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REGS : 10.34.32 Pharmacist Administration of Vaccinations (BOARD OF PHARMACY)

 

 Content Editor

 
PROPOSAL
Maryland Register
Issue Date:  December 27, 2013
Volume 40 • Issue 26 • Pages 2185—2188
 
Title 10 
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Subtitle 34 BOARD OF PHARMACY
10.34.32 Pharmacist Administration of Vaccinations
Authority: Health Occupations Article, §12-508, Annotated Code of Maryland
Notice of Proposed Action
[13-415-P]
 
The Secretary of Health and Mental Hygiene proposes to amend Regulations .02—.05, and .08, repeal existing Regulation .07 and adopt new Regulation .07, and repeal existing Regulation .09 under COMAR 10.34.32 Pharmacist Administration of Vaccinations.
This action was considered by the Board of Pharmacy at public meetings held August 21, 2013 and September 20, 2013, notice of which was given by publication on the Board of Pharmacy website www.dhmh.maryland.gov/pharmacyboard from July 19, 2013 through August 21, 2013 and August 21, 2013 through September 20, 2013, pursuant to the State Government Article, §10-506(c), Annotated Code of Maryland.
 
Statement of Purpose
The purpose of this action is to revise COMAR 10.34.32 to comply with statutory requirements as amended by Chapters 255 and 256, Acts of 2013 (SB 401/HB 179 Pharmacists – Administration of Vaccinations – Expanded Authority and Reporting Requirements), to allow pharmacists to administer vaccinations listed in the Centers for Disease Control and Prevention’s (CDC) recommended immunization schedule to an individual who is at least 11 years old, but under the age of 18 years old, and has a prescription from an authorized prescriber. It allows pharmacists to administer to an adult a vaccination that is listed in the CDC recommended immunization schedule or recommended by the CDC’s Health Information for International Travel. DHMH has established the criteria for protocols for adult immunization and it has been included in this proposal. The regulations also have been revised to include the requirement that a pharmacist report administration of all immunizations to the ImmuNet Program established under §18-109 of the Health-General Article. Additionally, the regulations were revised to include a pharmacist “report back” to the individual’s authorized prescriber that the vaccination has been administered or if the vaccination has not been administered in accordance with a prescription, inform the individual’s primary care provider or other usual source of care that the vaccination has been administered. Finally, the fee that a pharmacist may charge for the administration of vaccinations was revised to $50 in addition to the cost of each vaccination. Regulation .09 has been repealed as obsolete.
 
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
 
Estimate of Economic Impact
I. Summary of Economic Impact. There is a minimal economic impact on the Board staff due to receiving registration applications, reviewing registration applications, and issuing confirmation of registration letters to pharmacists who have applied for registration to administer immunizations. This workload for the staff has been absorbed at this time. As the program develops, the Board may reassess at a later date the necessity for imposing a fee for registration to administer vaccinations. The revision of Regulation .08 setting forth a new amount that a pharmacist may charge for administration of immunizations would have no economic effect on the Board of Pharmacy or any other State or local agency. It would affect the industry by allowing pharmacy permit holders and pharmacists to charge a fee commensurate with the costs and time involved to provide immunizations. It would affect the public by making vaccinations more readily available at an affordable cost.
 
 
Revenue (R+/R-)
 
II. Types of Economic Impact.
Expenditure (E+/E-)
Magnitude
 

 
 
 
 
 
A. On issuing agency:
NONE
 
B. On other State agencies:
NONE
 
C. On local governments:
NONE
 
 
 
Benefit (+)
Cost (-)
Magnitude
 

 
 
 
 
 
D. On regulated industries or trade groups:
(+)
Unidentifiable
E. On other industries or trade groups:
NONE
 
F. Direct and indirect effects on public:
(+)
Unquantifiable
III. Assumptions. (Identified by Impact Letter and Number from Section II.)
D. There is a positive unquantifiable economic impact on the regulated industry due to the broader availability of immunizations administered at the pharmacy by registered pharmacists. It would allow pharmacy permit holders and pharmacists to charge a fee commensurate with the costs and time involved to provide immunizations. Also the $50 fee allows a cushion to accommodate future costs or for particular expensive vaccines.
 
F. There is a positive unquantifiable benefit on the public due to the broader availability of influenza vaccines administered at the pharmacy by registered pharmacists. Pharmacists and pharmacy permit holders are not likely to charge any greater amount than other venues that administer immunizations. This would afford the patient or consumer more flexibility in obtaining recommended immunizations.
 
