Feedback deadline was: May 10, 2015
Summary
The Drug and Pharmacies Regulation Act (DPRA) legislation and its related regulations provide the framework for the Ontario College of Pharmacists to regulate pharmacy practice sites in Ontario. The College is currently seeking feedback on proposed revisions to the regulations related to the DPRA — Ontario Regulation 58/11.
Ontario Regulation 58/11 of the DPRA covers the following aspects of pharmacy operations:
- Drugs
- Certificates of Accreditation: Issuance and Renewal
- Standards for Accreditation and Operation
- Advertising
- Proprietary Misconduct / Conflict of Interest
- Information, Examination and Audit
Background
The passing of Bill 21: Safeguarding Health Care Integrity Act, 2014 extends the College’s authority to license and inspect pharmacies within public and private hospitals, as well as future authority over institutional pharmacy locations. As a result, the current DPRA regulations, which only address community pharmacy practice, needed to be revised.
Pharmacy practice is changing more rapidly than ever before as new technology becomes available and scopes of practice change. Simply adding provisions for hospital pharmacies to the existing regulation framework would not provide the flexibility needed to adapt to practice change and evolving practice settings.
Aligning with government’s regulatory policy pertaining to the drafting of regulations, the College took the opportunity to propose fundamental changes to Ontario Regulation 58/11.
In drafting the regulation, the College considered the following principles:
- Regulations will be performance-based.
- Regulations will focus on high-risk practices, those that impact patient and safety.
- The approach to drafting regulations will be high-level rather than specific. Standards, policies and guidelines will be used to address issues wherever possible.
- The regulations will support practice evolution and change.
- The regulations will be drafted without specificity to permit the contemplation of multiple classes of certificates of accreditation.
This new approach sets out the performance expectations of pharmacy practice sites in regulation, while excluding many of the details which become irrelevant over time. It also strives to avoid duplication with other legislation and reference national standards as appropriate to maintain our authority. Through a consultative process the College will develop policies to ensure expectations of the regulation are clearly articulated.
Read the Draft Regulation to the Drug and Pharmacies Regulation Act (DPRA)
Common Questions
1. How can I better understand the rationale behind the proposed changes?
There are two documents that help explain the rationale behind the proposed changes. The first document is a general, high-level explanation by section. The second document is a specific explanation by clause.
2. Can I see a document outlining just the proposed changes?
The proposed revisions to Ontario Regulation 58/11 are broad and substantive, and go far beyond adding or changing single provisions. While we usually post a document tracking all changes we make, in this case the document itself does not provide enough clarity. That said, to assist in understanding the broad nature of the revisions, a document tracking all changes made to the original regulation is available for review. Read above for more on the principle-based approach used to develop the proposed regulation.
3. Who is the “owner” of a hospital pharmacy?
The owner of a hospital pharmacy will be the hospital corporation. The certificate of accreditation will be issued in the name of the corporation. This is consistent with community pharmacies.
4. Why does the record retention period seem so long?
The existing record retention requirement is consistent with that for other healthcare professionals in Ontario and for hospitals. Software vendors may be of assistance in developing electronic workflow. Read more on our Record Keeping, Scanning and Documentation practice tool.
5. The requirement to include prices for 15 different drugs when advertising has been removed. Does that mean that pharmacies can now advertise a low price for one drug?
Yes. However, all other requirements related to a patient’s ability to make informed decisions based on advertising remain intact. Further details can be found in the rationale documents in question one above.
