While some aspects of the Nova Scotia Prescription Monitoring Program are effective, there are significant weaknesses in the Program’s control and monitoring processes that can allow abuse or misuse of prescription drugs to continue undetected. Improvements are needed to address these issues.
- There was adequate attendance at meetings of the Board and Practice Review Committee; however attendance at Drug Utilization Committee meetings was poor. The Committee did not have a full complement of members at any of its ten meetings during our audit period. At three of those meetings, less than half of the committee members attended.
- The Program’s volume and demand for its services have increased in recent years. 5.12 The Program processed approximately 700,000 prescriptions in 2010-11, an increase of 36% since 2007-08. Prescribers, pharmacists, licensing authorities and law enforcement can request patient profiles from the Program outlining an individual’s history of monitored drug purchases. The number of patient profile requests increased from 792 in 2007-08 to 1,643 in 2010-11.
- The abuse of prescription opiate medication has received considerable media attention 5.13 due to overdoses and deaths in the province attributed to monitored drugs in recent years. While the Program covers certain avenues to obtain monitored drugs, there are other legal sources that fall outside the Program, such as monitored drugs dispensed to hospital inpatients or through emergency rooms. Additionally, there are many potential illegal sources of monitored prescription drugs.
- Monitoring Gap – The Program is not responsible for monitored drugs provided to patients discharged from hospitals or emergency rooms. Health and Wellness management told us that hospitals are supposed to monitor utilization of these drugs.
- Although Regulations to the Prescription Monitoring Act state that prescriptions are not required on duplicate forms for those in hospital, this does not mean it is not necessary to supervise monitored drugs dispensed through hospitals.
- Although the system is a positive step towards examining the use of monitored drugs, we identified areas in which improvements are required. Pharmacists can fill prescriptions for monitored drugs without immediately entering the prescription in the online system; in these instances, the information is sent to the Program within 30 days. As a result, information is not available in a timely manner and we recommended that all pharmacists be required to enter monitored drug prescription information in the online system as soon as possible
- While the system notifies pharmacists of potential issues such as obtaining prescriptions from several physicians, the Program does not monitor the effectiveness of these notifications to assess whether they impact the potential abuse or misuse of monitored drugs. We found the Program relies on pharmacy audits to verify that prescription information was entered in the system accurately. However not all pharmacies have been audited and improvements are needed to audit processes.
- Although there could be many situations in which a pharmacist might appropriately 5.32 dispense a monitored drug after receiving a response code, we are concerned the Program is not tracking whether prescriptions are dispensed or canceled based on the response code. While these prescriptions may be dispensed legitimately, the Program could be monitoring long-term trends related to response codes to attempt to identify pharmacies which fall outside the normal patterns of dispensing. The results of such monitoring could be used to further educate pharmacists and to assist with the reduction of abuse or misuse of monitored drugs.
- Alerts – The Program also issues alerts to pharmacies and physicians for various matters including stolen duplicate prescription pads and possible situations in which an individual tries to obtain monitored drug prescriptions from more than one physician. During our audit period, 18 alerts were issued, the majority of which related to stolen duplicate prescription pads. One alert during our audit period related to attempts to obtain monitored drugs from several prescribers.
Medavie regularly provides alert information to the Board. However, as with 5.34 response codes, the Program does not monitor the effectiveness of the alerts it issues. Monitoring is important to confirm whether alerts are an effective tool to promote appropriate use and reduce misuse and abuse of monitored drugs.
- Timely information – Pharmacists are supposed to enter prescription information into the online system immediately. However, if the system is not available, the pharmacist is permitted to dispense the monitored drug provided the prescription is submitted to the Program within 30 days. When prescriptions are not entered immediately, resulting delays can reduce the effectiveness of the response codes sent to pharmacists. Potential issues, such as multiple prescriptions for the same monitored drug or a patient receiving monitored drug prescriptions from more than one physician, may not be identified until long after the medication has been dispensed. This problem could be avoided if pharmacists were required to enter information regarding monitored drugs dispensed when the system is not working as soon as the system becomes available.
- The Program has processes to monitor the prescribing and dispensing of monitored drugs but there are considerable weaknesses that allow potential abuse or misuse to continue undetected. Drug utilization review and multiple prescriber reports are not effective; each report identifies many possible issues but a very small number are followed up. There is no support to confirm that all situations identified in the reports were appropriately reviewed; we could not tell why cases were closed or flagged for further investigation. We identified instances in which the Program failed to take appropriate action when potential concerns were identified with the prescription and utilization of monitored drugs. Additionally, a methadone program was accidentally excluded from monitoring reports for 21 months.
