Approved by: Vice President & Chief Medical Officer Vice President & Chief Operating Officer Controlled Substances Corporate Policy & Procedures Manual Number: VII-B-245 Date Approved November 30, 2015 December 11, 2015 Next Review (3 years from Effective Date) December 2018 Purpose Policy Statement To ensure that control of and access to controlled substances is in compliance with the appropriate legislation and the Guidelines for the Secure Distribution of Narcotic and Controlled Drugs in Hospitals (1990). Controlled substances shall be controlled in a manner that ensures patient safety and permits full auditing of the product from receipt through to patient administration. The records will be available for inspection. Records for controlled substances administration and inventory logs are legal documents and must legally be retained for a period of at least two years. Controlled Substances inventory logs will be numerical and used sequentially. All ordering and administration of controlled substances shall be by health care professional and shall be within the confines of relevant legislation and ensuing Covenant Health policies. As per Guidelines for the Secure Distribution of Narcotic and Controlled Drugs in Hospitals (1990), one set of keys will be supplied per each locked storage cabinet. Any exception to this must be approved by the Site Administrator in consultation with the Pharmacy Manager or Director. Applicability This policy and procedure applies to all Covenant Health facilities, staff, members of the medical staff, volunteers, students and any other persons acting on behalf of Covenant Health. Responsibility Health care professionals shall demonstrate compliance with this policy, procedure and legislative requirements. The Accountable Leader of the site is accountable for: all matters related to controlled substances as per the regulations governing narcotic and controlled substances; delegating the responsibilities of purchasing, receipt of drug deliveries, inventory control and distribution to the Manager of Pharmacy/Site Pharmacist/Contract Provider; and delegating the responsibilities of secure storage on patient/resident care units, access to the secure storage, inventory on patient/resident care units and administration to the Unit Administrator. Principles Controlled substances are regulated by the Controlled Drugs and Substances Act and are under the control of the Office of Controlled Substances Division of Health Canada. * 1 All references to patients in this document are meant to be inclusive of patients, residents and clients.
VII-B-245 Page 2 of 11 Procedure 1. STORAGE AND KEYS 1.1 Controlled substances shall be kept in a designated locked storage cabinet in all patient care areas. Exception: When a controlled substance is in the possession of a patient/family member or health care professional while accompanying a patient to other departments/hospitals/facilities for tests or procedures. 1.1.2 Controlled substances dispensed by Pharmacy as pass medications shall be kept in a secure storage area as per 1.1 above until the patient leaves on pass. 1.1.3 Controlled substances that require refrigeration will be stored securely with a lock. 1.2 The key used to access controlled substance cupboards/drawers must be secured or shall be in the possession of a health care professional at all times. 1.2.1 The controlled substances key and patient controlled analgesia (PCA) pump keys shall be kept separate from one another and from other keys. 1.2.2 The health care professional in charge is responsible for the key and consequently for the contents in locked storage during their shift. The health care professional may delegate this responsibility only to another health care profession. 1.2.3 The unit administrator or delegate is responsible for ensuring that only health care professionals have access to the controlled substances key and that end of shift counts are completed per policy. 1.2.4 The unit administrator or delegate is responsible to ensure staff who have Identification (ID) access cards to access controlled substance do not share their ID access cards with any other staff. 1.3 Lost keys or ID access cards are immediately communicated to the appropriate management personnel. 1.3.1 The health care professional in charge is responsible for ensuring that security of contents is maintained until the lock can be changed. 1. 3.2 The appropriate unit administrator or designate must be notified. 1. 3.3 The health care professional in charge or delegate shall sign for and receive a new lock and key.
VII-B-245 Page 3 of 11 1.3.4 If the missing key reappears, it must be returned to Facilities Management/Physical Plant as soon as possible for disposal. Exception: Controlled substance cabinets which have a locking Medeco key mechanism will not need to be replaced if key is found as they cannot be duplicated. Lost or missing Medeco key must still be reported as stated in the policy. 1.4 Controlled substances may be stored in automated dispensing cabinets (example: Pyxis). 1.4.1 The health care professional in charge is responsible to investigate count discrepancies in locked storage in the automated dispensing cabinets (refer to Section 4). The health care professional may delegate this responsibility only to another health care professional. 1.5 Once a dose of controlled substance has been removed from locked storage, the medication must remain in the possession of the health care professional until administered. Any amount not immediately administered from a single use dosage form must be wasted and properly documented according to the policy and procedure. Exception: Controlled substances removed for a patient to be administered while out on pass or temporary transfer to another care provider. 2. RECORD OF CONTROLLED SUBSTANCES ADMINISTRATION 2.1 For each dose of a controlled substance withdrawn from the storage area, the following information must be recorded on the daily record of controlled substance administration, or automated dispensing cabinet record as outlined below: patient name drug name, dosage form, and quantity removed drug quantity remaining date and time of withdrawal prescribing physician, and signature/electronic ID of the qualified staff member who withdrew the dose from the storage area initials may be used provided a signature log is maintained 2.2 When a controlled substance has been administered by a health care professional while accompanying patients going to other departments / hospitals/facilities for tests or procedures, the record of administration will be completed as soon as possible on their return. Any unused controlled substances are to be wasted into a sharps/biohazard container and witnessed as such by another health care professional.