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Helpful Links
Read this pharmacist’s comments by [downloading this PDF.](/library/consultations/download/DPRA_response12.pdf)
We at UAPF United Association of Pharmacists Franchisees, believe that there is a great need to make sure that the trusted profession of pharmacy stays in control of the professionals in that profession. We are encouraged that OCP is addressing the update of the DPRA act, as sections need to be addressed in this time of a rapidly evolving profession. Download comments from the [United Association of Pharmacists Franchisees here.](/library/consultations/download/DPRA_response10.pdf)
Shoppers Drug Mart (Shoppers) appreciates the opportunity offered by the Ontario College of Pharmacists (the College) to comment on the proposed changes to the Drug and Pharmacies Regulation Act (DPRA), 1990, O. Reg. 58/11. Download comments from [Shoppers Drug Mart here.](/library/consultations/download/DPRA_response9.pdf)
The Ontario Pharmacists Association (OPA or the ‘Association’ ) welcomes the opportunity from the Ontario College of Pharmacists (OCP or the ‘College’ ) to comment on the proposed changes to the Drug and Pharmacies Regulation Act (DPRA), 1990, O. Reg. 58/11. Download comments from the [Ontario Pharmacists Association here.](/library/consultations/download/DPRA_response4.pdf)
OnPharm would like to take this opportunity to respond to the regulations on the proposed changes to the Drug and Pharmacies Regulation Act (DPRA), 1990, O. Reg. 58/11. OnPharm represents 265 Independent Pharmacies in Ontario. Most of our pharmacies are operated by the owner and thus these regulations affect us tremendously. We support many aspects of the regulations however we have some concerns in regards to the safety to the public and understanding where accountability lies. Download comments from the [OnPharm here.](/library/consultations/download/DPRA_response6.pdf)
The Ontario Hospital Association (OHA) is pleased to have the opportunity to provide comments on behalf of its members on the proposed Regulation 58/11 under the Drug and Pharmacies Regulation Act (DPRA). Access to safe and effective drugs and pharmacies are fundamental parts of providing quality health care in Ontario, and the OHA believes that it is essential that any regulations impacting drugs enhance patient care. Download comments from the [Ontario Hospital Association here.](/library/consultations/download/DPRA_response11.pdf)
Thank you for the opportunity to provide feedback on the proposed regulations to the Drugs and Pharmacies Regulation Act. The Neighbourhood Pharmacy Association of Canada (Neighbourhood Pharmacies) is a strong voice and the leading advocate for the business of neighbourhood pharmacy and its vital role in sustaining the accessibility, quality and affordability of patient care for Canadians where they work, live, and play. Download comments from the [Neighbourhood Pharmacy Association of Canada here.](/library/consultations/download/DPRA_response8.pdf)
MedAvail Technologies Inc. (‘MedAvail’ ) is an Ontario-based healthcare technology provider that has developed a patient facing remote dispensing automated pharmacy solution, the MedAvail MedCenter®. The MedCenter supports the dispensing of both prescription and over the counter medications while the patient is engaged in a live, two-way audio and video conference with a pharmacist. Download comments from the [MedAvail Technologies Inc. here.](/library/consultations/download/DPRA_response7.pdf)
Loblaw welcomes the opportunity to comment on the proposed changes to the Drug and Pharmacies Regulation Act (DPRA), 1990, O. Reg. 58/11. Download comments from the [Loblaw Companies Limited here.](/library/consultations/download/DPRA_response3.pdf)
The Ontario Branch of the Canadian Society of Hospital Pharmacists (CSHP-OB) welcomes the opportunity to submit comments on the draft regulations to the Drug and Pharmacies Regulation Act (DPRA). Download comments from the [Canadian Society of Hospital Pharmacists – Ontario Branch here.](/library/consultations/download/DPRA_response5.pdf)
Read this pharmacist’s comments by [downloading this PDF.](/library/consultations/download/DPRA_response1.pdf)
Regarding the DPRA, I would like to comment as follows: 1) For part 2, drug schedules, the DPRA should read that a pharmacist or pharmacy student/intern working under the direct supervision of a pharmacist shall be available for consultation and shall supervise the sale of Schedule 3 products. This ensures that the health professional with proper training in therapeutics is overseeing the sale of these products in line with the patient’s best interest. 2) Regarding O. Reg 58/11, there should be an outright ban on drug price advertising for Schedule 1 products. Also, there should be an outright ban on advertising involving price for professional services related to Schedule 1 and 2 products. This will help to ensure continuity of care and reduce the potential for errors occurring with frequent transfers. For professional services such as vaccinations, frequent transfers driven by promotions makes it more difficult to track patients who require a series of time sensitive injections and ensure proper compliance. Interruptions in this schedule could impact upon the effectiveness of the vaccine. 3) For Part VI, acts of proprietary misconduct, 32. The following are acts of proprietary misconduct for the purpose of section 140 of the Act: 18. Entering into any agreement that restricts a person’s choice of a pharmacy or pharmacist without the consent of that person. The word consent should read express written consent and add language to this clause that includes entering into agreements that limit and/or deny a patient’s medication coverage, without consent, so that it would also be considered as an act of proprietary misconduct. Patients should be able to seek out the care that best meets their individual needs without having their choice encumbered by insurance plans that unnecessarily restrict their coverage. Part of the therapeutic relationship involves the trust that is built up between a patient and their individual pharmacist. Some patients have been forced to go to pharmacies outside of their community to ensure full insurance coverage even though some patients have limited mobility and means to travel. 