Massachusetts Pharmacy Regulation Study Guide PDF

Jurisprudence Exam II Study Guide Exam Date: August 10, 2023 Lectures 11 and 12 Massachusetts Pharmacy Regulation (23 Questions) Laws/Topics Notes # Qs M.G.L c. 13, 22-25 M.G.L. c. 94C § 6 MA Pharmacy Board Members Exemptions to membership requirements and terms M.G.L c. 94C § 6: gives the board...

Jurisprudence Exam II Study Guide Exam Date: August 10, 2023 Lectures 11 and 12 Massachusetts Pharmacy Regulation (23 Questions) Laws/Topics Notes # Qs M.G.L c. 13, 22-25 M.G.L. c. 94C § 6 MA Pharmacy Board Members Exemptions to membership requirements and terms M.G.L c. 94C § 6: gives the board the authority to promulgate regulations regarding the manufacture, distribution, dispensing, and possession of controlled substances MGL c. 13 § 22: the Board of Registration in pharmacy, including membership, qualifications, appointment, term, and ethics 1. The governor shall appoint 13 members to the board 2. Members must be residents of the commonwealth 3. Members of the board cannot have been convicted of a felony or other crime involving embezzlement, theft, fraud, or perjury 4. Includes the mission of the board and the composition of the members a. Mission of the board is to protect the public through the regulation of the practice of pharmacy 13 Board Members: a. 8 Pharmacists i. 2 chain pharmacists ii. 2 independent pharmacists iii. 1 hospital pharmacist iv. 1 academia pharmacist v. 1 sterile compounder vi. 1 LTCF pharmacist b. 1 physician c. 1 nurse d. 1 pharmacy technician e. 2 members of the public i. 1 with experience in patient safety and quality improvement ii. 1 with experience in healthcare delivery, administration, or consumer advocacy Terms: 3 years, maximum of 2 consecutive terms Experience: Members must have at least 7 consecutive years of experience in the practice of pharmacy and shall currently b employed in the practice of pharmacy in the commonwealth Board of Pharmacy staff: executive director, associate director, director of compliance, quality assurance pharmacist, board counsel, administration Office of Public protection: includes director of investigations, compliance officer, investigators (full time, contractors) The Board oversees consumer protection: complaints, quality related events, consumer complaints, self-reported, abnormal results, probation monitoring, drug loss/diversion, inspections (sterile 797, 3 non-sterile 975, and routine with 795 section for simple non-sterile compounding) M.G.L. c.112 §24A 247 CMR 3 Licensing of RPh Scope of Practice M.G.L. c. 112 §24-42: Pharmacy Personnel Licensure M.G.L. c. 112 §24 and 247 CMR 3.01: Pharmacist Licensure In order for a pharmacist to be registered in MA, they must: a. Be at least 18 years old b. Earned a qualifying degree in pharmacy from a college/school of pharmacy accredited by the ACPE or approved by the board c. Have completed 1500 hours of practical experience as a pharmacy intern under the supervision of a pharmacist preceptor d. Be of good moral character e. Pass the NAPLEX and MPJE (75%+) A non-ACPE accredited school (foreign graduate) may be eligible if: a. The received official Foreign Pharmacy Graduate Examination Committee (FPGEC) Certification b. Have submitted official copy of the FPGEC Certificate to the board c. Board has received notification from NABP of the applicant's FPGEC Certification 247 CMR 3.02: Licensure by Reciprocity, the board may approve an application for licensure to an applicant who: a. Is licensed by examination in another state b. Is in good standing in all states where they are registered Licensure by reciprocity can be approved provided that the other state requires a degree of competency equal to that required of Massachusetts and that Massachusetts recognizes the other state for purposes of licensure by reciprocity Scope of Practice (Policy 2020-15) Testing: no aspects of testing may be conducted within a pharmacy’s licensed prescription area, including the counter Telepharmacy: Limited to remote pharmacist clinical activities and verification of final patient-specific products 1. Unless provided in conjunction with a prescription filled in a non-resident pharmacy, a non-resident pharmacist must be licensed in MA to provide cognitive services to a MA patient 2. The practice for having a pharmacy technician fill and dispense a prescription without a pharmacist on site is not allowed Veterinary drugs: Pharmacists are prohibited by federal law to recommend a human OTC drug for an animal unless there is a prescription or documentation from a veterinarian. Pharmacists may compound Schedule VI emergency medications for veterinary office use Immunizations: 