VII-B-245 Page 4 of 11 3. WASTAGE 3.1 Two health care professional signatures or initials (provided a signature log is maintained), both of which is a witness to the destruction, are required for all wastage (including breakage and partially used ampoules, tablets, IV bags or syringes) of controlled substances. See Policy/Procedure regarding Automated Medication Distribution, for wastage in automated dispensing cabinets. Exception: 1. If there are not two health care professionals available, the wastage may be witnessed by another staff member. That staff member must sign that they witnessed the destruction. 2. Used narcotic patches are to be disposed of in a sharps/biohazard container and do not require a witness. 3.2 All wastage must be disposed in the sharps/ biohazard containers in a manner that prevents the drugs from being recovered. Do not pour any wastage into the sink or toilet. 4. DISCREPANCIES: COUNTING AND REPORTING 4.1 For patient care units where controlled substances are not stored in automated dispensing cabinets: 4.1.1 A perpetual inventory (e.g. Record of Controlled Substances Drug Administration Log) of all controlled substances shall be kept. 4.1.2 At minimum, when authority is transferred (at staff changes) all balances of controlled substances shall be verified by two qualified staff via physical count. Unless physically impossible, the health care professional shall be one from the incoming shift and one from the outgoing shift. Both staff members must verify and sign the daily Record of Controlled Substance Drug Administration Log by: 1. Reviewing that all controlled substances removed from storage since the last count is accurately and completely documented. This includes confirming that the quantities deducted from the perpetual inventory are consistent with the dose administered, that any wastage has been cosigned as being witnessed, that balance totals brought forward to new sheets are accurate and that all the information ( as outlined in Section 2.1) is complete.
VII-B-245 Page 5 of 11 2. Both health care professionals must visually examine the actual controlled substance products and verify the amount remaining is correct. 3. Both health care professionals must verify the correct counts of controlled substances are recorded on the Record of Controlled Substances Drug Administration Log. If a discrepancy occurs a recount must be performed. Refer to 4.3 if discrepancy remains. 4.2 For patient care units where controlled substances are stored in automated dispensing cabinets. See policy/procedure regarding, Automated Medication Distribution, for count verification procedures. 4.3 For all patient care units where controlled substances are stored, the nurse in charge shall ensure that all inventory discrepancies are resolved. The Charge Nurse must verify the count if discrepancy remains. All staff must remain on unit until loss is recovered or all charts, administrations and documentations are verified. 4.3.1 For any controlled substances that have not been accounted for before authority is transferred, including those in an automated dispensing cabinet, a Controlled Drug and Controlled Substances Discrepancy Resolution Report (Appendix 1) shall be completed and forwarded to the unit administrator. Further investigation may be required dependant on the type of discrepancy. Refer to the Pyxis User Manual for the discrepancy resolution procedure for automated dispensing cabinets. Exception: A discrepancy directly involving a patient who has been reported through the incident reporting system (RLS) need not be reported via the Narcotic and Controlled Substance Discrepancy Reporting Form. 4.3.2 For bulk oral liquids, an unexplained discrepancy of 10% or less of the original volume is allowed. 4.3.3 The unit administrator shall conduct a thorough investigation of all discrepancy incidents, and identify any recurring trends. Trends in narcotic or controlled substance discrepancies will be reported to senior leadership and appropriate investigation and action plans will be implemented. 4.3.4 The theft or suspected theft of controlled substances shall be immediately reported to Protective Services and Pharmacy Services by the person who discovers the alleged theft. 4.3.5 The unit administrator shall complete the Health Canada Loss or Theft Report Form for Controlled Substances and Precursors (Appendix 2)
VII-B-245 Page 6 of 11 and forward to Health Canada for any unexplained loss or any theft or suspected theft of a narcotic within ten days of discovery thereof. The unit administrator will forward a copy to Pharmacy Services for informational purposes. 5. TRANSFER, DELIVERY AND RECEIPT 5.1 When transferring controlled substances from one area inventory to another in the same site, a unit health care professional or a Pharmacy technician/assistant must deduct the amount transferred from the inventory (Record of Controlled Substances Drug Administration Log) of the area sending the controlled substance and the same individual must add the amount received to the inventory of the area receiving the controlled substance. 