Pharmacy Dkector (F) 401-739-9770 · example, the buccal HIV swab test. Some states require...

Sincerely,

Rick Mandm; RPh Pharmacy Dkector PharMerica 83 Vermont Avenue Warwick; Rf 02888 (P) 1-800-446-1190 ext 876502 (F) 401-739-9770

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To: [email protected] and [email protected] CC: [email protected]

Dear Mr. Ragosta,

Respectfully, I am a Registered Pharmacist and a Board Certified licensed physician in the State of Rhode Island. I have recently reviewed the proposed changes to the Pharmacy Regulations. My primary area of practice is Family Medicine. Therefore, I have two perspectives from which to view this proposed regulation. My areas of concern from the physician side of practice are the following:

1. Pharmacist prescribing of Oral Contraceptive therapy It is my opinion that a simple questionnaire prior to authorizing a prescription is insufficient to determine a 1-listory from a patient, especially if that patient does not receive regular medical care. With the adoption of the new USPTSF recommendations it is true that a woman need not undergo a PAP or GYN examination prior to being prescribed an OCP provided that the she has been screened as recommended by age and result previously.

Also, any adopted screening tool should be extensively validated prior to initiation of use, and there is no indication in your legislation that this has been done.

Are pharmacists trained to elicit a thorough medical history in a brief face-to-face encounter? It requires years of specialized training and practice to complete this quickly and competently. Also, there are physical components such as blood pressure and pregnancy screening that should be performed as a minimum requirement of prescribing.

I firmly believe that a 3 month training course is insufficient to provide pharmacists the capability to prescribe any medication. My concerns are lack of follow-up care and comprehensive management of the prescription with confounding medical conditions and prescriptions. As with any medication, when OCPs are initially prescribed a thorough evaluation of risks vs. harm to the patient should be performed. I doubt that busy pharmacists will be able to provide this proficiency of care, nor will want to assume the liability.

2. Direct prescribing to kiosks with automated dispensing

From my perusal of this topic in the proposed legislation, physicians may have the option of directly prescribing to automated dispensing kiosks. I feel this is a danger and disservice to patients for the following reasons. With the deluge of daily documentation and miscellaneous paperwork practicing physicians are now required to perform the question becomes will this disassociation of care between Medicine and Pharmacy promote patient harm and negative outcomes? For example: who shall provide drug-use review, insure the correct dispensing of product and dose and perform mandatory opt-out patient counseling?

A pharmacist is extensively trained to perform these duties and in many cases is essential in assisting physicians with reconciling current medication lists and compiling complete histories. In addition to increased patient risk disconnection from such resources presents a further liability the physician must assume. Has the Board of Pharmacy presented this proposed legislation to the Board of Medicine for dissemination to practicing physicians as it directly affects their scope of practice as well?

3. Point of care testing and resulting

AgaiA, it is my opinion that this practice could contribute to patient harm. While there are now numerous antigen-based test kits available over-thecounter that patients themselves may perform, a true result is based upon the sensitivity and specificity of the product. Will the patient be informed of the reliability of the test in delivering a correct result? And how should they be directed, if needed, for management?

While I agree that many conditions may be managed with over-the-counter medications, what shall the patient do with certain results? Take, for example, the buccal HIV swab test. Some states require mandatory patient counseling prior to performing an HIV screen as well as after a positive result is obtained. Should pharmacists be required to counsel the patients at point-of-care testing? Or consider a patient who requests a fingerstick blood glucose test because "my Dad has diabetes". Are pharmacists adequately trained to assess and direct the management of a subtly intermediate (or worse, critical) positive result?

I am concerned that this will, again, burden the pharmacist with increased liability and place him or her in a situation that they may not have the skills to manage.

Regarding the practice of Pharmacy:

I also would like to highlight some key areas of concern that I believe may negatively impact the public with respect to medication safety and adversely affect the profession of pharmacy and Medicine.

My area(s) of concern and request(s) for change(s) regarding the practice of Pharmacy are as follows:

• Please c-onsider removing 1.1.3.14 from the proposed Regulations in its entirety "A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not publish or circulate false, misleading, or otherwise deceptive statements concerning the practice of pharmacy".

• Please consider adding "All modifications of-pharmacist license renewal fees shall be reviewed and approved by the Board of Pharmacy prior to initiation." to 1.1 .4.16.B.

• Please consider removing the addition of "in writing" from 1.1.5.14.A related to acceptable forms of patient counseling.

• Please consider adding "mandatory live verbal counseling (in person or via approved AN equipment) for all new medication prescribed to an existing patient and any medications where the dose, strength, route of administration, or directions for use has changed" to sections 1.1.5.14.A, 1.8.3.d, 1.1.8.3.2.b(1 ), 1.1.8.3.2.b(2) and 1.1.11.B.5.

• Please consider returning to the original language in section 1.1.5.23 "Verification by a pharmacist of a filled prescription must include verification of the prescription label and product against the original or scanned prescription" instead of limiting to a first refill only.

• Please consier limiting automated "RAPS" devices as outlined in 1.1.8.3 with controlled substances dispensing to nursing facilities, medical institutions, assisted living, rehabilitation, hospitals, hospice care or correctional facilities.

• Please consider ensuring that pharmacists have oversight of implementation and maintenance of the automated storage and distribution systems described in section 1.1.8.3.

• Please consider clarifying/ensuring that technicians are not able to prepare or determine patient eligibility for vaccines in section 1.1. 12.1.8.

• Please consider removing technician ability to perform limited-function laboratory tests in section 1.1.12.2.B.2.

• Please consider retaining the requirement for technicians to "complete at least three (3) hours (0.3 continuing education units) of the required ten (10) hours of continuing education as live hours" in section 1 .1.13.1 .J .1.

• Please consider ensuring that pharmacy technician product verification cannot be performed when the electronic verification system (e.g. bar code scanning) is unavailable or overridden for part or all of the dispensing process.

• Please consider adding language to ensure that each pharmacy utilizing a verification technician program must staff pharmacists to verification technicians in no more than a 1 :2 ratio during all times the pharmacy is open to the public.

Thank you for your diligence in this process of revising the Pharmacy Regulations and for your consideration of including additional safeguards to ensure public safety, access to appropriate patient counseling, and continuation of entrusted professional activities by pharmacists in Rhode Island.

Sincerely,

Christina S. Morris MD, RPh

NATIONAL ASSOCIATION OF CHAIN DRUG STORES

Submitted via email: [email protected]

July 16,2018

Ms. Paula Pullano Rhode Island Department of Health 3 Capitol Hill Providence, RI 02908-5097

RE: Proposed Amendments to rules and regulations for Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors (216-RICR-40-15-1)

Dear Ms. Pullano:

On behalf of the 168 chain pharmacies operating in the state of Rhode Island, the National Association of Cain Drug Stores (NACDS) is writing in support of the proposed changes to Section 216-RICR-40-15-1 which establishes rules and regulations for pharmacists, pharmacies, and manufacturers, wholesalers, and distributors.

NACDS support the vast majority of the changes that are included in the proposed rules. We believe that the proposed amendments will result in increased patient access to prescription drugs and the many other services retail community pharmacies provide. Additionally, we believe that the proposed amendments will decrease barriers and provide better healthcare for the patients overall in Rhode Island.

Patients have always relied on their local pharmacists to meet their healthcare needs - trusted, highly accessible healthcare providers deeply committed to providing accurate prescriptions aJ,d helping patients take medications as prescribed. Retail community pharmacists are even more highly valued by those that rely on them most - older Americans, individuals managing chronic diseases, and those in urban, rural, and underserved areas. Pharmacy services improve quality oflife and healthcare affordability. Helping patients take their medications effectively and providing preventive services, pharmacists help avoid more costly forms of care down the line. Pharmacists also help patients identify strategies to save money, such as understanding their pharmacy benefits, using generic drugs, and obtaining 90-day supplies of prescription drugs from local pharmacies. Because of the vital role that pharmacies play in providing quality patient healthcare, we applaud the Rhode Island Department of Health (RJDOH) for recognizing the importance of patient access to valuable healthcare services provided by retail community pharmacies that will result in better medication adherence, maintain continuity of care and result in overall better patient outcomes.

Thank you for the opportunity to submit comments on these very important matters. NA CDS and its member are open to further communication and collaboration with the RJDOH as the move to adopt these amended changes.

