Feedback for Seeking Feedback on Proposed Implementation Timeline for NAPRA's Sterile Compounding Standards

1.
Pharmacist  ·  May 13, 2016

I have recently completed a course on Sterile Compounding provided by ASHP. But we do not prepare any sterile products at the pharmacy where I currently practice.

2.
Pharmacy Assistant  ·  May 14, 2016

the stability of the reconstituted product begin when the diluent is added to the powder, or when the final product is added to the mini bag. Also puncture of the rubber stopper on both the bag and the vial. ( up to five puncture )

3.
Pharmacy Technician  ·  May 14, 2016

I do not believe 2 years will be sufficient to obtain compliance in a hospital setting. I would like to suggest a 5 year timeline. Hospital budgets are determined one year in advance, therefore, a 2 year timeline would give the hospital only one year to allocate funds and perform any necessary construction. This is simply not enough time. It may be necessary for the organization to raise funds from the community in order to complete the necessary construction in order to become compliant with the standards, and again, 2 years may not be sufficient for fund raising. If a facility requires considerable construction in order to become compliant the tendering process for the construction work would also cause a delay in the timeline. The new reduction of BUD to a 9 day timeline for a refrigerated product may cause the facility to need an increase in staffing and/or operating hours and procedures all of which require budget adjustments which would require more than 2 years to consider. Perhaps the timeline could be prorated based on what requirements each facility needs to do in order to become compliant. Thank you for considering my comments

4.
Pharmacist  ·  May 14, 2016

Two years should be enough time to implement the necessary changes. I would like to know what assistance if any will be given to pharmacies that provide this service. Will there be guidance and support provided ?

5.
Pharmacist  ·  May 14, 2016

Two years should be enough time to implement the changes. I would like to know if any guidance or support will be provided ?

6.
Pharmacy Assistant  ·  May 14, 2016

2 years may be ambitious for hospital pharmacies in small rural hospitals due to lack of government funding. Budget requests had to be in months ago for next year and that doesn't mean that we will get what we asked for. Unfortunately although I agree totally with the standards in order to comply it is very expensive and simply put we do not have the budget for it.

7.
Pharmacist  ·  May 14, 2016

I have recently completed a course on Sterile Compounding provided by ASHP. But we do not prepare any sterile products at the pharmacy where I currently practice.

8.
Pharmacist  ·  May 15, 2016

I think a 3 year implementation period would be more reasonable given that facility redesign and construction will be necessary in addition to a lot of policy and procedures/SOP's that will need to be written. Some of those will not be able to be finalized until after the construction is complete.

9.
Pharmacist  ·  May 16, 2016

It would be nice to standardize the quality assurance piece across the hospital sterile compounding sites. It probably should be done by the college or an outside source to prevent bias. I think this initiative in necessary to increase patient safety and prevent errors.

10.
Pharmacist  ·  May 16, 2016

With respect to Oncology, I think a pharmacist should be the compounding supervisor. I agree with everything else in the proposal. I do suggest that an outside auditor (OCP?) performs the q 6 month quality assurance checks to prevent any bias.

11.
Pharmacist  ·  May 16, 2016

Reprints@ijpc.com Edited By Lloyd Allen Ph. D has recent articles discussing the logistics. You can't get any better source

12.
Pharmacist  ·  May 16, 2016

I believe that 3 years is a more appropriate timeline. Extensive renovations will be required in most locations. In many situations it will take 6-12 months to get approval from a hospital board and/or zoning bi-law changes/building permits that may be required. Add that to a 6-month construction and you've only got a potential 6 months left to get all the details into place and staff appropriately trained. All this is assuming no extensive delays, so I think the 2-year timeline is a bit optimistic.

13.
Pharmacist  ·  May 16, 2016

I agree with the proposed Implementation Timeline for NAPRA's Sterile Compounding Standards. Two years is sufficient period to implement the changes. Pharmacies that can not comply with the implementation should not perform sterile compounding. My experience in sterile compounding is over 10 years and I completely agree that for the safety of our patient changes must be implemented.

14.
Pharmacist  ·  May 16, 2016

A two year deadline is definitely not enough time for hospitals to secure funding and additional resources that will be required to be fully compliant with the NAPRA standards. I think that a 5 year deadline is likely more feasible considering funding cycles and the "competition" for funding that occurs in most hospitals. Most hospitals in Ontario will require extensive facility renovations in order to be compliant which will cost huge amounts of money for the government. How is OCP advocating and/or supporting the flow of money from the government to facilities that require extensive work? Further, facility improvement is only one part of NAPRA compliance. The costs of supplies, cleaning reagents, sterile alcohol, testing (QA) and training/certification of staff also will add up quickly. In most cases, hospitals will also need to hire/train/maintain more staff to keep up with the standards especially when it comes to the imposed BUD (hospitals will no longer be able to batch in large quantities to gain efficiencies due to imposed QA). Added to all of this is time needed to create new procedures and policies to support and sustain the NAPRA standards. Thus, the two year deadline seems unrealistic when considering what it will take to be fully compliant with NAPRA. I would like to know what OCP is doing to educate CEOs and senior leaders in all hospitals across Ontario that the requests for financial and human resources are going to be soaring high over the next few years from pharmacy....in the midst of all the other accountabilities they have to ensure funding models/metrics are met, budgetary and financial responsibilities are managed within their means.

Pharmacy Technician  ·  May 30, 2016

I agree completely with your comments.

15.
Pharmacy Technician  ·  May 17, 2016

I believe 2 years is not sufficient time to implement such a vast change in practice considering the facility demands that NAPRA demands. Many hospitals (where I'm employed) simply don't receive the budget to make these changes and if they do it requires at least a year to get the funds, another to build and another to implement the many changes. I would think a 4-5 year expectation is sufficient. Also, I would hope that OCP supplies tools to help facilitate the many changes required to be compliant with the NAPRA requirements.

16.
Pharmacist  ·  May 19, 2016

I think while 2 years is a good goal for everyone to strive for in that we need to work quickly to standardize the processes and facilities to protect the public, it is not a reasonable deadline by which everyone must meet.
Things to consider; - this is likely not the only goal most hospital pharmacies are working to in order to protect the public. There may be others that actually pose a greater risk. I believe there to be at my hospital. While this is one that currently has the public/media spotlight and OCP must answer to, as professionals we have a responsibility also to focus on the greatest risk. It will take more time to get the both goals completed. - For those that did not manage to put in a capital submission in January 2016 or it was not approved, it leaves only a year to complete the project (assuming approval) when submitted in Jan 2017. - Once the capital project is approved (April 2017), priorities must be set within the approvals and then funding must be sought. Often this takes months if not years. - Once funding is obtained, one needs external subject experts to help prepare plans, vendors to provide estimates (RFP process), and training programs to be available. With potentially even half of the 240 hospitals needing renovations and many staff needing training and certification, where will the external subject matter experts, vendors, trainers come from to complete even a small portion of this work in likely the last 6 months? Given that most of the hospitals are smaller and remote, will they be able to get the experts, vendors, etc to come to them when there is more work than they can handle in the larger centres? - If there are 5 technicians making the IV's and needing training/finger-tip certification, one must consider how many can go off for 3 days to training at a time and then if the sessions are offered monthly how long even that step takes. - Currently it is not easy to find who the vendors even are. There needs to be an electronic bulletin board, not endorsed by any organization, where potential vendors can post their services and references, that helps hospitals identify potential places to start.
- While there is a CSHP / OPA training program it is expensive and said to be quite basic. Is an advanced one being planned? When will it be available? - If there is a big push for the vendor services in the last 6 months of an impossible timeline, will the price charged drastically go up (what the market will bear) costing the system (tax payer) more than it's worth? - I believe this will require a lot more supportive coordination by groups such as CSHP (guidelines are very high level; web-in-airs are getting there but still don't hit the mark) to provide the advanced training for the workers and day long workshops for the directors/managers in design, policy and procedures, etc.
Only when these supports are in place, should we be talking about a timeline for completion. That timeline should take into account how much work is required to be done across the province and the extent to which the resources available can meet the demand.

