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Dis iscl closures I have no relevant financial relationships with - - PDF document

1/11/2018 Dis iscl closures I have no relevant financial relationships with the organizer of todays event. Alaska Board of Pharmacy Employed by Walmart. Richard Holt, BS Pharm, PharmD, MBA Vice-Chair I am a member of the Alaska


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SLIDE 1

1/11/2018 1

Alaska Board of Pharmacy

Richard Holt, BS Pharm, PharmD, MBA Vice-Chair

February 10, 2018 Alaska Board of Pharmacy

Dis iscl closures

  • I have no relevant financial relationships with the
  • rganizer of today’s event.
  • Employed by Walmart.
  • I am a member of the Alaska Pharmacist’s

Association.

Alaska Board of Pharmacy

February 10, 2018

Dis iscl claim imer

This is not a Board of Pharmacy meeting. Any feedback on regulation presented during this CE does not represent your official position to the Board of Pharmacy. To express your official position you must do so during a publicly notified Board of Pharmacy meeting during the public comment period.

Alaska Board of Pharmacy

February 10, 2018

Dis iscl claim imer

If the regulations presented in this CE are current and active they will be represented with their actual regulation number, i.e. 12 AAC …. Otherwise, all regulations presented are

  • ngoing discussions by the Board and

represent a draft.

Alaska Board of Pharmacy

February 10, 2018

Goals and Objectives

  • To review the current composition of the Board of Pharmacy.
  • To review regulations:
  • SB74 and HB159;
  • Emergency Preparedness;
  • Nationally Certified Pharmacy Technicians;
  • License Requirements for Individual Pharmacists Working for Tribal Health Programs;
  • Control Substance Prescription Drug Orders;
  • Refills;
  • Collaborative Practice Agreements;
  • Substitution; and
  • Return or Exchange of Drugs.

Alaska Board of Pharmacy

February 10, 2018

Boa Board Comp Composit ition

7 members

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SLIDE 2

1/11/2018 2 Boa Board Comp Composit ition

Alaska Board of Pharmacy

2 members

Anne Gruening (Juneau) 1 Vacant

5 members

Leif Holm (North Pole) James Henderson (Soldotna) Phil Sanders (Soldotna) Lana Bell (Anchorage) Richard Holt (Eagle River)

February 10, 2018

Ques esti tion

How many board members are required to sign an application before it can be approved? a) 1 b) 2 c) 3 d) 4 e) 5

Alaska Board of Pharmacy

February 10, 2018

Sec ec. . 08 08.80 80.0 .070: : Quorum

  • Four members constitute a quorum for the transaction of

business.

  • However, when the board meets for the purpose of examining

applications for licensure, three members of the board constitute a quorum.

Alaska Board of Pharmacy

February 10, 2018

Ques esti tion

How many board members are required to sign an application before it can be approved? a) 1 b) 2 c) 3 d) 4 e) 5

when the board meets for the purpose of examining applications for licensure, three members of the board constitute a quorum.

Alaska Board of Pharmacy

February 10, 2018

RE REGISTRATIO ION wit with PDMP

(a) A licensed pharmacist shall register with the Prescription Drug Monitoring Program’s controlled substance prescription database (PDMP) before dispensing a schedule II, III, or IV controlled substance under federal law. . (b) Before dispensing, prescribing, or administering a schedule II, III, or IV controlled substance under federal law, a pharmacist or practitioner required to register with the PDMP must (1) register online on the PDMP website; and (2) pay the fee established in 12 AAC 02.310.

Alaska Board of Pharmacy

February 10, 2018

RE REGISTRATIO ION wit with PDMP

(c) After completing the registration requirements, a pharmacist or practitioner required to register with the PDMP will be issued a user account, login name, and password by the department. (d) A pharmacist or practitioner required to register with the PDMP must access information in the PDMP using the user account, login name, and password issued by the department. (e) A pharmacist or practitioner required to register with the PDMP may access information in the PDMP using another registrant’s credentials only as authorized by a contract executed by the department for the purposes of AS 47.07.038.

