Feedback deadline was: August 6, 2018
Summary
This consultation is now closed.
The College is now consulting on a supplemental Standard of Practice (sSOP), in accordance with our consultation framework. Pharmacy professionals, stakeholders, members of the public and others are invited to comment on whether the sSOP provide clear guidance on the expectations of pharmacists and pharmacy technicians in regards to the Medication Safety Program.
Following the consultation, the final sSOP will be brought forward for approval by Council in September 2018.
The Ontario College of Pharmacists has launched a province-wide Medication Safety Program with the goal of identifying medication incident trends and supporting continuous quality improvement in pharmacy practice. The components of the program were confirmed in spring of 2017, after a formal consultation process. Since then, the expectations for pharmacy professionals have been outlined in a sSOP which was considered by Council in June 2018.
The sSOP is an adjustment to the NAPRA Model Standards of Practice (pharmacists and pharmacy technicians) related to safety and quality, to provide additional detail on what is expected of Ontario pharmacy professionals under the Medication Safety Program. The sSOP will also be reinforced in the pharmacy through the Operational Standards for Pharmacy in Ontario, which are also currently posted for consultation.
Review the supplemental Standard of Practice prior to submitting your feedback.
Question to Guide Your Feedback
Does the supplemental Standard of Practice provide clear guidance on the College’s expectations of pharmacy professionals in regards to the Medication Safety Program?
Frequently Asked Questions
What are the responsibilities of pharmacy professionals in meeting the sSOP?
Pharmacy professionals must practice in accordance with all of the requirements of the Medication Safety Program.
Under the supplemental Standard of Practice, all pharmacists and pharmacy technicians have the responsibility and obligation to manage medication incidents and address unsafe practices. This includes documenting and communicating all medication incidents and near misses with the entire pharmacy staff, and as appropriate to the patient and other health care providers (e.g. if the incident reaches the patient).
There is an expectation that pharmacy professionals will record medication incidents and near misses, and engage in continuous quality improvement planning and initiatives to improve system vulnerabilities.
What are the responsibilities of Pharmacy Owners and Designated Managers (DMs) in Meeting the sSOP?
Pharmacy owners and DMs must enable a culture that supports learning and accountability rather than blame and punishment, and encourages individuals to discuss medication incidents without fear of punitive outcomes. It is an expectation that all pharmacy operations are conducted in a manner that supports the aim of the Medication Safety Program (as outlined in the introduction), the Standards of Operation, and the requirements outlined in the sSOP. This includes ensuring that pharmacy staff are able to anonymously record medication incidents, and implementing processes to continually document, identify, and apply learnings from medication incidents to improve workflow within the pharmacy.
Why is the Medication Safety Program important?
Patient safety and protecting patients from harm associated with medication incidents is a priority we all share. By identifying and sharing sources of risk and system vulnerabilities, prevention strategies can be put in place across the system that will better protect patients.
Moving forward with a formal Medication Safety Program will lead to standardized, accurate and complete tracking of information on medication incidents across the province and help provide a better understanding of how they occurred and how they can be prevented. Through aggregate data obtained by reporting, the College will be able to identify areas of risk and provide appropriate guidance to pharmacy professionals. Additionally, the program will support ongoing continuous quality improvement within and among pharmacies. Not only will the program help encourage and promote a positive safety and learning culture in individual pharmacies and help reduce the risk of medication errors, it will help contribute to a safer health system as learnings from incidents will be shared among all pharmacies and health care system partners, not just in Ontario but also throughout the country.
When will this program be implemented?
All components of the Medication Safety Program will be in place by December 2018. It is the College’s expectation that pharmacies are currently preparing for implementation of the program by familiarizing themselves with the program requirements and educating staff about the program, including how it will help to improve patient safety and outcomes. Pharmacies will be onboarded to the reporting platform, managed by the College’s third party vendor Pharmapod, in phases throughout early 2019. You will be contacted by Pharmapod when it is time for you to receive access.
How will the sSOP work in hospital pharmacies?
