Controlled Drugs and Substances in Hospitals and ... Publications... · Controlled substances...
34
CSHP Diversion Guideline – Draft for Public Consultation 1 Controlled Drugs and Substances in Hospitals and Healthcare Facilities: Guidelines on Secure Management and Diversion Prevention © Canadian Society of Hospital Pharmacists, 2018 This document is a draft for public consultation and is being distributed without warranty of any kind. You may use, reproduce, redistribute, and share the link to this document only for the purpose of providing feedback on this document.
Transcript of Controlled Drugs and Substances in Hospitals and ... Publications... · Controlled substances...
CSHP Diversion Guideline – Draft for Public Consultation 1
Controlled Drugs and Substances in Hospitals and Healthcare Facilities: Guidelines on Secure Management and Diversion Prevention
© Canadian Society of Hospital Pharmacists, 2018
This document is a draft for public consultation and is being distributed without warranty of any kind.
You may use, reproduce, redistribute, and share the link to this document only for the purpose of
providing feedback on this document.
CSHP Diversion Guideline – Draft for Public Consultation 2
Table of Contents Introduction .................................................................................................................................................. 4
1 Scope ..................................................................................................................................................... 5
2 Overview of Requirements ................................................................................................................... 5
3 Organizational Accountability ............................................................................................................... 6
4 Quality Management and Control ........................................................................................................ 8
5 Inventory Management ........................................................................................................................ 9
5.1 Determining Inventory Requirements .......................................................................................... 9
5.2 Procurement ............................................................................................................................... 10
5.2.1 Manual Procurement Process ............................................................................................. 11
5.2.2 Electronic Procurement Process ......................................................................................... 11
5.3 Receipt ........................................................................................................................................ 11
5.3.1 Receiving Department ........................................................................................................ 12
5.3.2 Pharmacy Department ........................................................................................................ 13
5.4 Storage in the Pharmacy Department ........................................................................................ 14
5.5 Considerations for Special Patient Care Areas ............................................................................ 14
5.5.1 Operating Room, Other Anesthetizing Locations, Labour and Delivery Room .................. 15
5.5.2 Special Clinics ...................................................................................................................... 15
5.5.3 Emergency Department ...................................................................................................... 15
5.5.4 Remote Clinics ..................................................................................................................... 16
5.5.5 Pre-hospital Care ................................................................................................................. 16
5.5.6 Long-term Care ................................................................................................................... 16
6 Preparation, Dispensing, and Distribution .......................................................................................... 16
6.1 Pharmacy .................................................................................................................................... 16
6.2 From Pharmacy to Patient Care Area ......................................................................................... 17
6.3 Patient Care Area ........................................................................................................................ 19
6.3.1 Storage ................................................................................................................................ 19
6.3.2 Access .................................................................................................................................. 19
6.3.3 Reconciliation ...................................................................................................................... 19
6.4 Automated Dispensing Cabinets ................................................................................................. 20
6.5 Considerations for Special Patient Care Areas ............................................................................ 20
6.5.1 Operating Room, Other Anesthetizing Locations, Labour and Delivery Room .................. 20
6.5.2 Special Clinics ...................................................................................................................... 21
CSHP Diversion Guideline – Draft for Public Consultation 3
7 Prescribing........................................................................................................................................... 21
7.1 Prescription pads ........................................................................................................................ 21
8 Administration to Patient ................................................................................................................... 21
8.1 Considerations for Special Patient Care Areas ............................................................................ 23
8.1.1 Operating Room, Other Anesthetizing Locations, Labour and Delivery Room .................. 23
9 Waste and Disposal of Unusable Drugs .............................................................................................. 23
9.1 Considerations for Special Patient Care Areas ............................................................................ 26
9.1.1 Operating Room, Other Anesthetizing Locations, Labour and Delivery Room .................. 26
10 Identifying Diversion ....................................................................................................................... 26
10.1 Examples of Diversion ................................................................................................................. 27
10.2 Record-keeping and Audits ......................................................................................................... 28
10.2.1 Pharmacy ............................................................................................................................ 28
10.2.2 Patient Care Area ................................................................................................................ 29
10.3 Physical Counts ........................................................................................................................... 30
11 Investigating Diversion .................................................................................................................... 31
11.1 Reporting Suspected Diversion ................................................................................................... 31
11.2 Investigation of Suspected Diversion .......................................................................................... 31
11.3 Guidelines for Conducting a Diversion Investigation .................................................................. 32
11.4 Interview of Suspected Diverter ................................................................................................. 32
11.5 Response to Confirmed Diversion .............................................................................................. 33
12 Glossary ........................................................................................................................................... 33
Acknowledgements ..................................................................................................................................... 34
CSHP Diversion Guideline – Draft for Public Consultation 4
Introduction Controlled substances provide valuable treatments for many patients across the healthcare system, and
are therefore commonly used in nearly every type of healthcare facility within Canada. Regrettably, this
common usage increases the potential for misuse or diversion by healthcare workers who have access
to these drugs in their work environment. Such diversion puts patient safety, staff safety, and public
health at risk.
Around the world, healthcare leaders are beginning to think differently about diversion of controlled
substances from healthcare facilities. Rather than denying or minimizing the problem, they recognize
that it is common and often preventable. Some guidelines1 now stress the importance of having a
dedicated diversion prevention committee – a multidisciplinary group focused on creating policies,
educating staff, encouraging reporting, investigating incidents, analyzing trends in the data, and
improving the system accordingly.
Lessons can be learned from the subject of medication errors and medication safety, where healthcare
workers have moved from a culture of denial, finger-pointing, and individual blame, to a culture of
shared responsibility, universal reporting, and system improvement.
This document aims to provide Canadian healthcare facilities with advice and guidance on how to
develop a system to prevent, detect, and respond to diversion of controlled substances, and how to
continuously improve that system.
The guideline was published as one of CSHP’s commitments under the Joint Statement of Action to
Address the Opioid Crisis2 with the collaboration of many valued partners who are all responding to an
opioid crisis of unprecedented proportions.3,4 Across Canada, there is increased attention on the harms
of controlled substances, and new clinical practice guidelines are suggesting more conservative use.5
The concept of opioid stewardship,6 or coordinated interventions to improve the use of opioids, is
beginning to be recognized. Much of this important work is outside the scope of these guidelines.
1 Brummond PW, Chen DF, Churchill WW, et al. ASHP Guidelines on Preventing Diversion of Controlled Substances American Journal of Health-System Pharmacy March 2017, 74 (5) 325-348; DOI: https://doi.org/10.2146/ajhp160919 2 Joint Statement of Action to Address the Opioid Crisis. Health Canada, 2016. Accessed: July 5, 2018. Available from: https://www.canada.ca/en/health-canada/services/substance-abuse/opioid-conference/joint-statement-action-address-opioid-crisis.html 3 Responding to Canada’s opioid crisis. Health Canada, 2018. Accessed: July 5, 2018. Available from: https://www.canada.ca/en/health-canada/services/substance-abuse/prescription-drug-abuse/opioids/responding-canada-opioid-crisis.html 4 Opioids in Canada. Canadian Institute for Health Information, 2018. Accessed: July 5, 2018. Available from: https://www.cihi.ca/en/opioids-in-canada 5 Busse JW, Craigie S, Juurlink D, et al. Guideline for opioid therapy and chronic noncancer pain. CMAJ. 2017, 189 (18), E659-E666; DOI: https://doi.org/10.1503/cmaj.170363. 6 Opioid Stewardship. Institute for Safe Medication Practices Canada, 2018. Accessed: July 5, 2018. Available from: https://www.ismp-canada.org/opioid_stewardship/
CSHP Diversion Guideline – Draft for Public Consultation 5
1 Scope These guidelines apply to all staff who handle or administer controlled substances in any Canadian
healthcare facility.
This document replaces Guidelines for the Secure Distribution of Narcotic and Controlled Drugs in
Hospitals, published by Health Canada through the Bureau of Dangerous Drugs in 1990. However, this is
not a Health Canada publication and adherence to these guidelines is strictly voluntary.
The document aims to provide practical guidance on best practices in managing controlled substances
within a healthcare facility, and is intended to complement all relevant legislation
(federal/provincial/territorial), accepted patient safety practices, and the facility’s own policies and
procedures. These guidelines should not be used as justification to deviate from practice that is
authorized or required by law.
In general, mandatory requirements that are found in legislation, regulation, accreditation standards, or
professional regulatory authority requirements are so noted by use of the term shall, whereas best
practices or recommendations use the term should.
Sections 2 to 4 discuss fundamental principles in the management of controlled substances, including
the importance of implementing a dedicated, multidisciplinary, diversion prevention committee.
Diversion prevention is a shared responsibility and final accountability rests with the person in charge of
the facility. A quality management approach should be taken, and responsibilities and accountabilities
across the medication-use system should be clearly defined in policy.
Sections 5 to 9 focus on prevention. These sections follow a controlled substance as it moves through
the facility, from procurement to disposal. Strategies to minimize potential diversion at each step should
be designed so as not to adversely affect drug availability. General principles and procedures are
described, which apply to all practitioners in all areas of the facility. Where there are special
considerations for specific areas, these are noted at the end of each section.
Sections 10 and 11 focus on how to identify diversion, including common examples of diversion, and
how to investigate and report diversion when it does occur.
2 Overview of Requirements Everyone concerned with the management of controlled substances should understand the relevant:
regulatory requirements;
accreditation requirements; and
professional requirements.