Alaska Board of Pharmacy

February 10, 2018

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SLIDE 3

1/11/2018 3 ACCE CCESSIN ING th the e PDMP

For the purposes of AS 17.30.200(d)(3) and (4), a licensed practitioner or licensed or registered pharmacist authorizing an “agent or employee” to access the PDMP is responsible for maintaining and terminating the agent or employee’s access to the PDMP.

Alaska Board of Pharmacy

February 10, 2018

REP REPORTIN ING & & REVI REVIEWIN ING th the e PDMP

(a) Unless excused from reporting under AS 17.30.200(u), information required under AS 17.30.200(b) must be submitted by a pharmacist, if the pharmacist-in-charge is not present. (b) Unless excused from reporting under AS 17.30.200(u), a pharmacist or practitioner required to submit information under AS 17.30.200(b) must submit the information to the Alaska Prescription Drug Monitoring Program (PDMP) daily as of the previous submission date. DAILY: becomes law July 1, 2018.

Alaska Board of Pharmacy

February 10, 2018

REP REPORTIN ING & & REVI REVIEWIN ING th the e PDMP

(c) The time computation under 12 AAC 02.920(b) applies to a submission of information under AS 17.30.200(b) and this section. (d) For the purposes of AS 17.30.200(b)(8), “other appropriate identifier” and “other appropriate identifying information” means the state issued license number of the prescribing practitioner, and the dispensing pharmacist or practitioner. (e) Within 72 hours of discovering an error in information submitted under AS 17.30.200(b), a pharmacist or practitioner required to submit the information under AS 17.30.200(b) must submit information correcting the error to the PDMP administrator. The time computation under 12 AAC 02.920(b) applies to a submission of information correcting an error in information submitted under AS 17.30.200(b).

Alaska Board of Pharmacy

February 10, 2018

REP REPORTIN ING & & REVI REVIEWIN ING th the e PDMP

(f) Unless excused from reporting under AS 17.30.200(u), or a waiver is granted under 12 AAC 52.870, a pharmacist or practitioner required to submit information under AS 17.30.200(b)must submit the information to the PDMP electronically through the website provided by the board. (g) Unless excused from reviewing the PDMP under AS 17.30.200(k)(4)(A) – (B), a practitioner, but not a pharmacist, must review the information in the PDMP to check a patient's prescription records before dispensing, prescribing, or administering a schedule II or III controlled substance under federal law.

Alaska Board of Pharmacy

February 10, 2018

Grounds for Dis isci ciplin ine

A violation of 12 AAC 52.855—12 AAC 52.890 by a pharmacist is grounds for the imposition of disciplinary sanctions under AS 08.01.075 and AS 08.80.261.

Alaska Board of Pharmacy

February 10, 2018

Init itial l Quanti tity ty of f Opio ioid ids: 9/ 9/19 19/2 /201 017 7 BO BOP Statem ement

Alaska Board of Pharmacy

February 10, 2018

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SLIDE 4

1/11/2018 4 Init itial l Quanti tity ty of f Opio ioid ids: 9/ 9/19 19/2 /201 017 7 BO BOP Statem ement

Alaska Board of Pharmacy

February 10, 2018

Ques esti tion

True or False. Emergency Preparedness already exist in AS 08.80? a) True b) False

Alaska Board of Pharmacy

February 10, 2018

Emer ergency Prep eparedness ss

The Emergency Preparedness Regulations being discussed currently address:

  • Redefining 12 AAC 52.110 (Emergency Pharmacist Permit);
  • A natural disaster, terrorist attack or state emergency declared the

by Governor of Alaska;

  • A natural disaster, terrorist attack or state emergency declared by

another state’s Governor resulting in patients being temporarily relocated to Alaska;

Alaska Board of Pharmacy

February 10, 2018

Emer ergency Prep eparedness ss

Results in pharmacist being authorized to dispense up to a 30- day supply of medication if:

  • In RPh professional opinion the medication is essential to

the maintenance of life or to the continuation of therapy and

  • The order is reduced to writing marked “emergency

prescription” and filed according to existing regulations. If the declared state of emergency continues for more than 21-days after the emergency 30-day dispensing, one additional dispensing

  • f up to a 30-day supply may be dispensed.