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
 
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
 
Opportunity for Public Comment
Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through January 27, 2014. A public hearing has not been scheduled.
 
.02 Definitions.
A. (text unchanged)
B. Terms Defined.
(1)—(6) (text unchanged)
[(7) “Vaccination” means a herpes zoster, influenza, or pneumococcal pneumonia vaccination authorized by Health Occupations Article, §12-508, Annotated Code of Maryland.]
(7) “Primary care provider” means a health care practitioner who provides an individual’s primary care services and is the primary coordinator of health care services for the individual.
(8) “Vaccination” means a vaccination:
(a) That is listed in the Centers for Disease Control and Prevention’s Recommended Immunization Adult Schedule authorized by Health Occupations Article, §12-508, Annotated Code of Maryland;
(b) Recommended in the Centers for Disease Control and Prevention’s Health Information for International Travel authorized by Health Occupations Article, §12-508, Annotated Code of Maryland;
(c) Recommended for individuals between 11 years old and 18 years old in the Centers for Disease Control and Prevention’s Recommended Immunization Schedule for Persons aged 0 through 18 years old; or
(d) An influenza vaccination authorized by Health Occupations Article, §12-508, Annotated Code of Maryland.
(9) “Vaccine information statement” means the information sheet, produced by the Centers for Disease Control and Prevention that explains both the benefits and risks of a specific vaccine to the vaccine recipient, their parent, or their legal representative.
.03 Requirements to Administer Vaccinations.
A. Registration.
(1) (text unchanged)
(2) The registration form shall include verification from the licensed pharmacist of the following:
(a) Successful completion of a certification course approved by the Board of Pharmacy that includes the current guidelines and recommendations of the Centers for Disease Control and Prevention [for herpes zoster, influenza, and pneumococcal pneumonia vaccines] regarding vaccinations; and
(b) (text unchanged)
(3) A registration authorizing a licensed pharmacist to administer vaccinations expires with the expiration of the license to practice pharmacy unless the licensed pharmacist has completed:
(a) [Except as provided in §A(5) of this regulation, 4] Four hours of continuing education credits related to vaccinations; and
(b) (text unchanged)
(4) (text unchanged)
[(5) A pharmacist registered to administer vaccines before October 1, 2008 shall, for the first renewal of the registration after that date, demonstrate that 4 continuing education credits taken include education about the herpes zoster and pneumococcal pneumonia vaccines.]
B. A licensed pharmacist may [not] administer[:
(1) An] an influenza vaccination to an individual who is [younger than] 9 years old [; or
(2) Vaccinations, other than influenza, to any individual younger than 18 years old] or older in accordance with a protocol that meets the requirements of Regulation .07 of this chapter.
B-1. A licensed pharmacist may only administer a vaccination that is listed in the Centers for Disease Control and Prevention’s recommended immunization schedule to an individual who:
(1) Is between 11 years old and 18 years old; and
(2) Has a prescription from an authorized prescriber.
B-2. Except as provided in §§B and B-1 of this regulation, a licensed pharmacist may administer to an adult a vaccination in accordance with a protocol that meets the requirements of Regulation .07 of this chapter that is:
(1) Listed in the Center for Disease Control and Prevention’s Recommended Immunization Schedule; or
(2) Listed in the Center for Disease Control and Prevention’s Health Information for International Travel.
C. A pharmacist shall report to the [Maryland Immunization Registry an influenza] ImmuNet Program established under Health-General Article, §18-109, Annotated Code of Maryland, a vaccination administered by the pharmacist to [individuals who are from 9 to 18 years old] an individual.
D. A pharmacist shall:
(1)—(2) (text unchanged)
(3) Observe the patient for a period of at least 15 minutes after administration of the vaccine for adverse effects including syncope.
E. (text unchanged)
.04 Training Program Requirements.
In order to administer vaccinations, the Board shall assure that any course that it approves contains at a minimum the following elements:
A.—C. (text unchanged)
D. Advisory Committee on Immunization Practices and Centers for Disease Control guidelines for [herpes zoster, influenza, and pneumococcal pneumonia] vaccines.
.05 Record Keeping.
A. The pharmacy permit holder shall maintain documentation in the pharmacy from which the vaccine was administered for a minimum of 5 years that includes [the]:
(1) [Name] The name, address, and date of birth of the individual receiving the vaccination;
(2) [Date] The date of administration and route and site of vaccinations;
(3) [Name]The name, dose, manufacturer’s lot number, and expiration date of the vaccine;
