hospital trusts, care homes, pharmaceutical wholesalers and manufacturers. Although not a legal requirement, it is good practice, where one pharmacy orders a CD from another pharmacy, for written requisitions to be used.

The person ordering the CDs (recipient) should issue a requisition for CDs that can be computer generated or handwritten and must contain the following information:

  • Signed by the recipient (must be handwritten)
  • States the name, address and profession or occupation of the recipient
  • The purpose for which the drug is supplied and the total quantity to be supplied

The regulations require the supplier of the controlled drug to mark on the requisition their name and address at the time the supply is made. A pharmacy stamp containing the name and adress of the pharmacy should enable this requirement to be met.

In England, a standard requisition form, FP10CDF has been developed to make sure all of the legal requirements for ordering CDs are met. In exceptional circumstances, where for example an individual may have difficulty in obtaining the standard form, a CD can be supplied in response to an order written on a non standard form, providing all the legal requirements are met.

Pharmacies can obtain copies of the requisition form from their PCT.

The regulations require that the original requisition form FP10CDF for all Schedule 1, 2 and 3 controlled drugs be submitted to NHS Prescription Services using the submission document FP34PCD. Community pharmacies require a private controlled drug account number which should be used when submitting FP10PCD Private forms and FP10CDF requisition forms and is a different account to the NHS account number used by contractors to submit NHS prescriptions. Suppliers who need to submit requisitions but who do not already have a private CD prescription F code must contact their local PCT. Guidance on how forms should be submitted can be found in Part XX of the Drug Tariff. Requisitions not received on standard form, FP10CDF cannot be processed by the NHS Prescription Services and will be sent to the appropriate PCT where possible so that they can ensure there is a supply of the form available for future use.  

In Wales, a standard requisition form WP10CDF should be used when ordering a schedule 1, 2 or 3 controlled drug. Pharmacies in Wales can obtain form WP10CDF from local Business Service Centre Stores.

The regulations require that the original requisition form WP10CDF should be submitted to Health Solution Wales using the WP34C form which can be downloaded from here.

The original WP10PCD/WP10PCDASS prescription forms & WP10CDF requisiton forms should be submitted to the following address:

Health Solutions Wales
12th Floor Brunel House
2 Fitzalan Road
Cardiff
CF24 0HA

More information is available on the NHS Prescription Services Website.


Monitoring and Inspection Arrangements

New arrangements were introduced in January 2007 for monitoring the management, usage and other aspects of controlled drugs in England. These arrangements do not yet apply in Wales.

Every healthcare organisation (e.g. PCT) must have an appointed ‘Accountable Officer’ with a duty to oversee the management and use of controlled drugs. The accountable officers appointed by PCTs have a range of responsibilities including ensuring that pharmacies have adequate and up-to-date standard operating procedures (SOPs) in relation to the use of CDs, have appropriate arrangements in place for securing the safe destruction and disposal of CDs and systems in place to alert the Accountable Officer of complaints or concerns involving the management and use of CDs.

As part of the new arrangements, the RPSGB now ask pharmacy contractors to make a declaration in relation to the management and use of CDs at each of their premises. This forms part of the annual premises retention fee cycle.

SOPs: Pharmacy contractors are required under their terms of service to have SOPs for dispensing and repeat dispensing. The regulations now also require SOPs relating to the management and use of controlled drugs to cover the following points:

  • Ordering and receipt of CDs;
  • Assigning responsibilities;
  • Where the Controlled Drugs are stored
  • Who has access to the CDs
  • Who should be alerted if complications arise
  • Security in relation to the storage and transportation of CDs as required by the Misuse of Drugs regulations
  • Disposal and destruction of CDs
  • Record keeping, including maintaining relevant CDRs under the Misuse of Drugs legislation and maintaining a record of the CDs specified in Schedule 2 to the Misuse of Drugs Regulations 2001 that have been returned by patients

Monitoring and Supporting Staff Handling CDs: Pharmacy contractors need to have in place arrangements for monitoring and auditing the management and use of CDs by pharmacists and staff. The arrangements are required to include:

  • Recording any concerns raised in relation to the management and use of CDs by the relevant individual;
  • Assessing and investigating any concerns raised regarding the management and use of CDs by the relevant individual; and
  • Determine if there are any concerns in relation to the management and use of CDs by a relevant individual which the pharmacy contractor considers should be shared with a responsible body e.g. RPSGB

Pharmacy contractor must also ensure that pharmacists and staff handling CDs receive from time to time, appropriate training to carry out their responsibilities in the management and use of CDs.

Recording concerns: Pharmacy contractors should record concerns expressed about incidents that involved or may have involved improper management or use of CDs by a pharmacist or member of staff. The record should include the following:

  • The date on which the concern is made known;
  • The dates on which the matters giving rise to the concern;
  • Details regarding the nature of the concern;
  • Details of the pharmacist or staff involved;
  • Details of the person or body raising the concern;
  • Details of any action taken;
  • An assessment of whether information should be disclosed to a responsible body; and
  • If disclosure to a responsible body takes place, details of the disclosure and the responsible body to which the disclosure was made

An Accountable officer and police officers would have the power to enter and inspect pharmacy premises if concerns were being investigated.

Further guidance on the details required in the SOPs for CDs can obtained from the RPSGB and templates for CD SOPs may be obtained from the NPA.


