POLICY 98-001
Policy on Technicians and Refill Authorizations

The Board of Registration In Pharmacy recognizes the ability of trained technicians to telephone a prescriber's office in order to request refill authorizations for patients. It is the Board's policy to allow trained technicians to request refill authorization from a prescriber's office when, and only when, that office uses a voice mail response system and/or when the agent of the prescriber transcribes the requested information for a follow-up phone call to the pharmacist after reviewing the request with the prescriber.

For the purpose of this policy a trained technician must have a minimum of one year, full-time pharmacy experience or be nationally certified as a pharmacy technician. The responsibility for insuring the qualifications and competence of such a trained technician rests with the Pharmacy Manager of Record or the Director of Pharmacy and must be part of the information that is required to be made available to the Board upon request, pursuant to 247 CMR 8.02(6).

Adoption: August 05, 1997
Authority: M.G.L. c. 112, § 42(A)

POLICY 98-002
POLICY ON CONTINUING EDUCATION AUDITS and COMPLIANCE

Whereas, Board of Registration in Pharmacy (Board) Regulations (247 CMR 4.03) require all pharmacists to complete continuing education credits (CEUs) to ensure continued competence; and

Whereas, pharmacists are required to renew their licenses every two years and sign the renewal application under the pains and penalties of perjury that they have completed required CEUs for the preceding two year period; and

Whereas, the Board conducts random continuing education compliance audits of pharmacists every renewal cycle and at all investigative conferences to measure compliance with the Board regulations; and

Whereas, Board Regulation (247 CMR 4.03(6)) permits pharmacists to apply to the Board for a waiver of CEU requirements due to extenuating circumstances; and

Whereas, compliance with continuing education regulatory requirements is MANDATORY and integral to the Board's effort to assure the continuing competence of pharmacists.

NOW THEREFORE, it shall be the policy of the Board that the following procedures and sanctions shall apply when pharmacists fail to comply with continuing education requirements for license renewal.

FIRST Continuing Education Audit Deficiency

  1. If, on initial audit, the Board finds a pharmacist to be deficient in satisfying continuing education requirements for license renewal by less than 0.5 CEUs (5.0 contact hours) in any calendar year, the pharmacist will be required to complete 0.3 CEUs (3.0 contact hours) for EACH deficient contact hour of credit, all such required contact hours to be completed as directed by the Board.
  2. If, on initial audit, the Board finds a pharmacist to be deficient in satisfying continuing education requirements for license renewal by 0.5 or more CEUs (5.0 contact hours) in any calendar year:
    1. the pharmacist will be required to complete 0.3 additional CEUs (3.0 contact hours) for EACH deficient contact hour of credit, all such required contact hours to be completed as directed by the Board;
      AND
    2. the Board may open a complaint in the name of the pharmacist and initiate formal disciplinary proceedings to suspend or otherwise discipline the license of the pharmacist. The Board will consider a minimum two (2) week suspension period for a pharmacist found to be deficient by 0.5 or more CEUs.
  3. The Board will audit the pharmacist for the next three renewal cycles, with renewal of license permitted only upon documentation of compliance with 247 CMR 4.03.
  4. A pharmacist deficient in continuing education credits may also be required to comply with such other terms and conditions as the Board determines.
  5. During the period that a pharmacist is completing additional required CEUs, the license will be current and in good standing.

SECOND Continuing Education Credit Audit Deficiency

In the event a pharmacist is found to be deficient in CEUs upon subsequent audit by the Board or if the pharmacist fails to complete CEUs as required after initial audit, the Board will open a complaint in the name of the pharmacist and initiate formal disciplinary proceedings to suspend or otherwise discipline the license of the pharmacist. The Board will consider a minimum two (2) week suspension period for a pharmacist found to be deficient by 5.0 or more CEUs.

IMPORTANT NOTE: Notice of formal discipline of a pharmacist's license is reported to the National Association of Boards of Pharmacy (NABP) and the Health Care Integrity & Protection Data Bank and listed on the Division of Professional Licensure website and database. Records of complaints filed against Board licensees are public information available on request.

