Please work with the WSPA and WSMA to ensure any future rule is not prohibitive in nature, does not negatively impact services provided in community/outpatient setting, and provides access to care for patients in WA state.

As a student pharmacist, a significant part of our education is designed to prepare us to provide the services that are currently at odds with the current wording. It is vital in this time of provider shortage that pharmacists are not prohibited from providing necessary care. WSPA and the WSMA must be involved in any rewrite as to meet current patient needs and not set healthcare progress back by several years.

Please include the WSPA in the rule making process. The current collaborative agreement model has allowed many pharmacists to provide care in substantial and positive ways that has also mutually benefited the medical community, always with the utmost concern for patient safety in mind. As both medical and pharmacy practices evolve, I hope that any new rules remain flexible enough to continue recognizing the value, expertise, and potential that all individuals can bring to the health care team, as well as granting these individuals the freedom and responsibility to provide care as such.

As a pharmacist who has participated in collaborative agreements with physicians, ARNPs, dentists and other health care providers since 1979 I'm struck by this CR-101's potential to limit patient access to care. In the almost total absence of CDTA clinical failures or legal actions that span 40-plus years of pharmacists initiating millions of prescriptions, this CR-101 seems to be a poorly designed solution for a non-existent problem. In particular, this CR-101 limits clinical decisions, i.e. prior diagnoses, black box warnings, etc. that should not be in a CR-10 but rather embedded in the collaborative agreements themselves and based on evidence-based decisions between collaborating clinicians rather than being cemented in rules. This is a time in history when practicing physicians are asking pharmacists to contribute more to shared patient therapeutic decisions and this CR-101 is not consistent with this progressive care model. Finally, physicians are just one of a number of health care providers that pharmacists sign collaborative agreements with in Washington State. This CR-101 as written will likely cause some pharmacists to use other, non-physician, health care providers to sign collaborative agreements that are more patient centered and are less likely to exclude patient access to care.

I trust the practitioners that are willing to engage in a CDTA. I feel the Commission has been generous in the latitude and independence historically allowed to practitioners to determine what is appropriate to allocate to a pharmacist. This professional relationship between pharmacists and practitioners through a CDTA has been fruitful. It creates perpetual win-wins for both patients and practitioners alike. To establish limits or restrictions has the potential to unravel many services and points of access that our great citizens of Washington have become reliant upon. I do not believe that ground can be gained with this CR101 toward increasing access or improving public health in the environment of forecasted shortages of primary care physicians where the AAMC tells us by 2033 we will be shy 55,000 practitioners to meet demand. Our current relationship requires no change. If truth be told, the lack of prescribers warrants the expansion of CDTA roles or new bold forms of this relationship. The practitioner is the ultimate authority and may cease the CDTA at their will at any time for any reason if any part of the CDTA is not followed as agreed. CDTAs increase access to care that would otherwise not exist. If you feel there are worries of safety, then they should be shared as a guidance document as ‘things to consider for the practitioner engaging in a CDTA’. This would allow for specific messaging the commission wishes to promulgate and will leave the great practitioners of Washington to remain independent in their delegations to pharmacists wanting to serve. I speak as a retail pharmacist that wishes to continue to serve my patients with our current CDTA structure.

As a pharmacist practicing under CDTAs for over 10 years with a number of hospice agencies, I find the proposed language problematic. The physicians, other providers, or I will prescribe off-label use or prescribe medications with box warnings. These potential restrictions on my prescribing do not enhance access to timely care for my end-of-life patients and will add to the burden of our home care physician colleagues. I am also concerned about the Medical Commission considering creating rules to indirectly regulate pharmacy practice. I don’t believe that the Pharmacy Commission would create a rule that states a pharmacist shall not dispense a prescription if the physician does not include an appropriate diagnosis. Most of the language in the CR-101 is covered in WAC 246-945-350. A CDTA is a contractual arrangement between a pharmacist and physician, or other licensed prescriber. The agreement clearly states the prescribing authority of the pharmacist and the terms and conditions under which the pharmacist is allowed to prescribe. The agreement also must have a communication / feedback plan between the physician and pharmacist. Contract law would cover any violation of the CDTA. Perhaps CME or guidance from the Medical Commission or Medical Association on things to consider before entering into a CDTA with a pharmacist would meet the needs of the licensees. I feel the proposed rules are unnecessary. Please work with the Pharmacy Commission and Pharmacy Association on issues related to pharmacy practice.

