Audit of Medication Management

Internal Audit Report

378-1-277

November 13, 2012

Table of Contents

 

EXECUTIVE SUMMARY

Background

The Audit of Medication Management was conducted as part of Correctional Service Canada's (CSC) Internal Audit Sector 2011-2014 Risk-Based Audit Plan. This audit links to the CSC corporate priorities of "safety and security of staff and offenders both in the institutions and in the community" and to "efficient and effective management practices that reflect value based leadership." In addition, this audit will also link to the corporate risks of "essential health care for offenders" and "safety and security. The audit is material as providing offenders with efficient and effective health services is a legislative obligation contained in the Corrections and Conditional Release Act (CCRA). It is also an essential requirement for CSC to fully contribute to the offenders safe reintegration into society and to achieve its Mission.

In Fiscal Year 2011-12 CSC spent a total of 18 million dollars on medication. These funds, which are managed by the Health Services Sector, represent the cost of the medication being provided to offenders. In order to minimize the cost of drugs, Public Works and Government Services Canada has created a National Master Standing Offer with a health-related products national supplier to deliver medicines and health products to CSC and other Departments of the Government of Canada. This standing offer provides a "one stop shop" service to the Federal Government, including CSC, for the purchase of pharmaceutical products at a discount price due to larger purchasing volumes. The Regional Pharmacies within CSC typically order their drugs directly from this supplier and the majority of institutions typically use the services of the regional pharmacies, where available, to fill the required prescriptions.

The Audit of Medication Management was national in scope and focused on medication being provided by CSC Health Services to offenders while they are in a federal institution.

The objectives of this audit were:

  • to provide reasonable assurance that the management framework in place supports the effective management of medication; and
  • to provide reasonable assurance that CSC is complying with relevant legislation and policy related to the management of medication.

Conclusion

Overall, the audit found that a framework was in place to support the management of medication. A number of CDs and health services guidelines were in place to support the management of medication and these policies and guidelines were in line with applicable legislation and professional standards. In addition, clinical roles and responsibilities were well understood by health services staff within the regions. Finally, formal monitoring and reporting requirements were documented.

However, there are areas where additional work can be done to improve the management framework. These include:

  • formalizing processes to ensure that health services policy and guidelines are shared with operational staff;
  • ensuring that operational staff are aware of specific responsibilities related to their role in the management of medication, namely the requirement to complete threat risk assessments (TRAs) for any offender carrying EpiPens and Insulin needles; and
  • ensuring that sites are completing all of the required monitoring reports.

Moreover, CSC was complying with legislation and professional standards on a number of areas including educating offenders on their medication, maintaining offender privacy, and disposing of medication. However, CSC's compliance with other areas related to the management of medication could be improved. These include:

  • ensuring that the allergy status in the pharmacy systems is accurate;
  • preparing medications and signing the medication administration record (MAR) at the appropriate times;
  • delivering medication directly to health services staff and reconciling the orders once received; and
  • maintaining the appropriate levels of wardstock medication in their inventories.

Office of Primary Interest Response

The Health Services Sector agrees with the audit findings and the recommendations as presented in the report. We have prepared a detailed action plan to address the issues raised in the audit. More details on the actions to be taken have been provided for each recommendation. All actions to address recommendations are to be implemented by October 2013.

STATEMENT OF ASSURANCE AND CONFORMANCE

This engagement was conducted at a high level of assurance.i

In my professional judgment as Chief Audit Executive, sufficient and appropriate audit procedures have been conducted and evidence gathered to support the accuracy of the opinion provided and contained in this report. The opinion is based on a comparison of the conditions, as they existed at the time, against pre-established audit criteria that were agreed on with management. The opinion is applicable only to the area examined.

The audit conforms with the Internal Auditing Standards for Government of Canada, as supported by the results of the quality assurance and improvement program. The evidence gathered was sufficient to provide senior management with proof of the opinion derived from the internal audit.

__________________________________ Date: __________________
Sylvie Soucy, CIA

1.0 INTRODUCTION

1.1 Background

An Audit of Medication Management was conducted as part of Correctional Service Canada's (CSC) Internal Audit Sector 2011-2014 Risk-Based Audit Plan. This audit links to the CSC corporate priorities of "safety and security of staff and offenders both in the institutions and in the community" and to "efficient and effective management practices that reflect value based leadership." In addition, this audit also links to the corporate risks of "essential health care for offenders" and "safety and security." The audit is material because providing offenders with efficient and effective health services is a legislative obligation contained in the Corrections and Conditional Release Act (CCRA). It is also an essential requirement for CSC to fully contribute to the offenders safe reintegration into society and to achieve its Mission.

In Fiscal Year 2011-12, CSC spent a total of $18 million on medication. These funds, which are managed by the Health Services Sector, represent the cost of the medication being provided to offenders. In order to minimize drug costs, Public Works and Government Services Canada has created a National Master Standing Offer with a national supplier of health related products to deliver medicines and health products to CSC and other Government of Canada Departments. This standing offer provides a "one stop shop" service to the Federal Government, including CSC, for the purchase of pharmaceutical products at a discounted price due to larger purchasing volumes. The regional pharmacies within CSC typically order their drugs directly from this supplier, and the majority of institutions typically use the services of the regional pharmacies, where available, to fill the required prescriptions.

CSC currently has four regional pharmacies supplying the majority of the institutions, and it is anticipated that a regional pharmacy will be opening in the Quebec Region in the fall of 2012. At the time of the audit, the vast majority of sites in the four regions outside of Québec were receiving their medications directly from a regional pharmacy. In Quebec, institutions either had their own pharmacies on site or arrangements had been made with an outside pharmacy to supply the medication for CSC's offenders.

1.2 Legislative and Policy Framework

Health service delivery within CSC must adhere to the CCRA1 which states that the Service shall provide every inmate with essential health care that will contribute to the inmate's rehabilitation and successful reintegration into the community. The CCRA also states that the provision of health care shall conform to professionally accepted standards.2

CSC Policies relating to medication management must respect Federal Regulations such as The Controlled Drug and Substances Act and Canada's Food and Drugs Act and Regulations when storing3, preparing, transporting, dispensing, documenting medications and reporting medication events4.

Since CSC pharmacies and institutions are located in different provinces, health care staff, including those at the pharmacies, are also subject to applicable provincial/territorial professional standards of practice, laws, legislation and policies.

Commissioner's Directive 805 Administration of Medication

The purpose of Commissioner's Directive (CD) 805 is to ensure the safe, legal and cost effective management, storage, recording, dispensing and administration of medication in order to meet CSC's obligation to provide health care, in accordance with the Corrections and Conditional Release Act (CCRA).

The CD outlines the definitions and responsibilities related to the pharmacy services, including administering, ordering, delivering and dispensing of medication. The CD describes the responsibilities of the Health Services Sector regarding the development and maintenance of a drug formulary; the institutional and regional responsibilities relating to auditing and monitoring all elements of the institutional pharmaceutical process; the appropriate licensing of staff and the responsibilities of nursing and non-medical staff regarding the management and administration of medication, including methadone, narcotics and controlled substances. The policy provides clarity on prescribing medications, on self-administering of medication by offenders, on the necessary documentation, and on the delivery of medication by non-medical staff.

Regional Pharmacy Services: Operations and Standards Manual

CSC has adopted the Model Standards of Practice for Canadian Pharmacists, which have been developed by the National Association of Pharmacy Regulatory Authorities (NAPRA). The standards are intended to provide guidance to pharmacists when undertaking activities that require safe and effective pharmacy practice. While there are a variety of professional roles fulfilled by pharmacists, not all pharmacists perform each of the roles as part of their daily work. When they do, they are expected to achieve the level specified in the standards. In this way, regardless of the setting or regulatory authority, the expectation of care associated with a particular role is consistent.

Medication Distribution and Administration Manual

These guidelines, developed by CSC, are intended to help ensure that health care professionals follow best practices for regarding medication distribution and administration, and to decrease medication events. The guidelines also outline a nationally accepted approach to providing medications to inmates in CSC institutions, as well as guidance with regard to managing medications provided by CSC Health Services through the multi-dose distribution of medication. The guidelines also offer guidance to health services staff in the management and distribution of an EpiPen and insulin. Furthermore, they aim to ensure that offenders who require an EpiPen or insulin receive instructions on the medication's use and understand their responsibilities.

CSC National Formulary

The purpose of the CSC National Formulary is to provide a tool for physicians and pharmacists to encourage the selection of optimal, cost effective drug therapy. All CSC institutions must abide by the National Formulary.

1.3 Previous Audits

While the Internal Audit Sector has not previously completed an audit regarding the management of medication, the administration of prescription medication was included as part of the 2009 Audit of the Regional Treatment Centres and the Regional Psychiatric Centre.

One of the criterion for this audit related to the administration of medication at the treatment centres. The audit found that at three of the five treatment centres visited, the nurse signed the medication and administration record when the medication was prepared, as opposed to when it was administered, as required by policy. The audit also observed issues with how controlled drugs were being secured in the medication room and how the drugs were being transported between the medication room and other areas within the institution.

A recommendation was made that Regional Deputy Commissioners ensure that policies on the administration of medication are being followed when medication is administered to inmates. This audit followed-up on the action plan to ensure that these concerns have been addressed.