17.
Pharmacy Technician  ·  May 23, 2016

Two years is not enough time for hospitals to implement these changes and meet criteria. With our current state of affairs in this province and the gov't we have in power, there will be no money allocated to this endeavour. Hospital foundations will have to raise the funds. There simply wont be enough in the budget to renovate and provide the level of staffing. The face of pharmacy is changing and I am not sure it is for the better. Hospitals will be forced to outsource all sterile preparation work to private firms with investors who have the money to build and staff these facilities. One step closer to privatization of pharmacy services all together. You will need to look at each facility's strategic plan and determine on a case by case basis what timelime is appropriate. Pharmacy Technicians havee been fighting for recognition and good secure employment for many years and I believe this will lead to a loss of jobs for us.

18.
Pharmacy Technician  ·  May 23, 2016

Two years is not enough time for hospitals to implement these changes and meet criteria. With our current state of affairs in this province and the gov't we have in power, there will be no money allocated to this endeavour. Hospital foundations will have to raise the funds. There simply wont be enough in the budget to renovate and provide the level of staffing. The face of pharmacy is changing and I am not sure it is for the better. Hospitals will be forced to outsource all sterile preparation work to private firms with investors who have the money to build and staff these facilities. One step closer to privatization of pharmacy services all together. You will need to look at each facility's strategic plan and determine on a case by case basis what timelime is appropriate. Pharmacy Technicians havee been fighting for recognition and good secure employment for many years and I believe this will lead to a loss of jobs for us.

19.
Pharmacy Technician  ·  May 27, 2016

Currently undergoing such changes and the process began 1 year ago. Research alone is ongoing; acquiring products and PPE's suitable for meeting the criteria, workflow analysis, policy and procedure changes are continually under review. The guidance is conflicting and decision making is difficult. The building of a proper anteroom, cleanroom requires a great deal of consideration of current and more importantly future workload and staffing models. Truthfully, funding and current department footprints need thorough consideration before "jumping into changes" A good start, while the planning is underway, is with staff improvement; this will help alleviate the shock of drastic change for some. The funding? Well after 3 proposals from reputable modular cleanroom builders, the end price varied from 400 k to 900+ k. One would think this a "no-brainer" however, cost must not be the only driving factor and that in itself can cause a great deal of delays as advocates will be expected to revisit all of the above aforementioned variables and determine what the department can and cannot "live without" or make provision for. Q= Can a hospital setting get this done in 2 years? NO. It would likely take 3 years and that would require very dedicated people rethinking current practice and footprints to meet the NAPRA/USP 797 Standards. Currently, under the "private practice" setting, we will complete in 2 years but that is with relocation to a larger space; hospitals do not have that luxury and as such, experience more difficulties with the implementation of the guidelines and standards. My personal thought: 3-5 years with constant feedback to and from the accrediting bodies would be required to “get it right” for each individual practice setting. This is not a one model fits all fix and each institution will need to review the financial sustainability of such changes and determine if outsourcing some of the workload is feasible. Talk to those that have begun the process, get ideas, and massage them to fit your model and workload. Collaborate with each other and understand that each has differing vision but that in the end, the Standards must be met to ensure patient and employee safety.

20.
Pharmacist  ·  May 29, 2016

Two years is not enough time to become compliant with NAPRA Standards. Many hospitals will require significant renovation, requiring capital investment. Most hospitals in the province have very little capital left in the coffers and we are competing with other major requests including mental health infrastructure support, infusion pump replacements etc etc etc In addition to the capital investment, material increases in operating budgets are required. We are planning NOW for 17/18. We are not in a position today to detail exactly what ongoing operational pressures this will results in. I would request 3 years lead time, please.

21.
Pharmacy Technician  ·  May 30, 2016

If the implementation of the new NAPRA sterile compounding standards will be required by Sept 2018 will hospitals be given more staffing budget to accommodate the changes? The proposed requirements will greatly impact daily processes. As well, workload will increase for pharmacists, pharmacy technicians, and pharmacy assistants to maintain and meet these standards.

22.
Pharmacist  ·  May 30, 2016

The document is excellent and very extensive, however; few things need to be further clarified in order to avoid misinterpretation and deviations: 1- Third part at arm’s length: this should be replaced by a clear definition of the third party 2- Provide a diagram/sketch of a proper IV Room with minimum and ideal requirements for nonhazardous and hazardous iv compounding areas. 3- Keep in mind that many inpatient pharmacies are limited in allocated space and area expansions/remodeling may not be possible. Thank you.

Pharmacist  ·  May 30, 2016

This is exactly why creating such a "standard" when they are already covered under internationally-recognized USP chapters (<797>, <800>) are going to create huge conflicts and confusion. Your very request for a "diagram" is satisfied if you look at the acceptable room scenarios outlined in detail in USP <800>. These proposed standards are being said to be "no input into them" but only the timeline -- yet, the standard will CONFLICT with the USP (eg: USP <797> now only has two categories of sterile preparations, not 3; the NAPRA document is already out of date).

23.
Pharmacist  ·  June 10, 2016

Hello, 2 years is not remotely a reasonable timeline for public organizations like a hospital to implement these standards. All of the changes that are needed for hospital pharmacies (and any other pharmacies no doubt) require funding, however hospital pharmacies are bound by budgeting processes mandated by the Ministry of Health and as such we are only going to be working on next year's budget starting in the fall to be implemented in April of 2017. We committed in the fall of 2015 to what we were going to be funding for the fiscal year 2016/17 and do not have these funds in our budgets currently. Hospitals are facing huge cuts every year as the funding for organizations is not increasing yet the implementation of these standards will require hundreds of thousands of dollars for almost every organization, some probably costing into the millions. Regarding the hazardous standards, has the college coordinated this with Cancer Care Ontario? They fund the overwhelming amount of hazardous medication preparation in the province so it will likely be their funding that will be diverted to meet these standards - is there the capacity from them to ensure that patient care can be maintained while the extra funding is diverted?

