2017 Maine Pharmacy Association Spring Convention - PowerPoint Presentation

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2017 Maine Pharmacy Association Spring Convention

G. Cameron 2017

Pharmacy Law UpdateHusson UniversityApril 1, 2017Greg Cameron, R.Ph(NO APRIL FOOLS)

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2017 Maine Pharmacy Association Spring Convention

G. Cameron 2017

Dental Hygienists and Fluoride DispensingOpioid Law and Regulations Update

Drug Quality and Security Act 2013

Comprehensive Addiction & Recovery Act 2016

Technician & Intern Duties

Recent Board of Pharmacy Actions

OBJECTIVES

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2017 Maine Pharmacy Association Spring Convention

G. Cameron 2017

Public Law 114–198, 114th CongressComprehensive Addiction and Recovery Act of 2016

(

696 PAGES

)

REASON:To authorize the Attorney General and Secretary of Health and Human

Services to award grants to address the prescription opioid abuse and heroin use crisis, and

for other

purposes

Comprehensive Addiction and Recovery Act of 2016

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2017 Maine Pharmacy Association Spring Convention

G. Cameron 2017

Parts of this LAW:TITLE I—PREVENTION AND EDUCATION

TITLE

II—LAW ENFORCEMENT AND

TREATMENT

TITLE III—TREATMENT AND RECOVERY

TITLE IV—ADDRESSING COLLATERAL CONSEQUENCES

TITLE

V—ADDICTION AND TREATMENT SERVICES FOR WOMEN, FAMILIES

, AND VETERANS

TITLE

VI—INCENTIVIZING STATE COMPREHENSIVE INITIATIVES TO ADDRESS PRESCRIPTION OPIOID

ABUSE

TITLE VII—MISCELLANEOUS

Sec

. 702. Partial fills of schedule II controlled substances

Comprehensive Addiction and Recovery Act of 2016

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SEC. 702. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES

Partial Fills - A prescription for a controlled substance in schedule II may be partially filled if—

it is not prohibited by State lawthe prescription is written and filled in accordance with this title, regulations prescribed by the Attorney General, and State lawthe partial fill is requested by the patient or the practitioner that wrote the prescription; and the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed

Comprehensive Addiction and Recovery Act of 2016

2017 Maine Pharmacy Association Spring Convention

G. Cameron 2017

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SEC. 702. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES

REMAINING PORTIONS.— IN GENERAL.—Except as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II—

may be filled; and shall be filled not later than 30 days after the date on which the prescription is writtenEMERGENCY SITUATIONS.—In emergency situations, the remaining portions of a partially filled prescription for a controlled substance in schedule II—

may be filled; and

shall be filled not later than 72 hours after the prescription is issued

2017 Maine Pharmacy Association Spring Convention

Comprehensive Addiction and Recovery Act of 2016

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SEC. 702. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES

CURRENTLY LAWFUL PARTIAL FILLS.—Notwithstanding paragraph (1) or (2), in any circumstance in which, as of the day before the date of enactment of this subsection,

a prescription for a controlled substance in schedule II may be lawfully partially filled, the Attorney General may allow such a prescription to be partially filled

2017 Maine Pharmacy Association Spring Convention

Comprehensive Addiction and Recovery Act of 2016

G. Cameron 2017

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SEC. 702. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES

RULE OF CONSTRUCTION.—Nothing in this section shall be construed to affect the authority of the Attorney General to allow a prescription for a controlled substance in schedule III, IV, or V of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) to be partially filled

2017 Maine Pharmacy Association Spring Convention

Comprehensive Addiction and Recovery Act of 2016

G. Cameron 2017

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Compounding Quality Act 

Title I of the Drug Quality and Security Act of 2013 

On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), legislation that contains important provisions relating to the oversight of compounding of human drugs.