Federal regulations define responsibilities and requirements regarding the receipt and distribution of
controlled substances. Controlled substances are regulated under the Controlled Drugs and Substances
Act (CDSA) and its regulations,7 federal statutes administered by the Office of Controlled Substances of
Health Canada. Regulations made under the CDSA include Access to Cannabis for Medical Purposes
7 Controlled Drugs and Substances Act. S.C. 1996, c. 19 (Current to May 9, 2018). Available from: http://laws-lois.justice.gc.ca/eng/acts/C-38.8/
CSHP Diversion Guideline – Draft for Public Consultation 6
Regulations (ACMPR),8 Benzodiazepines and Other Targeted Substances Regulations,9 Narcotic Control
Regulations (NCR),10 and others.
Provincial and territorial regulations govern the delivery of healthcare. This includes the operation of
hospitals, pharmacies, and other healthcare facilities, as well as the services provided by healthcare
professionals. These regulations differ across Canada and must be consulted individually.
Accreditation Canada assesses healthcare facilities against standards developed by Health Standards
Organization (HSO). According to HSO’s Medication Management Standard, facilities must have security
processes in place for controlled substances, including “monitoring withdrawals, wastage, and
administration of controlled substances to identify signs of abuse and diversion, as well as analyzing,
documenting, and reporting such situations.”11
Beyond regulatory and accreditation requirements, all regulated health professionals have standards of
practice that must be met. Provincial and territorial regulatory authorities for each profession are
responsible for setting standards of practice and codes of ethics for that profession. Regulatory
authorities license health professionals and ensure that members of the profession meet the standards
of practice and any other ongoing requirements for licensure. In some jurisdictions, the pharmacy
regulatory authority also licences hospital pharmacies.
3 Organizational Accountability
According to the federal regulations governing controlled substances, the person in charge of a hospital
(administrator) is held accountable for matters related to these drugs within that institution.12 Specific
responsibilities may be delegated to others at an operational level. The level of delegation, specified
areas of responsibility, and the principles upon which procedures are developed should be defined in
the institution’s formal policy.
Although the pharmacy department has responsibility for all procurement, receipt, initial storage, and
distribution of controlled substances to patient care areas, management of controlled substances
8 Access to Cannabis for Medical Purposes Regulations. SOR/2016-230 (Current to June 20, 2018). Available from: http://laws-lois.justice.gc.ca/eng/regulations/SOR-2016-230/index.html 9 Benzodiazepines and Other Targeted Substances Regulations. SOR/2000-217 (Current to June 20, 2018). Available from: http://laws-lois.justice.gc.ca/eng/regulations/SOR-2000-217/index.html 10 Narcotic Control Regulations. C.R.C., c. 1041 (Current to June 20, 2018). Available from: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._1041/index.html 11 Medication Management (Draft for Public Review). Health Standards Organization, 2018. 12 Controlled Drugs and Substances Act. S.C. 1996, c. 19 (Current to May 9, 2018). Available from: http://laws-lois.justice.gc.ca/eng/acts/C-38.8/
Within any healthcare facility, no single department holds accountability for controlled
substances. It is a shared responsibility, and all departments should understand their role in
managing controlled substances. Federal regulations place final accountability on the “person in
charge of a hospital” – in other words, those at the highest level of the organization are ultimately
responsible for preventing diversion.
CSHP Diversion Guideline – Draft for Public Consultation 7
extends far beyond the pharmacy department. It is important that responsibility and accountability of all
persons who have access to controlled substances be clearly articulated in organizational policy.
For each healthcare facility or organization, an interdisciplinary committee shall have policies to oversee
the security of all controlled substances.13 This committee is often the Pharmacy and Therapeutics
Committee, a medication safety committee, or other body that oversees management of medications in
the facility. It is increasingly recognized that facilities should have a comprehensive diversion prevention
framework, with a dedicated diversion prevention committee and at least one staff member who is a
diversion prevention specialist.14,15,16
The diversion prevention committee should be responsible for:
ensuring that the facility complies with all regulations and standards;
developing and reviewing facility policies to ensure safe handling of controlled substances;
educating staff on policies, standards, and legislation;
educating staff on substance use disorder, signs of diversion, and how to report;
ensuring that incident reports can be easily made at any time;
ensuring that reporting to Health Canada and the professional regulatory authorities is
completed promptly as described in Reporting Suspected Diversion;
regularly reviewing incident reports, in order to identify data trends and make policy
adjustments; and
promoting a culture of shared responsibility and system improvement.
The diversion prevention committee should be responsible for ensuring that there is a diversion
response team to investigate incidents promptly. The diversion response team may be the committee
itself, a subset of the committee, committee members by rotation, the diversion specialist with other
assistants as needed, or some other arrangement.
Diversion prevention committees or diversion response teams could be part of existing interdisciplinary
committees (such as the Pharmacy and Therapeutics Committee). However, the NCR places
accountability for controlled substances on the person in charge of a hospital. Therefore, the committee
should report to the senior leadership of the facility.
Suggested committee membership includes staff from the following departments: pharmacy, nursing,
medicine, anesthesia, security, facilities management, human resources, risk management, legal,
information management/technology, and employee health.17
Successful implementation of an effective program for secure distribution and diversion prevention
requires commitment at all levels of the organizational structure. The commitment and accountability of
13 Medication Management (Draft for Public Review). Health Standards Organization, 2018. 14 ASHP Guidelines on Preventing Diversion of Controlled Substances. Am J Health-Syst Pharm. 2017; 74:e10-33. 15 Controlled drugs: safe use and management. National Institute for Health and Care Excellence, 2016. Accessed: July 7, 2018. Available from: https://www.nice.org.uk/guidance/ng46 16 New K and Burke J. Diversion by Healthcare Personnel 101. International Health Facility Diversion Association. Accessed: July 7, 2018. Available from: https://ihfda.org/wp-content/uploads/presentations/IHFDA-Webinar-4-11-16.pdf 17 ASHP Guidelines on Preventing Diversion of Controlled Substances. Am J Health-Syst Pharm. 2017; 74:e10-33.
CSHP Diversion Guideline – Draft for Public Consultation 8
those at the highest levels is reflected in the policies and procedures established within the facility or
organization.
4 Quality Management and Control Despite best efforts to implement systems designed to prevent, detect, and respond to drug diversion,
processes will always be limited by current knowledge and technology. Therefore, it is essential to
incorporate continuous quality improvement processes into medication management systems.
Generally, quality control can be exerted at the administrative (and regulatory compliance) level,
through organizational processes, and at the provider level.18 Change control should also be defined and
implemented, to ensure that changes to the system are introduced and managed in a systematic fashion
without unwanted consequences.
Fundamental principles for the secure management of controlled substances include the following:
A continuous quality improvement approach is taken.
Controlled drugs and substances are securely stored and handled throughout the distribution
system, from the point of ordering to the time of administration or destruction.
Quantities of controlled drugs and substances are kept to a minimum of what is needed based
on the patient population and degree of urgency.
All staff who handle a controlled drug or substance have the authority given to them through
the CDSA, either directly (e.g., pharmacists, practitioners, or hospital administrators) or
indirectly (via the hospital administrator).
Segregation of duties is implemented for critical functions such as procurement, receiving, and
distribution.
Only authorized staff prescribe or administer controlled substances.
Controlled substances are stored in restricted areas, such as locked rooms, carts, or fridges.
Authorized staff do not share keys, passwords, or other means of ordering or accessing a
controlled drug or substance. Passwords are changed frequently according to facility policies.
Accurate and complete records of all transactions involving a controlled drug or substance are
maintained in a timely manner. This includes record keeping at the points of ordering, receipt,
prescribing, dispensing or issuing, administration, and destruction.
All staff check for completeness and accuracy of the records they are responsible for, and
immediately resolve any discrepancies.
All staff inspect the integrity of the controlled drug or substance (as required to safely execute
their responsibilities).
Everyone who orders or handles a controlled drug or substance has a responsibility to ensure
the safety and security of the system. All staff should pay attention to signals, report incidents,
and be authorized to “stop the line” (i.e., speak up and immediately halt processes if they see a
safety risk).
Creative compliance with the regulatory framework is not tolerated.
18 ASHP Guidelines on Preventing Diversion of Controlled Substances. Am J Health-Syst Pharm. 2017; 74:e10-33.
CSHP Diversion Guideline – Draft for Public Consultation 9
Before establishing performance indicators and the standard reports to be monitored, the management
processes for controlled substances should be mapped. When the potential for diversion or actual
diversion is identified, the steps, participants, documentation, and hand-offs should be assessed for
weaknesses in the system and auditing plans established. Facilities can conduct a risk assessment based
on usage, discrepancies, frequency of staff turnover, and other data from reported incidents.19
Key performance indicators (KPIs) related to controlled drug diversion should be defined by each
organization and reported regularly. These may include:
• physical security audits of all areas where controlled substances are stored;
• process audits by internal audit services;
• number of unresolved controlled drug discrepancies by patient care area;
• completion accuracy rate of paper-based documents by patient care area;
• number of loss or theft reports to Health Canada by facility;
• number of instances of confirmed diversion and resulting actions; and
• number of instances of confirmed diversion resulting in patient harm.
Based on these indicators and results of associated investigations (and results of root cause analyses,
where appropriate), relevant changes should be made to the controlled substance management system
to address identified gaps.
5 Inventory Management Key principles of successful inventory management include keeping stock secure at all times,
maintaining accountability and sign-offs at all transition points, and checking for completeness of the
order and integrity of the product at all transition points. Procurement, receipt, backorder management,
distribution, physical counts, and audits should be conducted by different staff members to the extent
that this is feasible, but should all be part of a linked system that allows controlled substances to be
easily tracked as they move through the facility.
5.1 Determining Inventory Requirements To ensure availability of, and control over, controlled substances, it is important to accurately determine
the needs of the healthcare facility, and more specifically, the needs of individual patient care areas.
