Medicines management

Medicines management

All aspects of CD medicines management and governance should be detailed in local CD SOPs; these should reflect relevant aspects of CD legislation as well as NHS guidance and any additional local requirements specified in the trust’s medicine policies. The following paragraphs are intended to provide an overview of some areas where the law and guidance meet and suggest further best-practice considerations. More detailed guidance can be found in the further reading provided at the end of this chapter.

Storage

It is the Misuse of Drugs (Safe Custody) Regulations 1973 that impose controls on the storage of CDs, requiring safe custody, in certain types of premises. Retail dealers (pharmacies), including any registered pharmacy premises in hospitals, private hospitals and care homes, must store their CDs in a CD cabinet or safe which complies with the specifications in the regulations or obtain a police certificate to confirm an adequate degree of security.

NHS hospitals are required to keep CDs in a ‘locked receptacle’ which can only be opened by a person who can lawfully be in possession of CDs, for example a pharmacist or a senior registered nurse in charge of a hospital ward or department. It is generally considered good practice to ensure that wards store CDs in a specific cupboard that conforms, as a minimum, to an appro-priate British Standard (for example, BS2881).

Additional security measures may be considered necessary for areas where staff are not present for 24 hours in a day or closure occurs at weekends. CD cupboards should not be used to store anything else, including patient valuables, to minimise the occasions when access is required.

Some organisations apply CD secure storage and recording procedures to CD medicines which are not subject to the legal safe storage requirements, for example, midazolam, or where these procedures are used as a means of reducing the risk of inadvertent selection or administration, for example, concentrated potassium-containing products. Local SOPs should make these situations clear to staff and they should form part of induction and training activities.

Ordering and transport

All stationery which is used to order, return or distribute CDs must be stored securely and access to it should be restricted. Stock of CDs for wards, oper-ating theatres and departments is obtained from a hospital pharmacy by an authorised practitioner using duplicate requisitions, most frequently in the standard NHS CD supplies order book. It is good practice to verify that the person placing the order is authorised to do so through a system such as having a list of authorised signatories available at the point of dispensing, ideally validated and authorised through appropriate management routes. Registered operating department practitioners and senior registered nurses or acting senior registered nurses are authorised to order, possess and supply CDs.

It is considered good practice to have systems and SOPs that ensure at each point where a CD moves from the authorised possession of one person to another, a retrievable record is made which contributes to the maintenance of a full audit trail for each product.

Administration

A record of the administration of schedule 2 CDs should be made in patient-specific documentation or medical record systems and in a CD stock record book, following local organisational procedures. The Nursing and Midwifery Council recommends that the record of administration of CDs within sec-ondary care, or similar healthcare setting, requires a second signatory.

Controlled drug record-keeping requirements

A record should be kept of all schedule 2 CDs that are received or issued, throughout the hospital. The Nursing and Midwifery Council recommends that all entries must be signed by two registrants and that the stock balance of an individual preparation must be confirmed to be correct after every admin-istration when the balance is recorded in the CD record book.

It is good practice to require that the stock balance of all medicines entered in the CD record book should be checked and reconciled with the amounts in the cupboard with sufficient frequency to ensure that discrepancies can be identified and investigated in a timely way. If long periods lapse between stock checks it becomes far more difficult to identify the cause of any discrepancy and, indeed, those staff who may be linked to the event.

Before 2007 the legally required CD register was of a prescribed layout. This was replaced with the requirement that a CD register must contain specific headings. A standard NHS register for hospital pharmacy receipts and issues and a generic ward CD record book are still the predominant documentation used to maintain a complete audit trail of all CDs received into, supplied and used across hospital services. Additional purpose-specific record books are now also being developed and used in some hospitals, for example, theatre CD record book and patients’ own medicines CD record book.

The amended regulations also included a new requirement to add specific information to the legally required CD register, to record information about the identity of the person collecting schedule 2 CDs.

