- 2000-01: Policy on Disease State Management Requirements - Pharmacist Credentialing Requirements
- 2000-02: Policy on Canadian Colleges/Universities of Pharmacy Education - License policy on Canadian Graduates
- 2000-03: Policy on Pharmacy Operations During the Temporary Absence of a Pharmacist
- 2000-04: Proposed Policy and Guideline for Confidentiality and Compliance Programs
- 2000-05: Policy on Board-Approved Continuing Education Programs
- 2000-06: Medication Error/Adverse Drug Event Reporting Policy
Policy on Disease State Management Requirements
Pharmacist Credentialing Requirements
It is the policy of the Board that pharmacists participating in Disease State Management Examinations sponsored by the National Association of Boards of Pharmacy ("NABP") follow the following guidelines:
Requirements for Pharmacist Credentialing in Specified
Disease State Management Areas
- An applicant must submit a formal application request to the Massachusetts Board of Registration in Pharmacy ("Board") through its elected sponsor ("Sponsoring Entity").
1.1. Should the pharmacist desire to become credentialed in more than one disease state management area, a separate application must be submitted for each practice area.
- The applicant must be a currently licensed pharmacist in good standing (amended November 16, 1999).
- The applicant must provide documentation of successful completion of an American Council on Pharmaceutical Education ("ACPE"), nationally recognized , or other Board approved, certificate program in disease state management ("approved certificate program") for each disease state management area in which the applicant is applying for credentialing. Alternatively, an applicant may document advanced standing in the specified practice area.
3.1. Applicants with advanced standing may be allowed to take the credentialing examination without the need for completion of an approved certificate program.
3.2. Applicants who request advanced standing status must attach documentation indicating the extent of their advanced standing.
3.2.1. To qualify for advanced standing status, an applicant must document credentialing as an approved provider by an organization recognized by the Board as an approved credentialing organization.
3.2.2. Advanced standing status may also be granted by the Board through its Sponsoring Entity, if the applicant can document to the satisfaction of the Board that the applicant has accrued at least one year part-time experience totaling a minimum of four hundred (400) hours working with patients in any particular disease state management area.
- A subcommittee of the Board and/or its Sponsoring Entity will review the completed application and documentation.
4.1. Applicants who have successfully completed the application will be allowed to take the appropriate section or sections of the National Association of Boards of Pharmacy ("NABP") Credentialing Examination.
4.2. Individuals who successfully pass the NABP credentialing examination will be credentialed in the respective disease state management area.
4.3. Individuals who do not successfully pass the NABP Credentialing Examination will be allowed to retake the NABP Credentialing Examination up to two additional times. Applicants who fail to pass the examination after three attempts may be required by the Board to complete a Board approved certificate program before they will be allowed to retake the NABP Credentialing Examination for a fourth time.
4.4. Individuals granted advanced standing who do not pass the NABP Credentialing Examination on their first sitting shall forfeit their advanced standing status and must successfully complete an approved certificate program.
- Re-certification is required every four (4) years.
5.1. To become re-certified, the pharmacist must show documentation of completing a total of twelve (12) hours of continuing education ( a minimum of three (3) hours of continuing education in each year for four years) in each area in which the pharmacist is credentialed.
5.2. The continuing education hours completed for re-certification may also be used to meet the continuing education requirements for license renewal at 247CMR§ 4.03 et seq
5.3. The continuing education requirements may be met by attendance at either an ACPE or Board approved program.
5.4. In addition, the pharmacist will be required to take and successfully pass the applicable NABP credentialing examination.
These Guidelines are modeled after the National Institute for Standards in Pharmacist Credentialing ("NISPC") Board and may change from time to time.
Adopted October 05, 1999
Amended November 16, 1999
Authority G.L. c. 112 § 42(A)
Policy on Canadian Colleges/Universities of Pharmacy Education
License policy on Canadian Graduates
It is the policy of the Board that colleges of pharmacy located in the Canadian Provinces and accredited by the Canadian Council for Accreditation of Pharmacy Programs ("CCAPP") may be considered approved colleges of pharmacy upon application to the Board. For those graduates who may be seeking licensure in Massachusetts, and have successfully completed NABP preliminary approval, the following provisions apply:
- Must have been graduated from a CCAPP approved college of pharmacy;
- Must complete NABP, FPGEC preliminary approval (except FPGEC Examination) and provide a copy to the Board;
- Must complete a preliminary screening Test of Spoken English ("TSE") and receive a passing score. In the event that the candidate does not receive a passing score, the candidate will be required to complete the TSE Examination requirement and receive a score of at least 50;
- Must hold a valid license to practice pharmacy in the Canadian Province;
- Must complete a 300 hour internship in a Massachusetts Pharmacy;and,
- Following completion of the above requirements, a prospective candidate will be allowed to apply to the Board, take the North American Pharmacy Licensing Examination ("NAPLEX") and Multistate Pharmacy Jurisprudence Examination ("MPJE"), must receive a passing score of at least 75% and meet such other terms and conditions as the Board may, from time to time require.
