Chapter 2 - Drug storage and disposal of controlled and non-controlled drugs
The regulation of the use of controlled drugs is an important consideration for the government owing to the harm these drugs may have if misused. This may range from the damage that addictive behaviours may cause, through to the abuse of controlled drugs undertaken by the serial killer Harold Shipman, who was found to have appropriated large quantities of opioid drugs which he used to kill elderly patients. Therefore, to protect the public and healthcare professionals, it is necessary to regulate all stages of controlled drug usage to ensure that there is no opportunity for abuse or removal of controlled drugs from the regulatory system at any stage of the controlled drug lifecycle (from production, to storage, to administration to disposal). This chapter will review the storage and disposal of controlled and non-controlled drugs, and review how the recommended procedures for handling help protect patients and staff. The administration of controlled and non-controlled drugs will be covered in future chapters. A case study scenario will be presented at the end of this chapter to explore the practical application of drug management legislation in the context of nursing practice.
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 (e.g. a patient's home), and why it is so important that nurses closely follow these procedures.
- 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, and the reasons for this.
- Consider the appropriate legislation and guidance from professional bodies in the context of your institutions own protocols and identify any differences. Do your institution's policies go above and beyond what is legally required?
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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. This legislation came into force in 2013, following the implementation of the changes to healthcare management that occurred when the Health and Social Care Act 2012 came into force. This legislation covers any organisation that is involved in the administration of controlled drugs, such as NHS hospital trusts, the NHS Commissioning Board, Independent Hospitals and both the Regular and Reserved Armed Forces. 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 (except, for example in emergency situations), but is a senior manager or directly answerable to a senior manager. This might be a Chief Nurse, Chief Pharmacist, or Medical Director for example. 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. This sets out recommendations for adoption by organisations on various aspects of drug management, including record keeping, risk assessment, the reporting of breaches of management and the storage of controlled drugs. Recommendations for the safe management of non-controlled drugs is addressed by a range of guidelines and pathways covering the different aspects of medication use for example, drugs with specific uses e.g. intravenous fluid therapies, or the management of drugs in specific environments, such as nursing homes. 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 conduct enquiries where necessary to investigate potential breaches of regulation. They also report to the government on the effectiveness with which individual agencies work together.
Further to this, the relevant legislative and guidance bodies for each healthcare profession (for example the NMC or the General Medical Council (GMC)) also produce regulatory and protocol recommendations for the management of controlled and non-controlled 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 all 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 2016 version of the Standards for Medicines Management.
The management and use of controlled drugs in England and Wales is legally regulated by the "Controlled drugs (supervision of management and use) regulations"
Recommendations for the safe management of controlled drugs are also made by NICE, and the NMC as well as other regulatory bodies
The implementation of these guidelines is monitored by the CQC, and local governance procedures
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 secure lockable cupboards, or in lockable refrigerators or freezers if the drug storage instructions indicate that this is necessary. Lockable trolleys are a useful alternative to a fixed cupboard as they are portable, and can easily be taken to the patient's bedside during ward rounds. However, 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 and subsequently medical errors. Every item should be clearly labelled, and stored in the original container the drug was dispensed in by the pharmacy, as this ensures that the drug preparation is both stored in accordance with the manufacturers guidance, and reduces the chance of medical errors caused by the wrong medication being selected. Extreme variation of temperature should also be avoided, for example, by not siting the cabinet in direct sunlight. Individual preparations may have specific storage recommendations made by the manufacturer, and these should always be considered, for example, aerosol preparations usually have the recommendation to store away from direct sunlight or near radiators, and medications designed for application to the eye often have an instruction to dispose of any remaining medication after a short period, usually 7 days. 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. There are also automated medicine cabinets now available which use a barcode system to ensure that only the drawer of the cabinet containing the correct medication opens, which is thought to help reduce medication errors (Cottney, 2014). 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 (see later in this chapter for further discussion). 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 etc. 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, and compared with usage figures 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 (and should therefore should not be destroyed without the patient's consent), these should still be stored in accordance with the same regulations and policies as hospital-held drugs. For example, these could be stored in a lockable immobilised bedside medication cupboard.