Original Adoption Date: January 27, 1998
Amendment: December 4, 2001
Authority: G.L. c. 112, § 42(A) and 247 CMR 4.03 (below)

247 CMR 4.03: Continuing Education Requirement

  1. As set forth by M.G.L. c. 112, § 24A, each registered pharmacist seeking personal registration renewal shall complete continuing education as a condition precedent to such renewal.
  2. No registrant shall be eligible for renewal of a personal registration without completion of the requisite number of CEUs for such renewal.
  3. A registrant seeking renewal of a personal registration shall submit to the Board with a renewal application a statement, signed under the penalties of perjury, that the applicant has satisfactorily completed a minimum of 3.0 CEUs (30 contact hours) required for such renewal.
  4. A registrant seeking renewal of a personal registration must complete a minimum of 1.5 CEUs (15 contact hours) each calendar year of the two-year renewal cycle. Of the 15 contact hours, effective for the renewal period beginning January 1, 1991:

    (a) at least two contact hours shall be in the area of pharmacy law; and
    (b) not more than ten contact hours shall be acquired through home study and other mediated instruction.

  5. No CEUs may be carried over from one calendar year to another.
  6. Notwithstanding any other provisions of 247 CMR 4.03, in the event of extenuating circumstances an applicant for renewal of personal registration who has failed to complete the requisite number of CEUs, or is unable because of a physical disability to conform to the limitation on the number of CEUs acquired through home study and other mediated instruction, shall submit to the Board a detailed statement, signed under the penalties of perjury, setting forth with detail and specificity such extenuating circumstances. In such case, the Board shall determine whether or not a renewal shall be granted. The Board shall notify the applicant of the Board's determination and its reasons therefore.
  7. Notwithstanding any other provisions of 247 CMR 4.00, CEUs shall not be required of any applicant for personal registration renewal for the period of time when the applicant was actively serving in the Armed Forces of the United States or in the Public Health Service of the United States, unless the applicant was actively practicing pharmacy independent of said Armed Forces or Public Health Service.
  8. A registrant may not earn more than eight hours of continuing education in a calendar day.
  9. A registrant shall not be required to complete continuing education in the calendar year in which the registrant has graduated from an approved college/school of pharmacy.

POLICY 98-003
Policy on Computerized Compendia

It shall be the policy of the Board that compendia requirements at 247 CMR § 6.01(6)(a)(1),(2),(3) et seq may be met by utilizing a current computerized version provided that any such computerized version provides for information to be updated at least quarterly.

Adoption Date: November 04, 1997
Authority: G.L. c. 112 § 42(A)

POLICY 98-004
Continuing Education Policy for Non-Traditional Pharm. D. Programs

Policy on Continuing Education Requirements for students in non traditional pathways leading to a Pharm.D. degree.

It is the policy of the Board that a registered pharmacist enrolled in a non-traditional pathway, at an ACPE accredited non-traditional Doctor of Pharmacy program, leading to a Pharm.D. degree, may be exempt from continuing education requirements provided that the courses taken at an A.C.P.E. accredited non-traditional Doctor of Pharmacy program provide at least one-semester hour of credit per semester and provided that the college transcript is sent to the Board upon request.

Unless any such program contains a law component, and unless the courses are administered in live or mediated instruction, the registered pharmacist must still complete two hours of law each year and five hours live instruction pursuant to 247 CMR § 4.03(4)(a),(b).

Adoption date: January 27, 1998
Authority: G.L. c. 112, § 42(A)

POLICY 98-005
Policy on Automated Dispensing Devices

It is the policy of the Board that health system pharmacies which utilize an automated drug delivery system for the dispensing of prescription drug products follow the guidelines proposed by the Board and the Department of Public Health, Division of Drug Control on January 13, 1998 (guidelines attached).