5.2 Two health care professional members signatures, one from the transferring unit and one from the receiving unit are required on each Record of Controlled Substances Drug Administration Log when transferring controlled substance products between units in the same site. For procedure when borrowing from an automated dispensing cabinet, see Policy/Procedure regarding Automated Medication Distribution or Pyxis Manual. 5.3 Controlled substances transported within the site must be transported in a secure and safe manner. Examples include the use of a locked delivery cart; use of an opaque container; ensuring delivery container is in the staff member s possession at all times. 5.4 Only health care professionals may requisition and/or pick up controlled substances from Pharmacy. When picking up medications from Pharmacy, staff must present Hospital ID and Pharmacy staff must verify the ID prior to release of the medications. 5.5 Only health care professionals and pharmacy personnel may deliver controlled substances within the hospital. 5.6 A form of secured mechanical transportation is permitted to deliver controlled substances within the same site (i.e. tube system with security features such as password access). 5.7 Requests received by a patient care unit from another site to borrow controlled substances must be referred to the Pharmacy department. The Pharmacy department will follow their internal operational process. 6. PATIENT SPECIFIC NARCOTIC (PSN) Note: PSN does not apply when a patient care area has an approved Required Organizational Practice
VII-B-245 Page 7 of 11 6.1 PSN is a restricted narcotic that is required for the care of a specific patient while they are admitted, but will not be routinely stocked in patient care areas. 6.2 PSN include by are not limited to the following items: 6.2.1 High potency narcotics restricted: HYDROmorphone 10mg/mL HYDROmorphone 50mg/mL morphine 50mg/mL 6.2.2 Narcotics restricted by Health Canada: methadone all strengths and forms used for the treatment of addiction 6.2.3 Non-formulary and/or restricted narcotics (e.g. meperidine as per provincial formulary restrictions). 6.2.4 Patients own narcotic medications following approval by pharmacy. 6.2.5 Patient specific narcotic epidural infusions 6.3 Pharmacy will label the product directly with: Computer generated patient label Please return to Pharmacy when Discontinued label Appropriate auxiliary labels 6.4 PSNs will be recorded on a Patient Specific Narcotic and Controlled Drug record. (Appendix 3). 6.4.1 On delivery to the unit, in RED ink, enter the date (dd/mm/yy), and time of delivery (delivery from pharmacy). 6.4.2 Locate the column at the top of the record for the correct patient. If it is a new patient, enter patient and PSN being delivered. 6.4.3 At the intersection of the row and column, enter the amount being provided and the new total (e.g. 10/19). Pharmacy staff will then sign in 6.4.4 On receipt, nursing staff will confirm the patient name, PSN, strength and quantity as entered by pharmacy. Nursing will physically confirm this information with the product being delivered, then sign in the Nursing signature column. Store these narcotics in designated PSN storage bins. 6.4.5 PSN storage area is to be labelled with: High Alert Medication labels CAUTION High Potency Medication Confirm Dose label
6.5 Nursing Procedures: VII-B-245 Page 8 of 11 6.5.1 On receipt from Pharmacy, a patient care unit health care professional will confirm patient name, PSN name, strength, and quantity as entered by pharmacy. 6.5.2 Physically confirm all of this information with the product being delivered. 6.5.3 Patient care unit health care professional will sign in the Nursing signature column on the Patient Specific Narcotic and Controlled Drug Record sheet. 6.5.4 On administration, in BLACK ink, enter the date (dd/mm/yy), time, patient name, ordering physician, and dose being administered. 6.5.5 Locate the column along the top of the record for the correct patient. 6.5.6 At the intersection of the row and column, indicate the remaining balance of the PSN, then sign in the Nursing Signature column. 6.5.7 Wastage can be indicated in the wastage column if a partial tablet/ ampoule/vial is being administered. 6.5.8 Signature of a witness is required. 6.6 When no longer required, the patient specific narcotic will be removed by Pharmacy. 7 DISCHARGED PATIENTS 7.1 Controlled substances stored on patient care areas (inpatient and outpatient), including Emergency Departments, are NOT to be given to discharged patients (except where indicated in 7.1.3 below). 7.1.1 For patients being transferred to continuing care beds, including subacute and hospice beds, a sufficient supply of controlled substances may be provided by pharmacy to last until the receiving facility s supply can be accessed. Consult Policy/Procedure regarding Patient Transfers to Continuing Care Beds, if applicable. 7.1.2 Pharmacy, or a unit health care professional when pharmacy is not available, may dispense a maximum 72 hour bridging supply of controlled substances for patients discharged to communities without a supply of the drug, provided the requirements of the Bridge Supply of Medication for Discharged Patients policy are met;