This requires that a record is made of the person collecting the schedule 2 CD, be this the patient, patient’s representative or healthcare professional, and if the person who collected the drug was a healthcare professional acting on behalf of the patient, that person’s name and address.

A ‘yes/no’ is recorded against two questions:

·        Was proof of identity requested of patient/patient’s representative?

·        Was proof of identity of person collecting provided?

In hospitals the recording of schedule 2 CD medicines supplied to a patient to take home at discharge should be subject to clear local procedures which may also encompass recording some of these additional elements of information, as diversion can occur at any point in the supply and transport processes, particularly when multiple steps are involved.

Controlled drug prescribing

In hospital practice, inpatient medicine charts are used to provide written directions for the administration of medicines. If a supply on an individual-patient basis is made the prescription must meet the requirements of the Misuse of Drugs Regulations 2001. This applies in outpatient settings and for discharge. The usual approach for inpatients is to supply on a ward stock basis.

Doctors and dentists may prescribe all CDs. Nurse independent pre-scribers can prescribe from a specific list of products for specific medical conditions. Further amendments to the Misuse of Drugs Regulations 2001 are planned to allow nurse and pharmacist independent prescribers additional authority in relation to CDs. Registered supplementary prescribers can pre-scribe a CD as long as it is within the clinical management plan specific to that patient and is agreed between the independent prescriber (doctor or dentist), supplementary prescriber and patient.

A limited number of specified CDs can be included in patient group directions.

Controlled drug destruction

Schedule 1 and 2 CD stock (‘stock’ is defined as product not supplied to or dispensed for an individual patient) can only be destroyed in the presence of a person authorised under the Misuse of Drugs Regulations 2001 who acts as witness for the destruction. Accountable officers can nominate personnel within their organisation to witness the destruction of CDs. Accountable officers for CDs cannot undertake the role of witness to destruction them-selves. This authority allows accountable officers to ensure that out-of-date or surplus CD stocks are appropriately destroyed in a timely manner so they cannot be diverted or misused. Hospital pharmacists should also consider how unwanted medicines classified in other CD schedules are safely disposed, minimising the risk of misuse.

The method of disposal should ensure that the CD is rendered unrecover-able prior to onward safe disposal. Guidance on suitable approaches is provided by the Royal Pharmaceutical Society and in the Department of Health Safer Management of Controlled Drugs: A Guide to Good Practice in Secondary Care (England or Northern Ireland).

In some hospital clinical areas the use of CD products is routine, for example in palliative care services, intensive care units and operating depart-ment theatres. Destruction procedures should not only direct the management of unwanted or out-of-date stock medicines but should also set out the expected management of CD product excess to patient care needs. Health-care practitioners should not forget that there is a potential to misuse or mis-direct any CD product, including unused product issued for patient care, and it is important that procedures require that all CD product is accounted for in appropriate documentation or recording processes, and actions such as destruction of unwanted product are always witnessed.

Patients’ own CD medicines, prescribed through a hospital or in the community, that are no longer wanted or required may be returned or left in the hospital. Hospital SOPs should include procedures detailing how records of schedule 2 drugs returned by patients are stored, managed and disposed.

Mixing medicines prior to administration in clinical practice

The MHRA recently put in place changes to medicines regulations to enable the mixing of medicines prior to administration in clinical practice. The MHRA has also approached the Home Office and the Advisory Council for the Misuse of Drugs with the Commission on Human Medicine’s recommen-dation that corresponding amendments for CDs are made to the Misuse of Drugs Regulations. Meanwhile, existing good-practice arrangements should continue on mixing, which may include a CD, before administration.

Nurse and pharmacist independent prescribers

In March 2007 a public consultation to consider options that might support the independent prescribing of a broader range of CDs by both nurse and pharmacist independent prescribers was initiated. The Department of Health, the Home Office and the Commission on Human Medicines sup-ported the consultation and we now await the required amendments to the Medicines Act and the Misuse of Drugs Act. On a related matter, legislative changes which could affect patient group directions and the supply and/or administration of certain CDs in specific circumstances are being considered at the time of writing.