Alaska Board of Pharmacy

February 10, 2018

Ques esti tion

True or False. Emergency Preparedness already exist in AS 08.80? a) True b) False They are currently being drafted but do not currently exist in regulation.

Alaska Board of Pharmacy

February 10, 2018

License Req equirements for r RPh Work rking for r Tribal Heal ealth Pr Programs

  • For many years, the Board has been working on attempting to

understand what pharmacists are living and practicing within the State under another State’s license and create regulations to make such pharmacists known.

  • AGO AN2009102500, April 17 2012. Located within

“Frequently Asked Questions” on Board of Pharmacy website.

  • Not unique to the Board of Pharmacy: 12 AAC 40.981

Alaska Board of Pharmacy

February 10, 2018

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SLIDE 5

1/11/2018 5

License Req equirements for r RPh Work rking for r Tribal Heal ealth Pr Programs

Alaska Board of Pharmacy

February 10, 2018

License Req equirements for r RPh Work rking for r Tribal Heal ealth Pr Programs

Regulations being discussed by the Board: LICENSE REQUIREMENTS FOR INDIVIDUAL PHARMACISTS WORKING FOR TRIBAL HEALTH PROGRAMS. (a) a pharmacist who engages in the practice of pharmacy in a tribal health program in this state must be licensed by the board unless they notify the board that they are practicing under another license in accordance with 25 U.S.C. 1621t (sec. 221, Indian Health Care Improvement Act). Notice required under this section must be received no later than 14 days after employment at a tribal health program in this state, and must include

  • (1) a completed Alaska State Pharmacist License Exemption form provided

by the Department;

  • (2) a certified true copy of a current, valid pharmacist license in good

standing from another jurisdiction; and

  • (3) proof of employment by a tribal health program that is operating under

an agreement with the federal Indian Health Service under 25 U.S.C. 450- 458ddd-2 (Indian Self-Determination and Education Assistance Act).

  • (A) if the out-of-state pharmacist is employed with the tribal health

program as an independent contractor then the pharmacist must also provide a copy of the contract.

Alaska Board of Pharmacy

February 10, 2018

License Req equirements for r RPh Work rking for r Tribal Heal ealth Pr Programs

  • (b) a pharmacist practicing under the exemption may not

practice beyond the scope of the other state license.

  • (c) the licensing exemption only applies during time spent

working for the tribal health program and does not extend to “moonlighting”. An out-of-state licensed pharmacist working

  • utside of their contracted employment with a tribal health

program must apply for licensure as a pharmacist in accordance with AS 08.80.

Alaska Board of Pharmacy

February 10, 2018

Ques esti tion

True or False. A patient may return to the pharmacy and exchange a medication that has been incorrectly filled or recalled by the Food and Drug Administration? a) True b) False

Alaska Board of Pharmacy

February 10, 2018

Retu turn or Exch change of f Drugs gs

  • 12 AAC 52.530. RETURN OR EXCHANGE OF DRUGS. (a) Except as

provided in (b) of this section, a pharmacy or pharmacist may not accept a drug for return or exchange after the drug has been taken from the premises where the drug was sold, distributed, or dispensed.