Sincerely,

If /(I(& hl!oUJJ' Anne Fellows Director, State Government Affairs

·1176 Wilson Blvd • Suite 200 • Arlington, VA 22209 • 703.549.3001 • Fax: 703.836.4869 • www.NACDS.org

Roberts, Sullivan (RIDOH)

From: Sent: To: Subject:

Pullano, Paula (RIDOH) Tuesday, July 17, 2018 9:50 AM Roberts, Sullivan (RIDOH) FW: [EXTERNAL] : Comments on Proposed Rule Making for Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors (216-RICR-40-15-1)

From: Kelly Orr [mailto:[email protected]] Sent: Sunday, July 15, 2018 9:03 PM To: Pullano, Paula {RIDOH) <[email protected]>; Ragosta, Peter {RIDOH) <[email protected]> Cc: Stacey Ranucci <[email protected]> Subject: [EXTERNAL]: Comments on Proposed Rule Making for Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors {216-RICR-40-15-1)

I am writing to formally submit comments on selected areas of the proposed rule making for Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors {216-RICR-40-15-1). Though there are many positive changes in the draft, I feel there are areas that should be further discussed and addressed before moving forward into the final rule making process. ·

1.1.5.14 Counseling in Writing - In reviewing this, I now see there is potential for an adverse consequence to occur with a pharmacist providing a patient with written information when a conversation should have taken place. There are often situations, especially with clinically significant drug-drug or disease-drug interactions, storage recommendations, administration, etc. when verbal counseling with the patient to verify understanding is necessary. Though the regulation states in in the professional judgment of the pharmacist; providing language here of written counseling could have unintended safety consequences and is not in the best interest of public health.

1.11 Telepharmacy- During open session discussions at Board of Pharmacy meetings, I voiced concern regarding this change occurring through strictly a regulatory process vs. legislative. This entire section will have a monumental-impact on the practice of pharmacy in the state and I personally do not feel comfortable with this section moving forward as is.

I am especially concerned about community pharmacy sites where this erodes the patient-pharmacist relationship. Though pharmacists are available remotely, patients often want a quick consult more than ever and may not bother to telephonically contact the pharmacist. I am worried about the technician who may feel they are capable to answer questions that should be directed to a pharmacist in these cases too.

As an educator primarily responsible for teaching self-care/nonprescription medications, not having a

pharmacist on-site at a location dispensing medications or selling nonprescription medications in a community

setting. For example, I recall counseling a patient on their warfarin, I looked down and noticed the patient was

holding a box of ginkgo biloba, a dietary supplement that may also increase bleeding. I don't know if I would have caught that interaction through a remote consultation, she had not thought to ask if they would interact

either. As more and more medications move to nonprescription status, it is more critical than ever to be

vigilant of patients' self-care needs. Most importantly, pharmacists can triage patients looking to self-treat who need greater medical attention. This is a public health consequence that may have adverse impact not fully recognized yet.

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Other states have addressed telepharmacy through legislation, most recently with it being voted down in Florida (S.848 and H.679) this spring. I would recommend removing this section entirely and moving it to a legislative bill in the spring if it is desired by the Board and Department of Health to move forward.

1.1.8.3 RAPS - I can see this being beneficial in provider offices for non-controlled medications, specifically those with pharmacists on site within the practice. I do want to express concern about kiosk fills in a pharmacy for the same reasons stated above with telepharmacy and lack of presence of a pharmacist.

1.12.B.2 Limited Function Tests

The language states a pharmacist, intern or technician II performing a limited-function test. The statute supporting this only states pharmacist.

1.13.1 Technician II Verification Program

Overall, the intention here is to help free up pharmacists to provide more clinical services, and there is data to support accuracy/safety of technicians performing this duty in the right setting with appropriate training. Though there is little data, that I am aware of, to demonstrate what may occur should a pharmacist presence be reduced in these settings. I understand public comments of fear this may result in a reduction number of pharmacists hours to perform many of these clinical activities since a business model is not in place to support services, even more troubling to think that a pharmacist may be eliminated, or at least have a reduced presence, from the pharmacy site. Adding language for a requirement of having adequate pharmacists present with the ability to safely oversee technician dtities in this process may help here. Questions have also arisen about who is ultimately responsible should an error occur. Other states have also approached this through legislative vs. regulatory changes, though I understand the Board can determine pharmacy technician duties, it may be of public health interest to move this to a legislative bill should itgo forward so concerns can be fully vetted through hearings.

In closing, I know the Board of Pharmacy worked on these with the understanding these were only draft changes and public comment would play a critical role in how they will proceed. Valid concerns during the comment period should be seriously considered and addressed with the next phase of rule making in conjunction with ORR and the Board of Pharmacy. It is my hope that they do not all go into effect at this time and would· welcome the opportunity for Board -members to further discuss in an open meeting setting to demonstrate public concerns are being considered.

Thank you for the opportunity to provide comments.

K. Kelly Orr, PharmD, AE-C Clinical Professor College of Pharmacy The University of Rhode Island Avedisia n Hall 7 Greenhouse Rd. Kingston, RI 02881 Phone: 401-874-5522 Email: [email protected]

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July 16, 2018

Peter Ragosta, RPh RI Department of Health To: [email protected]

Dear Mr. Ragosta,

I am writing about the proposed amendments to the Rhode Island rules and regulations for Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors. I am a licensed pharmacist in the State of Rhode Island and have recently reviewed the proposed changes-to the Pharmacy Regulations. I have also read the list of specific areas of concern compiled by the RI Pharmacists Association and I am in complete agreement.


Sincerely,

Noemi Ramos-Desimone, PhD, PharmD

RI Pharmacist #04621

cc: Paula Pullano ([email protected])

Rhode Island Pharmacists Association ([email protected])

!v\ed

July 13, 2018

Ms. Paula Pullano Rhode Island Department of Health 3 Capitol Hill Providence, RI 02908

Re: Proposed amendments to regulations for Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors (216-RICR-40-15-1)

Dear Ms. Pullano:

I am writing to you in my capacity as Director of Pharmacy and Regulatory Affairs for MedAvail Technologies, Inc. ("MedAVail"). MedAvail ls a company that manufactures and distributes an automated pharmacy system that is used by pharmacies improve patient access to pharmacy services. We appreciate the efforts undertaken by the Rhode Island Board to draft regulations that will allow pharmacies to leverage technology to improve patient care. MedAvail has successfully partnered with retail and health system pharmacies across the country to provide patients with a safe and convenient way to obtain prescription medications and to consult with a pharmacisU4 hours a day/7 days a week, from locations where pharmacy services were not previously available. The Board's proposed Automated Pharmacy System regulations will allow Rhode Island residents to.have that same type of access to pharmacy services, and promote the pharmacist-patient relationship that is so vital to patient care.

MedAvaTI whole heartedly supports for the proposed amendments to regulations for Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors (216-RICR-40-15-1), and specifically supports the newly created Remote Automated Pharmacy System section of the regulations. We have just a few comments and suggested revisions, which we believe will further the Board's intent to improve patient care through the use of pharmacist controlled automated, and will allow Rhode Island patients to .

1) Section 1.2. Definitions

The newly created definition for "automated pharmacy system" de.scribes the technology from the perspective of the automated dispensing unit. The following proposed revision is intended to convey that the system must be tied to a home pharmacy that is responsible for maintenance of transaction information. In addition, we suggest adding "labeling" as a function performed by the automated system. Here is our proposed revision:

A.10. "Automated pharmacy system" means a mechanical system, located within or adjacent to the prescription department, or at a location that is remote from the prescription department location, that performs operations or activities, other than compounding or administration, relative to storage, packaging, dispensing, labeling. or distribution of medication, and which collects, controls, and maintains all transaction information in the home pharmacy's pharmacy operating system.

