Chapter 2 - Drug storage and disposal of controlled and non-controlled drugs
Learning objectives for this chapter
By the end of this chapter, we would like you to:
- Understand how and why both controlled and non-controlled drugs are regulated in the UK
- Understand the different ways in which drugs are managed under UK law, NICE recommendations and the guidance offered by organisations such as the Nursing and Midwifery Council (NMC).
- Understand how both non-controlled and controlled drugs should be stored in the hospital and community environment.
- Understand how the procedures in place to store controlled drugs correctly can also help improve patient safety.
- Understand how excess or expired non-controlled and controlled drugs are safely destroyed both in the hospital and community.
The Regulation of Controlled Drugs in the UK
The Department of Health (DoH) legislates procedures and duties for the correct management of controlled drugs in England and Scotland under the "Controlled drugs (supervision of management and use) regulations" legislation. One of the stipulations of this legislation is that every institution with more than 10 staff should appoint an appropriately qualified and experienced person as the Controlled Drugs Accountable Officer (CDAO), who does not routinely administer or destroy controlled drugs, but is a senior manager or directly answerable to a senior manager. Any incidents or concerns about the use of controlled drugs should be directed to the CDAO, who should have a protocol for escalating any serious incidents.
NICE regulate the safe management of controlled drugs by healthcare professionals and local healthcare commissioners with NICE guideline NG46 (2016). This sets out recommendations on various aspects of drug management, including record keeping, risk assessment, and the reporting of breaches. In the UK, the use of controlled drugs is overseen by the Care Quality Commission, who review how other regulators and agencies manage their use of controlled drugs, and investigate potential breaches of regulation.
Further to this, the relevant legislative and guidance bodies for each healthcare profession also produce recommendations for the management of medications. The NMC Code stipulates that nurses should prescribe, dispense and administer medications in accordance with the nurse's individual limits of training and competence, and always in accordance with the law and local policies. Nurses should ensure that medications are stored securely, and act in accordance with the specific laws governing the use and management of controlled drugs. The specific guidance for the use and management of medications by the NMC is laid out in the Standards for Medicines Management.
Storage of non-controlled drugs
All medications must be stored in a safe and secure manner to ensure compliance with the Misuse of Drugs Act 1971, and the Control of Substances Hazardous to Health Regulations 2002. Therefore, all drugs should be stored in lockable containers. Lockable trolleys are a useful alternative to a fixed cupboard, but these should be secured to an immovable object when not in use to maintain the security of the drugs kept within it. These cupboards should also be organised to allow the segregation of internal and external medications, intravenous preparations, topical agents and diagnostic kits or reagents, which helps reduce confusion between items. Every item should be clearly labelled, and stored in the original container the drug was dispensed in by the pharmacy, as this reduces the chance of medical errors caused by the wrong medication being selected. Extreme variation of temperature should also be avoided. Individual preparations may have specific storage recommendations made by the manufacturer, and these should always be considered. Medications and preparations for emergency resuscitation procedures should be stored in a closed drawer on the resuscitation trolley, with regular inspection of tamper-proof seals. The stationery required for the prescription and ordering of medications (for example blank prescription forms) should also be stored securely to prevent inappropriate use.
Drug preparations will have an individual expiry date, after which the drug should be safely disposed of. To ensure that old stock does not accumulate, new medications should be added to the medicines storage cupboard in a rotational system, so that the oldest medication is used first. The nurse in charge is considered to have overall responsibility for drug storage and safekeeping, however all nurses have a responsibility to consider the security of drug storage at all times. The keys for medication storage cupboards or refrigerators should be held by the nurse in charge, unless they are in immediate use by the nurse undertaking the drug round.
The nurse in charge should consider which drugs are in frequent use in the ward or department and maintain necessary stocks of these preparations. The list of drugs to be held on the ward should be reviewed regularly to ensure that medications are not held on the ward unnecessarily. This decision is usually made in conjunction with the hospital pharmacist and any other relevant medical staff. Drugs should also be contained within a lockable unit for transportation from the pharmacy.
Prior to hospital admission, patients are often requested to bring any medications they are currently prescribed with them. Although these always remain the property of the patient, these should still be stored in accordance with the same regulations and policies as hospital-held drugs.
Storage of controlled drugs
On receipt of the controlled drug from the pharmacy by a designated person, the drug should be entered into the controlled drug register with the date of requisition, name, formulation and quantity of the requisition, the name and signature of the person making the addition to the stock, and the current balance of the stock. This process should be witnessed to confirm the accuracy of the addition. Like non-controlled drugs, controlled drugs should be transported in a secure and locked container, and the person responsible for transport should be aware of the regulations for safe management of controlled drugs, and wear a valid identification badge. The medication should also be signed over to the authorised recipient on the ward. Nurses should not routinely transport controlled drugs as this is not good practice, but if it becomes necessary they may do so.