G. Cameron 2017

Drug Quality and Security Act of

2013 (Compounding Quality Act)

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2017 Maine Pharmacy Association Spring ConventionSlide10

H.R.3204 — 113th Congress (2013-2014)

Public Law No: 113-54 (11/27/2013)

Drug Quality and Security Act - Title I: Drug Compounding - Compounding Quality Act(Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs

G. Cameron 2017

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide11

Exempts compounded drugs from:

new drug requirements

labeling requirementstrack and trace requirementsIF, the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide12

Establishes annual registration requirement for any

outsourcing facility

Requires a facility to report biannually to the Secretary of Health and Human Services (HHS) on what drugs are compounded in the facility and to submit adverse event reportsSubjects such facilities to a risk-based inspection schedule

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide13

Requires the Secretary to:

Assess an annual establishment fee on each outsourcing facility

A re-inspection fee, as necessary

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide14

Prohibits the resale of a compounded drug labeled “not for resale” or the intentional falsification of a prescription for a compounded drug

Deems a compounded drug to be misbranded if its advertising or promotion is false or misleading

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide15

State Boards of Pharmacy are required to send reports:

Describing any disciplinary actions taken against compounding pharmacies

Any recall of a compounded drugAny concerns that a compounding pharmacy may be violating the FFDCA

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide16

Revises compounding pharmacy requirements:

Repeals prohibitions on advertising and promotion of compounded drugs

Repeals the requirement that prescriptions filled by a compounding pharmacy be unsolicited

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide17

LABELING OF DRUGS.

LABEL.—The label of the drug includes—

the statement ‘This is a compounded drug.’ or a reasonable comparable alternative statement (as specified by the Secretary) that prominently identifies the drug as a compounded drugthe name, address, and phone number of the applicable outsourcing facility

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide18

LABELING OF DRUGS.

LABEL.—The label of the drug includes—

with respect to the drug—the lot or batch number;the established name of the drug

the dosage form and strength

the statement of quantity or volume, as appropriate

the date that the drug was compounded

the expiration date

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide19

LABELING OF DRUGS.

LABEL.—The label of the drug includes—

with respect to the drug— (CONTINUED)storage and handling instructions

the National Drug Code number, if available

the statement ‘Not for resale’, and

if the drug is dispensed or distributed other than pursuant to a prescription for an individual identified patient, the statement ‘Office Use Only’

a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient. (If it doesn’t fit on the label , see container requirement).

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide20

Labeling of the

CONTAINER

—The container from which the individual units of the drug are removed for dispensing or for administration (such as a plastic bag containing individual product syringes) shall include—a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredientinformation to facilitate adverse event reporting:

www.fda.gov/medwatch and 1–800– FDA–1088

directions for use, including, as appropriate, dosage and administration

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide21

REGISTRATION OF OUTSOURCING FACILITIES

ANNUAL REGISTRATION

Upon electing and in order to become an outsourcing facility, shall register with the Secretary its name, place of business, a point contact email address, and unique facility identifiershall indicate whether the outsourcing facility intends to compound a drug that appears on the list in effect under section 506E during the subsequent calendar year

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide22

REGISTRATION OF OUTSOURCING FACILITIES

AVAILABILITY OF REGISTRATION FOR INSPECTION LIST

The Secretary shall make available for inspection, to any person so requesting, any registration filed or facility registered as an outsourcing facilityState in which each such facility is located

whether the facility compounds from bulk drug substances, and

whether any such compounding from bulk drug substances is for sterile or non-sterile drugs

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide23

REGISTRATION OF OUTSOURCING FACILITIES (Continued)

DRUG REPORTING BY OUTSOURCING FACILITIES

Report due once during the month of June, and once during the month of December of each yearidentifying the drugs compounded during the previous 6-month period and

with respect to each drug identified providing the active ingredient, the source of such active ingredient, the NDC of the source drug or bulk active ingredient, if available, the strength of the active ingredient per unit, the dosage form and route of administration, the package description, the number of individual units produced, and the National Drug Code number of the final product, if assigned