24.
Pharmacist  ·  June 13, 2016

Suggest that the timeline by extended to 3-5 years. The currently capital model plans for many organizations are 3-5 years in advance. If changes need to be made there is significant processes to get approvals and funding. This requires both internal capital planning and planning for the implementation (depending on how significant the changes are required - can include architects, engineers, etc). Also, if construction needs to happen, a back-up plan to support ongoing patient care is required.

25.
Winchester District Memorial Hospital  ·  June 14, 2016

Two years is not enough time for hospitals to implement these changes and become compliant with the NAPRA standards. Many hospitals will require significant renovations requiring capital investment, Bid tenders and approval at multiple levels. I don’t believe that the Province of Ontario or Regional LHINs, given their current financial state, would be allocated any money towards this endeavour. Most hospitals in the province are given very little capital money for requests and are competing with other departments for other major requests. Fund raising may be in order therefore the hospital foundation would be approached for funds but time is needed to fundraise. Budgets are already in place for 2017/18. Then there is the time required for planning, building, training, developing policies and procedures etc. Expertise is also a big concern. Are the hospital pharmacists expected to guide the decisions on renovations to meet standards? We are clinical experts in the field of oncology but not well versed on mechanical ventilation, HEPA filter requirements, positive/negative pressure requirements for rooms….and it’s very hard to find those experts! OCP should find the experts for surrounding areas of specific LHINS with a specific mandate to do all the hospital assessments within the next year. The report would also be shared with OCP and a reasonable timeline for implementation would then be agreed upon. Regional cancer units with bigger budgets will have a major advantage with these new guidelines given that they have more money from the province. Rural hospitals with care closer to home for patients have limited funds and are considered satellites for the Urban centres. The suggested guidelines and 2 year timeline is completely unreasonable for satellites, not to mention we don’t have experts in the field of retrofitting chemo suites to meet these standards. WDMH is the biggest oncology satellite in Ontario. These standards and timeline would threaten the survival of our program. We believe that a more appropriate time-line would be 5 years after the experts have given their recommendations on requirements to meet the NAPRA standards. As mentioned previously, OCP should have a set reference list of experts for the province to ensure hospitals are steered in the right directions and that all requirements are met. A two year mandate would simply result in forced closing of oncology sites, loss of employment and diminished patient care in forcing chemotherapy in overcrowded urban centres.

26.
Pharmacist  ·  June 15, 2016

I strongly disagree with the unaltered adoption of NAPRA's terminology with respect to provision of compounds on a "patient-specific"-only basis. Canada is suffering from the worst drug shortages in its history. The ability of hospitals, as one example, to access products for provision to their patients will be even more severely compromised. Also, specialists in urology and pain management frequently request "Office Use" prescriptions in order to administer test doses in their clinics. As a compounding pharmacist, I receive requests to supply non-commercially-available compounds all the time. The College must replace the terminology put forward by NAPRA in order to preserve the long-standing, convenient, safe, and effective practice of prescribing extemporaneous compounds "for Office Use". Failure to do so may result in an "out-of-province" situation, whereby any province that does not adopt the NAPRA Standards unchanged will provide their pharmacy practitioners with an unfair advantage in this regard. It would be egregious for the College to allow this to happen.

Pharmacist  ·  June 30, 2016

I strongly agree with these points made. Patient specific term must be defined and I believe the prescriber should be included in this definition.

27.
Pharmacist  ·  June 16, 2016

I believe 3 years would be more reasonable given that the guidelines are more stringent. This gives us time to source out contractors to change our sterile rooms if needed. Perhaps we could set up a committee to review all these new changes. There's a lot of new information in that NAPRA standard that I have questions about.

28.
Chiron Compounding Pharmacy Inc.  ·  June 17, 2016

We appreciate the College allowing pharmacists to provide feedback to the proposed implementation timeline of the Sterile Compounding Standards – hazardous and non-hazardous. There are two aspects to this proposal that must be considered independently:

  1. USP <797> proposal for Pharmacy Compounding of Non-Hazardous Sterile Preparations and

  2. USP <800> component which addresses hazardous sterile preparation. Although the College does not directly reference USP<800> the basis of the document entitled Pharmacy Compounding of Hazardous Sterile Preparations has identical requirements to USP <800>.

These are two very different requirements with huge cost implications to the pharmacy. We do not feel it is acceptable for the College to adopt both requirements at the same time. We appreciate the need for implementing USP <797> to ensure safety of compounded sterile medications. Although the College is not concerned with the cost of implementing these requirements, the College should be concerned with patient access to vital care and how feasible it will be to have continued access to required compounded medications. A pharmacy requiring major renovations to comply with USP <797>, will have difficulty ensuring capital is available for construction costs to comply with both USP <797> and <800> by September 2018. We agree that all pharmacies providing sterile compounding should be well on their way to compliance by September 2018 with full implementation by September 2019.

The regulation entitled Pharmacy Compounding of Hazardous Sterile Preparations (USP <800>) has not been written to protect public safety. It is written to protect the worker. The College should assess if it has the appropriate expertise to audit this regulation or if it is better governed by Occupational Health and Safety. Pharmacies working with appropriate hoods, PPE and policies are already protecting the worker and there is no supporting evidence to indicate that harm has come to any pharmacy worker. By implementing USP <800> the College will definitely adversely affect patient access to medication, at least in the short term. There will be many medications to which patients will have limited access (chemotherapy, special antifungal eye drops, progesterone suppositories, estradiol valerate injections ) which may result in therapeutic failures. The cost to a pharmacy to implement both programs simultaneously, will be between $500K and $1 million depending on the size of the pharmacy. To cover construction costs, increased electricity costs to run a negative pressure room 24 hours a day, training, equipment, developing SOP’s, increased costs for PPE, will require pharmacies to increase prices which will result in increased costs to the patient, ODB and drug plans. The increased costs required to implement Pharmacy Compounding of Hazardous Sterile Preparations (USP<800>)will not result in increased medication or patient safety. Unless the College takes a lead on changes to reimbursement, it will be difficult to expect pharmacies to comply.

Compliance costs associated with Compounding of Hazardous Sterile Preparations USP <800>:

  1. Threatens the continued financial viability of practices

  2. Jeopardizes patient access to pharmacist care and services for vital compounded medications

Compliance with Compounding of Hazardous Sterile Preparations (USP <800>) should be considered best practices not a requirement. We would suggest the College conducts a full risk assessment and reviews the scope of practice before forcing Compounding of Hazardous Sterile Preparations (USP <800>) on pharmacies. Health and Safety of staff members is paramount, but should not be mandated by the College. Manufacturers must comply with GMP regulations: • However, they are not required to follow USP <800> • The possibility adverse reactions in patients is much higher if errors occur with a manufactured product due to the large batch sizes • In a manufacturing environment – the exposure of workers to “hazardous materials” is much higher than in a compounding pharmacy. This requirement places an unfair burden on compounding pharmacies.

Is this requirement a way for the College to try and eliminate the practice of compounding?

We trust that the College will fully consider the implication these standards will have on patient access to compounded medications and on the ability of pharmacies to provide patient care.

