HC Pub.: 3278
Cat.: H34-160/2010(Print)
ISBN: 978-1-100-52205-0 (Print)
Cat.: H34-160/2010E-PDF (Web site version - English)
ISBN: 978-1-100-16593-60 (Web site version - English)
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Health Canada's Non-Insured Health Benefits (NIHB) Program provides a limited range of medically necessary goods and services to eligible First Nations and Inuit clients. The Program is part of Health Canada's First Nations and Inuit Health Branch (FNIHB). The overarching goal of this Branch is to address the gap in health status that exists between First Nations and Inuit and other Canadians. NIHB does not provide prescription medications directly to clients. The Program, like other public and private drug plans, relies on physicians and other authorized prescribers to issue prescriptions and on pharmacists to dispense medications based on professional judgement. NIHB, with the assistance of a third party claims processing contractor, reimburses pharmacists for the cost of drugs as well as a fee for professional dispensing services. Eligible drug benefits are 100% covered for clients.
In 2009, the NIHB Program processed 14.9 million pharmacy claim lines1. Figure 1 demonstrates a steady increase in demand for prescription medications. This increase is in line with the population growth among First Nations and Inuit in Canada, which is approximately double the national rate. Of these requests, 12.5 million were approved, 794,355 were approved but reversed because they were never received by clients (i.e. not picked up) and 1.6 million were rejected either because the request was outside the mandate of the Program or because of client safety concerns.
This report provides an update on the Non-Insured Health Benefits Program's efforts in the area of client safety since the publication of NIHB's 2009 Report on Client Safety.
Figure 1 - NIHB paid claims by calendar year

Prescription drugs have the capacity to heal but also the capacity to do harm if not used correctly. Public drug plans, like the Non-Insured Health Benefits Program, bear a responsibility to those they serve. Timely information to health professionals and analysis of individual situations and broader trend observations are crucial in ensuring that clients are well served. NIHB has invested considerable time and effort in designing and modernizing its prescription drug benefit program with these responsibilities in mind.
The NIHB Program continues to place a high priority on addressing cases of concern and on enhancing and encouraging the safe use of prescription medications.
Our approach consists of 4 Pillars of Client Safety:
As described throughout this report, the NIHB Program is beginning to see positive impacts as a result of key interventions under these pillars. In the next year, the focus will be on expansion of the Prescription Monitoring Program (PMP) and enhancing controls on Oxycontin.
Communication between the NIHB Program and front-line pharmacists is essential in protecting client safety. NIHB has implemented a number of significant changes to enhance the important relationship between the Program and pharmacists. NIHB has been part of an industry-wide system for administering pharmacy benefit claims since the early 1990s that allows the Program to send messages electronically in real-time at the point-of-sale to warn pharmacists about potential client safety issues including drug interactions and repeat prescriptions. The full list of NIHB warning codes is set out in Appendix 1. Certain warning messages also require the pharmacist to report back with specific codes that give the Program information about the actions they have taken related to the warning code received. A list of these response codes is included as Appendix 2.
Warning messages are important tools that supplement pharmacists' professional judgement at the point-of-sale. The NIHB Program actively monitors the number of pharmacy claims that are flagged with warning messages or rejected by this system.
Figure 2 shows the number of warning messages sent by the NIHB Program to pharmacies across the country since 2001. Over the past number of years the Program has significantly increased its interventions with pharmacists. The information provided via these warning messages greatly improves the range of information available to pharmacists and, as a result, enhances their ability to exercise their professional judgement when serving NIHB clients.
Figure 2 - NIHB warning messages over time

NIHB monitors for pharmacies who are found to be frequently overriding warnings These pharmacies may be audited to ensure that client safety and the Program's financial integrity are not being compromised.
In April 2006, the NIHB Program created a special warning message in response to clinical evidence with respect to the health risks associated with the misuse of specific drugs of concern. These drugs include opioids (such as morphine, codeine, and oxycodone which are used to relieve pain), benzodiazepines (so-called "minor" tranquilizers, sleep aids and anti-anxiety medications) and methadone (a long-acting synthetic opioid used to treat opioid addiction or pain).