1. Authorized vaccinations: FDA approved and recommended by ACIP and CDC 1 2. Pharmacy personnel may only administer vaccinations to individuals who are 5 years and older 3. Pharmacists and interns must take an ACPE accredited training course prior to administering vaccines a. Pharmacy technicians must meet additional requirements 4. Communication of the vaccine administration must be sent to the patient’s PCP 5. Reporting of adverse events is required 6. Vaccine storage and handling (drawing up for future use is considered sterile compounding and must be done in compliance with 797) M.G.L. c.112 §24C & §24G 247 CMR 8 Pharmacy Interns and Technicians Interns, Technicians (Registered, Certified, Trainee), Requirements for Registration Authorized Duties Ratios and Handling CIIs 247 CMR 8: Support personnel (Interns and Technicians) Pharmacy Intern (247 CMR 8.01) To be eligible for personal registration as a pharmacist, the registrant must have completed a pharmacy internship Interns must have: 1. Completed 2 years of education or achieved standing as a student beyond the second year in an approved college/school of pharmacy in which the candidate is currently enrolled 2. Completed 15000 hours of board approved pharmacy internship experience 3. Direct supervision via a registered pharmacist preceptor A pharmacy intern may receive up to 12 hours of credit per day A pharmacy intern who has graduated from their school may continue to be an intern until he or she becomes a pharmacist The pharmacy intern must wear a name tag with their first name and “Pharmacy Intern” A pharmacy intern acting under the direct supervision of a pharmacist may supervise pharmacy technicians Pharmacy Intern Scope of Practice: a Pharm D graduate who has accepted a residency in MA shall hold a MA Pharmacy Intern License (and be supervised by a pharmacist) until they obtain a MA Pharmacist License An intern must be directed supervised by a pharmacist at all times (a pharmacist may not supervise more than 2 interns at a time) Exception: a pharmacist may directly supervise up to 4 interns at one time IF they are not in a pharmacy or engaged in the filling/dispensing of prescriptions OR if they are exclusively conducting immunization clinics Pharmacy Technician Trainees (247 CMR 8.03) A pharmacy technician trainee must be: 1. At least 16 years of age 2. Be a high school graduate or currently enrolled in a program which awards such degree 3. Be of good moral character 4. Has not been convicted of a drug related felony or admitted 4 to sufficient facts to warrant such findings 5. Wearing a name tag with the individual’s first name and title A pharmacy technician trainee can perform the same duties as a pharmacy technician while receiving training and while under the direct supervision of a pharmacist with the exception of taking prescriptions over the phone Pharmacy Technician (247 CMR 8.02) A pharmacy technician must be: 1. At least 18 years of age 2. Be a high school graduate or currently enrolled in a program which awards such degree or certificate 3. Be of good moral character 4. Has not been convicted for a drug-related felony or admitted to facts that warrant such findings 5. Successfully completed a board approved pharmacy technician training program and passed a board approved exam, OR a. Has successfully completed 500 hours of employment as a trainee and passed a board approved exam A pharmacy technician may relay to the patient the pharmacist’s offer to counsel With approval of the pharmacist on duty, the pharmacy technician may request and accept authorizations for refills from a prescriber and a prescriber’s agent provided that no information has changed from the original prescription A pharmacy technician may not: 1. Administer medications or vaccines 2. Perform DURs 3. Conduct clinical conflict resolution 4. Contact prescribers concerning therapy clarification or modification 5. Provide patient counseling, or perform final validation at dispensing Certified Pharmacy Technician must wear a name tag with the individual's first name and title A certified pharmacy technician may relay the pharmacist’s offer to counsel to the patient After identifying themselves to the provider as a certified pharmacy technician, they may request refill authorizations, and with the approval of the pharmacist, receive new or omitted informations regarding an existing prescription A certified pharmacy technician may, with approval from the pharmacist on duty, perform transfers between pharmacies for prescriptions issued for controlled substances in Schedule IV only A certified pharmacy technician may not: 1. Administer controlled substances 2. Perform DUR 3. Conduct