20581 Permitting pharmacists to administer pneumococcal and influenza vaccinations, including H1N1, to any person age eighteen (18) and older pursuant to one written protocol and standing order with one District of Columbia licensed physician.
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DEPARTMENT OF HEALTH
NOTICE OF EMERGENCY AND PROPOSED RULEMAKING
The Director of the Department of Health, pursuant to the authority set forth under § 302 (14) of the District of Columbia Health Occupation Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code § 3-1203.02 (14)) (“Act”), Mayor’s Order 98-140, dated August 20, 1998, gives notice of the adoption on an emergency basis of an amendment to chapter 65 of Title 17 of the District of Columbia Municipal Regulations (DCMR) (Pharmacists) by adding a new § 6512.7(c)(6).
This emergency action will permit pharmacists, who have been certified by the Board of Pharmacy to administer immunizations and vaccinations, to administer pneumococcal and influenza vaccinations, including H1N1, to any person age eighteen (18) and older pursuant to one written protocol and standing order with one District of Columbia licensed physician. This will eliminate the need for multiple protocols and standing orders when the delegation is expressly limited to pneumococcal and influenza vaccinations.
This emergency action is being taken in order to assist the District in preparing for the upcoming influenza season and in response to the continuing threat to the District’s citizens posed by the H1N1 pandemic. It is believed that eliminating the requirement for multiple protocols, where the delegation is strictly limited to pneumococcal and influenza vaccinations, including H1N1, will result in an increase of the number of pharmacies that will participate in providing these services.
This emergency rule was adopted on August 18, 2009, and became effective immediately on that date.
The emergency rule will expire on December 18, 2009, or upon publication of a Notice of Final Rulemaking in the D.C. Register, whichever occurs first.
The Director also gives notice of his intent to take final rulemaking action to adopt this amendment in not less than thirty (30) days from the date of publication of this notice in the D.C. Register.
17 DCMR Section 6512.7 is amended to read as follows:
6512.7 The written protocol shall contain, at a minimum, the following:
(a) A statement identifying the individual physician authorized to prescribe
drugs and responsible for the delegation of administration of immunizations
or vaccinations;
(b) A statement identifying the individual pharmacist(s) authorized to administer
immunizations or vaccinations as delegated by the physician;
(c) A statement identifying the patient or groups of patients to receive the
authorized immunization or vaccination; which shall be limited to:
(1) Patients who are currently under the individual physician’s care or
with whom the physician has provided medical treatment or care
within the twelve months prior to the date of the written protocol;
(2) Patients who are currently under the practice’s care or with whom a
physician within the practice has provided medical treatment or care
within the twelve months prior to the date of the written protocol;
(3) Residents of a health care, residential services, or assisted living
facility, when the medical director of such facility is the physician
making the delegation;
(4) District resident populations identified by the Director of the
Department of Health as part of a public health services program,
when the Director, or his or her designee, is the physician making the
delegation;
(5) Inmates of the District of Columbia jail, when the medical director for
the facility is the physician making the delegation; and
(6) The patient group covered by the protocol may cover any person age
eighteen (18) and older with valid identification, if the protocol is expressly limited to only pneumococcal vaccinations and influenza vaccinations, including but not limited to H1N1 and other epidemic vaccinations which are then currently called for by the World Health Organization or the Center for Disease Control at the time of the vaccination; and
(d) A statement identifying the location(s) at which the pharmacist may administer immunizations or vaccinations which shall not include where a patient resides, except for a licensed nursing home, residential care facility, assisted living center, the District of Columbia jail, or a hospital;
(e) A statement identifying the immunizations and vaccinations and emergency
anaphylactic reaction treatment that may be administered by the pharmacist;
(f) A statement identifying the activities the pharmacist shall follow in the course
of administering immunizations and vaccinations, including procedures to follow in the case of reactions following administration; and
(g) A statement that describes the content of, and the appropriate mechanisms for
the pharmacist to report the administration of immunizations and vaccinations to the physician issuing the written protocol within the time frames specified in the protocol; which shall include providing the physician with a copy of the following records:
(i) The name, address, gender, allergies and date of birth of the individual
receiving the immunization or vaccination;
(ii) The date of administration
(iii) The route and site of the immunization or vaccination;
(iv) The name, dose, manufacturer’s lot number, and expiration date of the
vaccine;
(v) The name of the pharmacist administering the immunization or
vaccination;
(vi) Any adverse events encountered.
All persons desiring to comment on the subject matter of this proposed rulemaking action shall submit written comments, not later than thirty (30) days after the date of publication of this notice in the D.C. Register, to Kenneth Campbell, General Counsel, Department of Health, Office of the General Counsel, 825 North Capitol Street, N.E., 4th Floor, Washington, D.C. 20002. Copies of the proposed rules may be obtained between the hours of 9:00 a.m. and 5:00 p.m. at the address listed above.