Responsibility for this function rests jointly with pharmacy, the patient care area, the Pharmacy and
Therapeutics committee, and the diversion prevention committee.
Consideration should be given to maintaining the lowest amount of inventory possible while ensuring
reasonable and timely access.
Factors to consider when determining the drug needs of a healthcare facility or a patient care area are:
medical conditions being treated;
local protocols, pathways, and care maps;
drug formulary, and formulary policies such as automatic substitution;
utilization and prescribing patterns;
19 National Institute for Health and Care Excellence. Controlled drugs: safe use and management. April 2016. Accessed: July 3, 2018. Available from: https://www.nice.org.uk/guidance/ng46
CSHP Diversion Guideline – Draft for Public Consultation 10
range of dosing (e.g., pediatric vs. adult care; acute vs. chronic pain management); and
inventory turnover rate;
inventory returns from patient care areas;
destruction of outdated or unserviceable (unusable) drugs (e.g., records of specific drugs and
quantities destroyed, frequency of destruction)
availability and capacity of secure storage;
cost implications (both drug cost and human resource cost to manage inventory control);
after-hours access to drugs (e.g., through a “night cupboard” or on-call pharmacy staff);
logistical travel time between receiving, pharmacy, care units, or other sites; and
turnaround time between ordering and delivery from suppliers.
Once established, drug use patterns should be periodically reviewed to assess:
minimum and maximum stock levels;
changes in utilization trends;
changes in clinical practice or patient mix;
changes in regulatory requirements (e.g., schedules);
issues such as medication safety incidents that may shed light on potential for misuse or
diversion of controlled substances; and
factors previously considered to determine drug needs.
There should be consideration for maintaining the lowest quantities of controlled substances that are
feasible for each area. Unit of use packaging should be used whenever possible.
5.2 Procurement According to the NCR, licensed dealers (e.g., manufacturers and distributors) shall supply a hospital with
a controlled substance only if they have first received a written or electronically transmitted order that
has been signed and dated by an individual to whom responsibility and authority for ordering these
drugs has been delegated by the person in charge of the hospital, and who is approved by their
professional regulatory authority (e.g., as in the case of pharmacists in certain jurisdictions).20 The
facility should define who may order such drugs and under what circumstances, and limit the number of
individuals designated as such.
Outstanding backorders for controlled substances are a potential source of diversion, especially when
there is no separation of duties (i.e., the same person orders and receives drugs). According to Health
Canada policy, orders for controlled substances shall not be split into multiple shipments. When an
ordered item is on backorder, the licensed dealer should notify the pharmacist and the order should be
cancelled. If the drug is available in a reduced quantity, a new order should be placed for the amount
available. Once the drug is available in the required quantity, the pharmacy should order the drug.
Group purchasing organizations can help establish contractual expectations with licensed dealers, which
will help to proactively manage or mitigate a drug shortage.
20 Narcotic Control Regulations. C.R.C., c. 1041 (Current to May 9, 2018). Available from: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._1041/
CSHP Diversion Guideline – Draft for Public Consultation 11
5.2.1 Manual Procurement Process Manual processes refer to issuing paper-based purchase orders and signing these by hand, rather than
electronically submitting these and signing by means of a digital or electronic signature. Manual
ordering should be minimized. When a manual procurement process is used, the forms used to
purchase controlled substances should be sequentially pre-numbered and closely controlled using a log
or other system that monitors:
distribution of blank forms;
forms which have been used, including all the information necessary to identify a specific
transaction or order; and
orders which are pending or have a backorder – a procedure for appropriate prompt follow-up
action, which takes into consideration the normal or expected turnaround time for each
supplier, should be in place.
Under no circumstances should blank purchase orders or requisitions for controlled substances be pre-
signed or left unsecured.
5.2.2 Electronic Procurement Process According to Health Canada policy, electronic ordering of controlled substances is acceptable as long as
the digital signatures used can be authenticated in a similar manner as manual signatures.21 Each
individual authorized to order controlled substances shall have a unique access code. Access codes shall
not be shared or used by others.
Staff responsible for implementing electronic procurement processes shall ensure that the system they
choose to use “will permit them to meet the requirements of the relevant regulations.”22
Benefits of electronic ordering systems include secure transactions with individual user IDs, traceability,
retention of data, and the ability to generate reports as needed.
5.3 Receipt Separation of purchasing and receiving duties is key to strengthening internal inventory controls.
All pharmacy goods and supplies, including controlled substances, should be delivered directly to and
received by the pharmacy without any intervention.
When this is not feasible, the healthcare facility should have policies and procedures requiring that:
packages remain unopened by the staff receiving them (emergency exceptions to be defined in
procedures);
21 Policy Statement on the Electronic Ordering of Controlled Substances. Health Canada, 2012. Accessed: July 4, 2018. Available from: https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/policy-regulations/policy-documents/policy-statement-electronic-ordering-controlled-substances.html 22 Policy Statement on the Electronic Ordering of Controlled Substances. Health Canada, 2012. Accessed: July 4, 2018. Available from: https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/policy-regulations/policy-documents/policy-statement-electronic-ordering-controlled-substances.html
CSHP Diversion Guideline – Draft for Public Consultation 12
packages are stored securely during those times when both the receiving department and the
pharmacy are closed;
there is a secure storage area reserved for pharmacy goods;
access to the secure storage area is limited to designated pharmacy and receiving department
staff;
the secure storage area is never left unsecured;
pharmacy packages should be immediately placed in the designated secure storage area and
delivered to the pharmacy or picked up by pharmacy staff on a priority basis; and
as for any movement of drugs through the facility, there is clear accountability, transfer of
responsibility, and tracking through the use of a “chain of signatures.”
The facility should have a procedure for reporting and investigating shipments that are lost in transit.
Licensed dealers should ship packages of controlled substances in a manner such that neither the
packages containing the controlled substances nor the documents accompanying them indicate the
nature of their contents. This is done with the aim of limiting potential diversion of these packages and
staff should maintain this anonymity as packages move through the facility.
5.3.1 Receiving Department When accepting delivery of packages intended for the pharmacy, the individual in the receiving
department assumes responsibility for these goods until they are delivered to and received by the
pharmacy department. It is therefore necessary for the receiving department staff to:
ensure that the number of packages received corresponds with the number recorded on the
documents accompanying the shipment; and
examine the exterior of the package(s) for any signs of tampering or damage.
Any discrepancies, damage, or signs of tampering should be recorded on the waybill at the time of
delivery and reported to the pharmacy department as soon as possible.
A separate log for pharmacy deliveries should be maintained in the receiving department or any other
area in the facility designated to accept goods for the pharmacy.
The log (manual or electronic) should include:
date and time received;
company or supplier;
number of packages received;
any identification numbers;
carrier;
name and signature of driver;
name and signature of individual receiving the goods;
name and signature of the individual delivering the goods to the pharmacy;
name and signature of pharmacy staff (when delivered);
date and time delivered to the pharmacy department;
number of packages delivered to the pharmacy department; and
comments regarding discrepancies, damage or signs of tampering.
CSHP Diversion Guideline – Draft for Public Consultation 13
5.3.2 Pharmacy Department According to the procedures suggested above, an individual from the receiving department is required
to obtain, in the receiving log, the name and signature of the pharmacy staff member accepting the
packages. By signing for the packages, the responsibility for the packages and their contents is
transferred from the individual from the receiving department to the pharmacy staff member. If
problems or discrepancies are noted following this transfer, the pharmacy staff member who signed for
the packages is held responsible.
On receiving a package from the receiving department, the pharmacy receiver should:
ensure that packages are sealed and have not been opened at any time;
confirm that the order is complete (number of packages received corresponds with the number
noted on the documentation that accompanies them);
ensure that there has been no tampering with or damage to the packages;
record and report any discrepancies or signs of damage on the shipping documents and on both
the receiving department and pharmacy department logs, which are then signed off by both
parties; and
sign the packing slip to document the transfer of responsibility from the receiving department to
the pharmacy department.
Packages received in the pharmacy department should be opened as soon as possible after they are
received. If this is not practical, they should be stored in a designated secure area within the pharmacy
until they can be processed.
Once the packages are opened, the balance of the information necessary for the receiving log is
recorded. The log (manual or electronic) should include:
information already recorded by the receiving department (see bulleted list under Receiving
Department);
invoice number;
purchase order number;
drug name (brand and generic);
strength;
formulation;
quantity (number of doses, vials, or other applicable units, to match those on the purchase
order);
lot number;
expiration date; and
comments regarding discrepancies or damage.
At the time the original package or container is first opened, it is suggested that the individual
responsible visually confirm the contents of each. It is further suggested to perform a physical count of
solid dosage forms and measure the volume of liquids to ensure that the contents correspond with the
expected quantity or volume. Discrepancies should be noted and reported to the director of pharmacy
or delegate.
CSHP Diversion Guideline – Draft for Public Consultation 14
Automated data capture, such as bar code scanning of packages, can help to improve efficiencies and
accuracy when ordering and receiving controlled substances. When integrated in the pharmacy
information system data base, this has the capacity to further enable traceability through electronically
capturing the medication lot number and expiry date, and other pertinent data.
Problems relating to discrepancies, tampering, or damage should be reported immediately to the
director of pharmacy or delegate, as well as to the diversion prevention committee. See Reporting
Suspected Diversion for more guidance.