clinical conflict resolution 4. Contact prescribers concerning prescription clarification or therapy modification 5. Provide patient counseling 6. Perform final verification during dispensing Additional Considerations: Controlled Substance Handling Accountability for and security of Schedule II controlled substances is the direct responsibility of the pharmacist Under the supervision of a Pharmacist: 1. A pharmacy technician may assist in the transporting of schedule II substances 2. A certified pharmacy technician may assist in the transporting and handling of schedule II medications A certified pharmacy technician, a pharmacy technician, or a pharmacy technician trainee may never handle any hydrocodone-only ER medication that is not in abuse deterrent form a. Only Pharmacy Interns may handle this medication under the direct supervision of a pharmacist Supervisory Ratios (247 CMR 8.06) -Generally, 2:1 (2 technicians to one pharmacist) -May increase to 3:1 if one of the support personnel is an intern or a certified pharmacy technician -May increase to 4:1 if at least 1 of the support personnel is a CPhT and 1 is an intern OR 2 are CPhT OR 2 are interns Note: salesclerks, messengers, delivery personnel, secretaries are not included in the ratios as long as they are not supporting the pharmacist in any professional capacity Stocking an automated dispensing device (ADD) (Policy 2023-08) General Requirements 1. These activities may only occur in healthcare facilities if they have on-site pharmacies and the ADDs are at the same physical address as the facility 2. The pharmacy must have internal policies in place with respect to permitted activities, which includes training requirements 3. A licensed HCP must use an barcode scanner or other electronic verification to product verification upon removal or administration 247 CMR 9 Related MA BORP Policies Code for professional conduct and professional standards 247 CMR 9: Code for Professional Conduct and Professional Standards for Pharmacists, Pharmacies, and Pharmacy Departments Scope of Practice Responsibilities: 1. A pharmacist is responsible for the proper preservation and security of all drugs in the pharmacy, including proper refrigeration and storage 2. A pharmacist may not limit his services to a particular segment or segments for the general public 3. A pharmacist must keep a perpetual inventory of each CII 5 Related Board Policies received, dispensed, or disposed of at least once every 10 days 247 CMR 9.04(8): A pharmacist may not fill or dispense a prescription for ER hydrocodone only medications not in an abuse deterrent form unless: 1. The medication is stored in a securely locked/substantially constructed cabinet 2. The medication is provided with a child safety cap or a within a locked box 3. The prescriber provides a Letter of Medical Necessity 4. The prescription is dispensed with a statement of the dangers of the medication 5. The pharmacist provides counseling that includes a review of the written warning 6. The Pharmacist verifies the patient’s fill history with PMP 247 CMR 9.06: Verifying a prescriber’s prescriptive authority A prescription may only be filled if the pharmacist determines: 1. The prescription is issued with a valid patient/practitioner relationship and for legitimate medical purpose by an authorized prescriber acting in the course of their professional practice 2. The prescription is authentic 247 CMR 6 Related MA BORP Policies Registration, management and operation of a pharmacy or pharmacy department 247 CMR 6: REgistration, Management, and Operation of a Pharmacy or Pharmacy Department Operational Requirements: 1. Prescription area a. Square footage- not less than 300 square feet b. Consultation area- must have a designated consultation area with signage stating “Patient consultation area” designed for adequate privacy (visual and auditory) and must be accessible outside of the dispensing area 2. Signage a. Lock boxes- the pharmacy must have a sign on or near the pharmacy counter that is at least 4x5 inches and states: “lock boxes for securing your prescription medications are available at this pharmacy” b. Counseling- a sign not less than 11x14 inches must be posted in a conspicuous place next to the dispensing area that states, “Dear patients, you have the right to know about proper use of your medication and its effects. If you need more information, please ask the pharmacist.” c. A pharmacy must have a reasonably sized sign at the main entrance of the building identifying that it is a pharmacy d. A pharmacy must display next to the main entrance the name of the manager of record (not less than 1 inch letters) e. Hours of