  • (b) A pharmacy serving an institutional facility may accept for

return or reuse unit dose packages or full or partial multiple dose medication cards if …

Alaska Board of Pharmacy

February 10, 2018

Ques esti tion

True or False. A patient may return to the pharmacy and exchange a medication that has been incorrectly filled or recalled by the Food and Drug Administration? a) True b) False

Alaska Board of Pharmacy

February 10, 2018

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SLIDE 6

1/11/2018 6 Retu turn or Exch change of f Drugs gs

  • Is that ideal?
  • Current Board discussion:
  • (a) A pharmacy or pharmacist may accept a drug for return or

exchange after the drug has been taken from the premises where the drug was sold, distributed, or dispensed if

  • (1) the prescription was dispensed in a manner

inconsistent with the original prescription drug order; or

  • (2) the medication was recalled by the manufacturer or

FDA; and

  • (3) it is segregated from the normal pharmacy inventory

and may not be dispensed.

Alaska Board of Pharmacy

February 10, 2018

Con Contr trol l Substance Presc escripti tion Drug g Order ers

  • Sec. 08.80.345. PRESCRIPTION FOR AN OPIOID; VOLUNTARY

REQUEST FOR LESSER QUANTITY.

  • (a) A pharmacist filling a prescription for an opioid that is a

schedule II or III controlled substance under federal law may, at the request of the individual for whom the prescription is written, dispense the prescribed opioid in a lesser quantity than prescribed.

  • (b) Nothing in this section shall be construed to prevent

substitution of an equivalent drug under AS 08.80.295.

Alaska Board of Pharmacy

February 10, 2018

Con Contr trol l Substance Presc escripti tion Drug g Order ers

Current Board Discussion: CONTROLLED SUBSTANCE PRESCRIPTION DRUG ORDERS. (a) A prescription drug order for a Schedule II controlled substance may be partially filled if prescribed for

  • (A) a terminally ill patient or a patient residing in a long term care facility, in

accordance with 21 CFR §1306.13; or

Alaska Board of Pharmacy

February 10, 2018

Con Contr trol l Substance Presc escripti tion Drug g Order ers

  • (B) a patient who is not terminally ill or residing in a long term care facility if;
  • (i) the partial fill is requested by the patient or the practitioner that

wrote the prescription;

  • (ii) the total quantity dispensed in all partial fillings does not exceed the

total quantity prescribed;

  • (iii) each partial fill is electronically documented in the patient record;
  • (iv) the remaining portions are filled not later than 30 days after the

date on which the prescription is written; and

  • (v) it only occurs at the pharmacy where the original prescription order

is on file.

Alaska Board of Pharmacy

February 10, 2018

Refi fills ls

12 AAC 52.470. REFILLS. (a) A pharmacist may dispense a refill of a prescription drug

  • rder only in accordance with the prescribing practitioner’s authorization as indicated on

the prescription drug order. If there are no refill instructions on the prescription drug

  • rder, or if all refills authorized on the original prescription drug order have been

dispensed, a pharmacist shall obtain authorization from the prescribing practitioner before dispensing a refill. (b) A pharmacist may not dispense a refill of a prescription drug order for a noncontrolled substance after one year from the date of issue of the original prescription drug order. (c) Each time a prescription drug order is dispensed, the pharmacist shall record the refill electronically or on the back of the prescription drug order by listing the date of dispensing, the written initials or identification code of the dispensing pharmacist, and the amount dispensed if different from the quantity on the original prescription drug

  • rder.

Alaska Board of Pharmacy

February 10, 2018

Refi fills ls

If a prescription drug order has sufficient quantity remaining on a refill, would you like the ability to increase the quantity to a 90-day supply WITHOUT having to call and get permission? Board Discussion is to add: (d) If an original prescription drug order is prescribed as a 30-day supply, the pharmacist may dispense up to a 90-day supply on refills provided that the (1) patient has completed an initial 30-day supply of the drug; (2) total quantity of dosage units dispensed does not exceed the total quantity of dosage units authorized by the prescriber on the prescription, including refills; (3) drug is not a control substance; and (4) the pharmacist is exercising professional judgment. (e) To indicate that an increased supply shall not be dispensed pursuant to this section, a prescriber may indicate “No change to quantity”, or words of similar meaning, on the prescription drug order. (f) Nothing in this section shall be construed to require a health care service plan, health insurer, workers’ compensation insurance plan, pharmacy benefits manager, or any other person or entity, including, but not limited to, a state program or state employer, to provide coverage for a drug in a manner inconsistent with a beneficiary’s plan benefit. Alaska Board of Pharmacy