For these reasons, Chiron would support a 3 year timeline for compliance with Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations (USP <797>) and five years for the Pharmacy Compounding of Hazardous Sterile Preparations (USP<800>).

29.
Pharmacist  ·  June 17, 2016

2 years should be enough if you already have all the set up required.

30.
Pharmacy Technician  ·  June 23, 2016

Realistically we would need 4 to 5 years to implement these changes, With lots of competing priorities and lack of funding it would be a real challenge to implement this change in practice in 2 yrs.

31.
Health Sciences North  ·  June 23, 2016

One of our areas requires a facility renovation to meet the standards for ante room/air flow etc. – funding for this renovation and timeline for planning/build may exceed 2 years.

32.
Pharmacist  ·  June 23, 2016

I firmly believe these standards are the right way to go, and a timeline is essential. I think that 2 years is sufficient time for - Gap analysis, action plan, training, quality improvement plans. My only concern, is regarding the physical requirements / renovation requirements. I worry this will end up moving hospital pharmacy backwards, as more doses will be prepared on the patient care unit by nursing. I believe 4 years for completion of renovations is a more reasonable time line, but all other NAPRA standards, 2 years is reasonable.

33.
Pharmacist  ·  June 24, 2016

A two year deadline is not realistic for hospitals to secure funding for capital and operating costs, to contract external expertise, to complete RFP processes, to complete physical renovations, to recruit staff to develop, implement and maintain the standards. All of this is even more challenging for small, rural hospitals who already struggle with budgets and recruitment.
It is unlikely that the province or LIHNs will allocate additional funding towards the initial capital and operating costs or the continual increases operating costs, and negotiating hospital budgets and hospital foundation fundraising takes time. Expertise is required to assess workflow and to properly design a renovation that meets standards within the physical restraints of available space. Finding that expertise is difficult. A reference list of experts for the province would be very useful. Human resources are limited, especially in smaller hospitals. Managers already wear multiple hats and have conflicting priorities. The implementation and maintenance of the standards will require additional staffing. Recruitment is difficult in small, rural settings, for both pharmacists and registered technicians. The alternative of not providing compounding services in the rural, northern setting would result in patients traveling significant distances to receive care. Or the hospital could consider outsourcing, which is not always a viable option due to transportation issues and cost implications. Training is essential but poses another challenge for smaller hospitals. It is not realistic to assume that multiple staff can be away at the same time to attend training, which means the time to train all staff at an external education location extends over a longer period of time. In conclusion, to meet these standards, there needs to be consideration at the provincial and LIHN levels, and at OCP of the significant costs to each hospital and how those costs are going to be covered; significant improvement in the supports and readily available expertise required to complete all the work necessary; a strong communication network to assist those at the frontline of managing this improvement project, including a shared resource approach; and finally, time in which to complete this significant, and valuable work. A gap analysis of all hospitals and a review of this information by the LIHNs and province would be a good starting point. Armed with that information, a realistic goal for each hospital could be made, and then a timeline determined to either compliance with standards or a different model of service to provide safe patient care.

34.
Pharmacist  ·  June 24, 2016

I think that 2 years is not enough to expect full compliance with these regulations. If a hospital is currently in a position that they can't meet the standards and need to rebuild their sterile areas it takes significant time to secure approvals and funds to make that happen. I do not see them being able to do the evaluation make a plan and be able to implement in 2 years. Just the process of contracting out the work etc. for hospitals is time consuming. I don't think you can accomplish this in two years.

35.
WWLHIN Pharmacy Council  ·  June 27, 2016

WWLHIN Pharmacy Council response for feedback to NAPRA standards implementation by September 2018

Feedback deadline: June 30, 2016 Background Summary from OCP Following an extensive consultation process, the National Association of Pharmacy Regulatory Authorities (NAPRA) has approved national standards for pharmacy compounding of hazardous and non-hazardous sterile preparations. The Ontario College of Pharmacists is expected to adopt these standards at their September 2016 Council meeting. Current pharmacy practice for the preparation of sterile products in Canada includes many of the same patient safety and quality assurance requirements as these new standards. However, there are some additional requirements in the new standards, including an onsite quality assurance program, increased oversight, beyond-use-dates, recall procedures, and more. Since some pharmacies may require additional time to become fully compliant with these new standards, the College is proposing a two-year implementation timeline. Assuming Council approves the adoption of the standards in September 2016, all pharmacies in Ontario that are engaged in compounding hazardous and/or non-hazardous sterile preparations would be required to be fully compliant with the NAPRA standards by September 2018. Pharmacies currently engaged in sterile compounding are expected to review these new standards, identify any gaps in current practice and establish an action plan to ensure full compliance on or before the proposed timeline. The College is currently seeking your feedback regarding the proposed two-year implementation timeline. To help ensure feedback is focused and constructive, please read the “Points to Consider” and ”Common Questions” sections below prior to responding. For easy reference, links to the NAPRA standards are provided:


Points to Consider The College is seeking feedback with regard to the two-year implementation timeline only. The NAPRA standards for pharmacy compounding of hazardous and non-hazardous sterile preparations are finalized. No further feedback or changes to the standards are being sought. 1. Is two years enough time for pharmacies engaging in compounding hazardous and/or non-hazardous sterile preparations to: o Review the NAPRA standards and identify any gaps in the pharmacy’s current practice GRH has been working on addressing the NAPRA standards since the renovation of our inpatient pharmacy sterile room. Meeting the NAPRA standards for the inpatient pharmacy sterile room would be possible by the proposed September 2018 timeline as many of the NAPRA standards have been implemented. Work is in progress that includes post-construction sterile room remediation, additional training of personnel involved in sterile compounding, enhanced environmental cleaning and environmental and personnel testing. With the experience gained from the inpatient pharmacy and with the NAPRA and USP <800> standards approved, a two year timeline to identify gaps for the preparation of hazardous products in the Grand River Regional Cancer Centre (GRRCC) Pharmacy is feasible.

