Montana Board of Pharmacy Update

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1 Montana Board of Pharmacy Update Questions from the Field RECENT DRUG DEVELOPMENT AND LAW UPDATE MISSOULA, MT MARCH 3, 2019 JOHN DOUGLAS, RPh BOARD INSPECTOR MONTANA BOARD OF PHARMACY

2 Disclosure I have no actual or potential conflict of interest in relation to this presentation

3 Objective At the conclusion of this presentation, pharmacists and pharmacy technicians will be able to list the seven required items in a DEA Biennial Inventory.

4 From the DEA Pharamcist s Manual:

5 INVENTORY REQUIREMENTS From the DEA Pharmacist s Manual, 2010 Biennial Inventory 1. The date of the inventory 2. Whether the inventory was taken at the beginning or close of business 3. The name of each controlled substance inventoried 4. The finished form of each of the substances (e.g., 10 milligram tablet) 5. The number of dosage units of each finished form in the commercial container (e.g., 100 tablet bottle), 6. The number of commercial containers of each finished form (e.g., four 100 tablet bottles) 7. A count of the substance - if the substance is listed in schedule II, an exact count or measure of the contents or if the substance is listed in schedules III, IV, or V, an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case, an exact count of the contents is required.

6 Question: Good Afternoon, I have a question regarding the rules around pharmacy technicians providing patient education. We are hoping to hire a pharmacy technician to work with our clinical pharmacists at RiverStone Health in Billings. This person would have a variety of functions, including some direct patient interaction. Our clinical pharmacist would be working alongside this individual anytime patients are being seen by our service. What I am wondering is, what is the guidance around pharmacy technicians helping patients with educational needs such as learning to use their glucometer, insulin pen device, or inhaler? Or showing a patient a handout about the DASH diet or MT Quit Line? I want to be sure that we are not tasking our technician with duties that are considered beyond the scope of their role by the Board.

7 Answer: USE OF PHARMACY TECHNICIAN (1) A pharmacy technician may not perform tasks which require the exercise of the pharmacist's independent professional judgment, including but not limited to, patient counseling, drug product selection, drug interaction review or drug regimen review. (2) When a pharmacist is not in the prescription department, there shall be no dispensing of new prescriptions that the pharmacist has checked and that are waiting to be picked up, nor shall counseling be provided by the pharmacy technician. (3) No medication may be released to a patient without review by a registered pharmacist for the accuracy and appropriateness of the prescription drug order. (4) All technicians and auxiliary staff shall be made visually identifiable by name and job title utilizing letters of 16 point or larger on a name badge. (5) All pharmacy technician licenses and technician-in-training permits must be conspicuously displayed at all times in the place of business. History: , MCA; IMP, , , , , MCA; NEW, 1992 MAR p. 1608, Eff. 7/31/92; AMD, 2000 MAR p. 2005, Eff. 7/28/00; AMD, 2002 MAR p. 86, Eff. 1/18/02; TRANS, from Commerce, 2002 MAR p. 904; AMD, 2010 MAR p. 74, Eff. 1/15/10.

8 Question: Sorry to bug you but I have a question about injections and the scope of practice a pharmacy has in order to administer injections. My main question is can a pharmacy dispense an anti-psychotic med, such as Haldol, and inject the patient on site. If so, what do we need to do in order to provide this service? All of us here were under the impression it was for vaccinations only and not monthly medication injections.

9 Answer: Montana Code Annotated 2017 TITLE 37. PROFESSIONS AND OCCUPATIONS CHAPTER 7. PHARMACY Part 1. General Definitions Definitions: (36) "Practice of pharmacy" means: (a) interpreting, evaluating, and implementing prescriber orders; (b) administering drugs and devices pursuant to a collaborative practice agreement, except as provided in , and compounding, labeling, dispensing, and distributing drugs and devices, including patient counseling; (c) properly and safely procuring, storing, distributing, and disposing of drugs and devices and maintaining proper records; (d) monitoring drug therapy and use; (e) initiating or modifying drug therapy in accordance with collaborative pharmacy practice agreements established and approved by health care facilities or voluntary agreements with prescribers;.

