1

SAFE AND SECURE HANDLING OF MEDICINES

Section 8.8: Management of Controlled Drugs in Wards and Departments

8.8 8.8.1	Management of Controlled Drugs in wards and departments: Accountability and responsibility The Registered Nurse or Midwife in Charge of a ward or department is responsible for the safe keeping and management of CDs in that area. The Registered Nurse or Midwife in charge may delegate related tasks to another Registered Nurse or Midwife, however legal responsibility remains with the Registered Nurse or Midwife in charge.
8.8.2	Management of Controlled Drugs in wards and departments: Requisitioning Controlled Drugs The Registered Nurse or Midwife in charge of a ward or department is responsible for the requisitioning of CDs used in that area. The responsibility for ordering CDs can be delegated to another Registered Nurse or Midwife, however the legal responsibility remains with the Registered Nurse or Midwife in charge. CD order books must be stored in a locked cupboard. The Registered Nurse/Midwife in charge. CD order books must be stored in a locked cupboard. The Registered Nurse/Midwife in charge must ensure that access to CD order books is restricted to those staff authorised to order CDs. Controlled Drugs for ward use must only be ordered on a Controlled Drug order book. A separate page must be used for each item ordered. The entry must clearly detail; The name of hospital, ward / department and the date. Drug name, form, and strength and ampoule size if more than one available. Total quantity required in dosage unites e.g. number of tablets, ampoules or millilitres The order must contain the signature and printed name of the Registered Nurse or suitably qualified Practitioner who is authorised by the Nurse in Charge of the ward or department.
8.8.3	Management of Controlled Drugs in wards and departments: Receipt of Controlled Drugs At the point of delivery, the contents of the container must be checked immediately by a Registered Nurse/Midwife and witnessed by a second Registered Nurse/Midwife, Student Nurse/Midwife, Pharmacist or Doctor. A non-registered member of staff may sign for a sealed delivery container but it remains in their possession until they locate a Registered Nurse/Midwife to appropriately secure the CDs. As a matter of good practice and whenever possible, the person ordering the medicine should be different to the person receiving the medicine in to stock, this separation of duties helps create a more thorough audit trail. Any discrepancy must be reported to the Specialist Pharmacy Technician or Senior Pharmacist in the dispensary immediately. The receipt must be confirmed by the signature of the recipient on the controlled drug order book. Details of the receipt of the CD must be entered into the Controlled Drug Register: There must be a designated page for each medication, form and strength. Entries in the Controlled Drug register must be made in ballpoint pen. The serial number of the order, the date and the quantity received (in words) and the current balance must be entered and signed by the Nurse/Midwife and witness. The stock balance in the register must be checked against the stock in the Controlled Drug Cupboard. Tamper-evident sealed packs/bottles need not be opened on receipt. This leads to damage to the containers and increases the risk of breakage. When sealed containers are opened for use this should be done in the presence of a second, Registered Nurse/Midwife. Any discrepancy must be reported to the Clinical Pharmacist.
8.8.4	Management of Controlled Drugs in wards and departments: Storage of Controlled Drugs Storage of Controlled Drugs must conform to the Misuse of Drugs Safe Custody Regulations 1973. Locations suitable for stock of Controlled Drugs are in a locked safe, cabinet or room, which is constructed and maintained to prevent unauthorised access to the drugs. For existing or any new CD cupboards or rooms, the Pharmacy Department may be contacted for advice. Within wards and department, all CDs must be stored in a locked cupboard, which can only be opened by a person who can lawfully be in possession, such as a pharmacist or the Registered Nurse or Midwife in charge or a pharmacist. General measures for the storage of CDs include the following: Cupboards must be kept locked when not in use The lock must not be common to any other lock in the hospital Keys must only be available to authorised members of staff and at any time the key holder should be readily identifiable No other medicines or items should normally be stored in the CD cupboard CDs must be locked away when not in use The Registered Nurse/Midwife in charge is responsible for ensuring that the keys are kept secure when not in use. This is particularly important for wards and department that are not operational at all times. Care should be taken on the storage of high strength opiates (diamorphine and morphine). It is a requirement that low strength products (5mg, 10mg) are stored on a separate shelf, bag, cupboard or box than high strength products used to prepare infusions. The different strengths need to be clearly differentiated, and staff should be made aware of the similarities in packaging. Unpackaged ampoules should not be stored or transported and should always be contained within a well packaged box or container. In all clinical locations where strong opioids are stored or administered a supply of naloxone 400micrograms in 1mL should be made available.
8.8.5	Management of Controlled Drugs in wards and departments: Responsibility for CD Keys The Registered Nurse or Midwife in charge is responsible for the CD keys. The CD keys should be kept on a separate key ring from other keys and only given access to staff when access to CDs is required. Key holding may be delegated to other suitably trained, registered healthcare professionals, but the legal responsibility rests with the Registered Nurse or Midwife in charge. The CD keys should be returned to the nurse or midwife in charge immediately after use by another registered member of staff. For the purpose of stock checking, the CD keys may be handed to a member of pharmacy staff.