Although the Medication Safety Program is currently being implemented in community pharmacies, the sSOP reinforce the important role hospital pharmacy professionals play in medication safety. Hospital pharmacy professionals also have the responsibility and obligation to manage medication incidents and address unsafe practice and will be expected to practice in accordance with the requirements of the program. The sSOP will support pharmacy professionals practicing in hospital to actively participate in medication safety while following the hospital’s procedure for incident documentation. This will facilitate incident review and analysis to drive continuous quality improvement and enhance patient safety in hospitals. The College will expand reporting mechanisms in hospital practice, to enhance current reporting practices, following implementation in community pharmacies.
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Dear colleagues at the Ontario College of Pharmacists: The Canadian Society of Hospital Pharmacists (CSHP) is a national voluntary organization of pharmacists committed to patient care through the advancement of safe, effective medication use in hospitals and other collaborative healthcare settings. Members of CSHP Ontario Branch (CSHP OB) have reviewed the Supplemental Standards of Practice: Mandatory Standardized Medication Safety Program in Ontario Pharmacies, the following feedback was received and collated for your review and consideration: While the OCP Supplemental Standard of Practice recommend that each instance of reporting be anonymous, hospitals have had success with incident reporting systems that are not anonymous. In fact, the anonymity would hinder any attempts for follow-up and additional investigation required to determine the root cause of an incident. This process is described in the ‘Analyze’ step. Please give some consideration that anonymity of incident reporting may hinder the ability to determine causal factors and identification of root cause flaws in the systems/processes. Given that most hospitals have established electronic incident reporting systems that are not anonymous, will the anonymity be solely at the level of the third-party incident reporting system for the purposes of the College’s Medication Safety Program? Will the third-party incident reporting system accept aggregate reports from hospitals? Hospital electronic incident reporting systems contain patient and staff confidential information. How will this information be handled by the third-party incident reporting system? There is concern on behalf of hospital Pharmacists for the requirement of double-reporting (documenting in 2 separate systems: the hospital’s incident reporting system and the College’s third-party incident reporting system). Is the College/third-party incident reporting system working with electronic reporting vendors to have data from the current programs interface/send-receive data to the third-party vendor’s system? Or will Pharmacists have to enter the incident into 2 separate systems in order to fulfill the reporting requirement? Challenges with dual reporting have already been encountered since the Ontario Hospital’s Association mandate in 2011 to report critical incidents into CIHI’s National System for Incident Reporting (NSIR). The specific challenges encountered from dual reporting are: o Finding the time for the dual reporting. The burden will be significant if all near misses and incidents are to be reporting in the College’s third-party incident reporting system. o Ensuring any and all organization/unit/patient identifying information from any freetext fields is deleted prior to submission. What are the capabilities of the third-party incident reporting system? Will hospital pharmacies be able to view aggregate data for all hospitals across the province? Will collaborative care settings Pharmacists be able to review aggregate medication incident reporting data specific to their practice settings? Will specific guidelines for reporting be developed? Hospitals use many acronyms (ie: MD, RN, RPN, ER, ID) that are not accepted by NSIR and are therefore sent back to the organization for correction. The development of specific guidelines and acceptable reporting practices will be valuable to minimize the requirement to correct reports and this in turn will increase reporting compliance. How will the College ensure that work will not have to be duplicated for hospital and collaborative care setting Pharmacists where adequate medication safety governance has been established? As per the Medication Management Standards of Health Services Organization (previously Accreditation Canada), all institutions must establish an interdisciplinary committee that oversees medication safety within the institution. Will hospitals be able to leverage this governance over medication safety for the purposes of this program? Will the requirement include the mandatory of reporting all medication related incidents? Hospitals have many medication related incidents that are not directly related to Pharmacy processes (i.e.: delayed administration of a medication ‘" due to factors not within the control of the Pharmacy department). Will these incidents have to be reported to meet the College’s requirements? Please contact me if you have any questions or would like CSHP OB to provide more information on this feedback. Thank you for the opportunity to provide this feedback. Sincerely, Kathryn Hollis
