Audit of the Handling of Controlled Drug Substances in FNIHB Health Facilities Within Two Selected Regions Manitoba and Ontario/Nunavut April 11, 2006

Executive Summary

Introduction

The audit of the Handling of Controlled Drug Substances¹ in FNIHB Health Facilities within Two Selected Regions was added to the 2004-05/2005-06 risk-based audit plan at the request of the Deputy Minister and the Associate Deputy Minister based on the results of a risk assessment conducted by the Audit and Accountability Bureau (AAB).

In health facilities where the drug program is under the supervision of the First Nations and Inuit Health Branch (FNIHB), and in locations where there is no pharmacist, FNIHB registered nurses who are the primary on-site health care providers have an expanded scope of practice which includes the distribution of controlled drug substances (CDS). The system for the distribution of CDS includes the receiving, storage, distribution and disposal of drugs. FNIHB manages approximately 74 health facilities (health centres and nursing stations) across Canada where the drug program is under its supervision and registered nurses are responsible for the control of CDS.

The audit scope encompassed an examination of the management of risks related to the custody, control, record-keeping and accounting of narcotics, controlled drugs, benzodiazepines and other targeted substances within the Manitoba and Ontario/Nunavut regions. Within each of these regions, one small remote nursing station was selected (Peawanuk in Ontario/Nunavut and Tadoule Lake in Manitoba) and one nursing station serving a larger patient base (Sandy Lake in Ontario/Nunavut and Cross Lake in Manitoba). Audit work covered CDS handling records for the 2003-04 and 2004-05 fiscal years, and previous years as required.

The objective of the directed audit was to assess the effectiveness of the controls in place to mitigate the risks and the residual risk status associated with the handling of CDS in FNIHB health facilities within two regions and formulate recommended courses of action for FNIHB by determining the level of compliance to the legal framework, HC policy and procedures for controlled substances; the degree to which risks are mitigated with adequate management controls; and the appropriate use of information for management decision-making.

Key Findings

In the Manitoba and Ontario/Nunavut regions, knowledge and awareness of the new FNIHB Policy and Procedures for the Control of Controlled Substances in First Nations and Inuit Health Branch Health Facilities (Policy and Procedures), issued December 1, 2004, appeared to be high. The degree of implementation of the Policy and Procedures in the Manitoba Region was high while in the Ontario/Nunavut Region the phase-in was moving at a more moderate pace in the Sioux Lookout Zone and needed substantial improvement in the Moose Factory Zone. Considering that the audit was conducted during the implementation phase of the Policy and Procedures, the audit noted that the Branch has made significant progress in strengthening the level of compliance to the legal framework for CDS in a number of areas.

As a result of the careful collection, analysis and examination of information pertaining to the objectives of this assignment, the audit identified four key findings, three of which are summarized below by sub-objective and the fourth audit finding although not directly related to the audit sub-objectives, is provided separately to highlight its significance. Items of a more minor nature will be directly addressed to each region by means of management letters. A table highlighting the extent of risk mitigation observed at the time of the audit in each of the two regions is attached as Appendix A.

1. The level of compliance to the legal framework, HC policy and procedures for controlled substances

A number of control elements have been established as prescribed procedures in the Policy and Procedures to ensure that each region establishes effective control over the handling of CDS, thereby minimizing the associated risks. These control elements are designed to meet the legal framework established by the Controlled Drug Substance Act and Regulations, and the Food and Drug Act and Regulations, and to enhance accountability over the handling of CDS in FNIHB regions. The audit noted a number of gaps in the application of the Policy and Procedures in the areas noted below.

The Controlled Substance Registers forms which nurses use to record the receipt, dispensing and destruction of CDS are considered one of the key documents in the CDS handling process. All the nursing stations visited were using the forms but there were varying levels of improvement needed in the information provided and in the record-keeping process. The conduct of controlled substance audits exceeded the national standard in Manitoba but has fallen well below the standard in the Ontario/Nunavut Region.

The established process related to the security of the CDS inventory requires that the various medications be counted and recorded on a regular basis, and that any discrepancies be investigated and reported. Any unresolved discrepancies must be reported to the Office of Controlled Substances within the Healthy Environments and Consumer Safety Branch, by means of a Controlled Drugs and Substances Loss/Theft Report, after the Report has been reviewed and signed by the appropriate regional authority. The auditors were unable to locate documentation confirming that all unresolved CDS count discrepancies were consistently reported to the required regional authorities and the Office of Controlled Substances.

In both the Manitoba and Ontario/Nunavut regions, the pharmacies which supply wardstock CDS to the nursing stations also carry out the destruction of expired CDS. A written request for destruction must be initiated by nursing stations for all expired drugs from both the wardstock inventory and patient-specific CDS prescriptions to avoid their accidental utilization or diversion, and the overstatement of usable CDS wardstock. The audit found that there were expired CDS medications in all four of the nursing stations visited and that there was no rigourous process in place to ensure that the procedure for initiating the destruction of expired medications is being followed.

