Controlled drugs: regulations and prescribing
General Practitioner, Leeds
MRC Research Fellow and General Practitioner, University of Southampton, Southampton, UK
E-mail: will.bolland{at}doctors.org.uk
E-mail: chantal.simon{at}oxfordjournals.org
As a GP, it is important to know the regulations surrounding controlled drugs, both to be able to give patients advice and to enable you to prescribe controlled drugs safely. This article aims to outline the major pieces of legislation governing prescribing and usage of controlled drugs and to highlight good practice.
Every GP must be able to demonstrate skills in therapeutics, including the appropriate and safe use of controlled drugs to treat conditions encountered in primary care. This includes having an understanding of the legal frameworks in which health care is given at a practice level. In particular, a GP should be able to:
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Misuse of drugs legislation |
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The Misuse of Drugs Act 1971 controls the availability of drugs considered to be dangerous or otherwise harmful, and which have the potential for diversion and misuse. These drugs are listed in the Act and termed ‘controlled drugs’. Controlled drugs are further classified according to their perceived harmfulness into Class A, B or C drugs, with Class A drugs being the most harmful (Table 1). Offences under the Act include:
- Possession of a controlled substance unlawfully
- Possession of a controlled substance with intent to supply it
- Supplying or offering to supply a controlled drug (even where no charge is made for the drug)
- Allowing premises you occupy or manage to be used unlawfully for the purpose of producing or supplying controlled drugs
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As many controlled drugs also have legitimate medical purposes, the Misuse of Drugs Regulations (2001) authorize and govern certain activities which would otherwise be illegal under the Misuse of Drugs Act. The Regulations identify those health care professionals who may legitimately possess and supply controlled drugs. They also establish a regime of control around prescribing, administrating, safe custody of, dispensing, record keeping and destruction or disposal of controlled drugs.
The 2001 Regulations divide controlled drugs into five schedule, which dictate the degree to which the drug's use is regulated (Table 2). The schedule in which a controlled drug is placed depends upon its medicinal or therapeutic benefit balanced against its harm when misused. Schedule 1 drugs are subject to the highest level of control. Preparations in Schedules 2 and 3 of the 2001 Regulations are identified throughout the British National Formulary (BNF) by the symbol (controlled drug).
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Controlled drugs for stock use |
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It is important to distinguish between supplies of controlled drugs prescribed for individual patients on a prescription, and those obtained for practice stock, or bags for home visits, etc.
Practices should appoint an individual responsible for ensuring the safe management and use of controlled drugs. This should include ensuring that the controlled drug regulations are met. The police may enter premises to inspect stocks and records of controlled drugs at any time. Any practice or individual doctor that holds stocks of controlled drugs should keep stock levels to a minimum but keep enough to meet clinical need. One way to do this is to check controlled drug usage over a period of time, for example the past year, to gauge future need. Review the level of stock carried at least annually.
Many doctors only use the controlled drug stock carried in their bag on rare occasions. The stock levels held in this bag should also be kept to a minimum and informed by previous requirements. Ensure that only a single strength of each controlled drug is kept in your bag in order to minimize the risk of confusion, error and inappropriate administration. Oral preparations of controlled drugs should not routinely be carried in a doctor's bag.
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Requisitions and invoices for controlled drugs |
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Doctors may obtain Schedule 2 or 3 controlled drugs from pharmacies or wholesalers using a written requisition. A requisition is not needed for Schedule 4 or 5 drugs. Requisitions must be in writing and not computer generated, but do not have to be written by a doctor; however, a doctor must sign the requisition. Requisitions must also include the doctor's name, address and profession (it is good practice to include the doctor's GMC number too), and specify the total quantity of the drug and purpose for which it is required (for example ‘for practice use’). Faxed or electronically transmitted requisitions are not permitted. Requisitions and invoices for controlled drugs from all five schedules must be kept for at least 2 years.
| Medicines prescribed for an individual patient must be supplied to, and used by, that patient only. Practitioners must not use patient-specific controlled drug prescriptions to replace or ‘top-up’ their bags for home visits, etc, or practice stock, even if the stock was used for that patient initially. This could be considered as a potential offence under the Theft Act 1968 and might be seen as a means of obtaining controlled drugs by deception.