4) I fully agree with the following: • Acts of Proprietary Misconduct [Newly proposed section 34]: 34: It is a conflict of interest for a responsible person to do, or to cause or permit another person to do, directly or indirectly, any of the following: (e) Enters into any agreement or arrangement that adversely influences or appears to adversely influence the exercise of professional expertise or judgment or the ability of a member working in the pharmacy to engage in the practice of the profession in an ethical manner or in accordance with the standards of practice of the profession 5) I support the maintenance of the existing language of O. Reg. 58/11 as it pertains to the availability of pharmacy references. This will ensure consistent minimum standards are set regarding references so that pharmacists are able to provide optimal care. 6) Remote dispensing should only be authorized in locations where reasonable and documented efforts have failed to obtain the services of a physically present pharmacist. In line with best practice, a physically present pharmacist can offer a suite of services unmatched by the machines. The physical assessment of patients is facilitated by the physical presence of a pharmacist and vital services such as vaccinations require the physical presence of a pharmacist. A physically present pharmacist can detect the smell of alcohol on the breath of patients or their unsteady gait which may be a sign of intoxication and intervene to prevent potentially dangerous interactions with benzodiazepines or alcohol to name a few. Remote dispensing should not be used in a way to displace physically present pharmacist services which would be contrary to the public interest. 7) Regarding the DPRA, pre-54 charters should not be allowed to be passed on so that there is movement towards full accountability for all owners. Currently there is one class of owners, pharmacists, who have the education and accountability necessary for the College to regulate the profession in the best interest of the public. Non-pharmacist owners have no license to practice and so are immune from suspension of this license. Non-pharmacist owners also do not have the education necessary to know which products have an acceptable risk benefit profile when deciding which products to carry. As an example, many retail pharmacies continued to sell Kava kava long after reports of liver toxicity surfaced. A pharmacist owner who continued to sell these products could be held to a higher standard than a non-pharmacist owner by the College given their training and education.
To whom it may concern, Regarding the DPRA, I would like to comment as follows : 1. For part 2, drug schedules, the DPRA should read that a pharmacist or pharmacy student/intern working under the direct supervision of a pharmacist shall be available for consultation and shall supervise the sale of Schedule 3 products. This ensures that the health professional with proper training in therapeutics is overseeing the sale of these products in line with the patient’s best interest. 2. Regarding O. Reg 58/11, there should be an outright ban on drug price advertising for Schedule 1 products. Also, there should be an outright ban on advertising involving price for professional services related to Schedule 1 and 2 products. This will help to ensure continuity of care and reduce the potential for errors occurring with frequent transfers. For professional services such as vaccinations, frequent transfers driven by promotions makes it more difficult to track patients who require a series of time sensitive injections and ensure proper compliance. Interruptions in this schedule could impact upon the effectiveness of the vaccine. 3. For Part VI, acts of proprietary misconduct, 32. The following are acts of proprietary misconduct for the purpose of section 140 of the Act: 18. Entering into any agreement that restricts a person’s choice of a pharmacy or pharmacist without the consent of that person. The word consent should read express written consent and add language to this clause that includes entering into agreements that limit and/or deny a patient’s medication coverage, without consent, so that it would also be considered as an act of proprietary misconduct. Patients should be able to seek out the care that best meets their individual needs without having their choice encumbered by insurance plans that unnecessarily restrict their coverage. Part of the therapeutic relationship involves the trust that is built up between a patient and their individual pharmacist. Some patients have been forced to go to pharmacies outside of their community to ensure full insurance coverage even though some patients have limited mobility and means to travel. 4. I fully agree with the following: • Acts of Proprietary Misconduct [Newly proposed section 34]: 34. It is a conflict of interest for a responsible person to do, or to cause or permit another person to do, directly or indirectly, any of the following: (e) Enters into any agreement or arrangement that adversely influences or appears to adversely influence the exercise of professional expertise or judgment or the ability of a member working in the pharmacy to engage in the practice of the profession in an ethical manner or in accordance with the standards of practice of the profession 5. I support the maintenance of the existing language of O. Reg. 58/11 as it pertains to the availability of pharmacy references. This will ensure consistent minimum standards are set regarding references so that pharmacists are able to provide optimal care. 6. Remote dispensing should only be authorized in locations where reasonable and documented efforts have failed to obtain the services of a physically present pharmacist. In line with best practice, a physically present pharmacist can offer a suite of services unmatched by the machines. The physical assessment of patients is facilitated by the physical presence of a pharmacist and vital services such as vaccinations require the physical presence of a pharmacist. A physically present pharmacist can detect the smell of alcohol on the breath of patients or their unsteady gait which may be a sign of intoxication and intervene to prevent potentially dangerous interactions with benzodiazepines or alcohol to name a few. Remote dispensing should not be used in a way to displace physically present pharmacist services which would be contrary to the public interest.
