People have the right to be involved in discussions and make informed decisions about their care, as described in NICE's information on making decisions about your care. Show
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off‑label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding. These recommendations were developed using UK controlled drugs legislation and regulations, as amended and updated up to the end of 2015. Organisations and health and social care practitioners should refer to the most recent legislation and regulations (see the government's legislation website). 1.1 Developing and establishing systems and processes for organisationsThe recommendations in this section are for all organisations unless otherwise stated. Governance arrangements and accountability1.1.1 Organisations should agree governance arrangements with clear lines of responsibility and accountability for controlled drugs in their contracts. 1.1.3 Consider appointing a nominated person in organisations that are not required by legislation to appoint a controlled drugs accountable officer, to:
Policies, processes and procedures1.1.4 Develop a controlled drugs policy and standard operating procedures for storing, transporting, destroying and disposing of controlled drugs. 1.1.5 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. 1.1.6 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. 1.1.7 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. 1.1.8 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:
1.1.9 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. 1.1.10 Consider putting processes in place to access prescribing data for all controlled drugs to identify:
Processes and procedures for storage, stock checks and audits1.1.11 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:
1.1.12 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:
1.1.13 Develop standard operating procedures for audits of controlled drugs registers and cabinets that include, but are not limited to:
Processes and procedures for transportation1.1.14 When developing standard operating procedures for transporting controlled drugs, take into account:
1.1.15 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. Processes and procedures for destruction and disposal1.1.16 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. 1.1.17 When developing standard operating procedures for disposing of controlled drugs, including unwanted or expired stock and drugs returned by people, take into account:
1.1.18 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. Policies and processes for prescribing1.1.19 Ensure that prescribing policies support prescribers and do not create barriers that prevent health professionals who are competent to prescribe controlled drugs from prescribing. 1.2 Record keeping for organisationsRequisitions, records of destruction and invoices1.2.3 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. 1.2.4 Unless legislation specifies otherwise, consider keeping:
Using a locally determined standard requisition form1.2.5 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:
1.3 Risk assessment for organisations1.3.1 Carry out a risk assessment to determine if controlled drugs in Schedule 3, 4 and 5 should be handled in the same way as controlled drugs in Schedule 2. The risk assessment may include:
1.3.2 Ensure that standard operating procedures for administering controlled drugs include sufficient safety measures to minimise the risk of administration errors. Safety measures may include:
1.3.3 In organisations with an internal pharmacy or dispensing doctors, use a risk assessment (see Regulation 3 of the Management of Health and Safety at Work Regulations 1999) to determine locally the most appropriate place for destroying controlled drugs. This should take into account how close the place of destruction should be to where the drugs are used to help minimise risks of controlled drug‑related incidents. 1.5 Prescribing controlled drugsThe recommendations in this section are for all health professionals prescribing controlled drugs unless otherwise stated. Making and recording prescribing decisions1.5.1 When making decisions about prescribing controlled drugs take into account:
1.5.2 When prescribing controlled drugs:
1.5.3 When prescribing 'when required' controlled drugs:
1.5.4 When prescribing, reviewing or changing controlled drug prescriptions, prescribers should follow local (where available) or national guidelines and take into account the:
1.5.5 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. 1.5.6 Use a recognised opioid dose conversion guide when prescribing, reviewing or changing opioid prescriptions to ensure that the total opioid load is considered. 1.5.7 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):
1.5.8 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. Providing information and advice to people taking or carers administering controlled drugs1.5.9 Document and give information to the person taking the controlled drug or the carer administering it, including:
1.5.10 Inform people who are starting controlled drugs that they or their representative may need to show identification when they collect the controlled drugs. 1.5.11 When prescribing controlled drugs in primary care for use in the community, advise people how to safely dispose of:
Reviewing repeat prescriptions and anticipatory prescribing1.5.12 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. 1.5.13 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. 1.6 Obtaining and supplying controlled drugsThe recommendations in this section are for all health professionals supplying controlled drugs unless otherwise stated. Standards and safety checks for supplying controlled drugs1.6.1 When supplying prescribed controlled drugs:
1.6.2 When supplying controlled drugs to a person or their representative, take reasonable steps to confirm their identity before providing the controlled drug. 1.6.3 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. Providing information and advice to people receiving controlled drugs1.6.4 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. 1.6.5 When the total quantity of a controlled drug in Schedule 2, 3 or 4 cannot be supplied:
1.6.6 When supplying controlled drugs, advise people how to safely dispose of:
Recording supplies in the controlled drug register1.6.7 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. 1.6.8 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. Part supplies of stock controlled drugs1.6.11 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:
1.7 Administering controlled drugsThe recommendations in this section are for all health professionals administering controlled drugs unless otherwise stated. Standards and safety checks for administering controlled drugs1.7.1 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:
Providing information and advice to people having controlled drugs administered1.7.2 Tell the person having the controlled drug the name and dose of the drug before it is administered, unless the circumstances prevent this. 1.7.3 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. Records of administration1.7.4 Ensure records of administration for controlled drugs include the following:
1.7.5 Ensure the record of administration of a controlled drug for inpatients and people in the community is readily accessible to:
Using continuous administration for controlled drugs1.7.6 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. 1.7.7 Health professionals who use devices for continuous administration of controlled drugs should:
Recording left over controlled drugs in the controlled drug register1.7.8 For controlled drugs that are left over after administration, record in the controlled drugs register:
1.8 Handling controlled drugsThe recommendations in this section are for all health professionals handling controlled drugs unless otherwise stated. Records of handling controlled drugs1.8.1 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. Providing information and advice on storage to people prescribed controlled drugs1.8.2 Provide advice and information to people who are prescribed controlled drugs about how to store controlled drugs safely. Discuss storage options taking into account:
Witnessing and recording the destruction and disposal of stock controlled drugs1.8.3 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. 1.8.4 When destroying and disposing of stock controlled drugs in Schedule 2, health professionals:
1.8.5 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. 1.8.6 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:
Witnessing and recording the destruction and disposal of returned controlled drugs1.8.7 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. 1.8.8 Consider recording the destruction and disposal of controlled drugs that have been returned by people in a separate book for this purpose, and record:
Safely destroying and disposing of controlled drugs1.8.9 For stock controlled drugs, when disposing of bottles containing irretrievable amounts of liquid drugs:
1.8.10 When a person has died in their home and controlled drugs need to be removed for destruction and disposal in primary care, consider:
1.9 Monitoring the use of controlled drugsGovernance and safety in the use of controlled drugs1.9.1 NHS England lead controlled drugs accountable officers should:
1.9.2 NHS England lead controlled drugs accountable officers should:
Identifying and reporting trends and barriers1.9.4 NHS England lead controlled drugs accountable officers should consider identifying trends in incidents reported and barriers to reporting. Reviewing concerns and incidents and sharing information1.9.5 An organisation's controlled drugs accountable officer or nominated person should:
Terms used in this guidelineAuthorised personRegulation 27 of the Misuse of Drugs Regulations 2001 requires that controlled drugs held as stock by health professionals or organisations must only be destroyed in the presence of an authorised person. The Act designates certain people as authorised witnesses. This includes any police constable and inspectors of the General Pharmaceutical Council. The lead controlled drugs accountable officer of NHS England may also appoint people as authorised witnesses. Care recordA record of the care provided to a person in a health or social care setting. Care records can be written or electronic. They may include notes of clinical decisions; medicines prescribed and administered, or discharge information. The type of care record may vary depending on the arrangements of the care setting. Care records enable health and social care practitioners to have access to essential