o Establish an action plan to become fully compliant GRH has a plan to addressing the existing gaps for the NAPRA standards for our inpatient pharmacy sterile room. Work is in progress that includes post-construction sterile room remediation, additional training of personnel involved in sterile compounding, enhanced environmental cleaning and environmental and personnel testing. We have encountered some challenges in sourcing, at a reasonable cost to the operating budget, the required supplies to support the standards. As more sites are required to meet these standards, it is anticipated that more vendors will be available on the Canadian market to provide supplies to meet the standards, at a more competitive price. With the experience gained from the inpatient pharmacy and with the NAPRA and USP <800> standards approved, a two year timeline to develop an action plan for the preparation of hazardous products in the Cancer Centre Pharmacy is feasible. o Implement the plan and meet the NAPRA standards Since a lot of work has been done on the inpatient pharmacy non-hazardous sterile compounding, two years is feasible to meet the NAPRA standards. However, GRH also has the regional Cancer Centre. The sterile room in the Cancer Centre will require extensive renovations to meet NAPRA and USP <800> standards. A two year timeline for meeting these standards is not sufficient for several reasons: - Capital has already been approved for the 16/17 fiscal year. The call for 17/18 capital will not occur until the fall of 2016 and Board approval will not occur until March 2017. - The hospital must replace its hospital information system. This replacement will require a significant capital investment which will make it difficult to fund other capital requests. - Work on the hospital HIS replacement is the most critical project to be completed by the pharmacy before April 2018. Many resources will be dedicated to this project which will be difficult to resource for the Cancer Centre Pharmacy renovations and NAPRA standard implementation. - Implementation of other OCP hospital pharmacy standards requires resources, whether personnel or minor capital. - Once capital is approved, extensive consultation will be required to determine appropriate facilities design to meet the standards. Due to BPSA, procurement for consultants will take several months. - Renovation plans need to be approved by the MOHLTC due to the anticipated dollar cost involved. From experience, this approval may take several years, even if no funding from the MOHLTC is requested. - Once renovation approval is granted from the MOHLTC, a tender needs to be created for the renovation work. This takes several months. - Renovation planning will be required to maintain service to the Cancer Centre patients while decanting production elsewhere, potentially to other WWLHIN partners. If all sites are working towards the same timelines, it may reduce capacity to assist. - Other priority projects and medication safety initiatives as well as hospital OCP and Accreditation Canada work will be required during this timeline. - Even if a pharmacy decided to completely outsource the sterile compounding, due to the BPSA, this process would require up to a year to procure and complete a contract. GRH is working on this process at present for a subset of products and it has been very difficult and time-consuming in working with Purchasing to determine the best process under BPSA.

  1. If two years is not enough time to complete these tasks, why? How much time would be required? For the reasons outlined above two years would not be enough time to complete the hazardous drug compounding action plan for the Grand River Regional Cancer Centre Pharmacy. Five years is a more reasonable timeline for GRRCC.
  2. What challenges would pharmacies face in order to meet the proposed implementation timeline of two years? Pharmacies face the following challenges in meeting the proposed two-year timeline:
  3. Time required for capital approval, procurement, consultation, and implementation
  4. Competition for scarce resources (e.g capital budget, personnel)
  5. Competition for other medication safety improvements/initiatives (e.g. implementation of other OCP hospital standards, Accreditation Canada Managing Medication standards and Required Organizational Practices, etc)
36.
Toronto Central LHIN Hospital Pharmacy Directors  ·  June 27, 2016

This response was submitted by the Toronto Central LHIN Hospital Pharmacy Directors. Read the full submission here.

37.
Hamilton Health Sciences  ·  June 28, 2016

The two year time frame is too short if sterile room renovations are required as a typical capital project in the hospital setting from business case approval to final build may take several years or longer depending upon capital funding availability.

38.
Pharmacist  ·  June 29, 2016

I believe 2 years is not sufficient for hospitals to become fully compliant with the NAPRA guidelines. The changes involve the hospital executive level to have funding for all the physical renovations required. Securing funding and planning major renovations take more than two years. We have been trying to modfiy our existing oncology satellite for years and have not made any progress. NAPRA also requires a "third-party evaluator" to assess the competency of the sterile compounding supervisor. There is no structure in place for this entity. Who certifies the third-party in the first place? Until this is resolved it is not possible to move forward. There needs to be a national body to certify these third-party evaluators. NAPRA completely removed the sterility and stability testing allowed in USP797, meaning the BUD limits must be followed. This requires a complete change in workflow and an increase in costs as medications will have a much shorter BUD. For hospitals who cannot meet the standards, the existing Drug Dispensing Premises that are certified by OCP are not willing to manufacture any items that do not generate enough volume/profit. This is especially difficult for pediatrics hospitals that require less common preparations. Hospitals who cannot meet standards are driven to use DDPs which led to why all this began in the first place.

39.
Summit Veterinary Pharmacy Inc.  ·  June 29, 2016

This response was submitted by Summit Veterinary Pharmacy Inc. Read the full submission here.

40.
Shoppers Drug Mart and Loblaw Pharmacies  ·  June 30, 2016

We appreciate the two-year timeline being provided by the College for pharmacies engaging in compounding hazardous and/or non-hazardous sterile preparations to: o Review the NAPRA standards and identify any gaps in the pharmacy’s current practice o Establish an action plan to become fully compliant o Implement the plan and meet the NAPRA standards This is a reasonable approach that takes into consideration the time needed to address any workplace changes that may need to be implemented, and training that may be required. We are pleased to see that Ontario is considering these factors, which has not been the case in other jurisdictions.

41.
Cancer Care Ontario  ·  June 30, 2016

The Ontario College of Pharmacist (OCP) is expected to adopt the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations at the September 2016 Council meeting. OCP is requesting feedback on a proposed two-year time frame for facilities to become fully compliant with the standards. The following are considerations requested by OCP: 1. Is two years enough time for pharmacies engaging in compounding hazardous and/or non-hazardous sterile preparations to: o Review the NAPRA standards and identify any gaps in the pharmacy’s current practice o Establish an action plan to become fully compliant o Implement the plan and meet the NAPRA standards 2. If two years is not enough time to complete these tasks, why? How much time would be required? 3. What challenges would pharmacies face in order to meet the proposed implementation timeline of two years?

FEEDBACK

Cancer Care Ontario identified the following key areas where full implementation within a two-year time frame will not be possible for the 78 facilities providing systemic treatment in Ontario. Additionally, the impact on community pharmacies preparing sterile hazardous compounding and non-sterile hazardous compounding remain largely unknown to Cancer Care Ontario but we suspect challenges with full implementation within a two-year time frame and that there may be an impact on access of medications closer to home for cancer patients.

  1. Beyond-Use Date:

The NAPRA guidelines currently indicate that the BUD of hazardous drugs stored in single-dose vials is 6 hours, whereas the BUD of hazardous drugs stored in multi-dose vials is 28 days. This is a problem for single-dose vials because drug must be discarded in a short period of time after initial puncture of the vial. This drug wastage would have a significant financial and utilization impact, as 18 of 19 hazardous drugs funded through the New Drug Funding Program administered by Cancer Care Ontario are packaged into single-dose vials. Cancer Care Ontario is not aware of any facility that currently adopts a BUD of 6 hrs for single-dose vials.

Potential Financial Impact of BUD

A financial impact analysis has been completed to estimate the potential drug wastage implications of adopting BUD according to NAPRA. In considering only the the 18 NDFP funded drugs that are packaged as single-dose vials and the 14 Regional Cancer Centres, the costs in drug wastage exceed $10M. This is without taking into consideration the remaining 68 facilities that deliver systemic treatment in the province, or the many other drugs that would be impacted by this change in practice. This also does not take into consideration existing drug waste considerations, dose rounding, or batching.

Potential Strategies to Extend BUD

A few strategies have been identified to extend BUD, including use of a closed system transfer device, automated robot dispensing units (e.g. RIVA) and other processes currently used to reduce wastage (e.g. dose rounding, batching patients). These strategies will require a thorough assessment by each facility to determine feasibility of financial and space resource. As centres are already into the fiscal year, any plans for an increase in financial resources will need to be requested and approved by the hospital. This will take a minimum of 2 to 3 years. We suggest that this standard be phased in slowly over 5 years. We further recommend that at 2 years, facilities should have performed an assessment of the potential options to determine the best choice for the facility.

