Controlled drugs: safe use and management

Organisations should agree governance arrangements with clear lines of responsibility and accountability for controlled drugs in their contracts.

Designated bodies must appoint a controlled drugs accountable officer, who will quality assure processes for managing controlled drugs in their organisation, in line with Regulation 8 of the Controlled Drugs (Supervision of Management and Use) Regulations 2013.

Consider appointing a nominated person in organisations that are not required by legislation to appoint a controlled drugs accountable officer, to:

• work in accordance with governance arrangements for the safe use and management of controlled drugs

• make sure processes are in place for safe use and management of controlled drugs, and the reporting and investigating of concerns

• liaise with the local NHS England lead controlled drugs accountable officer and local intelligence network members.

Develop a controlled drugs policy and standard operating procedures for storing, transporting, destroying and disposing of controlled drugs.

Establish processes for developing, reviewing, updating, sharing and complying with controlled drugs‑related standard operating procedures, in line with legislation and national guidance. Consider using a risk assessment when establishing processes.

Designated bodies must put in place the minimum standard operating procedures for processes relating to prescribing, supplying and administering controlled drugs, including clinical monitoring for people who have been prescribed controlled drugs, in line with Regulation 11 of the Controlled Drugs (Supervision of Management and Use) Regulations 2013.

Ensure that national medicines safety guidance about controlled drugs, such as patient safety alerts, are incorporated into policy and acted on within a specified or locally agreed timeframe.

Consider developing standard operating procedures for risk assessing the use of controlled drugs in organisations providing inpatient care, where patients' own controlled drugs may be used and handled. The risk assessment may include:

• self‑administration or self‑possession

• storage requirements

• record keeping

• disposal.

Non‑healthcare settings, such as schools, should have systems and processes in place for storing, recording and transporting controlled drugs that belong to a person who is under the organisation's supervision.

Consider putting processes in place to access prescribing data for all controlled drugs to identify:

• prescribing trends and potential risks of unintended use

• the reasons for very high, increasing or very low volume prescribing.

When developing standard operating procedures for storing controlled drugs, ensure that they are in line with the Misuse of Drugs (Safe Custody) Regulations 1973, meet the needs of the service and take into account:

• the setting for use and whether the security setting is low, medium or high risk

• staff access to controlled drugs

• the storage environment, including temperature and space in the controlled drugs cabinet

• storage of stock (including unwanted or expired stock) and patients' own controlled drugs

• any additional storage needs for controlled drugs of different strengths with similar or 'lookalike' packaging.

Ensure that a standard operating procedure is in place for stock checks of all controlled drugs entered into the controlled drugs register. The procedure should include:

• checking the balance in the controlled drugs register against current stock

• visual inspection of liquid balances, periodic volume checks and checks to confirm the balance on completion of a bottle

• the frequency of stock checks, which should be based on the frequency of use and controlled drug‑related incidents, and risk assessment; for most organisations stock checks should be at least once a week, but they may be carried out more or less often depending on the circumstances

• recording stock checks along with the date and signature of the health professional carrying out the check

• having 2 people present to carry out stock checks, if possible.

Develop standard operating procedures for audits of controlled drugs registers and cabinets that include, but are not limited to:

• identifying the person responsible for auditing

• the frequency of audits

• reporting and managing discrepancies between stocks and records.

When developing standard operating procedures for transporting controlled drugs, take into account:

• storage while in transit

• security (for example, use of locked doctor's bags and ambulances)

• record keeping, such as the movement of controlled drugs supplied for use at different locations

• the supply process.

Ensure that governance arrangements and processes are in place for the safe transport of controlled drugs or prescriptions for controlled drugs if couriers, taxis or equivalent services are used.

Arrangements for destroying and disposing of controlled drugs must be in place and in line with the Misuse of Drugs Regulations 2001 and the Controlled Waste (England and Wales) Regulations 2012, regardless of the source of supply.

When developing standard operating procedures for disposing of controlled drugs, including unwanted or expired stock and drugs returned by people, take into account:

• the place of destruction

• local agreement and records of authorised people to witness the destruction of controlled drugs.

Consider developing standard operating procedures in primary care organisations based on local arrangements for destroying and disposing of controlled drugs that belonged to a person who has died.

