CITATION: Geris v. Ontario College of Pharmacists, 2020 ONSC 7437
DIVISIONAL COURT FILE NO.: CVD-TOR-28-20JR
DATE: 2020-12-14
ONTARIO
SUPERIOR COURT OF JUSTICE
DIVISIONAL COURT
Pattillo Penny and Kurke JJ
BETWEEN:
Mina Geris Applicant
– and –
Ontario College of Pharmacists Respondent
COUNSEL:
Asher G. Honickman for the applicant
Richard Steinecke for the Respondent
HEARD: November 19, 2020
[1] This is an application for judicial review seeking to quash the Decision of the Inquiries, Complaints and Reports Committee (ICRC) of the Ontario College of Pharmacists dated May 22, 2020. The ICRC found that the applicant failed to ensure proper policies were in place at his pharmacy, that he implemented an unsafe return-to-stock protocol following an incident in which an employee of the pharmacy dispensed the wrong medicine to a pediatric patient, and that the applicant’s conduct warranted the imposition of an oral caution and remedial course. The applicant takes the position that he was denied procedural fairness and that each one of the ICRC’s findings, individually and collectively, renders the Decision unreasonable.
Background
[2] The applicant, Mina Geris, has been a licensed pharmacist in Canada since 2013. Until this incident, he had not been the subject of any prior investigation or complaint. The applicant began working full time at the relevant Pharmacy, in the position of “designated manager”, on October 4, 2017. This was nine days prior to the incident that ultimately lead to these proceedings.
[3] On October 13, 2017, a pharmacist at the Pharmacy dispensed prednisolone to a pediatric patient which improperly contained risperidone. It was later determined that a pharmacy assistant had added 41 mL of prednisolone to an amber bottle already containing 15 mL of risperidone. She then put a prednisolone label over a label from the previous August which indicated that the bottle contained risperidone. The pharmacy assistant was working under the supervision of the dispensing pharmacist (not the applicant). The dispensing pharmacist did not notice the error and dispensed the bottle. As a result of this dispensing error, the patient was taken to hospital with serious symptoms and was required to spend the night there.
[4] The applicant was not present at the Pharmacy when the dispensing error occurred. Upon learning of the incident, the applicant immediately made sure that the pharmacist on duty contacted the family and properly documented the incident. When he next came to the Pharmacy, the applicant sought to understand how the error had occurred and implemented several new protocols. He also spoke with the family and apologized for the error on behalf of the pharmacy.
[5] Although the incident was brought to the attention of the College, there was no formal complaint. Rather it was processed as what is known as a Registrar’s Investigation. The College first investigated the dispensing pharmacist.[^1] The panel of the ICRC which considered the Registrar’s Investigation Report into the dispensing pharmacist had concerns about the role of the designated manager – the applicant – and brought those concerns to the attention of the Registrar.
[6] The Registrar then appointed investigators to examine the conduct of the applicant. The completed Registrar’s Investigation Report was disclosed to the applicant on March 6, 2020, the same day it was prepared. The Registrar offered the applicant an opportunity to respond to the Investigation Report. The applicant provided his response, through counsel, on March 18, 2020. The ICRC deliberated on the applicant’s matter on April 16, 2020, and its Decision and Reasons were released on May 22, 2020.
The ICRC Reasons
[7] The ICRC’s reasons begin with a statement of the ICRC’s purpose – to review a report of the Registrar about the applicant “with respect to his responsibilities as the Designated Manager of a pharmacy, including the training of staff and establishing processes for the operation of a pharmacy to ensure that the patient receives the correct medications.”
[8] The ICRC also noted that it had the authority, after considering the Registrar’s report: a) to refer the applicant to discipline for professional misconduct or incompetence; b) to refer the applicant to incapacity proceedings; and/or, c) to require the applicant to appear before the ICRC to be “cautioned” under s. 58 of the Health Professions Procedural Code and to require the applicant to complete a specific continuing education or remedial program.
[9] The ICRC reviewed the background circumstances around which, with one exception dealt with below, there was no material dispute. The ICRC also reviewed the applicant’s submission, to the effect that the applicant:
• instituted a new protocol and advised his staff that when unused medication is being returned, it must be poured into the “mother bottle” immediately, and if there is no mother bottle, it must be discarded immediately.
• instructed staff that a vial already containing medication must never be “topped up”; the vial and the medication inside must be discarded.