MedAvail Technologies Inc. l 10275 West Hl,Qgins Road, Suiie 490 ! Rosemo_nt, IL, USA60D18 I www.medavail.com

/V\ed

Similarly, we believe that the definition of "Home. Pharmacy"should be revised to reflect that automated pharmacy systems must be tied to a home pharmacy, As written, the definition addresses only "telepharmacy", and omits reference to Automated Pharmacy Systems. We propose the following revision:

"Home pharmacy" means a pharmacy staffed with a sufficient number of pharmacists as deemed appropriate by the Board to ensure the safe operation and supervision of all remote pharmacies utilized in the practice of telepharrnacv, or the operation of an Automated Pharmacy System,

Z) Section 1.8 Automated Storage and Distribution Devices, Automated Medication Filling Systems and Automated Pharmacy Systems

1.8.3 Use of Automated Pharmacy Systems at Remote Locations

We propose the following revision to clarify that when the home pharmacy may share services with another pharmacy to ensure access to a pharmacist and to pharmacy services. Shared service relationships are presently permitted under Rhode Island pharmacy law. The following proposed revision ensures that the Automated Pharmacy $ystem can be used to its full capabilities to ensLJre access to pharmacist care.

A.l.b. These systems shall have prescription inventory, which-must be secured in an automated pharmacy system and electronically dispensing device connected to and controlled by the home pharmacy. Dispensing and counseling may be performed by the Home Pharmacy, orby a Shared Services Pharmacy owned by or under contract with the Home Pharmacy.

Finally, as presently drafted, Section 1.8.3.A.l.d. appears to require the pharmacist to perform all parts of the dispensing function, Including the transcribing of prescription information into the pharmacy system. We believe that this section should be revised to clarify that technicians are permitted to assist with parts of the dispensing process that are otherwise permitted under Rhode Island law. Here ls our proposed language:

A.l.d, Dispensing and counseling as required by§ 1.5.14 of this part are performed by a pharmscist. An intern or a pharmacy technician may assist in the dispensing process.

MedAvail again thanks the Board for their hard work and foresight in proposing a regulation that will a.dvance pharmacy practice in the state, to the benefit of Rhode Island residents.

Sincerely,

s~~ Director, Pharmacy and Regulatory Affairs MedAvail Technologies, Inc.

MedAvall Technologies Inc. I 10275 West Higgins Road, Suite 490 I Rosemont IL, USA60018 I www.medavail.com



Pullano, Paula (RIDOH) Tuesday, July 17, 2018 9:59 AM Roberts, Sullivan (RIDOH) FW: [EXTERNAL] : Pharmacy Regulations

From: Nancy Tortolani [mailto:[email protected]] Sent: Monday, July 16, 2018 8:51 AM To: Ragosta, Peter (RIDOH) <[email protected]>; Pullano, Paula (RIDOH) <[email protected]> Cc: rip ha [email protected] Subject: [EXTERNAL] : Pharmacy Regulations

Dear Mr. Ragosta,

I am a licensed pharmacist in the State of Rhode Island and have recently reviewed the proposed changes to the Pharmacy Regulations. I am writing to thank the Board of Pharmacy for their obviously significant efforts in drafting these substantive changes.

I also would like to highlight some key areas of concern that I believe may negatively impact the public with respect to medication safety and adversely affect the profession of pharmacy.

My area of concern and requests for changes are with the scope of techs performing pharmacists' dispensing duties, the validity of established tech training program guidelines nationwide, and the oversite of tech-check-tech by a pharmacist available remotely. I feel that these changes need to be vented by the Board of Pharmacy with either approval or not to move forward and concerns whether these proposed changes are moUvated by profit by the pharmaceutical corporations instead of proper pharmaceutical care for the health of our patients need to be addressed. Pharmacists have been the most trusted, respected and accessible health care providers throughout history and to dramatically alter the dispensing practice of pharmaceutical care will result in negative and potentially harmful outcomes. Please consider the following:

• Please consider adding "mandatory live verbal counseling (in person or via approved AN equipment) for all new medication prescribed to an existing patient and any medications where the dose, strength, route of administration, or directions for use has changed" to sections 1.1.5.14.A, 1.8.3.d, 1.1.8.3.2.b(1 ), 1.1.8.3.2.b(2) and 1.1.11.B.5.


• Please consider clarifying/ensuring that technicians are not able to prepare or determine patient eligibility for vaccines in section 1.1.12.1.8.


• Please consider retaining the requirement for technicians to "complete at least three (3) hours (0.3 continuing education units) of the required ten (10) hours of continuing education as live hours" in section 1.1.13.1.J.1.

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Sincerely,

Nancy J. Tortolani, RPH 2768

Nancy J. Tortolani, R.Ph. Adjunct Clinical Assistant Professor and Coordinator, Pharmacy Outreach Program The University of Rhode Island College of Pharmacy 401-874-2272 [email protected]

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Pullano, Paula (RIDOH) Tuesday, July 17, 2018 9:48 AM Roberts, Sullivan (RIDOH)

FW: [EXTERNAL] : Public comments on the proposed regulation changes

From: Zuwallack, Alicia [mailto:[email protected]] Sent: Saturday, July 14, 2018 4:59 PM

To: Ragosta, Peter (RIDOH) <[email protected]>; Pullano, Paula (RIDOH) <[email protected]> Subject: [EXTERNAL] : Public comments on the proposed regulation changes

Dear Mr. Ragosta and Ms. Pullano,

Thank you for the opportunity to see the proposed regulation changes and to give comment. Overall, I think the revisions are very positive and very well done.

I wanted to express my thoughts on a few things:

I share the concern with other pharmacists that 1.1.3.14 should either be removed or clarified. I am not sure what the original intent was for this statement, but I am concerned that it could hinder a pharmacist's ability to speak candidly and for the best interest of the patient.

I would like to see the regs more strongly support of the role of counseling- verbal- and ideally face to face- for new prescriptions and therapy changes. We are a small state with great access to pharmacists. Working in an Emergency Room practice setting, I see many patients presenting with drug induced problems. Adding in words like "in writing" as a form of counseling, and allowing patients to decline counseling at a dispensing kiosk, are a step backwards. We should not be going in this direction, especially in a state with a lot of~lderly people on polypharmacy, with great pharmacy saturation. I would like to see mandatory live counseling on new prescriptions, and chronic refills only at a kiosk or remote site.

I am happy to see the new verbiage allowing technician verification. This is especially important in-a hospital where we have a lot of safety technology and innovation, and where it allows both the clinical pharmacists and the technicians to practice at the "top of the license". I applaud this, but I am concerned about how this might be implemented in a retail setting, where the pharmacist-to-tech ratios are not as small as in the hospital. I would urge the Board to install safeguards so this does not hinder patient access to pharmacists, but rather enhances it.

I imagine a ton of time and volunteer work went into this much-needed revision, and I congratulate all involved. Thanks again for the opportunity to weigh in.

Best regards,

Alicia ZuWallack, Pharm.D., BCPS Past President, RISHP (2016) Emergency Pharmacist Kent Hospital 455 Toll Gate Rd. Warwick, RI 02886 (401) 737-7000 ext. 3-1341

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Pullano, Paula (RIDOH) Monday, July 09, 2018 4:01 PM Roberts, Sullivan (RIDOH) FW: [EXTERNAL] : Testimony on the Proposed Pharmacy Regulations

From: Anita Jacobson [mailto:[email protected]] Sent: Monday, July 9, 2018 3:46 PM To: Ragosta, Peter (RIDOH) <[email protected]>; Campbell, Scott (RIDOH) <[email protected]>; Pullano, Paula (RIDOH) <[email protected]> Subject: [EXTERNAL] : Testimony on the Proposed Pharmacy Regulations

Tl ,a, ,k you -f.o1 ti ,e opp0rtu1 ,ity to:submit 11 ,.y testi,, ,or-i-y regar-dil ,g-tl 1e:p1 oposed-P-1 ,ai 1 ,-,acy-Regu recently drafted by the Board of Pharmacy. I appreciate the work that went into to creating the Regulations and see many opportunities within the proposal to advance the profession of pharmacy and positively impact patient care in RI.

I do have some areas of concern and suggestions regarding the proposed Regulations. I believe it is critical for the Department of Health to consider the potential impact on public safety of removing the pharmacist as the most accessible health care professional in the patient care team.

Unintended consequences of having sites where medications could be dispensed with no pharmacist on duty (or a pharmacist who is understaffed to oversee the large number of pharmacy technicians working under them) may include: increases in urgent care and ER visits due to pharmacist inaccessibility for conditions that could be managed with OTC medications, serious patient harm from incorrectly diagnosing and self-treating conditions that require urgent medical care, increased medication non-adherence from patients experiencing adverse drug events who were not specifically warned and educated on how to manage ADEs if they occur, and suboptimal treatment outcomes from patients incorrectly administering medications to themselves or their family members.