  1. Biological Safety Cabinets:

According to the NAPRA standards, biological safety cabinets (BSCs) are required for the preparation of hazardous materials. The standards indicate that Class II or III BSCs are required, without specifically suggesting Class II Type B2. In December 2013, Cancer Care Ontario and the Program in Evidence-Based Care (PEBC) published guidelines on safe handling that recommend use of Class II Type B2 BSCs. The Ministry of Labour is also recommending the use of a Class II Type B2 BSC. However, they have not mandated immediate adoption but rather when major renovations are planned.

Data from April 2014 showed that 51% of facilities that provide systemic treatment did not use a Class II Type B2 BSC. To convert the remaining 49% of facilities will incur significant capital expenditures where physically possible. Some pharmacy departments will need to be physically relocated to an area where external venting to the exterior is possible.

Cancer Care Ontario suggests that provincially there be one recommendation of BSC to be used when compounding sterile hazardous drugs. We further recommend the use of a Class II type B2. Additionally, we recommend that the expectations align with the Ministry of Labour in that a plan should be in place to implement a Class II type B2 BSC when major renovations are planned.

  1. Storage:

The NAPRA standards recommend that hazardous products should be stored in a negative pressure room that is properly ventilated to the exterior. This room has to be separate from the unpacking area. Proper ventilation is required to prevent contamination from hazardous drugs that may be volatile at room temperature. Currently, the NAPRA standards permit facilities to construct a separate storage room for hazardous products or to store hazardous products in clean rooms that are under negative pressure.

Informal data from 2012 suggest that only 1 to 2 facilities have separate negative pressure storage rooms that meet NAPRA standards. In order to meet NAPRA standards, significant capital resource and a possible physical relocation of the pharmacy department may be required. Although storage of hazardous drugs may be in the clean room under negative pressure, this may not be possible for centres with a small clean room or large volumes of inventory that cannot fit into the clean room. Cancer Care Ontario recommends that full adoption of this standard be phased in with major renovation plans.

Summary

We appreciate the opportunity to provide feedback to the two-year time frame for full implementation of the NAPRA standards. We recognize that while many standards may be implemented within this time frame, there are individual standards that will require thoughtful consideration of the financial impact and physical constraints on each facility in order to balance safety with access to care closer to home. As part of this work, we believe that other stakeholders will need to be engaged to find this balance. These stakeholders may include infection control, Ministry of Health, Ministry of Labour, Ontario Hospital Association (OHA) and the Canadian Association of Provincial Cancer Agencies (CAPCA) as well as other relevant stakeholders in community pharmacy impacted by this work.

42.
Canadian Society of Hospital Pharmacists - Ontario Branch  ·  June 30, 2016

The Ontario Branch of the Canadian Society of Hospital Pharmacists (CSHP-OB) welcomes the opportunity to provide feedback regarding the proposed two-year timeline to implement the National Association of Pharmacy Regulatory Authorities (NAPRA) national standards for pharmacy compounding of hazardous and non-hazardous sterile preparations. CSHB-OB both welcomes and fully supports the Ontario College of Pharmacists (OCP) adoption of the national standards for pharmacy compounding, as this would enhance patient safety. CSHB-OB further would like to recognize OCP for providing a reasonable proposed timeline for all pharmacies to be fully compliant with the national standards for compounding of sterile preparations. CSHB-OB concurs with OCP that additional time will be required to become fully compliant with these standards. From the hospital pharmacy perspective, CSHP-OB agrees that the proposed 2-year timeline from the date the NAPRA standards are adopted by OCP council is reasonable for hospital pharmacies to identify any gaps in current practice, establish an action plan, and implement process and procedural changes to meet the requirements. CSHP-OB has also reached out to its members for their feedback on the proposed timeline. Our members have expressed some concerns which CSHP-OB feels we should share with OCP.

Feedback from CSHP-OB members:

Any structural changes to meet standards may not be possible in many cases within the 2 year proposed timeline. The contract to make structural changes will have to go out for tender which could take 6-8 months to be awarded through the procurement process before any renovation or construction begins. Securing capital for major structural changes may also be challenging within this time frame. The Request for Proposal (RFP) process along with capital approval will likely not leave adequate time for planning, designing, construction and implementation.  Hospital pharmacies and facilities that do not have a strong pharmacy presence or leadership may have a more difficult time meeting the timelines Architectural standards for designing sterile compounding facilities are developing and may be misinterpreted if the process is hurried. The NAPRA national standards are functional standards. To help facilitate the transition to meet the NAPRA national standards for pharmacy compounding, CSHB-OB recommends the following: 1. Require all pharmacies to ensure process/procedures in preparing sterile preparations meet NAPRA national standards within the 2 year proposed timeline. OCP can require pharmacies to provide: a. Evidence of staff being trained/certified and meeting NAPRA compounding competencies b. Documentation of process compliance and appropriate sterility testing to show compliance with NAPRA national standards for compounding 2. Require all pharmacies to have, at minimum, a detailed action plan in place with secured funding for implementing structural changes within the 2-year proposed timeline. 3. Provide additional time beyond the 2-year proposed timeline for structural changes to be completed. This extended timeline can be site specific depending on the complexity of the changes required.

CSHP-OB will continue to work with provincial partners to advocate to the Ministry of Health and Long Term Care to make this issue a provincial priority and for increased funding for hospital pharmacies to meet the NAPRA national standards for pharmacy compounding. There will be a huge financial impact for the entire province at a time when hospital funding is not increasing. CSHP-OB also believes this is an opportunity for the Local Health Integration Networks to regionally support hospital pharmacies by securing services of experts in NAPRA national standards for pharmacy compounding and design/implementation of sound architectural sterile compounding rooms to cohesively meet the timelines. We hope our feedback will be of value to OCP. Please do not hesitate to reach out for further questions or clarifications regarding our feedback.

43.
Pharmacist  ·  June 30, 2016

I believe that the 2 year time frame that is proposed is an minimum at best. The time it would take to contact contractors, and design the space etc will take time and I am not sure all pharmacies could comply within the 2 year time frame. As well, would hospitals be included in this time frame? If pharmacies could not meet this time frame , are we putting patients at risk of not receiving their medication, ie pain pumps for intrathecal use. If compounded medications must be shipped from another pharmacy not located in the patients area then we run into stability issues (temperature sensitive drugs).

44.
Pharmacist  ·  June 30, 2016

I would suggest a review of changes at sterile compounding sites be done at 2 years. At that time, suggestions made by the inspector and any additional changes required, an extra year (3 years total) be given to make final changes. This will ensure sterile sites are on the right track to make all additional changes, and give pharmacies support and guidance along the way. I would also appreciate recommendations of specific training requirements be announced by OCP before the timeline is up on this project. It would also be helpful to make stakeholders aware of changes in requirements (hospitals, CCAC, long term care homes, etc) and request feedback.