1.4 Health Services Quality Improvement Initiatives

Accreditation - The CSC Health Services Sector had requested that Accreditation Canada conduct a national accreditation survey of National Headquarters, the five regional headquarters and the 57 CSC institutions. The survey resulted in Accreditation Canada awarding CSC with an Accreditation with condition. Accreditation Canada identified areas for improvement and committed to supporting the organization in order to continue to improve the quality of care and services it provides to its clients and the community.

In the National Accreditation Report, Accreditation Canada found that medication management is an area that requires attention in all regions, since many high-risk criteria were found to be unmet, including:

  • a need for more modern computer systems;
  • a need for a medication count upon receipt of medications in the institution;
  • labeling of medication storage shelves;
  • a need to improve the physical space and facilities in some regions and sites;
  • a need for increased surveillance of facility medication rooms;
  • a need for more secure dispensing methods; and
  • a need to train nursing staff.

Many of these concerns were considered as part of this audit.

1.5 Health Services Governance

Health Services Roles and Responsibilities

On September 4, 2007, the Health Services Branch was converted to a Sector, headed by an Assistant Commissioner, Health Services, reporting directly to the Commissioner of CSC.

National Headquarters (NHQ)

This diagram represents the National Headquarters (NHQ)Health Services Governance.

At the national level, health services governance is comprised of the Assistant Commissioner Health Services and is supported by four Director General (DGs) with functional authority for the Public Health Branch, the Mental Health Branch, the Policy, Planning and Quality Improvement Branch and the Clinical Services Branch. It is the Director General Clinical Services who is responsible for the functional direction of the issues surrounding medication in the institutions and the regional pharmacies.

Regional Headquarters (RHQ)

This diagram represents the Regional Headqquarters structure.

The health care portfolios in each of the five regions is managed by a Regional Director, Health Services, who reports directly to the Assistant Commissioner, Health Services at NHQ. The Regional Director is supported by four managers. All chiefs of health services from CSC Institutions report directly to the Regional Director, Health Services through the Manager, Clinical Services. The Regional Pharmacists report to the Manager, Planning, Pharmacy and Quality Improvement.

CSC Institutions

This diagram represents the <abbr>CSC</abbr> Institutions sturcture.

All nurses delivering physical health care at the sites ultimately report to their respective Chief, Health Services, who in turn ensures that appropriate levels of service and standardized health intervention are provided. It should be noted that institutional Health Services report to the Regional Manager, Clinical Services, and not to the Warden.

2.0 AUDIT OBJECTIVES AND SCOPE

2.1 Audit Objectives

The audit objectives were:

  • to provide reasonable assurance that the management framework in place supports the effective management of medication; and
  • to provide reasonable assurance that CSC is complying with relevant legislation and policy related to the management of medication.

The audit criteria in this engagement, which will assist us in meeting the audit objectives, originate from the Committee of Sponsoring Organizations (COSO) for the first objective and from CD 805 as well as some guidelines authored by the Health Services Sector for the second objective. Specific criteria related to each of the objectives are included in Annex A.

2.2 Audit Scope

The Audit of Medication Management was national in scope and focused on medication being provided by CSC Health Services to offenders while they are in a federal institution. The audit visited each regional pharmacy as well as a sample of institutions of all security levels and types in the five regions. A listing of the sites visited can be found in Annex C.

The audit assessed whether the management framework, including proper controls, was in place to support the effective management of medication, in compliance with professional standards and relevant CSC policies and procedures. To do so, the audit examined the process, from the time a medication was dispensed at the regional pharmacy to when the medication was administered to the offender at the institution. This audit also included the procedures surrounding the inventory management, storage, transportation and disposal of medication.

This audit did not examine controls around medication that offenders are able to obtain at the canteen. Furthermore, this audit did not examine the validity of the medication being prescribed by the physician. Finally, the management of medication for offenders in the community was scoped out of this audit because, while medication is being paid for by CSC Health Services, it is not typically dispensed or administered by CSC personnel.

3.0 AUDIT APPROACH AND METHODOLOGY

The audit team reviewed policies, procedures and legislation in place related to the management of medication, the roles and responsibilities of staff in the institutions and the regional pharmacies related to the medication process, and the monitoring and reporting that at these sites.

The audit team also assessed compliance with key legislation, policies and guidelines related to the management of medication. Key documents reviewed included many of the provincial professional standards for nurses and pharmacists, Commissioner's Directive 805, Administration of Medication, the Medication Distribution and Administration Guidelines, and the Regional Pharmacy Operations and Standards Manual. Compliance was tested through observations, file reviews and interviews with staff both at the institutions and in the regional pharmacies.

Annex B lists and describes the methodologies used to gather evidence to complete this audit.

4.0 AUDIT FINDINGS AND RECOMMENDATIONS

4.1 Framework for the Management of Medication

We assessed the extent to which a management framework was in place to support the effective management of medication. This included a review of legislation, professional standards, policies and guidelines, as well as the organizational structure of health services and the roles and responsibilities of those involved in the management of medication. We also reviewed monitoring and reporting mechanisms related to the management of medication within CSC.

4.1.1 Policies and Procedures

We expected to find that specific policies and procedures relating to the management of medication existed, that they were understood, and that they had been implemented. We also expected to find that these policies and procedures aligned with relevant legislation.

Policies and procedures related to the management of medication existed and were understood by health care staff.

Commissioner's Directive 805, Administration of Medication, exists to ensure the safe and legal management, storage, recording, dispensing and administration of medication. In addition to the CD, we also noted that the Health Services Sector has issued numerous policy guidelines including, but not limited to:

  • CSC's Regional Pharmacy Services Operations and Standards Manual (henceforth, referred to as the Regional Pharmacy Manual);
  • CSC's Medication Distribution and Administration Guidelines (henceforth referred to as the Medication Guidelines); and
  • CSC's National Formulary.

The majority of the health services staff interviewed had read the CD (78% - 42/54). Interviewees also told us that the CD did not include significant elements that were either unattainable or unfeasible. In addition, 80% (12/15) of the individuals interviewed in the pharmacies had read the Regional Pharmacy Manual and 65% (26/40) of the nurses and chiefs of health care reported that they had read the Medication Guidelines. The fact that some individuals had not read the manuals that relate to their duties could partially explain some of the compliance issues identified under Objective 2 of this report.

No formal process existed to ensure that policy or procedural changes relating to the management of medication are shared with operational staff at the institutions.

Following the accreditation process in September 2011, CSC introduced new policy guidelines, including the Regional Pharmacy Manual and the Medication Guidelines. During interviews at most sites, we were told that when new guidelines or policy changes are introduced, it is the responsibility of the chief of health services to share new or updated policies and procedures with operational staff. The audit team noted that in August 2011, a requirement was added to the Medication Guidelines stating that the assistant warden of operations, or equivalent, must ensure that a threat-risk assessment is done prior to an offender being permitted to carry either an EpiPen or insulin needle. That said, we found that eight of the 10 institutions visited where offenders carried either EpiPens or Insulin needles on them were not compliant with this policy. Many of the operational staff interviewed seemed to be unaware of this requirement.

CSC's CDs and guidelines that were reviewed relating to the management of medication were consistent with professional nursing and pharmacy standards.

The audit team compared a sample of topics, including the signature of the medication and administration records, and the preparation of medication and information sharing, against the CDs, guidelines and provincial and national professional standards. Overall, the audit team did not find any areas of concern or contradictions between the various written documentation.

4.1.2 Roles and Responsibilities

We expected to find that the Health Services organizational structure, as well as the roles and responsibilities of those involved with the management of medication, were clearly documented and understood.

All nurses we spoke with felt that they clearly understood their clinical roles and responsibilities. However, observations revealed that it was not always clear if they understood their role as it relates to security.

During interviews with health care staff and observations undertaken during the site visits, the audit team found that pharmacists, nurses and chiefs of health care typically understood their clinical roles. Many of the pharmacists and nurses stated during interviews that there is little difference in their roles, whether they work for CSC or work in the community.

The audit team did note that in some cases, while nurses understand their roles as a nurse, some may not fully grasp their role as it relates to working in a penitentiary. Most nurses interviewed stated that they had received very little formal CSC training and that the majority of learning was acquired on-the-job. Health Services has developed a New Nurse Orientation Training course to assist new nurses in learning their role as it relates to working for CSC. That said, the audit team found that very few of the nurses interviewed had received this training, and that in some regions, the course had yet to be offered.

Operational staff felt that they understand their roles and responsibilities as they relate to medication management, but were unaware of the requirement to conduct threat risk assessments for offenders who carry EpiPens or insulin needles.

During interviews wardens and assistant wardens of operation told the audit team that in their opinion, they feel that roles and responsibilities in relation to the management of medication are clear. Many stated that they do not have formally documented responsibilities related to medication. However, they were aware that they need to provide security and support health care during, including providing security while offenders wait in line to receive medication and observing the offenders for 20 minutes following the administration of methadone.

As previously stated in Section 4.1.1, assistant wardens of operations are required to conduct a threat risk assessment on any offender who the physician prescribes either an EpiPen or insulin and who will be carrying these needles on their person. That said, as the audit demonstrated a high level of non-compliance with this requirement, this indicated that operational staff were not fully aware of their formalized role in the management of medication.

4.1.3 Monitoring and Reporting

We expected to find an established process to report performance related to the management of medication at the national, regional and institutional levels.

Institutions were not completing all required monitoring and reporting.

