Opioids are controlled drugs and accordingly there are some restrictions on how they can be prescribed.
This module covers the key requirements for controlled drug prescriptions, the role of the Accountable Officer for monitoring opioid prescriptions and the implications of an opioid prescription for patients who drive.
01OPIOIDS AND UK LAW
Opioids are classified as controlled drugs under the Misuse of Drugs Act 1971 and 'classed' (A, B or C) according to the level of penalty for possession and dealing without a prescription. 1,2 Most prescription opioids are categorised as 'Class A' - including fentanyl, hydromorphone, morphine and pethidine - with codeine falling into 'Class B,' and buprenorphine into 'Class C.1,2
The Misuse of Drugs Regulations 2001 further divides controlled drugs into five schedules that determine how closely the substances are regulated. Opioids largely fall under Schedule 2 and Schedule 3 with preparations containing only small amounts of morphine and codeine being in Schedule 5.3
Summary of controlled drugs schedules1,3
Schedule Description Schedule 1 Includes drugs that are limited to research or other special purposes considered to be in the public interest; receive the highest level of control. Schedule 2 Includes the majority of the opioids, major stimulants, secobarbital and amphetamine; special requirements regarding their supply, storage and record keeping. Schedule 3 Includes the synthetic opioids buprenorphine and pentazocine, together with other substances including temazepam; some special requirements regarding their supply, storage and record keeping; however, their use does not have to be detailed within a controlled drugs book. Schedule 4 Includes benzodiazepines and anabolic steroids; supply similar to other prescription only medicines and no special requirements for their storage and record keeping. Schedule 5 Includes preparations of some controlled drugs when present in medicinal products of very low strengths and in compound with other active or inert ingredients; opioids include codeine (<2.5% base concentration) and medicinal opium or morphine (<0.2% base concentration); supply either by prescription or over-the-counter at pharmacies and no special requirements for their storage and record keeping.
The vast majority of the available opioids are controlled drugs and fall into one of the above schedules. However, exceptions include certain doses of codeine that fall under the Pharmacy Only “P” category of OTC medicines and are invariably combination products e.g. Solpadeine (paracetamol 500 mg/codeine phosphate 8 mg) or Nurofen Plus (ibuprofen 200 mg/codeine phosphate 12.8 mg).4
As the schedules dictate how each drug should be supplied, stored and documented, it is important to know which opioid falls into which category when prescribing.
A full list of drugs included within the schedules is available from legislation.gov.uk.
Further information about the supply and storage and record keeping of controlled drugs is available from the National Prescribing Centre (NPC) - A guide to good practice in the management of controlled drugs in primary care (England).
02CONTROLLED DRUGS AND MEDICINES MANAGEMENT
Currently, medical organisations including NHS Trusts and independent hospitals are responsible for appointing an Accountable Officer (AO) to help ensure the safe and effective use of controlled drugs within their organisation.1
- The role of the Accountable Officer includes:1
- maintaining standard operating procedures;
- monitoring and auditing the use of controlled drugs through prescription data;
- supporting the implementation of the Misuse of Drugs Regulations;
- providing guidance and/or resources if there are any queries with regards to the management of controlled drugs in primary care;
- arranging the destruction and disposal of controlled drugs;
- providing training to relevant individuals.
Further information about controlled drugs and medicines management is available from the National Prescribing Centre
- The role of the Accountable Officer includes:1
03COMPLETING OPIOID PRESCRIPTIONS CORRECTLY
Both the GP and the dispensing pharmacist have roles and legal obligations in ensuring an opioid prescription is written correctly.
- GPs play a key role in reducing any unnecessary delays by completing opioid prescriptions with due care, in line with the legal requirements of controlled drugs.
- Opioid prescriptions should not normally be made for more than 30 days' supply.
- Repeat prescriptions cannot be made for Schedule 2 and 3 Controlled Drugs; however, instalment prescriptions (i.e. those which are to be dispensed at specific intervals) are allowed.
- The checklist below provides the requirements to ensure an opioid prescription is valid.
Opioid prescription checklist4
To be valid, opioid prescriptions must:
- Be handwritten in ink, typed or computer generated.
- Be dated and signed (signature must be handwritten).
- the prescriber's address;
- full name and address of the patient;
- the formulation (e.g. tablets) and strength of drug;
- the quantity or dose units in both words and figures.
A pharmacist may not dispense a controlled drug unless all the information required by law is provided on the prescription.