In designing this warning message, it was important to recognize that all of these drugs have clinically valid applications. For example, opioid treatments are crucial in pain management for patients suffering from terminal cancer and palliative conditions.
Therefore, the warning message was designed to focus attention on cases where there were concerns about potential misuse, and where continued utilization was difficult to justify.
The warning message, called the "NE" code, addresses situations where clients access:
The warning provides a message to pharmacists indicating that potential misuse of prescription drugs should be explored. It is one more tool to supplement their professional judgement and to protect client safety.
In June 2007, the NIHB Program changed the NE code from a simple warning message to a warning that requires pharmacists to reply back to the Program with a response code. This added feature ensures that, if pharmacists override the NE code, they must document the rationale for doing so by sending a response code back to the NIHB Program. Pharmacists are expected to retain the supporting information justifying the response in case of a clinical or administrative audit. An assessment of the impact of the NE code is provided in the Evaluating Outcomes section of this report (Figure 9).
The NIHB Program also provides rejection messages to pharmacists when a client's claims history indicates potential misuse or overuse of a range of prescription medications. These rejection messages are different from the warning messages described in Pillar 1. It is not possible for a pharmacist to override these messages or to provide an electronic response code. Instead when a rejection message is received, a pharmacist must contact NIHB's Drug Exception Centre, a national toll-free call centre. The Drug Exception Centre will provide more information to the pharmacist about the situation and follow up with the prescribing physician before the Program will authorize payment for the drug in question. The NIHB Program reserves the right to refuse payment for medications that cannot be justified when there is evidence that suggests client safety may be negatively affected.
Over the past number of years, the Program has improved its ability to monitor situations where clients may be accessing prescriptions to the same drug via multiple sources. As a result of new sensitivities built into the electronic processing system, client claim requests will generate warning messages to alert pharmacists about potential duplicate therapies. When maximums are exceeded, a pharmacist will receive a message from the Program requiring them to consult with NIHB's Drug Exception Centre to verify the claim.
Prior to January 2005, NIHB applied maximum allowable rules to acetaminophen products that contained codeine, such as Tylenol 2 and 3. In January 2005, NIHB expanded system sensitivities to detect when maximum allowable dose limits were exceeded for all acetaminophen-based opioid products (e.g. Percocet and Tylenol 4). These measures are intended to place safeguards around medications most often subject to misuse.
On January 1, 2007, the Program expanded the NIHB system's maximum allowable sensitivities to apply to all acetaminophen-based products. Clients are often unaware of the long-term consequences of commonly available acetaminophen-based products. Negative health effects can result from prolonged use, including serious liver damage if recommended dosages are exceeded. This further enhancement protects the safety of clients beyond the focus of the initial intervention.
In 2004, NIHB rejected 480 claims when maximum allowable quantities were exceeded. In 2006, with the expansion of the maximum allowable rules to all acetaminophen containing opioids, 1,563 claims were rejected. The Program rejected a total of 1679 claims for acetaminophen or acetaminophen based opioids in 2009.
Based on the impact of the maximum allowables initiative, the NIHB Program also changed the benefit status of a prescription medication called meperidine (Demerol). Meperidine (Demerol) is an opioid and should only be used for a short period of time, as long-term use may lead to toxic effects, as well as addiction. To ensure the appropriate use of meperidine (Demerol), the Program established a maximum allowable quantity in December 2007. Utilization rates of meperidine (Demerol) as a result of this restriction have decreased by 38% over 2006 numbers (from 8,138 to 5,034 claims), and nearly 50% since peaking in 2003 (see Figure 3).
Figure 3 - Meperidine (Demerol) Utilization

Based on clinical evidence, the NIHB Program changed the status of drugs called Proton Pump Inhibitors (PPIs). These drugs are used to treat serious stomach disorders; however, overuse has been associated with osteoporosis, pneumonia and serious infectious diarrhea. To ensure the appropriate use of these drugs the Program had planned to establish a maximum allowable quantity in April 2009 however due to operational limitations, the NIHB Program implemented the measure in July 2010. Changes in utilization rates of PPIs as a result of this initiative will be reported in the next Report on Client Safety.