As a hospice pharmacist for more than 25 years, I can personally testify that the CDTA has been invaluable in providing medications efficiently in a timely manner to ensure that patients in their end-of-life (EOL) time. To change the parameters of the CDTA and thereby limit its effectiveness would be counter productive to ensuring that patients in EOL do not suffer. Many of the medications used in EOL care are "older" medications but are time and clinically tested medications. However, in the hospice patient many medications for symptom management are used "off-label" to specifically ensure that patients do not suffer. Two examples of off label use include morphine for terminal breathlessness, and haloperidol for nausea and vomiting. These "off-label" uses are standard of practice world-wide and are crucial for the the EOL patient. To deny the use of a CDTA for these two (and these are two of the most commonly used hospice medications) would delay symptom management, would increase suffering and would be a step backward. Requirement (4)(b) is already in place to ensure that the pharmacist has the educational and clinical expertise to have safe collaboration for EOL medications, many of whose use is "off label". Perhaps you did not envision the enormous ramifications of how a change in the CDTA would affect EOL patients, but the single statement alone about "off-label" use would dramatically influence suffering in EOL patients in a negative fashion. CDTAs have plenty of protections already to keep them legal and clinically safe. Do not go forward with a change in the CDTA rules that will move the care of EOL backwards a few decades. The Commission's job is to ensure that rules implemented do not deteriorate the care of patients. Please reconsider these rule changes. Thank your for taking the time to read this and consider my comments.

Please leave the CDTA in place. Changing it in the proposed way will affect the ability to rapidly get medications to our patients on Hospice. Many very standard hospice medications are used off-label. Having the CDTA is a key part of our ability to work in partnership with our pharmacy colleagues to provide timely prescribing to symptomatic individuals at end of life.

As a hospice nurse for more than 40 years I ask you to please reconsider these rule changes. Timely access to medications for symptom management is key to a safe, comfortable, and dignified end of life for our hospice patients. The CDTA has made it possible for hospice patients to receive medications timely which in turn leads to more effective symptom management and prevention of additional suffering. The CDTA is a critical tool in end of life/hospice care. Without the CDTA there will undoubtedly be delays in getting the appropriate medications to the patient’s home leading to increased patient suffering and additional stress for their caregivers. Thank you for considering this important consequence of the proposed rule change.

As a Hospice Clinical Nurse Specialist I see the positive impacts the CDTAs have on our patients, staff and provider groups. Removing the CDTA would cause major inconveniences and for our fragile patient population including delays in medications delivery and ability of the RNs to provide timely and appropriate care at end of life. Thank you for reconsidering.

As a hospice nurse of over 30 years and who is currently working out in the field, I have to strongly urge you to leave the CDTA in place. I remember before, when we didn’t have such quick access to the c-kits, how distressing it was for patients and families. The current system has been a God-send for patients and nurses trying to relieve their suffering. Also, being able to use Haldol and MS off-label allows us to quickly respond to common EOL symptoms, plus keeps the number of meds that pts have to use more manageable. Physicians are increasingly busy and it would be an additional burden and time lag to have to start writing these extra orders. We hospice nurses are highly knowledgeable in the appropriate and safe use of these medications, including off-label, to relieve suffering and we work closely with the pharmacists and physicians to ensure patient safety. It truly makes no sense to add unneeded barriers to our being able to provide timely comfort and peace when they are at end of life. Please reconsider these changes.

Please work with the WSPA. This could negatively impact many community patients (especially hospice patients) if it is not done correctly. The current CDTA guidelines provide my hospice pts with rapid access to the best symptom management. The changes proposed here would lead to many delays that negatively impact their end of life experiences.