See if you can spot the three errors on the prescription shown. Click 'reveal' to check your answers.
- REVEAL / HIDE
Quantity is only written in numbers - it must also be written in words, e.g. 30 (thirty).
Signature of prescriber is electronic - it must be a handwritten signature.
The date of the prescription is missing (can be handwritten or electronic).
- Pharmacists have an absolute legal obligation to ensure that prescriptions for controlled drugs are valid before dispensing.
- Dispensing pharmacists can only make minor corrections to the prescription:
- amend minor typographical or spelling mistakes;
- where the quantity or dosage units are specified in words or digits but not both, add the words or the figures as appropriate.
- Any alterations made to the prescription must be clear, unambiguous and attributable to the person making the correction, e.g. cross out, initial and date, write correction.
Dispensing pharmacists have a legal duty to adhere to these obligations when filling opioid prescriptions due to the legal and regulatory requirements.
04DRIVING WHILE TAKING OPIOIDS
UK law allows patients taking prescribed opioids for pain relief to continue driving as long as they are taking the prescribed dose and are fit to drive.5
Patients should be directed to the Driving and Vehicle Licensing Authority (DVLA)6 for advice about their legal right to hold a driving licence while taking an opioid.5
- Patients starting opioid therapy should be advised to inform the DVLA about their treatment.5
- Prescribers should document that this advice has been given.5
Further information is available at http://www.dft.gov.uk/dvla/medical/.
The British Pain Society suggests that patients taking opioids should be advised to avoid driving if they:5
- have just started opioid treatment;
- have recently had their opioid dose adjusted upwards or downwards;
- feel that the opioid effects could impair their driving ability;
- have a physical condition that could impair their driving ability;
- have consumed alcohol (even below the legal driving limit) or other drugs that can produce an additional sedative effect.
Further recommendations on driving and/or operating machinery can be found in the Summary of Product Characteristics (SPC) of individual opioid medications - accessible from http://www.medicines.org.uk/emc/ .
Patients starting opioid therapy should be advised that they may need to modify their domestic or working arrangements to accommodate these requirements.5
- For example, if the patient has to drive to work during the week they should not start the opioid regimen until Friday evening so that they have the weekend to start getting used to it.
- They could also inform their work to see if they could be flexible about their working arrangements while they start the opioid regimen.
How an opioid may affect a person's driving, and what the patient's obligations are with regard to informing the DVLA should form part of the GP/patient discussion when deciding whether or not an opioid regimen is suitable for an individual.
- For the opioid you are prescribing, do you know which controlled drug schedule it falls under?
- Who is your Accountable Officer?
- Have you filled out the prescription correctly?
- Have you informed the patient about special considerations for driving while taking opioids?
Apply your knowledge of these medico-legal considerations in the following case studies:
As opioids are controlled drugs it is important to be very aware of the obligations involved in prescribing them. This includes knowledge of the controlled drugs schedules and associated requirements, who your Accountable Officer is and who the supplying pharmacist is going to be. Patients should be advised about how an opioid may affect their driving and that they should inform the DVLA that they are taking an opioid medication.
REFERENCES 1. NHS National Prescribing Centre. A guide to good practice in the management of controlled drugs in primary care (England). Third Edition; 2009. Available at: [http://www.npc.nhs.uk/controlled_drugs/resources/controlled_drugs_third_edition.pdf] (Accessed June 2011) 2. The Misuse of Drugs Act 1971. Chapter 38. Available at: [http://www.legislation.gov.uk/ukpga/1971/38/pdfs/ukpga_19710038_en.pdf] (Accessed June 2011) 3. The Misuse of Drugs Regulations 2001. No 3998. Crown copyright. Available at: [http://www.legislation.gov.uk/uksi/2001/3998/made] (Accessed June 2011) 4. Royal Pharmaceutical Society of Great Britain (2010) Medicines, Ethics & Practice: A guide for pharmacists and pharmacy technicians. 1.2. Medicines for human use. Number 34 (July 2010). Available at: [http://www.rpharms.com/mep-pdfs/mep34s1-2.pdf] (Accessed June 2011) 5. British Pain Society. Opioids for persistent pain - good practice (2010). Available at: [http://www.britishpainsociety.org/book_opioid_main.pdf] (Accessed June 2011) 6. Department for Transport: Driver and Vehicle Licensing Agency (DVLA). Medical Information. Available at: [http://www.dft.gov.uk/dvla/medical/] (Accessed June 2011)