Dear Ms. Lum-Wilson: Re: Consultations on the: 1. Proposed Supplemental Standard of Practice: Mandatory Standardized Medication Safety Program in Ontario Pharmacies, and 2. Proposed Amendments to the Standards of Operations for Pharmacies in Ontario On behalf of the Board of Directors and members of the Ontario Pharmacists Association (‘˜OPA’, the ‘˜Association’), we welcome the opportunity to comment on the proposed amendments to the operating standards for pharmacies in the province. In addition, the Association offers commentary on the proposed supplemental standard of practice as related to implementation of a mandatory standardized medication safety program for pharmacies. OPA Commentary on the Proposed Supplemental Standard of Practice: Mandatory Standardized Medication Safety Program in Ontario Pharmacies OPA is committed to patient safety and driving excellence in practice and high-quality patient care. As a result, the Association strongly supports the mandatory standardized medication safety program. As with any new program, particularly large ones, logistics associated with rollout and implementation frequently require tweaks and adjustments to optimize its application, and OPA pledges to work with the Ontario College of Pharmacists (‘˜OCP’, the ‘˜College’) to ensure an optimal transition. The Association will work closely with the College, and its partner PharmaPod, to address any concerns about the anonymity of incident recordings, the time required of pharmacy professionals to record every incident, and the downstream costs to pharmacies and pharmacists for the new system. The data collected will provide important information to prevent future medication incidents, however, there are various links in the continuous quality improvement (‘˜CQI’) chain where breaches could occur outside of PharmaPod’s data warehouse. It is imperative that employers and colleagues strictly adhere to privacy and confidentiality in order to protect the professional integrity of everyone involved in a medication incident. Concerns relating to costs associated with the rollout of a mandatory medication safety program and the time required to record real and near-miss incidents are clearly linked and will likely be raised by pharmacy professionals, particularly as we get closer to full implementation. OPA is concerned about the individual impact this program will have on annual professional registration fees. In the absence of new opportunities to expand scope of practice that might support and sustain business viability, pharmacies may find themselves in a model that is unable to grow and expand, resulting in increased strains on productivity and financial resources. Therefore, unless pharmacists’ scope is expanded further to enable investment in staff and resources, OPA recommends that costs associated with the CQI program should not be passed on to either pharmacy businesses or individual pharmacy professionals in the form of increased accreditation or professional fees, respectively. OPA Commentary on Proposed Amendments to the Standards of Operations for Pharmacies in Ontario It is the opinion of the Ontario Pharmacists Association that the proposed amendments to the standards of operations for pharmacies in Ontario need to be reconsidered, particularly at this time when patient safety and quality of care is paramount in the minds of regulators, policy makers, health professionals and the general public. The newly proposed supplemental standard of practice and mandated medication safety program is a positive step forward, however, OPA is concerned that the proposed amendments to the standards of operations for pharmacists, could contradict and negatively impact any new measures that are taken to enhance the new medication safety program. With the continual stream of ‘new and improved’ medications into the Canadian market, the slow attrition of other molecules due to competitive market pressures, and increased wait times for a growing cohort of overworked primary care providers, patients are finding it harder to access the care they need in a timely fashion, and more often they are turning to their pharmacists to get answers and guidance in this ever-changing system. The draft standards of practice for the pharmacy profession call for revisions to the required reference guide for Ontario pharmacies and, more specifically, to the revised minimum library requirements. In theory, these changes will allow pharmacy professionals to determine what additional references and resources they require to support their practice. The myriad of resources available, however, may pose some confusion for today’s pharmacist. Pharmacists need guidance and, more importantly, someone to help them navigate and interpret the large amount of material available, some of which can be biased, poorly sourced or contradictory. As a result, the elimination of the requirement to have a drug information service that can dig deeper into the clinical issues and