Commissioner's Directive 805, Administration of Medication, states that the institutional Chief, Health Services, is responsible for auditing and monitoring all elements of the institutional pharmaceutical process. Our audit examined specific monitoring and reporting, including self-audits of medication rooms, medication spot checks, and medication events, and found that these reports are not always being completed as required by policy.

The self-audits of institutional medication storage areas and regional pharmacies are designed to ensure compliance with current pharmacy regulations and that acceptable standards of practice are maintained in the storage and handling of pharmaceutical supplies at all institutions and regional pharmacies. These self-audits are to be conducted on a monthly basis. At the 13 sites visited, the audit team requested copies of the self-audit for the two months prior to our visit, in order to assess compliance. The audit team found that 10 of the sites were compliant.

Nursing spot checks of inmate medication are required to be completed monthly for 10% of the inmates, up to a maximum of 20 spot checks. There are three main reasons for conducting spot checks of inmate medications. The first is to identify opportunities for patient education regarding medication administration. The second is to reinforce positive inmate practices in self-administering medication distribution. The third is to identify non-therapeutic self-administration practices and/or abuses of medication to determine if alternate methods of medication distribution are required. Using data provided by the Health Services Sector, the audit team reviewed compliance at the 13 sites where offenders were self-administering their medication to determine compliance over the seven-month period from September 2011 to March 2012. Only one of the 13 sites was compliant with completing the spot checks as required by policy. At many of the other sites, while they were compliant during some months, there were other months where no nursing spot checks occurred.

The audit team also examined the reporting of medication events. Medication events are any adverse event involving medications that may contribute to or result in harm to an offender. Reporting medication events is part of an overall quality improvement process to provide valuable information, even when the event did not cause any harm. The overall goal of reporting medication events is to prevent and reduce medication errors. Reporting these events is to be non-punitive and can be done anonymously. Medication events fall into three broad categories: "good save" incidents, which did not reach the offender; medication incidents, that reached offenders and may or may not have harmed them; and adverse reactions, which are those that reached offenders, were non-preventable and caused some harm.

During interviews with nurses and chiefs of health care, the audit team found that all interviewees were comfortable with the process, understood that the reason for reporting was for improving the process, and were not afraid of reprisal from such reports. Interviewees told us that they report medication events when required. That said, using data provided by the Health Services Sector, the audit team examined the number of medication events reported over a seven-month period from September 2011 to March 2012. While it is difficult to state how many medication events should have been reported by a site, an analysis of the data shows that some sites reported only one medication event during this period, while others reported as many as 79. In total, 7 of the 15 sites reviewed reported fewer than 10 medication events over the seven-month period, while five sites reported 20 or more medication events. As such, it appears that some sites may not be diligently reporting all of their medication events.

Many of the health services staff interviewed do not see the benefits of all the monitoring and reporting exercises that they completed. While staff are aware that this information is tracked for completion at the national and regional levels, the interviewees stated that they receive no feedback or analysis of the reports from the higher levels.

CONCLUSION

Overall, the management framework in place supported the effective management of medication.

The audit found the following:

  • the policies and guidelines were in place to support the management of medication and that these policies and guidelines were in line with applicable legislation and professional standards;
  • the clinical roles and responsibilities of health services staff within the regions were well understood; and
  • formal monitoring and reporting requirements were documented.

Although a number of areas audited have fully or partially met the expectations of the audit, we also found that:

  • no formalized process exists to ensure that health service policy and guidelines are shared with operational staff;
  • operational staff are unaware of specific responsibilities related to their role in the management of medication, namely the requirement to complete threat-risk assessment for any offender carrying an EpiPen and Insulin needles; and
  • sites are not completing all of the required monitoring reports.

Recommendation 1 5

The Assistant Commissioner Health Services should ensure that a formalized process is in place to share any policy or procedural changes related to medication management with other stakeholders in the regions and in the institutions.

Recommendation 2 6

The Assistant Commissioner Health Services, in collaboration with the Regional Deputy Commissioners should ensure that operational staff are completing threat risk assessments on any offender for whom health services staff have approved to carry and self-administer either EpiPens or insulin needles.

Office of Primary Interest Response

We agree with the recommendation 2 and we will ensure that there is a valid Threat Risk Assessment on file for inmates permitted to have EpiPens and Insulin Needles in their possession. Each Region will submit a plan with the proposed completion date to the Assistant Commissioner Health Services and Assistant Commissioner Correctional Operations and Programs by September 20, 2012.

Recommendation 3 7

The Assistant Commissioner Health Services should ensure that sites are completing all of the required monitoring and reporting including:

  • Medication Events;
  • Medication Spot-Checks; and
  • Medication Room Self-Audits.

Office of the Primary Interest Response

We agree with the recommendation 3 and we will formalise a process to report on medication events, medication spot checks and medication room self audits' by October 19, 2012.

4.2 Compliance with Policies and Guidelines

We assessed the extent to which CSC was in compliance with the relevant Commissioner's Directive and policy guidelines relating to the management of medication. This was done primarily through interviews and on-site observations.

4.2.1 Access to Regional Pharmacies and Institutional Medication Rooms

We expected to find controls in place to ensure that only authorized individuals had access to the regional pharmacies and institutional medication rooms.

No significant issues were found relating to access to either the regional pharmacies or the institutional medication rooms.

Commissioner's Directive 805, Administration of Medication, states that entry into the dispensary and supplies area of the Health Services Centre will be restricted and controlled by Health Services Staff. During observations, the audit team did not note any concerns with the access controls in place. We found that staff at the pharmacy and the nurses at the institutions control the keys to these restricted areas. Furthermore, we observed that the regional pharmacies and institutional medication rooms all have locked doors and windows to ensure that only authorized individuals may enter. The audit team did not observe any situations where non health services staff members were within the medication rooms.

During interviews at both the regional pharmacies and the institutions, most interviewees did not raise any concerns specifically pertaining to access to these medication storage areas, although other concerns were raised. For example, at one site, nurses had concerns that the medication room opened directly into an area where offenders regularly congregate.

We did note that in the treatment centres visited as part of this audit, the medication rooms were co-located with the correctional officer security offices. While this makes it difficult for an offender to access these areas, it allows correctional officers to easily access the medication rooms if nurses do not secure the rooms upon leaving.

4.2.2 Inventory

We expected to find that procedures were in place and being followed to ensure that the inventory levels of medications are reconciled and are within allowable limits, as per the CD and relevant guidelines.

While sites were compliant with maintaining a perpetual inventory system for inventory logs and were not always co-signed.

The Regional Pharmacy Manual states that a perpetual inventory system must be maintained for narcotics, controlled drugs and targeted substances, to ensure proper controls and to protect against losses, including internal diversion. For the pharmacies, the manual states that inventories on narcotics will be done at a minimum every three months, in conjunction with random reconciliations on specific narcotics. For institutions, the manual states that verification of this perpetual inventory must be done at the end of each shift, with outgoing and incoming nurses countersigning the balance on hand.

At all regional pharmacies, the audit found that a perpetual inventory existed for each narcotic and controlled substance dispensed. The audit team also found that regular verifications were conducted for each narcotic and controlled drug. At some of these pharmacies, we observed that the regular verifications were occurring as frequently as once per month, as interviewees stated that it was much less time consuming once errors were noted if they only needed to research the previous month of the perpetual inventory.

At the institutional level, it was confirmed that each medication room maintained a perpetual inventory of narcotic and controlled drugs.

Additionally, the audit team found that while all sites visited had a perpetual inventory system in place, there was evidence that the counts were not always co-signed by two nurses, as required. While there were occasions when counts could not be co-signed as only one nurse would be working the unit at that time, it was observed that at some sites that counts were rarely being co-signed.

Less than half of the institutions visited were maintaining the approved inventory levels of wardstock.

Wardstock medication is non-patient-specific supplies of medication that are kept at the institutional health centres. These drugs typically include commonly used PRN medication and drugs to be given to offenders as a first dose, until they receive their prescription from the pharmacy. CD 805 states that the amount of wardstock on hand must not exceed the required supply levels for a typical week. The Regional Pharmacy Manual states that each site, in collaboration with the regional pharmacist, must create a list to define what a week inventory level would be for that particular institution.

The audit team found that a list of wardstock supplies existed at 11 of the 13 sites visited. That said, at four of these 11 sites, the list provided only included the maximum number that could be ordered, not the maximum that could be on hand in the medication room. At the two sites that were unable to provide a list of wardstock, various reasons were given including that, in their opinion, it is difficult to determine what a one-week need for these drugs would be since situations are constantly changing.

At all sites visited, the audit team counted a sample of wardstock drugs to determine the current inventory levels and compared them to the wardstock lists in place at the institutions. The audit team found that at four of the 11 sites that had this list, wardstock inventory levels on some of the drugs were higher than the number on the approved list.

No controls exist to ensure the accurate and appropriate use of wardstock and to ensure that only the approved amounts of wardstock are being kept at the institution.

The Regional Pharmacy Manual states that all wardstock that has been administered to an offender must be reconciled with a corresponding order, which the order signed by the physician prescribing the medication. The manual also states that the nurse must enter the drug and reasons for its uses in the offender's health care record and must fax this information to the regional pharmacy, to be added into the offender's pharmacy profile.

During the site visits, the audit team raised concerns regarding the limited controls surrounding wardstock. Nurses and chiefs of health care told the audit team during interviews that they would note in the offender's file and on the Medication Administration Record (MAR) any wardstock medication administered to an offender, and that these medications were only administered if there was an order to do so. That said, we only found one region where nurses were informing the pharmacy of all wardstock medication being provided to their offenders and where the regional pharmacy was adding this information to the offender's pharmacy profile.

