From: Lori Lewicki
To: DPH-Testimony, Reg (DPH)
Subject: "BOP: 247 CMR 5.00, 6.00, 9.00, 12.00, 15.00 & 20.00"
Date: Friday, July 14, 2017 4:37:28 PM
To members of the Board of Pharmacy,
Thank you for the opportunity to submit some thoughts and provide some information about the proposed regulations….
6.10 Change of Manager of Record
(2) A licensee, or duly authorized representative of the licensee, and the proposed new Manager of Record shall sign an application for change of Manager of Record. A change of Manager of Record application shall include:
a) an attestation confirming the pharmacy performed an inventory of all controlled substances in Schedules II, III, IV, V, and VI and filed the inventory
When there is a change of manager, it is already very cumbersome to do the inventory on Schedules 2-5. Having to do an inventory on Schedule 6 would be extremely labor intensive and time consuming. Maybe 6 could be excluded??
9.01 (6) Unless otherwise permitted by law or regulation, a licensee may not dispense, package, label, or compound any medication that was previously processed or dispensed by another pharmacy. Unless otherwise permitted by law or regulation, a drug store pharmacy may not accept or store any medication that was previously processed or dispensed by another pharmacy.
At our FQHC, we established a Hepatitis C-HIV team that consists of infectious disease physicians, nurses, and pharmacists. A patient is identified for treatment by the clinic and a medication is chosen based on the patient’s genotype and insurance. That patient’s information is then conveyed to the pharmacy so that we can do a complete medication review and make clinical recommendations based on interactions etc. RPhs have access to the EHR so this is a comprehensive review. The medication is then ordered and we “tag team” the patient during the 12-24 week therapy to ensure compliance for this expensive treatment. In the past year, this process including clinical oversight of the patient has been impacted with the inception of insurances requiring specialty pharmacies to fill the medication. Our patients are a low income, low health literacy, inner city population. In addition to these medications not being able to be delivered easily at apartment complexes, these patients are not receiving the high quality of care via constant counseling needed in this special circumstance. Patients have asked to have their medication sent to HHC so that we can continue to monitor and counsel these patients throughout their therapy. We receive no direct financial benefit from providing this care; we do it for free. This regulation would prohibit us from doing so.
We are currently in a pilot Medicaid ACO with the state (that will become an established ACO in December) and it is our responsibility to manage our patients and to provide them with optimal health care. Allowing us to dispense specialty medications, previously filled at another pharmacy because of insurance limitations, benefits the patient and ultimately in the end the health center, the state and the overall health care system.
(22) A pharmacist shall wear a name tag with at least his or her first name and the title “Registered Pharmacist” or “R.Ph.”.
Our current badges for the health center say Pharmacist below the RPh’s name. I am
not sure why Registered would be required also on the badge with limited space since only registered pharmacists could work at the facility. Just putting RPh would be confusing for patients that do not understand acronyms.
9.4 5) A licensee shall ensure the label affixed to a prescription drug container is clearly printed by a computerized pharmacy system. In the event of printing or equipment failure, a prescription label may be legibly handwritten or typed during an emergency period not to exceed 48 hours.
Suggestion to remove the 48 hours and have it be unlimited. After the October storm a few years ago, many areas were without power longer than 48 hours. Although, we now have a generator to get us back up and running, it would have been important to handwrite or type labels even if it was after 48 hours to ensure that patients had their medications.
(8) A pharmacist who refills a prescription for a controlled substance in Schedules III through VI shall record the following information in the computerized pharmacy system or on the written prescription:
(a) the date of dispensing;
(b) the amount of drug dispensed; (c) his or her initials; and
(d) attestation to refilling controlled substance prescriptions in accordance with 21 CFR s. 1306.22.
Clarification needed on part d for attestation. Is signing the log at the end of the night considered to be the attestation??
9.5 2) Oral Prescriptions. Upon receiving an oral prescription for a brand name drug product, a pharmacist shall in ascertain whether or not the prescriber wishes “no substitution” to be marked on the prescription and record this information with all other required information in the computerized pharmacy system.
I believe if a brand name is required, it should be the responsibility of the provider or the provider’s agent to indicate this. Oftentimes, it is an agent calling in the prescription and if asked the question as to whether or not the prescription should be brand name, the answer could easily be yes. This may not be the intent of the prescriber and will place a burden upon the pharmacy to comply with other regulations such as having a Medicaid prescription say No Substitution Brand Name Medically Necessary.
9.6 3) The pharmacist Manager of Record of a pharmacy that maintains a standing order shall:
(a) file the standing order with the Board upon obtaining it and yearly thereafter; and
Is it necessary to file the standing order yearly thereafter? This is not done with DPH for the emergency contraception standing order; only the original one is filed. Also, other governing bodies such as Joint Commission check to be sure that standing orders are updated yearly so is this a duplication of efforts?
(7) A pharmacy that assembles opioid antagonist rescue kits shall affix a label to the outer package noting “Opioid Antagonist Rescue Kit” and the expiration date, which shall be based on the expiration dated of the included naloxone hydrochloride unit.
