National Drug Formulary Investigation Summary of Findings and Recommendations

January 27, 2015

Purpose

The Office of the Correctional Investigator conducted an investigation into the Correctional Service of Canada’s ( CSC ) National Drug Formulary. The investigation had two objectives: to assess the Formulary in context of the Service’s obligation to provide essential healthcare and to compare it to publicly funded provincial drug plans.

The investigative stage of the review unfolded over a six-month period (July to December 2014) and included the following elements:

1. An examination of CSC essential healthcare policies, the National Formulary and the process for non-formulary requests.
2. An analysis of inmate complaints received by the Office regarding the Formulary.
3. Qualitative, open-ended interviews with sixteen CSC institutional physicians representing all regions.
4. Consultations with senior Health Services sector management at National Headquarters.

Two medical experts were retained by the Office to review and assess drug therapies listed on the National Formulary, with a particular focus on chronic pain management and psychotropic medications. The expert review included comparing the CSC Formulary with the Ontario and Quebec publicly funded drug plans. The expert opinions are attached for reference.

Findings

For ease of reference, findings have been grouped into seven areas of concern.

1. Expert Review

Highlights from the two medical experts’ review include:

• The Formulary has limited treatment options for Attention Deficit and Hyperactivity Disorder and chronic pain management.
• The criteria applied to certain Formulary drugs are thought to be too restrictive in some instances and to unreasonably constrain a physician’s professional autonomy in others. For example, questions were raised regarding the need for listing criteria for a number of commonly used medications in psychiatry i.e. Aripiprazole (Abilify), Clozapine, Quetiapine (Seroquel), Bupropion (Wellbutrin), particularly given that both Ontario and Quebec provincial formularies do not contain such criteria. In addition, the review included a recommendation that the listing criteria for gabapentin be reconsidered.
• The use of sleep medications in exceptional circumstances should be reconsidered to ensure that unnecessary restrictions are not being imposed on offenders afflicted with more severe, chronic insomnia from psychiatric disorders.
• In the opinion of one reviewer, the requirement to convert from benzodiazepine to an equivalent dose of clonazepan through tapering was questioned as there are many legitimate indications for using benzodiazepines.
• One expert (along with CSC physicians) questioned whether it is appropriate that the final decision to accept or reject a non-formulary request should reside with the Regional Pharmacist, especially given that pharmacists do not have access to the patient or the clinical file.

2. Continuity of Care

CSC institutional physicians reported that there is not sufficient time to meet and assess all new admissions to federal custody (many inmates wait 30 days or more before seeing a CSC institutional physician at a regional reception centre). Moreover, they felt that they do not have sufficient information or support when making decisions   regarding medication reconciliation for patients they have not personally or previously assessed. Some doctors reported it is common practice to discontinue certain medications (i.e. particularly medications with high abuse potential) for newly admitted inmates until they can be seen and their medications reconciled by the attending physician. This practice effectively introduces interruptions in care and may be particularly inappropriate or unsafe for first time federal offenders with a mental health condition.  Careful consideration should be given to allowing new admissions from provincial custody to continue with their treatment regime until they can be assessed and their medication appropriately reconciled by the attending CSC physician.

Continuity of care issues were also reported with respect to institutional transfers. The review found that the attending institutional physician at the receiving institution may decide (based on experience or preference) to alter or withdraw medication(s) prior to an in-patient assessment. This situation is particularly concerning in cases where an inmate is discharged from a regional treatment centre and is  returning to his/her parent institution with a new or different drug treatment regime. As one expert stated in his report, “Automatically substituting or stopping non-listed medications improperly or requiring special authorization without medical consultations may be problematic, even dangerous in some cases.”

3. Non-Formulary Requests

Interviews with physicians indicated that the non-formulary request process is problematic. Decisions to accept or reject requests were not consistent nationally or even within a region. Moreover, when a decision is made to reject a non-formulary request, no written reason, explanation or alternative is typically provided by the Regional Pharmacist. Furthermore, when a non-formulary request is accepted after having been rejected for a number of other patients, there is no process to ensure previously denied similar cases are once again considered. Some institutional physicians reported that they often stop submitting non-formulary requests for a particular medication after a number have been rejected. These issues, in all likelihood, could be rectified with improved communication between the Regional Pharmacist and institutional physicians.

Non-formulary medications prescribed by specialists in the community tend to create additional problems. CSC institutional physicians are sometimes caught in the awkward position of being responsible for submitting or advocating for a non-formulary drug prescribed by an external doctor that can be overridden by the Regional Pharmacist through the non-formulary request process. While external specialists cannot be expected to be aware of CSC ’s Formulary, in cases of disagreement a process should be in place that requires a consultation between the attending institutional physician, the Regional Pharmacist and the referring specialist to determine the most appropriate treatment regime.

4. Limited Medication Options

For certain medical conditions (Attention Deficit and Hyperactivity Disorder and chronic pain) the Formulary does not seem to provide sufficient or comprehensive treatment options. Additionally, both medical experts retained by the Office agreed that some listing criteria may unnecessarily restrict patient access to the most efficacious course of treatment. Physicians reported that these two issues significantly restrict their professional autonomy and clinical judgement. The uniqueness of the correctional environment and the abuse/diversion potential of certain medications represent legitimate concerns. However, it is inconsistent with the Service’s health care mandate that access to certain treatment options may be unduly restricted.