NIHB actively analyzes broad patterns of utilization, prescribing, and dispensing on an on-going basis. This work is conducted by a team of licensed pharmacists and experts in data analysis. Once patterns are identified, the Program intervenes to prevent the recurrence of inappropriate prescription drug use.
In 2008, the NIHB Program took steps in a number of cases to report patterns of inappropriate prescription drug use to professional colleges, such as Colleges of Physicians and Surgeons and Pharmacy Colleges. These bodies deal with all issues related to professional practice. Specific concerns were raised around the prescribing of methadone in Ontario and the prescribing of Ritalin SR in Saskatchewan. In 2009, NIHB continued to monitor, but did not have to report on any cases. The NIHB Program will continue to fulfill its commitment to client safety by following up on these and other issues with professional colleges when data suggest such an action is warranted.
NIHB staff are also in regular contact with their federal, provincial and territorial counterparts who operate similar drug benefit plans to share best practice knowledge across jurisdictions.
In 2008-2009, the NIHB Program commissioned a benchmarking study to look at client safety initiatives in other public drug plans. The purpose of the study was to provide comparisons between NIHB and similar health programs in other jurisdictions. The report concluded that overall, the NIHB Program compared favourably to other drug plans with respect to client safety initiatives.
A review of NIHB's client safety initiatives versus client safety initiatives from other public drug plans showed many commonalities. These included:
The review also found that there were client safety initiatives that only NIHB was doing. These included:
The report noted that any additional client safety initiatives implemented by NIHB would involve numerous partners, thereby making it very challenging. In most cases, NIHB has followed the lead of specific jurisdictions. As a result, it could be perceived that there are inequities in the scope of initiatives that are being offered across the country for NIHB clients. For example, currently NIHB reimburses for a trial prescription program for some of its clients but this is only possible in those provinces where it is part of the standard of care and where mechanisms are in place to coordinate these services (e.g., the Trial Prescription Program in Saskatchewan encourages pharmacists to dispense a seven or ten day supply for the initial prescription of certain drugs, monitor the effect on the patient and if the outcomes are positive, dispense the full prescription as directed by the physician).
The report gave the following recommendations to further enhance NIHB's client safety initiatives.
Recommendation 1: The NIHB Program should work with interested provinces and relevant sections of the First Nations and Inuit Health Branch in educating their client base on the importance of client safety initiatives
Recommendation 2: The NIHB Program should explore Program changes that would enhance the clinical aspects of its current system. This could include automated alert messages on dosing recommendations for at risk groups, payment for refusal to fill suspected cases of drug misuse, greater communication of information regarding the NE code, and streamlining the special authorization process through automation of the criteria code wherever possible.
Recommendation 3: The NIHB Program should establish criteria for medication reviews for their clients and implement this initiative wherever possible starting minimally with clients in those jurisdictions where it is a standard of practice.
Recommendation 4: The NIHB Program should initiate collaboration with medical and pharmacy associations and faculties to develop a chronic disease management strategy for addiction.
The NIHB Program is currently working on the feasibility of implementing these recommendations. Progress will be reported in future Reports on Client Safety.
The Program has developed a methodology that allows NIHB staff to identify clients at highest potential risk for misuse of benzodiazepines and/or opioid-based products.
To improve communication with health professionals and to add an extra element to its approach to client safety, NIHB has developed the NIHB Prescription Monitoring Program (PMP) which focuses on the questionable use of benzodiazepine and opioid drugs.
The NIHB PMP complements existing activities and promotes the optimal use of medications by allowing the Program to enhance its interventions when drug use patterns of concern are observed. Variables like the number of physicians visited ("doctor shopping"), the number of pharmacies visited and the number of opioids or benzodiazepines claimed may result in identifying clients for enrolment into the PMP. Enrolment may restrict clients to a specific physician or require clients to have future claims verified and authorized by a pharmacist at NIHB's Drug Exception Centre. If clients or their health care providers cannot provide evidence to support the continuation of the drug therapy in question, the Program reserves the right to refuse payment for the medications requested.