The audit team did note concerns that, while institutions are instructed to order only a one-week supply of wardstock, there were no controls in place to ensure that the actual inventory levels on hand were in line with the approved list. In addition, it is of concern that there was no process in place to monitor the inventory levels of wardstock because no reconciliation is occurring at any level between the medications ordered and the medications administered to offenders. Since no form of a perpetual inventory or reconciliation method exists for the wardstock inventory, it would be impossible for health services to validate how much wardstock has been given to offenders versus how much of it has been dispensed or disposed. Furthermore, these lacks of controls make it difficult for institutions to catch and stop any potential diversion of wardstock medication at the institutions. Wardens at some institutions raised additional concerns that if no accurate inventory of current wardstock existed at an institution, it would be difficult to determine the quantity of medication that offenders accessed, should they ever breach the medication room.

Patient specific medication was being kept as wardstock and not being returned to the pharmacy at five of the institutions visited.

A 2009 policy bulletin related to CD 805 states that when an offender is transferred or released, any remaining patient-specific medication will be returned to the regional pharmacy and will not be kept and used as wardstock. The Accreditation Canada Medication Management Standards states that separating these medications in the medication storage area prevents confusion and promotes patient safety. At five of the institutions visited, the audit team found evidence that patient specific medication was being used as wardstock.

4.2.3 Storage

We expected to find that medication is being stored in compliance with both CSC policies and procedures, professional standards, and any applicable legislated requirements.

Most medication rooms were well organized and arranged in accordance with policy.

The Regional Pharmacy Manual states that wardstock should be kept in a separate area from patient-specific blister cards, and medications for disposal should be stored separately from other medication. This practice is to prevent medication errors. In addition, the medication storage cupboards are to be constructed in such a way that their contents are not visible to offenders. The manual also states that these rooms must be clean, well lit, organized, clutter-free, properly ventilated and temperature controlled.

The audit team did observe that look-alike, sound-alike and high-risk medication were not always being stored separately. At many sites, it was observed that this was due to space constraints within the medication rooms. To alleviate these concerns, regional pharmacies typically either used tall man lettering to emphasize the name of the product of concern or used auxiliary labels on the packaging. These practices exist to provide an additional cue to nurses when administering these drugs, to ensure that they were administering the appropriate one.

The Regional Pharmacy Manual states that each Institutional Health Care Centre must store all narcotics, including methadone, controlled drugs and targeted substances, in a designated safe at all times.

All drugs which need refrigeration were always stored within the fridge, although many sites were not compliant with the requirements to complete the temperature logs.

The Vaccine/Refrigerated Medication Storage and Handling Guidelines require that refrigerated medications and vaccines be stored in the fridge with a constant temperature between two and eight degrees Celsius. It also requires that the temperature be assessed twice daily, once in the morning and once at the end of the day, and be recorded on a log kept on site for a period of one year.

While at the regional pharmacies and at the institutions, the audit team examined the medication available and found that all medication requiring refrigeration was in the fridge. The audit team also reviewed the current temperature of all refrigerators and did not find any instances where the temperature was outside of the acceptable range. That said, when we examined the temperature logs for the 60 days prior to the audit visit, we found that seven of the sites did not maintain a fridge log and complete it twice a day. At some sites, the audit team found that the responsibility for completing the log was assigned to a specific individual, such as the mental health nurse. As such, when the specific individual assigned with completing the fridge logs was absent from the institution, no one would complete the log. This creates a risk for the institution, as there would be no way to demonstrate how long the fridge temperature had been outside of the correct levels.

Not all sites were compliant with the procedures to provide offenders access to their medication after hours.

The Medication Guidelines define the procedure to be followed when non health care professionals provide medication access to offenders and allow them to self-administer medication that otherwise could not be issued. The procedure states that the medication is to be prepared in advance by an appropriate licensed health care professional and placed in a locked box to which the offender has the key. The Medication Guidelines state that the non health services staff's responsibility is limited to unlocking the designated location where the offenders' medication is placed, to allow the offender to remove his/her own medication and self-administer it. The manual clearly states that the non health care professional is not to handle or distribute medication to offenders.

The audit team found that only five institutions allowed non health care staff, normally correctional officers or correctional managers, to provide medication to offenders. However, at these five sites, the audit team heard that non health care staff was handling the medication and giving it to the offender, as opposed to simply providing the offender with access to the medication. In most cases, the medication was in an envelope and was handed to the offender, typically by a correctional officer or correctional manager. Only one site visited had lock boxes where offenders would be able to access their medication; however, this site did not use the lock boxes because they found it easier to have correctional managers deliver the medication to the offenders.

During interviews, the audit team heard concerns relating to correctional officers not being comfortable with their involvement in giving medication to offenders after hours. That said, if the sites that delivered medication to offenders after hours used the prescribed process, the responsibility of correctional officers would be minimized since they would only be providing the offender with access to the medication and not actually doing any task that could be construed as administering the medication to the offenders.

4.2.4 Dispensing of Medication

We expected to find that pharmacists and pharmacy technicians in the regional pharmacies were adhering to relevant federal and provincial legislation, CSC CDs and CSC guidelines relating to the preparation and dispensing of medications.

There is no national pharmacy system being used.

One consistent issue raised by the regional pharmacists interviewed was that no national pharmacy system is being used within CSC. Each region is using a different system to manage its pharmacies. This creates a challenge for the pharmacies when implementing procedures, since each pharmacy system has different capabilities. For example, the pharmacy system in some regions allows the pharmacy to maintain an up-to-date, accurate, perpetual inventory for each drug, while others are unable to use their system for inventory management. The audit team also heard numerous concerns in some regions that the system being used was out of date and was no longer supported by the company that created it. In one region, pharmacy staff raised concerns that drug interaction information, which was a part of the system, was no longer being updated. Pharmacists use this information as an extra control to make sure there will be no drug interaction. That said, pharmacists in this region stated they could not rely on that information as it was out of date and no longer accurate.

All pharmacists had up to date pharmacy licenses.

The professional standards for pharmacists require that all pharmacists hold a valid license through the college of pharmacists in the province where they are working. Through a review of the online database of pharmacists in each province, the audit team was able to confirm that all pharmacists who were either employed or contracted by CSC and who were working in the regions held a valid pharmacy license. The audit team did note that there was no national or regional tracking procedure or process to ensure that all pharmacists maintained up-to-date licenses. In most regions, this task is the responsibility of the regional pharmacist.

The allergy status information in the pharmacy system was not always entered or it did not always match the information in the offender's file.

The Regional Pharmacy Manual requires that all drug allergies and adverse drug reactions be entered into the pharmacy system. The pharmacy system should automatically alert the pharmacists when an offending medication is being dispensed. When an offender arrives at a new institution, nurses must complete a thorough preliminary assessment, including the medication reconciliation form, within 24 hours. This form, which outlines all the offender's medication, also includes an area for any known allergies to be documented. This information, including the offender's known allergy status, is then forwarded to the pharmacy and entered into the pharmacy system.

The audit team verified a total of 150 offender files and reconciled the allergy status within each offender's health care file to the information within the pharmacy system. In 43% of the files (45/104), the audit team found that while the offenders file showed no known drug allergies, the pharmacy system was blank. As such, a pharmacist examining the pharmacy system would not know whether the offender had no known drug allergy or whether the information had not been entered into the system. Of greater concern, however, the audit team found that in 7% of the cases (11/150), the offender had an allergy recorded in the file but the pharmacy system either stated no known drug allergy or was blank. For example, in two files, the audit team found that the offenders were allergic to penicillin whereas the pharmacy system contained no such information.

Pharmacists informed us that the system is the control in place to warn them of any potential drug allergy. If the information in the system is not up-to-date, pharmacists could possibly dispense life-threatening drugs to an offender.

4.2.5 Administration of Medications

We expected to find that nurses were following relevant federal and provincial legislation, CSC policies and guidelines pertaining to the distribution and administration of medication.

All but two of the nurses at the institutions visited had valid up-to-date nursing licenses, although no formal process existed to track this information.

The professional standards for nurses require that they hold a valid license through the college of nurses in the province where they are practicing.

Through a review of the nursing licenses publicly available on the provincial college of nurses websites, the audit team verified the license status of the nurses employed at the sites included as part of this audit. Where discrepancies were found, confirmation was received from the colleges validating the license status of the nurses in question. Of the 260 nurses reviewed, all but two of them had a valid up-to-date license. One of these individuals was currently on leave from work and was not a practicing nurse. That said, at one site, the audit team found that one nurse was working but had not yet paid the required licensing fees for the current year and was working with a license that had expired one week prior to the audit. The situation was quickly rectified by the site and the employee was immediately placed on leave until the license was reactivated.

In the audit of the Regional Treatment Centres and the Regional Psychiatric Centre conducted in 2009, it was noted that there was no standardized practice for confirming that health care providers were members in good standing with their respective licensing body. This concern still exists at the time of this audit, since the audit team found that in the majority of regions, the chiefs of health care are responsible for ensuring that the nurses working in their institutions hold up–to-date licenses.

Some institutions were preparing medication too far in advance and not signing the medication administration record as per professional standards.