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Storage of controlled drugs for stock use |
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The Misuse of Drugs (Safe Custody) Regulations 1973 (the Safe Custody Regulations) imposes controls on the storage of controlled drugs. The degree of control depends on the premises within which the drugs are being stored. All Schedule 2 and some Schedule 3 drugs should be stored in a cabinet or safe, locked with a key. It should be made of metal, with suitable hinges and fixed to a wall or the floor with rag bolts that are not accessible from outside the cabinet. It should only be opened by a person authorized to possess the controlled drug, or his or her authorized representative.
For a bag for home visits, a digital combination lock on a case is often the most practical and convenient solution to the safe storage of controlled drugs and avoids problems with keys. Bags containing controlled drugs should not be left in a vehicle overnight, or in a vehicle left unattended for long periods of time.
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Register requirements |
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Records for Schedule 2 controlled drugs must be kept in a controlled drugs register. This is not a legal requirement for Schedule 3, 4 or 5 controlled drugs. All health care professionals who hold personal controlled drugs stock must keep their own controlled drugs register, and they are personally responsible for keeping this accurate and up-to-date.
The format and requirements for registers are specified in Regulations 19, 20 and Schedule 6 of the Misuse of Drugs Regulations 2001. In all cases, the register should be kept at the premises to which it relates and be available for inspection at any time. A separate register must be kept for each set of premises (for example if a practice has a branch surgery, separate registers must be kept for controlled drugs stored at the main and branch surgery). A controlled drug register should not be used for any other purpose than the register.
Registers can be in book form or computerized. Conventional written registers must be in bound volumes, not loose leaved, and completed in indelible ink. Cancellations or alterations should be made by signed and dated entry in the margin or at the bottom of the page. Completed volumes should be kept for a minimum of 2 years after the date of the last entry. Computerized registers must be kept on an approved computer system. Computerized entries must have an unerasable audit trail and entries must be attributable to individuals using the system. Computerized records must also be kept for a minimum of 2 years.
Within the register, there should be class sections for each individual drug (for example a section for diamorphine, another for morphine and a further section for pethidine). The name of the drug must be specified at the top of the page. Entries must be made within each section in chronological order on the day of the transaction or the following day. Information to include is listed in Box 1. These are the minimum requirements only and it is acceptable to include additional information if desired.
| Box 1. Information to include in the controlled drugs register For controlled drugs received into stock:
For controlled drugs supplied to patients:
For controlled drugs removed from practice stock to restock a doctor's bag:
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Where a GP carries a bag for home visits containing controlled drugs, a separate controlled drugs register should be kept for the controlled drugs stock held within that bag. Each doctor is responsible for the receipt and supply of controlled drugs from their own bag. Restocking of GPs’ bags from practice stock should be witnessed by another member of the practice staff, as should the appropriate entries into the practice's controlled drugs register.
Where a prescription is written by a doctor following the administration of a controlled drug to a patient, the doctor should endorse the prescription form with the word ‘administered’ and then date it. This aims to avoid unauthorized individuals attempting to reuse such prescriptions to obtain controlled drugs illegally. Information should also be entered into the patients record as soon as practicable.
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Destruction of stock controlled drugs |
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Those health care professionals and service providers required to maintain a controlled drugs register are not allowed to destroy expired Schedule 2 drugs from their stock without the destruction being witnessed by an authorized person. When Schedule 2 drugs (plus temazepam, flunitrazepam, buprenorphine and diethylpropion) pass their expiry date, they should be stored in the controlled drugs cabinet or safe until destruction. They should be segregated and clearly marked as ‘date-expired’ stock to prevent them being issued in error to patients.
Authorized individuals include police officers, Primary Care Trust (PCT) chief pharmacists, medical directors of PCTs or other board members with responsibility for clinical governance or risk management. When a controlled drug is destroyed, details of the drug must be entered into the controlled drug register. This should include the name of the drug, form, strength and quantity, the date it was destroyed and the signature of the authorized person who witnessed the destruction and the professional destroying it (that is two signatures). When signing the controlled drugs register, it is good practice for the authorized person to state their authority, for example PCT medical director.
If controlled drugs kept in a bag for home visits expire, they should be returned to the central practice stock for future destruction in the presence of an authorized individual. If the practice does not hold central stock, then the controlled drugs must be destroyed directly from the bag, witnessed by an authorized individual and appropriate records should be made in the controlled drugs register.