Regarding the DPRA, pre-54 charters should not be allowed to be passed on so that there is movement towards full accountability for all owners. Currently there is one class of owners, pharmacists, who have the education and accountability necessary for the College to regulate the profession in the best interest of the public. Non-pharmacist owners have no license to practice and so are immune from suspension of this license. Non-pharmacist owners also do not have the education necessary to know which products have an acceptable risk benefit profile when deciding which products to carry. As an example, many retail pharmacies continued to sell Kava kava long after reports of liver toxicity surfaced. A pharmacist owner who continued to sell these products could be held to a higher standard than a non-pharmacist owner by the College given their training and education.
DPRA Part VI Proprietary Misconduct 19- needs revision. Some prescription insurance companies are restricting choice of pharmacies by requiring the insured to deal with pharmacies of the insurer’s choice, NOT with pharmacies of the insured’s choice. The insurance companies (and the employers purchasing prescription insurance) use their dominant positlons to coerce people to obtain prescriptions from favored suppliers by such means as refusing to reimburse if prescriptions are obtained in another pharmacy, and/or arranging pricing discrimination with the insurance company’s chosen pharmacy or pharmacies. Under these circumstances, an insured employee is basically powerless regarding free choice of pharmacy. (i.e. Sign or you have no coverage.) This is where OCP’s mandate to serve and protect the public and advocate for the best interests of the patient comes into play. OCP does not have control over insurance companies and employers buying insurance, but it DOES have control over pharmacies I suggest amending Part VI Proprietary Misconduct 19, for example, to: Entering into any agreement that restricts a person’s choice of pharmacy or pharmacist with the exception of nursing homes, or without prior authorization of OCP is proprietary misconduct The phrase "without the consent of that person" appears to be a loophole that has morphed into a noose that can throttle a patient’s choice. An employee of any reasonably large company has little or no control over the employer or insurance company. That is why they need OCP to step in to protect their right to choose their own pharmacy and/or pharmacist without restraints forced upon them. Isn’t there a legal term about signing under duress? That could probably be applied here. It makes sense for a nursing home to be able to choose a single supplier, as it would be an administrative nightmare, interfering with patient care, to have e.g. 30 pharmacies supplying one hundred residents. For the rest of Ontario residents, the OCP can step in to protect their freedom of choice . Please modify this legislation to protect the public . Continuity of care in the pharmacy of choice needs to be protected by OCP on an ongoing basis.
Dear Ms. Resnick, Thank you for the time that you and Tina Perlman (Manager, Pharmacy Practice) spent with staff from the College of Nurses of Ontario (the College) to discuss questions about the Ontario College of Pharmacists’ (OCP’s) proposed regulation under the Drug and Pharmacies Regulation Act (DPRA). OCP’s principle-based approach is consistent with recent directions that we have taken in nursing regulation. The DPRA definition of a hospital pharmacy includes any ‘…location in the hospital where drugs are stores or supplied from’¦’ for hospital patients (1). This definition could include locations of a hospital where nurses commonly practise (e.g., medication rooms and cart systems located on patient units). The College is interested in participating in any future consultation that OCP may conduct regarding standards for hospital pharmacies as it may impact nursing practice. When OCP inspects premises where nurses work, we request that any concerns related to nursing practice (e.g., incapacity, incompetence, misconduct) be reported to the College (2). Finally, Council recently approved a new Medication Practice Standard (3), which took effect May 5th and applies to medication practises by nurses in all practice settings. Thank you for the opportunity to comment on the proposed regulation. Please feel free to contact us if you have any questions. Sincerely, Janet Anderson (Director, Professional Practice) CNO 1. Sub-section 119 (1) Drug and Pharmacies Regulation Act 2. Disclosure is permitted by section 36 of the Regulated Health Professions Act, 1991 3. Available at http://www.cno.org
Re: Advertising of Schedule 1 Drugs Historically, I believe that the requirement for listing prices of at least fifteen prescription drug costs, in at least ten categories,was created in response to some pharmacies wanting to advertise discount prescription prices for birth control prescriptions. These proposed changes look like of a re-run of a previous game, but including more drugs (maybe Viagra?) Advertising of single or a few multiple prescriptions has the potential to adversely affect patient care because it may encourage "cherry-picking" at various locations, rather than the ideal of continuity of care at the pharmacy of choice. Such advertising could also give the misleading impression that a bargain-offering pharmacy would have lower overall prices. OCP probably has records of the discussions which occurred when the previous legislation was created, which would present more reasons for the existence of this legislation. Please review. I still question whether there is really any need to advertise prescription prices. After all, anyone can just ask at a pharmacy. I also wonder who is pushing for these changes, as I doubt this request for change came from the front-line pharmacists who give direct personal care to their patients. I believe that the previous legislation requiring the list of fifteen prices be continued. The idea of also specifying start and stop dates for the prices may be a valid additional requirement to advertising prices. Maybe it would be allowable to place an asterisk next to "real deals" on the price lists. In order to continue to encourage patients to keep their prescription records in one pharmacy of their choice (therefore enabling better and more complete continuity of care) the current legislation requiring the list of at least fifteen drugs in ten categories should be continued.