10 Question: I m the new pharmacist at public drug. We met in May or June when I was about to take my law exam. I was just double checking about vaccines that we are able to do both pneumonia 13 and 23 vaccines without a collaborative practice. Also, we can give tetanus vaccine and tdap but not Dtap without a collaborative practice right?

11 Answer: Montana Code Annotated 2017 TITLE 37. PROFESSIONS AND OCCUPATIONS CHAPTER 7. PHARMACY Part 1. General Administration Of Immunizations Administration of immunizations. (1) An immunization-certified pharmacist may prescribe and administer the following immunizations without a collaborative practice agreement in place: (a) influenza to individuals who are 12 years of age or older; (b) pneumococcal, tetanus, and diphtheria to individuals who are 18 years of age or older; (c) herpes zoster to those individuals identified in the guidelines published by the United States centers for disease control and prevention's advisory committee on immunization practices; or (d) in the event of an adverse reaction, epinephrine or diphenhydramine to individuals who are 12 years of age or older.

12 Answer, con t ADMINISTRATION OF VACCINES BY PHARMACISTS (1) An immunization-certified pharmacist may prescribe and administer those immunizations listed in , MCA, without a collaborative practice agreement in place, as required by the statute. (2) An immunization-certified pharmacist must have a collaborative practice agreement with a practitioner authorized to prescribe drugs to administer immunizations not listed in , MCA, to persons 18 years of age or older; or, in the case of a public health emergency, a directive from the State Medical Officer of the Montana Department of Public Health and Human Services.

13 Question: My current clinic offers b-12 injections. We have a few out of town people who can t come in frequently to get the injections given or due to weather or job are not able to make it in on the appropriate administration schedule. Can we provide them with pre drawn syringes if doses for self injection? Or do we have to write a prescription for patient to have their own vial to self inject similar to prescribing insulin? Please advise ASAP. I want to make sure we are able to accommodate patients but also stay within the scope of a non dispensing facility. Thanks.

14 Question: I have a question. If a Clinic provider needs a control medication (etc. Morphine 10mg vial) can they get form Hospital Pharmacy? Do they need a DEA 222? Can they write a prescription to get the morphine 10mg vial? Because our Retail Pharmacy is going to close. These questions were sent to me.

15 Question: Upon further review, our CPA states the agreement stands for 24 months. Does that work or is there a default 12 month expiration?

16 Answer: COLLABORATIVE PRACTICE AGREEMENT REQUIREMENTS... (j) the annual date by which review, renewal, and revision, if necessary, will be accomplished...

17 Post-test Question: Which of the following are required elements of the DEA Biennial Inventory? (SELECT ALL THAT APPLY) 1. The date of the inventory. 2. Whether the inventory was taken at the beginning or close of business. 3. The name of each controlled substance inventoried. 4. The finished form of each of the substances (e.g., 10 milligram tablet). 5. The number of dosage units of each finished form in the commercial container (e.g., 100 tablet bottle). 6. The number of commercial containers of each finished form (e.g., four 100 tablet bottles). 7. A count of the substance.

18 Post-test Question (answer): Which of the following are required elements of the DEA Biennial Inventory? (SELECT ALL THAT APPLY) 1. The date of the inventory. 2. Whether the inventory was taken at the beginning or close of business. 3. The name of each controlled substance inventoried. 4. The finished form of each of the substances (e.g., 10 milligram tablet). 5. The number of dosage units of each finished form in the commercial container (e.g., 100 tablet bottle). 6. The number of commercial containers of each finished form (e.g., four 100 tablet bottles). 7. A count of the substance.

19 Questions?

5. returning the medication container to proper secured storage; and

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