information about a person's care to help provide safe treatment. Continuous administration devicesA controlled automatic device for administering medicines, including controlled drugs, at a set rate of dose per time. An example of this is a syringe pump. Designated bodyDesignated bodies in England are NHS foundation trusts, NHS trusts, English independent hospitals, NHS England and the headquarters in England of regular or reserve forces. See Regulation 7 of the Controlled Drugs (Supervision of Management and Use) Regulations 2013 for more information. DiversionRemoval of controlled drugs for unauthorised use. External pharmacyA pharmacy that is not owned by the organisation it supplies medicines to (a different legal entity), for example, a community pharmacy that supplies medicines to a hospital. Internal (or inpatient) pharmacyAn onsite pharmacy owned by the organisation it supplies medicines to (within the same legal entity), for example, a hospital or prison pharmacy that supplies medicines within the organisation. Local intelligence networkA local intelligence network is drawn from representatives of designated and responsible bodies. It is for the NHS England lead controlled drug accountable officer to determine the number and membership of local intelligence networks appropriate to their area. Local intelligence network members have certain duties and functions set out in Regulation 14, Regulation 15 and Regulation 16 of the Controlled Drugs (Supervision of Management and Use) Regulations 2013. These include a duty to cooperate with other local intelligence network members in identifying cases where action may be appropriate. Medicines or inpatient recordA record of all the medicines the person is taking when in an inpatient setting. Each medicine entry has to be signed by a prescriber. The record forms the authority to administer the medicine. NHS England lead controlled drugs accountable officerRegulation 8 of the Controlled Drugs (Supervision of Management and Use) Regulations 2013, places a requirement on NHS England to nominate or appoint a fit, proper and suitably experienced person to be NHS England's lead controlled drugs accountable officer for each of its local intelligence network areas. A lead controlled drugs accountable officer can be responsible for 1 or more local intelligence network areas. Nominated personA person who is not involved in the day‑to‑day handling of controlled drugs who has been appointed to oversee the management and governance of activities related to controlled drugs. Part supplyAn incomplete supply of a requested drug, for example, when a pharmacy does not have the full quantity of a medicine requested by prescription. Repeat prescriptionPrescription for a regular medicine on a repeat basis without the need for consultation with a prescriber.
Responsible bodyResponsible bodies in England are regulatory bodies that include: designated bodies, clinical commissioning groups, NHS Protect, the Prescription Pricing Division of the NHS Business Services Authority, the Care Quality Commission, local authorities, and police forces. See Regulation 6 of the Controlled Drugs (Supervision of Management and Use) Regulations 2013 for more information. Standard operating procedureA standard operating procedure specifies in writing what should be done, when, where and by whom in order to manage safely and accountably any set of processes. For example, the management of controlled drugs. Stock (controlled drug)Controlled drugs that have not been issued or dispensed to a patient, but are kept by the healthcare provider or health professional for administration or supply. Total opioid loadThe total dose of opioid (often converted to morphine equivalent daily dose for comparison) that is taken in a 24‑hour period. When requiredMedicines that are taken when they are needed to manage a symptom, for example, a pain killer for short‑term pain. WitnessA person who witnesses controlled drugs‑related activities such as administration or destruction. This can be a registered health professional, for example, a doctor, pharmacist, nurse or pharmacy technician, or another competent health or social care practitioner depending on the setting and local standard operating procedure. When are the 3 checks of medication administration?The label on the medication must be checked for name, dose, and route, and compared with the MAR at three different times: When the medication is taken out of the drawer. When the medication is being poured. When the medication is being put away/or at bedside.
What should you check before administering medication?Rights of Medication Administration. Right patient. Check the name on the order and the patient. ... . Right medication. Check the medication label. ... . Right dose. Check the order. ... . Right route. Again, check the order and appropriateness of the route ordered. ... . Right time. ... . Right documentation. ... . Right reason. ... . Right response.. What are the 6 Rights and 3 checks of medication administration?6 Rights of Medication Administration
These 6 rights include the right patient, medication, dose, time, route and documentation. Futhermore, nurses are also urged to do the three checks; checking the MAR, checking while drawing up medication and checking again at bedside.
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