help read between the lines of the research to answer or advise on questions is, in our opinion, a profound mistake when patient safety and quality are so high on everyone’s agenda. OPA strongly believes that OCP should continue with a mandated DI subscription for pharmacies to ensure that today’s complex healthcare issues can be quickly managed in an effective and safe manner. A drug information subscription ensures that pharmacists can provide professional and up-to-the-minute expertise in-real time, is not cost-prohibitive and has proven to possibly save lives and promote patient safety. They respond to hundreds of inquiries a day, and help pharmacists with topics such as: • Identifying safe use of drugs in pediatrics • Identifying safe use of drugs in pregnancy and lactation • Confidently administering vaccines’”particularly during the flu season • Identifying alternative medications that are safe and effective’”such as during the valsartan recall • Identifying drug interactions that may compromise patient safety • Verifying the safety and efficacy of herbal products • Providing formulations for compounding Using the same logic that OCP uses to mandate professional liability insurance, a subscription to a drug information service should continue to be a requirement to ensure pharmacists, the pharmacy and their patients are appropriately protected with the highest quality information and advice available. Conclusion The Ontario Pharmacists Association appreciates the opportunity to comment on these two important consultations. The Association is eager to work closely and collaboratively with OCP on the rollout and implementation of the mandatory medication safety program in Ontario, beginning first with community pharmacies and eventually with hospital pharmacies. Regarding the draft standards of practice related to library requirements, OPA agrees that some flexibility is needed; however, the concept of a mandated subscription to a drug information and resource service is critical to provide real-time, unbiased support, advice and guidance to frontline practitioners, particularly when the questions posed are not exactly addressed in a textbook or online resource. Intraprofessional collaboration will be critical to ensure patient safety is entrenched. Should you have any questions as it relates to this submission, please do not hesitate to contact me at your earliest convenience. Respectfully submitted, Bill Wilson, Interim Chief Executive Officer
This is an excellent initiative to support quality and safety. But I believe a number of clarifications related to the practicalities of implementation are required. The standards clearly state that ‘˜all’ incidents and near misses must be reported. This is a strong requirement. I think it will be important to be very clear on what constitutes an incident and a near miss. For example if an error is made, but caught by the usual checks, is that a near miss? In the hospital setting are these limited to events that occur within the pharmacy? I couldn’t see the link between anonymous reporting to a third party, and the pharmacy’s in-house quality program. Is the expectation that there is anonymous reporting to the third party, plus internal reporting to the pharmacy manager or the institutions reporting system to support the internal quality program? I’m concerned the double reporting, externally to the third party, plus internally, will be quite onerous. Will be able to access ‘˜our own’ data within the third party system. Will there be linkages between the third party system and hospital incident systems? I was hoping for more clarification on the documentation section. Is there a requirement it is linked to the patient record or Rx, or can it be part of a separate CQI document, or use of the internal incident reporting system? I know ISMP already collects incident reports from professionals and the public and generates many recommendations based on these reports. Will the OCP system also populate the ISMP system?
As hospitals already have a reporting system for errors and near misses, I believe pharmacists practicing in hospital should not be asked to double document the errors. I believe they should be held accountable for demonstrating that they have documented errors and participated in a CQI process to address errors. Is it mandatory that the system be anonymous or that there is a possibility for reporting to be anonymous? If pharmacists are reluctant to report an error unless anonymous that speaks to a lack of a culture of safety which is a concern.
I am participating in the pilot. Unfortunately, I am not convinced that PharmaPod is the best system. It seems kind of clumsy as a system (although I have not used the ISMP program myself). However, it probably was the most appropriate option at the time of program planning and design. I am sure we will have more flexible, robust, convenient and advanced open source products available to us in the near future (given how quickly tech is evolving).
It should be mandatory for pharmacists to check chemotherapy and cytotoxic preparations. There are sites that do tech-check-tech for chemotherapy. Yes, you read that correctly: chemotherapy without pharmacist product checks.