- Reports – Drug utilization review intervention reports are generated every 56 days to identify those individuals who received a medication dosage in excess of an established threshold. Reports are reviewed to identify instances which may suggest inappropriate prescribing, abuse or misuse. For situations identified as requiring follow-up, an automated letter is sent to the prescriber requesting an explanation for the medication and dosage prescribed. Responses are assessed for reasonableness. If uncertainty exists regarding the response, additional information may be requested or the Program’s medical consultant may be contacted. If Program staff are satisfied with the prescriber’s response, the case is closed with no further action required.
- Multiple prescriber reports are generated every 28 days to identify individuals who 5.43 have received prescriptions from three or more prescribers. If it appears a patient may be trying to inappropriately obtain prescriptions for monitored drugs from more than one prescriber, staff may send letters notifying prescribers of this activity. These letters are sent for information only; prescribers are not required to provide a response to the Program.
- Thresholds – Currently, both drug utilization review and multiple prescriber reports are very large.
• The drug utilization review reports averaged 2,000 situations identified as exceeding thresholds; only 2% of these cases resulted in letters to prescribers and further analysis.
• The multiple prescriber reports averaged 215 situations identified, with notification letters sent in 13% of these cases.
• In many instances, the same individuals are flagged on these reports regardless of whether their circumstances have changed. This includes instances in which a prescriber has already given the Program a reasonable explanation, and instances in which Program staff previously determined a letter was not necessary.
- One person is responsible for the review of both drug utilization and multiple 5.45 prescriber reports. We were told this review takes approximately three days to complete. With an average of 2,000 situations identified on each drug utilization report, most cases can only receive a very brief review. Furthermore, the size of the reports greatly increases the risk of human error. We are concerned whether a thorough and consistent review of each case can be completed. We found a drug category was mistakenly excluded from the drug utilization review for three consecutive reports during our audit period. The previous seven drug utilization review reports flagged approximately 2,100 cases. This dropped to roughly 1,300 for three reports, a decline of 40%. While these errors were eventually detected by Program staff, the exclusion of a drug category, and resulting 40% decline in the size of the reports, should have been detected immediately. The fact that this went unnoticed for three reports further highlights the challenges with manually reviewing large reports.
- Lack of Consistency – – We analyzed the data from the drug utilization reports during our audit period and found there was no consistent pattern to the situations for which letters were sent. We identified many instances in which a letter was sent when someone was one to two percent over the threshold; conversely, there were also many instances in which letters were not sent when an individual was prescribed 10 to 20 times the dosage threshold. While Program staff were able to provide possible explanations, there was no documentation to confirm this was the rationale considered when the cases were reviewed. Given these inconsistencies and the absence of any documentation supporting why cases were identified for follow-up, it is impossible to know whether all situations were followed up or whether the action taken was appropriate.
- We reviewed the 17 drug utilization reports and 34 multiple prescriber reports prepared during our audit period and selected samples from each to determine whether decisions reached were supported.
We were unable to determine why cases were identified for further follow-up or why 5.52 other situations were deemed acceptable. Since there is no documentation of the review, staff were only able to provide potential reasons for actions taken. Additionally, one of the items we identified for testing had been reviewed by a staff member who is no longer with the Program. The current staff member responsible for reviewing these reports felt a letter should have been sent, but because there is no documentation, was unable to explain why this situation was not followed up. Adequate documentation of the review, along with the reason for final decisions, is necessary to ensure all cases receive an appropriate review and are treated consistently.We also found there is no independent review of staff’s assessment of drug utilizatiion and multiple prescriber reports.
- Enforcement processes – The Program may send letters to prescribers following the review of a drug utilization report. Prescribers are required to provide a response. The Program’s medical consultant may also contact prescribers to discuss the specifics of a situation or may request additional information. If the prescriber does not reply before the deadline, a second letter is sent. If a response is still not provided, a final letter is sent indicating the matter will be referred to the College of Physicians and Surgeons of Nova Scotia if a reply is not received.
We tested 24 initial letters to prescribers and identified three instances in which 5.55 the file was closed even though the prescriber failed to respond to letters from the Program. While additional evidence may dictate a case can be closed, it is important the Program require all prescribers to respond to its requests for information. The Program should also document decisions made in these cases.
