Controlled Drug prescription forms and validity
Controlled Drug prescription forms and validity
|REF: The Misuse of Drugs Regulations 2001 (16(2))|
|Dispensing Controlled Drugs|
|Emergency supplies of CDs|
|Record keeping requirements|
|Destruction of CDs|
|Monitoring and inspection|
Prescriptions for Controlled Drugs
Controlled Drug (CD) prescription writing requirements:
To be valid, in addition to 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):
- Patient name and address
- Drug name
- Dose (‘as directed’ on its own is not permitted)
- Strength (where appropriate)
- Total quantity/dosage units of the preparation in both words and figures (for liquids, total volume in ml)
- Prescriber signature and address
- Date of issue
- 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.
Length of treatment:
The Department of Health and Social Care (DHSC) has issued strong recommendations that prescriptions for Schedule 2, 3 and 4 CDs are limited to the quantity necessary for up to 30 days’ treatment. Exceptionally, where a prescriber believes that a prescription for a CD should be issued for a longer period he/she may do so where there is a genuine clinical need and it does not pose an unacceptable risk to patient safety. Pharmacists can dispense prescriptions ordering more than 30 days’ supply of any Schedule 2, 3 and 4 CDs.
Prescriptions for Schedule 2, 3 and 4 CDs are only valid for 28 days from the appropriate date (i.e. date of signing unless the prescriber indicates a date before which the CD should not be dispensed). Note: a prescriber may forward-date a CD prescription in which case the date of validity is 28 days from the forward-date, or the start date, where specified.
Prescriptions for Schedule 5 CDs are valid for dispensing for 6 months from the appropriate date. For further information on prescription validity, click here.
In the case of owings, any remaining balance of Schedule 2, 3 or 4 CDs must be dispensed within 28 days of the appropriate date on the prescription. It is good practice for the pharmacist to make the patient or their representative aware from the outset that they will not be able to receive a supply of any prescribed Schedule 2, 3 or 4 CDs beyond the 28 day period of prescription validity.
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. Only Schedule 4 and 5 CDss are permitted on repeatable 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 episode is complete, 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 episode is complete, the repeats are legally valid within the normal periods of validity of the repeatable prescription.
For ‘blue’ FP10MDA prescriptions, the first instalment must be dispensed within 28 days of the appropriate date and the remainder should be dispensed in accordance with the directions on the prescription. The prescription must be marked with the date of each supply. The instalment direction is a legal requirement and needs to be complied with. However, for certain situations (e.g. if a pharmacy is closed on the day an instalment is due), the Home Office has approved specific wording which provides pharmacists some flexibility for making a supply. Note: there remains no provision to dispense CDs in instalments on a standard paper FP10 prescription form or via EPS. For further information on endorsing instalment prescription forms correctly, click here.
For more information on dispensing methadone oral liquid on FP10 and FP10MDA forms see PSNC’s page on Methadone dispensing (FP10 and FP10MDA).
Prescribers can issue EPS prescriptions for all Controlled Drugs (CDs) including Schedule 2 and 3 CDs but are currently unable to issue instalment ‘blue’ FP10MDA prescriptions electronically).
A method of “marking” the prescription “at the time of supply” should be decided to ensure compliance with the Misuse of Drugs Regulations 2001. The dispense notification message may be suitable for this but depending on local system configuration, another patient medication record (PMR) process that records a date and leaves an electronic audit trail may be suitable.
The 28-day validity period to supply a CD is different from the 180-day EPS technical time limit for sending dispense and claim notification messages for reimbursement and EPS technical purposes. Note: Some patient medication record (PMR) systems may refer to item/prescription ‘expiry’ , validity period or the 180-day EPS technical time limit.
Amending typographical errors on paper prescriptions
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; or
- 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); 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 prescribers’ intentions. 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 (e.g. name, date, signature and GPhC registration number). If there is more than one amendment on the same prescription, each amendment must be countersigned.
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.
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 and details must be recorded in the CD register.
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.
For information on record keeping requirements click here.
Collectors of CDs signing the back of prescription forms or tokens
Best practice guidance to record the details of the person collecting a Schedule 2 or 3 CD remains in place; the reverse of NHS prescription forms and EPS dispensing tokens (FP10DT) have a box for the ‘Signature of collector of Schedule 2 & 3 CDs’ which can be used to obtain a signature. Any tokens used to collect a signature can be sent to the NHS Business Services Authority (NHSBSA), as appropriate. Alternatively, some contractors may wish to record details of the CD collector electronically (e.g. within the patient’s record). Retaining electronic records within the pharmacy and reducing use of paper tokens helps to align with the long-term NHS paperless objectives.
Where the person collecting the CDs refuses to provide their details (e.g. the name to record in the PMR or not signing the reverse of the form/token), pharmacists may apply their discretion on whether or not to supply the CDs.