1. Please consider removing Section 1.1.3.14 A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not publish or circulate false, misleading, or otherwise deceptive statements concerning the practice of pharmacy.

• This section leaves open the possibility for censorship of the opinions and concerns of pharmacists regarding the profession of pharmacy and is in direct opposition to first amendment rights. Who would decide what is false or misleading? This is a slippery slope to expanding "gag clauses" that already exist in pharmacy benefit manager contracts and is not in the best interest of the public.

2. Please consider removing "in writing" from Section 1.1.5.14 After receipt of a new prescription and following a review of the patient's record, a pharmacist or pharmacy intern, as defined in the Act; shall initiate discussion of matters which will enhance or optimize drug therapy with each patient or care giver of such patient. Such discussion shall be in person whenever practicable, by telephone, in writing or electronic means, and shall include appropriate elements of patient counseling, as is appropriate for the patient in the professional judgment of the pharmacist. The offer to counsel may be delegated by the pharmacist. Nothing in this section will prohibit a pharmacist from counseling a patient on a refill prescription when deemed necessary in the professional judgment of the pharmacist.

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• The phrase "in writing" leaves open the possibility for the pamphlet or handout of printed information that accompanies a prescription when dispensed to qualify as "patient counseling". These handouts are not patient specific and include an overwhelming amount of information that cannot be interpreted and applied by a patient who does not have advanced medical training.

3. Please consider strengthening Section 1.1.5.14 to include a requirement for in-person patient counseling on all new prescriptions or prescriptions with significant modifications.

• Consider language that ensures patient counseling occurs to enhance the publics' awareness of potential adverse drug reactions and other medication-related problems. "Live verbal counseling with a patient and/or care giver must be provided by a pharmacist or pharmacy intern for all new medication prescribed to a new or existing patient and any medications where the dose, strength, route of administration, or directions for use has changed. An offer to counsel may be made by the pharmacist or a delegate for refills of a previously filled medication (within last 12 months) or for new patients who have transferred active prescriptions from another pharmacy"

• What is currently happening with the "offer to counsel" in the community pharmacy setting is not worliiog_ Patients do not realize that they-ara-mi.s~i:119::imP.Qfia•t information abo__yt their me_gications or that they heard/recall information incorrectly from their provider at the time of prescribing. Pharmacist directed patient counseling is the only mechanism of protection to catch cognitive errors and ensure patients have the knowledge that they need to take their medications correctly and safely, or to administer them safely to their loved ones.

4. Please consider modifying sections 1.1.8.3 and 1.1.8.3.2 and 1.1.11.B to ensure that only refills of chronic medications are available at remote dispensing sites, remote automated pharmacy systems (RAPS) and kiosks.

• It is potentially unsafe and inappropriate for patients to fill prescriptions for brand new medications {e.g. antibiotics, inhalers. anticoagulants, hypoglycemics, analgesics, cardiovascular agents, etc) at a site with no pharmacist on duty. Rhode Island is a small state, there is no geographic need for telepharmacy or remote dispensing sites, unlike the large rural states in the western US. States that have implemented these programs have done so to respond to urgent pharmacist care shortages and to address the needs of people who may have to drive 2 or more hours to the closest pharmacy. No location in the State of RI is more than 10-15 minutes from a pharmacy, so the need to provide this lower level of urgent automated pharmacy care does not exist in

our state.

5. Please consider strengthening section 1.1.13.1.L to ensure adequate staffing ratios of pharmacists to technicians.

• The main reason cited in verbal testimony by CVS Health for having a verification technician program in RI is to allow pharmacists to practice at the top of their license. Unfortunately many of the services provided by pharmacists to the public such as patient counseling, medication therapy management, self care therapy selection, and triaging of conditions are either provided at no cost to the patient/insurer or at a low rate of reimbursement for the amount of time allocated. Without protections in place to ensure that the pharmacist would not have to oversee a large number of product verification technicians it is unlikely that pharmacies would be staffed for pharmacists to truly be untethered to provide these cognitive services and practice at the

top of their license. • Please consider adding: Each pharmacy utilizing a verification technician program must staff pharmacists to

verification technicians in no more than a 1:2 ratio during all times the pharmacy is open to the public

I am pleased to see that the proposed regulations allow for pharmacists to potentially enhance services currently offered and expand into new areas that would greatly benefit public health. I hope that the Board of Pharmacy and Department of Health will consider including these safeguards to protect the pharmacist-patient relationship and ensure

continued access to personalized medication information and recommendations.

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I

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Thank you and please do not hesitate to contact me for additional input or clarification.

Anita N. Jacobson, Pharm.D. Rhode Island RPh License number 4030

401-640-7933

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Pullano, Paula (RIDOH) Wednesday, July 11, 2018 9:45 AM Roberts, Sullivan (RIDOH) FW: [EXTERNAL] : Proposed changes to pharmacy regulations in Rhode Island

From: Michelle Caetano [mai1to:[email protected]]

Sent: Tuesday, July 10, 2018 11:18 PM To: Pullano, Paula (RIDOH) <[email protected]> Subject: [EXTERNAL) : Proposed changes to pharmacy regulations in Rhode Island

Dear Board of Pharmacy,

I am writing as an individual pharmacist licensed in the State of Rhode Island to express my grave concern regarding the proposed amendments to the rules and regulations for Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors (216-RICR-40-15-1) proposed on June 15th , 2018.

As written, these regulations jeopardize public safety. In allowing technicians to verify prescriptions, clarify prescription orders with prescribers, and transfer prescriptions from one pharmacy to another without direct pharmacist supervision, and without a corresponding requirement to limit the number of technicians or sites that can operate under a single pharmacist, or a requirement for pharmacists to provide patient counseling in-person for all new or significantly changed prescriptions - these regulations will allow chain drug stores to operate remote sites without a pharmacist present and decrease patient interaction with pharmacists.

I vehemently do not support the proposed regulations as currently written. I implore the Board to make the following changes in order to protect the public interest:

1. Please consider removing Section 1.1.3.14 • A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not publish or circulate false, misleading, or otherwise deceptive statements concerning the practice of pharmacy • Who is determining what is misleading or deceptive here? This opens the door for censorship of opinions and concerns of pharmacists regarding the practice of pharmacy and is in in direct opposition to the first amendment right to freedom of speech.

2. Please consider removing "in writing" from Section 1.1.5.14 • After receipt of a new prescription and following a review of the patient's record, a pharmacist or pharmacy intern, as defined in the Act, shall initiate discussion of matters which will enhance or optimize drug therapy with each patient or care giver of such patient. Such discussion shall be in person whenever practicable, by telephone, in writing or electronic means, and shall include appropriate elements of patient counseling, as is appropriate for the patient in the professional judgment of the pharmacist. • This would make it possible for the information leaflets that accompany prescriptions to count as patient counseling. These contain general information that is not patient-specific, and is often difficult for patients to understand and apply.

3. Please consider strengthening Section 1.1.5.14 to include a requirement for pharmacists to provide inperson patient counseling on all new prescriptions or prescriptions with significant modifications.

• Although patients will still get an opportunity to ask a pharmacist questions via remote audio/visual link, the vast majority of patients don't even know what questions they should ask, and generally don't initiate discussion with the pharmacist despite the offer to counsel. Requiring a pharmacist on site to counsel enhances patient safety by proactively providing patient counseling, even when not expressly requested by the patient.

4. Please consider modifying sections 1.1.8.3 and 1. 1.8.3.2 and 1.1.11.B to ensure that only refills of chronic medications are available at remote dispensing sites, remote automated pharmacy systems (RAPS) and kiosks.

1

• Although this may be convenient for refills, it is potentially dangerous to allow patients to acquire new prescriptions from a site with no pharmacist on duty. See point above.

5. Please consider strengthening section 1.1 .13.1.L to ensure safe staffing ratios of pharmacists to technicians.

• As written, the current regulations do not have any cap on the amount of technicians a pharmacist could safely supervise. There could be a handful of pharmacists in one location completing drugutilization review over an unlimited number of technicians or remote sites. This will only increase the high volumes of prescriptions that pharmacists will be expected to check, while potentially never interacting with the patient, technician, or drugs dispensed. Drug chains have every incentive to maximize the number of technicians and minimize the number of pharmacists despite the potential to jeopardize patient safety with ever-increasing workloads on individual pharmacists.