Ensure that prescribing policies support prescribers and do not create barriers that prevent health professionals who are competent to prescribe controlled drugs from prescribing.

A separate controlled drugs register must be kept for each of the premises of an organisation where controlled drugs in Schedule 2 are stored, in line with Regulation 20 of the Misuse of Drugs Regulations 2001.

Controlled drugs registers must be kept for 2 years from the date of the last entry, in line with Regulation 23 of the Misuse of Drugs Regulations 2001.

Requisitions of supplied controlled drugs should be kept by organisations for 2 years from the date on the requisition, in line with Regulation 23 of the Misuse of Drugs Regulations 2001.

Unless legislation specifies otherwise, consider keeping:

• records of the destruction of a patient's own controlled drugs for a minimum of 7 years

• invoices for controlled drugs for 6 years.

In organisations with an internal pharmacy, consider using a locally determined standard requisition form across the whole of an organisation when a mandatory form is not legally required for obtaining stock controlled drugs in Schedule 2 and 3. Include on the form:

• the signature and printed name of the person ordering the controlled drug

• the name of the care setting

• the ward, department or location

• the controlled drug name, form, strength, and for ampoules, the size if more than 1 is available

• the total quantity of the controlled drug to be supplied

• the date of the request

• the signature of the person issuing the controlled drug from the pharmacy.

When making decisions about prescribing controlled drugs take into account:

• the benefits of controlled drug treatment

• the risks of prescribing, including dependency, overdose and diversion

• all prescribed and non‑prescribed medicines the person is taking (particularly any centrally acting agents) and whether the person may be opioid naive

• evidence‑based sources, such as NICE and the BNF, for prescribing decisions when possible.

When prescribing controlled drugs:

• document clearly the indication and regimen for the controlled drug in the person's care record

• check the person's current clinical needs and, if appropriate, adjust the dose until a good balance is achieved between benefits and harms

• discuss with the person the arrangements for reviewing and monitoring treatment

• be prepared to discuss the prescribing decision with other health professionals if further information is requested about the prescription.

When prescribing 'when required' controlled drugs:

• document clear instructions for when and how to take or use the drug in the person's care record

• include dosage instructions on the prescription (with the maximum daily amount or frequency of doses) so that this can be included on the label when dispensed

• ask about and take into account any existing supplies the person has of 'when required' controlled drugs.

When prescribing, reviewing or changing controlled drug prescriptions, prescribers should follow local (where available) or national guidelines and take into account the:

• appropriate route

• dose (including when dose conversions or dose equivalence is needed)

• formulation (including changes to formulations).
  
  If guidance on prescribing is not followed, document the reasons why in the person's care record.

Prescribe enough of a controlled drug to meet the person's clinical needs for no more than 30 days. If, under exceptional circumstances, a larger quantity is prescribed, the reasons for this should be documented in the person's care record.

Use a recognised opioid dose conversion guide when prescribing, reviewing or changing opioid prescriptions to ensure that the total opioid load is considered.

When prescribing controlled drugs outside general practice (for example, in hospital or out of hours), inform the person's GP of all prescribing decisions and record this information in the person's care record so the GP has access to it. When sharing information, take into account the following 5 rules (from the Health and Social Care Information Centre's guide to confidentiality in health and social care, 2013):

• Confidential information about service users or patients should be treated confidentially and respectfully.

• Members of a care team should share confidential information when it is needed for the safe and effective care of an individual.

• Information that is shared for the benefit of the community should be anonymised.

• An individual's right to object to the sharing of confidential information about them should be respected.

• Organisations should put policies, procedures and systems in place to ensure the confidentiality rules are followed.

When prescribing controlled drugs for inpatients (for example, on a medicines or inpatient record) that are to be administered by different routes, prescribe each as a separate item and clearly state when each should be used to avoid administration errors.

Document and give information to the person taking the controlled drug or the carer administering it, including:

• how long the person is expected to use the drug

• how long it will take to work

• what it has been prescribed for

• how to use controlled drugs when sustained-release and immediate-release formulations are prescribed together

• how it may affect the person's ability to drive (see the advice from the Department for Transport on drug driving and medicine: advice for healthcare professionals)

• that it is to be used only by the person it is prescribed for.

Inform people who are starting controlled drugs that they or their representative may need to show identification when they collect the controlled drugs.