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Prescribing for medicinal purposes |
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The responsibilities of the prescriber
Prescribers have a duty to prescribe responsibly to prevent patients receiving legitimate prescriptions from developing dependency to their prescribed drugs. They also have a duty to prevent patients who abuse drugs from obtaining those drugs on prescription by deception.
When prescribing any controlled drug for a patient for legitimate medicinal purposes, consider carefully whether that drug is required and only prescribe if absolutely necessary. Monitor the controlled drug usage carefully and ensure that the patient does not gradually increase the dose of drug to the point where dependence becomes more likely. This is particularly important when prescribing benzodiazepines for sleeping problems or anxiety. Keep a watchful eye on prescription requests to prevent patients accumulating stocks. If it is apparent that dependence is developing, decrease dosages steadily or issue weekly or even daily prescriptions for small amounts.
Drug misusers may obtain supplies of drugs on prescription by visiting more than one doctor under several names, fabricating stories and forging prescriptions. To avoid being an unwitting source for addicts, be suspicious if a temporary resident or new patient requests a prescription for any controlled drug. If you decide to prescribe, only provide a small amount of the drug unless the patient can provide evidence that they have an ongoing condition requiring treatment with that drug. Where possible, check the patient's story out with their usual or previous GP before prescribing. If you suspect a drug misuser is going around surgeries with intent to obtain supplies, contact your PCT so that they can issue a warning to other practices.
It is also important to look after your own blank prescription forms. Stocks of prescription forms should be kept securely locked away and records of the prescription numbers on pads issued to doctors should be noted when the pads are issued. Your current prescription pad should be locked away when unattended, for example in a desk drawer. Never leave prescription pads unattended in visible locations such as a car or on top of a consulting room desk. If a prescription pad is stolen, report the theft to the police and to the local counter-fraud specialist at the PCT as soon as possible after the theft is confirmed. Give details of the approximate number of scripts stolen, their identification numbers and where and when they were stolen. You may then be asked to sign your prescriptions in another colour (usually red) for a period of time. Local pharmacists are warned that scripts not signed in this colour should be queried.
Writing prescriptions
Any prescription for Schedule 2 and 3 controlled drugs (with the exception of temazepam) must contain the following details, written so as to be indelible, for example written by hand, typed or computer generated (Fig. 1):
- The patient's full name, address and where appropriate, age—if the patient is homeless, ‘no fixed abode’ is an acceptable address
- The name and form of the drug, even if only one form exists
- The strength of the preparation, where appropriate
- The dose to be taken
- The total quantity of the preparation, or the number of dose units, to be supplied in both words and figures
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Prescriptions must be signed by the prescriber with their usual signature (this must be handwritten) and dated by them (the date does not have to be handwritten). In addition, it is good practice to include the GMC number of the person who signs the prescription. The address of the prescriber must be stated on the prescription and must be within the UK (the UK does not include the Channel Islands or the Isle of Man).
Computer systems should be used, wherever feasible, as an additional method to record and audit the prescribing of controlled drugs. For example, if a prescriber makes a domiciliary visit, and a controlled drug is administered or a handwritten prescription for a controlled drug is issued, it is good practice to make a note of this on the patient's computer record as soon as possible after the event. The doctor should also record the administration of a controlled drug to a patient in his or her own CD register for that bag.
Prescriptions for temazepam and for Schedules 4 and 5 controlled drugs are exempt from the specific prescription requirements of the Misuse of Drugs Regulations 2001. However, there is nothing to prevent you writing the quantity being supplied in both figures and words, and this makes it harder to alter the quantity on the prescription.
The Department of Health guidance in June 2006 suggested that, in general, prescriptions for controlled drugs in Schedules 2, 3, and 4 should be limited to a supply of up to 30 days’ treatment; exceptionally, to cover a justifiable clinical need and after consideration of any risk, a prescription can be issued for a longer period, but the reasons for the decision should be recorded on the patient's notes.