The Medication Distribution and Administration Manual states that offender medication is not to be pre-poured, and requires that unit dose oral medication remain in the pharmacy's packaging until it is administered to the offender. The professional standards allow for the preparation of medication in advance providing it is done shortly before it is to be administered, that the nurse who prepares it remains with the medication at all times and that this same nurse will administer it to the offenders. For the purpose of this audit, the audit team differentiated between preparing, which could take place an hour or two in advance with the nurse remaining with the medication at all times, and pre-pouring, which could occur hours before the administration of the drugs and be left unattended by the nurse who prepared it.

During observations of the medication parades, the audit team found that at five sites, nurses were preparing medication only at the time when it was administered. At an additional five sites visited, the audit team found that nurses were still compliant with the policy because they were preparing the medication shortly before administration by placing it in marked cups or envelopes, although they would ensure that the medication remained secured until the time of administration. At these sites, the nurses told us that they do not feel comfortable pre-pouring medication any further in advance as it increases the chance of the offender receiving incorrect medication. At three other sites, the audit team found that nurses were clearly pre-pouring medication hours before its administration and were leaving it unattended, sometimes overnight. While nurses explained that this practice exists due to time limitations for the delivery of medication, it was noted that this is against the standards of practice for nurses and increases the likelihood of a possible medication error.

The professional standards for nurses require that nurses review the Medication and Administration Record (MAR) when preparing the medication but only sign the MAR once the medication has been administered. This signing should take place either at the time of administration or shortly thereafter, once the medication parade is completed. The audit team noted however that at two sites, the MARs were being signed when the medication was being prepared. In these cases, nurses explained that although they signed the MAR when preparing the medication, they would ensure that the MARs were updated by crossing out the entry for any offender who did not receive their medication that day. This practice also goes against the standards of practice for nurses. Concerns were raised by the audit team, as it was stated that if the medication was dropped or accidentally mixed up, there would be no way to confirm which offenders had been given their medication and which ones had not.

Nurses were always requesting the offender's identification card prior to providing or administering medication.

The Medication Distribution and Administration Manual requires that prior to distributing or administrating medication, nurses must verify the identity of the offender by using their photo identification card. Nurses are not to rely on the cell location of the individual to ascertain the identity because offenders may move cells and health care may not have been made aware of this cell change.

At all sites visited, the audit team saw that nurses were typically verifying the identity of the offenders by looking at their identification card. That said, at one site the audit team noted that offenders needed to be prodded to produce their identification card and that offenders seemed surprised by this request. This led the audit team to believe that this practice of always reviewing the identification card may not occur on a regular basis. Furthermore, the audit team noted that many offenders in segregation and in some units within treatment centres did not always have their identification cards on them. In these cases, nurses relied on the unit correctional officers and the cell location of the offender to determine their identity. This leads to an increased risk of offenders being given the incorrect medication.

Nurses were able to discuss medication concerns with offenders and ensure that they understand the medication which they are taking, although maintaining offender privacy can sometimes be a challenge.

The Medication Guidelines require that nurses educate the offenders on their medication, especially for those who will self-administer it. The guidelines state that nurses should provide any literature available on the medication to the offender and discuss with them all relevant details including purpose, dose and side effects, and that they should allow the offender to ask any questions that they may have.

During interviews with nurses, the audit team found that they are cognizant of their responsibilities to ensure the offender is educated regarding their medication. In some regions, the regional pharmacies attached an information document to each new prescription being given to the offender. In other regions, the regional pharmacies prepared a binder of drug information sheets for the most common medication, and the nurses provided the offender with this information. During interviews with members of the inmate committees, the audit team heard that, for the most part, nurses were fairly good at providing offenders with the information on their medication, although it was sometimes up to the offender to ask for this information. That said, all inmate committee members interviewed agreed that nurses were willing to answer questions on their medication when asked.

During observations, however, the audit team noted that maintaining patient privacy can be a challenge at some sites, depending on the physical layout of the medication dispensing area. For example, at some sites nurses go to the offender's cell and have discussions regarding medication through the cell doors. In some other site, it was observed that the dispensing area would be in an open corridor, with individuals walking past. Nurses were aware of the importance of maintaining confidentiality, however, at many sites where these discussions cannot take place during the medication parade, nurses stated that they bring the offender back to the health care unit to educate the offender.

Nurses were typically observing offenders ingest their medication for drugs that are required to be administered as direct observed therapy. That said, concerns were raised regarding the direct and constant 20-minute observation period following methadone administration.

The Medication Distribution and Administration Manual requires that, when nurses are administering medication through direct observation (as opposed to self-administer by the offender), they are to do one of the following: have the offender open his/her mouth, have the offender speak to them or have the offender drink water. Through observations at the sites, the audit team had no concerns with the process used to directly observe offenders taking these drugs. In some instances, nurses explained to the audit team that not all offenders need to be observed taking their drugs. In some cases the offenders are not given specific medication to self-administer because they may be pressured to divert this medication. However, by having them come to the health care unit for the medication, this pressure diminishes significantly.

While the audit team noted that nurses administering methadone were very cognizant of ensuring that the offender ingested their medication, some concerns were observed by the audit team in relation to the direct and constant observation for 20 minutes following the administration. It appeared to the audit team that while it was typically correctional officers conducting the supervision, many did not ensure constant and direct observation. The intended purpose of the 20 minute observation is to further ensure offenders do not divert their methadone. As such, by not conducting constant and direct observation, there is an increased chance of methadone being diverted.

4.2.6 Transportation of Medication

We expected to find that health services staff, both in the regional pharmacies and within the institutions, followed CSC policies regarding the transportation and receiving of medications.

All drug deliveries between the regional pharmacies and the institutions were being delivered by authorized methods, were being stored in locked tamper resistant boxes and were typically being received directly by health care staff at the institutions.

The Regional Pharmacy Manual requires that medications be delivered to the institutions in secured medication boxes. This manual also states that medication deliveries are to be delivered directly to the health care unit. If this cannot be done, health care staff must be contacted to receive the order.

During interviews with nurses and during observations at the sites, the audit team found that at the 11 sites visited that were receiving medication from an off-site pharmacy, a formalized process existed to receive medication deliveries from the pharmacy. This delivery process varied between sites and regions but typically consisted of either a CSC driver or a contracted courier doing the deliveries. At all of the sites visited, the audit team found that medication deliveries were being sent to the institution in either locked boxes or were secured with tampered-resistant numbered tabs. At one site it was only the first day that this institution had implemented this process. Upon further follow-up, the institution confirmed that this process has now been fully implemented.

During on-site observations and interviews with nurses, the audit team found that three sites did not ensure that drugs were given directly to health services staff. At these sites, it was observed that medications were either received in the warehouse or were received at the front gate and would be held there until a nurse would be able to take the medication down to the health care unit. During interviews, the audit team found that this practice occurs because either nurses were too busy to leave the health care unit at the time when the drugs arrived or that the site will only move drugs while the offenders are locked in their cells.

If medication deliveries are left with non health care staff, the medication could be left unattended and possible diversion of it could exist. Furthermore, the risk exists that drugs requiring a cold chain to remain effective these drugs may be left outside of the health care unit for any length of time potentially causing the cold-chain to fail. This could force institutions to either use medication that could have been exposed to a broken cold-chain, rendering them less effective or disposing of this medication.

Few institutions were consistently reconciling the medication orders received from the regional pharmacies.

The Regional Pharmacy Manual requires that nurses receiving medication shipments verify that all items are present and report any discrepancies to the regional pharmacists so they can be investigated accordingly.

Through a combination of interviews and observations completed while on site, the audit team found that only six of the 13 sites were consistently verifying the contents of the medication shipment against the packing information from the pharmacy. At three of the institutions visited, we were informed that this comparison did not occur because it was deemed that the benefit of doing so was not worth the time involved. At the remaining four institutions, we found that, depending on the specific nurse and the workload at the time of the order arriving, this practice would only occur upon occasion.

During discussions with the national and regional pharmacists, the audit team was told that this reconciliation is not required as it is a duplication of work. The pharmacy already reconciles the order when placing the medication in the boxes for delivery. That said, if an issue with missing inventory is not detected when the order is received by the health care unit, when the offender comes for the medication, it may not have it readily available. Furthermore, it could be challenging to determine when the medication went missing and to look for the cause.

4.2.7 Disposal of Medication

We expected to find that processes existed to ensure that the disposal of medication at both the regional pharmacies and the institutions is being conducted in accordance with CSC policies and guidelines and in accordance with relevant legislation.

The majority of sites visited were returning all medication requiring disposal to the regional pharmacies.

The Regional Pharmacy Manual states that all discontinued or outdated offender medication are to be returned to the pharmacy. Any medication still in sealed, unopened containers may be re-issued by the regional pharmacy, while all other medication is to be disposed of by the pharmacy.

At all but one site visited, the audit team observed that all medication that requiring disposal was always returned to the pharmacies for disposal. We noted that the non compliant site was receiving its medication from a local contract pharmacy because there was no capacity at the regional pharmacy to take on this site. The contract pharmacy would not accept any returns of medication from this site. At the time of the audit visit, the audit team noted that, while this site was returning all unused methadone to the regional pharmacy for disposal. Following discussions with the regional pharmacist, this site confirmed that they will now return all narcotics to the regional pharmacy for disposal.

Regional pharmacies ensured that all drugs requiring disposal were being disposed of according to policy.