When prescribing controlled drugs in primary care for use in the community, advise people how to safely dispose of:

• unwanted controlled drugs at a community pharmacy

• used controlled drugs.

When prescribing a repeat prescription of a controlled drug for treating a long‑term condition in primary care, take into account the controlled drug and the person's individual circumstances to determine the frequency of review for further repeat prescriptions.

Follow locally agreed processes for reviewing anticipatory prescribing of controlled drugs in primary care and palliative care services. Determine the type of review needed on a case‑by‑case basis, including the ongoing clinical need and, where practicable, the expiry dates of any controlled drugs already stored by the person.

When supplying prescribed controlled drugs:

• follow relevant standards set by the professional regulator

• check with the prescriber about any safety concerns, such as whether the prescribed dose is safe for the person.

When supplying controlled drugs to a person or their representative, take reasonable steps to confirm their identity before providing the controlled drug.

If intending to supply dispensed controlled drugs to a person in police custody, first check whether the custody staff have adequate arrangements and handling facilities for controlled drugs.

When supplying more than 1 formulation (for example, immediate-release and sustained-release formulations) of a controlled drug, discuss the differences between the formulations with the person, and their family members or carers if appropriate, and check that they understand what the different formulations are for and when to take them.

When the total quantity of a controlled drug in Schedule 2, 3 or 4 cannot be supplied:

• inform the person receiving the drug that only part of their supply is available

• tell them when the rest will be available

• ask them to collect it within 28 days of the date stated on the prescription.

When supplying controlled drugs, advise people how to safely dispose of:

• unwanted controlled drugs at a community pharmacy

• used controlled drugs.

When health professionals in primary care dispense controlled drugs in Schedule 2 in advance of collection, they should document the supply in the controlled drug register only after the drugs are collected by the person or their representative.

Pharmacists or dispensing doctors who are unable to supply the total quantity of a prescribed controlled drug in Schedule 2, must make an entry in the controlled drugs register for only the quantity of the controlled drug supplied, in line with Regulation 19 of the Misuse of Drugs Regulations 2001. They must then make a further entry in the register when the balance is supplied.

When obtaining controlled drugs for use in the community, health professionals in primary care must use the approved mandatory form for the requisitioning of controlled drugs in Schedule 2 and 3, in line with Regulation 14 of the Misuse of Drugs Regulations 2001 and the Misuse of Drugs (Amendment) (No. 2) (England, Wales and Scotland) Regulations 2015.

When obtaining stocks of controlled drugs in Schedule 2 and 3 from an organisation's contracted external pharmacy, a requisition signed by a doctor or dentist employed or engaged in the organisation must be provided, in line with Regulation 14 of the Misuse of Drugs Regulations 2001.

Pharmacists in internal pharmacies (such as hospital and prison pharmacies) who are unable to supply the total quantity of a stock controlled drug requested by requisition should ensure that the recipient is aware that:

• a part supply has been made and no further supplies will be made for that requisition

• the quantity on the requisition has been amended to the amount actually supplied and is initialled or signed by the supplier.

Follow the relevant standards set by the professional regulator when administering controlled drugs, and when necessary check with the prescriber about any safety concerns such as:

• whether the prescribed dose is safe for the person

• whether other formulations have already been prescribed for the person

• whether the formulation is appropriate

• that any past doses prescribed have been taken.

Tell the person having the controlled drug the name and dose of the drug before it is administered, unless the circumstances prevent this.

Provide advice on how different formulations of controlled drugs are administered, and check that the person understands the advice. Ensure that appropriate equipment is available for the correct dose to be administered.

Ensure records of administration for controlled drugs include the following:

• name of the person having the dose administered

• date and time of the dose

• name, formulation and strength of the controlled drug administered

• dose of the controlled drug administered

• name and signature or initials of the person who administered the dose

• name and signature or initials of any witness to administration.

Ensure the record of administration of a controlled drug for inpatients and people in the community is readily accessible to:

• ensure continuity of care

• prevent doses being missed or duplicated

• avoid treatment being delayed.

When prescribing controlled drugs, involve the person's GP and any lead health professionals for other care teams involved in the person's care in decisions about whether to use a device for continuous administration. Record the decision in the person's care record. If prescribing outside normal working hours, tell the GP about the decision the next working day.