8.8.6	Management of Controlled Drugs in wards and departments: Missing CD Keys If the CD keys go missing, this must be reported immediately to the Registered Nurse/Midwife in Charge, who must ensure that the following steps are taken as a matter of urgency: Ask all staff on duty to check if they have the keys on their person. Contact staff who have left the premises. If one of them has the key, they must return it immediately. Conduct a thorough search of the environment. If the keys remain missing (either assumed lost or with a member of staff unable to return it) then the duplicate key may be issued for use. Carry out a full stock check. If the lock has to be replaced, ensure that the cupboard is not left unsupervised until that has been completed. Complete a Datix report recording all relevant details and actions taken. All Incident Reports involved a CD must be tagged as a CD Incident on the Incident Reporting System to ensure that the report is automatically forwarded to the CD Accountable Officer Team.
8.8.7	Management of Controlled Drugs in wards and departments: Record Keeping Entries made in to the CD register should be made in chronological order and in ballpoint pen. If a mistake is made in the CD register, it should be bracketed in such a way that the original entry is still clearly legible, it must not be crossed out or obliterated. The words ‘entered in error’ should be written on the same or next line, this should be signed, dated and witnessed by a second Registered Nurse or Midwife, the witness should also sign the correction.
8.8.8	Management of Controlled Drugs in wards and departments: Record Keeping - Records of receipts For CDs received the following details must be recorded on the appropriate page of the CD register: Date of entry Serial number of the requisition Quantity (in words) received Form (name, formulation and strength) in which received Signature and printed name of nurse making the entry Signature and printed name of witness Balance in stock After every administration, the stock balance of an individual preparation should be confirmed as to be correct and the balance recorded in the CD register. The entry should be signed and dated.
8.8.9	Management of Controlled Drugs in wards and departments: Controlled Drug stock checks Within NHS Tayside all wards and departments possessing stocks of Controlled Drugs must carry out a stock balance reconciliation every 24 hours. The Registered Nurse/Midwife in Charge is responsible for ensuring that this is carried out. Two registered nurses, midwives or other registered health professionals should perform this check. Where possible the staff undertaking this check should be rotated periodically. The following procedure must be followed: Each page of the CD register must be checked against the contents of the CD cupboard, not the reverse, to ensure all balances are checked. The physical stock of each item should be counted. It is not necessary to open packs with intact tamper-evident seals for stock checking purposes, e.g. manufacturer's complete sealed packs. Stock balances of liquid medicines should generally be checked by visual inspection but periodic volume checks may be helpful. The balance must be confirmed to be correct on completion of a bottle. A record must be made that the stock check has been carried out and this record must include, as a minimum, the date and time of the reconciliation check and be signed by both members of staff. See Appendix 7 for recording form. Any discrepancy must be investigated in accordance with Section 8.2 Dealing with Discrepancies. Minor discrepancies in volumes of liquid CDs will be corrected by a Registered Nurse/Midwife or Pharmacist/Pharmacy Technician and countersigned by the Nurse/Midwife in Charge or deputy. A minor discrepancy is considered to be 5% of the volume contained in the bottle or 10mL, whichever is the smaller volume. A check of all CDs stocked within wards and departments must be completed every 3 months by Pharmacy (either a pharmacist or pharmacy technician). See Appendix 8 for 3 monthly controlled drug check report.
8.8.10	Management of Controlled Drugs in wards and departments: Archiving of controlled drug records All registers and CD order books must be kept securely by the Registered Nurse/Midwife in charge for a period of two years from the date when the last entry was made, then disposed of in a confidential waste bin.
8.8.11	Management of Controlled Drugs in wards and departments: Prescribing
8.8.11.1	Management of Controlled Drugs in wards and departments: Prescribing - checking the dose When opioid medicines are prescribed in anything other than acute emergencies, the healthcare practitioner concerned should: Confirm any recent opioid dose, formulation, frequency of administration and any other analgesic medicines prescribed for the patient. This may be done, for example, through discussion with the patient or their representative (Although not in the case of treatment for addiction), the prescriber or through medication records. Ensure where a dose increase is intended, that the calculated dose is safe for the patient (e.g. for oral morphine or oxycodone in adult patients, not normally more than 50% higher than the previous dose). Ensure they are familiar with the following characteristics of that medicine and formulation: usual starting dose, frequency of administration , standard dosing increments, symptoms overdose, common side effects.
8.8.11.2	Management of Controlled Drugs in wards and departments: Prescribing - Prescribing for inpatients For hospital inpatients CDs can be prescribed on the TPAR, the written requirements for these medicines are the same as for other medicine: Drug name and form Route Dose Frequency (if prescribed “when required” a minimum interval for administration should be specified, e.g. every six hours, and a maximum total quantity to be administered in 24 hours) Include a finish date where appropriate Start date Signature of prescriber
8.8.11.3	Management of Controlled Drugs in wards and departments: Prescribing - Prescribing for discharge patients It is unlawful for a practitioner to issue a prescription for a Controlled Drug other than a drug specified in Schedule 4 or 5 or temazepam, or for a pharmacist to dispense it unless it complies with the requirements described in Section 8.1. See example in Appendix 4 ‘How to write a Controlled Drug Prescription’.