• instituted a protocol that the pharmacist on duty is responsible for filling the vial during normal working hours. The pharmacy assistant is responsible for inputting the prescription into the system and bringing the pharmacist the mother bottle and the vial; the pharmacist then measures the dosage and fills the vial while the assistant observes. If the pharmacy is very busy, the assistant will sometimes fill the vial, but only under the direct supervision of the pharmacist, who first ensures that the vial is completely empty and ensures that the assistant fills the vial from the proper mother bottle.
[10] The ICRC noted that pediatric patients are “red flag” patients and liquid medications are “red flag” medications.
[11] The ICRC expressed serious concerns that a medication bottle containing risperidone, with a blacked out name on the label, and without an expiry date, DIN and LOT number, was put back on the pharmacy shelves to be used, and was used, for further dispensing.
[12] The ICRC was also concerned that the pharmacy’s return to stock procedure, as instituted by the applicant, “will create the risk of contaminating entire stock bottles”, emphasizing that a liquid medication should never be added back into a stock bottle. The ICRC was of the opinion that, without a robust return to stock policy, the likelihood of a recurrence of this type of error remained high, particularly for liquid medications, which are difficult for the dispensing pharmacist to check visually.
[13] While acknowledging that the applicant was new to his role as designated manager, the ICRC stated that the error should not have occurred. The ICRC concluded that the applicant, in his role as designated manager, did not ensure that the pharmacy had robust policies in place related to safe medication practices, particularly regarding return to stock practices. Further, the applicant did not ensure pharmacy staff were adhering to processes that would ensure the patient received the correct medication.
[14] Having reached these conclusions, the ICRC decided that the issuance of an “oral caution” and attendance at and successful completion of a workshop on “root cause analysis” was the appropriate course of action. The oral caution was administered and the applicant has, I understand, successfully completed the workshop on root cause analysis.
Analysis
Standard of Review
[15] The parties agree on the standard of review. Regarding procedural fairness, the standard is whether the requisite procedural fairness was afforded to the applicant. The standard of review of the Decision of the ICRC is reasonableness, as formulated by the Supreme Court of Canada in Canada (Minister of Citizenship) v. Vavilov, 2019 SCC 65. In connection with judicial review of the Decision itself, therefore, the burden is on the party challenging the decision to show that it is unreasonable. Before a decision can be set aside on this basis, the reviewing court must be satisfied that there are sufficiently serious shortcomings in the decision that it cannot be said to exhibit the requisite degree of justification, intelligibility, and transparency. Any alleged flaws or shortcomings must be more than merely superficial or peripheral to the merits of the decision. It would be improper for a reviewing court to overturn an administrative decision simply because its reasoning exhibits a minor misstep. Instead, the court must be satisfied that any shortcomings or flaws relied on by the party challenging the decision are sufficiently central or significant to render the decision unreasonable: Vavilov, para. 100.
Procedural Fairness
[16] The applicant submits that the ICRC denied him procedural fairness in three ways: 1) its investigation was wholly inadequate; 2) it prejudicially delayed the matter and breached the timelines prescribed under the Code; and, 3) it failed to notify the applicant that his post-incident return-to-stock protocols were under investigation and failed to provide him with an opportunity to clarify the details of the procedure, and thus to make full answer and defence.
[17] In connection with the allegation of inadequate investigation, the mechanism of how the dispensing error occurred was ascertained very early on. There was no dispute over how the error occurred. The only issue in doubt was whether the bottle of risperidone was placed on the storage shelf the day before the dispensing error or a several weeks prior (before the applicant was designated manager of the Pharmacy). The applicant says he was denied procedural fairness because the pharmacy assistant was not interviewed to resolve this uncertainty. I cannot agree.
[18] When the applicant assumed the role of designated manager at the Pharmacy, he submitted a form to the College acknowledging the following:
The DM is accountable for the following pharmacy functions:
• Professional Supervision of the Pharmacy • Facilities, Equipment, Supplies and Drug Information • Record Keeping and Documentation • Medication Procurement and Inventory Management • Training and Orientation • Safe Medication Practices
Before accepting the role of DM, it is important for the pharmacist to review the roles and responsibilities expected of this position. The DM must be familiar with the legislation and operational requirements for the profession and the business as well as the policies and procedures that are in place at the pharmacy.
[19] Thus, the applicant certified an acknowledgement of his duty to be aware of the policies and procedures when he assumed the role of designated manager. While the return to stock of the risperidone bottle may have taken place before the applicant was designated manager, the use of this medication in filling a prescription, and the dispensing of the contaminated medicine, took place after the applicant had become designated manager. The concerns of the Registrar and the ICRC were with policies and procedures in place when and after the applicant took on the role of designated manager. Whether the return to stock of the risperidone took place before or after October 4, 2017 was not the issue. I cannot accept that the fact that the College did not interview the pharmacy assistant resulted in any denial of procedural fairness. It is clear that interviewing the pharmacy assistant would not have affected the outcome.