I fully agree with the proposed changes to DPRA regulations.
With an overall of the DPRA I feel that it is essential to reconsider what intention of section 18 under part VI (proprietary misconduct), should be. This section lists proprietary misconduct as "Entering into any agreement that restricts a person’s choice of a pharmacy or pharmacist without the consent of that person." In my practice I have seen patients restricted by preferred provider networks by virtue of having to pay substantially more to have their medication filled at a pharmacy of their choice, versus what their plan mandates. From my knowledge of the current pharmacy landscape in the USA, PPNs are a slipperly slope, with increasing restrictions forcing patients to rely on mail-in-pharmacies to meet their medication needs. If our profession is serious about advancing patient care and continuing the expansion of pharmacist services, we should strongly consider the shocking direction these indirect restrictions are sending our profession.
we need to monitor the sale of Tylenol #1, Gravol, cause people are using a lot, i think it number one addiction going on now, no ceiling for its sales, which makes it easy to overuse it
Concerning Accreditation of Pharmacies I understand that there are pharmacies in Ontario which still operate under pre-1954 charters, not requiring the majority control of pharmacies to be under licensed pharmacists. This was a grandfather clause to avoid interruption of service, but such clauses are generally considered to be an interim solution to allow time to adjust to new standards. There are still advertisements around, offering pre-1954 charters for sale. Any grandfather alive in 1954 (over sixty years ago) would normally be dead by now. Requirements for accreditation of pharmacies should be updated to address this situation. Can OCP add a specific clause to the current legislation stating that any pharmacy operating under a pre-1954 charter cannot pass that status forward, and if such pharmacy is re-located, enlarged or sold, new ownership must meet current ownership requirements of pharmacist majority. Furthermore, any pre-1954 charter may not be used to start up a new pharmacy, nor can ownership of the charter be changed from current ownership. This sixty-year old leftover should be dealt with ASAP. It has gone on too long.
Now is a prefect time for the college to protect the public from insurance plans that restrict the choice of pharmacist/pharmacy. But VI (18) needs to be expanded. Consider the type I diabetic with significant drug costs who can’t be home for delivery of their cooler, or the mental health patient who needs drugs the same day on a Friday afternoon, WHAT IF they have insurance that covers 60% locally, 80% by mail order? I am seeing patients make very dangerous choices since such an agreement went into place in my town. The college should define this as an unfair restriction of choice."No pharmacy can sign an agreememt that restricts the choice of pharmacist/pharmacy by the member of an insured group by means of obtaining a greater insurance reimbursement to themselves vs any other pharmacy by the insurance of that group" for example.
I am adding further comments and thoughts to my colleague’s feedback (#9-dated March 26,2015) regarding advertising of waiving of ODB fees. This type of advertising is A PUBLIC DECLARATION OF UNJUSTIFIED FAVORITISM AND/OR PREJUDICE. Isn’t that unethical? Would OCP allow the advertising of waiving of fees for cash-paying patients? (After all,the ODB patients are already being subsidized by the province.) Would OCP accept the advertising of waiving of fees for other third-parties such as Green Shield ? Is it acceptable to advertise waiving of fees for all brown-eyed patients? or if you are wearing green on St.Patrick’s Day? My optometrist’s office recently sent me a reminder to arrange a date for a check-up. To quote from part of that letter "In Ontario, Optometrists are legally PROHIBITED from publicly advertising products and prices" (capitalization of PROHIBITED was done by Optometrists). Are Pharmacists expected to have lower standards of advertising than Optometrists? If OCP continues to condone any form of public advertising of waiving of ODB fees,the public image of Pharmacists is sullied by the actions of some members. (In other words, makes our public image stink.) DPRA Part V Advertising #30 ODBA information, allowing PUBLIC DECLARATION OF FAVORITISM should be completely deleted.