Private Prescriptions for Schedule 2 & 3 CDs

In England, prescribers can now only order Schedule 2 or 3 controlled drugs privately on pink private prescription form FP10PCD. In Wales, the required form is WP10PCD or WP10PCDSS and in Scotland, Form PPCD (1). This requirement does not extend to Veterinary prescriptions.

All private prescribers have been allocated a six digit prescriber identification number (issued by the relevant NHS agency) which must be included on private form FP10PCD (or the Welsh or Scottish equivalent). Private prescriptions for schedule 2 or 3 controlled drugs should not be dispensed in community pharmacies if they do not contain this identifier. Private prescribers should be referred to their primary care organisation (e.g. PCT) if they require a private prescriber identification number.

The Misuse of Drugs Regulations 2001 were amended in 2006 to introduce a requirement for all private prescriptions for schedule 2 and 3 CDs to be sent to the NHS Prescription Services or its equivalent body for analysis and monitoring purposes.

Amendments to the medicines legislation (the Medicines for Human Use (Administration and Sale or Supply)(Miscellaneous Amendments) Order 2007 and the Medicines (Sale or Supply) (Miscellaneous Provisions Amendment Regulations 2007) have been made to allow for the original private FP10PCD prescriptions to be sent to NHS Prescription Services and came into effect on the 1st September 2007.

Pharmacy contractors in England are required to submit the original FP10PCD form to NHS Prescription Services for audit purposes each month using a special submission document, FP34PCD. The equivalent original forms originating from Wales or Scotland should also be submitted.

A copy of the submission form can be downloaded from the NHS Prescription Services website or alternatively pharmacies may call NHS Prescription Services on 0300 330 1349 and ask for the form to be faxed to them. Guidance on the submission process can be found in Part XX of the Drug Tariff.

Pharmacy contractors in Wales should also submit the original of private prescription form WP10PCD to Health Solutions Wales on a monthly basis at the same time as submitting other NHS prescription forms. The equivalent forms originating from England or Scotland should also be submitted.


Patient Drug Record Cards

Pilots are being undertaken in which patients are handed drug record cards with all dispensed injectable schedule 2 controlled drugs. These cards are used by the patient or their nurse to record each administration event, and to carry out an audit of stock remaining if any at the end of a course of treatment.

Until the trials are complete, the precise processes will not be decided, but a common feature of all the pilots is that the dispensing pharmacist prepares the drug record card. We expect these changes to happen at some time in the future and further guidance will be provided.


FAQs

The RPSGB has published comprehensive frequently asked questions on their website. The PSNC top frequently asked questions are published below:

I have received a prescription for a Schedule 2 CD. The date has been computer generated, is this acceptable?

Yes, Prescribers can now issue computer-generated prescriptions for all CDs including Schedule 2 and 3 CDs; all details except the signature can be computer-generated.

I have received a prescription for a Schedule 2 CD. The date is missing. Is it acceptable for this to be added in the pharmacy?

No, pharmacists can only amend minor spelling or typographical error or the omission of either words or figures on prescriptions for Schedule 2 or 3 CDs. It is not possible for pharmacists to add a missing date or other information such as a missing dose or pharmaceutical form.

I've received a standard FP10 prescription for ‘Diazepam Tablets' which requests installment dispensing. Will I be reimbursed for dispensing in installments?

No, there is no provision to dispense medicines in installments on a standard FP10 prescription form. The prescriber is breaking their Terms of Service* by not using the form provided specially for the purpose of supply in instalments.

In England, Form FP10MDA allows installment dispensing of Schedule 2 Controlled Drugs plus Buprenorphine, Buprenorphine/Naloxone (Suboxone) and Diazepam. In Wales, the rules are slightly different. Schedule 2, 3, 4 and 5 Controlled Drugs can be prescribed in installments on Form WP10MDA in Wales. If a WP10MDA prescription is presented for dispensing in England, the English rules apply; contractors will only be reimbursed for dispensing Schedule 2 Controlled Drugs, Buprenorphine, Buprenorphine/Naloxone and Diazepam in instalments.

Another option for the prescriber could be the repeat dispensing arrangements, provided that the patient fits into the suggested criteria for patient selection i.e. they have a long-term condition that is considered likely to remain stable for the duration of repeat dispensing.

 

* The National Health Service (General Medical Services Contracts) Regulations 2004 outlines the regulations surrounding Controlled Drug instalment dispensing:

“Where a prescriber orders the drug buprenorphine or a drug specified in Schedule 2 to the Misuse of Drugs Regulations 2001 for supply by instalments for treating addiction to any drug specified in that Schedule, he shall—

(a) use only the prescription form provided specially for the purposes of supply by instalments;

(b) specify the number of instalments to be dispensed and the interval between each instalment; and

(c) order only such quantity of the drug as will provide treatment for a period not exceeding 14 days.”


Related Resources

Copy of the FP34PCD Submission Document

List of commonly available Schedule 1, 2 and 3 Controlled Drugs (2010) (PDF) - correct as of August 2010


More Information


FP10MDA (Instalment Dispensing) Guidance (new)

DH Guidance on CDs

RPSGB Guidance on CDs

Advice is also available from the RPSGB Legal & Ethical Advisory Service: 020 7572 2308 / ftp@rpsgb.org

Technical Errors on Prescriptions for Schedule 2 & 3 CDs: RPSGB Law & Ethics Bulletin

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