February 10, 2018

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SLIDE 7

1/11/2018 7 Substi titution

12 AAC 52.510. SUBSTITUTION. (a) A pharmacist may dispense an equivalent drug product instead of the prescribed drug if (1) the prescribing practitioner does not hand write or electronically note on the prescription drug order that a specific brand must be dispensed, using language such as “brand medically necessary” or similar wording; (2) the patient is notified and consents to the substitution; (3) the equivalent drug product costs the patient less than the prescribed drug product; and (4) for the drug product actually dispensed, the pharmacist notes on the prescription drug

  • rder one of the following:

(A) the drug product’s manufacturer or distributor; (B) national drug code number; (C) short name code; or (D) trade name. (b) The determination of the drug product to be dispensed for a prescription drug order is a professional responsibility of the pharmacist. A pharmacist may not dispense any product that in the pharmacist’s professional opinion is not an equivalent drug product as the term “equivalent drug product” is defined in AS 08.80.480.

Alaska Board of Pharmacy

February 10, 2018

Substi titution

What’s the problem with our current regulation? 12 AAC 52.510. SUBSTITUTION. (a) A pharmacist may dispense an equivalent drug product instead of the prescribed drug if (1) the prescribing practitioner does not hand write or electronically note on the prescription drug order that a specific brand must be dispensed, using language such as “brand medically necessary” or similar wording; (2) the patient is notified and consents to the substitution; (3) the equivalent drug product costs the patient less than the prescribed drug product; and (4) for the drug product actually dispensed, the pharmacist notes on the prescription drug

  • rder one of the following:

(A) the drug product’s manufacturer or distributor; (B) national drug code number; (C) short name code; or (D) trade name.

Alaska Board of Pharmacy

February 10, 2018

Substi titution

Current Board Discussion: (a) A pharmacist may dispense an equivalent drug product instead of the prescribed drug if (1) the prescribing practitioner does not hand write or electronically note indicate on the prescription drug order that a specific brand must be dispensed, using language such as “brand medically necessary”, “dispense as written – DAW”, “Do Not Substitute” or other similar wording; (2) the patient is notified and consents to the substitution; (3) the equivalent drug product costs the patient less than the prescribed drug product; and (4) for the drug product actually dispensed, the pharmacist pharmacy notes record shall contain on the prescription drug order one of the following: (A) the drug product’s manufacturer or distributor; (B) national drug code number; (C) short name code; or (D) trade name.

Alaska Board of Pharmacy

February 10, 2018

Col Collab laborativ ive e Pract ctic ice Agr Agree eemen ents ts

  • Currently requires Board approval.
  • Current Board Discussion:
  • Move to a checklist format by Board Staff.
  • Reduces turn-around for approval.

Alaska Board of Pharmacy

February 10, 2018

Ques esti tion

True or False. Nationally Certified Pharmacy Technicians are currently recognized by the Board of Pharmacy? a) True b) False

Alaska Board of Pharmacy

February 10, 2018

Nati tionally Cer Certi tifi fied Pharmacy Tec echnic icians

  • Current Board Discussion & High-Level Overview:
  • It will not be mandated.
  • There will not be a separate nationally certified pharmacy

technician license.

  • It will be defined in regulation.
  • There will be authorized activities a nationally certified

pharmacy technician can perform that a pharmacy technician licensee cannot.