With respect to "Requirements of a Pharmacy" section 19: "Every pharmacy must, (a) be safe, clean, orderly, and properly maintained". Common food allergens in the dispensary would not meet the definition of safe or clean, at least not to an anaphylaxis-prone patient. The fact is that many staff pharmacists are forced to eat in the dispensary because we are exempt from the provincial employment standards that allow meal breaks for employees. And so we are bringing common food allergens like nuts, eggs, wheat, dairy, fish, shellfish, etc. etc. into the dispensary as a matter of our own survival. Since we may be alone in the dispensary and multi-tasking, we may not have time to wash hands before we have to answer the phone or touch other equipment. Other healthcare environments are getting serious about limiting consumption of food to non-patient care areas. Change cannot happen in pharmacies until there is a change in the employment standards governing pharmacists; there’s too much pressure on individual pharmacists in their workplaces to challenge the status quo. OCP is tasked with protecting the public. Clearly this issue is bigger than DPRA but, as a profession, let’s start moving in the right direction.
I feel what these large corporations such as walmart are doing is unfair to the practice of pharmacy. If the walmart employee goes to a walmart pharmacy the copay is x…but if they go to any other pharmacy it’s y…. this should not be allowed….it should be patient choice as to where they want to go….this must be stopped ASAP…before the practice of pharmacy becomes a corporate practice and the independent voice cannot be heard any longer!
With respect to loosening the regulations to allow advertising of prices of single Schedule 1 drugs, it makes absolutely no sense at all to do that from a "protection of the public" perspective. I get it that there are pressures to do so from commercial interests, that the Competition Bureau might like that, that "everyone else is allowing it", but are those valid reasons to do so ? What we will end up with is an American style free-for-all on prescription drugs that will involve manufacturers and large corporate interests using the watered down regs to encourage patients to transfer prescriptions to the pharmacy-of-the-day. Patients will ask their doctor for prescriptions that fit their wallet condition and not their medical condition. The fee waiving wars amongst pharmacies will pale by comparison and hard fought efforts to promote the professionalism of pharmacists will disintegrate in favour of commodity selling retail tactics. This proposed change cannot possibly benefit good patient care or the public image of the pharmacist. Let us not give in to the wrong reasons on this and open the doors to a situation that is not necessary nor of any benefit to those OCP is mandated to protect. Leave the Schedule 1 advertising regs as they were or tighten them up even further.
Thank you for including the College of Medical Laboratory Technologists of Ontario (CMLTO) on your list of stakeholders for the circulation of the Proposed Regulations to the Drug and Pharmacies Regulation Act (DPRA). We have reviewed the document and have no comments or suggested revisions to offer to the Ontario College of Pharmacists. We thank you again for inviting us to review and commend on the Proposed Regulations to the Drug and Pharmacies Regulation Act (DPRA).
Regarding prescription transters. We obtained legal advice on this issue in 2006 after an incident in which a family member requested a transfer to another pharmacy on behalf of his mother. The pharmacy notified us and we transferred the prescription immediately. Subsequently the mother contacted us and we advised her of the transfer. She was livid with her son for doing this and with us for not contacting her first. At that time based on the advice of our lawyer we began to require written authorization for all transfers. It is our informed opinion that the "loose" way transfers are currently handled is unprofessional and not consistent with any other health profession. For the protection of patients and pharmacists written authorization should be the standard. Furthermore, pharmacists who choose to exceed the existing standard should not be sanctioned.
I disagree with #29. I do not agree with the College having a regulation that allows for advertising of prescription prices-sales. Prescription drugs should not appear as that type of commodity in my opinion.
I have reviewed and am in agreement with proposed changes. Thank you.
I am concerned that large corporations have more control over the practice of pharmacy than pharmacists and our licensing bodies do. Pharmacists are forced to sign agreements that put revenue generation ahead of patient care. While revenue is important no pharmacist should be forced to sign an agreement where the total legal risk is on the pharmacist manager and not the corporation that is demanding compliance or loss of employment. Legislation must be in place that prohibits forced agreements where patient care is secondary to revenue generation and allows the big corporation to hide behind a pharmacy managers licence to practice.