5.4 Storage in the Pharmacy Department Controlled substances maintained in the pharmacy department shall be stored in a manner which
ensures their physical security, adheres to the recommended storage conditions for the drug, and meets
relevant standards (e.g., from accreditation or regulatory authorities).23
Consideration should be given to the Directive On Physical Security Requirements For Controlled
Substances (Security Requirements For Licensed Dealers for the Storage of Controlled Substances) issued
by Health Canada’s Office of Controlled Substances.24 Although the directive is geared to licensed
dealers and research labs, it is cited in both NCR and ACMPR, and provides a valuable risk assessment
tool that takes into account:
• the cost to society of the drug reaching the illicit market (diversion);
• the cost to the organization; and
• the probability of the drug reaching the illicit market, based on:
• location;
• illicit market value;
• armed robbery;
• theft; and
• pilferage.
Access to the pharmacy area should be restricted to pharmacy staff. Access to controlled substances or
the areas where they are stored should be limited to designated pharmacy staff. The issue of access and
the list of individuals who may enter these areas should be specifically addressed in the facility’s policies
and procedures.
5.5 Considerations for Special Patient Care Areas Typically, substantial quantities of controlled substances are used in special patient care areas, such as
the operating room, labour/delivery, intensive care unit, and emergency department. Exercising
adequate control over the distribution and use of such drugs in these areas is often complicated by the
nature and volume of the work, the demands placed on the staff, and other operational considerations.
In spite of the foregoing, the principles of responsibility and accountability with respect to the receipt,
distribution and use of controlled substances apply as much to these special areas as they do to other
patient care areas. The policies and procedures for ordering, receipt, storage, access, prescribing,
23 Medication Management (Draft for Public Review). Health Standards Organization, 2018. 24 Physical Security Directive. Accessed: July 3, 2018. Available from: https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/controlled-substances/physical-security-directive.html
CSHP Diversion Guideline – Draft for Public Consultation 15
administration, and record keeping in the special patient care areas should follow the same general
principles as other patient care areas. Differing policies and procedures may be appropriate and
reasonable for anesthesiologists with respect to access, prescribing, administration, and record keeping.
Additional precautions may be required for these areas due to operational considerations, the large
quantities of drugs used, the nature of these drugs, and access to these areas by a variety of individuals,
including patients and the public.
5.5.1 Operating Room, Other Anesthetizing Locations, Labour and Delivery Room The maintenance of adequate control over the distribution and use of controlled substances in the
operating room presents certain unique problems. Within the operating room, many individuals have
ready access to large quantities of controlled substances. Information available suggests that
accessibility to these drugs and the stressful nature of the work places operating room staff in a
vulnerable position.25,26 An effective control system is therefore of utmost importance.
Emerging best practices to support appropriate transactions in the operating room include installing
automated anesthesia cabinets (AACs) or automated dispensing cabinets (ADCs), adopting disposal and
destruction systems to dispose of controlled substance waste, and implementing equipment to test the
validity of controlled substances prior to destruction.
The use of AACs or ADCs in the operating room facilitates access to controlled substances while
maintaining safe, secure storage. These cabinets also support the documentation of controlled
substances used, wasted, and can document a witness when required.
As in other patient care areas, the inventory and records for the central operating room stock should be
verified at each shift change, at a minimum. The operating room and other anesthetizing locations
should be recognized as high-risk areas27 (along with the main pharmacy vault and any other high-usage
areas) and consideration should be given to more security surveillance, more frequent restocking by
pharmacy, and more frequent audits. See Physical Counts.
5.5.2 Special Clinics Frequently, minor surgical procedures requiring certain controlled drugs are performed in special clinics
within the hospital. Ideally, controlled substances should not be maintained on-site when the clinic is
not open. When it is not practical to remove the drugs, physical and procedural security measures
should be implemented to protect them. Due to staffing limitations, there is often a single person who
oversees drug ordering, receives the drugs, and stocks them. However, separation of ordering, receiving,
and stocking duties is considered a best practice to prevent diversion during the procurement process.
5.5.3 Emergency Department On any given day, there may be a large number of attending physicians, consulting physicians, trainees,
and other health professionals passing through the emergency department. As well, controlled
substances are commonly used in the emergency department for sedation or treatment of acute pain.
25 Bryson EO and Silverstein JH. Addiction and Substance Abuse in Anesthesiology. Anesthesiology. 2008 Nov; 109(5): 905-917. 26 Berge KH, Dillon KR, Sikkink KM, et al. Diversion of Drugs Within Health Care Facilities, a Multiple-Victim Crime: Patterns of Diversion, Scope, Consequences, Detection, and Prevention. Mayo Clin Proc. 2012 Jul; 87(7): 674-682. 27 ASHP Guidelines on Preventing Diversion of Controlled Substances. Am J Health-Syst Pharm. 2017; 74:e10-33.
CSHP Diversion Guideline – Draft for Public Consultation 16
Special consideration should be given to physical and procedural security measures in this high-traffic,
high-usage area. Staff who regularly work in the emergency department (generally nurses and nurse
managers) should implement systems that balance access and availability with staff safety and diversion
prevention.
5.5.4 Remote Clinics [Content will be added if/when provided by nursing reviewers.]
5.5.5 Pre-hospital Care [Content will be added if/when provided by paramedic reviewers.]
5.5.6 Long-term Care [Content will be added if/when provided by long-term care reviewers.]
6 Preparation, Dispensing, and Distribution
6.1 Pharmacy Although many departments within a healthcare facility are responsible for management of controlled
substances, pharmacy is generally the central storage, preparation, and distribution point. Retrievable
documentation shall be maintained for the storage, manipulation, and distribution of these medications
throughout the hospital.28 This includes all repackaged, compounded, and unusable drugs.
Pharmacies in large facilities may carry many forms of controlled substances in various packaging. Oral
solids may be received in stock bottles, unit dose strips, or easy-to-count blister cards. Oral liquids may
be received in large stock bottles, injectables in vials or ampoules, and powders in glass bottles. It is not
uncommon to have to repackage or compound the medication prior to dispensing it to patient care
areas. Repackaging and compounding methods should ensure that the controlled substances are easy to
secure, tamper evident, and easy to count. Compounding standards shall be followed to ensure that the
quality and integrity of the medications are maintained.29,30
Each formulation and container type should have a separate record within the perpetual inventory. As
the medication is manipulated, each “new” type of repackaged or compounded medication requires a
new inventory record. For example:
If 100-count stock bottles of codeine 30 mg tablets are each repackaged into four 25-count
blister cards, there will be an inventory record for the stock bottles and a second inventory
record for the blister cards.
If several fentanyl 5 mL vials are used to compound each fentanyl 50 mL infusion bag, there will
be separate inventory records for the vials and the infusion bags.
28 Narcotic Control Regulations. C.R.C., c. 1041 (Current to June 20, 2018). Available from: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._1041/index.html 29 Model Standards for Pharmacy Compounding of Non-sterile Preparations. National Association of Pharmacy Regulatory Authorities, 2018. Accessed: July 4, 2018. Available from: http://napra.ca/general-practice-resources/model-standards-pharmacy-compounding-non-sterile-preparations 30 Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations. National Association of Pharmacy Regulatory Authorities, 2016. Accessed: July 4, 2018. Available from: http://napra.ca/general-practice-resources/model-standards-pharmacy-compounding-non-hazardous-sterile-preparations
CSHP Diversion Guideline – Draft for Public Consultation 17
If 250 mL stock bottles of morphine 1 mg/mL oral liquid are repackaged into 5 mL oral syringes,
there will be separate inventory records for the stock bottles and the oral syringes.
This makes all medications easier to track and assists in discrepancy investigation.
All repackaging and compounding must be documented on corresponding records or “worksheets”, and
it is best practice to store all of these records in close proximity to the controlled substances themselves;
e.g., in the narcotic vault. Occasionally original containers received from the manufacturer will be
slightly over or under in quantity. These unanticipated quantity discrepancies are often identified during
the repackaging or compounding processes. Losses outside of normal parameters shall be reported to
Health Canada within ten days.31 Refer to Reporting of loss or theft of controlled substances and
precursors32 for further guidance. Also see Waste and Disposal of Unusable Drugs.
6.2 From Pharmacy to Patient Care Area The system used to supply or replenish patient care areas with controlled substances varies from facility
to facility. Whatever system is used, it is crucial that the movement of these medications is recorded in a
manner that will permit monitoring of the process and ensure responsibility and accountability for all
medications at all times.
The most important aspect of the distribution system is written documentation in both the pharmacy
and the patient care area. Comparing the documentation in each of the two areas adds an element of
accountability that helps prevent diversion and is also useful for determining and correcting errors.
Typically, distribution of controlled substances within a healthcare facility is conducted via a wardstock-
based system with supplementation of some patient-specific medications such as narcotic infusion bags.
Pharmacy staff deliver the medications to the patient care areas according to a delivery schedule.
Pharmacy staff assess the medication usage within each patient care area, review the patient care area
records for completeness, estimate the quantities required until the next scheduled delivery, select
these medications from the narcotic vault and subtract them from the pharmacy’s perpetual inventory
record, and ensure that nursing staff add them to the patient care area’s perpetual inventory record.
The delivery of controlled substances to patient care areas shall be performed using secure methods.33
Unattended, unsecured pneumatic tubes or dumbwaiters are not recommended due to the ease of
theft or diversion; pneumatic tubes may be used for delivery only if the product is accessible by security
code. Best practice is to have a pharmacy staff member deliver medications throughout the hospital
using a closed, opaque container to mask the contents. Travel through non-public areas and on service
elevators provides the greatest level of safety and security during transport. Consideration should be
given to delivering controlled substances at staggered (less predictable) times, if possible.