Prescriptions for all controlled drugs must also comply with the general prescription requirements specified under the Medicines Act, that is they must include the patient's details (name, address and age or date of birth if under 12 years of age), date, full name of the drug with quantity to be supplied and dose interval, the name and address of the prescriber and signature in ink. When filling in a prescription form, it is also good practice to draw a diagonal line across the blank part of the form under the prescription. This prevents additional items from being added. Alterations are best avoided, but if you do make an alteration, ensure that it is clear and unambiguous and initial any changes. If prescriptions are left for collection, for example at a reception desk, ensure that they are put in a sealed envelope and kept in a secure place.
Private prescriptions
Private prescriptions for controlled drugs in Schedules 2 and 3 (including temazepam) that are presented for dispensing in the community (but not in hospitals) must be written on specially designated forms provided by PCTs in England, Health Boards in Scotland, or Local Health Boards in Wales. These forms must include the private prescriber's unique six-digit identification number issued specifically for their private prescribing activity.
Validity of prescriptions
In order to reduce the likelihood of controlled drugs being dispensed when the clinical need has gone, and stored or diverted inappropriately, the maximum validity of a prescription form was amended in July 2006. The validity period of NHS and private prescriptions for Schedule 1, 2, 3 and 4 controlled drugs have been restricted to 28 days.
Repeat prescriptions
Schedule 2 and 3 drugs cannot be prescribed on repeat prescriptions or under repeat dispensing schemes.
Returned controlled drugs
Controlled Drugs (Supervision of Management and Use) Regulations 2006 require there to be procedures in place for maintaining a record of Schedule 2 drugs that have been returned by patients. It is good practice for doctors to keep a separate book to record all controlled drugs returned by patients. Although it is not a legal requirement for destruction of ‘patient-returned’ controlled drugs to be overseen by an authorized witness, it is good practice to ensure that destruction is witnessed by another member of staff and that the signature of both the person witnessing and the person destroying the drugs should be entered in a separate book set aside for this purpose.
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Prescribing for drug misusers |
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Prescribing for drug misusers is an area of controlled drug prescribing that should be approached with special caution. It is important to stress to drug misusers that methadone and other prescribed medicines must be kept out of reach and out of sight of children and other vulnerable individuals. Children (under 18) of patients prescribed controlled drugs must not be authorized to collect their parents’ (or others’) medication from the pharmacy. It is also important to stress to drug misusers being prescribed methodone the dangers of overdose and death if their medication is taken by any individual not used to taking opioids.
Prescribing in instalments
Some controlled drugs can be dispensed to substance misusers in instalments providing that they are prescribed using specific NHS prescription forms. The forms and regulations vary slightly between countries within the UK (Table 3). A prescriber writing a private prescription can also ask for the prescription to be dispensed in instalments.
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As a general principle, substitute opioid medicines should be prescribed in daily instalments. If a controlled drug prescription is to be dispensed in instalments, then the prescription must specify the following details:
- The number of instalments
- The intervals to be observed between instalments, and if necessary instructions for supplies at weekends or bank holidays
- The total quantity of controlled drugs that will provide treatment for a period not exceeding 14 days
- The quantity to be supplied in each instalment.
The prescription must be dispensed on the date on which it is due. If the patient does not collect an instalment when it is due, that supply is no longer valid. If a prescriber has ordered several days’ instalments to be collected on one day (for example before a weekend) and the patient does not come in on the specified day, then the patient loses not only the instalment for that day but also for all the days covered. In such cases, pharmacists should endorse the prescription ‘not dispensed’ for that instalment and, if possible, notify the prescriber. An exception to this is when specific wording authorized by the Home Office is included on the prescription (Box 2). In those cases, the remainder of the instalments (less the instalment for the missed days) can be collected for the remaining days.
| Box 2. Home Office wording allowing late collection of installments of controlled drugs ‘Supervised consumption of daily dose specified days; the remainder of supply to take home. If an installment prescription covers more than one day and is not collected on the specified day, the total amount prescribed less the amount prescribed for the days used may be supplied.’ ‘Unsupervised consumption; instalment prescriptions covering more than one day should be collected on the specified day; if this collection is missed the remainder of the instalment (i.e. the instalment less the amount prescribed for the days missed) may be supplied.’