The draft DPRA regulations allow for increased flexibility and adaptability as practice and standards changes in the future. I applaud the work of the College on this initiative. In addition, the inclusion of remote pharmacies for both community and hospital practice are anticipating opportunities to best service our patients in remote locations. I noticed that in reading the posted Drug and Pharmacies Regulation Act (e-laws/Service Ontario), it indicates that a hospital pharmacy is: Despite anything else in this Act, where drugs are compounded, dispensed or supplied for hospital patients by a hospital in premises located in a hospital, the primary location or locations in the hospital where drugs are compounded, dispensed or supplied from, together with any other location in the hospital where drugs are stored or supplied from and any other location prescribed in regulations made under subsection (2), is deemed to be a pharmacy for the purposes of the following provisions of this Act, subject to the regulations and to any necessary modifications: Under the proposed draft DPRA regulations, there is a definition of ‘medications’ ‘" means drugs and other substances usually maintained in a pharmacy, including substances used in the compounding of drugs: Is there any opportunity to have the draft DRPA Regulations have all areas that prepare/compound drugs and medications for patients under the ‘Pharmacy’ ? I am anticipating in the future that hospital may employ/contract with Regulated Health Professional such as Naturopaths, Chiropractors, TCM practitioners and it may serve in the public’s best interest if the provision of medications including natural health products or compounding of these products within the hospital setting was done with the same standards as those in the pharmacy. I would recommend the dispensing, compounding may be best under the supervision of the pharmacy and meet consistently high standards. Also, my interpretation would be that medications prepared by nursing staff on the inpatient units would need to be done to the same safe standard as those prepared in an aseptic environment (laminar flow hood) in the pharmacy. I look forward to the implementation of the new legislation and improvement in patient care within the hospital sector.
Many improvements have been made to improve the readability of the regulations. There are a couple of paragraphs that may benefit from additional clarity/editing: P.24 "Business Practices" – it appears that products can be resold if returned to a pharmacy in original packaging. Is this the intent? ;P.27 "Conflict of Interest" – should bullet #35 be removed? ; Schedules A&B are referenced where?
While I agree whole heartedly with the college coming in to hospital pharmacies to oversee what is going on as well as give expectations, I would also ask that they please consider that small rural hospitals seem to continually be underfunded. I would love to see the college come in and demanded certain things to change, I work in a hospital where the norm has been for us to make do with what we have. While I believe we have done a great job with what we have, knowing that a hospital just 45 minutes up the road was given approval for $100,000.00 plus more in funding is very upsetting. Safety has always been the first priority of our manager and staff and we work very hard to carry out this endeavor. please set these guidelines with at least the thought that we don’t always get the funding required to implement all of the technology as well as the equipment to follow through with all of these things that will be set upon us. Thank you
Compare these standards to Accreditation Canada and remove the ones that would be covered within passing standards. Consider scheduling licensing on the same cycle as Accreditation Canada.
Regarding: 48. Nothing in this Part prohibits a pharmacy from publishing, displaying, distributing or using, or permitting, directly or indirectly, the publication, display, distribution or use of, an advertisement that relates solely to the co-payment or dispensing fee charged by the pharmacy for supplying a drug that is a listed drug product under the Ontario Drug Benefit Act to an eligible person under that Act. O. Reg. 58/11, s. 48. I would like to propose that discounts advertised for professional services and drug products should apply to all patients who receives the equivalent service or product and not just select and privileged groups. For example, if there is a $2.00 co-pay discount policy, it should apply to everyone with an insurance policy with a co-pay and all cash patients. My rationale is: 1) The co-pay discount is advertised and provided only to members of the group with Ontario Drug Benefit coverage. This is promoting a discount to members of a preferred patient group to the exclusion of other groups, which is unethical. It is disallowed to create or advertise a preferred patient club (ex. CostCo pharmacy members) with rewards programs, including medication discounts. In effect, advertising this special discount creates an exclusive "ODB-eligible patients" group. This is done for the sole purpose of increasing the perception of value and competitiveness, which are financial motivations. This creates inequitable access to pharmacy services for other patients and adversely influences patient choice over pharmacist for ODB patients. 2) Many stores and chains prominently advertise co-pay waiving for ODB patients in order to appear more competitive. This may create a false perception of value for drugs dispensed to non-ODB patients. When the co-pay discount is advertised on the radio or on signs, this may mislead non-ODB eligible members of the public into thinking that the pharmacy can provide them more value than another. This may influence patient choice over their pharmacy on false pretenses. In summary: I believe that when a pharmacy advertises a discount for a professional service or a drug product, the discount should apply to every patient who receives the equivalent service or drug product. $2 co-pay waiving is a form of price discrimination whereby drug products are discounted for an exclusive group. This creates inequitable access and adversely effects patient choice.