Adoption Date: June 09, 1998
Authority: G.L. c. 112, § 42(A)

POLICY 98-006
Policy on Canadian Council On Continuing Pharmaceutical Education(CCCEP)

The Board recognizes that there are Massachusetts registered pharmacists practicing in the Canadian Provinces who may have difficulty in fulfilling Board requirements at 247 CMR § 4.03(4)(b), which require that a registered pharmacist seeking renewal must complete not more than ten contact hours,of the fifteen hours required, through home study or other mediated instruction. The Board also recognizes that programs approved by The Canadian Council On Continuing Pharmaceutical Education (C.C.C.E.P.) follow similar guidelines to the programs approved by The American Council On Continuing Education ("ACPE"). Therefore it is the policy of the Board to grant approval to pharmacists maintaining dual licensure in Massachusetts and a Canadian Province, for five, live contact hours annually of CCCEP approved programs.

Adoption: December 16, 1997
Authority: M.G.L. c. 112, § 42(A)

POLICY 98-007
Policy on Hospital Volunteers

Rescinded by vote on August 8, 1998

POLICY 98-008
Policy on Emergency Kits

It is the policy of the Board that pharmacies supplying emergency medication kits in compliance with Department of Public Health Regulations at 105 CMR§§ 150.008(E)(F)(G), shall follow the list approved by the Department on September 12, 1997, and adopted by the Board on January 13, 1998.

On November 01, 2004, the Department revised the List of Controlled Substances in Schedule II-VI Approved for inclusion in Long-Term Care Facilities Emergency Kits. ( guidelines attached)

Adoption: January 27, 1998
Amended: November 1, 2004
Authority: M.G.L. c. 112§ 42(A)

POLICY 98-009
Policy on Probationary License Status

It is the policy of the Board that should a registered pharmacist licensee be placed upon probationary status, the registered pharmacist shall not be approved to act in the capacity of Manager-Of-Record of a retail pharmacy/ pharmacy department or Director of Pharmacy of an institutional pharmacy, clinic pharmacy or other health system pharmacy department, until such time as the registered pharmacist licensee has applied for, and has been approved by the Board, for a removal of said probationary status.

Adoption: January 27, 1998
Authority: M.G.L.c. 112 § 42(A)

POLICY 98-010
Policy on Extended Leave

It is the policy of the Board that when a registered pharmacist Manager-of- Record of a retail pharmacy/pharmacy department, Director of Pharmacy of a institutional pharmacy, clinic pharmacy or other health system pharmacy department is intending to be away from the position greater than thirty days, an interim manager must be appointed and a controlled substance inventory taken, which must be signed by both the present manager as well as the interim manager. In the event that the registered pharmacist Manager-of-Record or Director of Pharmacy is away from the position for one-hundred days or more, a new application must be submitted to the Board for a change in Manager-of-Record and appropriate inventories must be taken pursuant to 247 CMR § 6.03(1) et seq.

Proposed for review on January 13, 1998, January 27, 1998, February 10, 1998, March 10, 1998.

Adoption: March 31, 1998
Authority: M.G.L. c. 112 § 42(A)

POLICY 98-011
Policy on Customized Patient Packaging

It is the policy of the Board that when a pharmacist dispenses prescription drugs in patient systems containing two or more drugs in the same compartment, that the pharmacist shall follow United States Pharmacopeia guidelines for "Customized Patient Medication Packages", except where otherwise prohibited .

Customized Patient Medication Packages

In lieu of dispensing two or more prescribed drug products in separate containers, a pharmacist may, with the consent of the patient, the patient's caregiver, or a prescriber, provide a customized patient medication package (patient med pak).
A patient med pak is a package prepared by a pharmacist for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. The patient med pak is so designed or each container is so labeled as to indicate the day and time, or period of time, that the contents within each container are to be taken.
It is the responsibility of the dispenser to instruct the patient or caregiver on the use of the patient med pak.

