The Medicines Act ([194]) and the regulations made under the act set out the requirements for the legal sale, supply and administration of medicines. They also allow certain exemptions from the general restrictions on the sale, supply and administration of medicines; for example, these enable midwives to supply and/or administer diamorphine, morphine, pethidine and pentazocine.

A number of healthcare professionals are permitted to supply and/or administer medicines generally in accordance with a patient group direction (PGD) (see ‘Patient group directions’ above). Some of these professional groups, but not all, are permitted to possess, supply or administer CDs in accordance with a PGD under the misuse of drugs legislation.

The Misuse of Drugs Act ([215]) controls certain classes of dangerous drugs (e.g. diamorphine, morphine, amphetamines and benzodiazepines), which are listed in Schedule 2 and are subject to the controls stipulated in the act. The use of CDs in medicine is permitted by the Misuse of Drugs Regulations ([218]) (see below) and related regulations. The regulations’ main purpose is to prevent the misuse of these drugs by imposing a total ban on the possession, supply, manufacture or importation of CDs, except as allowed by regulations.

Drugs controlled under the Misuse of Drugs Act ([215]) are divided into three classes (A, B and C) for the purposes of establishing the maximum penalties that can be imposed. The act also controls the manufacture of CDs. Other regulations of the act govern safe storage, destruction and supply to known addicts.

Practitioners responsible for ordering, administering, prescribing or safe custody of CDs should familiarize themselves with the Misuse of Drugs Act ([215]) and the regulations (as summarized in BNF [25]).

The Misuse of Drugs (Safe Custody) Regulations ([219]) control the storage of CDs. The level of control of storage depends on the premises in which the drugs are being stored and the schedule of the drug.

The use of CDs in medicine is regulated by the Misuse of Drugs Regulations ([218]). The regulations define the classes of person who are authorized to supply and possess CDs while undertaking their professional duties and stipulates the conditions in which they must undertake these tasks. The requirements of the regulations as they apply to nurses working in a hospital with a pharmacy department are described in Table 15.7.

Under these regulations, CDs are classified into five schedules, each representing a different level of control for each task, including prescribing and recording keeping (Table 15.8). The schedule in which a CD is placed depends on its medicinal or therapeutic benefit balanced against its harm when misused:

This list is not exhaustive and as updates to legislation occur, they will inform practice. A comprehensive list of drugs included within the schedules is given in the Misuse of Drugs Regulations ([218]) and can be accessed at https://tinyurl.com/hdvm9uh.

The Controlled Drugs (Supervision of Management and Use) Regulations ([44]) were introduced as part of the government's response to the Shipman Inquiry's fourth report (Shipman Enquiry [334]). The aim of these regulations was to strengthen the governance arrangements for the use and management of CDs, which are essential to modern clinical care. As such, it is essential that the NHS enforces robust arrangements for the management and use of CDs to minimize patient harm, misuse and criminality. As a consequence of the passage of the Health and Social Care Act ([125]), the 2006 regulations have been revised to reflect the new architecture in the NHS in England. The Controlled Drugs (Supervision of Management and Use) Regulations ([45]) came into force in England on 1 April 2013.

There is a statutory requirement for NHS bodies to appoint an accountable officer for CDs within their organization, responsible for the safe management of CDs. The duties and responsibilities of the accountable officer are to improve the management and use of CDs. These regulations also allow for the periodic inspection of premises.

The Misuse of Drugs and Misuse of Drugs (Safe Custody) (Amendment) Regulations ([217]) give accountable officers authority to nominate persons to witness the destruction of Schedules 1 and 2 CDs. Accountable officers must be independent of the day‐to‐day management of CDs and therefore are not authorized to witness destructions, but they must be able to ensure there are adequate witnesses within their organization to prevent build‐up of expired or surplus stock, which can lead to associated risk of diversion or misuse.

The 2007 regulations removed the descriptive term ‘sister’ (which was considered obsolete), replacing it with ‘senior registered nurse’ to reflect current terminology. The 2007 regulations also allow operating department practitioners to order, possess and supply CDs.

In addition, the 2007 regulations set out changes to the requirements around record keeping and CDs; for example, each strength and form of CD is recorded on a separate page. Other mandatory fields of information included are the person collecting the Schedule 2 CD (the patient, the patient's representative or a healthcare professional). If it is a healthcare professional, there is a requirement for the name and address of that person to be recorded. Records need to be kept regarding whether proof of identity was requested of the patient or the patient's representative and whether this proof of identity was provided.

The amendment rescheduled midazolam from Schedule 4 to Schedule 3 to ensure there were tighter controls in respect of the prescribing, requisition and record keeping of this CD.

The nurse in charge of an area is responsible for the safe and appropriate management of CDs in that area. Certain tasks, such as holding keys, can be delegated to a registered nurse but the overall responsibility remains with the nurse in charge.