A representative from CVS who spoke at the public hearing yesterday cited the reason to allow technicians to check the work of other technicians is to free up pharmacists to engage in functions such as patient counseling, medication therapy management, self-care therapy selection, and triaging of acute medical concerns, (or, as it is often stated, to "work at the top of our license").

Unfortunately, nothing could be further from the truth. While CVS pays lip service to improved patient access to pharmacists, without the proper protections in place, these regulations will actually allow chain pharmacies to completely . . .

Most of these "cognitive" services provided by pharmacist are provided at no cost to the patient or insurer. Even in the rare instance that billing mechanisms exist, reimbursement rates are too low to make these activities generate enough revenue to pay a pharmacist. There is no fiscal incentive for a pharmacy chain to pay the salary of a pharmacist to provide high-quality patient care when it is separated from the dispensing of prescriptions. Without protections in place to ensure that the pharmacist would not have to oversee a large number of product verification technicians it is highly unlikely that pharmacies would be staffed for pharmacists to truly be untethered to provide these cognitive services and practice at the top of their license.

It is far more likely that there will be a bank of pharmacists operating in a distant central location to do the drug interaction check and prospective drug-utilization review via computer for multiple pharmacies at a time, with technicians inputting the prescription, preparing the prescription, and doing the final product verification at a "remote site". Most pharmacies that currently exist will become "remote sites" staffed only by pharmacy technicians, with a pharmacist available to answer patient questions by video/audio link. Chain pharmacies have every financial incentive to lower personnel costs by replacing 1 pharmacist with 3-4 technicians.

Without a pharmacist present in the pharmacy - patients will find it much more difficult to find a highly trained medical professional to ask a quick question about which over the counter item they should select, and if they do take the initiative to contact the remote pharmacist - the pharmacist will no longer be able to walk them to the aisle to review the treatment options available, or place the correct product in the patient's hands. While they could show a rash to a remote pharmacist, the nuances of physical assessment are lost in remote viewing (is it raised? is it warmer than the surrounding area? Does it blanche under pressure? is there pitting edema present?) When picking up a new prescription for the first time, although they will still get an opportunity to ask a pharmacist questions, the vast majority of patients don't even know what questions they should ask, and generally don't initiate discussion with the pharmacist.

If these regulations included language that required a pharmacist to conduct in-person counseling for new or significantly changed prescriptions or proposed a safe ratio of one pharmacist for every 2-3 technicians then perhaps I could believe CVS when they state they want to enhance patient care. However, as currently written these regulations are much more likely to allow for the removal of the pharmacist from the community pharmacy, increase the chance of medication errors, increase the risk of narcotic diversion by pharmacy staff, and increase the cost of health care for society.

Lastly, I request that all registered pharmacists in the state are notified of the proposed changes and the potential impact of these changes, and that the comment period be extended to allow all pharmacists in RI the time to consider and comment on these changes.

Respectfully Submitted,

Michelle L. Caetano, Pharm.D., BCACP, CDOE, CVDOE 2

3


From: Pullano, Paula (RIDOH)

Sent: Thursday, July 12, 2018 10:23 AM Roberts, Sullivan (RIDOH) To:

Subject: FW: [EXTERNAL] : Re: proposed changes to the Pharmacy Regulations

• =c··--.--; .-•~•--=---•--••••"'"' .,---

From: Kenny Correia [mailto:[email protected]]

Sent: Thursday, Ju ly 12, 2018 10:23 AM To: Ragosta, Peter (RIDOH) <[email protected]>; Pullano, Paula (RIDOH) <[email protected]>;

AlexanderScott, Nicole (RIDOH) <[email protected]>

Subject [Df FER-NA-~ O:Sed changes to the Pharmat y 8egulat iQRs

Dear Dr Alexander-Scott and Mr. Ragosta,

I am a licensed pharmacist in the State of Rhode Island and have recently reviewed the proposed changes to the Pharmacy Regu lations. I am writing to thank the Board of Pharmacy for their obviously significant efforts in drafting these substant ive changes. I also would like to highlight some key areas of concern that I believe may negatively impact the public wit h respect to medication safety and adversely affect the profession of pharmacy.

My area(s) of concern and request(s) for change(s) include:

• These regufations would allow for technician-check··technician prog rams without the safeguard of pharmacist staffing ratios, and could allow pre-printed handouts to count as patient counseling at remote dispensing sites/kiosks.

• The possibility of removing pharmacists as the most accessible healthcare professional and allowing for "technician only" or even "automat ic dispensing machines only" pharmacies could have a negative impact on the practice of pharmacy and represents a significant potential risk to public health.

• I ask that the Department of Health and the Board of Pharmacy consider modification to these Regulations to help protect and expand requirements regarding patient access to pharmacists; including expanding access to interactive pharmacist counseling and pharmacist provided cl inical services.

• Please consider adding "mandatory live verbal counseling (in person or via approved A/V equipment) for al l new medication prescribed to an existing patient and any medicat ions wh.ere the dose, strength, route of administration, or directions for use has changed" to sections 1.1.5.14.A, 1.8.3.d, 1.1.8.3.2.b(l), 1.1.8.3.2.b(2) and 1.1.11.B.5.

• Please consider returning to the orig inal language in section 1.1 .5.23 "Verification by a pharmacist of a fi lled prescription must include verificat ion of the prescription label and product against the original or scanned prescription" instead of limiting to a first refi ll only .

• Please consider removing the addition of " in writing" from 1.1. 5. 14.A related to acceptable forms of patient counseling.

• Please consider ensuring that pharmacy technician product verification cannot be performed when the electron ic verification system (e.g . bar code scanning) is unavailable or overridden for part or all of the dispensing process.

1

• Please consider limiting automated "RAPS" devices as outlined in 1.1.8.3 with controlled substances dispensing to nursing facilities, medical institutions, assisted living, rehabilitation, hospitals, hospice care or correctional facilities.




• Please consider retaining the requ irement for technicians to "complete at least three (3) hours (0.3 continuing education units) of the required ten (10) hours of continuing education as live hours" in section 1.1.13.1.J.1.

• Please consider removing 1.1.3.14 from the proposed Regulations in its entirety "A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not publish or circulate false, misleading, or otherwise deceptive statements concerning the practice of

ff

• Please consider adding "All modifications of pharmacist license renewal fees shall be reviewed and approved by the Board of Pharmacy prior to initiation." to 1.1.4.16.B.

• Please consider adding language to ensure that each pharmacy utilizing a verification technician program must staff pharmacists to verification technicians in no more than a l:2 ratio during all times the pharmacy is open to the publ ic.

Th-ank you for your diligence in this process of revising t he Pharmacy Regulations and for your consideration of including additional safeguards to ensure public safety, access to appropriate patient counseling, and continuation of entrusted professional activities by pharmacists in Rhode Island.

Sincerely,

Kenny Correia, PharmD, BCACP, CDOE, CVDOE Board Certified Ambulatory Care Pharmacist

2


From: Pullano, Paula (RIDOH) Thursday, July 12, 2018 4:55 PM Roberts, Sullivan (RIDOH)

Sent: To: Subject: FW: [EXTERNAL] : Proposed Regulation Changes

From: Ginger Lemay [mailto:[email protected]) Sent: Thursday, July 12, 2018 4:54 PM To: Ragosta, Peter (RIDOH) <[email protected]> Cc: Rhode Island Pharmacists <[email protected]>; Pullano, Paula (RIDOH) <[email protected]> Subject: [EXTERNAL] : Proposed Regulation Changes

Dear Peter,

I am sending along this template letter in support of the re-evaluation of the proposed regulation changes. I strongly support of all of the items listed below. I have worked in a community pharmacy since 1991, as a technician, intern, and licensed pharmacist. Of the many hats I wear, working as a community pharmacist is by far the most challenging, and rewarding. The proposed changes in the regulations would, in my opinion, make my role as a community pharmacist even more challenging, with less reward. I respectfully request these regulations be reconsidered as outlined below.

Dear Mr. Ragosta,

I am a licensed pharmacist in t he State of Rhode Island and have recently reviewed the proposed changes to the Pharmacy Regulat ions. I am writing to t hank t he Board of Pharmacy for their obvious ly significant efforts in drafting these substant ive changes.

I also would like t o highlight some key areas of concern that I believe may negatively impact the public wit h respect to medication safet y and adversely affect t he profession of pharmacy.

