1. PHARMACY LAW UPDATE 2015 Gregory Cameron, R.Ph Assistant Professor of Pharmacy Practice Husson University Field Coordinator, Community Sites Hollywood Casino September 12, 2015 Pharmacy Law Update 2015- G. Cameron

2. OBJECTIVES Pharmacy Inspection Problems and Preventative Actions Updates on “Collaborative Practice” Regs PIC responsibilities Recent Board of Pharmacy Actions

3. Pharmacy Law Update 2015- G. Cameron 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?????

4. Inspection Issues  Expired Licenses  Biennial Inventory  Outdated Inventory on the shelf (50%)  Video Cameras (talk more about this)  Other drugs being diverted since Vicodin switch

5. Pharmacy Law Update 2015- G. Cameron 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 minimum o prescription filling area o self-service customer kiosks o dispensing machines that are part of an automated pharmacy system o controlled drug storage areas o checkout area o compounding area (if applicable) o Shall operate continuously 24 hours per day o 30 days of storage

6. Pharmacy Law Update 2015- G. Cameron Items to watch from MBOP  Administration of Vaccines by Pharmacy Intern vaccines to a person 18 years of age or older 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.

7. Pharmacy Law Update 2015- G. Cameron 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!

8. Pharmacy Law Update 2015- G. Cameron MBOP Recent Actions (Cont.)  Pharmacist giving an Influenza Shot o Patient comes to counter to get Flu Shot o Observes pharmacist go straight from working to drawing out the dose o Patient indicates on a blood thinner o Pharmacist gives shot with NO gloves o Patient starts bleeding and pharmacist uses cotton ball and bandage o Patient counseled o Pharmacist goes straight back to work without washing hands

9. Pharmacy Law Update 2015- G. Cameron MBOP Recent Actions (Cont.)  Pharmacist giving an Influenza Shot (Cont.) o What regulations (if any) have been violated

10. Pharmacy Law Update 2015- G. Cameron MBOP Recent Actions (Cont.) 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

11. 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 Pharmacy Law Update 2015- G. Cameron

12. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  Collaboration in developing these rules- o Maine Board of Pharmacy o Maine Board of Licensure in Medicine  NOT GOING TO A PUBLIC HEARING!!!!! o Difficult in getting times together for both boards o Extended public comment session o Will post dates for public comment on MPA Website o Board voted unanimously to send these rules to AG’s office for review. Pharmacy Law Update 2015- G. Cameron

13. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  Definitions: o Board- means Maine Board of Pharmacy o 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: Pharmacy Law Update 2015- G. Cameron

14. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  Definitions (Cont.) Qualifying Conditions: o Anticoagulation o Asthma o Diabetes o Dyslipidemia o Hyperlipidemia o Hypertension o Infectious Disease o Cancer o Thyroid Disorder Pharmacy Law Update 2015- G. Cameron

15. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  Definitions (Cont.) o Treatment protocol- referenced in 32 MRS § 13845 o 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 Pharmacy Law Update 2015- G. Cameron

16. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  Application o 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 Pharmacy Law Update 2015- G. Cameron

17. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  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 Pharmacy Law Update 2015- G. Cameron

18. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  Collaborative Practice Agreement Submission o 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 Pharmacy Law Update 2015- G. Cameron

19. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  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 Pharmacy Law Update 2015- G. Cameron

20. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  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 involved o Beginning and ending dates o Provision that allows either party to cancel the collaborative agreement by written notification Pharmacy Law Update 2015- G. Cameron

21. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  Collaborative Practice Agreement Content- must contain the following(Cont.) 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 Pharmacy Law Update 2015- G. Cameron

22. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  Collaborative Practice Agreement Content- must contain the following(Cont.) o Plan for measuring and assessing patient outcomes o Proof liability insurance is maintained by all parties o Specific identification of the treatment protocols that will be utilized under this agreement o 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 Pharmacy Law Update 2015- G. Cameron

23. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  Collaborative Practice Agreement Content- must contain the following(Cont.) 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 Pharmacy Law Update 2015- G. Cameron

24. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  Treatment Protocol Content o 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 in o Documentation A description of the manner in which the pharmacist shall document all activities Pharmacy Law Update 2015- G. Cameron

25. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  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 hours Pharmacy Law Update 2015- G. Cameron

26. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  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 Pharmacy Law Update 2015- G. Cameron

27. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  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 Requirements o See Chapter 24 of the MBOP Rules Pharmacy Law Update 2015- G. Cameron

28. Rulemaking – Chapter 39 Collaborative Drug Therapy Management Proposed Rules- (Cont.)  Complaints o Information can be shared between the Boards  Duty to Report Disciplinary Action o 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 Pharmacy Law Update 2015- G. Cameron

29. 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

30. Pharmacy Law Update 2015- G. Cameron Pharmacy Intern Theft or Drug-Related Misconduct of Pharmacy Intern any resignation or discharge from an internship program or termination of employment 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.

31. Pharmacy Law Update 2015- G. Cameron 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

32. Pharmacy Law Update 2015- G. Cameron Orders for HCPs. Every DEA registrant who distributes HCPs must comply with order form requirements, pursuant to 21 U.S.C. 821, 828, 871 and in accordance with 21 CFR parts 1305 and 1307 as of October 6, 201421 U.S.C. 82121 CFR parts 1305 In other words DEA Form 222 Prescriptions. All prescriptions for HCPs must comply with all the CII requirements as of October 6, 2014 No prescription for HCPs issued on or after October 6, 2014 shall authorize any refills Any prescriptions for HCPs that are issued before October 6, 2014, and authorized for refilling, may be dispensed in accordance with 21 CFR 1306.22-1306.23, 1306.25, and 1306.27, if such dispensing occurs before April 8, 201521 CFR 1306.22 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;

33. Pharmacy Law Update 2015- G. Cameron 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.)

34. 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 within 7 days 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; or o Theft of cash or credit/debit card data. Pharmacy Law Update 2015- G. Cameron Notice of Employment and Non-Employment of Pharmacy Technicians