I have a couple of comments on the part of the act with respect to the retention of records. I feel that simply duplicating the record keeping requirements of physicians is overly simplistic and fails to recognize the differences between our practices. Since we file prescription hard copies sequentially by prescription and not by patient, this part of the act essentially requires us to keep all hard copies for 28 years. While I think it is appropriate to retain non-dispensing records as directed by the act (ie: flu shots, interventions, medication reviews, etc.), unfortunately most software vendors treat these additional scope items like prescriptions when it comes to record keeping. Record keeping would not be an issue if we were able to be truly paperless. The ability of pharmacies to scan prescriptions and hard copies is nice, but results in increased time and labour costs. I understand OCP has been working with other regulatory bodies to enable electronic prescribing, but to be paperless, we also require pharmacy software vendors to develop the tools necessary to allow for checking and authorization by the pharmacist electronically. Until all of these pieces are a reality, OCP needs to recognize that, for the most part, pharmacies will be required to keep their paper records for 28 years, which is neither feasible, nor realistic.
I have the following questions: Part III; 6. who is the "owner" of a hospital pharmacy? 8. how is "5% votng share" determined for a hospital pharmacy 11. who is the "specific name of the person" who owns a hosp. pharmacy? 14. "owner" for hosp pharm. 18(2). "owner" for hosp pharm (definition of owner for a hospital pharmacy) 19(j). …"symbol"… visible to pts or public; – a hospital pharmacy is not accessible to the public or patients, where will this need to be displayed? 20(2) ..records…electronic; how will hospitals that are not fully electronic comply with this? especially with respect to narcotic and controlled drugs.
I agree with the proposed changes to the DRPA regulations.
Given the substantive nature of the legislative changes, surely a webinar, at least, would help explain some of the implications, changes, and vision behind them. As a management of change, this would encourage some buy in (and less cynicism). Many of us don’t quite have the time to mull over these individually, but would value the short cut of a group discussion. As a long time OCP member, I have often observed and experienced a deep disconnect between the OCP administration and the membership. I offer this as constructive feedback, wishing to help the process along.
I have reviewed and am in agreement with proposed changes. Thank you.
I look forward to the upcoming changes. In the past we have had guidelines/recommendations only’¦’¦I believe having standards to follow will help move us all forward into the right/same direction. I feel so many hospital pharmacies are doing same/similar tasks differently. I am excited for our profession to now have support to help make or move toward the right changes Thank-you
After watching the CBC Marketplace program, it seems most pharmacies are not implementing the laws and regulations regarding the sale of schedule 2 products including sch 2 narcotics. So far no study has been published on Tylenol #1 addiction in Ontario or Canada as the sale of this product is not documented and it is impossible to do any study on this issue. I e-mailed so many researchers at CAMH and non of them was able to provide any information on Tylenol#1 addiction in Ontario or Canada. I suggest the following procedure so that CAMH or other researchers can collect data from pharmacies and determine the significance of Tylenol#1 addiction: SALES OF SCHEDULE II DRUGS 1- When a patient comes to the dispensary requesting a Sch II medication, the PA shall direct the patient to the counseling area. 2- The pharmacist checks if the patient has a profile in the computer or not. 3- The pharmacist creates a new profile if the patient is new to the pharmacy and documents all the essential information on the profile in addition to the list of medications the patient is taking. 4- The pharmacist runs the request as a cash Rx authorized by her/him if convinced the medication will be safe and effective for the patient. 5- The Rx is processed. 6- The pharmacist checks the Rx and if needed provides further counseling to the patient. Advantages of the above procedure 1- The pharmacist is implementing the laws and regulations by being involved directly in the sale process. 2- Effectiveness and safety of the medication for the patient are assured. 3- The medication is added to the patient’s profile and can be communicated with the family physician or other prescribers if needed. 4- The pharmacist can prevent misuse or abuse of these products. 5- Research projects can be performed on the consumption of these products by collecting the data from pharmacies and this will enable regulatory authorities to take decisions or amend regulations if required. 6- Regulatory authorities will know the quantities of these products purchased by non-Canadians and transported outside Canada particularly Sch II Narcotics. 7- CAMH can analyze the data collected from pharmacies and determine the significance of addiction on Sch II Narcotics in various locations of Canada and accordingly suggest recommendations to resolve this issue.
Is it possible to have the amendments or changes highlighted in order to make it easier to identify them?