pharmacy law update 2015 gregory cameron, r.ph assistant professor of pharmacy practice husson...

PHARMACY LAW UPDATE 2015

Gregory Cameron, R.PhAssistant Professor of Pharmacy Practice

Husson University Field Coordinator, Community Sites

Hollywood CasinoSeptember 12, 2015

Pharmacy Law Update 2015- G. Cameron


OBJECTIVES

• Pharmacy Inspection Problems and Preventative Actions

• Updates on “Collaborative Practice” Regs

• PIC responsibilities

• Recent Board of Pharmacy Actions


Items to watch from MBOP

• CEU Newly-Licensed Pharmacists- All pharmacists

who obtain an initial license to practice pharmacy in Maine by examination or by reciprocity shall complete 1.25 hours of continuing pharmacy education for each month following initial licensure through December 31 of the calendar year in which they were initially licensed.

Licensed today- then next month Oct, Nov, Dec (3x1.25)= 3.75CEU

Board website shows 5CEU

What do you do?????

Inspection Issues

Expired Licenses

Biennial Inventory

Outdated Inventory on the shelf (50%)

Video Cameras (talk more about this)

Other drugs being diverted since Vicodin switch


Items to watch from MBOP• Security Cameras• A retail pharmacy shall deploy security cameras

sufficient in number to monitor the critical areas of the pharmacy department, including, at a minimumo prescription filling areao self-service customer kioskso dispensing machines that are part of an automated

pharmacy systemo controlled drug storage areaso checkout areao compounding area (if applicable)o Shall operate continuously 24 hours per dayo 30 days of storage


Items to watch from MBOP

Administration of Vaccines by Pharmacy Intern

o A pharmacy intern who is under the direct supervision of a pharmacist holding a certificate of administration and has obtained the drug administration training required by 32 MRSA §13832(3) may administer drugs and vaccines to a person 18 years of age or older.


MBOP Recent Actions

• Reporting PIC changes

Accounted for the majority of complaints heard at board in the past few months.

$250/week x3 weeks then $500/week x 3 weeks, then $1000 per week after that!

Just heard a complaint against a pharmacy that was $28,000!


MBOP Recent Actions (Cont.)

Pharmacist giving an Influenza Shoto Patient comes to counter to get Flu Shoto Observes pharmacist go straight from working to

drawing out the doseo Patient indicates on a blood thinnero Pharmacist gives shot with NO gloveso Patient starts bleeding and pharmacist uses

cotton ball and bandageo Patient counseledo Pharmacist goes straight back to work without

washing hands



Pharmacist giving an Influenza Shot (Cont.)

o What regulations (if any) have been violated



• Diversion Theft from pharmacy stock bottles Theft from waiting prescriptions

Patients coming back and complaining about being short

Review video recordings May have to re-adjust the camera or add Technicians carrying filled bags around

Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules

Over important steps remaining on these proposed rules

Go over each section (some really briefly)

Required Training

CEUs


Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)

Collaboration in developing these rules-o Maine Board of Pharmacyo Maine Board of Licensure in Medicine

NOT GOING TO A PUBLIC HEARING!!!!!o Difficult in getting times together for both boardso Extended public comment sessiono Will post dates for public comment on MPA

Websiteo Board voted unanimously to send these rules to

AG’s office for review.Pharmacy Law Update 2015- G. Cameron


Definitions:o Board- means Maine Board of Pharmacyo Collaborative drug therapy management- defined

in 32 MRS § 13702-A(2A)o Collaborative practice agreement- defined in 32

MRS § 13702-A(2-B)o Practitioner- defined in 32 MRS § 13702-A(29)o Qualifying condition- means a condition or

disease with generally accepted standards of care, which may include the following examples:



Definitions (Cont.) Qualifying Conditions:o Anticoagulationo Asthmao Diabeteso Dyslipidemiao Hyperlipidemiao Hypertensiono Infectious Diseaseo Cancero Thyroid Disorder



Definitions (Cont.)

o Treatment protocol- referenced in 32 MRS § 13845o Unrestricted pharmacist license- means that the

authorized scope of practice of pharmacy granted to the pharmacist pursuant to his or her license has not been limited



Applicationo In order to enter into a collaborative practice

agreement with a practitioner, a pharmacist must meet the qualifications set forth in 32 MRS § 13842. Possesses certification from the Board of Pharmacy

Specialties, or completed an accredited residency program

PharmD, 2 years professional experience, and at least 15 hours of CEU in that practice area

BS Pharmacy, 3 years professional experience, and at least 15 hours of CEU in that practice area



Application(Cont.)

o The 15 hours of CE referred to in 32 MRS § 13842(2)(A)(B)(C) must be obtained by the pharmacist within the TWO years preceding the date of the application

Application Submission

o Pharmacist must submit to the Board an application form and other information the Board might require