Health professionals who use devices for continuous administration of controlled drugs should:

• complete training in setting up the specific devices used by their service and have their competence confirmed

• seek specialist advice if needed when setting up devices for continuous administration.

For controlled drugs that are left over after administration, record in the controlled drugs register:

• the amount of controlled drug administered

• the amount of controlled drug to be disposed of after administration

• the signatures of the person disposing of the remaining controlled drug and any witness to the disposal.

Keep records to provide an audit trail for the supply, administration and disposal of controlled drugs, and the movement of them from 1 location to another.

Provide advice and information to people who are prescribed controlled drugs about how to store controlled drugs safely. Discuss storage options taking into account:

• the person's preference for a lockable or non‑lockable storage box

• whether the controlled drugs will be accessible to people who should and should not have access to them

• whether the storage method could increase the risk of controlled drug‑related incidents, including patient safety incidents.

Health professionals and service providers who are required by the Misuse of Drugs Regulations 2001 to maintain a controlled drugs register must have an authorised person present to witness the destruction of stock controlled drugs in Schedule 2 in line with Regulation 27 of the Misuse of Drugs Regulations 2001.

When destroying and disposing of stock controlled drugs in Schedule 2, health professionals:

• must record the following, in line with Regulation 27 of the Misuse of Drugs Regulations 2001:

  • the name, strength and form of the controlled drug

  • the quantity

  • the date of destruction

  • the signature of the authorised person witnessing the destruction

• should record the signature of the person destroying the controlled drugs.

If the legislation does not require a witness to be present when destroying stock controlled drugs in Schedule 3 and 4 (part I), consider having a witness present.

If the legislation does not require records to be kept of destruction and disposal of stock controlled drugs in Schedule 3 and 4 (part I), consider recording:

• the name, strength and form of the controlled drug

• the quantity

• the date of destruction

• the signatures of the person destroying the controlled drugs and any witness to the destruction.

Consider asking a second member of staff (preferably a registered health professional) to witness the destruction and disposal of a patient's returned controlled drugs.

Consider recording the destruction and disposal of controlled drugs that have been returned by people in a separate book for this purpose, and record:

• the date of receipt of the controlled drugs

• the date of destruction

• the signatures of the person destroying the controlled drugs and any witness.

For stock controlled drugs, when disposing of bottles containing irretrievable amounts of liquid drugs:

• consider rinsing the bottle and disposing of the liquid into a pharmaceutical waste bin

• remove or obliterate labels and other identifiers from the container

• dispose of the clean, empty container into the recycling waste.
  
  Disposal of irretrievable amounts of controlled drugs does not need to be recorded.

When a person has died in their home and controlled drugs need to be removed for destruction and disposal in primary care, consider:

• discussing the removal of controlled drugs with a family member or carer

• recording the action taken and details of the controlled drugs listed in the person's medical record or notes

• having a witness to the removal

• any requirements of the coroner to keep medicines in the person's home for a period of time

• taking the drugs to a health professional, such as a community pharmacist who is legally allowed to possess controlled drugs, for safe disposal at the earliest opportunity.

NHS England lead controlled drugs accountable officers should:

• work with local intelligence networks in other areas when needed

• identify and manage poor engagement

• consider including other relevant local organisations (such as substance misuse, palliative care and out‑of‑hours services, and secure environments) in the wider network part of the local intelligence network.

NHS England lead controlled drugs accountable officers should:

• provide feedback (such as actions from controlled drugs related incidents and occurrence reports) to controlled drugs accountable officers

• share learning with their controlled drugs accountable officers, including trends or significant incidents.

Controlled drugs accountable officers must ensure that robust systems are in place for raising and reporting concerns or incidents about controlled drugs in a timely way (including systems for starting investigations) in line with Regulation 11 and Regulation 13 of the Controlled Drugs (Supervision of Management and Use) Regulations 2013. This should involve liaising with the following responsible bodies:

• a designated body

• the Care Quality Commission

• NHS Protect

• a police force

• a relevant regulated body.

NHS England lead controlled drugs accountable officers should consider identifying trends in incidents reported and barriers to reporting.

An organisation's controlled drugs accountable officer or nominated person should:

• review controlled drug‑related concerns or incidents and take any action needed on a case‑by‑case basis

• share information and learning throughout the organisation from controlled drug local intelligence networks.