operation- prominently posted at all (Exclude 247 CMR 6.01(5)(c) CIVAS)) Related Board Policies 5 consumer entrances and at the main retail entrance, if applicable f. Items conspicuously displayed and prominently posted: pharmacy’s permit, pharmacy’s MA controlled substance registration, pharmacy’s US DEA registration, and pharmacy’s certificate of fitness 3. Manager of Record Responsibilities: establishment, monitoring, and enforcement of all policies and procedures which maintain the standards of professional practice including proper supervision of technicians a. Examples: security of CS, supervision of support staff, inventory of CS, theft and loss, proper destruction and disposal of drugs, policies and procedures, required references, and maintenance of equipment b. A licensed pharmacist who signs the application for pharmacy permit and assumes full legal responsibility for operation of the pharmacy. The individual pharmacist can be disciplined if the pharmacy is found to be in violation of any laws or regulations. c. Change in MOR: a complete and exact count of all CII-V must be taken and filed with the pharmacy’s controlled substance records (must be completed with 2 pharmacists) 4. Required References and Equipment a. A current copy or electronic version of the Massachusetts List of Interchangeable Drugs, including the orange book, additional list, and exception list b. A current copy or electronic version (with quarterly updates) or a compendia applicable to the practice setting c. A scale that can weigh amounts as small at 13 mg (annually inspected and certified) d. All the necessary equipment to conduct compounding per USP e. Prescription labels with the name and address of the pharmacy f. Appropriate sanitary appliances, including a sink with hot and cold water next to the dispensing area g. A book for recording over the counter sales of controlled substances h. A book for recording the sales of alcoholic beverages 5. Inspection/Plan of Correction 247 CMR 6.14: Duty to report improper dispensing to the board A pharmacy has a duty to report within 15 business days the improper dispensing of a prescription drug that results in serious injury or death Duty to Inform: Prior Authorizations Pharmacists must notify the patient and the healthcare provider when health insurance informs the pharmacy that a prior authorization is required to be filled out by the physician prior to dispensing the medication Proper Storage of Refrigerated and Frozen Medications (Board Policy 2020-5) 1. Freezer must be frost free with an automatic defrost cycle 2. A unit that contains a freezer component within the refrigerator space is not allowed 3. Utilize thermometers that have a certificate of calibration 4. Development of a policy to handle maintenance, monitoring, and cleaning of the equipment as recommended by the manufacturer 5. Establish a backup plan to assure proper storage of refrigerated or frozen medications in the event of a power failure or other unforeseen circumstance Compliance Packaging and Reusable Dose Planner (Board Policy 2023-01): At the patient's request, medications may be dispensed in a reusable daily dose planner provided that certain requirements are met (single drug-single dose and multi drug-single dose) Automated Pharmacy Systems (Board Policy 2022-07): an automated patient-facing device that performs operations or activities other than compounding or administration. The APS releases medications after the patient has been identified. The APS must: 1. Be secure and monitored via video surveillance 2. May not be stocked with refrigerated or frozen medications 3. Must collect the identify of the person to whom the medication is released in addition to all PMP information for Schedule IV-VI 4. Use technological verification 5. Patient chooses whether to use APS or not 6. Pharmacy must provide offer to counsel for new or changed therapy 7. Must maintain policies and procedures Automated Dispensing Device Use (Board Policy 2019-02): a mechanical system designed for use in healthcare facilities allowing for computer controlled storage and dispensing of drugs and devices to health care professionals near the point of care ADDs must: 1. Remain the property of the pharmacy, including its contents 2. Have adequate and appropriate policies, procedures, and QA programs to assure safety, accuracy, security, accountability, patient confidentiality, and proper functioning 3. Restricted access 4. Patient-specific or order-specific dispensing 5. Records must be maintained 6. Medications must be in the manufacturers sealed original packaging or repackaged in accordance with professional standards 7. Medication losses must be reported