8.8.12	Management of Controlled Drugs in wards and departments: Administration of Controlled Drugs It is a requirement for two people, one of whom must be a suitably qualified Registered Nurse/Midwife to be involved in the administration of Controlled Drugs. The second person may be either a registered nurse/midwife, a student nurse/midwife (if the drug route is not intravenous) or a doctor. This may be relaxed ONLY in instances where this is not practicable, e.g. community hospital settings when there is only one Registered Nurse on duty. In such cases administration may be carried out by a single Registered Nurse/Midwife in line with locally agreed Operating Procedures. Unregistered staff should not be involved in the administration process. The practitioners administering the controlled drug must verify that the appropriate prescription requirements are in place and independently check appropriate details at the controlled drug cupboard. Checks relate to: The drug name. The correct dose. Reconciling balance of stock after removing required quantity of drug against the register balance. Volume of bolus/infusion (additive, diluent/infusion). Route and rte of administration. Expiry date/time. The CD register should be completed with the following details: Date and time when dose administered. Name of patient. Quantity administered. Form (name, formulation and strength) administered. Name/signature and printed name of nurse administering the dose. Name/signature and printed name of witness to the administration. Balance in stock. Where only part of an ampoule containing a CD is used, the Registered Nurse of Midwife should record the amount administered and the amount discarded. This should be witnessed by a second Registered Nurse or Midwife who should also sign the record. Both practitioners complete the controlled drug register, signing at the time the drug is removed from the cupboard, verifying the drug and dose - the practitioner administering the drug signs the 'given' column. Details of the amount of drug given and discarded for use of part of an ampoule will be witnessed by both practitioners. If it is indicated that a controlled drug needs titrated, the dose given and amount discarded will be documented in the register following administration. Any controlled drug discarded is done so in line with Section 8.7.13. Packaging is not discarded until the bedside check has been completed. Both practitioners independently* check appropriate details at the bedside. Checks relate to: The patient's name and date of birth - on their name band and on asking the patient - corresponds with the details on the prescription. Where this is not practical (e.g. patients with cognitive impairment), the patient may be identified via other means in accordance with local procedures. Confirm the patient is not allergic to the drug. The correct date and time of administration. The drug name. The dose requested is correct in relation to the prescription form and is safe for the patient. The drug details on the original ampoule. Volume of bolus/infusion. Route and rate of administration. Expiry date/time. Both practitioners sign the TPAR alongside the date and time of administration, verifying that the controlled drug has been administered correctly. *independently is defined as an individual undertaking the above process on their own without verbal or other communication during the checking process. Two suitably qualified healthcare practitioners (one of whom should be a Registered Nurse) must be involved in the administration of CDs and both must be present during the whole of the administration procedure. This is a two step process, step one is the check at the drug cupboard, step two is the check at the patients bedside.
8.8.13	Management of Controlled Drugs in wards and departments: Destruction and disposal Unused doses, part doses or partly used prepared doses of CDs must be destroyed promptly and witnessed by a Registered Nurse. The CD to be discarded must be rendered irretrievable by emptying the contents of ampoule/vial, syringe or infusion bag into a pharmaceutical waste bin (generally blue lidded). Liquids should be rendered secure by use of a self-setting compound (such as Pre-Gel or equivalent). Tablets should be crushed, where possible and capsules should be opened prior to disposal. Full details of the destruction must be recorded in the CD register (for part ampoules or other unused doses) or on the patient's prescribing/recording chart (for partly used prepared doses) including the names and signatures of those involved. Used medicated patches may still contain a small quantity of active drug and should therefore be folded in half and disposed of in a pharmaceutical waste bin (generally blue lidded). Controlled drugs which have expired or are no longer required (stock or patients own) must not be returned to pharmacy. They should be clearly marked and segregated within the CD cupboard so they are not used for patients, then destroyed on the ward/clinic in the presence of a pharmacist or pharmacy technician in accordance with pharmacy procedures. For further information refer to Section 8.10.
8.8.14	Management of Controlled Drugs in wards and departments: Transfer of patients with controlled drugs attached When a patient is transferred to another clinical area within the same site with controlled drugs such as infusions, syringe drivers or patches, the current administration and monitoring chart must be transferred with him/her. The registered nurse in the clinical area the patient leaves must check the administration system and volume/quantity remaining and sign, date and time the administration and monitoring chart to confirm that the record is accurate when the patient is handed over and that the quantity remaining is correct. The registered nurse in the clinical area to which the patient is transferred must check the administration system and volume/quantity remaining and sign, date and time the administration and monitoring chart to confirm that the record is accurate. When a patient is discharged to another care facility, e.g. hospital, care home, other hospital with controlled drugs, the fllowing information must be provided as a minimum: Copy of the current administration and monitoring chart. Medical / nursing summary as per local immediate discharge guidance. Syringe driver chart if appropriate, detailing product prescribed, dose, rate, time started. Where patients are being transferred home with syringe pumps attached it is essential that there is timely transfer of information to the services who will be responsible for ensuring continuity of care, e.g. out of hours service, district nursing service.