To ensure CDs are managed appropriately and safely, most hospitals will store Schedule 3 CDs (e.g. tramadol, temazepam, midazolam, pregabalin and gabapentin) in a lockable cupboard, as for Schedule 2 CDs.

A witness is required for the administration of a CD; this may be a registered healthcare professional or another competent health or social care practitioner, depending on the setting and local procedures (NICE [248]). The witness should observe the whole administration process, from access of medications from the CD cupboard to administration at the patient's bedside.

The nurse in charge of an area is responsible for the requisition of CDs for that area. This task can be delegated to a registered nurse but the overall responsibility remains with the nurse in charge. Orders should be written on suitable stationery and must be signed by an authorized signatory. All those who are authorized to order CDs should have a copy of their signatures in the front of the order book, which must be countersigned by the senior registered nurse for validation. All stationery that is used to order, record, supply and return CDs must be stored securely in a locked cupboard and access to it should be restricted.

When CDs are delivered to the ward, they must be delivered in a tamper‐evident bag or locked box and must be handed to a registered nurse and not left unattended. The registered nurse receiving the CD order should then check (in the presence of a second registered nurse) the contents of the tamper‐evident bag against the requisition order, including the quantity ordered and received. If the items supplied are correct, the nurse should sign the ‘received by’ section of the order book (Figure 15.3).

The CD should then be entered in the CD record book with the following information:

The updated balance should be checked against the CD physical stock to ensure these are the same. The CDs should then be placed in the CD cupboard.

CDs should be stored in a locked cupboard reserved solely for the storage of CDs that is fixed permanently to the wall. The CD cupboard must conform to British Standard BS2881. Cupboards should be locked when not in use. The lock must not be common to any other lock in the hospital.

The nurse in charge of the ward or clinical area is responsible for the CD keys and is responsible for controlling access to the CD cupboard. To prevent delays in access to medication, the responsibility can be delegated to another registered nurse if the registered nurse in charge is occupied for a length of time, but overall responsibility lies with the registered nurse in charge.

For the purpose of stock checking, the key may be handed to an authorized member of pharmacy staff. If keys are lost, the senior nurse, the pharmacy manager and the accountable officer must be contacted. Appropriate actions must be taken to replace the lock to ensure that patient care is not impeded.

Each ward that holds CDs should keep a record of received and administered CDs in a CD record book. The nurse in charge is responsible for keeping the CD record book up to date and available for inspection at any time. The record book should not be used for any other purpose and should be kept for a minimum of 2 years after the date of the last entry or the last use of the book. A computerized CD record may also be used, subject to it meeting the requirements of the relevant regulations (see DH [63], paras. 9 and 10).

The CD record book should have sequentially numbered pages and a separate page for each drug and strength. Entries should be in chronological order and in ink. The entries in the CD record book should be signed by a registered nurse and then witnessed by a second registered nurse. If a second nurse is unavailable, the transaction can be witnessed by another registered practitioner such as a doctor, pharmacist or pharmacy technician.

To avoid staff using patients’ own CDs, most organizations stipulate that if patients bring their CDs into hospital with them, they must be segregated from ward CD stock and recorded in separate CD record books.

When the end of a page is reached, the balance should be transferred to another page. The new number should be written on the bottom of the finished page and as a matter of good practice the transfer should be witnessed.

If a mistake is made in the record book, for audit purposes the mistake should be bracketed and ‘error’ written with the amended details written adjacent to the entry (Figure 15.4). This must be signed, dated and witnessed by a second registered nurse, who must also sign the amendment.

The registered nurse in charge is responsible for ensuring the stock balance of CDs is checked at least once every 24 hours. However, it is good practice to check the stock balance once per shift.

The stock balance entered in the CD record book should be checked against the physical amount in the cupboard, and any CDs not accounted for in the record book must be reported to the nurse. In addition, quarterly stock checks should be carried out by the pharmacy. The stock checks should be carried out by two registered nurses. When checking the balance:

A record should be made in the record book of the date and time that the stock was checked, with words such as ‘CD stock level checked’ together with the signature of the registered nurse and the witness. Any discrepancy must be reported to the nurse in charge immediately. In the event of a discrepancy in a CD's stock balance or the loss of CDs, the matter should be investigated immediately.

The registered nurse in charge of investigating the discrepancy should check that:

If an error is found, the nurse in charge should make an entry to correct the balance, and this should be witnessed. If an error is identified but its source cannot be found, the chief pharmacist and the accountable officer should be contacted immediately.

CD record books, order books and returns book must be stored for a minimum of 2 years from the date the last entry was made or the date of use.

Any registered practitioner can administer any drug specified as Schedule 2, 3 or 4, provided they are acting in accordance with the directions of an appropriately qualified prescriber (see ‘Prescribing’ below). CDs must usually be administered at the specified time; if they are not, the reason should be documented on the patient's drug chart. CDs must not be administered if the prescription is unclear, illegible or ambiguous or if there is any reason for doubt.