It should be emphasized that until the drugs are delivered and accepted by the patient care area, the
pharmacy department retains responsibility for them. Before signing for the drugs, both pharmacy staff
31 Loss or Theft Report Form. Health Canada, 2018. Accessed: July 4, 2018. Available from: https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/controlled-substances/compliance-monitoring/loss-theft-forgery/loss-theft-report-form.html 32 Reporting of loss or theft of controlled substances and precursors. Health Canada Guidance Document CS-GD-005. Accessed: July 4, 2018. Available from: https://www.canada.ca/en/health-canada/services/publications/healthy-living/loss-theft-controlled-substances-precursors.html 33 Medication Management (Draft for Public Review). Health Standards Organization, 2018.
CSHP Diversion Guideline – Draft for Public Consultation 18
and nursing staff should check the drug, strength, dosage form, and quantity being transferred. Once
the nurse signs the appropriate record, the responsibility and accountability for the drugs is then
transferred to that individual and to that patient care area.
If additional products or quantities are needed prior to the next regular delivery, perhaps due to a new
order or unanticipated usage, nursing staff may pick up the product from the pharmacy. As with
delivery, the pick-up from pharmacy by nurses shall also be performed using secure methods. Patient
care area staff should be authorized to pick up controlled substances and show hospital identification in
order to receive the medications. They should bring their patient care area record with them so that the
medications picked up can be documented and signed for in the same way as regular delivery to the
care area. Information recorded on the care area record during pick-up should be identical to that
required when delivering controlled substance medications.
Various documentation methods may be used for tracking the delivery of products. However, the basic
principle is that both the pharmacy and the patient care area retain a record at the transition point of
each medication movement. The same principles apply for controlled substance medications going to
the care area and from the care area back to pharmacy (returns). All manual documentation must be
made in ink. Inventory records should be kept in a secure location that ensures access is restricted to
essential staff only.
For each medication movement, the pharmacy record should include:
date;
patient care area;
drug name, strength, and dosage form;
quantity delivered or returned; and
names and signatures of pharmacy and patient care area staff.
For each medication movement, the patient care area record should include:
date;
time of receipt;
“Issued by Pharmacy” or “Returned to Pharmacy” to indicate the movement action;
drug name, strength, and dosage form;
quantity added or subtracted;
“New Balance” (total after the addition or subtraction has been completed); and
names and signatures of pharmacy and patient care area staff.
Note: The new balance total does not necessarily reflect the correct balance. Pharmacy staff are not
responsible for errors and corrections that occur in the patient care area, and vice versa. When
delivering specific items (as opposed to doing a full restock), staff are generally not expected to wait
while physical counts are performed and discrepancies are resolved.
CSHP Diversion Guideline – Draft for Public Consultation 19
6.3 Patient Care Area
6.3.1 Storage Hospitals that do not have ADCs should use a double or triple lock procedure; e.g., a locked cupboard or
cabinet inside a locked medication room, or a locked cupboard inside a locked storage area inside a
locked room.34 The medication room door and the locked cupboard never have the same lock, so this
two-key system is desirable from a security and medication control standpoint. Alternatively, controlled
substances may also be stored in locked drawers in medication carts used to deliver the medications to
patients. If the cart is ever to be left unattended, it should be secured and locked to the wall or locked in
a secure area such as a medication room, and the controlled substance drawer should remain locked at
all times.
Whatever container, cupboard, or cabinet is used, it should have secure locks and be constructed in
such a way as to minimize the possibility of undetected forced entry. Consideration should be given to
the type of locks and hardware that are used, how they are installed (e.g., with inside hinges), the
construction of the container, compartment or drawer, and the structure into or onto which it is secured
or attached. All drug cabinets, drawers, compartments or other storage areas should be locked when
not in use.
6.3.2 Access Within each facility, a policy should be established regarding access to drug storage. The policy should
describe who has access within the patient care area and the responsibilities associated with such
access. The policy should also address access for other staff, such as agency nurses, graduates, and
students.
If a manual key is used to access controlled substances, then the use, distribution, and control of keys
should be guided by local policy. A key control log is recommended, in which nursing staff can sign when
they take the key and when they return it. Under no circumstances should a key leave the hospital. If
the key has been lost or removed from the hospital, the locks to the storage cabinet or compartment
should be changed. Locks should also be changed when a significant loss has been discovered. If a
patient care area chooses to maintain more than one key, they will perform a count of the keys each
time the medications themselves are counted and at every shift change. This ensures that the keys are
accounted for at all times.
If electronic codes, access cards, or other methods are used to access controlled substances, sharing
should never be allowed and passwords should be changed frequently.
6.3.3 Reconciliation At each change of shift, physical counts of the controlled substances should be conducted by a nurse
coming on duty and a nurse going off duty. If manual access keys are used, responsibility for the key is
transferred at this time, and any additional keys are counted. In this way, responsibility for both the key
and the medications is formally transferred to the nurse coming on duty.
34 HSO Medication Management Standard (draft).
CSHP Diversion Guideline – Draft for Public Consultation 20
6.4 Automated Dispensing Cabinets Many facilities have ADCs for storage and management of controlled substances. Potential advantages
of ADCs include shorter delivery time from prescribing to administration, greater inventory control and
security measures, and potentially fewer medication errors.35 However, ADCs can create a false sense of
security if not supported by rigorous policies and procedures.36
Ideally, all ADCs should have profiling functionality. With profiled ADCs, the pharmacist reviews new
orders before the medications appear in the patient’s profile and are available for the nurse to remove
from the ADC. The nurse can then access a patient-specific medication that has been validated by
pharmacy staff. In many cases, ADCs can be part of a closed-loop medication management system that
integrates the electronic medical record (EMR), computerized prescriber order entry (CPOE), pharmacist
review, and medication administration record (MAR).
Inventory management and distribution to the patient care area are conducted in the same general
manner as manual systems, with the addition of automated reports on drug use patterns to assist with
replenishment of stock to appropriate levels. Movement of medications is controlled by unique user
identification (ID). User IDs are used by pharmacy staff to restock the ADC and by nursing staff to access
medications. When the nurse removes a medication, the inventory count is automatically updated.
Waste is verified and documented in the system by a second nurse via user ID. Controlled substance
waste is handled as usual (see Waste and Disposal of Unusable Drugs).
Audits and physical counts should be conducted frequently, as guided by local policy. In some systems, a
second witness may not be required during stocking or replenishing of the ADC. The result of the
physical count is entered by pharmacy staff and updated by the system. When a second witness is
required (either between pharmacy and nursing, or between nursing shifts), both parties can enter their
user ID to verify the count. Variances are flagged and investigated.
This entire process is paperless; however, many reports are available to help with discrepancy resolution
and aid in diversion identification. In many cases, barcode verification can also be used as an additional
safety feature.
6.5 Considerations for Special Patient Care Areas
6.5.1 Operating Room, Other Anesthetizing Locations, Labour and Delivery Room Depending upon the system being used, controlled substances may either be allocated to a specific
operating room or to a specific practitioner. Anesthesiologists may, at the start of the day, access and
assume custody of a supply of medications adequate for their anticipated needs for that day.
Drugs that have been allocated to a practitioner called to another area of the facility should not be
removed from the area.
When controlled substances are removed from central stock, a record (either manual or electronic)
should be created that includes:
date and time of removal;
35 Guidelines for the Safe Use of Automated Dispensing Cabinets. Institute for Safe Medication Practices, 2009. Accessed: July 7, 2018. Available from: https://www.ismp.org/guidelines/safe-use-automated-dispensing-cabinets 36 ASHP Guidelines on the Safe Use of Automated Dispensing Devices. Am J Health-Syst Pharm. 2010; 67:483-90.
CSHP Diversion Guideline – Draft for Public Consultation 21
name and quantity of controlled substance(s);
name and signature of the practitioner; and
destination (e.g., number of the operating room).
6.5.2 Special Clinics Clinics such as dentistry, endoscopy, or others performing minor surgical procedures may only operate
during daytime hours. In these clinics, the physical counts of controlled substances and secure storage
of the keys or access cards should be undertaken at the end of each business day. As these clinics may
have minimal nursing staff, practitioners and departments should work together to ensure that the
count is verified by two regulated health professionals.
7 Prescribing Prescribers should follow all applicable accreditation standards and provincial/territorial regulatory
authority requirements, as well as high-quality clinical practice guidelines. Local policy should describe
who is allowed to prescribe controlled substances, whether verbal or telephone orders are acceptable,
and when such orders need to be co-signed.37 Orders for “as needed” controlled substances should
include clear instructions on frequency of dosing or maximum daily amounts.38 Practitioners who
prescribe controlled substances shall not be the subject of any notice issued under the NCR, and they
shall prescribe controlled substances only for persons who are under their professional treatment.39
7.1 Prescription pads Security measures are required for paper-based prescriptions used by practitioners in the emergency
department and other outpatient areas. Diversion by means of forgery using prescription pads stolen
from hospitals represents a major means of diversion of controlled substances. Prescription pads should
not be left unattended in any part of the hospital. Prescription pads should be signed out to individual
practitioners from a central distribution point (generally the pharmacy) and a log should be maintained.
Pads not in use should be securely stored. Consideration should be given to using tamper-proof
prescription pads with a controlled numbering system.
8 Administration to Patient As surveillance of controlled substances continues to become more regulated, increasing vulnerability of
diversion exists at the point of administration. Patient harm is possible with any form of diversion,
particularly if the patient’s caregiver is working under the influence of a controlled substance. However,
diversion at the bedside can frequently result in poor pain control for patients, as they may be given
partial doses, a substitute drug, or no drug at all. Bedside diversion can also pose a significant public
health risk if a staff member tampers with injectable drugs.40 See Examples of Diversion.
