July 11, 2017
Massachusetts Board of Registration in Pharmacy
Department of Public Health
Division of Health Professions Licensure
239 Causeway Street Suite 500
Boston, MA 02114
Re: Proposed Regulations 247 CMR 247 5.00, 6.00, 9.00, 12.00, 15.00 & 20.00
VIA ELECTRONIC MAIL TO
Dear Board of Pharmacy,
The Massachusetts Independent Pharmacists Association represents the majority of independently owned pharmacies in Massachusetts. On behalf of our members we would like to submit this testimony on the proposed regulations:
6.03(9) A pharmacist with prescriptive privileges (i.e., a collaborative practice agreement) should be eligible for a pharmacy license. We suggest the regulation be revised to “independent prescriptive privileges” this would provide an exemption for this situation.
6.10(2) There is no need for a complete inventory of schedule VI medications upon a change in Manager of Record. This is overly burdensome and will not produce any benefits. We ask that these medications be removed from this requirement.
6.13(3) The requirement to notify each patient who has received a prescription within the past 90 days is overly burdensome and unnecessary. For example it is not clear why a patient who received a 7 or 10 day prescription 2-3 months ago would need such notification. Current practice requires a closing pharmacy to post a sign on the premises. There is no indication that this current practice is insufficient. We request the regulation be change so that it is consistent with current practice.
It is difficult to provide a complete set of comments/concerns on 247 CMR 9.00 due to the fact that many different terms are used and it is not clear what the definition for each term is or difference between terms is. For example what is a pharmacy department and a pharmacy premises and how are these different? The same is question relates to prescription area and prescription department and ancillary staff and support staff. Despite this we would like to provide the following comments/suggestions;
9.01(2) The term “processed need to be defined to ensure adequate understanding and compliance. In addition this regulation should apply any health professional or licensed prescriber who is dispensing a medication.
9.01(15) Pharmacies currently provide information to prescribers on previous prescriptions when initiating refill requests. Often this information is formatted to look like a prescription to assist the prescriber in determining if they want to continue with current therapy or modify it. Depending on the interpretation of this regulation such practices could be prohibited. We ask that this regulation be amended to allow for these types of activities.
9.01(18) The Health Insurance Portability and Accountability Act of 1996 provides protection for confidential information. We do not see any need to deviate from this standard. We ask this regulation be eliminated or modified to adopt this standard. Having two different standards will only cause potential confusion with no additional benefit.
9.01(19) The limitation should be revised so it is clear that the time limitation only applies to pharmacist providing pharmacy or patient care services and not to a pharmacist performing administrative tasks or monitoring the pharmacy during construction, renovation or other similar situations.
9.01(23) The regulation does not state when the name tag must be worn. The limitation should be revised so it is clear that the time limitation only applies to pharmacist providing pharmacy or patient care services and not to a pharmacist performing administrative tasks or monitoring the pharmacy during construction, renovation or other similar situations.
9.01(24) It is not clear what is meant by “the practice of pharmacy”. To ensure adequate understanding and compliance please define.
9.03 The Food and Drug Administration approves labeling and advertising information for drug products. This standard is sufficient. This section is outdated and no longer relevant and should be deleted.
9.04(1) It is not clear what is meant by “verify”. A pharmacist already has corresponding responsibility to ensure a prescription is issued by a licensed prescriber, is within the scope of practice and is appropriate for the patient. We think these standards are sufficient and see no need to change them. We recommend this regulation be re-written to be consistent with current requirements and impose no new requirements.
9.04(2) This regulation is too broad and could be interpreted to apply to anything. It should be reworded to the expectations and compliance is clearly defined.
9.04(4) This regulation is confusing. It is not clear which technologies should be used. Pharmacies should be free to utilize technologies that work in their practice and allow them to meet practice expectations. Limiting technologies to only those approved by the Board will slow down the adoption of new technologies and there is no evidence this will produce any benefits. Please remove.
9.04(5) This does not provide an exemption for emergencies that may extend beyond 48 hours. We recommend any limit or time period be removed. Pharmacies already have multiple incentives to use these procedures as little as possible and for the shortest time period possible.
9.04(7)(d) There is no need for the pharmacist to make a separate attestation for each prescription. They are already required to follow CFR 1306.22. Requiring a separate attestation is time consuming, overly burdensome, and will not produce any tangible benefits. Please remove.
9.04(9) This is overly burdensome. The NDC number is all that is needed as the manufacturer or distributer information is part of the NDC number.
9.04(10) This regulation is not clear. Why would a pharmacist need approval from another pharmacist to receive oral prescriptions?
9.04(14)(e) This should be modified to “provide the offer to counsel”. The pharmacist cannot force the patient to accept counseling.
9.04(14)(f) The pharmacist is in the best position to determine when the prescription monitoring program should be reviewed. We suggest you insert in the beginning of the regulation “When appropriate based upon the pharmacists professional judgement”….
9.06(2) We do not agree that an oral-liquid-single-dose package needs a safety cap. We find no reason why a liquid would require different packaging than a solid. In addition is a common practice to dispense an oral-liquid-single dose in an oral syringe. The above regulation would prohibit this common practice. We recommend removing this regulation.
