Controlled Drug prescription forms and validity
Controlled Drug prescription forms and validity
|REF: The Misuse of Drugs Regulations 2001 (16(2))|
|Dispensing Controlled Drugs|
NHS prescriptions for Controlled Drugs
Controlled Drug (CD) prescription writing requirements:
To be valid, on top of the normal prescription requirements for prescription only medicines (as required by the Human Medicines Regulations 2012), prescriptions for Schedule 2 and 3 CDs must also contain the following (as outlined in The Misuse of Drugs Regulations 2001):
The strength (where appropriate);
The total quantity or dosage units of the preparation in both words and figures;
For instalment prescriptions, specify the instalment amount AND instalment interval
The words “for dental treatment only” written on it if issued by a dentist
Medicines Ethics and Practice, published annually by the Royal Pharmaceutical Society, provides further and more detailed guidance on these requirements.
Note: From 1 June 2015, Temazepam is no longer exempt from the CD prescription writing requirements, meaning that prescriptions will need to comply fully with the requirements for Schedule 3 CDs.
Prescribers can now issue computer-generated paper prescriptions for all Controlled Drugs (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.
Prescriptions for Schedule 5 CDs ar valid for 6 months.
Length of treatment:
There is a good practice requirement that the quantity of Schedule 2, 3 and 4 CDs 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.
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.
Schedule 2 and 3 CDs cannot 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.
Electronic prescriptions for Schedule 2 or 3 CDs
From 1 July 2015, legislation comes into force allowing Schedule 2 and 3 CDs to be prescribed and dispensed using the NHS electronic prescription service (EPS) release 2 messages, using an Advanced Electronic Signature.
EPS release 2 prescriptions for Schedule 2 and 3 CDs will need to satisfy the usual prescription writing requirements (see below) including the need to express the total quantity in words and figures.
In PSNC’s response to the consultation on allowing Schedule 2 and 3 CDs to be prescribed via EPS we suggested that this requirement should not apply to electronic prescriptions, but the Home Office concluded that the requirement should remain.
The Health and Social Care Information Centre (HSCIC) has issued all GP and community pharmacy system suppliers with the technical requirements to implement CDs prescribing via EPS. All dispensing systems must be updated and fully deployed across all pharmacy sites, before it is possible to enable the new functionality. This is to avoid the possible risk of a prescriber sending a prescription for a CD to a pharmacy which can’t then dispense it.
The change in legislation to allow CDs to be sent via EPS included the requirement for the quantity in words to be included in the electronic prescription; HSCIC said in May 2016 that the anticipated timescale for all pharmacy system suppliers to develop this functionality may be as late as December 2018. Due to these extended timescales, a new tactical fix has been developed by HSCIC which will not require the pharmacy system suppliers to upgrade their systems immediately, instead the fix would rely on the prescribing system suppliers. The tactical fix will be to put the quantity in words into the additional instructions field of the EPS message. A notification has now been submitted to the prescribing suppliers about the need for this fix, and when they are able to make the necessary changes, HSCIC assurance will take place, with the aim to make the functionality available as soon as possible.
HSCIC will update their website with system supplier progress regarding the ability to process CDs. Once transmission of CDs becomes possible via EPS R2, PSNC will announce the news on its website and within its newsletters.
Amending typographical errors
Pharmacists are able to amend prescriptions for Schedule 2 and 3 CDs 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); and/or
- 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.
Collection of prescriptions for CDs and 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.
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.
Private prescriptions for Schedule 2 & 3 CDs
In England, prescribers can now only order Schedule 2 or 3 CDs 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.
Prescriber identification number
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 CDs 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. local NHS England team) 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 FP10PCD forms to NHS Prescription Services for audit purposes each month using a special submission document, FP34PCD* which is available on the NHS Prescription Services website or alternatively, pharmacy teams may telephone or email NHS Prescription Services on 0300 330 1349 or email@example.com to receive another form. The equivalent forms originating from Wales or Scotland should also be submitted.
Community pharmacies require a private CD account number which should be used when submitting FP10PCD private forms which is a different account to the NHS account number used by contractors to submit NHS prescriptions. In England, suppliers who need to submit private prescription forms but who do not already have a private CD prescription F code must contact their local NHS England team.
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.
Guidance on how forms should be submitted in England and Wales and can be found in Part XX of the Drug Tariff.