The first phase of the NIHB PMP was launched in Alberta in January of 2007. Since that time, the NIHB PMP has been expanded to Nova Scotia in 2009. Plans are underway to expand Program to New Brunswick in 2010.
In 2009, the NIHB PMP modified its process for restricting a client's physician with respect to prescriptions for benzodiazepines and opioids. In the previous process, the NIHB Program was responsible for selecting which physician to ask to be the patient's sole physician. Clients in the NIHB PMP can now select the physician of their choice.
During the H1N1 pandemic, NIHB conducted extensive surveillance of the utilization of drugs related to H1N1 and other influenza-like illnesses. This included surveillance of antiviral medications (oseltamivir (Tamiflu®) and zanamivir (Relenza®)), antibiotics, cough & cold products, acetaminophen (Tylenol® & generics) and ibuprofen (Advil® & generics). Surveillance reports were used to identify potential outbreaks of H1N1 and prompted temporary changes to the listing status of some of the drugs listed above.
To further strengthen client safety initiatives, the Program established the NIHB Drug Use Evaluation Advisory Committee (DUEAC) in 2003. This committee provides independent expert advice to promote improvements in health outcomes of First Nations and Inuit clients through effective use of medications. This Advisory Committee is composed of various health care professionals, including a number of First Nations physicians. It meets 3-4 times per year to review drug-use trends, to make recommendations for Program interventions, and to follow-up on specific issues. For example, before NIHB changes the listing status of drugs subject to overuse/misuse, NIHB consults with this expert body to confirm the clinical validity of restrictions or removals of medications from the approved drug benefit list.
The Advisory Committee has undertaken specific reviews on a wide range of drugs (40 studies complete/ongoing) with a view to improving client safety. The result of these analyses are periodically sent to health professionals across the country through the Drug Use Evaluation (DUE) Bulletin. These bulletins are available on-line.
In previous years, on the advice of this Committee, the Program has sent letters raising concerns to top prescribers of benzodiazepines. Other contributions of the Committee include an active role in the development of the NE code for opioids, benzodiazepines and methadone, as well as completed studies on asthma drugs, statin drugs for cholesterol and chronic obstructive pulmonary disorder. A full list of ongoing and complete studies is set out in Appendix 3. The Program will continue to look to the Committee to provide valuable advice on further enhancements to client safety.
In 2009, the NIHB Program has been working with expert groups, including the Drug Use Evaluation Advisory Committee, on strategies to reduce the inappropriate use of oxycodone controlled release tablets (Oxycontin). Results of these strategies will be reported in the next Report on Client Safety.
The NIHB Program is committed to measuring and demonstrating the impact of interventions to promote client safety. The advice of the Drug Use Evaluation Advisory Committee has been invaluable in helping NIHB develop a measurement methodology to produce useful data over the long term. In this regard, evaluations to measure the influence of three interventions are detailed below.
In March 2008, the NIHB Program changed the benefit status of two asthma inhalers, salmeterol and formoterol. Health Canada had issued a safety alert recommending these asthma inhalers be used together with steroid inhalers. There were reports of deaths when these inhalers were used without a steroid inhaler for the treatment of asthma. Claims data showed that several clients with asthma were using these inhalers without steroid inhalers. The Program sent letters to clients' pharmacies and physicians informing them of the inappropriate use of these asthma inhalers by their patients, changed the benefit status of salmeterol and formoterol from "Open Benefit" to "Limited Use" and issued a DUE bulletin.
Figure 4 - Utilization of Salmeterol and Formoterol Without Steroid Inhalers

In October 2005, the NIHB Program changed the benefit status of a prescription pain patch called fentanyl (Duragesic). This product is a potent long-acting opioid product that was being requested in increasing amounts for a number of years. Evaluations concluding that this particular drug was subject to overuse prompted the Program to change fentanyl's benefit status from "Open Benefit" to "Limited Use". This change requires special authorization from NIHB's Drug Exception Centre before approvals can be granted. Claims data indicate that, since these restrictions were put in place, the Program has effectively reversed the inappropriate utilization trend for this particular drug (see Figure 5).