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide24

REGISTRATION OF OUTSOURCING FACILITIES

RISK-BASED INSPECTION FREQUENCY

Outsourcing facilitiesshall be subject to inspectionRISK-BASED SCHEDULE.—The Secretary, acting through one or more officers or employees duly designated shall inspect outsourcing facilities in accordance with a risk-based schedule established by the Secretary’

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide25

REGISTRATION OF OUTSOURCING FACILITIES

RISK FACTORS.—shall inspect outsourcing facilities according to the known safety risks of such outsourcing facilities, which shall be based on the following factors

The compliance history of the outsourcing facilityThe record, history, and nature of recalls linked to the outsourcing facility

The inherent risk of the drugs compounded at the outsourcing facility

The inspection frequency and history of the outsourcing facility

Whether the outsourcing facility has registered

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide26

REGISTRATION OF OUTSOURCING FACILITIES

ADVERSE EVENT REPORTING.—Outsourcing facilities shall submit adverse event reports to the Secretary

INTERIM LIST.— the Secretary may designate drugs, categories of drugs, or conditionsUPDATES.—The Secretary shall review, and update as necessary, the regulations containing the lists of drugs, categories of drugs, or conditions regularly, but not less than once every 4 years

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide27

REGISTRATION OF OUTSOURCING FACILITIES

DEFINITIONS

The term ‘compounding’ includes the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drugG. Cameron 2017

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide28

REGISTRATION OF OUTSOURCING FACILITIES

DEFINITIONS

The term ‘essentially a copy of an approved drug’ meansa drug that is identical or nearly identical to an approved drug, or a marketed drug

a drug, a component of which is a bulk drug substance that is a component of an approved drug or a marketed drug, unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide29

REGISTRATION OF OUTSOURCING FACILITIES

DEFINITIONS

The term ‘approved drug’ means a drug that is approved and does not appear on the list of drugs that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide30

REGISTRATION OF OUTSOURCING FACILITIES

DEFINITIONS

The term ‘outsourcing facility’ means a facility at one geographic location or address that—is engaged in the compounding of sterile drugshas elected to register as an outsourcing facility and

complies with all of the requirements of this section

is not required to be a licensed pharmacy

may or may not obtain prescriptions for identified individual patients

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide31

REGISTRATION OF OUTSOURCING FACILITIES

DEFINITIONS

The term ‘sterile drug’ means a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under Federal or State law.’’

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2017 Maine Pharmacy Association Spring Convention

Drug Quality and Security Act of

2013 (Compounding Quality Act)Slide32

2017 Maine Pharmacy Association Spring Convention

G. Cameron 2017

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2017 Maine Pharmacy Association Spring Convention

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An Act To Allow Dental Hygienists To Prescribe Fluoride Dentifrice And Antibacterial RinseApply topical antimicrobials, excluding antibiotics, including fluoride, for the purposes of bacterial reduction, caries control and desensitization in the oral cavity

The independent practice dental hygienist shall follow current manufacturer’s instructions in the use of these medicaments

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Dental HygienistsSlide34

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Prescribe, dispense, or administer anticavity toothpastes or topical gels with 1.1% or LESS sodium fluoride and oral rinses with 0.05%, 0.2%, 0.44%, or 0.5% sodium fluoride and:Prescribe, dispense, or administer chlorhexidine

gluconate

oral rinse

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Dental HygienistsSlide35

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35Opiate Law Update LD 1646

Effective 7/1/2017

Total MMEs are not to exceed 100mg /

day unless an exception

Pharmacists may dispense a lesser quantity than is

prescribed if requested by the patient

Pharmacist must notify the prescriber within 7 days

Remaining quantity is void (different then new Federal Law)

All opioid medications must be prescribed electronically, or prescribers must request a waiver from

DHHSSlide36

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36Opiate Law Update LD 1646

PMP for the pharmacists (when to check)