Requisitions for Schedule 2 and 3 CDs
On 1 January 2008, amendments to the Misuse of Drugs Regulations 2001 came into effect in respect of requisitions used for the supply of Schedule 1, 2 and 3 CDs for use in the community. A dedicated requisition form (FP10CDF) (the standard form) was introduced for the supply of Schedule 1, 2 and 3 CDs which should be used unless there were “exceptional circumstances” e.g. where an individual may have difficulty in obtaining the standard form, so a supply could be made in response to an order written on a non-standard form, providing all the legal requirements were met. These changes applied to the supply of Schedule 1, 2 and 3 CDs by authorised practitioners and others.
From 30 November 2015, amendments to the Misuse of Drugs Regulations 2001 introduced the mandatory use of the new FP10CDF CD Requisition Form (the mandatory form) for requisitioning all Schedule 2 and 3 CDs. The mandatory use will apply to England, Scotland and Wales; however, Scotland and Wales have their own approved CD requisition forms which professionals in those countries should continue to use.
Those who must provide a requisition form to be supplied a Schedule 1, 2 and 3 CD:
- a practitioner;
- the person in charge or acting person in charge of a hospital, organisation providing ambulance services or care home*;
- a person who is in charge of a laboratory;
- the owner of a ship, or the master of a ship which does not carry a doctor among the seamen employed in it;
- the master of a foreign ship in a port in Great Britain;
- the installation manager of an offshore installation;
- a supplementary prescriber;
- a nurse independent prescriber;
- a pharmacist independent prescriber;
- a person who holds a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State, or a person who is a registered paramedic.
*Note: exemptions from those who must provide a requisition form include those for use in a prison; or for use in a care home, which as its whole or main purpose provides palliative care for persons resident there who are suffering from a progressive disease in its final stages (e.g. a ‘hospice’).
According to the Misuse of Drugs Act 1971 – the primary piece of legislation to the Misuse of Drugs Regulations 2001 – the term “Practitioner” (except in the expression “veterinary practitioner”) means a doctor, dentist, veterinary practitioner or veterinary surgeon.
The mandatory form
In England, the new mandatory form has been developed to make sure all of the current legal requirements for ordering Schedule 2 and 3 CDs are met. Pharmacy contractors must ensure that requisitions for Schedule 2 and 3 CDs are obtained on the new mandatory form from 30 November 2015. NHS Prescription Services has indicated that requisitions not received on the new mandatory form cannot be processed. The new mandatory form can be obtained online from the NHS Prescription Services website. They can be downloaded, completed online, printed and signed in wet ink.
In Wales, a standard requisition form WP10CDF should be used when ordering a Schedule 2 or 3 CD. Pharmacy contractors in Wales can obtain form WP10CDF from the local Business Service Centre Stores.
Marking of requisitions
The regulations also require the supplier of the CD to mark on the requisition their name and address at the time the supply is made. A pharmacy stamp containing the name and address of the pharmacy could meet this requirement.
In England, the regulations require that the original completed and signed mandatory form (FP10CDF) for all schedule 2 and 3 CDs be submitted to NHS Prescription Services using the submission document FP34PCD* which is available on the NHS Prescription Services website or alternatively, pharmacy teams may telephone or email NHS Prescription Services on 0300 330 1349 or firstname.lastname@example.org to receive another form.
Community pharmacies require a private CD account number which should be used when submitting FP10CDF mandatory requisition forms, which is a different account to the NHS account number used by contractors to submit NHS prescriptions.In England, suppliers who need to submit requisition forms but who do not already have a private CD prescription F code must contact their local NHS England team.
In Wales, the regulations require that the original completed and signed requisition form WP10CDF be submitted to NHS Wales Shared Services Partnership (NWSSP) – Primary Care Services using the WP34C submission form. Please contact Community Pharmacy Wales (CPW) for more support.
Guidance on how forms should be submitted in England and Wales and can be found in Part XX of the Drug Tariff.
More information is available on the NHS Prescription Services website.
Q. Must I provide the mandatory CD requisition form to wholesalers to be supplied a Schedule 1, 2 or 3 CD?
A. It is our understanding that registered pharmacy businesses are not required under the Misuse of Drugs Regulations to provide a requisition to their wholesaler in order to be supplied a Schedule 1, 2 or 3 CD.
Nonetheless, pharmacies are recommended to use the standard requisition for Schedule 1, 2 and 3 CDs if obtaining them from another pharmacy, so that an audit trail is provided.
Further guidance may be obtained from the Home Office or from the Royal Pharmaceutical Society (if a member of the Society).