Controlled drugs should be stored in designated lockable cupboards conforming to British Standard BS2881. These cupboards and cabinets should only be used to store controlled drugs. Access should be restricted to only the staff who have need to use it, and the keys held when not in immediate use by authorised members of staff. Key holding responsibilities can be delegated to other suitably trained staff members, but the ultimate legal responsibility remains with the designated key holder. This individual should always be aware of the location of the key in order to maintain security of the drug stocks, and to ensure that staff have timely access to medications. For stock taking purposes, the key may also be passed to an authorised pharmacy staff member. If controlled drug storage keys go missing, staff should investigate this as a matter of urgency. Local procedures for informing the nurse in charge, the nursing manager and the duty pharmacist should be followed to protect the security of the controlled drug stocks.
High strength preparations of controlled drugs should be stored separately from low strength preparations (Dougherty et al., 2015, p.830) in the interests of helping to prevent drug administration errors. As with the management of non-controlled drugs, it should be considered whether controlled drugs need to be stored on the ward, and whether the amount held is appropriate. This prevents both delays in accessing medications, and prevents the stockpiling of controlled medications. To provide emergency care in the event of an inadvertent or deliberate opioid overdose, it is recommended that the opioid reversal drug naloxone should also be stored in any clinical area in which morphine or diamorphine are stored. A comprehensive stock take should also be performed on a regular basis. These should be recorded along with the signature of the nurse carrying out the stock take and the date. Ideally, NICE recommends that two people carry out stock checks where possible.
Risk assessments for the storage of controlled drugs should also be carried out on a regular basis. These should consider the types of controlled drug in use, the storage facilities, the frequency of any discrepancies in stock balances at the end of shifts, the security of the setting, the number of staff who have access to controlled drugs, the frequency of staff turnover in the department and the results of investigations from any previously reported incidents.
The stationery necessary for the ordering and requisition of controlled drugs should also be held securely. Only one book of requisition forms should be used by the ward. When it becomes necessary for a new requisition book to be obtained, the transferring of stock balances from the old book to the new one should be witnessed by a registered nurse.
Controlled drugs are also used widely outside of the hospital setting, particularly in the community. The drugs may be stored at the patient's home, and nurses may also be responsible for collecting the controlled drugs from the pharmacy and transporting them to the patient's home. Community nurses also often work alone, therefore security to prevent theft or potential violence should be considered. It may also not be feasible for a second authorised person to witness the management of controlled drugs in this setting, in which case local policy should be followed.
Disposal of non-controlled drugs
Pharmaceutical waste should usually be returned to the pharmacy for safe destruction in accordance with the Hazardous Waste Regulations (2005). Pharmacy staff should be trained appropriately in separating any incompatible substances so that they can be safely destroyed. From here, the waste can be transported to a contractor with suitable licencing who can destroy the medication by incineration.
Nurses in the community setting should not remove waste drugs that belong to the patient from their home. Instead they should advise the patient or their carer to return the drugs to their local pharmacy for safe destruction.
Disposal of controlled drugs
Controlled drugs can also be returned to the pharmacy for destruction by an authorised individual. In the hospital pharmacy, the amount and type of drug is recorded and signed for. The ward controlled drug book should be updated to reflect this, and any drug that is returned to the pharmacy for destruction clearly indicated. This procedure should be witnessed by a second registered nurse. Liquid preparations of controlled drugs should be emptied into an in-use sharps bin, along with the empty syringe. Empty infusion bags can then be disposed of along with normal clinical waste. The drug should be destroyed in such a way that it could not be recovered or reused.
This procedure should be witnessed by two appropriately qualified people, one of whom should be the nurse caring for the patient that the drug was originally prescribed for. The name, concentration and form of the controlled drug to be destroyed should be recorded, along with the date of destruction.
When very small or irretrievable quantities of controlled drug are to be destroyed, the container can be rinsed out and disposed of into a pharmaceutical waste bin. It is also good practice to remove or obliterate any identifying labels on the medication containers. The destruction of these irretrievable amounts of controlled drug does not need to be recorded.
If a person receiving controlled drugs at home has died, the community nurse should ensure that the removal of any leftover controlled drugs is discussed with the family, and any actions witnessed and recorded. The nurse should ideally not remove drugs from the patient's home, but recommend that a carer or family member take them to their local pharmacy for disposal.
Protocols for the management of drugs usually vary between institutions, however most protocols are designed to meet both the legal requirements of the "Controlled drugs (supervision of management and use) regulations" legislation (2013), recommendations for good practice by NICE and other recommendations for professional practice by organisations such as the NMC. Nurses should be aware of their responsibilities under the law and the guidelines issued by professional organisations, however they should always be aware and operate in accordance with the guidelines issued by their institution. Nurses outside the hospital setting may have different responsibilities and risks to address.
Dougherty, L., Lister, S. and West-Oram, A. (2015). The Royal Marsden Manual of Clinical Nursing Procedures. 9th ed. Chichester: John Wiley & Sons.
NICE. (2016). NICE Guideline NG46: Controlled Drugs: Safe Use and Management. NICE. [Online]. Available at: https://www.nice.org.uk/guidance/ng46 [Accessed: 1 November 2016].
The Crown. (2005). Statutory Instrument No.894: The Hazardous Waste (England and Wales) Regulations 2005. The Stationery Office. [Online]. Available at: http://www.legislation.gov.uk/uksi/2005/894/pdfs/uksi_20050894_en.pdf [Accessed: 1 November 2016].
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