The Regional Pharmacy Manual requires that when disposing of narcotics and controlled drugs, the regional pharmacy implement safe, legal and environmentally sound policies and procedures for the disposal of medication. For the disposal of narcotics and controlled substances, the manual states that these medications must be rendered unusable by creating some type of liquid substance for expired medications. Prior to the disposal of narcotics and targeted substances, permission must be sought from Health Canada.

During observations at the regional pharmacies, the audit team found that each of the pharmacies stored medication for disposal separately from other medication. The audit team also confirmed that all narcotics and controlled drugs were being rendered into slurry to make them unusable. At each regional pharmacy visited, the audit team verified that permission had been obtained from Health Canada prior to the disposal of narcotics.

4.2.8 Communication

We expected to find that staff were adhering to relevant federal and provincial legislation/regulations, CSC Guidelines and Commissioner's Directives regarding the sharing of information on offender medication.

No Commissioner's Directive existed related to the sharing of offender medication information, although nurses felt the standard of practice is fairly clear.

Although no specific CSC CDs or guidelines exist pertaining to the sharing of offender medication information, the audit team found various sources of documentation specifying what personal information can be shared. For example, CD 701, Information Sharing, states that personal health information is protected and may be shared with other CSC staff without consent, once the need to know has been established. The information shared must be limited to that which is relevant for the staff member in order to perform his or her duties. Other sources of reference include the Privacy Act and various provincial government legislation such as the Personal Health Information Protection Act (Ontario). The Professional Standards for Nurses in Ontario states that when a nurse learns information that, if not revealed, could result in harm to the client or others, following consultation with the health care team, this information can be shared with the person or groups effected.

During interviews, the audit team questioned whether it was clear to both health services and operational staff what information could be shared regarding an offender's medication. At most sites, the audit team found that nurses were comfortable with the offender medication information that they could share with the operational staff. Most of them stated that, while no CD exists, their standards of practice from their province were fairly clear in what information could be shared with non health care staff. Operational staff stated that, while they always prefer more information than nurses are prepared to share, they understand the confidentiality of patient medical information.

The audit team noted that the specific information being shared by health services to operational staff varied by institution. For example, at some sites the audit team was told that nurses would confirm to operational staff which medication an offender was on but would not tell them why they were taking it. At other sites the audit team was told that if operational staff would bring pills to nurses, they would confirm if they belonged to a given offender but would not say what they were.

The audit team noted that in 2011, the Health Care Sector released guidelines for the sharing of mental health information. That said, no similar document has been released stating what medication information can be shared and when it is appropriate to do so. As such, the decision regarding the amount of medication information being shared was left up to the discretion of the individual health services team at the institution and varied significantly between sites.

CONCLUSION

We found that overall, CSC was complying with relevant legislation and many of the professional standards that exist surrounding the management of medication.

We found the following:

  • access controls to the medication rooms were in place and the medication rooms and pharmacies were well organized and laid out;
  • all pharmacists and the vast majority of nurses held valid licenses as required by their position;
  • nurses ensure offenders are educated and aware of the medication they are taking and try to ensure offender privacy is maintained at all times; and
  • medication is being disposed of in accordance with CSC policies and applicable legislation.

There were, however, a number of areas audited where CSC was not compliant with certain requirements of policy, legislation and professional standards were found. These include:

  • the allergy status in the pharmacy systems was not accurate;
  • some institutions were preparing medication too far in advance and were not signing the MARs at the appropriate times;
  • deliveries of medication was not always being delivered directly to health services staff and many sites do not reconcile the orders once received;
  • wardstock inventory higher than the approved levels; and
  • many sites were not reconciling deliveries of medications when received at the institution

Recommendation 4 8

The Assistant Commissioner Health Services should ensure both sound management and compliance with policies relating to inventory levels and storage of medication by:

  1. ensuring that processes are in place to track and monitor the appropriate use of wardstock
  2. ensuring that institutions are not maintaining wardstock inventory higher than the site determined one-week limit;
  3. ensuring that all medication deliveries are given directly to health care staff and that institutions reconcile medication orders received.

Office of the Primary Interest Response

We agree with the recommendation 4 and we will implement a series of policies and procedures to improve the process and we will review compliance with policies, all actions to be implemented will be completed by March 31, 2013 and reviewed again on July 20, 2013.

Recommendation 5 9

The Assistant Commissioner Health Services should ensure that all offender allergies are accurately and timely entered into the pharmacy system.

Office of Primary Interest Response

We agree with the recommendation 5 and we will review all offender files and where necessary ensure information is accurately entered into the pharmacy system. Regions will provide monthly progress reports to the Assistant Commissioner Health Services and Regional Deputy Commissioners beginning October 31, 2012.

Recommendation 6 10

The Assistant Commissioner Health Service should ensure that institutions are not preparing medication too far in advance of its administration and that they are signing the Medication Administration Records at the appropriate times.

Office of Primary Interest Response

We agree with the recommendation 6 we will ensure that nursing practices conform to professional standards by November 9, 2012.

5.0 OVERALL CONCLUSION

Overall, the audit found that a framework was in place to support the management of medication. A number CDs and health services guidelines were in place to support the management of medication and these policies and guidelines were in line with applicable legislation and professional standards. In addition, clinical roles and responsibilities were well understood by health services staff within the regions. Finally, formal monitoring and reporting requirements were document.

However, there are areas where additional work can be done to improve the management framework. These include:

  • formalizing processes to ensure that health services policy and guidelines are shared with operational staff;
  • ensuring that operational staff are aware of specific responsibilities related to their role in the management of medication, namely the requirement to complete TRAs for any offender carrying EpiPens and Insulin needles; and
  • ensuring that sites are completing all of the required monitoring reports.

Moreover, CSC was complying with legislation and professional standards on a number of areas including educating offenders on their medication, maintaining offender privacy, and disposing of medication. However, CSC's compliance with other areas related to the management of medication could be improved. These include:

  • ensuring that the allergy status in the pharmacy systems is accurate;
  • preparing medications and signing the MARs at the appropriate times;
  • delivering medication directly to health services staff and reconciling the orders once received; and
  • maintaining the appropriate levels of wardstock medication in their inventories.

Office of Primary Interest Response

The Health Services Sector agrees with the audit findings and the recommendations as presented in the report. We have prepared a detailed action plan to address the issues raised in the audit. More details on the actions to be taken have been provided for each recommendation. All actions to address recommendations are to be implemented by October 2013.

ANNEX A

AUDIT OBJECTIVES AND CRITERIA

OBJECTIVES CRITERIA
1. To provide reasonable assurance that the management framework in place supports the effective management of medication. 1.1 Policies and Procedures CSC policies and procedures relating to the management of medication exist, are consistent with relevant legislation and industry standards, are communicated and are understood.
1.2 Roles and Responsibilities – Health Services organizational structure, roles and responsibilities relating to the management of medication are clearly defined, understood and documented.
1.3 Monitoring & Reporting – There is a process established to measure and report on performance at national, regional, and institutional levels, regarding the management of medication. This includes monitoring compliance and assessing continuous improvement.
2. To provide reasonable assurance that CSC is complying with relevant legislation and policy related to the management of medication. 2.1 Pharmacy and Medication Room Access – Controls are in place and are being used to ensure that only authorized individuals have access to the pharmacies and medication rooms.
2.2 Inventory – Procedures are undertaken to ensure that the inventory levels of medication are reconciled and are within allowable limits as per CSC Guidelines and Commissioner's Directives.
2.3 Storage of Medication – Medication is being stored in compliance with both applicable legislation, industry standards/and CSC policies and procedures.
2.4 Preparation and Dispensing - Pharmacy staff is adhering to relevant federal and provincial legislation/regulations, CSC Guidelines and Commissioner's Directives relating to the preparation and dispensing of medications.
2.5 Medication Distribution, Administration and Access – Relevant federal and provincial legislation/regulations and CSC policies relating to the distribution, administration and access of medication are being followed.
2.6 Transportation and Receiving – Health Services staff follows CSC policies regarding the transportation and receiving of medications for both deliveries and returns between the regional pharmacies and the institutions.
2.7 Disposal – Processes are in place to ensure that the disposal of medication by institutions and CSC pharmacies is conducted in accordance with relevant legislation/regulations and policies.
2.8 Information Sharing CSC Health Services staff is adhering to relevant federal and provincial legislation/regulations, CSC Guidelines and Commissioner's Directives relating to the sharing of information relating to offenders medication.

ANNEX B

AUDIT APPROACH AND METHODOLOGY

Audit evidence was gathered through a number of techniques as follows:

Review of Documentation: Relevant documentation was reviewed including legislation, applicable regulations, industry standards, policies, procedures and performance measurement data.

Interviews: Interviews were conducted with 107 individuals involved in the management of medication at the institutions and the regional pharmacies. At the regional pharmacies, the audit team interviewed the regional pharmacists, staff pharmacists and pharmacy technicians. At the institutions, the audit team interviewed wardens, assistant warden operations, security intelligence officers, chiefs of health services and institutional nurses. When possible, the audit team also interviewed the inmate committees from the institutions visited.

Observations: Observations were conducted in regards to the storage, dispensing, a, transporting and disposing of medication to determine if sufficient and corroborating evidence exists and supports the management framework relative to medication management.

Analytical Review: Physical counts of inventory of medication and a validation of the accuracy of offender allergy information within the pharmacy computer system were completed to confirm and validate the effectiveness of these controls.

Site Selection: Various factors were used in the selection of institutions for this audit. These included institutional security levels and capacity, institutions serviced by one of the CSC regional pharmacies, institutions serviced by private pharmacies, the geographical location of the institutions to ensure selection of both urban and rural sites and other site irregularities.