Applies to Opioids and Benzodiazepines

Patient is not a Maine Resident

Rx is written by an out of state prescriber

Patient has not received a prescription for Opioids or Benzodiazepine within the previous 12 months

Patient pays cash when the actually have insurance

Pharmacists may be fined $250 per violation / $5,000 per year for failure to report to the PMPSlide37

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37Opiate Law Update LD 1646

PMP Dispensers Must Review:

# of pharmacies filling controlled substances for this patient

# of prescribers prescribing controlled substances for this patient

Aggregate MME

Notify the PMP Office Coordinator and decline filling the prescription until you can contact the prescriber if you suspect the prescription is fraudulent or may be duplication of therapySlide38

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38Opiate Law Update LD 1646

Days Supply

Indication of acute pain

7 days

Indication of chronic pain

30 days

Early RefillsSlide39

2017 Maine Pharmacy Association Spring Convention

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39Opiate Law Update LD 1646

Regulations

Definitions

Acute Pain

–

pain that is the normal, predicted physiological response to noxious chemical, thermal, or mechanical stimulus. This pain is typically associated with invasive procedures, trauma, and disease and is usually time-limited

Chronic Pain

–

pain that persists beyond the usual course of an acute disease or healing and may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or yearsSlide40

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40Opiate Law Update LD 1646

Code

Exemption

A

Pain associated with active and aftercare cancer treatment. Providers must document in the medical record that pain is directly related to cancer or cancer treatment. An exemption for aftercare may be claimed up to 6 months post-remission

B

Palliative care in conjunction with serious illness

C

End-of-life and hospice care

D

Medication assisted treatment

for SUD

E

Pregnant individual with pre-existing prescription for >100MMEs

(only applies during pregnancy

F

Acute pain for the patient with pre-existing opioid prescription for chronic pain. The acute pain must be new or onset or postoperative, 7day limit applies

G

Individuals pursuing an active taper of opioid medications with a maximum taper period of 6 months after which the opioid limitations

will apply unless the patient meets additional exceptionsSlide41

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41Opiate Law Update LD 1646

Diagnosis

code:

ICD-10

code must be included on any (aggregate) prescription that exceeds 100 MMEs

Not required on veterinary prescriptions

Exemption code:

Must

be included if claiming exemption from the 100 MME aggregate daily limitSlide42

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42Opiate Law Update LD 1646

Requirement that Dispensers Report Information to the PMP by Electronic

Means

No

later than the close of business on the next business day after dispensing a controlled substance, dispensers must report:

Dispenser identification numberDates prescription was filled and delivered (issued)Prescription number

Whether the prescription is new or a refill

National drug code (NDC) of the drug dispensed

Quantity

dispensed, Dosage

Patient ID number, name, address, and date of birthDate prescription was issued by the prescriberExemption code and ICD-10 code if aggregate >100 MMEs

If prescription is for animal

useSlide43

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43Opiate Law Update LD 1646

https://

www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf

Calculating

Total Daily Dose of Opioids For Safer Dosage -

CDChttp://www.agencymeddirectors.wa.gov/Calculator/DoseCalculator.htm

Opioid Comparison TableSlide44

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44Pharmacy Technicians & Pharmacy Interns

§13834. Prohibited acts

1.

Delegate authority.

  A pharmacist may not delegate the pharmacist's authority to administer drugs or vaccines; except that a pharmacist licensed under this chapter who has obtained a certificate of administration pursuant to section 13832

may delegate the authority to administer drugs and vaccines to a pharmacy intern who is under that pharmacist's direct supervision and who has obtained drug administration training

pursuant to section 13832, subsection 3. A pharmacy intern may administer drugs and vaccines only

to a person 18 years of age or older

. [ 2013, c. 98, §1 (AMD) .]Slide45

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45Pharmacy Technicians & Pharmacy Interns

Pharmacy Technicians

- A

pharmacy technician or pharmacy intern working under the direct supervision of a pharmacist

may:

Accept

delivery of prescription medication to be loaded into a dispensing machine at a point of care

location

Stock

a dispensing machine at a point of care

location

Remove

drugs from a dispensing machine at a point of care location for quality assurance purposes or to carry out a change in formulary;

and

Perform

other functions related to an automated pharmacy system except for

the removal of drugs from a dispensing machine at a point of care location for purposes of administration or dispensing to

patients.Slide46

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46Pharmacy Technicians & Pharmacy Interns

No

person with access to a dispensing machine may remove more drugs than necessary to fill a prescription or meet the immediate needs of a patient in a hospital or

institution.Slide47

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47Pharmacy Technicians & Pharmacy Interns

Telephone

Prescription Drug

Orders

A

pharmacist or

pharmacy intern may accept an original or renewal prescription drug order telephoned to a pharmacy by a practitioner or authorized agent of the

practitioner

A

pharmacy technician may accept an original or renewal prescription drug order telephoned to a pharmacy by a practitioner or authorized agent of the practitioner to the extent authorized by the pharmacist on

duty.

Facsimile

Prescription Drug

Orders

A

pharmacist, pharmacy intern or pharmacy technician

may accept a prescription drug order transmitted by facsimile machine or facsimile computer software directly to a pharmacy. Slide48

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48Pharmacy Technicians & Pharmacy Interns

Generally

The

pharmacist in charge or the pharmacy shall determine the duties of pharmacy technicians based upon the needs of the

pharmacy

Pharmacy

technicians are limited to performing tasks in the dispensing of prescription legend drugs and nonjudgmental support

services

Automated

Pharmacy

Systems

A

pharmacy technician on duty at an institutional

pharmacy may

perform the duties relating to an automated pharmacy system

under

the direct supervision of a

pharmacistSlide49

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49Pharmacy Technicians & Pharmacy Interns

Limitations

A

pharmacy technician may not perform any of the following

tasks:

Clinically

evaluate a patient profile relative to drugs that have or will be

dispensed;

Perform

patient

counseling;

Make

decisions that require the education and professional training of a pharmacist;

or

Sign

any federally-required controlled substance or inventory

formSlide50

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50Pharmacy Technicians & Pharmacy Interns

Verification

of

Status

The

pharmacist in charge

shall ensure that each pharmacy technician employed at the pharmacy for which the pharmacist in charge is responsible is licensed with the

board

A

pharmacy technician shall carry the wallet-sized license card

issued by the board at all times the technician is on duty and shall produce the card upon request of the pharmacist in charge, a pharmacist on duty or an agent of the

board

No

pharmacist in charge or pharmacist on duty

shall permit a person who is not licensed

pursuant to the terms of this chapter to perform the duties of a pharmacy

technicianSlide51

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51Pharmacy Technicians & Pharmacy Interns

Notice

of Employment and Non-Employment of Pharmacy

Technicians

The

pharmacist in charge shall notify the board via letter, fax, email or on line

within 10 days after the commencement or cessation of employment

of any pharmacy technician at a pharmacy for which the pharmacist in charge is

responsibleSlide52

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52Pharmacy Technicians & Pharmacy Interns

Notice

of Termination of Employment For Drug-Related Reasons or

Theft

The

pharmacist in charge or a designee of the pharmacist in charge shall notify the board via letter, fax, email or on line of the termination of employment of a pharmacy technician for any of the following reasons and shall include in the notice the reason for the termination. Notice shall be provided

within 7 days after the

termination

Any

drug-related reason, including but not limited to adulteration, abuse, theft or

diversion;

Theft

of non-drug merchandise;

or

Theft

of cash or credit/debit card data

.Slide53

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53Pharmacy Technicians & Pharmacy Interns

Discipline

Pharmacy

technicians are subject to the disciplinary provisions of 10 MRSA §8003(5-A), 32 MRSA §§ 13742-A and 13743 and Chapters 30, 31 and 32 of the board's rules.