Alaska Board of Pharmacy

February 10, 2018

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1/11/2018 8 Nati tionally Cer Certi tifi fied Pharmacy Tec echnic icians

Definition: “nationally certified pharmacy technician” means a pharmacy technician who obtains and maintains an active national certification through the Pharmacy Technician Certification Board (PTCB) or the Institute for the Certification of Pharmacy Technicians (ICPT).

Alaska Board of Pharmacy

February 10, 2018

Nati tionally Cer Certi tifi fied Pharmacy Tec echnic icians

Re-define 12 AAC 52.230:

(e)Before an individual may regularly perform the tasks of a pharmacy technician or nationally certified pharmacy technician in accordance with 12 AAC … the individual shall complete training required by the pharmacist-in-charge. Duties performed by the pharmacy technician must be consistent with the training the pharmacy technician has received. (g) A nationally certified pharmacy technician shall conspicuously display, in the practice site, the licensee’s active national

  • certificate. The active national certificate of a nationally certified

pharmacy technician practicing in an institutional facility may be displayed in a central location.

Alaska Board of Pharmacy

February 10, 2018

Nati tionally Cer Certi tifi fied Pharmacy Tec echnic icians

Retail Approved Functions (drafted from other states, mostly Idaho): (a) A nationally certified pharmacy technician, working under the direct supervision of a pharmacist, may (1) in a retail pharmacy (A) dispense a non-controlled substance prescription if

  • the prescription drug order has previously undergone

prospective drug review by a pharmacist, including determination in substitution of equivalent drug product;

  • the pharmacy uses an automated dispensing system or other

technology assisted filling equipment that uses bar code scanning that confirms the drug stock selected to fill the prescription is the same as indicated on the prescription label;

Alaska Board of Pharmacy

February 10, 2018

Nati tionally Cer Certi tifi fied Pharmacy Tec echnic icians

  • the pharmacy uses dispensing software that displays the image of the

correct drug being verified and if there is any deviation from the image and actual product being dispensed the nationally certified pharmacy technician may not dispense the order and a pharmacist must review and dispense the order; and

  • each prescription dispensed is electronically verified and documented in

the patient record in accordance with 12 AAC 52.460 and 12AAC 52.470. (B) clarify the following non-control substance prescription drug order information with the practitioner or the practitioner’s authorized agent

  • i. number of refills;
  • ii. quantity of medication;
  • iii. date prescription drug order was written;
  • iv. diagnosis codes; or
  • v. “medically necessary” documentation for insurance purposes.

Alaska Board of Pharmacy

February 10, 2018

Nati tionally Cer Certi tifi fied Pharmacy Tec echnic icians

(C) documentation of prescription drug order information clarifications from (B) shall be documented by writing the following information on the prescription drug order (i) the result of the clarification; (ii) the initials or name of the nationally certified pharmacy technician making the clarification; (iii) the initials of the name of the supervising pharmacist; (iv) the name of the prescriber or authorized agent they spoke to; and (v) the date and time of the call. thoughts?

Alaska Board of Pharmacy

February 10, 2018

Nati tionally Cer Certi tifi fied Pharmacy Tec echnic icians

(D) administer an immunization or related emergency medication in accordance with 12 AAC 52.992; and (E) transfer a non-controlled substance prescription drug order in accordance with 12 AAC 52.500;

Alaska Board of Pharmacy

February 10, 2018

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SLIDE 9

1/11/2018 9 Nati tionally Cer Certi tifi fied Pharmacy Tec echnic icians

(2) in an institutional facility (A) obtain a printed patient medication history from the patients pharmacy; (B) be involved with patient discharge coordination; and (C) verify the accuracy of pharmacy technicians work in refilling of (i) automated medication distribution units, (ii) unit dose med carts, or (iii) long term care medications. (3) participate in patient medication reconciliation.

Alaska Board of Pharmacy

February 10, 2018

Qu Questions? s?

Alaska Board of Pharmacy

February 10, 2018