- Medical consultant review – The sample we selected from drug utilization review reports included three cases which were referred to the medical consultant for review. While all three situations were reviewed, there is no evidence of when the review was actually completed. The review results were entered in the Program’s system between 44 and 92 days after the initial referral to the medical consultant. The contract with the medical consultant establishes review timeframes of between seven and 30 days, although Program management told us these deadlines are not used in practice. Timely review by the medical consultant is important to address potentially inappropriate prescribing practices and prevent misuse or abuse of monitored drugs from continuing for longer than necessary.
- Complaints – The Program receives complaints regarding potential abuse or misuse of monitored drugs from a variety of sources including the public, pharmacists, physicians and law enforcement. We reviewed a sample of 21 complaints and found all were addressed in accordance with Program policies. However, we were unable to determine if seven of these complaints were addressed in a timely manner as the completion date was not documented. The remaining 14 complaints were dealt with in a timely manner.
- Monitoring of methadone programs -– Methadone patients cannot take most other monitored drugs for safety reasons. The Program uses weekly reports to identify any patients in publicly-funded methadone programs who have received monitored drugs, other than methadone. The reports do not identify methadone prescriptions. This is a gap in the Program since a patient could obtain additional methadone from another prescriber and this would not be detected by these weekly reports.
- We selected a sample of 30 weekly methadone monitoring reports and 30 patient agreement reports. We tested one patient from each report whom we had identified as either having received monitored drugs while taking methadone, or as receiving drugs from another physician after agreeing not to. We found the Program failed to take appropriate action in six of the 60 cases we reviewed; in these instances the prescribers were not informed that their patients had received monitored drugs from another prescriber or pharmacist. Program staff need to ensure letters are sent when required. Recommendation 5.10 in this Chapter notes the need for a quality assurance process to check staff work; implementing this recommendation will also help address this issue.
Department of Health and Wellness Additional Comments
The Department of Health and Wellness notes the audit recognizes the dual mandate of the Prescription Monitoring Program (encouraging appropriate use and monitoring abuse), but is not in agreement with the Auditor General’s assessment that the Program emphasizes its education mandate over its monitoring mandate. The audit scope was not sufficient to make this determination as, “ we [the Auditor General] focused our audit largely on the monitoring type activities the Board conducts, as these provided some coverage of all aspects of its mandate.”
The Department appreciates the thorough review by the Auditor General on the Prescription Monitoring Program. The Department agrees with all of the recommendations pertaining to the Department and recognizes the importance of monitoring the prescribing and utilization of monitored drugs and appropriate action when potential abuse is identified. Over the next year, the Department will direct the Board on developing and enhancing existing measures for monitoring and evaluating the Board’s related compliance.
Nova Scotia Prescription Monitoring Program Board Additional Comments
The Board has confidence in the Program’s performance and effectiveness with respect to its legislated mandate to promote the appropriate use of monitored drugs and the reduction of the abuse/misuse of monitored drugs. It recognizes the importance of continuous quality improvement and will collaborate with the DHW to incorporate the recommendations of the Auditor General into the Program’s ongoing quality assurance processes.
While the Board agrees with the individual recommendations, it is disappointed with the overall tone of the report and is of the position that it would have benefitted from the report providing comment on whether or not the Program is meeting its mandate. The opportunity existed for the report to acknowledge the existence of a valuable and unique entity of which Nova Scotians should be proud. If that had been the case, the recommendations concerning the need for ongoing Program enhancements and the identification of additional resources to support valuable initiatives would have been a more positive investment in the Program’s objectives and its future.
The Board is of the opinion that the audit would have been of even more value to the Board, the Program Administrator and the Nova Scotia public if the Program’s performance had been benchmarked against other prescription monitoring programs across the country or industry best practices and further, if the expertise of clinical experts had been utilized during the audit process.
The Board does not agree with the report’s suggestion that the Board appears to emphasize education over active monitoring. The Board agrees that its work in the area of education is critical to achieving the Program’s legislated mandate of promoting the appropriate use of monitored drugs and the reduction of the abuse/misuse of monitored drugs; however these efforts are not being carried out in a manner that is disproportionate or detrimental to its monitoring role.
Office of the Auditor General Comments
The Board has provided additional comments in their response to this Chapter which can be found below.
It is not our practice to attempt to compare Nova Scotia programs with those of other provinces. We are not in a position to verify information available publicly on the internet or elsewhere regarding these programs.
The use of outside expertise was not necessary for this audit.
Link to full report : http://www.oag-ns.ca/may2012/fullreport.pdf