5. Over-the-Counter Drugs

Most CSC physicians agreed that the lack of over-the-counter drugs on the Formulary meant that they sometimes prescribe medication for conditions that could be treated with commonly accessible drugs. For example, one CSC physician reported prescribing an anti-biotic nasal gel to treat dry nose which he agreed was costly and excessive. Nonetheless, he prescribed the medication as he believed it was the only   way the inmate would be able to access treatment. A number of common over-the- counter products (e.g. Tylenol, medicated shampoo) used to be provided by CSC , however, certain “non-essential” services and products have been progressively de- listed requiring inmates to purchase these items through the inmate canteen. The problem is that these items are not widely or consistently available through the inmate canteen and when they are available the cost may be prohibitive. In consultation with CSC institutional physicians and inmate committees, consideration should be given to developing a list of commonly used over-the-counter products (i.e. Tylenol, medicated shampoos, skin care, etc.) that would be made available for purchase through the inmate canteen. An exemption process should be in place based on the ability to pay.

6. Balancing Security and Patient Needs

Institutional safety and security concerns mean that some medications are administered via Direct Observation Therapy ( DOT ). While DOT decreases the likelihood that drugs will be diverted or abused, in some cases it means that CSC physicians must adjust the frequency of the dosage to accommodate the DOT process (this is particularly the case for pain management drugs). DOT is time consuming to administer. Most institutions do not have 24 hour healthcare services that could accommodate more frequent dosages and possibly more effective drug therapies. Additionally, DOT means that access to certain classes of drugs is automatically restricted. As such, an inmate  may be prescribed a once per day dosage which may be less effective but more convenient for the institution to administer and control. This situation can significantly impact patient need and the clinical judgement of physicians. Other options should be explored to allow physicians to prescribe the most appropriate/effective course of treatment, without compromising safety and security (e.g. lockboxes).

7. Lack of Relevant Data

The review found very little evidence of systematic tracking or monitoring, at the regional or national level, of the prescribing practices of CSC physicians, the number of non-formulary requests, the types of drugs requested through the non-formulary process, or the rejection/acceptance rate of non-formulary requests. While some pharmaceutical data can be gathered through a manual extraction process, an electronic offender health information system capacity is required to provide reliable data about what drugs are being prescribed, how often and for what purpose. In the absence of an electronic platform to collect and analyze drug utilization trends across the Service, the delivery of essential health services inside federal facilities is compromised. As the Office’s 2013-14 Annual Report notes: “A competent, efficient and accountable prison health care service requires a modern monitoring and reporting e-health information system.” This investigation reaffirms this requirement.

Conclusion

Findings from interviews with CSC institutional physicians, Health Services sector and the two medical experts retained by the Office indicate that CSC ’s National Drug Formulary is generally comprehensive and broadly comparable to provincially funded drug plans. That said, a number of process improvement issues were identified in the course of the review. Overall, while these issues do not point to fatal gaps in the Formulary, they are nonetheless significant given the rising number offenders experiencing chronic physical and mental health conditions. The investigation confirms that the Formulary could be more responsive from a population-based health needs perspective.

In that respect, the recent decision to add new and potentially game changing Hepatitis C treatments to the Formulary is an encouraging example of the CSC being proactive. This is a significant development and the Service should be commended. As this investigation suggests, there are other conditions or advances in treatment that require the same kind of forward-looking consideration by the Service, especially where Formulary options and criteria for managing particular health conditions and disorders are known to be limited by institutional security requirements.

Recommendations

1. New admissions to federal custody with a valid prescription or who require medical treatment should be seen by an attending institutional physician within 72 hours of being admitted. This practice will ensure that prescribed medications are appropriately and efficiently reconciled and continuity of care between the community or provincial and federal custody is maintained.
2. CSC should immediately amend policy to ensure that the medication regime for inmates being transferred is not changed unless or until the attending physician at the receiving institution has conducted either an in-patient assessment or consultation with the transferring institution.
3. Communication should be improved by initiating regular meetings (at least semi- annually) between Regional Pharmacists and institutional physicians and by distributing summary information involving non-formulary decisions made on appeal to the National Pharmacist.
4. To ensure consistency and accountability CSC should implement a national electronic pharmaceutical database to provide reliable data on drug utilization trends.
5. CSC should conduct an administrative review of the non-formulary request process responsive to issues identified in this investigation, including, in particular, an assessment of the appropriateness of Regional Pharmacists making the final decision on non-formulary requests.
6. In consultation with institutional physicians, CSC should amend areas of its Formulary where sufficient treatment options appear to be lacking (e.g. Psychotherapy, chronic pain management, Attention Deficit and Hyperactivity Disorder).
7. In consultation with institutional physicians and Inmate Committees, CSC should develop a list of commonly used/requested over-the-counter health care products which would be made available for purchase through inmate canteens.
8. CSC should develop options (e.g. lockboxes) to ensure patients can receive medications when health care staff are not available.
9. The two external expert reviews (attached) should be examined by the National Pharmacy and Therapeutics Committee and the Health Care Advisory Committee at their next meetings with a view to bringing forward recommended changes to the Formulary.

Notes:

¹ Farmer, Olivier (MD), Professional Consultation Report (Psychiatry), completed for the OCI, December 2014.

Date modified  
2015-08-14