Figure 5 - Impact of changing the listing status of Fentanyl (Duragesic)

The Program is continuing to monitor use patterns of fentanyl (Duragesic) to ensure that clients with a legitimate need for this drug (chronic and cancer pain) continue to have appropriate access.
The range of interventions highlighted in this document are aimed at reducing problematic drug use. One of the main areas of concern has been benzodiazepine use. This class of drugs is meant to be a short-term remedy for individuals coping with anxiety or sleep problems. There is little clinical evidence to support long-term use of benzodiazepines.
Physical addiction can often result from long-term use and can produce adverse health and social effects. Based on well-documented concerns, NIHB removed a number of long-acting benzodiazepines from its approved Drug Benefit List in September 2007. The use of long-acting benzodiazepines in the elderly is of grave concern because of the link to cognitive impairment and serious injuries as a result of falling accidents.
The NIHB Program has undertaken specific evaluations of trends in benzodiazepine use to measure the effectiveness of recent interventions. The number of clients accessing benzodiazepines, the number of claims approved and the number of clients exceeding the maximum recommended daily dose (equivalent to 40 mg per day of diazepam) have all declined in the past few years (see Figures 6 and 7).
In 2003, the percentage of eligible First Nations and Inuit receiving a benzodiazepine peaked at 7.6% and began to decline afterward. By 2009 the share of eligible clients receiving a benzodiazepine had decreased to 6.8%. In absolute numbers, there were nearly 4,900 fewer clients receiving benzodiazepines in 2009 than there would have been had the percentage of eligible clients receiving benzodiazepine remained at its 2003 value of 7.6%.
Figure 6 - Percentage of clients receiving benzodiazepines


To evaluate the impact of the "NE code", NIHB has measured the number and percent of clients who accessed three or more benzodiazepines, three or more opioids or opioids in conjunction with methadone treatment. Utilization of these medications at these thresholds of concern continued to remain low in 2009 (see Figure 8).
Of note is the very low percentage of clients who have claimed these drugs of concern at these levels (a fraction of 1%).
Figure 8 - Measuring the impact of the NE Code
Number and percentage of clients claiming 3 or more benzodiazepines, 3 or more opioids, or opioids in association with methadone.

Figure 9 - Measuring the impact of changing the NE Code from a soft edit to hard edit

In addition to the interventions undertaken by the NIHB Program, the First Nations and Inuit Health Branch's Community Programs Directorate is actively working at the community level to promote healthy lifestyles and to prevent the misuse and abuse of prescription drugs. A review of on-reserve addictions programming is currently underway to identify a comprehensive program framework, and prescription drugs have been identified as a specific area for action. Best practices identified through earlier prescription drug pilot projects will inform the development of the renewed on-reserve addictions program framework which will include a focus on prescription drugs, and will support the implementation of addictions services that are attuned to local priorities.
An evaluation tool has been developed by NIHB to generate community reports that describe the utilization of certain drugs within First Nations communities. These reports allow the NIHB Program to compare utilization rates across bands, regions and nationally. Results have been shared with First Nations stakeholders.
The Non-Insured Health Benefits Program is taking an active, evidenced-based and measured approach to further develop client safety activities. This approach stresses the appropriate use of medications with a view to achieving the best possible health outcomes for First Nations and Inuit clients. Significant interventions are now in place. The Program is committed to monitoring and measuring the impact of these interventions and working with expert advisors, stakeholders and other key players to identify further improvements to the NIHB client safety regime.
With a First Nations and Inuit client-base growing two times faster than the Canadian average, the Non-Insured Health Benefits Program has experienced yearly increases in utilization rates, particularly for prescription medications, the Program's most frequently used benefit. The Program has taken steps to confine and reduce the inappropriate use of medications. Consequently, although the utilization numbers for drugs of concern declined only slightly in the past few years, in sheer numbers, these reductions represent significant improvements to client safety when viewed in the larger context of client population growth.