[20] Regarding the allegation of delay, it must be noted that the applicant did not raise any issue of delay before the ICRC or assert, then or now, any specific facts that would establish prejudice by reason of delay.
[21] There is a perfectly good explanation for the “delay”, in any event. The College completed its investigation of the dispensing pharmacist first. It was only in the course of its review of the dispensing pharmacist that this prior panel of the ICRC raised concerns about the applicant’s role as designated manager and reported those concerns to the Registrar.
[22] Further, the evidence is that the applicant acknowledged the seriousness of the incident immediately after it occurred. As a result, he took steps to document and respond to it thoroughly, including:
• ensuring a Dispensing Error Incident Form was completed, • ensuring the documentation of the incident in the pharmacy records, • ensuring that both the family of the patient and the prescriber were notified, • retrieving security videos of the incident, • obtaining interviews or statements from all relevant staff members, and • instituting new protocols.
[23] In addition to the applicant’s own acknowledgement of the seriousness of the dispensing error, the need to preserve evidence was reinforced by the request from the College for information and documents only seventeen days after the incident occurred, and the fact, known to the applicant, that the family of the patient retained a lawyer.
[24] Finally, the applicant is incorrect when he submits the College was required to dispose of the complaint within 150 days and that the College failed to provide him with written notice of its failure to do so, pursuant to section 28(3) of the Code. The applicant has confused the provisions relating to Registrar’s investigations and reports with those applicable to formal complaints. Section 25 of the Code distinguishes between a formal letter of complaint and information that results in a Registrar’s investigation report. The former is subject to the 150-day requirement; the latter is not. Section 25(6) of the Code requires the College to provide notice to the member within 14 days of the receipt of the Registrar’s report. This requirement was met; the applicant was given the Registrar’s Report the very day it was received.
[25] For these reasons, I am unable to agree that delay by the College resulted in any denial of procedural fairness.
[26] I am also unable to accept the applicant’s assertion that he was unaware that post-incident return-to-stock policies were part of the investigation or the considerations of the ICRC. Among the documents requested by the College was a copy of the Pharmacy’s policies and procedures for responding to a medication error. The applicant provided no policies or procedures that existed at the time of the incident. Instead, the applicant provided the new, one-page policy which he created in direct response to the incident. This policy dealt with safeguards when pouring liquid medication and returning the medication to stock once it is poured.
[27] The introduction to the Registrar’s Report, which was given to the applicant well before his response was filed, states that the ICRC panel dealing with the investigation into the dispensing pharmacist triggered the investigation of the applicant because of concerns “about the training of nonregulated pharmacy staff, the policies and processes in place at the Pharmacy, and the accountability of the Designated Manager”.
[28] The applicant’s response to the Registrar’s Report again did not provide any information about the policies and procedures that existed at the time of the incident that might, if followed, have prevented the error. Indeed, based on the applicant’s lack of response to a direct question from the College about this, it is quite apparent that there were no policies in place about returning previously dispensed medicine to stock. The applicant merely stated that he did not observe “any deficiencies” in the Pharmacy’s policies at large. The applicant’s response did, however, include a detailed explanation of the post-incident policies which he had established after the dispensing error.
[29] The applicant was clearly aware of the need to address his response to the incident, including what he had done to ensure there could be no repetition of the mistake. This included his post-incident policies, which he submitted and explained to the College in his response to the Registrar’s Report.
[30] For all these reasons, I would not accept any of the applicant’s arguments that he was denied procedural fairness.
Reasonableness of the Decision
[31] The applicant submits that the ICRC’s determination that he acted improperly and that his conduct warranted an oral caution was based on three findings, each one of which was unreasonable: 1) the applicant failed to ensure that proper policies were in place, which contributed to the dispensing error; 2) the applicant implemented an improper return-to-stock procedure post-incident; and, 3) the applicant’s conduct was sufficiently serious to justify an oral caution. The decision to issue an oral caution was based on the totality of these findings. Thus, to the extent that any one of them was unreasonable, the ICRC Decision, he submits, should be quashed.
[32] The ICRC performs a screening function. It does not make findings of disputed fact and is not required to resolve every factual dispute through additional investigation or, for that matter, in its reasons. Neither does it make findings of professional misconduct. Rather, it investigates concerns and determines whether they warrant a referral to discipline or other, less intrusive, responses: Armogan v Health Professions Appeal and Review Board, 2013 ONSC 3095 (Div. Ct.) at para. 5.