As a practicing hospice care pharmacist for nearly 10 years I can not imagine caring for our hospice patients without CDTA's. CDTA's provide clear, safe and effective guidelines stating how the pharmacist(s) works within the physicians care plan to provide safe, accurate and timely care for our patients. Timely access to medication is vital for our hospice patients, especially at end-of-life. As a pharmacist working within CDTA guidelines, we prescribe medications only as dictated by the physician for indications (off-label or not) the physician has clearly spelled out in the CDTA. The CDTA agreement also provides guidelines as to how the pharmacist communicates with the physician. CDTA's have made a world of difference by allowing pharmacists to provide critically needed medications within well defined parameters to patients in need. Please consider the consequences of any proposed rule changes since those changes will have a direct impact on patient care in Washington State.

It is imperative that WSPA be included in any potential rule making regarding Collaborate Drug Therapy Agreements (CDTA). CDTA allow pharmacists like myself to provide essential services to my community. My pharmacy has vaccinated thousands of patients and prescribed countless opioid reversal agents via CDTA. Without CDTA there would be a significant gap in care in many aspects of patient care. It is of utmost importance to patient care that all stakeholders are able to work together to ensure that access to care is preserved.

Even though it’s been 40 years since the legislature passed the enabling legislation for CDTAs it’s certainly appropriate for the MQAC to review the impact of the legislation on its practitioners. It’s my understanding that the Commission’s interest in this legislation was piqued a few years ago when it became an issue in some disciplinary matters. An opinion from the Attorney General also validated the current practices spawned by the original legislation. I am hopeful that the MQAC will only seek to tweak some of the mechanical issues that surround the legislation and PQAC rules (probably most helpful would be in identifying and defining when a CDTA is truly a patient care tool vs. a system’s economic tool of convenience). Getting too proscriptive runs the risk of diminishing the many positive outcomes that the current system provides residents of the State of Washington as well as puts medical practitioners at a disadvantage relative to their colleagues in osteopathy, nursing, and other independent prescribing professions. Others have testified quite eloquently as to the potential for serious negative impacts on a variety of programs which use CDTAs for efficiency and better patient outcomes (as well as insurance coverage of certain products/procedures) and I encourage the Commission to heed their advice. I would also hope that the MQAC considers the entire spectrum of CDTAs in all practice settings, not just outpatient settings. Anything else would appear to be unfair or prejudicial. Personally, in my 40 years of practice, I have participated in CDTAs ranging from the prescribing of epidural opiates all the way to all-purpose nipple ointment. I have found the process to be nothing but the highest expression of collaborative care with my practitioners with patient outcomes always being positive. Is the system perfect? No, of course not (what process is?). But when patient care is the focus of the plan, the system works. Thank you.

22-Jun-2021 Thank you for the opportunity to comment on the proposed rule 249-919-xxx/246-918-xxx regarding Collaborative Drug Therapy Agreements (CDTAs). I can understand that the Washington Medical Commission would be interested in having guardrails in place for CDTAs. It has been over 40 years since the passage of the law allowing CDTAs between pharmacists and other prescribers. During this time CDTAs have been constituted between countless pharmacists and allopathic physicians, osteopathic physicians, nurse practitioners, dentists, and presumably with veterinarians. Basically, any licensed independent prescriber can delegate prescribing privileges to a pharmacist as is defined by the CDTA (“prescribing contract”). I am interested in understanding what precipitated the need for regulations 40 years after the fact? Has there been a sudden increase in patient harms because of CDTAs, or is there another reason for the sudden interest in regulating this professional collaboration? I would guess that if an allopathic physician sees benefits for patients and has confidence in the abilities of a pharmacist then a CDTA would seem like a useful arrangement. I would also assume that if there were concerns then it would be addressed either through training, oversight, and the composition of the CDTA, or the physician would not sign it. Again, what is the impetus for needing such a restrictive regulation after four decades? I believe it will severely limit collaboration and decrease patient access to care unnecessarily. If this is not the intention it will be the consequence. I can understand if the commission wants to have a regulation to provide guidance to the medical profession as to what should be included in the CDTA like the Pharmacy Commission requires. It should reflect similar concerns but not arbitrarily restrict how pharmacy and medical colleagues collaborate. Please extend an invitation to the Pharmacy Commission to provide guidance and feedback as this regulation is crafted. Thank you again for allowing me to provide comment on this proposed regulation. Sincerely, Jason McCauley, PharmD