- Both controlled and non-controlled drugs should be stored in designated lockable cabinets, refrigerators or freezers (as appropriate)
- Nurses should take the manufactures guidance into account when storing any medication
- Cabinets should be secure, and if mobile, should have the capacity to be fastened securely to an immovable object
- Patient medication brought onto the ward is not subject to the same regulation as hospital-administered medication, but should still be stored securely
- Drug ordering stationery and prescription stationery should also be stored securely as this also has the potential for abuse
- All nurses should consider the safety and security of stored drugs at all times
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Storage of controlled drugs
It may be necessary for controlled drugs to be stored in the hospital environment, for example on a critical care ward. NICE stipulates that institutions should implement standard operating procedures for the safe and secure storage of controlled drugs, and the recording of their use. On receipt of the controlled drug from the pharmacy by a designated person (the definition of which will vary by local policy), 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 via a visual inspection. This process should be witnessed, and the witness should also add their name, signature and the date to the register 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 (for example from the pharmacy to the patient's home) as this is not good practice, but if it becomes necessary they may do so, but should prove their identity and professional registration status.
Controlled drugs should be stored in designated lockable cupboards conforming to British Standard BS2881, or be approved by the pharmacy department for this purpose. These cupboards and cabinets should only be used to store controlled drugs. Access to this cupboard 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 (again, this will vary in accordance with local procedure but is usually the nurse in charge). 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 needed by their patients in order to support quality and timely administration of nursing care. 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.
Similarly to the storage of non-controlled drugs, controlled drugs should also be labelled clearly, with different medications stored separately in their original packaging. Further to these regulations, high strength preparations of controlled drugs (such as >30mg preparations of morphine or diamorphine) should be stored separately from low strength preparations (<10mg morphine or diamorphine) (Dougherty et al., 2015, p.830) in the interests of helping to prevent drug administration errors. Some institutions also recommend the use of alerting stickers for packages of high strength preparations of controlled drugs. As with the management of non-controlled drugs, controlled drug usage should be monitored and it should be considered whether controlled drugs need to be stored on the ward (or could be ordered on a patient by patient basis if only used infrequently), and whether the amount held on the ward is appropriate for the needs of that environment. 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 (an inverse agonist for the µ opioid receptor which can reverse the symptoms opioid agonist overdose) should also be stored in any clinical area that morphine or diamorphine are stored. A comprehensive stock take should also be performed on a regular basis; the frequency of which should be set by the institution however, NICE recommends that a frequency of once a week should be considered, dependant on the frequency of use, risk assessment of the controlled drug storage and the frequency of any controlled drug-related incidents. These should also be recorded in the appropriate record book, along with the signature of the nurse carrying out the stock take and the appropriate date. Ideally, NICE recommends that 2 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 (low, medium or high risk), 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, for example thefts or drugs unaccounted for. Any such incidents should be reported as per local policy, with a new risk assessment being performed, and the current protocols reviewed in order to reduce future risk.
The stationery necessary for the ordering and requisition of controlled drugs should also be held securely in a locked cupboard or drawer to prevent abuse by inappropriate ordering. This stationery should only be released to the ward by the pharmacy on receipt of a requisition form signed by an appropriate member of staff. Only one book of requisition forms should be used by the ward, and this should also be held securely. 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. NICE also recommends that all records relating to the ordering, management and administration of controlled drugs should be kept for at least 2 years from the date of entry.
Controlled drugs are also used widely outside of the hospital setting, particularly in the community, for example in the administration of opioid analgesics to patients receiving palliative care. 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 when writing local policies. 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, for example asking a carer to witness the procedure.
The storage of controlled drugs is subject to similar protocols as non-controlled drugs, but with additional steps in procedures and documentation to reduce the risks that these drugs pose
Additional requirements include:
- Witnessing of all procedures (where possible, in accordance with local policy) by a second authourised person
- The use of cabinets conforming to specific security requirements, for example with locks in compliance with British Standard BS2881
- Documentation of every action relating to the management of controlled drugs, with the name of the operator and witness clearly recorded, with a signature and date
- Specific local policies should be in place to govern the use of controlled drugs outside the hospital setting e.g. in the community. Community nurses should ensure they follow these policies to maintain both the security of the controlled drugs and their personal safety
From your knowledge of the published legislation and guidance relating to the use of controlled drugs, which of the following is correct? The correct answers can be found after the references for this chapter.
- Controlled drugs should be stored in a lockable cupboard approved by the pharmacy department.