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The patient ideally should collect the controlled drug in person. He or she will usually be asked for identification on the first occasion and will usually be asked to sign the back of the prescription form. If he or she is unable to collect prescriptions personally, the patient may arrange for a representative to collect it. The representative should bring a suitable note on each occasion to ensure authority to collect. Without this note it is illegal for a patient's representative to collect their drugs as they would have unauthorized possession, and thus illegal possession of controlled drugs. The representative will also be asked for identification, and it is good practice to ask the representative to sign the back of the prescription form.
Prescribing controlled drugs for addiction
The Misuse of Drugs (Supply to Addicts) Regulations 1997 prohibit doctors from prescribing, administering or supplying diamorphine, cocaine or dipipanone for the treatment of addiction or suspected addiction except under a Home Office licence. Other practitioners must refer any addict who requires these drugs to a treatment centre. A licence is not required to prescribe these drugs for patients, including substance misusers, for relief of pain due to organic disease or injury.
Other equipment for drug misusers
Section 9a of the Misuse of Drugs Act 1971 made it an offence to supply any article for administering a controlled drug unlawfully, except supply of hypodermic syringes and needles, or to supply any article used to prepare such a drug for administration. This was amended by a new regulation in 2003 to allow doctors, pharmacists and drug workers to provide supplies of alcohol swabs, sterile water (no more than 10 ampoules of 2 ml or less), mixing utensils, filters and citric acid to drug misusers for the purposes of harm reduction.
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Notification of drug misusers |
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Doctors are expected to report patients at the time of first presentation for drug misuse, or if they re-present after 6 months or more, to the National Drug Treatment Monitoring Centres or regional equivalents. All types of problem drug misuse should be reported. Databases cannot be used as a check on multiple prescribing as data are anonymized. Forms are available in the BNF of Department of Health Clinical Guidelines and contact numbers are listed in Table 4. Except in Northern Ireland, there is no longer a legal requirement for doctors in the UK to notify the authorities if they suspect a patient is addicted to a controlled drug.
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Travelling abroad with controlled drugs |
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Prescribed drugs listed in Schedule 4 (Part 2) and Schedule 5 of the Misuse of Drugs Regulations 2001 are not subject to import or export licensing. If the patient is traveling for less than 28 days and if the patient obtains controlled drugs on prescription, no import or export license is required. Patients intending to travel abroad for more than 28 days carrying drugs listed in Schedule 2, 3 or 4 (Part 1) do require an export licence, as do doctors who wish to take controlled drugs abroad while accompanying patients. Applications must be made to the Home Office (Box 3) and supported by a covering letter from the prescribing doctor giving details of:
- the patient's name and address
- the quantities of drugs to be carried
- the strength and form in which the drugs will be dispensed
- the country of destination
- the dates of travel to and from the UK.
| Box 3. Obtaining export licenses for controlled drugs At least 2 weeks should be allowed for processing applications. Applications for licences should be sent to:The Home Office Drugs Licensing Section 6th Floor, Peel Building 2 Marsham Street London SW1P 4DF Further details may be obtained at www.drugs.gov.uk/drugs-laws/licensing/personal, or from the Home Office by contacting (020) 7035 0482 or licensing_enquiry.aadu{at}homeoffice.gsi.gov.uk.
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Key points
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British National Formulary Available from: http://www.bnf.org [date last accessed 26.2.08].
Department of Health. Controlled Drugs. Available from: http://www.dh.gov.uk/en/Policyandguidance/Medicinespharmacyandindustry/Prescriptions/ControlledDrugs/index.htm [date last accessed 11.12.2007].
Department of Health. The Orange Book—Drug Misuse and Dependence: Guidelines on Clinical Management (1999—updated 2007) Available from: http://www.dh.gov.uk www.nta.nhs.uk; http://www.nta.nhs.uk/areas/clinical_guidance/clinical_guidelines/docs/clinical_guidelines_2007.pdf; http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4009665 [date last accessed 16.12.2007].
Home Office. Tackling Drugs: Changing Lives. Available from: http://drugs.homeoffice.gov.uk/ [date last accessed 11.12.2007].
Morley N. Controlled Drugs in Primary Care—The Law, Probity and Good Practice (2005) 2nd edition.
National Prescribing Centre (NPC). A Guide to Good Practice in the Management of Controlled Drugs in Primary Care (England) (2007) Available from: http://www.npc.co.uk/controlled_drugs/CDGuide_2ndedition_February_2007.pdf [date last accessed 11.12.2007].
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