My area(s) of concern and request (s) for change(s) include:

• Please consider removing 1.1.3.14 from the proposed Regulations in its entirety "A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not publish or circulate false, misleading, or otherwise deceptive statements concerning the practice of pharmacy".

• Please consider adding "All modifications of pharmacist license renewal fees shall be reviewed and approved by the Board of Pharmacy p_r.ior to initiation." to 1.1.4.16.B.

• Please consider removing the addition of " in writing" from 1.1.5.14.A related to acceptable forms of patient counseling.

1

• Please consider adding "mandatory live verbal counseling (in person or via approved A/V equipment) for all new medication prescribed to an existing patient and any medications where the dose, strength, route of administration, or directions for use has changed" to sections 1.1.5.14.A, 1.8.3.d, 1.1.8.3.2.b(l), l.l.8.3.2.b(2)

and 1.1.11.B.5.


• Please consider limiting automated "RAPS" devices as outlined in 1.1.8.3 with controlled substances dispensing to nursing facilities, medical institutions, assisted living, rehabilitation, hospitals, hospice care or correctional

facilities.




• Please consider retaining the requirement for technicians to "complete at least three (3) hours (0.3 continuing education units) of the required ten (10) hours of continuing education as live hours" in section 1.1.13.1.J.l.


• Please consider adding language to ensure that each pharmacy utilizing a verification technician program must staff pharmacists to verification technicians in no more than a 1:2 ratio during all times the pharmacy is open to

the public.

Thank you for your diligence in this process of revising the Pharmacy Regulations and for your consideration of including additional safeguards to ensure public safety, access to appropriate patient counseling, and continuation of entrusted

professional activities by pharmacists in Rhode Island.

2

Sincerely,

Ginger Lemay RPh license #04194

Ginger Lemay, PharrnD, CDOE, CVDOE Clinical Associate Professor PGYl Community Residency Program Director University of Rhode Island College of Pharmacy

and

Rite Aid Community Pharmacist MTM Specialist, Certified Immunizer, Diabetes Educator

http://web.uri.edu/pharmacy/2016/10/20/the-university-of-rhode-island-rite-aid-pharmacy-pgy1-community

residency/ (web.uri.eduj

3

July 13, 2018

Peter Ragosta, RPh Department of Health

Dear Mr. Ragosta,

As you know, I am a licensed pharmacist in the State of Rhode Island and a former community pharmacist. I have recently reviewed the proposed changes to the Pharmacy Regulations and while I appreciate the efforts to make substantial changes, there is language that appears to be detrimental to the profession.

I also would like to highlight some key areas of concern that I believe may negatively =irn13aet the-public witt-1 r-espect te rnedicaHen=safety-and acfveisely- affect l:l1e=pwfess-im-1 of pharmacy.


• Please consider removing the addition of "in writing" from 1.1.5.14.A related to acceptable forms of patient counseling.

In my opinion, written counseling should NEVER replace any type of verbal communication by a pharmacist. You cannot tell me that the majority of our patients fully grasp those overwhelming patient information sheets that are supplements to any prescription. These use language that many of our patients do not understand nor do they prioritize the most important information. Also, what if a patient has a question As they often do when they review this type of material. This will have an extreme detrimental effect on patient care and the appropriate use of medications.


Limiting prescription verification to the first refill does not consider that patient health changes and new medications (by prescription and over-the-counter) are begun. Pharmacist review is essential to catch changes in health status over time. While computerized warning systems catch a lot of things (including relatively unimportant things), they are not a catchall and can fail.


• Please consider clarifying/ensuring that technicians are not able to prepare or determine patient eligibility for vaccines in section 1.1 .12.1 .8.

I

I

Simply stated, technicians are not trained in patient assessment nor detailed pathophysiology of vaccine-preventable diseases and should not be allowed to determine who is eligible for a vaccination.

• Please consider removing technician ability to perform limited-function laboratory tests in section 1.1.12.2.8.2.

Same as above - technicians are not trained in the assessment of laboratory data.



While I see the benefit of tech vs. tech verification in a health-system setting, I oppose any removal of a pharmacist from any licensed pharmacy period. This again is a patient safety issue and it goes against one of our greatest strengths which is being the most accessible healthcare provider. While financially I understand the reasoning of this from a large corporation, however it is not in the best interest of the public nor the profession of pharmacy. It is against everything the profession has stood for to see a pharmacist in some remote office by themselves with no patient interaction. This would be the death of our profession.


Sincerely,

Brett Feret, PharmD (#4029)



Pullano, Paula (RIDOH) Friday, July 13, 2018 9:46 AM Roberts, Sullivan (RIDOH) FW: [EXTERNAL] : Pharm Reg changes

,;sw•,•..-·.-,- _,_.....,...,.,,.-., -~··---- · . ~-·· ·· ,_.. ____ __..,.,, . ,.._. .. ,.,,.,..,.. __ -·• ·~· _._,_., .. ...,. ..

From: 1980Jennifer Alam [mailto:[email protected]]

Sent: Thursday, July 12, 2018 9:07 PM To: Pullano, Paula (RIDOH) <[email protected]>; Ragosta, Peter (RIDOH) <[email protected]>

Cc: [email protected] Subject: [EXTERNAL] : Pharm Reg changes

Dear Mr. Ragosta,

I am a licensed Family Nurse Practitioner in the State of Rhode Island and have recently reviewed the proposed changes to the Pharmacy Regulations. I am writing to thank the Board of Pharmacy for their obviously significant efforts in

drafting these substantive changes.

I also would like to highlight some key areas of concern that I believe may negatively impact the public with respect to

medication safety and adversely affect the profession of pharmacy.


• Please consider removing 1.1.3.14 from the proposed Regulations in its entirety "A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not publish or circulate false, misleading, or otherwise deceptive statements concerning the practice of pharmacy".

• Please consider adding "All modifications of pharmacist license renewal fees shall be reviewed and approved

by the Board of Pharmacy prior to initiation." to 1.1.4.16.B.

• Please consider removing the addition of "in writing" from 1.1.5.14.A related to acceptable forms of patient

counseling.

• Please consider adding "mandatory live verbal counseling (in person or via approved A/V equipment) for all new medication prescribed to an existing patient and any medications where the dose, strength, route of administration, or directions for use has changed" to sections 1.1.5.14.A, 1.8.3.d, 1.1.8.3.2.b(l), 1.1.8.3.2.b(2)

and 1.1.11.B.5.

• Please consider returning to the original language in section 1.1.5.23 "Verification by a pharmacist of a filled prescription must include verification of the prescription label and product against the original or scanned

prescription" instead of limiting to a first refill only.

• Please consier limiting automated "RAPS'' devices as outlined in 1.1.8.3 with controlled substances dispensing to nursing facilities, medical institutions, assisted living, rehabilitation, hospitals, hospice care or correctional

facilities.


• Please consider clarifying/ensuring that technicians are not able to prepare or determine patient eligibility for

vaccines in section 1.1.12.1.8.


• Please consider retaining the requirement for technicians to "complete at least three (3) hours (0.3 continuing education units) of the required ten (10) hours of continuing education as live hours" in section 1.1.13.1.J.1.

• Please consider ensuring that pharmacy technician product verification cannot be performed when the electronic verification system (e.g. bar code scanning) is unavailable or overridden for part or all of the

dispensing process.

• Please consider adding language to ensure that each pharmacy utilizing a verification technician program must staff pharmacists to verification technicians in no more than a 1:2 ratio during all times the pharmacy is open to

the public.

Thank you for your diligence in this process of revising the Pharmacy Regulations and for your consideration of including

additional safeguards to ensure public safety, access to appropriate patient counseling, and continuation of entrusted

Sincerely, Jennifer Hopgood, FNP-BC

2


From: Pullano, Paula (RIDOH)

Friday, July 13, 2018 2:08 PM Roberts, Sullivan (RIDOH)

FW: [EXTERNAL) : Concerns

Sent: To: Subject:

------·- -·-·. From: Jill Makowski [mailto:[email protected]]

Sent: Friday, July 13, 2018 1:04 PM To: Pullano, Paula (RIDOH) <[email protected]>; Ragosta, Peter (RIDOH) <[email protected]>

Cc: [email protected] Subject: [EXTERNAL] : Concerns

To: [email protected] and [email protected]

Dear Mr. Ragosta and Ms. Pullano,

l am a licensed phammcist in the State of Rhode Island and have recently reviewed the proposed changes to the Pharmacy Regulations. I am writing to thank the Board of Phannacy for their obviously significant efforts in drafting these substantive changes.