37 Medication Management (Draft for Public Review). Health Standards Organization, 2018. 38 Controlled drugs: safe use and management. National Institute for Health and Care Excellence, 2016. Accessed: July 18, 2018. Available from: https://www.nice.org.uk/guidance/ng46 39 Narcotic Control Regulations. C.R.C., c. 1041 (Current to June 20, 2018). Available from: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._1041/index.html 40 Risks of Healthcare-associated Infections from Drug Diversion. Centers for Disease Control and Prevention, 2017. Accessed: July 4, 2018. Available from: https://www.cdc.gov/injectionsafety/drugdiversion/index.html
CSHP Diversion Guideline – Draft for Public Consultation 22
In general, there are three potential participants in bedside diversion, who may work alone or in
collaboration with each other. Diversion may arise from the actions of:
staff administering the drug;
patients diverting the administered drug (e.g., a patient "cheeks" an oral medication, and then
surreptitiously spits it out); or
a third party, such as a family member or a patient in a neighbouring bed, diverting an
unsecured drug.
When administering a controlled substance:
verify that an order for the controlled substance exists on the patient's chart;
sign out the controlled substance (i.e., remove it from secure storage) in alignment with the
facility’s policy;
bring the MAR and the medication to the patient’s bedside and confirm the patient’s identify
using two client identifiers;
prior to administration, verify the medication order, dose, route, and frequency;
administer the medication, directly witnessing ingestion or absorption;
document within the medication administration record as soon as possible after administration;
and
document any wastage as soon as possible after administration. Partial doses should not be
saved for later use. See Waste and Disposal of Unusable Drugs for details.
The facility shall establish a list of high-alert medications for which an independent double check is
required.41,42 An independent double check means that two regulated healthcare professionals
independently confirm the medication order, dose, route, frequency, and patient identity.43
If nursing staff have suspicions that a patient may be diverting an administered medication, they should
share their concerns with the care team, and the prescriber should assess the patient for risk of
substance use disorder.
Nursing staff should not routinely crush tablets to prevent diversion. Routinely crushing tablets may
unnecessarily increase nursing workload and may increase risk of harm; e.g. through the accidental
crushing of a slow-release opioid tablet.
The facility shall have a policy for handling patients’ own medications that are brought into the facility.44
Controlled substances should be stored in the same manner as those belonging to the facility.
41 Medication Management (Draft for Public Review). Health Standards Organization, 2018. 42 High-Alert Medications in Acute Care Settings. Institute for Safe Medication Practices, 2014. Accessed: July 3, 2018. Available from: https://www.ismp.org/recommendations/high-alert-medications-acute-list 43 Independent Double Checks: Undervalued and Misused: Selective Use of This Strategy Can Play an Important Role in Medication Safety. Institute for Safe Medication Practices, 2013. Accessed: July 3, 2018. Available from: https://www.ismp.org/resources/independent-double-checks-undervalued-and-misused-selective-use-strategy-can-play 44 Medication Management (Draft for Public Review). Health Standards Organization, 2018.
CSHP Diversion Guideline – Draft for Public Consultation 23
8.1 Considerations for Special Patient Care Areas
8.1.1 Operating Room, Other Anesthetizing Locations, Labour and Delivery Room An administration record (either manual or electronic) should accompany controlled substances that are
removed from central stock, and the practitioner should record:
date and time of administration;
name and ID number of patient;
name and quantity (in mg and volume) of drug administered;
name and signature of the practitioner; and
number of the operating room.
It is important that the administration form be completed as soon after the drug is administered as
possible. Further, it is the responsibility of the practitioner who administered the drug to complete this
record. Operating room staff should not be called upon to complete these records on behalf of the
practitioner; this practice is inappropriate and unacceptable.
9 Waste and Disposal of Unusable Drugs Health Canada defines unserviceable stock as products that are unusable, expired, or that cannot be
dispensed.
In practice, this includes:
expired or recalled drugs;
drugs that were “poured” (opened, or made ready for administration) but were discontinued,
refused by the patient, or otherwise not administered;
overfill in vials;
partial doses;
partial drug remaining in vials, ampules, infusion bags, syringes, or cassettes;
partial drug remaining in transdermal delivery systems;
drugs that were specially compounded and cannot be used for a different patient; and
other unusable drugs; e.g., drugs that fell on the floor, were spit out by the patient, or prepared
for the wrong patient.
Drugs that are returned to the pharmacy from patient care areas, but that have not left the facility, are
generally not considered unusable unless they have been damaged in some way.
CSHP Diversion Guideline – Draft for Public Consultation 24
Unusable controlled substances shall be destroyed in accordance with Health Canada guidance45 and
shall respect all applicable environmental laws. Such drugs shall either be sent to a licensed dealer for
destruction or destroyed locally. Principles of local destruction include the following:46
The controlled substance shall be “altered or denatured to such an extent that consumption is
rendered impossible or improbable.”
The method of destruction should be guided by local policy. Generally, incineration or chemical
denaturing is limited to licensed dealers who have the appropriate equipment. Local destruction
usually involves physical destruction such as emptying vials into gauze or paper towel to render
the product unusable.
Local destructions shall be carried out by a pharmacist or a person in charge of a hospital,
“except where the unserviceable stock represents any partial or unusable doses, and the
unserviceable drug is already outside the pharmacy, e.g., on a ward. In this case, local
destruction can be carried out by a licensed health professional, at the discretion of the person
in charge of a hospital.”
All local destructions shall be witnessed by a practitioner, pharmacist, a pharmacy intern, a
pharmacy technician, or a Health Canada inspector.
On occasion, it is necessary to dispose of a small volume of medication when the supplied formulation is
greater than the required dose. This is called a “partial” or a partial dose, and the partial dose is
“wasted” or becomes “wastage.” The normal practice under these circumstances is to destroy the
wastage in the presence of a witness (a health professional who is entitled by law to perform this
function), although the wastage may be placed in a tamper-proof container for destruction at a later
time. The manner in which this is to be completed should be defined or specified in policy and
procedures established by the facility.
General principles in developing organizational policy for controlled substance wastage include the
following:
Consideration should be given to having a policy inclusive of all pharmaceutical waste (wastage
of controlled substances to be a subset of this policy).
Wastage of all controlled substances should be witnessed and documented by two independent
regulated health professionals.
Waste should be disposed of in a safe and secure manner (protects the public, health care
providers, and the environment) only in designated pharmaceutical waste containers.
45 Guidance Document for Pharmacists, Practitioners and Persons in Charge of Hospitals: Handling and Destruction of Unserviceable Stock Containing Narcotics, Controlled Drugs or Targeted Substances. Health Canada, 2018. Accessed: July 7, 2018. Available from: https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/controlled-substances/compliance-monitoring/compliance-monitoring-controlled-substances/unserviceable-stock.html 46 Guidance Document for Pharmacists, Practitioners and Persons in Charge of Hospitals: Handling and Destruction of Unserviceable Stock Containing Narcotics, Controlled Drugs or Targeted Substances. Health Canada, 2018. Accessed: July 7, 2018. Available from: https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/controlled-substances/compliance-monitoring/compliance-monitoring-controlled-substances/unserviceable-stock.html
CSHP Diversion Guideline – Draft for Public Consultation 25
Preparation and disposal of controlled substances should occur in an open and/or observable
designated medication preparation area.
For administration of a single dose, excess drug that requires discarding will be wasted prior to
the administration of the dose at the patient bedside.
All pharmaceutical waste containers will be secured and where possible tethered to prevent
unauthorized removal.
If controlled substances are stored in automated dispensing cabinets, wastage should be
documented in the same device from which it was removed.
When witnessing wastage, the witness should:
o verify the drug label;
o confirm that the amount wasted and the actual physical drug matches the
documentation; and
o observe disposal of the drug into the appropriate waste container.
Random assays of waste can be considered especially in high risk areas to determine if there has
been any tampering/substitution of the waste product.
Whenever an ampoule is broken, the breakage must be documented by two regulated health
professionals, i.e. the person who broke the item as well as a witness. Similarly, whenever overage or
loss occurs during compounding or repackaging, the discrepancy must be documented by two regulated
health professionals. The drug administration form, the inventory control sheet or any other document
used for this purpose must be completed as required and signed by both parties.
Damaged medication (which is not destroyed in the patient care area), excess medication or medication
that has exceeded the expiry date should be returned to the pharmacy as soon as possible. All records
maintained in the patient care area must be modified to reflect this transfer of stock.
Occasionally, patient care areas return drugs to the pharmacy which are no longer required, which have
expired or been damaged. Designated nursing staff within the patient care area should be given
responsibility for this function. Where drugs are returned to the pharmacy’s active dispensary inventory,
the appropriate records or documents related to the perpetual inventory system are completed. A
separate log should be maintained for drugs that are no longer usable, have been destroyed, returned
to the supplier, or otherwise removed from the active drug inventory. This log should include:
date removed from inventory;
name, strength, and form;
quantity;
reason for removal from inventory; and
name and signature of pharmacy staff responsible.
Drugs that have been designated for destruction should be secured in a tamper resistant container that
is not opened until destruction occurs. Local destruction or return to a licenced dealer should occur in a
timely manner, as a large amount of unusable stock can be a target for diversion.
CSHP Diversion Guideline – Draft for Public Consultation 26
9.1 Considerations for Special Patient Care Areas
9.1.1 Operating Room, Other Anesthetizing Locations, Labour and Delivery Room Wastage by anesthesiologists may require special consideration. Anesthesiologists routinely access a
quantity of controlled substances sufficient for the day’s procedures and the stock is allocated to a
specific practitioner. They may therefore use partial vials of medication for subsequent patients rather
than wasting each partial vial. Wastage is generally documented only at the end of the day. The amount
of wastage should be equal to:
the quantity of unopened medication containers allocated at the start of the day, minus
the total dose of medication administered to each patient (documented on the administration
record), minus
the number of unopened medication containers returned to central stock at the end of the day.