We have been doing Naloxone kits containing the atomizers for many years. We switched over the past year because of the unavailability of the atomizers due to recall and the ease of the brand name Narcan that does not require assembly. Our kits are labeled as Naloxone-Narcan kits. I believe this is how the product is presented in the media and how most patients would identify with this product. I do not believe, especially in our population, that renaming the kit to Opioid Antagonist Rescue Kit benefits the consumer. In fact, I think it
would be detrimental and cause confusion amongst our patients.
9.8 (2) Oral-Liquid-Single-Dose
(a) A licensee may not dispense a medication in an oral-liquid-single-dose package unless the package has a child proof safety cap.
At our FQHC, our pediatric dental department does conscious sedation using liquid Midazolam. The prescriptions come down with a weight listed on them so that the dose can be double checked by a pharmacist. The medication, Midazolam, is then drawn up into an Exacto-med oral syringe for a single dose for the patient. It has a stopper capping the syringe, but this is not child proof. The parent comes to the pharmacy to sign for the medication so that an employee does not have to sign and give information for the controlled substance page. The dental resident that accompanies the parent is given custody of the medication. It is then administered upstairs so no child proof safety cap is really warranted since a child does not have access to it. This regulation would just add another task to perform by the pharmacist by having to label a 60 dram vial to insert the filled syringe into that already has a label butterflied on it.
(4) Multi-Drug-Single-Dose Packaging
a) A licensee may not dispense more than a 34 day supply of medication in a multi- drug-single-dose package.
We currently do Medboxes (compliance/adherence packaging) for about 700 of our high risk patients who have multiple prescriptions. I AGREE with the 34 days since we often see changes in doses or medication regimens. However, my concern is IF Masshealth puts through the required 90 day supply for maintenance medications in October, we may have a problem with this regulation. They have said that there would be exceptions such as long term care and group homes, but we do not fall into these categories. My concern is that this would limit the patients that we could do packaging for who currently see benefit from this free clinical service. Again, with the initiation of the Medicaid ACO model that we are part of, it is essential that we manage these patients for everyone’s benefit.
(b) A licensee may not dispense Schedules II or III controlled substances in a multi- drug-single-dose package.
For patients that take medications from these schedules as maintenance therapy, it seems that there should be no restriction like with maintenance IV-V. It seems like there is less likelihood of diversion if the medication is in a bubble becuase it would be apparent if it was tampered with rather than having to do a pill count. Also, patients could not “take extra” by mistake or on purpose if the medication was not accessible in a vial.
9.11 A pharmacy may utilize Pharmacy Processing Automation (“PPA”) to count, fill vials or specialty packages, and label, provided the following requirements are met:
(b) a pharmacist verifies the stocking of the PPA;
We have a Parata Max machine and the automation requires that the person put in a unique code to do any function such as filling a cell, doing an RTS etc. It does not seem like a good use of pharmacist time or having a pharmacist practicing at the top of their license to oversee this function. We do maintain a workflow and competency exam that is done yearly with ALL staff to be sure that procedures are being followed to reduce the risk of error.
(g) lot numbers are not comingled in a single cell.
To maintain workflow in a very busy pharmacy, cells are filled on a regular basis when they become low. IF there was ever a problem, ALL medication in that cell would be assumed to be the affected lot and be discarded as such. To wait and drain a cell to zero would be detrimental to the overall workflow of
the pharmacy.
9.12 Automated Dispensing Devices
(7) Medications returned to the ADD return bin or returned to the pharmacy shall be verified by a pharmacist prior to reloading into the ADD dispensing compartment
Same as 9.11b Only certified technicians with unique identifying numbers following set policies and procedures are returning medications to the ADD.
9.13 Return to Stock
(b) Only a pharmacist, pharmacy intern, or pharmacy technician may return medications to stock. A pharmacist shall verify any return to stock
performed by a pharmacy intern or pharmacy technician.
RTS is performed by a certified technician by removing the medication that is over 10 days old from the pick- up area, returning the medication to the shelf after blackening out identifying patient information and then processing the reversal to the insurance in the computer system. These tasks are time consuming and having a pharmacist verify each and every one would not be a good use of RPh time.
9.18 Patient Counseling
(8) A pharmacist or pharmacist’s designee shall maintain patient confidentiality when counseling and making the offer to counsel.
Patients are at a register with other patients in the vicinity. It is almost impossible to confidentially make an offer to counsel in this setting. Maybe this verbiage is not necessary?
9.21 Security of Controlled Substances
(10)
(d) A pharmacy shall require any perpetual inventory adjustment be performed only by the pharmacist Manager of Record. In the absence of the Manager of Record, a pharmacist designee may make the changes and report to Manager of Record.
If a change is made to the perpetual inventory via our written log and/or the computer system, does this change being reported to the MOR need to be in writing? The computer would have a record of a change made, but the written binder would not. Or is a verbal report okay?
Thank you again for allowing pharmacist input and comment on the pending changes to the regulations.
Sincerely, Lori Lewicki
Lori Lewicki Pharmacy Director
Holyoke Health Center Inc. 230 Maple Street
Holyoke, MA 01040
(413) 420-2285 (p)
(413) 533-4571 (f)