- Controlled drugs should only be stored in a cupboard conforming to British Standard BS2881
- Naloxone should also be stored within the controlled drugs cupboard
- Naloxone should be stored near the controlled drugs cupboard
- Controlled drugs for use in resuscitation emergencies should be locked in the controlled drugs cupboard
- Only the nurse in charge should be able to access the controlled drug cupboard
- A student nurse can witness a procedure relating to the management of a controlled drug
- If there is no nurse available in the hospital setting, a family member can act as a witness to the use of a controlled drug
- If there is no nurse available in the community setting, a family member can act as a witness to the use of a controlled drug
- Controlled drug stationery should be kept locked at all times
- Only the nurse in charge should have access to the ward controlled drug register
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Think about how the recommended procedures relating to the storage of controlled drugs may also help to reduce the risk of medical errors. Please consider the common causes of medical errors, for example selection of the wrong drug, administration of the wrong dosage to the patient or delivery by the wrong route. Please also consider how the use of a second competent person witnessing the procedure could help identify medical errors.
Disposal of non-controlled drugs
Pharmaceutical waste, for example out of date medications or waste from diagnostic testing should usually be returned to the pharmacy for safe destruction in accordance with the Hazardous Waste Regulations (2005), although individual organisations will likely have different localised protocols. Pharmacy staff should be trained appropriately in that they can separate any incompatible substances so that they can be safely destroyed, without risk to staff. From here, the waste can be transported to a contractor with suitable licencing who can destroy the medication by incineration. Cytotoxic drugs require specific handling procedures as they are considered to be hazardous waste.
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, for example excess drug remaining in the ampule following the preparation of the prescribed dose, 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 destruction of controlled drugs on the ward (for example, excess quantity of pre-prepared controlled drug) should be performed in a timely manner, so that the amount of controlled drug does not build up. The drug should be destroyed in such a way that it could not be recovered or reused, for example using a denaturing kit or dissolving the drug in soapy water.
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. The authorised person witnessing the destruction should also sign.
When very small or irretrievable quantities of controlled drug are to be destroyed (e.g. the remnants of liquid drugs in their original container when all possible volume has been removed), 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, for example the delivery of the drugs to a community pharmacist. 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.
- Both controlled and non-controlled drugs should be disposed of carefully to prevent environmental contamination, and to remove the possibility of the drugs being obtained by someone who may abuse them
- Small volumes of controlled drugs may be destroyed using denaturing kits or dissolving in soapy water. Tablets can be crushed and denatured for safe disposal. Larger volumes should be returned to the pharmacy for safe disposal
- The negligible volumes left in controlled drug containers should be managed by rinsing and destroying any labels, before disposing of the container with normal clinical waste (in accordance with local policy)
- Community nurses should not usually remove controlled drugs from a patient home, but advise a carer to return any controlled drugs for disposal (in accordance with local policy)
In what ways do the storage and disposal requirements of controlled drugs exceed the requirements for non-controlled drugs? Why is this?
In this chapter, we have reviewed the common protocols and procedures in place for the safe storage of both controlled and non-controlled drugs, and considered how excess or waste drugs can be safely disposed of, with minimal potential harm to the environment or the public. Protocols for the management of both controlled and non-controlled 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 optimal 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, for example the potential risks to personal safety posed by lone working with controlled drugs in the community. However, local policies should be in place to optimise safety and efficiency. Finally, nurses should also consider how good drug management can optimise both patient safety and quality of care.
Nurses should understand:
- The difference in storage procedures for controlled and non-controlled drugs
- The correct methods for safe disposal of both controlled and non-controlled drugs
- How applying these procedures and protocols helps to prevent both drug abuse and crime, therefore helping to ensure the safety of both healthcare professionals and patients
- Their responsibilities for correct drug management under the NMC Code, and the NMC Standards for Medicines Management
- How good drug storage and organisation practice can prevent medical errors
- Their responsibilities under their local protocols in the context of the law
CASE STUDY SCENARIO:
Clare is a newly qualified registered nurse, and the named nurse for her patient, Mary, who will require a 25mg dose of IV morphine at 2pm, but first, Clare must correctly sign in a new delivery of morphine from the pharmacy and perform a controlled drug stock check.