For those candidates who have graduated from a CCAPP approved college/university of pharmacy located in a Canadian Province, but do not as yet hold a license to practice, the following provisions apply:
- Must have been graduated from a CCAPP approved college/university of pharmacy and obtained a degree equivalent to the United States;
- Must complete NABP, FPGEC preliminary approval (except FPGEC Examination) and provide a copy to the Board;
- Must complete a 1500 hour internship in a Massachusetts pharmacy;
- Must complete a preliminary screening Test of Spoken English ("TSE") and receive a passing score. In the event that a candidate does not receive a passing score, the candidate will be required to complete the TSE Examination requirement and receive a score of at least 50 basis points; and
- Following completion of the above requirements, a prospective candidate will be allowed to apply to the Board, take the North American Pharmacy Licensing Examination ("NAPLEX") and Multistate Pharmacy Jurisprudence Examination ("MPJE"), must receive a passing score of at least 75% and meet such other conditions as the Board may, from time to time require.
Voted to adopt by the Board on October 05, 1999, pending counsel review
Submitted to counsel October 15, 1999
Revised November 8, 1999, November 10, 1999, December 07, 1999 and January 28, 2000
Effective date: Approved by Board Counsel Lori Bassinger on April 04, 2000
Authority MGL c. 112 § 42(A)
Policy on Pharmacy Operations During the
Temporary Absence of a Pharmacist
Board Regulations at 247 CMR § 6.02(9)(a) state:
" A registered pharmacist shall be on duty and shall be present at all times when non-pharmacist personnel have unrestricted access to the pharmacy department"
This requirement shall not apply during the temporary absence of a pharmacist as set forth below provided that the following requirement is strictly adhered to at all times during the temporary absence of the pharmacist.
This policy is adopted to ensure that pharmacists are able to have necessary and appropriate duty free breaks and meal periods without unreasonably impairing the ability of a pharmacy to remain open.
- In any pharmacy that is staffed by a single pharmacist, the pharmacist may leave the pharmacy temporarily for necessary and appropriate breaks and meal periods without closing the pharmacy and removing ancillary staff from the pharmacy if the pharmacist reasonably believes that the security of the dangerous drugs and devices will be maintained in his or her absence.
If in the professional judgment of the pharmacist, for reasons of security or otherwise, the pharmacist determines that the pharmacy should close during his or her absence, then the pharmacist shall close the pharmacy and remove all ancillary staff from the pharmacy during his or her absence.
- During the pharmacist's temporary absence, no prescription medication may be provided to a patient or to a patient's agent unless the prescription medication is a refill medication that the pharmacist has checked; and determined not to require the consultation of a pharmacist; prior to being released for furnishing to the patient.
A new prescription which has been previously prepared, visibly checked by a pharmacist and had a drug utilization performed by a pharmacist, may be picked up by a patient provided that a log, including the patients phone number, of all such transactions is kept. The pharmacist, upon return from break, and within a reasonable time, shall call the patient to review any pertinent counseling deemed appropriate.
- During such times that the pharmacist is temporarily absent from the pharmacy, the pharmacy technical support staff may continue to perform the non-discretionary duties authorized to them by pharmacy law. However, any duty performed by any member of the ancillary staff shall be reviewed by a pharmacist upon his or her return to the pharmacy.
- Pharmacist managers, at their discretion, may develop a written policy for allowing Pharmacy Technician Certification Board ("PTCB") and/or Board approved certified technicians and pharmacy interns to receive telephone prescription orders from practitioners, unless otherwise prohibited by law.
- In pharmacies where there are two or more pharmacists on duty, the pharmacists shall stagger their breaks and meal periods so that the pharmacy is not left without a pharmacist for a temporary period.
- The temporary absence authorized by this section shall not exceed 30 minutes. The pharmacist who is on break shall not be required to remain in the pharmacy area during the break period, however the pharmacist shall be required to remain on the premises, licensed by the Board. The total temporary absence shall not exceed more than 30 minutes absence during any work period of at least six consecutive hours.