I a lso would like to highlight some key areas of concern that I believe may negatively impact the public \Vith respect to medication safety and adversely affect the profession of phannacy.


• Please consider removing 1.1.3.14 from the proposed Regulations in its entirety "A phannacist-incharge, registered pharmacist, pharmacy, or anyone acting on behalf of a pham1acy or pharmacy department shall not publish or circulate false, misleading, or otherwise deceptive statements concerning the practice of pham1acy".

• Please consider adding "All modifications of pharmacist license renewal fees shall be reviewed and approved by the Board of Phannacy prior to initiation." to 1.1 .4.16.B.

• Please consider removing the addition of "in vvriti.ng" from 1.1.5.14.A related to acceptable forms of patient cow1seling.

1

• Please consider adding ··mandatory live verbal counseling (in person or via approved A/V equipment) for all ne,v medication prescribed to an existing patient and any medications where the dose, strength, route of administration, or directions for use has changed·' to sections l .1.5.14.A, 1.8.3.d, l.1.8.3.2.b(l). 1.l.8.3.2.b(2) and 1.1.1 l.B.5.

• Please consider returning to the original language in section 1. 1.5.23 "Verification by a pharmacist of a filled prescription must include verification of the prescription label and product against the original or scanned prescription" instead of limiting to a first refill only.

• Please consider 1i.rniting automated "RAPS" devices as outlined in 1. 1.8.3 ·with controlled substances dispensing to nursing facilities, medical institutions, assisted living, rehabilitation, hospitals, hospice

• Please consider ensuring that phannacists have oversight of implementation and maintenance of the autom.ated storage and distribution systems described in section 1.1.8.3.

• Please consider clarifying/ensuring that technicians are not able to prepare or detemune patient eligibility for vaccines in section l .1.12.1 .8.


• Please consider retaining the requirement for technicians to "complete at least three (3) hours (0.3 continuing education ttnits) of the required ten (l 0) hours of continuing education as live hours'' in section 1. 1.13. l .J .1.

• Please consider ensuring that phmmacy technician product verification cannot be perfonnecl ,vhen the electronic verification system ( e.g. bar code scmming) is unavailable or overridden for part or all of the dispensing process.

2



Sincerely,

Jill Makuwski R I Lie # 044 70

Jm L Ma"Rowslc1,RPh Clinical Pharmacy Specialist - Infectious Disease Antimicrobial Stewardship St Luke's Hospital and Tobey Hospitals 101 Page Street, New Bedford, MA 02740 Pager #11944 Extension #37506 [email protected]

CONFIDENTIALITY NOTICE: This email (including any attachments) may contain confidential, privileged or otherwise protected information. It is intended for a particular recipient. If you are not the intended recipient, please immediately notify the sender by reply email, delete this email and destroy any copies of the email and its attachments. Any unauthorized use or disclosure of this email and its attachments is strictly prohibited. The recipient has full responsibility for protecting its systems from viruses and other breaches of the system's integrity and Southcoast accepts no liability

for any damage caused by any virus transmitted by this email or its attachments.

3


From: Sent: To:

Pullano, Paula (RIDOH) Friday, July 13, 2018 3:56 PM Roberts, Sullivan (RIDOH)

Subject: FW: [EXTERNAL] : New regulations

From: Diana Mercurio [mailto:[email protected]]

Sent: Friday, July 13, 2018 3:55 PM To: Ragosta, Peter (RIDOH) <[email protected]>; Pullano, Paula (RIDOH) <[email protected]>

Subject: [EXTERNAL] : New regulations

Dear:Mc. ::Rag

I am a licensed pharmacist in the State of Rhode Island and have recently reviewed the proposed changes to the Pharmacy Regulations. I am writing to thank the Board of Pharmacy for their obviously significant efforts in drafting

these substantive changes.

I also would like to highlight some key areas of concern that I believe may negatively impact the public with respect to

medication safety and adversely affect the profession of pharmacy.


* Please consider removing 1.1.3.14 from the proposed Regulations in its entirety "A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not publish or circulate false, misleading, or otherwise deceptive statements concerning the practice of pharmacy".

* Please consider adding "All modifications of pharmacist license renewal fees shall be reviewed and approved by

the Board of Pharmacy prior to initiation." to 1.1.4.16.8.

* Please consider removing the addition of "in writing" from 1.1.5.14.A related to acceptable forms of patient

counseling.

* Please consider adding "mandatory live verbal counseling (in person or via approved A/V equipment) for all new medication prescribed to an existing patient and any medications where the dose, strength, route of administration, or directions for use has changed" to sections 1.1.5.14.A, 1.8.3.d, 1.1.8.3.2.b(l), l.l.8.3.2.b(2) and 1.1.11.B.S.

* Please consider returning to the original language in section 1.1.5.23 "Verification by a pharmacist of a filled prescription must include verification of the prescription label and product against the original or scanned prescription"

instead of limiting to a first refill only.

* Please consider limiting automated "RAPS" devices as outlined in 1.1.8.3 with control led substances dispensing to nursing facilities, medical institutions, assisted living, rehabilitation, hospitals, hospice care or correctional facilit ies.

1

* Please consider ensuring that pharmacists have oversight of implementation and maintenance of the automated storage and distribution systems described in section 1.1.8.3.

* Please consider clarifying/ensuring that technicians are not able to prepare or determine patient eligibility for

vaccines in section 1.1.12.1.8.

* Please consider retaining the requirement for technicians to "complete at least three (3) hours (0.3 continuing education units) of the required ten (10) hours of continuing education as live hours" in section 1.1.13.1.J.1.

* Please consider ensuring that pharmacy technician product verification cannot be performed when the electronic verification system (e.g. bar code scanning) is unavailable or overridden for part or all of the dispensing

rocess.

* Please consider adding language to ensure that each pharmacy utilizing a verification technician program must staff pharmacists to verification technicians in no more than a 1:2 ratio during all times the pharmacy is open to the

public.


Sincerely,

Diana G. Mercurio RPH license# 2292

2



Pullano, Paula (RIDOH) Friday, July 13, 2018 9:49 AM Roberts, Sullivan (RIDOH) FW: [EXTERNAL] : concerns about the currently proposed pharmacy regulations

From: Norma Owens [mailto:[email protected]] Sent: Friday, July 13, 2018 9:21 AM To: Ragosta, Peter (RIDOH) <[email protected]> Cc: Pullano, Paula (RIDOH) <[email protected]> Subject: [EXTERNAL] : concerns about the currently proposed pharmacy regulations

Dear Mr. Ragosta,

I am a licensed pharmacist in the State of Rhode Island and the Associate Dean in the College of Pharmacy. I have reviewed the proposed changes to the Pharmacy Regulations and have several areas of concern that I believe may negatively impact the public with respect to medication safety.

I've listed my areas of concern and requests for changes below:

• Please remove 1.1.3.14 from the proposed Regulations in its entirety "A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not publish or circulate false, misleading, or otherwise deceptive statements concerning the practice of pharmacy".

• Please consider adding "mandatory live verbal counseling (in person or via approved NV equipment) for all new medication prescribed to an existing patient and any medications where the dose, strength, route of administration, or directions for use has changed" to sections 1.1 .5.14.A, 1.8.3.d, 1.1.8.3.2.b(1), 1.1.8.3.2.b(2) and 1.1.11 .8.5.


• Please limit automated "RAPS" devices as outlined in 1.1.8.3 with controlled substances dispensing to nursing facilities, medical institutions, assisted living, rehabilitation, hospitals, hospice care or correctional facilities.

• Please ensure that pharmacists have oversight of implementation and maintenance of the automated storage and distribution systems described in section 1.1.8.3.

• Please ensure that technicians are not able to prepare or determine patient eligibility for vaccines in section 1.1.12.1.8.

• Please remove technician ability to perform limited-function laboratory tests in section 1.1 .12.2.B.2.

• Please retain the requirement for technicians to "complete at least three (3) hours (0.3 continuing education units) of the required ten (10) hours of continuing education as live hours" in section 1.1.1 3.1.J.1.

• Please ensure that pharmacy technician product verification cannot be performed when the electronic verification system (e.g. bar code scanning) is unavailable or overridden for part or all of the dispensing process.