Firstly, Clare checks the ID of the porter delivering the morphine. She opens the tamper proof lockable box the controlled drugs are delivered in, and double checks the quantity of morphine in the box with the amount on the order, to check that no medication is missing. Once she has confirmed it is complete, as an authorised recipient of controlled drugs under her hospital's local policy, she signs for the delivery, clearly writing her name in the appropriate space and dating the entry. Clare then asks the nurse in charge for the keys to the controlled drug cabinet, explaining her reasons for needing access and then asks Fiona, who is also a registered nurse, to witness her transferring the new stock into the controlled drug cabinet. The controlled drug cabinet is lockable, but for ease of use during drug rounds is movable from its usual position near the nurse's station in clear view of the staff. Clare completes the ward controlled drug register with the date of the requisition, the name of the drug, and the formulation and quantity being added. She confirms the accuracy of this entry by entering her name, signature and today's date into the book. Next, Fiona, who has witnessed the process also adds her name, signature and today's date to confirm that Clare has accurately completed the controlled drug register, and that the amounts entered in the record book are correct. The packages of morphine are then transferred to the back of the appropriate section of the controlled drug cabinet to ensure that the oldest preparation is used first. Clare puts the 10mg packages of morphine into the correctly labelled compartment, and repeats this for the packages of 30mg of morphine to ensure that they are kept separately. In accordance with local policy, Clare also adds a "high dose alert" sticker to those packages that contain doses >30mg morphine.
Clare and Fiona then carry out a stock check of the medications within the controlled drug cabinet. Firstly, they ensure that all drug preparations and packages are in their correctly labelled locations, moving any packages that have not been returned to their correct place. They then review each type of medication in the cabinet, and check the expiry date on each package. On this occasion, they do not identify any expired medication, but had they done so, they would then arrange for its safe destruction. They also check that all medication is in the correct boxes. Once this is complete, Clare and Fiona count the quantity of each strength of preparation. They compare this result with the ward controlled drug register to ensure that no medication is unaccounted for. On this occasion, Clare and Fiona confirm that the quantities present in the cabinet reflect those in the register. They then complete the stock check entry in the register. They also review the levels of medication in the register in order to identify any medications which are not being frequently used, so that they can flag this up to the nurse in charge, who may consider removing seldom used medications from the controlled drug stock maintained on the ward.
Clare then prepares Mary's dose of morphine. Clare checks Mary's prescription chart to ensure that the medication dose she is about to prepare is correct, and carries out the appropriate safety checks (see Chapter 3 for more information on the correct and safe administration of both controlled and non-controlled drugs).
With Fiona present as the second registered nurse required to witness the administration of controlled drugs, Clare takes the controlled drug record book and turns to the appropriate section for the 30mg strength of morphine. Together, Clare and Fiona check the stock level recorded in the book with the level of stock in the cabinet to confirm again that all stock is accounted for. With Fiona witnessing and checking, Clare selects the oldest package of 30mg morphine from its designated section of the controlled drugs cabinet (in order to make up the prescribed 25mg dose of morphine requested for Mary). Clare checks that the dose and concentration of the preparation is correct in comparison with the dose ordered in Mary's notes. She removes the ampule from the package and places in a medicine pot for preparation. Clare ensures that the remaining stock is returned, locks the cabinet and secures it in its designated place near the nurse's station to help prevent any potential theft of the cabinet. She then promptly returns the keys to the nurse in charge.
Clare enters the date, drug name, dosage, new stock level and the patients name into the ward record book. She signs and dates the entry, making sure her name is legible. As Fiona is still present to witness the administration of this drug, she also signs and dates the entry to confirm that she has witnessed the medication being selected. Clare then prepares the dose by transferring it to a syringe. In doing this, there is 5mg left in the ampule that needs to be destroyed in accordance with the law, hospital policy and NMC guidelines.
To destroy the remaining 5mg morphine to prevent it from the from potential abuse, Clare takes the small volume and mixes it with soapy water, before flushing it down the sink in the sluice room. Fiona remains to witness the destruction of the drug, and they both complete the controlled drug record book to confirm that it has been safely destroyed. Had Clare needed to destroy a larger volume, she could have opted to use a denaturing kit, however in this case, in accordance with her local policies, dilution in soapy water was deemed to be adequate to safely destroy this small volume.
The correct administration of this prepared dosage is continued in the case study scenario detailed in Chapter 3.
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Answers to example questions
The following options are correct: a, d, g, i, j.
Explanation for wrong answers:
b. Incorrect as can either be stored in a cupboard conforming to this standard, or one approved by the pharmacy department.
c. Naloxone is not a controlled drug, therefore it should not technically be stored in the controlled drug cupboard but should be stored near it (although this may vary with local policy).
e. They should be in a drawer on the resuscitation trolley, easily accessible to staff in an emergency.
f. Any authorised nurse can access the controlled drugs cupboard.
h. Incorrect, this should only happen in the community where no healthcare professional is available to witness.
k. Any authorised nurse can access the controlled drugs register.
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