When the CD is supplied, it is a requirement to mark the prescription with the date of supply at the time the supply is made. With EPS, that marking may be done automatically (see EPS prescriptions section above).
Private prescriptions for Schedule 2 & 3 CDs
In England, prescribers can now only order Schedule 2 or 3 CDs privately on a specially designated 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.
Q. Can instalments be ordered on an FP10 prescription form?
A. No. There remains no provision to dispense drugs in instalments on a standard FP10 prescription form or via EPS. The prescriber may not be complying with the General Medical Services (GMS) contract requirements* by not using the form provided specifically for the purpose of supply in instalments. Ultimately, it is for NHS England and Improvement (NHSE&I) to decide whether a general practitioner is compliant with their Terms of Service.
*Part 8 of the National Health Service (General Medical Services Contracts) Regulations 2015 specifies the following prescribing requirements: “Where prescriber orders the drug buprenorphine or diazepam or a drug specified in Part 1 of 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 installments;
(b) Specify the number of installments to be dispensed and the interval between each installment; and
(c) Order only such quantity of the drug as will provide treatment for a period not exceeding 14 days.”
Q. What drugs are permitted on an FP10MDA form?
A. FP10MDA forms can only be used for the purpose of ordering a supply by installments for Schedule 2 CDs, buprenorphine, buprenorphine/naloxone (Suboxone®), and diazepam Single supplies of water for injections can also be prescribed where appropriate, for example when diamorphine dry powder injection is prescribed to be dispensed in installments.
Q. Is there a limit to the quantity that can be prescribed on an FP10MDA form?
A. Yes. When using a FP10MDA form, a prescriber must only order a quantity of a CD that provides treatment for a period not exceeding 14 days.
Q. Can EPS be used to prescribe Controlled Drugs in installments?
A. Although CDs may be prescribed using EPS, they cannot be ordered as installments because there is no equivalent electronic FP10MDA form type available. To order CDs in installments, prescribers will need to continue using paper hand signed FP10MDA prescription forms.
Q. Do the dispense and claim notification messages for a Schedule 2 or 3 CD prescribed using EPS need to be submitted within 28 days of the date on the prescription?
A. Legally, all Schedule 2 and 3 CDs must be dispensed within 28 days of the appropriate date. However, for the purposes of claiming reimbursement, pharmacy systems should allow you to send the dispense and claim notification messages after the validity period of 28 days as it is recognised that scenarios may exist (e.g., due to technical/internet outages) where it may not be possible to submit a claim before the 28 days even though medicines were supplied within 28 days.
Your system supplier may alert you to any CD prescriptions yet to be dispensed and approaching their 28-day expiry. Further information is available on PSNC’s Period of validity webpage.
Q. Is it a legal requirement to collect signature on reverse of FP10/Token?
A. It is best practice to record the details of the person collecting a Schedule 2 or 3 CD; the reverse of NHS prescription forms and EPS dispensing tokens (FP10DT) have a box for the ‘Signature of collector of Schedule 2 & 3 CDs’ which can be used to obtain a signature. Any tokens used to collect a signature can be sent to the NHS Business Services Authority (NHSBSA), as appropriate. Alternatively, some contractors may wish to record details of the CD collector electronically (e.g., within the patient’s record). Retaining electronic records within the pharmacy and reducing use of paper tokens helps to align with the long-term NHS paperless objectives.
Q. On an EPS prescription, can I claim packaged dose (PD) fees for supplying methadone oral liquid in daily dose containers?
A. Yes, contractors can claim a packaged dose (PD) fee of £0.55 for each separately packaged dose supplied against paper and electronic prescriptions for methadone oral liquid . The PD fee is calculated by adding the number of doses separately packaged minus the number of times the medicine has been dispensed to the patient (patient interactions).
Although there remains no provision to dispense methadone oral liquid in installments using electronic prescriptions, the PD fee can be claimed for daily dose containers supplied against electronic prescriptions requesting a one-off supply of methadone oral liquid We recommend checking with your system supplier to see if this functionality is enabled on your pharmacy system.
Q.Is there a limit to the quantities of a CD that can be ordered on a prescription?
A. The Department of Health and Social Care have issued strong recommendations that prescriptions for Schedule 2, 3 and 4 CDs are limited to the quantity necessary for up to 30 days’ treatment. Exceptionally, where a prescriber believes that a prescription for a CD should be issued for a longer period, he/she may do so where there is a genuine clinical need, and it does not pose an unacceptable risk to patient safety. Although pharmacists can dispense prescriptions ordering more than 30 days’ supply of any Schedule 2, 3 and 4 CDs, prescribers may be asked to justify their decision for prescribing CDs for an extended duration and should keep a record of their reasons.