45.
The Association of Compounding Pharmacists of Canada  ·  June 30, 2016

The ACPC welcomes the opportunity to respond and comment on the implementation timeline for NAPRA’S Standards for Pharmacy Compounding of Hazardous (and Non-Hazardous) Sterile Preparations.

It is recognized that the implementation of compounding standards for sterile preparations is necessary to ensure the safe compounding of quality sterile products. Further, it is recognized that proper handling of hazardous drugs in the sterile room setting, as well as in any environment, is crucial not only for the protection of pharmacy staff but also to prevent cross-contamination and limit exposure of our patients and the environment.

CONFLICTING GUIDELINES: Pharmacy compounding is already held to a high standard for patient safety reasons, as well as for consistency of preparations, through pharmacists adhering to the requirements set out in the United States Pharmacopeia (USP 39-NF34). In particular, chapters <795> (non-sterile compounding) and <797> (sterile compounding) address compounding. A recent USP call for comments on proposed amendments to USP<797> resulted in a revamping of that chapter, which will be published on November 1, 2016 and go into force on May 1, 2017 (assuming no further amendments are made). Similarly, a newly-proposed chapter to the USP has received substantial scrutiny (USP<800>, Hazardous Drugs -- Handling in Healthcare Settings). This chapter will be relevant to all healthcare personnel who "handle HD preparations and all entities that store, prepare, transport, or administer HDs (e.g., pharmacies, hospitals and other healthcare institutions, patient treatment clinics, physicians' practice facilities, or veterinarians' offices)”.

In many instances, the NAPRA guidelines are either in conflict, incomplete or outdated when compared to USP standards. This will create confusion amongst compounders, many of whom are already in compliance with the universally-accepted USP standards and are therefore compounding sterile preparations in a safe, professional manner. The NAPRA guidelines may not be implemented by all provinces and territories. This will also add a bevy of issues around entrenching a national standard of practice for compounding sterile preparations. USP is already in place and could easily be adopted nationally.

OFFICE-USE: Dispensing for office-use is a vital pharmacy practice in which a pharmacist receives an order from a licensed prescriber for a specified medication, and then dispenses that medication to that prescriber for use in treating their patients. The key component of this practice is the prescriber-pharmacist relationship that exists at the time the order is being placed. Under no circumstances is the pharmacist dispensing medication without that relationship with the prescriber who is directly involved in treating patients.

Dispensing for office-use is critical to effective patient care in many settings. While emergency-use preparations are most widely recognized, prescribers in many specialties rely on office-use to effectively treat their patients. These environments include:
• Maternal Fetal Medicine • Urology • Ophthalmologists and retina specialists • Addiction medicine • Dermatology • Dentistry • Autism • General practice and pediatrics • Ear, nose and throat specialists • Pain management • Veterinary medicine

Currently, office-use is allowed in Canada and by the provincial regulatory authorities. Significantly, the very terms "patient-specific" and “office-use” are not defined in the NAPRA documents. These critical terms are incorporated into both documents, which pharmacy PRAs are now considering adopting without further modifications. The terms must be defined in the documents in which they are used, as is done with other important terms found within the documents. One such definition suggested is: "patient-specific" shall include "office-use" prescription orders of a practitioner entitled to prescribe in a province/territory of Canada.

TIMELINE: Any pharmacy performing sterile compounding should already have SOPs in place (http://www.ocpinfo.com/regulations-standards/policies-guidelines/compounding) as required by the licensing body, along with an internal quality assurance program and follow USP<797>.

Until pharmacists are able to evaluate and resolve any conflicts between the NAPRA documents and current recognized standards, a timeline for implementation is impossible to calculate. As such, any comment on “timeline” must make reference to what is required to be put into place within that timeline (ie, contents of proposed standards).
It is the opinion of the ACPC that changes need to be made to the NAPRA documents to address the issues above and to bring them into compliance with current USP standards. The ACPC also believes that further stakeholder/public feedback is warranted on the content of the documents, given the discrepancies already identified between those documents and the reference documents to which they reference. It is premature at this time to simply look for a timeline to implement the proposed NAPRA standards and the ACPC suggests that input from the broad cross-section of practicing pharmacists with expertise in these areas regarding the content of the documents can only serve to better protect patient and employee safety.

46.
Ontario Pharmacists Association  ·  June 30, 2016

The Ontario Pharmacists Association (‘OPA’ or the ‘Association’) welcomes the opportunity to comment on the Ontario College of Pharmacists’ (‘OCP’ or the ‘College’) proposed timeline as it relates to the implementation and adoption of the standards for the compounding of non-hazardous and hazardous sterile preparations as set by the National Association of Pharmacy Regulatory Authorities (‘NAPRA’). The Ontario Pharmacists Association represents the interests of Ontario’s pharmacists, pharmacists-in-training and pharmacy technicians. Our more than 9,500 members work in a wide variety of settings, including but not limited to community pharmacies, hospitals, long-term care, family health teams, and industry. The Association maintains as a key element of its mandate the support for pharmacists in the delivery of the highest quality of care for all Ontarians. We recognize the importance of practice standards (and the establishment of competencies to meet those standards) as they pertain to the safety of both the patient, who requires a compounded preparation, and the pharmacy professional who is tasked with preparing it and delivering continuity of care. Notwithstanding the essential development of these robust standards that protect the patient and the practitioner, implementation of these new standards must be done in a way that is both rational and pragmatic, allowing for a reasonable rate of adoption and the full acknowledgement of the challenges toward that adoption. The Association appreciates the urgency that seems to drive NAPRA’s two-year implementation period, we suggest that this is a highly ambitious timeline that could contribute to unintended consequences, such as interruption in continuity of care due to an inability to be in full compliance by September 2018. For this reason we ask for in-depth needs and gap analysis and risk assessment to more appropriately inform the determination of a timeline that works for the majority of providers, in both the hospital and community pharmacy sector.

Based on discussions with interested stakeholders in both the community and hospital sectors, OPA is concerned that while the new standards are robust and necessary, implementation of them will pose significant challenges to pharmacy providers, including financial that should be considered. The comprehensiveness of the compounding standards for both non-hazardous and hazardous sterile preparations will require substantial changes to the physical layout and operational workflow of involved pharmacies, and the costs associated with such changes can be quite large, if not prohibitive. This is further magnified with the simultaneous rollout of both sets of standards for non-hazardous and hazardous preparations, which might make it difficult for many pharmacy providers to comprehend the magnitude of all of the changes, possibly leading to an underestimation of costs. Hospitals and community-based pharmacies are similar in the fact that both are businesses that rely on strategic business plans and a strict adherence to budgets. While some plans and budgets are perhaps more flexible than others, changes of the magnitude suggested by the new standards will require a significant reinvestment. With a particular focus on hospitals who continue to see little to no growth in their annual budgets, this will pose a serious fiscal strain on the institutions. Unless there is additional funding from the LHINs or the Ministry of Health and Long-Term Care, the Ontario Pharmacists Association sees this as a substantial and possibly insurmountable challenge. Insofar as this consultation is about the ability to meet the proposed two-year timeline, acquiring the financial capital to effect the needed changes will take considerable time, possibly four or even five years for some providers.