2. The degree to which risks are mitigated with adequate management controls

The audit found that the Manitoba Region is in the process of developing, refining and formalizing its monitoring/oversight function to ensure that the management controls are in place and working, however the auditors could find no evidence that all the required reporting is communicated by the zone offices to the Ontario/Nunavut Regional Office or that a regional position had been designated as the Regional Controlled Substances Officer (RCSO).

The FNIHB Professional Practice Advisory Committee has commissioned a Pharmacy Sub-Committee whose regional membership is comprised of one person from each region and whose responsibilities include identification of compliance gaps between the new Policy and Procedures and the old policy, and the creation of a National Formulary. The audit notes that the Sub-committee's nation-wide monitoring of the new policy's implementation is a proactive activity aimed at identifying and mitigating risks in the handling of CDS.

A number of initiatives have been completed or are underway in the Manitoba Region to enhance the delivery of pharmacy services and in the Sioux Lookout Zone of the Ontario/Nunavut Region to develop standardized narcotics audit tools. It would be beneficial to share CDS handling information and practices to ensure standardization across all regions and reduce redundancy. The Pharmacy Sub-Committee may be a good forum for sharing and promoting best practices at the national level.

3. The appropriate use of information for management decision-making

The auditors were unable to make a conclusion on this audit sub-objective due to the fact that the previous audit findings indicate that there is not yet a formalized process in place to provide management with the required level of information within the two regions audited or at a national level.

4. Handling of Patient-Specific Prescriptions

On a national level, there is a need to enhance and standardize the procedures for handling patient-specific CDS held at nursing stations. Both regions audited provide client communities in remote areas with the convenient service of temporarily holding prescriptions in nursing stations until they can be picked up by the patients. The current process, as observed by the auditors in the Manitoba Region and the Moose Factory Zone of the Ontario/Nunavut Region, does not provide documented confirmation that patient prescriptions for CDS were actually released to the prescribed patient. Although the Branch keeps individual patient medications at nursing stations as a service to communities, there is an implied responsibility to safeguard the CDS and an implied accountability for the Branch to establish a documented record of their distribution to clients. There is a need to securely store individual patient prescriptions and maintain a traceable record of all patient specific medications stored at the health facility for subsequent delivery to patients, including CDS prescriptions. Unclaimed patient-specific medications should also be returned to the dispensing pharmacy after being held at the nursing station for a reasonable length of time.

Conclusion

In conclusion, the auditors noted that the Branch has actively improved and promoted the direction and process for the handling of CDS in FNIHB health facilities where the drug program is under Branch supervision. The audit work highlighted the gaps between the framework outlined in the Policy and Procedures and the on-site application in the two regions visited by the audit team while recognizing the work and dedication of the nursing professionals who daily strive to meet the health-related needs of remote First Nation communities. The auditors noted the need for continued Branch focus on this area to increase compliance with the Branch Policy and Procedures; to ensure that formal processes, mechanisms and controls are in place within each region; and that effective monitoring/oversight and remedial actions are carried out on a regular basis as measures to mitigate the risks associated with the handling of CDS in health facilities.

The audit team wishes to thank all those who generously contributed their time and effort during the conduct of this audit assignment, including the FNIHB nursing staff who supported the audit team during the on-site visits to nursing stations.

Recommendations

It is recommended that:

1. The Assistant Deputy Minister of the First Nations and Inuit Health Branch ensure that FNIHB regions comply with the Policy and Procedures for the Control of Controlled Substances in First Nations and Inuit Health Branch Health Facilities in all aspects including count discrepancies, the handling of expired medications, the consistent conduct of controlled substances audits and all reporting requirements.
2. The Assistant Deputy Minister of the First Nations and Inuit Health Branch take action to ensure that the required level of consistent CDS reporting is carried out in all regions and that emerging risk areas in CDS handling are reported in a timely manner to Branch management by requiring that:
   1. the Manitoba Region further refine the quality of CDS reporting and finalize a formal process for the monitoring/oversight role;
   2. the Ontario/Nunavut Region meet the reporting requirements of the Policy and Procedures and develop a process to perform a regional monitoring/oversight role; and
   3. Branch management adopt a Branch-wide method to oversee development of the regional and Branch-wide monitoring/oversight role.
3. It is recommended that the Assistant Deputy Minister of the First Nations and Inuit Health Branch commission a review of the method used for handling patient-specific prescriptions for controlled drug substances in FNIHB health facilities, in order to achieve proper accountability, tracking and oversight of the CDS while respecting the professional liability of the nurses and pharmacists involved, and to better achieve the Branch objective of further promoting First Nations healthcare ownership.

Note: Management responses to each of the audit recommendations are included in the body of the report.