- The pharmacy shall have written policies and procedures regarding the operation of the pharmacy during the temporary absence of the pharmacist for breaks and meal periods. The policies and procedures shall include the authorized duties of ancillary staff, the pharmacist's responsibilities for checking all work performed by ancillary staff and the pharmacist's responsibility for maintaining the security of the pharmacy. The policies and procedures shall be open to inspection by the Board or its designee at all times during business hours.
A pharmacist who temporarily leaves the pharmacy for a break or meal period in compliance with this section shall not be subject to Massachusetts Board of Registration in Pharmacy disciplinary action or for acts that he or she did not authorize and that he or she, by the exercise of reasonable care, could not have prevented during his or her absence.
Proposed on May 16, 2000
Amended May 18, 2000
Submitted to counsel June 01, 2000
Adopted June 13, 2000
Authority G.L. c 112, § 42(A)
Massachusetts Board of Registration In Pharmacy ("Board")
Proposed Policy and Guideline for Confidentiality and Compliance Programs
The Board of Registration In Pharmacy adopted the following guidelines regarding patient confidentiality, compliance programs and the requirements of Board Regulations at 247 CMR § 9.01 (19), which states:
" A pharmacist shall maintain patient confidentiality at all times. Confidential information shall include information maintained by the pharmacist in the patient's records or information which is communicated to the patient as part of patient counseling, which is privileged and may be released only to the patient or those practitioners and other pharmacists where, in the pharmacist's professional judgment, such release is necessary to protect the patient's health and well being; and to such other persons or governmental agencies authorized by law to receive such confidential information".
Section One: Confidentiality of Health Care Information
Patient Compliance and Patient Intervention Programs shall be conducted in a manner to ensure the confidentiality of Confidential Health Care Information. The unauthorized release or disclosure of Confidential Health Care Information may constitute a violation of Massachusetts pharmacy practice acts or rules and/or other state and federal laws or regulations.
The following minimal safeguards shall be in place for Patient Compliance and Patient Intervention Programs:
- Confidential Health Care Information shall be maintained in a manner to protect against the unauthorized release of such information;
- Confidential Health Care Information shall be accessed only by the pharmacist or by individuals under the direct supervision of the pharmacist, and may be released or disclosed to an External Entity with authorization of the patient or caregiver;
- Confidential Health Care Information used to implement a Patient Compliance or Patient Intervention Program shall not be released or disclosed to any External Entity other than the External Entity implementing the program with, or on behalf of, the pharmacy;
- All personnel with access to Confidential Health Care Information shall sign and their employer shall retain on file current confidentiality and non-disclosure agreements;
- Representative copies of all form correspondence and lists of individual patients to whom such correspondence has been sent shall be maintained by the pharmacist/pharmacy and External Entity for a reasonable period of time. Records of specific patient interventions or compliance initiatives shall be traceable and easily accessible;
- If the Patient Compliance or Patient Intervention Program information is mailed, delivery systems that: 1) ensure the information will be delivered to the designated patient or caregiver and will remain confidential; and 2) allow for the return of the information if not deliverable, shall be utilized. For example, if the contact is via the U.S. Postal Service, the information should be mailed first class in a sealed security envelope;
- Methods to access, transmit, store, analyze, or purge Confidential Health Care Information shall be implemented using procedures generally recognized as secure by experts qualified by training and experience;
- External Entities maintaining Confidential Health Care Information outside the pharmacy's internal system shall adhere to the same security requirements adhered to by the pharmacy in regards to its internal system, including but not limited to those requirements addressing information access, storage, auditability, and release;
- Procedures shall be in place to ensure that purged Confidential Health Care Information cannot be misused or placed into active operation without appropriate authorization; and
- Internet connectivity or remote access tied directly to systems containing Confidential Health Care Information must be secure.
Section 2: Patient Participation
Patient Compliance and Patient Intervention Programs shall be conducted in the best interest of the patient and shall inform patients about the program's purpose and use of Confidential Health Care Information. The patient shall have the option to participate in ("opt in") or withdraw from ("opt out") any such program at any time. Patients electing to participate in such programs shall be provided with the following information:
- A description of the Patient Compliance or Patient Intervention Program;
- Benefits of the program to the patient;
- Nature of participation;
- How the program works and the potential contacts that will be made; and
- The name of the person making the contacts.
