Feedback deadline was: August 6, 2018
Summary
This consultation is now closed.
Standards of Operation are required to clarify the expectations of the College for accredited pharmacies. The College conducts regular assessments of pharmacies to ensure the pharmacy is adhering to these standards and has the proper processes and procedures in place to optimize healthcare outcomes.
Following the changes to the Drug and Pharmacies Regulation Act (DPRA), the Standards of Operation are required to clarify the expections of the College for accredited community and hospital pharmacies. Specific details outlining expectations for the operation of pharmacies were removed from the general regulations of the DPRA in favour of an outcome-based model which would allow the College to regulate in a more responsible and flexible manner. The College committed to formalizing these expectations as Standards of Operation for pharmacies.
Changes Within the Standards of Operation for Pharmacies in Ontario
Within the Standards of Operations, a couple of changes to existing standards have been made:
- Revisions to the Required Reference Guide for Ontario Pharmacies
- Changes to the Required Reference Guide for Ontario Pharmacies are being proposed, including revised Minimum Library Requirements.
- These changes will allow pharmacy professionals to determine what additional references and resources are required to support their practice.
- The Standards of Operation require that the environment is sufficient for the supplemental Standards of Practice (sSOP) to be met. The sSOP outlines the expectations for Ontario pharmacy professionals regarding medication safety based on the existing NAPRA Model Standards of Practice.
- The supplemental Standard of Practice is also currently posted for consultation.
No other changes are being introduced through the Standards of Operation.
The College is consulting on the Standards of Operation in accordance with our consultation framework. Pharmacy professionals, stakeholders, members of the public and others are invited to comment on whether the Standards of Operation provide clear guidance on the expectations of pharmacy owners and designated managers. Following the consultation, the final Standards of Operation will be brought forward for approval by Council in September 2018.
Review the draft Standards of Operation.
Review the revised Required Reference Guide for Ontario Pharmacies.
Questions to Guide Your Feedback
- The objective of the Standards of Operation are to clearly outline the College’s expectations regarding the operation of accredited pharmacies. Does the document achieve this objective?
- Would the revisions to the required reference guide for Ontario pharmacies have an impact on your practice, or the quality and safety of pharmacy care that patients receive?
Frequently Asked Questions
What expectations have changed under these Standards of Operation for pharmacies?
With the exception of revising the required reference guide and the addition of the supplemental Standard of Practice, there are no new expectations included in these standards.
What are the key changes to the Minimum Library Requirements?
To enable members to meet the standards of practice, at a minimum, every pharmacy should have at least one reference in each of the following areas:
- A Canadian Drug Reference / Compendium
- A Drug Interaction Publication
- A Drug Therapy Publication
- A Patient Counselling Guide
Additional references should be selected based on the pharmacy’s patient population to support the specific services provided. For example: natural health products, pediatrics, compounding, geriatrics, etc.
“A Subscription to a Drug Information Service,” is an optional library requirement and members are encouraged to assess their practice to determine what resource best meets their needs.
Will these standards have any impact on the pharmacy assessment process?
The Standards of Operation will not have an impact on the College’s assessment program with respect to the approach or frequency of assessments. The current assessment program is designed to ensure the pharmacy is adhering to operational standards and has the proper processes and procedures in place. While the assessment document and report may be modified, the overriding focus will remain the same.
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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
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 revised Standards of Operations for Pharmacies in Ontario and the revised Reference Guide for Ontario Pharmacies, the following feedback was received and collated for your review and consideration: Can you provide more information on references that meet the ‘Patient Counselling Guide’ requirement? CSHP OB strongly recommends that the Hospital Pharmacy Administrator be a Pharmacist who is a registered member of the College. As is required for all community pharmacies within Ontario, a Pharmacist must be assigned as the Designated Manager by ”¦the owner(s)’¦as responsible for managing the pharmacy.’ This requirement should be extended to the operation of all hospital pharmacies such that a Pharmacist is required for oversight of the hospital pharmacy operations to ensure that the pharmacy is operating within the requirements and specified by all applicable federal and provincial legislation, and standards of practice. Within the ‘Management and Employee Relations’ Standard there is the statement referring to ”¦adequate number of qualified and trained staff to maintain the accepted standards of practice’¦’ – How will this be determined and enforced by the College? Furthermore, how does this standard affect hospitals where there are no members of the College overseeing medication management within the hospital? How will this standard be upheld in hospitals in this situation? The ‘Information Management’ standard refers to the NAPRA National standards for pharmacy practice management systems. The current state of some hospital information systems, namely pharmacy information systems do not meet the auditability and traceability requirement described in the national standards. How does the College envision enforcing this standard when hospital electronic information systems are limited and any upgrades to said system are considered an enormous capital investment? Can the College provide explicit information on the expectations for pharmacies (in particular hospitals) with respect to meeting the auditability and traceability requirement within the limitations of current electronic health/pharmacy information systems? Thank you for the opportunity to provide this feedback. Please contact me if you have any questions or would like CSHP OB to provide more information on this feedback. Sincerely, Kathryn Hollis
I like that the library section has been updated to reflect the needs of patient care and availability of digital media/resources.
If we dont keep it a requirement to have resources and a drug-info service at the pharmacy level, then owners and corporate leaders will not be obliged to provide this. Every pharmacist i know has used drug-info service at some point. They keep us informed and patients safe. Patient safety shouldnt be optional.
Drug information services should remain a REQUIREMENT for store ownership. It is the only way to ensure a standard of care for all pharmacists in Ontario. Making this service an optional requirement will put patient safety at risk. Pharmacists do not have the time, or in many circumstances the access, to accurate and timely information to provide adequate patient care.
In regards to the removal of the mandatory Drug Information Service for pharmacies, I would like to express my concern that this should remain mandatory. Many staff pharmacists utilizing this service require access to this consultation service and if their owners/managers remove the access say, to save money, the staff pharmacists and their patient’s health may suffer as a result. Also, some corporations block many external website which prevent staff pharmacists from doing their own drug information searches (e.g. literature searches), which compromise patient health and safety as an end result. Lastly, a mandatory drug information service ensures access to a high standard of care across all practicing pharmacies in the province, whereby removing the requirement subjects pharmacists who need it to no longer have a say in their ability to access it.
These standards are very vague and subject to interpretation. For example, how do I know if the front of my pharmacy maintains "the dignity of the public"? What is the "appropriate level of delegation" for pharmacy staff? How do I judge the competence of my staff pharmacists? Isn’t that OCP’s job? OCP should just stop all these make work programs ad reduce our fees.
Non-pharmacists should not be able to takeover the role of hospital pharmacy administrators. The practice is too complex now and needs proper guidance.
Some of the areas that need to be recognized and considered are summarized below: 1. Transparency – the ability of the pharmacist to manage and control pharmacists when it comes to managing, ownership on different levels from corporate control to individual representation. 2. Private Insurances controlling continuity of care where high Cost drugs are controlled by selective insurances and who can dispense. Preferred Pharmacy Networks need to be eliminated. 3. Pre-Charter 54’s need to be eliminated as they do not give full justice to the Pharmacy Legislation on ownership.