Four regional pharmacies and 15 institutions were selected for this audit. The audit team conducted site visits to 13 institutions and conducted video conferences with an additional two. The institutions selected were a sample of medium and maximum security institutions, women's institutions and treatment centres. A list of the specific sites visited is included in Annex C.


ANNEX C

LOCATION OF SITE EXAMINATIONS

REGIONS SITES
Atlantic
  • Regional Pharmacy
  • Dorchester Penitentiary
  • Nova Institution for Women
Quebec
  • Centre Régional de Santé Mentale
  • Établissement La Macaza
  • Établissement Port-Cartier
Ontario
  • Regional Pharmacy
  • Collins Bay Institution
  • Grand Valley Institution for Women
  • Kingston Penitentiary
Prairies
  • Regional Pharmacy
  • Bowden Institution
  • Edmonton Institution
  • Regional Psychiatric Centre
Pacific
  • Regional Pharmacy
  • Matsqui Institution
  • William Head Institution

GLOSSARY

Accreditation: Health care organizations performance is evaluated against national standards of excellence. Organizations are surveyed once every three to four years.

Administration (of medication): A health care professional providing medication to an offender for immediate use.

Cold chain: Refers to the process used to maintain optimal conditions during the transport, storage, and handling of refrigerated medications such as vaccines and insulin, starting at the manufacturer and ending with the administration of the vaccine or distribution of the drug or insulin to the client.

Controlled substances: Substances included in Schedule I, II, III, IV or V of the Controlled Drugs and Substances Act; (example of schedule I incl. Codeine, Morphine, Methadone, Fentanyl; schedule II incl. Cannabis; schedule III incl. Amphetamines; schedule IV incl. Barbiturates).

Direct observed therapy: Ingestion of medication by an inmate in front of health care staff.

Dispensing (medication): Includes any one or more of the following:

  1. Evaluating a prescription for a drug
  2. Assessing the patient and the patient's health history and medication record
  3. Packaging and labeling of a drug
  4. Providing a drug to or for a person pursuant to a prescription.

Diversion (internal): Any act that removes a prescription drug from its intended path. This can include theft of the drugs.

Drug Formulary: A list of approved drugs which physicians are to prescribe from.

Medication administration record (MAR): The MAR outlines the expectations for administering medications to a client and is used by care providers to document when medications have been administered.

Medication error: Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Medication incidents may be related to professional practice, drug products, procedures, and systems, and include prescribing, order communication, product labeling/ packaging/ nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.

Medication event: Any adverse event involving medications that may contribute to, or result in, harm to an offender.

Medication Management: All aspects of a medication use process, from selection and preparation to administration of the medication and ongoing monitoring of clients.

Multi-dose distribution: The pharmacist dispenses all of the client's medications for a particular dosage time (e.g., 0800 hrs) in one sealed package or pouch. Multi-dose package systems are generally used in community and long-term care settings.

PRN: PRN medications are those prescribed to be given when a client needs them. A PRN prescription includes the frequency with which the medication may be given, such as Q4H PRN.

Professional standards: Support health care staff in providing safe and ethical care to the public. These documents outline the expectations and accountabilities for health care staff including pharmacists and nurses.

Perpetual Inventory: A record of inventory kept continuously up to date by detailed entries for all incoming and outgoing items.

Preparing (of medication): Medication Preparation includes the selecting, calculating, crushing, breaking, mixing, labeling and drawing up of the medication. The preparation of medication should be done as close as possible to the time you administer it.

Pre-pour: Medications should be prepared as close as possible to the time they are scheduled to be administered to clients and should be stored in a safe and secure area until they are administered.

Self-Administering: The process of administering medication to oneself.

Targeted substances: Are controlled substance included in Schedule 1 of the Benzodizepines and Other Targeted Substances Regulations. (Some examples of include Codeine, Morphine, Methadone and Fentanyl).

Threat risk assessment: Provides the organization with a snapshot of how well risk is being managed and whether the risk is acceptable or not.

Wardstock: Wardstock drugs are non-patient specific supplies of medication kept at the institutional Health Care Centre and include commonly used PRN medications such as analgesics and prescription drugs for medical directives or "first dose" purposes.

MANAGEMENT ACTION PLAN

AUDIT OF THE Medication Management

Recommendation: Recommendation 111
The Assistant Commissioner Health Services should ensure that a formalized process is in place to share any policy or procedural changes related to medication management with other stakeholders in the regions and in the institutions.
Management Response / Position: ___ Accepted ___ Accepted in Part ___ Rejected
Action(s) Deliverable(s) Approach Accountability Timeline for Implementation

What action(s) has / will be taken to address this recommendation?

Expected deliverable(s) / indicator(s) to demonstrate the completion of the action(s)

How does this approach address the recommendation?

Who is responsible for implementing this action(s)?

When will action(s) be completed to fully address the recommendation?

1) The current practice is that the Health Sector sends out frequent updates on policy and guidelines but will take additional steps to ensure consistent consultation and communication with stakeholders.

 

 

 

 

2) To strengthen our approach we have consulted with NHQ Security Operations on identifying the key managers who can ensure consistent communications with other stakeholders in the region and in institutions related to medication management.

Promulgate a consultation guideline co-signed by the ACHS and ACCOP, to promote consistent communications on policy or procedural changes that overlap the two Sectors.

It will establish a consistent methodology for consultation and communications between NHQ-Health Services, NHQ-COP Sector and between NHQ-Health Services and Regional Security Operations.

DGCS

2012-10-05

3) A memo will be sent to the ADCIOs group to ask for the selection of a liaison with Health Services to assist with consultation and communication on matters related to Health Services policy and procedures that have impact or implications for Security Operations.

Designated liaison to Health Services to facilitate communication.

To facilitate timely communication between Health Services and Security Operations on matters related to policy and procedures that have an impact on Security Operations.

DGCS

2012-09-20


Recommendation: Recommendation 212
The Assistant Commissioner Health Services, in collaboration with the Regional Deputy Commissioners should ensure that operational staff are completing threat risk assessments on any offender for whom health services staff have approved to carry and self-administer either EpiPens or insulin needles.
Management Response / Position: ___ Accepted ___ Accepted in Part ___ Rejected
Action(s) Deliverable(s) Approach Accountability Timeline for Implementation

What action(s) has / will be taken to address this recommendation?

Expected deliverable(s) / indicator(s) to demonstrate the completion of the action(s)

How does this approach address the recommendation?

Who is responsible for implementing this action(s)?

When will action(s) be completed to fully address the recommendation?

Memo from ACHS and ACCOP to Regional Deputy Commissioners and Regional Directors has been drafted and shared with Regional Directors by DGCS (August 15, 2012) asking Health Services staff and Operations staff to collaborate and ensure that there is a valid Threat Risk Assessment on file for inmates permitted to have EpiPens and Insulin Needles in their possession, consistent with the Medication Distribution and Administration Guidelines. All regions have indicated that they have started the process to ensure there is a valid threat risk assessment on the files that require one.

Threat Risk Assessments on all files of inmates permitted to have EpiPens and Insulin needles in their possession for self-administration.

This approach addresses the deficit in compliance and promotes on-going collaboration and compliance with the Guidelines.

ACHS
ACCOP
RDHS
RDC

2012-09-20

 

Each region will submit a plan with a proposed completion date to ACHS and ACCOP for approval by September 20, 2012.

Provides positive assurance of compliance.

 

2012-09-20


Recommendation: Recommendation 313
The Assistant Commissioner Health Services should ensure that sites are completing all of the required monitoring and reporting including:
  • Medication Events;
  • Medication Spot-Checks; and
  • Medication Room Self-Audits.
Management Response / Position: ___ Accepted ___ Accepted in Part ___ Rejected
Action(s) Deliverable(s) Approach Accountability Timeline for Implementation

What action(s) has / will be taken to address this recommendation?

Expected deliverable(s) / indicator(s) to demonstrate the completion of the action(s)

How does this approach address the recommendation?

Who is responsible for implementing this action(s)?

When will action(s) be completed to fully address the recommendation?

1) There are existing processes for national collecting and reporting on medication events, medication spot checks and medication room self-audits. And additional efforts will be made to ensure compliance. Currently Clinical Services is piloting a process to make national data collection of nursing spot checks easier (November 1, 2012).

Continued regular national reporting of medication events, medication spot checks and medication room self audits.

This approach will continue to provide the national status on results related to these activities.

DGCS

Ongoing

2) To strengthen the data collection and reporting process, all data related to medication events, medication spot-checks and medication room self-audits will be reviewed quarterly by the Regional Quality Improvement Patient Safety Committee and where needed Regional Health administration (RDHS and ED) will implement an action plan to address issues identified, including additional monitoring. National reports will continue.

Formalized process for Regional review of data collected on the above and development of action plans to address issues identified (second quarter data will be discussed in October 2012).

This approach addresses the recommendation by having a combined National reporting system and a Regional monitoring & compliance and quality improvement mechanism to address issues identified.

RDHS
ED
DGCS

2012-10-19
and
Ongoing

3) Compliance rate will be included in the existing national reporting process.

Compliance rate will be included in the existing national reporting process.

This will ensure monitoring and support compliance.