Documentation of doses administered in the health record should be routinely reconciled with
documentation of doses dispensed, wasted, and returned. The anesthesia and pharmacy department
should collaborate to assign accountability and to determine quantities of controlled substances to be
stocked.
Depending on local policy, anesthesiologists may be exempted from the requirement for witnessing of
wastage, provided that procedures and record-keeping meet Health Canada’s requirements for
destruction. However, consideration should be given to alternate methods for ensuring accountability,
such as random sampling of waste.
Destruction of unserviceable stock shall occur in the same manner as other patient care areas. The only
options are local destruction or sending to a licensed dealer. In either case, a practitioner, pharmacist, or
person in charge of a hospital shall create a written record including the name, quantity, and strength of
each item to be destroyed. For local destruction, a practitioner, pharmacist, pharmacy intern, pharmacy
technician, or Health Canada inspector shall witness the destruction.47
10 Identifying Diversion Diversion and the risk of diversion can take many forms and can occur anywhere in the medication-use
system, e.g., at procurement, preparation, dispensing, product selection/removal from storage,
administration, or waste disposal. Controlling and reducing fraud requires a thorough knowledge of how
controlled substances enter the system, how and where they are stored and used (and by whom), and
how stock exits the system.
Controls can take the form of physical security measures (e.g., no access to the vault via ventilation
system or ceiling) or administrative measures (e.g., policies and procedures, forcing functions in
technology, locks on doors). Automation can allow for improved tracking and identification of potential
diversion incidents. Diversion software is available that can compile and analyze large amounts of data
to produce easily-customizable reports. These are powerful tools, but diversion is often multifactorial
47 Guidance Document for Pharmacists, Practitioners and Persons in Charge of Hospitals: Handling and Destruction of Unserviceable Stock Containing Narcotics, Controlled Drugs or Targeted Substances. Health Canada, 2018. Accessed: July 7, 2018. Available from: https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/controlled-substances/compliance-monitoring/compliance-monitoring-controlled-substances/unserviceable-stock.html
CSHP Diversion Guideline – Draft for Public Consultation 27
and automation alone cannot prevent it. Detection often relies on staff awareness and timely reporting.
It also relies on having dedicated resources to receive and review reports in a timely manner and to
proactively look for unusual trends in usage or diversion reports.
10.1 Examples of Diversion Common methods of diversion include:
• entering a quantity of drugs into perpetual inventory (pharmacy or patient care area) that is
different from the quantity actually received;
• “borrowing” stock between patient care units;
• pilfering a non-controlled drug and reporting a missing dose;
• replacing package contents with a look-alike drug;
• replacing prepared syringe contents with saline;
• removing controlled drugs without an order;
• falsifying a verbal or electronic order;
• documenting administration of drugs without doing so;
• removing and documenting administration of a full dose, but administering a partial dose;
• removing a higher dose than ordered and not wasting the excess;
• removing a controlled drug, pilfering it, and administering a less potent analgesic;
• removing a controlled drug, pilfering it, and administering a drug that will mimic the side effects
of controlled drugs (e.g., drowsiness from diphenhydramine, dimenhydrinate, or haloperidol);
• tampering with an infusion pump or other device to remove drug at the bedside;
• prematurely replacing infusion bags or infusion devices;
• pilfering partial infusion bags or infusion devices when a treatment is discontinued;
• pilfering from drug waste, sharps containers, or patches removed from patients;
• pilfering patient-supplied drugs or not returning them at discharge; and
• removing drugs for a discharged or nonexistent patient.
Common signs of diversion include:
• missing purchase order or packing slip;
• compromised packaging (watch for excessive “accidents” and check rubber stoppers for
punctures);
• verbal orders created but not verified by prescriber;
• numerous unresolved discrepancies;
• numerous corrected transactions;
• removing drugs for more patients than are generally assigned to a single practitioner;
• removing drugs for patients assigned to another practitioner (beyond break coverage or a
team-based approach among nurses within a patient care area);
• failing to document waste;
• failing to discard wastage or render it unusable;
• frequent or excessive waste due to selection of a larger product size or dosage form than
required;
• frequent breakage or waste of entire doses;
• regularly choosing the same witness for wastage;
• delayed wastage (to facilitate substitution);
CSHP Diversion Guideline – Draft for Public Consultation 28
• bulk wastage entries at end of shift;
• controlled drugs disposed of in regular trash;
• staff member frequently volunteering to take out the trash;
• staff member frequently offering to administer doses for colleagues, arriving early, staying late,
or coming in on days off;
• staff member frequently volunteering to hold the keys to the controlled substance storage
area;
• patient or family complaints of inadequate pain management;
• patient’s pain is well-controlled on one shift but not another; and
• patient’s pain control differs greatly between similar procedures or surgeries.
Methods and signs of potential diversion that are unique to automated dispensing cabinets (ADCs)
include:
• frequent setup of temporary users or temporary patients;
• frequent medication overrides;
• removing drugs under a colleague’s sign-on;
• removing more doses than documented; and
• removing duplicate doses from the same or different cabinets.
10.2 Record-keeping and Audits
10.2.1 Pharmacy Physical counts and reconciliation of specific products should occur whenever new stock is received,
issued to a patient care area, or dispensed. Full reconciliation of all controlled substances stored in
pharmacy, including those being held for destruction, shall occur on a regular basis, in accordance with
provincial/territorial pharmacy regulatory authority standards. The longer the interval, the more difficult
it will be to reconcile any discrepancies.
A random verification of purchase orders placed, orders received, and entries into the perpetual
inventory system in the pharmacy should be undertaken on a regular basis (at least monthly) by a
member of the diversion prevention committee or other designated staff. Audits and verifications
should be conducted more frequently when there are staffing changes, when concerns exist, or when
there is a high volume of drug turnover.
The audit should include the monitoring or verification of:
• stock on hand;
• purchase orders that have been issued;
• purchase orders that are pending;
• backorders;
• records of receipt (pharmacy receiving log);
• records of distribution (items issued, received, returned, outstanding); and
records of drugs to be destroyed.
In a paper-based system, purchase orders should be tested for serial continuity to ensure that all forms
are accounted for. An inventory should be kept of all uniquely-numbered controlled substance logs
issued to patient care areas and completed logs returned. Returned logs should be reviewed by
CSHP Diversion Guideline – Draft for Public Consultation 29
pharmacy staff for completeness of entries (including page number verification) and returned to patient
care area leaders for resolution of discrepancies within two working days of receipt, if required. Logs
should be firmly bound and sorted by consecutively numbered pages. Logs not returned before 30 days
should be retrieved and reconciled. Frequent discrepancies require follow-up with patient care area
leadership.
Multi-facility health systems should maintain a consolidated list of all reported losses from all sites, to
help identify trends in control problems and to track staff involved in possible diversion who work
among different sites.
10.2.2 Patient Care Area In paper-based systems, a perpetual inventory log of controlled substances as above should be
maintained wherever these substances are stored on patient care areas. All issues to patients, wastage,
receipts from pharmacy, and returns should be documented. The log should include:
• date and time;
• patient name;
• drug name, dose, wastage (if applicable), strength, and number of units (e.g., tablets, vials,
syringes) removed or returned;
• new balance on hand; and
• name and signature of health care professional removing the dose.
Verification and co-signature by a second health care professional should be required for:
• receipt of stock from pharmacy or another unit;
• return of stock to pharmacy or transfer to another unit;
• copying forward of balances to new page of the log or new log book;
• wastage of partial dose;
• broken or contaminated products; and
• physical counts.
Upon completion of a log book, it should be reviewed by the patient care area manager for
completeness and accuracy of entries prior to returning to pharmacy.
In facilities with ADCs in patient care areas, a blind count back should be conducted each time a
controlled substance is removed for a specific patient. Discrepancies should be addressed immediately
and certainly before shift end. Physical inventory counts of controlled substances should be conducted
at least weekly on each cabinet.
Whether a facility is using paper-based or ADC distribution of controlled substances, audits of doses
removed versus doses administered should be conducted regularly (at least monthly) on 24 hours of
issues of a randomly chosen product to verify appropriateness of use. Audits may be conducted by
members of the diversion prevention committee or other designated staff. Audits should include a
review of the MAR as well as confirmation that:
• a valid prescriber’s order was present for the drug for the particular patient;
• dose removed was documented as administered;
• dose administered was the dose or was within the dose range ordered;
CSHP Diversion Guideline – Draft for Public Consultation 30
• dose administered plus amount wasted was equivalent to the amount removed;
• date and time of withdrawal reasonably coincided with the date and time administered;
• dose was removed and administered by a healthcare professional that was on shift at the time;
and
• documentation of patient response was completed.
In facilities using an eMAR as well as ADCs, this process can be automated and reviewed more
frequently. Similar processes and reporting can be undertaken where anesthesia work stations (AWSs)
are in use. Additional information available from automated systems to support detection of diversion
that should be reviewed regularly may include:
• reports of anomalous usage;
• reports of temporary user access to identify who was granted access, by whom, when, and
what medications were removed;
• controlled drug override occurrences, including frequency among users;
• same two healthcare providers repeatedly cosigning each other’s wastage – note that this can
occur in care areas where there are low staffing levels; and
• frequent cabinet access without record of drug removal.
10.3 Physical Counts Physical counts of all controlled substances in all areas of the facility shall occur at frequent and regular
intervals, in accordance with provincial/territorial pharmacy regulatory authority standards. Random,
unannounced counts should also be conducted. Counts should be conducted in the same manner
throughout the facility.
The physical count should be performed by two staff members. These two staff members should not
always be the same people.
One staff member should count the products on the shelf and read the quantities on hand to the other
staff member, who records the quantity into the perpetual inventory record. The count should be a
blind count, in which the recorder does not express to the counter the number that should be on hand.