Collaborative Practice Agreement Submissiono Prior to the commencement of the collaborative

practice: Submit a copy of the collaborative practice

agreement to both the Board of Pharmacy and the Board that licenses the practitioner

Copy of treatment protocols



Collaborative Practice Agreement Content- must contain the following:o Provision that states the activity in the initial 3

months of this agreement is limited to monitoring drug therapy

o After 3 months practitioner & pharmacist meet to review and determine the scope of the agreement



Collaborative Practice Agreement Content- must contain the following(Cont.)

o Can include the pharmacist’s initiating, monitoring, modifying, and discontinuing a patient’s drug therapy and

o Reporting these actions to the practitioner in a timely manner

o Identification and signatures of the parties involvedo Beginning and ending dateso Provision that allows either party to cancel the

collaborative agreement by written notificationPharmacy Law Update 2015- G. Cameron



o Specification of the site and setting where this will take place

o Specification of the qualifications of the participants in the agreement

o Detailed description of types of diseases, drugs or drug categories involved and drug therapy management allowed in each patient’s case

o Procedure for the referral of each patient to the practitioner




o Plan for measuring and assessing patient outcomeso Proof liability insurance is maintained by all partieso Specific identification of the treatment protocols

that will be utilized under this agreemento Provision that states the agreement will terminate

immediately in the event that the pharmacist no longer hold an unrestricted pharmacist license

o Provision that states the agreement will terminate upon the death of a party to the agreement




o Provision that states how the continuity of care for patients will be handled in the event that the agreement suddenly terminates

o These are the minimum requirements



Treatment Protocol Contento Informed Consent Procedures

Procedures for obtaining the informed consent from each patient

o Scope of Activities A description of the activities the pharmacist is

authorized to engage ino Documentation

A description of the manner in which the pharmacist shall document all activities



Treatment Protocol Content (Cont.)

o Communication A description of the procedures the pharmacist shall

follow for reporting activities and results to the practitioner Time frame in which the pharmacist must relay

normal test results

• Not to exceed one week for normal results

• 24 hours for abnormal results Time frame for reporting adverse drug events

• Not to exceed 24 hoursPharmacy Law Update 2015- G. Cameron


Treatment Protocol Content (Cont.)

o Supervision Provision that allows the practitioner to override

a decision by the pharmacist when appropriate Provision that provides for periodic review and

revision of the drug therapy management by the practitioner and pharmacist



Notifications-o Pharmacist shall notify the both Boards of the

occurrence of any of the following changes within 10 days after the change Change in collaborative agreement Change in treatment protocol Change in liability Insurance

Recordkeeping Requirementso See Chapter 24 of the MBOP Rules



Complaintso Information can be shared between the Boards

Duty to Report Disciplinary Actiono Any party to a collaborative practice agreement

whose license is subject to disciplinary action shall report to all other parties in the agreement and the licensing boards

o Guess how long???????o 10 days


• Reporting Other Changes Name changes (Marriage or Divorce) Address changes (including email) Pharmacy Technician changes Graduation from pharmacy school

Conviction of a crime Time allotted for reporting these changes How long to REPORT to MBOP

10 days

NOTIFICATIONS REQUIRED TO MBOP


Theft or Drug-Related Misconduct of Pharmacy Intern

The preceptor shall notify the board via letter, fax or email of any resignation or discharge from an internship program or termination of employment for any of the following reasons, provided that the report shall be made by a pharmacist in charge or supervising pharmacist if the reason for the resignation, discharge or termination arose outside of the IPPE/APPE

• Notice shall be provided within 48 hours after the termination:

o 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.


Pharmacist in Charge

• Responsibilities

o The pharmacist in charge is responsible legally and professionally for all activities related to the practice of pharmacy within the retail pharmacy for which the licensee is registered as pharmacist in charge


• The responsibilities of the pharmacist in charge include, but are not limited to:

o The pharmacy’s procedures for the procurement, storage, compounding and dispensing of drugs;

o The recordkeeping systems required in the practice of pharmacy for the purchase, sale, possession, storage and repackaging of drugs;

o The security of the prescription filling area and its contents;


o Notifying the board of termination of status as pharmacist in charge via letter, fax or email within 7 days of the termination;

o The supervision of pharmacy technicians and performance of administrative responsibilities

o Ensuring that each pharmacist employed at the pharmacy for which the pharmacist in charge is responsible is licensed with the board.

The responsibilities of the pharmacist in charge include, but are not limited to: (Cont.)

• 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

• 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 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:

o adulteration, abuse, theft or diversion;o Theft of non-drug merchandise; oro Theft of cash or credit/debit card data.


Notice of Employment and Non-Employment of Pharmacy Technicians

pharmacy law update 2015 gregory cameron, r.ph assistant professor of pharmacy practice husson...

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