Time itself will also be a barrier to many pharmacies attempting to become compliant with the new standards. To make the changes, budgets will need to be revisited, and this will certainly require time to ascertain the size and scope of the budgetary request, and such a request would need to be put into the organization’s budget process. For many, this may be months away. In addition, hospital and community pharmacies may need to pursue a formal and lengthy RFP process to secure the most appropriate service provider (e.g. contractors, architects, other vendors) who will ultimately be tasked to make the physical changes. These time constraints will be exacerbated with the degree of sophistication in ventilation requirements pursuant to the standards for preparation of hazardous sterile products. Further, while changes are being made, there will be the need for a significant time commitment and dedicated resources allocated to train staff and to establish new operating protocols and procedures once the physical changes have been completed. Finally, even when no physical changes are necessary, workflow and quality control will be impacted with new tasks and processes introduced with the new standards, and these must be taken into account with any consideration of timelines to effect change.

Just as patients are unique, so too are pharmacy providers. Each pharmacy, whether it is a community-based practice or one within a hospital, will have unique capabilities and challenges. Many of these capabilities and challenges will be related to the physical layout of the practice site and may or may not be readily changeable within the two-year timeline proposed for standards implementation and adoption. It appears that the proposed two-year NAPRA timeline was not well-informed, and in addition, seems to be a uniform approach for all affected providers. In other words, some providers may be better prepared for the new standards than others, and as such, their timetable to adoption may be shorter. Pursuant to an in-depth needs assessment and gap analysis commissioned by the Ontario College of Pharmacists and/or NAPRA, OPA recommends that each pharmacy provider develop and submit to OCP their own site-specific workplan for implementation and adoption. We believe that this would be the most fair and reasonable approach by OCP as it assists pharmacies in implementing the many changes as expediently as possible. However, as this might likely require additional visits from a College Practice Advisor to the practice sites, and therefore a new strain on the College, an alternative approach would be to extend the timeline to one that better addresses the needs of most providers – to a four or possibly five-year timeline (2020 or 2021), and perhaps coupled with an incentive for more rapid adoption (i.e. a one-time reduction in the site’s accreditation fee for adoption ahead of plan).

Summary The Ontario Pharmacists Association fully understands the importance of the standards and a process to drive implementation and adoption as quickly as possible. That said, the costs will be substantial to implement and may, in fact, be prohibitive, potentially forcing some providers out of the practice of compounding non-hazardous and hazardous sterile preparations. Should the latter occur, there will definitely be a tangible impact on continuity of patient care. It is imperative that NAPRA and OCP gain a full understanding the significant logistical barriers and the costs and time required to get by them given the depth of the changes. Second, too rapid an implementation plan may impact a smooth adoption plan, and accordingly, this could lead to unintended negative consequences for the patient. Lastly, it is worth recognizing the unique nature of each pharmacy operation and to have OCP help providers identify the gaps and needs via a thorough, site-specific assessment that could, in turn, lead to a unique implementation plan tailored specifically to the needs of the site. This site-specific assessment would be informed by an externally created needs assessment and gap analysis report commissioned by the College and/or NAPRA. Alternatively, OPA would recommend a more reasonable and achievable timeline that meets the needs of all providers – perhaps a four or even five-year plan instead of two.

The Ontario Pharmacists Association appreciates the opportunity to submit comments to the NAPRA proposed timelines. Should you have any questions or comments with respect to this submission, please do not hesitate to contact me at your earliest convenience.

47.
Windsor Regional Hospital  ·  June 30, 2016

Below is the feedback on behalf of Windsor Regional Hospital with respect to: NAPRA Standards & Feedback on Implementation Timelines

The pharmacy department has started the planning process for becoming 797 compliant.

We anticipate we will potentially be compliant with the standards by September 2018.

Specifically for the cancer center pharmacy - We have met with facilities to discuss our current floor plan and what modifications may be required. - We have mocked up the current floor plan drawing to “future state” - This will then be vetted through several people then finalized - Once finalized then a quote will be performed and submitted for capital - Also we are creating a project with regards to implementation of all other standards

Thank you,

48.
Pharmacist  ·  June 30, 2016

I find a number of the postings very...confusing...to say the least, especially with some coming from major organizations and associations of pharmacy.

Speaking only of the Sterile Non-Hazardous Preparations, it has always been expected that any pharmacist undertaking to make such preparations does so in compliance with existing standards/guidelines for sterile preparations. The OCP even has its own "Guidelines for Compounding" that include a section related to Sterile Compounding. The consultation has made it clear that if a pharmacy can't meet the standards, then it will have to discontinue the service in a way to not compromise patient care (i.e., referral to someone who does comply).

It is beyond comprehension that the OCP would even buy into suggestions to allow any such operation to continue with this specialty compounding, under OCP jurisdiction.

It is shocking to hear such suggestion from the OPA, as well. These standards could be applied across Canada -- not just in Ontario. They are "national" in scope.

Are we now to understand that some have been doing these tasks, have NOT complied with such guidelines/standards, and now want a "do over" to be able to put the same safeguards in place but be allowed to continue while installing the requirements? How would that sit with those who ensured their premises were complaint BEFORE they even undertook to practise in this area?

What will happen in the 2, 3, 4, 5, or more years should these non-compliant pharmacies be allowed to continue while they "come into compliance"? We're not talking here about slapping some menthol/phenol/camphor into Dermabase...we're talking about a requirement for sterility/endotoxin testing to be performed on a specific class of preparations that should only be allowed to be dispensed from fully-compliant premises.

I fail to see how certain chains of pharmacies that currently do not have such facilities (but have lots of room for grocery products) will be able to modify the premises to become compliant with what not only these standards require, but which have always been the requirement of USP standards.

It's one thing to say that having to revise the premises might result in "unintended negative patient consequences;" but this could certainly also occur if a non-compliant preparation is released to the patient while the years go by during "modifications."

It only takes one. Just ask New England Compounding Centre and the victims of that disaster. And recall the Thiessen Report findings (specifically the victims in that one), which are likely hugely mitigating in why these standards are even being created.

49.
Pharmacist  ·  June 30, 2016

Setting standards are an important part of maintaining a current place of practice. When new standards are developed and implementation dates are set, fiscal implications are the unfortunate reality that controls our ability to meet the standards.

In this era of continuous cuts to funding for hospitals, meeting standards within a short period of time will inevitably affect patient care. Hospitals can have the “gold standard” facility but will the health care system be able to then provide the funds for the medications themselves or the wages for the health care professionals?

I think it would be reasonable to ask facilities to have a plan in place by 2018, with implementation completion by 2021. This will allow for a 5 year period in which hospitals can plan structural changes without paying unreasonable costs. It would also allow for suppliers to develop more economical products to meet the demand of the centres requiring new equipment and technology.

“Haste makes waste”, and the system can not afford unnecessary waste.

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