This does not specify whether pharmacy staff should be responsible for reporting medication incidents that happen with someone else. Eg, nurse administered the wrong dose of a drug. In this case the error is medication-related but not necessarily pharmacy-related. I think the pharmacist should be consulted for any med-related error, however, I feel the person who discovered the error is the best one to record details of the incident. And most (if not all) hospitals already have their own incident reporting system in place. Will this be duplicate recording for hospitals?
It’s the only chance for pharmacist the show how bad hand writing of prescribers can be time consuming and pose misinterpretation of the prescription.
While the principle behind the requirement is sound and should be adhered to, there are obvious logistical and practical challenges, especially when the requirement is ‘recording of ALL medication incidents AND near misses’ . Given the known error rate, for a large inpatient pharmacy this could mean hundreds and thousands of potential near misses and incidents. Report all is simply not possible, and no institution will be able to comply. Under-reporting is a well-known phenomenon even at sites where the safety culture is great. In addition, most institution pharmacies, as well as outpatient pharmacies located/owned by the institutions already have an internal system for such reporting. Thus asking staff to report this to a ‘independent third party organization’ is double reporting, which will certainly yield non-compliance in a busy clinician day. Rather the College should establish pathways for institutions to submit summary report/extract from internal system as a substitute. Finally medication incidents, especially in a complex medication system in a large hospital, has errors in many of the nodes, many of them NOT related to pharmacy space, process or staff. Thus to only get reports from pharmacy professionals will yield skewed and inaccurate picture of the real problem, and also inadvertently put the pharmacy profession in a disadvantaged light to the public (if the only errors OCP receives are from pharmacist/techs that occurred in the pharmacy, not at the prescribing, administration or documentation nodes). Finally, in light of the recent Vanessa’s law requirement to report all severe ADR, one questions whether adding another level of reporting at this time is wise or timely, as reporting of ADRs is also known to be notoriously low.
The draft document clearly describes goals and each step in potential or actual medication incident reporting, documentation, assessment, dissemination of information to pharmacy staff. Perhaps more information can be included on the benefits to all citizens of Ontario in having the de-identified data disseminated to all registered Pharmacists and registered Pharmacy Technicians – to increase awareness of how to avoid medication incidents in their practice site.
I have unfortunately had the opportunity to use the reporting software (Pharmapod) a few times. I appreciate that there is a lot of functionality in the software, however it is quite cumbersome to enter an error or a near miss with all of the data requested. We have a number of pharmacists here, so the person who discovers the error is not always the person who dispensed, and there ends up being quite a bit of research done to determine time, staff involved, contributing factors, etc. I am sure that I am not fully appreciating all of the aspects of the software (e.g. is there a way for the ‘discoverer’ to enter their known information then pass along the file to management to follow-up on?). Though valuable to collect the data for analysis (I’m all for QI!), it becomes yet another demand on our time for more "paper"work…please let there be a more streamlined way! Thanks!
2 things need to be emphasized to the profession when rolling this out. 1. the anonymous nature of the process and the real purpose (which are both already being communicated) need to be made crystal clear over and over again to get sincere buy-in. 2. clarity on the subject of near misses that are already caught within established processes eg. the technical checking function, versus those that are caught eg. before handing out the finished Rx to the patient, and the documentation requirements of each. Perhaps using a different term to describe the two situations would help. The reality is that established processes catch the majority of these already.
As a hospital pharmacist working for multiple hospitals: hospitals already have a formal internal medication incident reporting system. I would not like to see duplication in reporting. The incident reporting system is used not only for medicaitons but for all processes/incdidents in the hospital and for ease of use from staff, one form for all is very important. If we can continue to use our own format then I am unsure how this data could be collected provincially. Our critical incidents are reported of course to NSIR. If the goal is an electronic form where the data can be used provincially, then the format for hospital requires the ability to report any near miss/incident with the ability to "send" med incident information securely and with no pt identifiers to a provincial data base. I would also like to ensure that all hospitals have a pharmacist review medication safety reports as this is not always done (some hospitals report only to MAC for these). Thank you
I agree that at present, most community pharmacy environments are not conducive to enabling appropriate time for this program as pharmacists’ duties increase more and more as employers attempt to cut operating costs in response to the pan-Canadian drug pricing legislation and the current automatic 2.8% reductions to all community pharmacies’ ODB remittance statements, implemented last fall. The pressure on pharmacists to do more at the same or less pay has never reached such a severe state. Personally, over the past year I have had to do a lot of my documentation and administration at home, after work. The Medication Safety Program is nonetheless vital to helping patients achieve optimal outcomes. I ask all key stokeholds, particularly members of parliament, to support pharmacists in benefiting society. Pharmacists have the expertise to do so much more to improve our healthcare system but we need the support of government and employers to do so.