Label

(A) The patient med pak shall bear a label stating:

(1) the name of the patient;
(2) a serial number for the patient med pak itself and a separate identifying serial number for each of the prescription orders for each of the drug products contained therein;
(3) the name, strength, physical description or identification, and total quantity of each drug product contained therein;
(4) the directions for use and cautionary statements, if any, contained in the prescription order for each drug product therein;
(5) any storage instructions or cautionary statements required by the official compendia;
(6) the name of the prescriber of each drug product;
(7) the date of preparation of the patient med pak and the beyond-use date or period of time assigned to the patient med pak (such beyond-use date or period of time shall be not longer than the shortest recommended beyond-use date for any dosage form included therein or not longer than 60 days from the date of preparation of the patient med pak and shall not exceed the shortest expiration date on the original manufacturer's bulk containers for the dosage forms included therein); alternatively, the package label shall state the date of the prescription(s) or the date of preparation of the patient med park, provided the package is accompanied by a record indicating the start date and the beyond-use date;
(8) the name, address, and telephone number of the dispenser (and the dispenser's registration number where necessary); and
(9) any other information, statements, or warnings required for any of the drug products contained therein.

(B) If the patient med pak allows for the removal or separation of the intact containers therefrom, each individual container shall bear a label identifying each of the drug products contained therein.

Labeling - The patient med pak shall be accompanied by a patient package insert, in the event that any medication therein is required to be dispensed with such insert as accompanying labeling. Alternatively, such required information may be incorporated into a single, overall educational insert provided by the pharmacist for the total patient med pak.

Packaging - In the absence of more stringent packaging requirements for any of the drug products contained therein, each container of the patient med pak shall comply with the moisture permeation requirements for a Class B single-unit or unit-dose container (see Containers-Permeation <617>). Each container shall be either not reclosable or so designed as to show evidence of having been opened.

Guidelines - It is the responsibility of the dispenser, when preparing a patient med pak to take into account any applicable compendial requirements or guidelines and the physical and chemical compatibility of the dosage forms placed within each container, as well as any therapeutic incompatibilities that may attend the simultaneous administration of the medications. In this regard, pharmacists are encouraged to report to USP headquarters any observed or reported incompatibilities.

Recordkeeping - In addition to any individual prescription filing requirements, a record of each patient med pak shall be made and filed. Each record shall contain, as a minimum:

(1) the name and address of the patient;
(2) the serial number of the prescription order for each drug product contained therein;
(3) the name of the manufacturer or labeler and lot number for each drug product contained therein;
(4) information identifying or describing the design, characteristics, or specifications of the patient med pak sufficient to allow subsequent preparation of an identical patient med pak for the patient;
(5) the date of preparation of the patient med pak and the beyond-use date that was assigned;
(6) any special labeling instructions; and
(7) the name or initials of the pharmacist who prepared the patient med pak.

<671> Containers - Permeation

The tests that follow are provided to determine the moisture permeability of containers utilized for drugs being dispensed on prescription. The section Multiple-unit Containers for Capsules and Tablets applies to multiple-unit containers (see Preservation, Packaging, Storage, and Labeling under General Notices). The section Single-unit Containers and Unit-dose Containers for Capsules and Tablets applies to single-unit and unit-dose containers (see Single-unit Containers and Unit-dose Containers for Nonsterile Solid and Liquid Dosage Forms under Containers <671>). As used herein, the term "container" refers to the entire system comprising, usually, the container itself, the liner (if used), the closure in the case of multiple-unit containers, and the lidding and blister in the case of single-unit and unit-dose containers.
Where the manufacturer's unopened multiple-unit, single-unit, or unit-dose packages are used for dispensing the drug, such containers are exempt from the requirements of this test.
It should be noted that there is no special exemption for patient med paks from the requirements of the Poison Prevention Packaging Act. Thus the patient med pak, if it does not meet child-resistant standards, shall be placed in an outer package that does comply, or the necessary consent of the purchaser or physician, to dispense in a container not intended to be child-resistant, shall be obtained.

Adoption: January 27, 1998
Authority: M.G.L. c. 112 § 42(A)


This information is provided by the Division of Health Professions Licensure within the Department of Public Health.