9.06(4)(d) A definition of “maintenance medication” is need to ensure understanding and compliance with this regulation.
9.08(4)(b) Schedule II or schedule III controlled substances should be allowed to be placed in a multi-drug-single-dose package if it prescribed for maintenance therapy (similar to schedule IV or V controlled substances). Prohibiting this will only exacerbate nonadherence in patients who clearly have a need for such packaging.
9.09(1)(a) A pharmacy technician should be allowed to stock a PPA (with verification by a pharmacist). With bar code and image technology available with the devices many possible system errors have been reduced or eliminated. Not allowing a pharmacy technician to stock a PPA is overly burdensome and many pharmacy technicians are more than capable of performing this with proper training.
9.09(1)(b) The pharmacist should not be required to verify the stocking of the PPA (unless stocked by a technician) because they are already required to check the prescription prior to dispensing. As written this regulation could require a pharmacist to perform the same check twice which is unnecessary.
9.09(1)(g) This is not needed as it is addressed in 9.09(3)(d)
9.09(2) It is not clear what is meant by “access”. This needs to be clearly defined.
9.09(3) It is not clear what is meant by “system access”. This needs to be clearly defined.
9.11(1) The term “pick up” needs to be defined. We suggest received by the patient or patient’s agent.
9.11(1)(a) We oppose this entire section. A medication filled by a PPA should be able to be placed back into the PPA cell if it is not used. PPAs have bar code and image scanning technology that allow this to be done as safely as using a stock bottle. Also products filled by a PPA should be able to be returned to the same stock bottle it came from. Once again bar code scanning and image technology allow for these activities to be done accurately and safely. Requiring these products to remain in a separate container will only create overcrowded shelves that will lead to filling errors.
9.12(3) This should be change from “at least 2 years” to “2 years”. Adding “at least” is confusing and not needed.
9.15(3)(d) We do not understand why Plumb’s Veterinarian Reference and other peer-reviewed medical literature are required. We recommend deleting “and”.
9.14(1) We are not sure what is meant by “readily retrievable” please define.
9.14(2),(3),(4) We do not understand why “available at the time of inspection” is used if in 9.14(1) the standard used is “readily retrievable”. We recommend changing to “readily retrievable”.
9.14(6)(a) Email address is not needed. Sending health information via email does not comply with federal standards (i.e., HIPAA) and therefore there is no reason why pharmacies need this information.
9.15(2) This regulation is too broad and infers that actions are need when in most cases none are. For example most medications have drug-food interactions and drug interactions. Patients are provided information on this when receiving their medication. In these situations no action from the pharmacist is required. We recommend the first sentence should be modified to “Upon identifying any of the above the pharmacist using their professional judgment may consider appropriate measures….”
9.15(5) Pharmacists should not be held responsible to conduct a DUR for non commercially available products that have proprietary formulas. This should be inserted into the regulation.
9.17(4) We do not understand the intent of this regulation particularly the word “calculated”?
9.16(4) MGL Chapter 94c Section 21A clearly states the pharmacist shall make the offer to counsel. By requiring counseling the proposed regulation is over-reaching and exceeds the authority granted by the legislature in creating the statute. This should be modified so it is consistent with MGL Chapter 94C Section 21A.
9.17(3) A qualified vendor may not be available in all cases and a pharmacist should be allowed to perform their own in-house assessment if they choose to do so. We request that the regulation be changed to allow a pharmacy to perform an in-house assessment or use a qualified vendor.
9.17(13) Please define automatic refill program. We feel all medications including NTI medications should be allowed.
9.19(15) Please change “fore” to “for”.
9.17(16) It is not clear what “on duty” means. Please define.
9.17(20) A pharmacy is not eligible for an e-Profile Number from the National Association of Board of Pharmacy.
9.17(23) This regulation references sections of 247CMR 9.18 that do not exist.
9.19(2) We do not understand why a separate room or locked cage would not be appropriate. As written it would not comply with this regulation.
9.19(5) We think thirty days is too long. A more reasonable requirement is 7 days.
9.19(6) We suggest “pharmacy” be changed to “pharmacy department.”
9.19(9) This regulation is missing. We are not sure if this is a numbering error or if there is an actual regulation that was inadvertently deleted?
9.19(10)(d) This should only apply to discrepancies and not mathematical errors.
9.19(10)(f) If a pharmacy technician is allowed to fill a prescription for a controlled substance they should be allowed to make the appropriate entry into a perpetual inventory. The pharmacist should then be required to check/verify both the filling of the prescription and the entry into the perpetual inventory. Please change to allow for this.
9.21(2)(h) We recommend this regulation be changed to “maintain a copy of all current standing orders used in the pharmacy.”
9.21(2)(i) It is the responsibility of the individual licensee to attest they have met continuing education requirements and it is the responsibility of the Board of Pharmacy to monitor and randomly check the attestations. The pharmacy manager should not be held responsible for evaluating individual continuing education programs and making a determination if they meet certain continuing education requirements. The pharmacy manager is already responsible for ensuring each licensee has a valid and active license. This should be sufficient. Please revise.
We would like to thank you in advance for the attention we know these comments will receive. Please contact us if we can be of assistance.
Sincerely,
Todd Brown MHP, RPh.
Executive Director
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