VII-B-245 Page 9 of 11 7.1.2.1 The controlled substances must be properly labelled. The label shall have the patient s name, physician s name, quantity of drug and the administration directions. 7.1.3 Emergency Departments and some outpatient clinics may give discharge patients the following controlled substances which are available pre-packaged by Pharmacy under the following circumstances: codeine 30 mg with acetaminophen 325mg oxycodone 5 mg with acetaminophen 325mg 7.1.3.1 Pre-packaged controlled substances may be dispensed to patients following discharge when a community pharmacy is not available or accessible to the patient. 7.1.3.2 Each patient is limited to only one pre-packaged controlled substance per Emergency Department/outpatient clinic visit. 7.1.3.3 The controlled substances are pre-packaged by Pharmacy and properly labelled including a warning about the danger to children. The label shall have space for the dispensing nurse to add the patient s name, physician s name, administration directions, date and his/her initials. 7.1.3.4 Pre-packaged medication will contain a maximum of six tablets/capsules. 7.1.3. 5 The dispensing health care professional is responsible for placing the packaged controlled substances into child resistant container. 7.2 With the exception of section 7.1.2 above, any discharge medication requiring a triplicate prescription in the community is the responsibility of the attending physician. 8. COCAINE and METHADONE 8.1 Cocaine 8.1.1 When possible, cocaine shall be dispensed in the smallest practical quantity required for administration, in unit dose containers. 8.2 Methadone 8.2.1 Only those physicians who are registered with the Health Canada Office of Controlled Substances may prescribe, change, or reorder orders for methadone, including orders to use a patient s own supply.
VII-B-245 Page 10 of 11 8.2.1.1 Should there not be a physician available with prescribing privileges, the attending physician may apply to Health Canada (613-946-5139) for temporary privileges. 8.2.2 Pharmacy will prepare methadone in the appropriate dose and dosage form according to the indication upon a signed order from a registered prescriber. 8.2.3 All solid dosage forms will be secured in a locked cupboard or automated dispensing cabinet. All administrations and wastage must be recorded as per sections 2, 3 and 4 of this procedure. 8.2.4 Liquid methadone preparations for patients in a dependency program will be prepared and issued by pharmacy in a patient specific format to the patient care unit. 8. 2.4.1 The methadone product must be consumed in the presence of a qualified staff member. 8.2.5 Patient specific methadone preparations, including those dispensed to patient care areas with automated dispensing cabinets must be secured in a locked cupboard and returned to Pharmacy as soon as possible upon discontinuation of the methadone or discharge of the patient. 8. 2.5.1 Exchange of patient specific oral methadone solutions between patients and/or patient care areas are prohibited. Definitions Controlled substances - refers to any substance included in Schedule I, II or III of the Controlled Drugs and Substances Act as amended or repealed from time to time or those drugs deemed by the employer to be handled like a controlled substance at the patient care unit, site, or regional level. Schedules can be found on-line http://lawslois.justice.gc.ca/eng/acts/c-38.8/page-24.html#doccont Key - may include electronic means of opening locked storage areas. If the electronic key is assigned to a specific staff members (i.e. via their staff ID badge) and the access to the locked storage area can be traced back to the specific staff member, the requirement for a single key to a locked storage area does not apply. Health care professional means an individual who is a member of a regulated health discipline, as defined by the Health Disciplines Act [Alberta] or the Health Professions Act [Alberta], and who practices within scope and role. Signature - implies hand written, or an electronic signature. Unit administrator -means the out of scope person responsible for the daily operations of the patient care unit. Related Documents Appendix 1 Narcotic and Controlled Substances Discrepancy Reporting Form Appendix 2 Loss or Theft Report Form for Controlled Substances and Precursors Appendix 3 Patient specific Narcotic and Controlled Drug record
VII-B-245 Page 11 of 11 Covenant Health Policies/Procedures: VII-A-30, High Alert Medications VII-A-40, Management of High Alert Medications: High Potency Narcotics VII-B-125, Medication Orders VII-A-50, Medication Administration VII-B-40, Pro Re Nata (PRN) Medication VII-B-120, Bridge Supply of Medication for Discharged Patients III-55, Records Management Medications for Residence on Pass to Family and Community Continuing Care Manual (corporate policy in development) VII-A-55, Automated Dispensing Machines (ADM. Pyxis ) Patients Own Medications (corporate policy in development) I-35, Identification Cards References Bureau of Dangerous Drugs, Canadian Hospital Association, Canadian Nurses Association, Canadian Society of Hospital Pharmacists. Guidelines for the Secure Distribution of Narcotic and controlled Drugs in Hospitals. January 1990. Revisions March 11, 2013 Pharmacy Services procedure VIII-10 Patient Specific Narcotics. April 2015.