[33] Cautions and educational or remedial directions are not meant as sanctions or penalties but are meant to benefit the practitioner and the patients by avoiding future complaints of a similar nature: Armogan, para. 9.
[34] It is true, as the applicant argues, that cautions and remedial orders regarding attendance at education programs are now placed on the public register. This was not the case when a number of the leading cases dealing with such orders were decided. However, the fact that the Legislature felt it would be in the public interest to make health disciplines bodies publish remedial orders of the kind issued by the ICRC in this case does not fundamentally alter the preventive, educational and remedial nature of such orders. I cannot agree that an entirely different approach must be taken now that remedial orders appear on the public register.
[35] Among other things, there is a mechanism in the legislation to remove entries from the public register where “the information is obsolete and no longer relevant to the member’s suitability to practise.”
[36] I cannot agree that the applicant was found accountable for something he had no ability to control. Each pharmacy is required by statute to have a designated manager who is responsible for the management of the pharmacy. A designated manager is responsible to ensure that the pharmacy follows safe medication practices, including having appropriate policies and procedures in place and responding appropriately to dispensing errors. The applicant, upon becoming the designated manager, acknowledged to the College that he was aware of the requirement that “[b]efore accepting the role of DM … The DM must be familiar with … the policies and procedures that are in place at the pharmacy.”
[37] While the applicant may have had no ability to control the original action whereby the risperidone was returned to stock, he became designated manager before it was wrongly dispensed, and inherited, as designated manager, a pharmacy that, on the evidence, apparently had no policy about returning previously dispensed medications to stock. The College was entitled to consider this shortcoming in procedures which continued ‘on the applicant’s watch’.
[38] More importantly, the ICRC assessed the applicant’s new, post-incident, return to stock policy, both as written and as described in the applicant’s submission to the College. Each of those descriptions contemplated the pouring of medication from a prescription bottle back into the stock bottle either by or under the supervision of a pharmacist. There was no mischaracterization of the applicant’s post-incident policy. The ICRC’s reasons on this point were, likewise, not vague or lacking in specificity. The ICRC concluded (as it was entitled to being an expert body of the applicant’s peers) that such a policy “will create the risk of contaminating entire stock bottles” and that “a liquid medication should never be added back into a stock bottle.”
[39] Finally, the ICRC concluded that educational and remedial measures could reduce the risk of such errors occurring in the future. It chose not to engage in an exercise of allocating blame for the incident amongst the various participants. The ICRC gave extensive reasons justifying how and why the applicant (and the public) would benefit from the educational and remedial measures it adopted.
[40] Finally, the applicant argues that the “penalty” was, in the circumstances, too harsh; mitigating factors were not given sufficient weight and, the dispensing pharmacist, who the applicant says was clearly more at fault, only received ‘advice and recommendations’. I do not agree.
[41] Directing the applicant to attend and receive an oral caution is not a penalty. Rather it is an educational and remedial measure intended to prevent the applicant from having a similar experience in the future and to protect the public. The ICRC did consider the mitigating factors that the applicant was new to the role of designated manager and that he had no record of prior incidents. The role and responsibilities (including accountabilities) of the designated manager, however, are central to the protection of the public under a regime in which only the individual pharmacists, not the pharmacy, are regulated. Someone has to be accountable for the policies and procedures of the pharmacy – that “someone” is the designated manager. The applicant is asking this court to re-weigh the relevant factors and come to a different result. That is not the role of any court on judicial review, especially where remedy is concerned: Mitelman v College of Veterinarians of Ontario, 2020 ONSC 3039.
[42] For these reasons, I would not accept the assertion of the applicant that the ICRC’s Decision was unreasonable.
Conclusion
[43] For the foregoing reasons, I would dismiss the application for judicial review.
Costs
[44] The parties agreed that there should be no order as to costs. We accept that resolution.
Penny J.
I agree _______________________________ Pattillo J.
I agree _______________________________ Kurke J.
Released: December 14, 2020
CITATION: Geris v. Ontario College of Pharmacists, 2020 ONSC 7437
DIVISIONAL COURT FILE NO.: CVD-TOR-28-20JR
DATE: 20201214
ONTARIO
SUPERIOR COURT OF JUSTICE
DIVISIONAL COURT
Pattillo Penny and Kurke JJ
BETWEEN:
Mina Geris, Applicant
– and –
Ontario College of Pharmacists, Respondent
REASONS FOR JUDGMENT
Released: December 14, 2020
[^1]: That panel of the ICRC concluded that the dispensing pharmacist would not receive an oral caution but would receive “advice and recommendations”.