Two practitioners must be involved in the administration of CDs, and both practitioners should be present during the whole administration procedure (NICE [248]). The two practitioners should have clearly defined roles. One should be the checker and the other should take responsibility for taking the drug out of the cupboard, preparing it and administering it. These roles should not be interchangeable during the procedure as this can result in errors. Both practitioners should witness the preparation, the CD being administered and the destruction of any surplus drug. An entry should be made in the CD record book recording the following information:

Unused CD stock should be returned to the pharmacy. CDs that have expired should also be returned to the pharmacy for safe destruction. All returns to the pharmacy should be completed with a pharmacist or pharmacy technician. An entry of the CD being returned should be made in the CD returns book and in the relevant page of the record book recording the following information:

Disposal of CDs can take place on the ward if a part vial is administered to the patient or if individual doses of CDs were prepared and not administered. If a part vial is being destroyed, the registered nurse should record the amount given and the amount wasted under the administration entry in the record book. For example, if a patient is prescribed diamorphine 2.5 mg and only a 5 mg preparation is available, the record should show ‘2.5 mg given and 2.5 mg wasted’.

The entry and destruction should be witnessed by a registered nurse or other registered professional. If an unused prepared CD is being destroyed, this should also be recorded in the record book and the entry and destruction witnessed by another registered professional. Destructions must be disposed of in a yellow sharps bin. Solid preparations should be crushed and mixed with a small amount of water prior to disposal, liquids should be directly emptied into the sharps bin, and patches should have their backing removed and then be folded over.

CD record books, patients’ own CD record books, CD order books and CD returns books are controlled stationery and must be obtained from the pharmacy. CD stationery is issued by the pharmacy against a written requisition signed by an appropriate member of staff. Only one requisition order book should be in use by a ward. CD stationery should not be stored in the CD cupboard but should be stored in a locked cupboard or drawer.

CDs should be transferred in a secure, locked or sealed, tamper‐evident container. A person collecting CDs should be aware of safe storage and security requirements, and of the importance of handing over to an authorized person to obtain a signature. They must also have a valid identification badge.

Nurses, when acting in their capacity as such under a PGD, are authorized to supply or offer to supply diamorphine and morphine where administration of such drugs is required for the immediate, necessary treatment of sick or injured persons (excluding the treatment of addiction) in any setting. They can also supply or administer any Schedule 3 or 4 CD in accordance with a PGD (except anabolic steroids in Schedule 4 Part II and injectable formulations for the purpose of treating a person who is addicted to a drug).

CDs must be prescribed in accordance with the British National Formulary (BNF [25]), NICE guidance (NICE [248]) and the Misuse of Drugs Regulations ([218]).

Schedules 1–3 of the Misuse of Drugs Act ([215]) require prescriptions to be written legibly and indelibly on an FP10 or the organization's CD prescription, stating:

When prescribing opioid medicines, the practitioner should:

When prescribing strong opioids, practitioners should be aware of the relevant guidance issued by NICE ([243]) and ensure that patient counselling is documented in the patient's record.

Prescriptions for all CDs, including temazepam, are valid for 28 days from the date of prescribing or from the ‘start date’ specified by the prescriber.

In hospital, FP10(HNC) prescriptions may be used to prescribe CDs for outpatients in exceptional circumstances. These prescriptions are for NHS patients only.

FP10 prescriptions can be used in the community to prescribe CDs for patients under the care of the medical or non‐medical independent prescriber (IP). In the case of non‐medical IPs, individuals must ensure that the CD is within their scope of practice and that they are competent to prescribe the CD. Prescribers must not prescribe or administer CDs for themselves, close family or friends except in exceptional circumstances.

A supplementary prescriber (SP), when acting in accordance with a clinical management plan, can prescribe a CD provided the CD is included in the clinical management plan. Nurse IPs may prescribe any CD listed in Schedules 2–5 for any medical condition, except diamorphine, cocaine and dipipanone for the treatment of addiction (other CDs can be prescribed by nurse IPs for the treatment of addiction). The authority to prescribe any CD is given on the basis that nurses must only prescribe within their competence.

In response to seven case reports published between 2000 and 2005 regarding deaths caused by the administration of high‐dose (30 mg or greater) morphine or diamorphine to patients who had not previously received doses of opiates, the NPSA released a Safer Practice Notice titled Ensuring Safer Practice with High Dose Ampoules of Morphine and Diamorphine (NPSA [263]). In line with this Safer Practice Notice, the guidance in Box 15.5 should be adhered to.

Between 2005 and 2008, 4223 incidents were reported to the NRLS involving opioid medicines and the ‘wrong/unclear dose or strength’ or ‘wrong frequency’ of medication. As a result, the NPSA released a Rapid Response Report in July 2008 containing the guidance shown in Box 15.6.

The NPSA was notified of 498 midazolam patient safety incidents between November 2004 and November 2008 where the dose prescribed or administered to the patient was inappropriate. Three midazolam‐related incidents resulted in death. As a result, the NPSA released a Rapid Response Report in 2008 containing the guidance in Box 15.7.