Appendix #1 Discrepancy Resolution Report (Attach all related hard copy documentation) Site Tracking #: Site: Date: Report Completed By: Signature: Witness Signature: Discrepancy Resolved: Drug Description (i.e.name, strength, dosage form): Discrepancy Unresolved: (notify Pharmacy Manager) Physical Count (A): Recorded Stock on hand (B) Computer Count (C): Discrepancy (when A,B or C are not all equal) Cause of Discrepancy: Explanation of Error: Count Adjusted (check one): Manual Records Computer Records Date pharmacy management notified of unresolved discrepancy: Pharmacy Management Investigation Discrepancy Resolved: Yes No Explanation: Loss or Theft Report Form Completed and Submitted to Health Canada: Date Loss/Theft Report Completed: Pharmacy Manager Signature: Yes No
Health Canada Santé Canada Protected A when completed Protégé A une fois rempli Loss or Theft Report Form for Controlled Substances and Precursors Rapport de pertes ou de vols des substances contrôlées et précurseurs Office of Controlled Substances Bureau des substances contrôlées File No. - N o de dossier Name Nom Date y/a y/a y/a y/a m m d/j d/j Street Rue City Ville Province Postal Code Code postal Telephone number Numéro de téléphone Pharmacy Hospital Practitioner Licensed Dealer Licence Number: Pharmacie Hôpital Practicien Distributeur autorisé Numéro de licence : ( ) Registered Dealer Registration Number: Other (specify) Distributeur inscrit Numéro d inscription : Autre (préciser) Type of Loss Type de perte Break and entry Pilferage Loss unexplained Armed Robbery Grab theft Loss in transit Vol par effraction Chapardage Perte inexpliquée Vol à main armée Vol à la sauvette Perte durant le transport Other (specify) Autre (préciser) Has this been reported to the police? Cette perte a-t-elle été signalée à la police? Yes No Oui Non Date y/a y/a y/a y/a m m d/j d/j Details of loss or theft discovery: Details de la découverte de la perte ou du vol : Name of police service Nom du corps policier Incident number Numéro de l incident Name of investigating officer Nom du policier responsable de l investigation Telephone Number Numéro de téléphone ( ) See Attachment voir pièce-jointe Description of physical security measures in place (Not applicable for licensed dealers of controlled substances) Description des mesures de sécurité physique en place (Ne s applique pas aux distributeurs autorisés des substances contrôlées) See Attachment voir pièce-jointe Description of security measures put in place to prevent future loss or theft Description des mesures de sécurité mis en place pour prevenir une perte ou un vol future See Attachment voir pièce-jointe For loss in transit Lors d une perte durant le transport Investigation Report Received Yes No Name of transport company Nom de la compagnie de transport Le rapport de l enquête reçu Oui Non List of controlled substances precursors lost or stolen Liste des substances contrôlées précurseurs perdus ou volés Brand name and unit strength. If no brand name exists, the generic or other product name La marque nominative de la substance et sa force par unité. En l absence de cette marque, son nom générique ou autre nom du produit Dosage form if applicable Forme posologique s il y a lieu Quantity Quantité Brand name and unit strength. If no brand name exists, the generic or other product name La marque nominative de la substance et sa force par unité. En l absence de cette marque, son nom générique ou autre nom du produit Dosage form if applicable Forme posologique s il y a lieu Quantity Quantité *Please indicate if a separate page is attached Veuillez indiquez s il y a une pièce-jointe Attachment Yes No Pièce-jointe Oui Non Name and title of official individual reporting loss or theft (printed) Nom et titre du responsable qui rapporte la perte ou le vol (en caractère d imprimerie) License or permit number for a practitioner or pharmacist Numéro de licence ou de permis pour un practicien ou un pharmacien Signature Date y/a y/a y/a y/a m m d/j d/j Submit to Soumettre à Health Canada Santé Canada Office of Controlled Substances Bureau des substances contrôlées Compliance, Monitoring & Liaison Division Division de la conformité, surveillance et liaison A.L./I.A. 3502B Ottawa, ON K1A 1B9 Tel./Tél. : (613) 954-1541 Fax: (613) 957-0110 HC/SC 4010 (08-2005 Revised Révisé)