1

• Please add language to ensure that each pharmacy utilizing a verification technician program must staff pharmacists to verification technicians in no more than a 1 :2 ratio during all times the pharmacy is open to the public.


Sincerely,

Norma J. Owens, license #2930

Norma J. Owens, PharmD, FCCP

Professor of Pharmacy Associate Dean of Student and Academic Affairs College of Pharmacy University of Rhode Island

2


From: Sent: To:

Pullano, Paula (RIDOH) Friday, July 13, 2018 4:20 PM Roberts, Sullivan (RIDOH)

Subject: FW: [EXTERNAL] : Proposed Pharmacy Regulations

From: Poirier, M ichael [mailto:[email protected]]

Sent: Friday, July 13, 2018 4:19 PM To: Ragosta, Peter (RIDOH) <[email protected]>; Pullano, Paula (RIDOH) <[email protected]> Cc: [email protected]

Subject: [EXTERNAL] : Proposed Pharmacy Regulations

Dear Mr. Ragosta,

I have recently reviewed the proposed changes to the Pharmacy Regulations. I am writing to thank the Board of Pharmacy for their obviously significant efforts in drafting these substantive changes.

I also would like to highlight some key areas of concern that I believe may negatively impact the public with respect to medication safety and adversely affect the profession of pharmacy.

My areas of concern and requests for changes include:

• Please consider removing 1.1.3.14 from the proposed Regulations in its entirety "A pharmacist-incharge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not publish or circulate false, misleading, or otherwise deceptive statements concerning the practice of pharmacy".

• Please consider adding "All modifications of pharmacist license renewal fees shall be reviewed and approved by the Board of Pharmacy prior to initiation." to 1. 1.4.16.B.

• Please consider removing the addition of "in writing" from 1.1 .5.14.A related to acceptable forms of patient counseling.

• Please consider adding "mandatory live verbal counseling (in person or via approved AN equipment) for all new medication prescribed to an existing patient and any medications where the dose, strength, route of administration, or directions for use has changed" to sections 1.1.5.14.A, 1.8.3.d, 1.1.8.3.2.b(1), 1.1.8.3.2.b(2) and 1.1 .11 .B.5.

• Please consider returning to the original language in section 1.1 .5.23 "Verification by a pharmacist of a filled prescription must include verification of the prescription label and product against the original or scanned prescription" instead of limiting to a first refill only.

• Please consider limiting automated "RAPS" devices as outlined in 1.1.8.3 with controlled substances dispensing to nursing facilities, medical institutions, assisted living, rehabilitation, hospitals, hospice care or correctional facilities.


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• Please consider removing technician ability to perform limited-function laboratory tests in section 1.1.12.2. 8 .2.

• Please consider retaining the requirement for technicians to "complete at least three (3) hours (0.3 continuing education units) of the required ten (10) hours of continuing education as live hours" in section 1.1 .13.1.J.1.




Sincerely,

1U t<i•ha~•l! t:fi,a,nE"i €~ir ~ ~h.a 1nn. !!). IU~!f ()1-H H ·~ Lifespan Pharmacy Manager Rhode Island Hospital and The Miriam Hospital

Office401-444-2746 !Fax.401-444-2263 I Cell40I-954-1998

This transmission is intended only for the addressee(s) listed above and may contain information that is confidential. If you are not the addressee, any use, disclosure, copying or communication of the contents of this message is prohibited. Please contact me if this message was transmitted in error.

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From: Sent: To:

Pullano, Paula (RIDOH)

Friday, July 13, 2018 9:48 AM Roberts, Sullivan (RIDOH)

Subject: FW: [EXTERNAL] : Proposed changes to regulations.

----Original Message----From: Renata Ricci [mailto:[email protected]] Sent: Friday, July 13, 2018 8:36 AM To: Ragosta, Peter (RIDOH) <[email protected]> Cc: Pullano, Paula (RIDOH) <[email protected]> ~blb;ject·d§.XTERNALl · Proposed changes to regulations

Dear Mr. Ragosta and Mrs. Pullano,

I agree with the proposed changes to the regulations that were revised by my colleagues from the Rhode Island Pharmacists Association to ensure that if these changes take effect pharmacists and the general public are protected.

• Please consider removing 1.1.3.14 from the proposed Regulations in its entirety "A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not publish or circulate false, misleading, or otherwise deceptive statements concerning the practice of pharmacy". • Please consider adding "All modifications of pharmacist license renewal fees shall be reviewed and approved by the Board of Pharmacy prior to initiation." to 1.1.4.16.B. • Please consider removing the addition of "in writing" from 1.1.5.14.A related to acceptable forms of patient counseling. • Please consider adding "mandatory live verbal counseling (in person or via approved A/V equipment) for all new medication prescribed to an existing patient and any medications where the dose, strength, route of administration, or directions for use has changed" to sections 1.1.5.14.A, 1.8.3.d, 1.1.8.3.2.b(l), 1.1.8.3.2.b(2) and 1.1.11.8.5. • Please consider returning to the original language in section 1.1.5.23 "Verification by a pharmacist of a filled prescription must include verification of the prescription label and product against the original or scanned prescription" instead of limiting to a first refill only. • Please consider limiting automated "RAPS" devices as outlined in 1.1.8.3 with controlled substances dispensing to nursing facilities, medical institutions, assisted living, rehabilitation, hospitals, hospice care or correctional facilities. • Please consider ensuring that pharmacists have oversight of implementation and maintenance of the automated storage and distribution systems described in section 1.1.8.3. • Please consider clarifying/ensuring that technicians are not able to prepare or determine patient eligibility for vaccines in section 1.1.12.1.8. • Please consider removing technician ability to perform limited-function laboratory tests in section 1.1.12.2.B.2. • Please consider retaining the requirement for technicians to "complete at least three (3) hours (0.3 continuing education units) of the required ten (10) hours of continuing education as live hours" in section 1.1.13.1.J.1. • Please consider ensuring that pharmacy technician product verification cannot be performed when the electronic verification system (e.g. bar code scanning) is unavailable or overridden for part or all of the dispensing process. • Please consider adding language to ensure that each pharmacy utilizing a verification technician program must staff pharmacists to verification technicians in no more than a 1:2 ratio during all times the pharmacy is open to the public.

Thank you so much again for the opportunity to submit our opinions as individual pharmacists in the state of Rhode Island.

1

Sincerely, Renata Grayce Ricci License number: RPH 04639.

Sent from my iPhone

2

July 13, 2018

Peter Ragosta, RPh Department of Health [email protected]

Dear Mr. Ragosta,

I provided testimony as a licensed pharmacist in the State of Rhode Island at the recent hearing held at the Department of Health regarding the new, proposed Pharmacy Regulations. The following written comments are meant to supplement my oral comments.

Clearly, a total review and revision of the State's Pharmacy Regulations is a gargantuan job, one for which the Board of Pharmacy should be commended. I respect that the Board was attempting to modernize our Pharmacy Regulations in light of new and emerging technologies that could allow pharmacists in the State to practice at the top of their license.

However, to ensure that goal, the regulations as written must be further revised and strengthened. The proposed regulations provide ample room for the erosion of the coveted patient-pharmacist relationship by allowing for the removal of the pharmacist from the community pharmacy. Although I have to believe this was not the intention, no safeguards are included in the proposed regulations to prevent this from happening. In my opinion. the removal of the pharmacist from the pharmacy would constitute a public health crisis.

The value of the community pharmacist-patient relationship and the resulting interventions are not well documented in the primary literature as many barriers exist to the implementation of such a study. For example, such a study would require pharmacist time to document; time is a precious commodity in the community setting. Likewise, because of the difficulty in designing an unbiased study, the value of face-toface patient counseling is difficult to assess. However, money should not be the driver when it comes to patient health and safety. I, and I am sure most of my pharmacist colleagues, can recall situations where one simple question to a patient opened a floodgate and resulted in dramatic opportunities to enhance the patient's health. It would be a mistake to assume that the value of the pharmacist to the patient can be replaced by a much less educated person functioning in a technician role or by a television screen.

Below are some specific areas of concern (in order of appearance in the proposed regulations) that I believe may impact the health and safety of the public and that may erode the role of the pharmacist and the profession of pharmacy.

1. Please consider removing 1.1.3.14 from the proposed Regulations in its entirety "A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a

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