The Non-Insured Health Benefits Program remains committed to ongoing evaluations of its client safety regime. The Program will continue to report on these issues on an annual basis by way of this report.
| Message | CodeTable 1 footnote 1 | Description |
|---|---|---|
Table 1 footnotes
|
||
| Duplicate Therapy | MX (soft) | Indicates that the client has received a drug from the same therapy class and has used less than 2/3 of the medication based on the days supply. |
| Duplicate Therapy Multi-Pharmacy | MZ (soft) | Indicates that the client has received a drug from the same Multi-Pharmacy therapy class; and has used less than 2/3 of the medication based on the days supply; however the original prescription was filled at another pharmacy. |
| Drug to drug | ME (hard) | Indicates that drug may interact with another current drug, based interaction potential on an accurate days supply submission. |
| Duplicate Drug | MW (hard) | Indicates that the client has received the same drug (same chemical entity) and has used less than 2/3 of the medication based on the days supply. |
| Duplicate Drug Multi-Pharmacy | MY (hard) | Indicates that the client has received the same drug (same chemical entity) and has used less than 2/3 of the medication based on the days supply; however the original prescription was filled at another pharmacy. |
| Potential Misuse of Prescription Drugs | NE (hard) | Indicates 3 or more benzodiazepines 3 or more opioids 3 or more benzodiazepines and 3 or more opioids methadone in combination with other opioid drugs |
The codes and messages described in Appendix 1 in bold font denote "hard" edit rejection codes. Claims submitted through the NIHB Point-of-Sale system which prompt any of these four messages will not be accepted for payment. To submit the claim for payment, pharmacists who receive these rejection codes must provide an override code back to the NIHB Program to explain the action that they took, based on their professional judgement, in deciding to dispense the claim. In cases where pharmacists choose to override a rejected claim, the prescriptions are paid by NIHB.
| Code | Interpretation |
|---|---|
| UA | Consulted Prescriber and Prescription Filled As Written |
| UB | Consulted Prescriber and Changed Dose |
| UC | Consulted Prescriber and Changed Instructions For Use |
| UD | Consulted Prescriber and Changed Drug |
| UE | Consulted Prescriber and Changed Quantity |
| UF | Patient Gave Adequate Explanation, Prescription Filled as Written |
| UG | Cautioned Patient, Prescription Filled As Written |
| UI | Consulted Other Sources. Prescription Filled As Written |
| UJ | Consulted Other Sources. Altered Prescription and Filled |
| UN | Assessed Patient. Therapy is Appropriate. |
| MR | Replacement, Item Lost or Broken. |
| Reviews Conducted to Date | Ongoing and Planned Analysis |
|---|---|
| • Acetaminophen limit | • Antibiotics |
| • Amitriptyline for pain | • Buprenorphine/Naloxone (Suboxone) |
| • Antidepressants in children and adolescents | • Community and physician reports |
| • Anti-psychotic medications | • Diabetes Survival Analysis |
| • Asthma | • Dose of Biologics |
| • Benzodiazepines | • Estrogen |
| • Biologics for Rheumatoid Arthritis | • Oxycodone in Ontario |
| • Cancer drugs | • Updated and standardized reporting on diabetic |
| • Chronic obstructive pulmonary disease (COPD) | and antibiotic medication use |
| • Clients with more than 50 prescriptions in 90 days | • Zopiclone (Imovane) |
| • Clopidogrel (Plavix) | |
| • Concurrent use of Cox IIs and proton pump inhibitors | |
| • Concurrent use of proton pump inhibitors and clopidrogrel | |
| • Contraceptive Use | |
| • Cough and cold medications | |
| • Diabetes medications | |
| • Diabetes medication update | |
| • Diabetic test strips | |
| • Drug use trends in seniors | |
| • Emergency dispensing trends in the Program | |
| • Evaluation of the proton pump inhibitors intervention | |
| • Evaluations of various NIHB Program interventions | |
| • Fentanyl patch | |
| • Folic acid and prenatal vitamins | |
| • Folic acid and prenatal vitamins update | |
| • HIV/AIDS medications | |
| • Methadone | |
| • Methylphenidate for ADHD | |
| • NE audit | |
| • Opioids | |
| • Oxycodone | |
| • Smoking cessation aids | |
| • Statins (Cholesterol) | |
| • Thiazolidinediones (diabetes drugs) |