DGCS

2012-10-12


Recommendation: Recommendation 414
The Assistant Commissioner Health Services should ensure both sound management and compliance with policies relating to inventory levels and storage of medication by:
  1. ensuring that processes are in place to track and monitor the appropriate use of wardstock;
  2. ensuring that institutions are not maintaining wardstock inventory higher than the site determined one-week limit;
  3. ensuring that all medication deliveries are given directly to health care staff and that institutions reconcile medication orders received.
Management Response / Position: ___ Accepted ___ Accepted in Part ___ Rejected
Action(s) Deliverable(s) Approach Accountability Timeline for Implementation

What action(s) has / will be taken to address this recommendation?

Expected deliverable(s) / indicator(s) to demonstrate the completion of the action(s)

How does this approach address the recommendation?

Who is responsible for implementing this action(s)?

When will action(s) be completed to fully address the recommendation?

1. On August 20, 2012, a memo was sent to Regional Directors Health Services and Executive Directors Treatment Centres identifying the above issues. A follow-up discussion was held at the Health Services Executive Team Meeting (HSET) September 6, 2012 to identify strategies to improve compliance. Regional Directors are working to immediately address the identified concerns. Similarly, the DGCS will attend a meeting of Executive Directors Treatment Centres to discuss the issue and identify strategies for addressing the issues (September 26, 2012).

A consistent and verifiable approach to managing medications in the health care centres.

This approach allows for immediate attention to addressing the issues and discussion of strategies for improving and sustaining compliance.

DGCS
RDHS
ED

2012-09-26

2. Items "a" and "b"
The "Regional Pharmacy Operations and Standards Manual" will be updated to be more specific and directive and will be re-communicated in order to better:

  1. track and monitor the appropriate use of wardstock;
  2. ensure approved wardstock inventory;

A consistent verifiable approach to monitoring and managing wardstock.

This approach eliminates varied Regional/local systems for managing wardstock in favour of a national standard and includes a process for systematic monitoring.

DGCS and
RDHS
ED

2012-11-09

 

For the first six months, the Chief Health Services will review compliance with policy and report to the Regional Directors and Executive Directors. At the end of six months, the frequency of compliance reviews will be reassessed.

 

DGCS and
RDHS
ED

Beginning of October 2012 to March 2013

3.

As above.

The approach provides positive assurance of compliance.

DGCS and
RDHS
ED

 

4. Item "d"
A survey of "Medication Safety Practices" was conducted to confirm that sites are now storing narcotics as required.

A roll-up of the status of current compliance with required storage practices.

The approach confirms a risk mitigation strategy has been implemented.

DGCS

2012-09-05

5.

%nbsp;

The approach will strengthen the accountability.

RDC Québec
and
RDHS Québec

2012-08-31
and
Ongoing

 

Progress reports to ACHS and RDC Quebec every two months beginning August 2012.

 

RHDS
ED
Wardens

2012-11-02

6.

 

The approach will provide a formal process for managing the delivery and reception of medications and allow for site specific differences.

RDHS
ED

2012-11-30

7. Nursing staff will be advised of the requirement to continue to reconcile medication orders received from CSC regional pharmacy and community pharmacy. In addition, the description in the Regional Pharmacy Services Standards and Operations Manual of what is required (in order to verify the contents of the medication shipment against the packing information from the pharmacy) will be made more explicit.

This is already a requirement in the Regional Pharmacy Operations Manual.

The approach will ensure that medication orders are reconciled when received at the institution.

DGCS

2012-10-31

 

Advise Regional Directors Health at the Health Services Executive Team of the requirement (Sept 25, 2012) and Executive Directors (Sept 26, 2012).

 

DGCS

2012-09-26

 

The pertinent section from the larger document describing what is required by nursing and pharmacy staff including the required documentation and subsequent analysis of rolled up data will be circulated seperately to nursing and pharmacy staff (via Regional Directors Health and Executive Directors).

This will allow for a review the efficacy of this practice.

EDs
RDHS

2012-11-12
(begin data collection)

 

Data will be collected on the number and type of errors identified and reviewed after 6 months.

 

EDs
RDHS

2013-07-20
(review data)


Recommendation: Recommendation 515
The Assistant Commissioner Health Services should ensure that all offender allergies are accurately and timely entered into the pharmacy system.
Management Response / Position: ___ Accepted ___ Accepted in Part ___ Rejected
Action(s) Deliverable(s) Approach Accountability Timeline for Implementation

What action(s) has / will be taken to address this recommendation?

Expected deliverable(s) / indicator(s) to demonstrate the completion of the action(s)

How does this approach address the recommendation?

Who is responsible for implementing this action(s)?

When will action(s) be completed to fully address the recommendation?

1. A memo was sent to the Regional Directors and Executive Directors August 20, 2012 outlining a number of issues identified in the audit including reporting of allergies.

Initial action has been taken by the Regional Directors and Executive Directors to begin to address this issue.

This approach serves to prompt immediate action towards addressing the issue.

RDHS
ED

2012-08-20

2. In addition, a memo specific to allergies will be sent to Pharmacists and nurses via Regional Directors Health and Executive Directors reminding them that the requirement to document and update allergy status is a professional standard for both nursing and pharmacy practice and consistent with CSC policy/guidelines and Accreditation standards.

All files will be reviewed and where necessary allergies accurately entered into the pharmacy system.

This approach addresses the recommendation by reminding staff of their professional obligation and supporting good practice by promoting more interdisciplinary collaboration.

DGCS
DHS
ED

2012-09-14

3. The Regional Directors, Health Services and the Executive Director RTC will provide progress reports to the ACHS and RDCs on completion of entry of all drug allergies into the pharmacy system.

Monthly progress report (beginning October 2012).

This approach provides additional accountability at the Senior Executive level.

RDHS
ED

2012-10-31
and ongoing

4. Regional Pharmacists will periodically attend Chief Health Services staff meetings to discuss and collaborate on issues related to medication safety including monitoring/feedback of allergy information on the pharmacy system.

Documented (via minutes of Chief Health Services meetings) interdisciplinary collaboration between pharmacists and nurses.

This approach will strengthen accountability and also allows for verification of interdisciplinary collaboration via minutes of Chief Health Services meetings.

RDHS
ED

2012-10-19


Recommendation: Recommendation 616
The Assistant Commissioner Health Service should ensure that institutions are not preparing medication too far in advance of its administration and that they are signing the Medication Administration Records at the appropriate times.
Management Response / Position: ___ Accepted ___ Accepted in Part ___ Rejected
Action(s) Deliverable(s) Approach Accountability Timeline for Implementation

What action(s) has / will be taken to address this recommendation?

Expected deliverable(s) / indicator(s) to demonstrate the completion of the action(s)

How does this approach address the recommendation?

Who is responsible for implementing this action(s)?

When will action(s) be completed to fully address the recommendation?

1. In the institutions where this issue was identified the practice was immediately modified, based on the debrief by the Audit team, to be in compliance with professional practice standards and CSC policy however, additional measures have been implemented to ensure ongoing compliance.

Immediate compliance in specific Institutions and Treatment Centres where the issue was observed.

This approach addresses the recommendation by immediately ensuring that nursing practices conform to professional standards.

DGCS
RDHS

2012-08-31

2. On August 20, 2012, a memo was sent to Regional Directors Health Services and Executive Directors Treatment Centres identifying the above issue. Follow-up discussion was held at the Health Services Executive Team Meeting September 6, 2012 to identify strategies to maintain compliance.

Similarly, the DGCS will attend a meeting of Executive Directors Treatment Centres to discuss the issue and identify a strategy for addressing the issue September 26, 2012).

The RDHS/ED via the site nurse manager will ensure full immediate compliance in all Institutions and Treatment Centres. In addition:

  1. where there has been a compliance issue the site nurse manager and the team will conduct a site specific analysis to discuss processes that support ongoing full compliance (for example look at processes/workload assignments/ etc.);
  2. adherence to professional practice standards will be a standing agenda item on the site nurse manager staff meeting in each Institution.

A site specific analysis allows institutions to problem solve and find ways of better monitoring and supporting good professional practices, for example removing barriers that may be inherent in workload/assignments etc. A sample of minutes of meetings will be reviewed by RHDS and ED periodically.

 

2012-11-09
and Ongoing

3. The Regional Director Health Services and Executive Director will conduct a compliance review in a sample of institutions after 6 months and again after 1 year.

Regional compliance report.

The approach will provide direct oversight to ensure that compliance is maintained.

 

2013-04-05
(6 months)
2013-10-04
(1 year)

i Amendment made on June 10, 2013 to reflect proper assurance level.

1 CCRA s.86(1)

2 CCRA s.86(2)

3 Controlled Drugs and Substances Act, 1996

4 Food and Drug Regulations, Amended August 4, 2012

5 Recommendation requires management's attention, oversight and monitoring.

6 Recommendation requires management's attention, oversight and monitoring.

7 Recommendation requires management's attention, oversight and monitoring.

8 Recommendation requires management’s immediate attention, oversight and monitoring.

9 Recommendation requires management's immediate attention, oversight and monitoring.

10 Recommendation requires management's immediate attention, oversight and monitoring.

11 Recommendation requires management's attention, oversight and monitoring.

12 Recommendation requires management's attention, oversight and monitoring.

13 Recommendation requires management's attention, oversight and monitoring.

14 Recommendation requires management's immediate attention, oversight and monitoring.

15 Recommendation requires management's immediate attention, oversight and monitoring.

16 Recommendation requires management's immediate attention, oversight and monitoring.