N.H. Code Admin. R. He-P 301.10

Current through Register No. 24, June 13, 2024

Section He-P 301.10 - Distribution of Pharmaceutical Agents

(a) Health care providers requesting pharmaceutical agents from the department shall make such requests via the online Vaccine Ordering Management System (VOMS) provided by the department at least 7 days prior to the desired delivery date. The department shall provide VOMS enrollment information upon request.

(b) Requestors pursuant to (a) above shall provide the following information via VOMS:

(1) The name of the physician, practice, or facility;

(2) The provider's number provided by the department's immunization program;

(3) The address of the practice or provider;

(4) The person responsible for ordering pharmaceutical agents;

(5) The phone number of the person named in (4) above; and

(6) The type and number of doses of pharmaceutical agents being ordered.

(c) Health care providers obtaining pharmaceutical agents from the department shall ensure proper storage and handling to prevent deterioration, in compliance with the requirements of RSA 318. All pharmaceutical agents shall be stored in accordance with the manufacturer's instructions that accompany each shipment of pharmaceutical agents. Providers shall be responsible for replacement of pharmaceutical agents if loss occurs due to the facility's negligent storage or handling procedures.

(d) Health care providers receiving vaccines from the department shall inform the recipients of such vaccines of their benefits and risks, in accordance with 42 CFR 110, vaccine information materials.

(e) Health care providers who wish to order state-supplied vaccines shall complete, on an annual basis, the vaccine provider's immunization certification form on which the provider certifies annually that he or she will comply with the following requirements:

(1) Exercise individualized medical judgment in the administration of state-supplied vaccines;

(2) Provide the recipient or parent or guardian of each recipient of such vaccine copies of the current vaccine information materials;

(3) Retain a written immunization record of the vaccine administered for a period of at least 3 years following the end of the calendar year in which the immunization was given and, upon request, furnish copies of the record to the department or the federal Centers for Disease Control and Prevention;

(4) Make no charge for vaccines provided by the department excluding usual or customary office or professional fees charged for vaccine administration;

(5) For medicaid federal vaccine eligible children to accept the reimbursement for immunization administration set by the state medicaid agency or the contracted medicaid health plans.

(6) Provide state-supplied vaccine to individuals regardless of their inability to pay vaccine administration fees, and prominently display a sign that vaccines will be so provided;

(7) To screen children for eligibility if mandated by state or federal vaccine programs; and

(8) To minimize vaccine wastage;

(9) To manage ordering, storage, and disposal of vaccine, including:

a. Ordering vaccine and maintaining appropriate inventories;

b. Not storing vaccine in dormitory-style units at any time;

c. Storing vaccine under proper storage conditions at all times, including using:

1. Refrigerator and freezer vaccine storage units; and

2. Temperature monitoring equipment and practices that meet NH Immunization Program (NHIP) storage and handling requirements as provided by the department; and

d. By returning all spoiled or expired public vaccines to the Center for Disease Control's (CDC) centralized vaccine distributor within 6 months of spoilage or expiration date;

(10) Develop policies to avoid fraud and abuse as defined in 42 CFR 455.2;

(11) Participate in vaccine for children (VFC) compliance site visits including unannounced visits, and other educational opportunities associated with VFC program requirements;

(12) All healthcare providers and medical director's or equivalent responsible representative shall certify the following:

a. That all healthcare provider staff, medical director, or equivalent responsible representative having access to the VOMS shall comply with all CDC regulations and guidelines and other applicable federal law related to accessing a CDC system and ordering publically funded vaccines;

b. That all healthcare providers or medical director, or equivalent responsible representative shall identify any individual staff, or representative of the healthcare provider who is authorized to order vaccines for the healthcare provider;

c. That a record will kept of any changes in staff or additions of new healthcare provider staff or representatives, and will maintain an accurate list of who is authorized to order vaccines;

d. That the name of anyone no longer authorized in (12) c. above shall be provided shall be provided to NH Division of Public Health Services within 24 hours; and

e. That the identity of the medical director or responsible representative has been accurately included on the provider enrollment form;

(13) Provide a statement that the healthcare provider medical director or the equivalent shall replace any vaccine purchased with state and federal funds that are deemed non-viable due to provider negligence on a dose-for-dose basis;

(14) Provide a statement that the healthcare provider medical director or the equivalent understands that healthcare provider or New Hampshire Immunization Program (NHIP) may terminate the agreement at any time; and

(15) Provide a statement that if the healthcare provider terminates the agreement, the unused federal vaccine shall be returned to NHIP as directed by NHIP.

(f) Vaccine providers shall document the following minimum information on the vaccine recipient's medical record:

(1) Type of vaccine;

(2) Date of vaccine administration;

(3) Manufacturer of vaccine administered;

(4) Lot number of vaccine;

(5) Route and site of vaccine administration;

(6) Name and title of the person administering the vaccine;

(7) Address where the vaccine was administered; and

(8) Results of eligibility screening of the child for federal vaccine assistance programs.

(g) When ordering vaccines, health care providers shall provide the following vaccine utilization information via the online VOMS provided by the department:

(1) Type, numerical sequence, and number of doses of vaccine administered for each specified age group;

(2) Current inventory with lot numbers;

(3) Expiration dates;

(4) Wastage in doses;

(5) Number of doses ordered;

(6) Physician or facility's vaccine provider number;

(7) Both mailing and street addresses;

(8) Name of provider or facility using vaccine;

(9) Person responsible for ordering vaccine; and

(10) Physician or facility's phone and fax numbers.

(h) In the case of an individual experiencing a vaccine-associated adverse medical event from a state-supplied vaccine, the health care provider shall immediately report to the national Vaccine Adverse Event Reporting System at www.vaers.org [File Link Not Available] or 1-800-822-7967 and notify the department of the report.

N.H. Code Admin. R. He-P 301.10

#4946, eff 10-2-90; EXPIRED: 10-2-96

New. #6634, eff 11-25-97; ss by #8242, eff 12-30-04; ss by #9172, eff 6-6-08

Amended by Volume XXXVI Number 45, Filed November 10, 2016, Proposed by #12033, Effective 11/3/2016, Expires 11/3/2026.