(4) [Name] The name and address of the primary health care provider of the individual receiving the vaccination, as identified by that individual;
(5) [Name] The name of the pharmacist, pharmacy student, physician, or nurse administering the vaccination;
(6) [Version] The version of the vaccination information statement provided to the individual receiving the vaccination;
(7) [Copy] The copy of the signed patient consent form of those individuals to whom the vaccine was administered; [and]
(8) [Nature] The nature and outcome of an adverse reaction and documentation that the adverse reaction was reported to:
(a) The primary care [physician] provider; and
(b) (text unchanged)
(9)  At least one effort made by the pharmacist to inform the individual’s authorized prescriber that the vaccination has been administered; and
(10)  If the authorized prescriber is not the individual’s primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual’s primary care provider or other usual source of care that the vaccination has been administered.
B. (text unchanged)
C. The pharmacist administering a vaccination as an independent provider at a location that is not a pharmacy shall maintain the following documentation for a minimum of 5 years:
(1)—(6) (text unchanged)
(7) Copy of the signed patient consent form of those individuals to whom the vaccine was administered; [and]
(8) Nature and outcome of an adverse reaction, and documentation that the adverse reaction was reported to:
(a) The primary care [physician] provider; and
(b) (text unchanged)
(9) At least one effort made by the pharmacist to inform the individual’s authorized prescriber that the vaccination has been administered; and
(10) If the authorized prescriber is not the individual’s primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual’s primary care provider or other usual source of care that the vaccination has been administered.
D. The pharmacist administering a vaccination on behalf of a permit holder at a location that is not a pharmacy shall maintain the following documentation with the permit holder for a minimum of 5 years:
(1)—(6) (text unchanged)
(7) Copy of the signed patient consent form of those individuals to whom the vaccine was administered; [and]
(8) Nature and outcome of an adverse reaction, and documentation that the adverse reaction was reported to:
(a) The primary care [physician] provider; and
(b) (text unchanged)
(9) At least one effort made by the pharmacist to inform the individual’s authorized prescriber that the vaccination has been administered; and
(10) If the authorized prescriber is not the individual’s primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual’s primary care provider or other usual source of care that the vaccination has been administered.
.07 Approved Protocols.
A. A pharmacist shall have and maintain a written protocol for any vaccine to be administered, including influenza vaccination.
B. The pharmacist shall administer vaccinations in accordance with the written protocol.
C. The written protocol for each vaccine shall contain at least the following elements:
(1) Identity and license number of the participating pharmacist;
(2) Vaccine;
(3) Precautions to vaccine use;
(4) Contraindications to vaccine use;
(5) Process to be followed for screening for:
(a) Indications;
(b) Precautions;
(c) Contraindications; and
(d) Allergies;
(6) Process for obtaining and documenting consent;
(7) Process for verification of prescription for patients 11—17 years old for vaccinations other than the influenza vaccine;
(8) Dose or doses of the vaccine that will be administered;
(9) The route or routes and site or sites of administration of the vaccine;
(10) The injection or administration procedures;
(11) Post-vaccination procedures, including waiting requirements;
(12) Process for handling adverse reactions, including but not limited to:
(a) Acute anaphylactic reactions; and
(b) Other acute emergencies; and
(13) Process for documenting and maintaining a vaccination record including at least:
(a) Patient:
(i) Name;
(ii) Date of birth; and
(iii) Address;
(b) Vaccination administration:
(i) Date;
(ii) Dose;
(iii) Site; and
(iv) Route;
(c) Vaccine:
(i) Manufacturer;
(ii) Lot number; and
(iii) Expiration date;
(d) Required Vaccine Information Statement:
(i) Version; and
(ii) Provision date;
(e) Name of the patient’s primary care provider or prescriber; 
(f) Documentation:
(i) Of at least one attempt to inform the patient’s primary care provider or prescriber that the vaccination has been administered; or
(ii) That the patient has no primary care provider;
(g) Documentation of an attempt to inform the patient’s primary care provider that the influenza vaccination has been administered may not be required; and
(h) The name of the vaccinator.
D. The protocol shall be:
(1) Signed and dated at least annually by the pharmacist;
(2) Available and presented for inspection to the Board of Pharmacy upon request; and
(3) Reviewed and updated as necessary.
.08 Fees.
Fees charged for the administration of vaccinations may not exceed [the Medicare reimbursement rate] $50 in addition to the cost of each vaccination.
JOSHUA M. SHARFSTEIN, M.D.
Secretary of Health and Mental Hygiene