M.G.L. c112 §24A 247 CMR 4 MA BORP Policy 2018-03 Pharmacist Continuing Education (CE) Requirements M.G.L. c. 112 §24A: Pharmacist Continuing Education Requirements If the pharmacist is seeking renewal of their license, they must complete the following continuing education requirements: 1. A minimum of 20 contact hours each calendar year (2 year renewal cycle) 2. If the pharmacist is overseeing or engaged in the practice of sterile compounding, they shall devote at least 5 of the 20 contact hours to the area of sterile compounding 3. If the pharmacist is overseeing or directly engaged with complex non-sterile compounding, they shall devote at least 3 of the 20 hours to the area of complex non-sterile compounding 247 CMR 4: RPh Continuing Education Requirements 1. No more than 15 hours per calendar year can be done via home study or other mediated instruction! Aka, the pharmacist must complete at least 5 hours live 2. The pharmacist must complete at least 2 contact hours per year in pharmacy law 3. Complete 5 additional contact hours that address the areas of practice generally related to the CDTM (collaborative practice) agreement during each year, if applicable 4. A pharmacist who oversees or is engaged in administration of vaccines must complete at least 1 contact hour of immunization training per calendar year (2 hours per 2 years) The board accepts 3 types of contact hours: ACPE, CME category 1, and Board Approved programs Pharmacists must retain documentation of completed continuing education requirements A registrant may not earn more than 8 hours of CE per day ACPE Course Numbering 1. Identifies the CPE provider 2. How the program was developed a. 0000: the provider developed the program alone b. 9999: the provider partnered with another provider 3. Two digit year in which the program was first released 4. Internal numbering code the provider uses to keep track of the program 5. Type of program a. L: live activities b. H: home study c. 01: Drug therapy d. 02: HIV/AIDs therapy e. 03: Law f. 04: General Pharmacy g. 05: Patient safety h. 06: Immunizations i. 07: Compounding 6. Target audience a. P: Pharmacist 4 b. T: Technician Additional Information: Contact hours may not be carried over for one calendar year to another (247 CMR 4.03(5)) A pharmacist who is a board approved instructor may only receive CE credit for the course taught one time per year (247 CMR 4.07) A registered pharmacist who is enrolled in a post-graduate program approved by the board shall be awarded contact hours with each completed course if the course covers one or more of the following topics: pharmacy, pharmaceutical sciences, pharmacy practice, and pharmacy law (247 CMR 4.08) Exceptions and Extensions to CE Requirements: 1. Newly licensed pharmacists: a registrant shall not be required to complete CE in the calendar year in which the registrant has graduated from an approved school 2. Military (Active): registration remains valid for a pharmacist engaged in active duty military service for 90 days after the release of the registrant from active duty. The CE requirements shall not apply to the two year cycle (on an even numbered year) if the registrant is engaged in active service after October 1 of that year 3. Recent Reciprocation: pharmacist who have gained their MA license via reciprocation on or after October 1 will be granted a grace period through April 30th of the following year to obtain all CE requirements from the previous year 247 CMR 15 Continuous Quality Improvement 247 CMR 15: Continuous Quality Improvement CQI programs mean a system of standards and procedures to identify and evaluate quality related events and improve patient care Each pharmacy shall establish a CQI program for the purpose of detecting, documenting, assessing, and preventing QREs CQIs must have: 1. Designated individual(s) to monitor the program 2. Identify and document QREs 3. Minimize impact of QREs on patients 4. Analyze data collected in response to QREs for contributing factors 5. Use the findings of the analysis to formulate an appropriate response to prevent QREs 6. Provide ongoing education at least annually regarding the CQI QRE: the incorrect dispensing of a prescribed medication that is received by the patient (a variation from the prescriber's order) Includes: dispensing an incorrect drug/drug strength/dosage form, dispensing to the wrong patient, providing inadequate or incorrect packaging, labeling, and directions QREs also induce failure to identify and manage: overutilization, therapeutic duplication, drug-disease CIs, drug-drug interactions, incorrect dose or duration of treatment, drug-allergy interactions, or clinical abuse/misuse 1