Medication safety program is a very important program to lessen the incident errors of medications and near misses by pharmacy staff . Implementing the guidelines accurately will help a lot for appropriate dispensing and proper conducting of work flow within the pharmacy. Our goal is always medication safety and this program will achieve this thing.
More regulatory burden with no extra time or money to implement it (in fact it will cost us money and time to implement). Oh so typical. One of the primary sources of error in all pharmacies is the lack of time and remuneration to do our jobs properly so by adding to the existing burdens you have effectively increased the risk of errors! No system will ever be completely error free (and this one will be no better) and the cost and burden just keep escalating to the point it is becoming unrealistic and unsustainable in terms of time and money. You have labelled this system as non-punitive but it is actually quite punitive by its very nature.
1) ‘Given the cost of the program, we anticipate that this will have an impact on [license renewal] fees for 2019, subject to Council approval in September 2018.’ ==> will there ever be an end to OCP’s crafty reasons for raising the license renewal fees? If this program is indeed designed to help protect the public from pharmacists’ errors then it should be paid for by the public or by the pharmacists who commit the errors in a weighted and proportionate manner. If I don’t make errors then why should I pay for a system to track and correct someone else’s errors? Alternatively, the member’s malpractice insurance policy should proportionately pay for the program which would be expected to (correctly) raise the pharmacist’s insurance premiums. This way we all pay for the program in a fair manner and this way the system would naturally weed out pharmacists who would not learn from their mistakes or who don’t care by making it impossible for them to be insured as a result of their repeat offenses (just like auto insurance). 2. Did the public ask for this system? Was there a problem with our current system? If so then the public should pay for it. Is the current system failing so miserably to justify the undoubtedly exorbitant costs of the new system? Where’s the evidence to justify the new system and how would we know in the future if it should be continued; is ocp planning on studying, tracking and evaluating the new system’s ability to better prevent errors compared to the existing system in order to justify its future costs? If the public did not ask for the new system then who came up with the idea and did she base it on? Did she base it on existing systems that have proven themselves in the real world? Or is this a big and costly experiment and the pharmacists are the lab rats? 3) any pharmacist could easily tell you why dispensing mistakes occur and what could be done to prevent them from recurring without needing a costly system like the one ocp is going to implement. It’s up to the pharmacist to take the initiative to fix her broken dispensing methods. If she decided to do nothing about her errors then nothing would be improved whether your expensive new system exists or not. What kind of new information that we don’t already know do you expect the new system to give us all? It’s going to tell us that dispensing errors occur because the DIN wasn’t checked, or because the member transcribed the prescription inaccurately, or because she selected the incorrect patient, etc. We already know about all the possible sources and causes of errors and we don’t need an expensive system to tell us about it. We tailor our error preventative solutions to the pharmacy and staff. Since no two pharmacies and staff are exactly the same it follows that someone else’s weaknesses don’t necessarily apply to me and therefore no need to implement their solutions in my practice environment beyond what I have already implemented and heard from your extremely knowledgeable and courteous inspectors.
The overall wording of the draft document is very repetitive in nature and could be reduced in size accordingly which would improve the readability. Also, the last sentence should include he word "safety" between the words improve and workflow. You can "…improve workflow…" without the defining the rational for doing so. Thanks for the opportunity to respond,