Programs designed to change a patient's medication or medication therapy solely for economic or financial gains or incentives without the consent of the patient and prescribing practitioner are contrary to these Guidelines and may violate the state pharmacy practice acts in Massachusetts and rules and/or other state and federal laws or regulations.
Nothing in these Guidelines supersedes existing state drug product selection laws or procedures for drug recalls, nor prevents access to Non-confidential Health Care Information for research purposes.
Section 3: Pharmacist Participation
A pharmacist shall oversee and approve all Patient Compliance and Patient Intervention Programs and shall be responsible for:
- maintaining an accurate list of participating patients; and
- the accuracy and appropriateness of the information being presented to the patients. Pharmacists involved in Patient Compliance and Patient Intervention Programs, whether through contact with patients or caregivers or through the design, implementation, management, and analysis of the programs, shall be educated about such programs and their objectives. Results of the programs shall be communicated to all participating pharmacists.
Section 4: Utilization of Non-confidential and Confidential Health Care Information for Research Purposes
Notwithstanding any other provision of law, nothing in these Guidelines shall be interpreted to prohibit the release of:
- Confidential Health Care Information for research that is subject to the requirements of federal laws and regulations protecting the rights and welfare of research participants; and
- Non-confidential Health Care Information for research purposes or analysis.
Section 5: Measurement and Analysis of Program
Patient Compliance and Patient Intervention Programs may include methodologies to measure the outcomes of the program in relation to patient care and the performance of the pharmacy/pharmacist. The following minimum guidelines shall be observed when measuring and analyzing the program outcomes:
- Analysis and aggregate data reports shall not contain Confidential Health Care Information;
- Study design, measurement, and analysis shall adhere to accepted research and study designs; and
- Reports prepared or published shall provide accurate and statistically correct information.
Authority: G.L. c. 112, § 42(A)
Board counsel Review 2/15/00
adopted March 14, 2000 (provisions)
Adoption date June 13, 2000
Policy on Board-Approved Continuing Education Programs
Board of Registration In Pharmacy (Board) Regulations at 247 CMR § 4.03: Continuing Education Requirement state:
- 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.
- Board Regulations at 247 CMR 2.00 (Definitions) defines a Board-approved program as " a program which has been approved by the Board for continuing education credits. Such program may be sponsored by the ACPE, and/or sponsored or co-sponsored by any person who has been granted prior written approval by the Board for the particular program. The Board may, within its discretion, accept comparable continuing education hours approved by other Boards of Pharmacy".
It shall be the policy of the Board that continuing education credit hours approved by a National Association of Boards of Pharmacy (NABP) member board of pharmacy, including United States Territories, to accept for comparable continuing education credit in Massachusetts, any continuing education credit approved by an NABP member board.
Submitted to counsel November 17, 2000
Presented to Board for vote: December 19, 2000
Adopted by Board: December 19, 2000
Authority MGL c. 112 § 42(A)
Medication Error/Adverse Drug Event Reporting Policy
Policy: "Medication Errors Reporting (MER) Program", or any other form(s) designated by the board, report forms will be completed and submitted for all complaints brought to the Board's attention involving confirmed medication errors and/or adverse drug events (ADEs) related to the consumption, use, delivery, dispensing and/or distribution of medications or medical devices. "Medication Errors Reporting (MER) Program" report forms will be completed and submitted by the pharmacist identified in the complaint or by the Manager of Record with a copy of the form sent to the Board as evidence of its completion, submission and identification of remedial actions taken, if any.
Whereas the definition of a medication error is broad: "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use," according to The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP, 1995); and
Whereas in the Harvard Medical Practice Study, ADEs accounted for 19.4% of all disabling medical injuries, and 45% of them were due to errors 1; and
Whereas medication errors and ADEs were estimated to add an additional $76.6 billion /year to health care costs 2 and collection of data related to same may be useful in identifying trends providing for effective means of warnings and/or interventions.
Be it resolved that the Board of Registration in Pharmacy of the Commonwealth of Massachusetts (Board) recommends adoption as policy:
Date Adopted by Board: December 19, 2000
Amended June 21, 2001
Authority G.L. c. 112 § 42(A)
1 Leape L, et al. Systems Analysis of Adverse Drug Events. JAMA, 1995. 274:35-43.
2 Johnson JA, Bootman JL. Drug-Related Morbidity and Mortality. Arch Int Med 1995, 155:1949-1956.
3 United States Pharmacopeil Convention, Inc. Medication Errors Reporting Program
This information is provided by the Division of Health Professions Licensure within the Department of Public Health.