The person counting can then verify the entries of the person recording. Both staff members should
verify balance totals that have been brought forward to the next page.
The person counting does not need to count the contents of sealed bottles or vials. However, an
examination of the product should be done to ensure that no tampering has taken place. The counter
should check that seals are intact, packaging is not damaged, rubber stoppers have not been punctured,
and so on.
If the physical count does not match the documented amount on hand, the discrepancy should be
investigated and resolved as soon as possible. Differences that cannot be reconciled shall be reported to
Blind count: How many oxycodone tablets are there?
Confirm count (or verify count): Are there ten oxycodone tablets?
CSHP Diversion Guideline – Draft for Public Consultation 31
with Health Canada within ten days.48 Refer to Reporting of loss or theft of controlled substances and
precursors49 for further guidance.
11 Investigating Diversion The facility should have a process for responding to discrepancies found through physical counts or audits, and to reports of diversion incidents. The facility should have a multidisciplinary diversion prevention committee as described in Organizational Accountability. This committee should ensure that policies are in place, staff education is routinely conducted, and diversion incidents are promptly investigated.
11.1 Reporting Suspected Diversion Real or potential diversion of controlled substances shall be reported to Health Canada within ten days
of discovery.50 It is not necessary to have completed a full investigation at the time the report is filed.
Health Canada defines a reportable loss as an unexplained incident in which there is a possibility that
the controlled substance has been diverted. Incidents such as spillage, breakage, and known dispensing
errors are not reportable losses. Refer to Reporting of loss or theft of controlled substances and
precursors51 for further guidance.
Incidents should also be reported to the facility’s diversion prevention committee. Facilities should
define in policy when reporting is required, who is responsible for reporting, who should receive the
reports, and who is responsible for acting on the reports.
All staff should receive education on signs of diversion. Desired competencies for staff should include the ability to:
• identify activity suspicious of diversion; • describe how to report suspicious activity; and • describe how to respond to reports of suspicious activity.
Consideration may be given to having a system for staff to report confidentially, such as a designated telephone line.
11.2 Investigation of Suspected Diversion The facility should have a process for conducting a diversion investigation.
48 Loss of Theft Report Form. Health Canada, 2018. Accessed: July 4, 2018. Available from: https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/controlled-substances/compliance-monitoring/loss-theft-forgery/loss-theft-report-form.html 49 Reporting of loss or theft of controlled substances and precursors. Health Canada Guidance Document CS-GD-005. Accessed: July 4, 2018. Available from: https://www.canada.ca/en/health-canada/services/publications/healthy-living/loss-theft-controlled-substances-precursors.html 50 Loss of Theft Report Form. Health Canada, 2018. Accessed: July 4, 2018. Available from: https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/controlled-substances/compliance-monitoring/loss-theft-forgery/loss-theft-report-form.html 51 Reporting of loss or theft of controlled substances and precursors. Health Canada Guidance Document CS-GD-005. Accessed: July 4, 2018. Available from: https://www.canada.ca/en/health-canada/services/publications/healthy-living/loss-theft-controlled-substances-precursors.html
CSHP Diversion Guideline – Draft for Public Consultation 32
The diversion prevention committee should have the authority to oversee diversion investigation and response, and may appoint a lead investigator for each incident.
Although the supervisor in the area where diversion is suspected will assist in conducting the investigation, those external to the area should be involved to ensure that biases do not influence the investigation.
It is essential that the individuals involved accurately record their observations and any other relevant details or information for consideration by the investigator.
11.3 Guidelines for Conducting a Diversion Investigation In conducting the investigation, it is important to maintain objectivity at all times and to recognize and examine all points within the distribution system where the diversion may have taken place.
It is probable that attempts have been or will be made to cover the diversion and divert attention or suspicion from the individual responsible. It is important to avoid allegations or accusations until the investigation is concluded. A review and verification of all records, forms and charts associated with the receipt and release of the drugs will help to track the transfer of responsibility and focus the investigation.
Other elements of the investigation should include:
checking for administration of medication just prior to discharge or transfer of patient;
verification that previous balances were carried forward correctly;
verification of medication counts conducted on shift changes;
examination of patterns of usage;
signs that record entries (names, dates, figures, signatures) have been altered;
errors in charting or signing out doses;
examination of drug waste and destruction (including frequency, patterns, and individuals involved);
verification that all records and forms are available;
observation of involved shifts over a period of time;
patient complaints, such as continuing pain;
examination of package for signs of tampering/substitution: o laboratory analysis as permitted by regulations;
behaviour of staff: o signs of physical impairment; o work habits; o work history; and
complaints regarding staff.
Note that a person who is diverting may not show poor work habits or work history. They may often volunteer for extra shifts, arrive at work early, stay late, or come in on their days off.
11.4 Interview of Suspected Diverter When sufficient evidence exists, the suspected individual should be questioned as soon as possible.
The facility should have a process for conducting an interview which defines who will lead the interview and who else should be present, with a focus on impartiality during the information-gathering phase.
CSHP Diversion Guideline – Draft for Public Consultation 33
11.5 Response to Confirmed Diversion The facility assesses whether to terminate, suspend, transfer to a lower-risk area, take other action (e.g., remove access to CS), or other sanctions against the HCW. This should be done in accordance with established local policy.
The facility establishes guidelines for engaging others external to the organization, such as local law enforcement.
The facility’s policy will determine what further action will be taken with respect to the individual within the institution. If the individual is found to have a substance use disorder, it would be appropriate to recommend treatment, rehabilitation and support, through an Employee Assistance Program or similar organization.
In the case of regulated health professionals, it is important to advise the relevant provincial/territorial regulatory authority. A cursory internet search will give many examples of harm done by health professionals who were known to have diverted controlled substances but were not reported to their regulatory authority and were therefore allowed to continue working at another facility.
The regulatory authority may take into consideration the motivation behind the diversion (e.g., personal substance use disorder versus trafficking). However, the regulatory authority must assess the person’s fitness to practice. In many provinces and territories, regulated health professionals are legally obligated to file a report when they suspect a health professional may be working while impaired.
12 Glossary CDSA Controlled Drugs and Substances Act
Controlled substances Any drug or substance found in the Schedules to the Controlled Drugs and Substances Act. 52 Includes narcotics, amphetamines, methylphenidate, cannabis and cannabinoids, barbiturates, benzodiazepines, anabolic steroids, and other such drugs, as well as precursor chemicals. These substances “can alter mental processes” and “may produce harm to an individual or to society when diverted to an illicit market.”53 A facility can choose to designate and treat additional substances as controlled substances for the purposes of their local policies and procedures.
Creative compliance The practice of finding ways to accomplish compliance with the letter of the law (or policy, or guideline) while undermining the spirit or the intent behind the words.
Healthcare facility A place where healthcare is delivered, including hospitals, ambulatory care clinics, ambulance services, long-term care homes, and other settings. In this document, healthcare facility does not refer to
52 Controlled Drugs and Substances Act. S.C. 1996, c. 19 (Current to April 24, 2018). Available from: http://laws-lois.justice.gc.ca/PDF/C-38.8.pdf 53 Frequently Asked Questions – Narcotic Control Regulations. Health Canada, 2015. Accessed: July 4, 2018. Available from: https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/frequently-asked-questions-narcotic-control-regulations.html
CSHP Diversion Guideline – Draft for Public Consultation 34
community pharmacies or practitioners’ private offices as these settings are subject to different regulations.
Healthcare organization An institution that includes multiple healthcare facilities, such as a health authority or a multi-site hospital system.
Narcotic Any drug listed in the Schedule to Narcotic Control Regulations. Used colloquially to describe any addictive drug that can reduce pain and cause stupor.
NCR Narcotic Control Regulations
Opioid Any drug resembling opium in its physiological effects. Examples include natural opioids such as morphine and codeine, semi-synthetic opioids such as oxycodone and hydromorphone, and synthetic opioids such as fentanyl.
Pharmacy and Therapeutics Committee
A committee that is composed of representatives from the pharmacy service, medicine, nursing, hospital administration, and other disciplines which serves as a policy-recommending body on all matters relating to the use of medications in a hospital. May be known by other names, e.g., pharmacology committee, pharmacotherapy committee.
Pharmacy staff May include pharmacy practitioners (pharmacists and regulated pharmacy technicians), pharmacy assistants, pharmacy students, and pharmacy technician students. Consideration should be given to limiting management of controlled substances to pharmacy practitioners.
Shall A mandatory requirement found in legislation, regulation, accreditation standards, or professional regulatory authority requirements.
Should A recommendation, something that is advised but not mandatory.
Unserviceable stock Any drug product in the pharmacy inventory that is unusable, expired, or that cannot be dispensed. In the hospital setting, this does not include partial or unusable doses outside of the pharmacy.54,55
Unusable drugs Unserviceable stock, as well as any drugs outside of the pharmacy that cannot be administered to a patient. This may include partial doses as well as other forms of wastage.
Acknowledgements [Members of the guideline development group will be acknowledged in the final version.]
54 Guidance Document for Pharmacists, Practitioners and Persons in Charge of Hospitals: Handling and Destruction of Unserviceable Stock Containing Narcotics, Controlled Drugs or Targeted Substances. Health Canada, 2018. Accessed: July 7, 2018. Available from: https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/controlled-substances/compliance-monitoring/compliance-monitoring-controlled-substances/unserviceable-stock.html 55 Destruction of Narcotics, Controlled Drugs, and Targeted Substances. Ontario College of Pharmacists, 2018. Accessed: July 18, 2018. Available from: http://www.ocpinfo.com/practice-education/practice-tools/fact-sheets/destruction/
