L.D. 456 Testimony




Joint Standing Committee on Labor, Commerce, Research, & Economic Development

Room 208, Cross State Office Building

Tuesday, March 7, 2017, 1:00 p.m.

Good afternoon Senator Volk, Representative Fecteau, and Members of the Joint Standing Committee on Labor, Commerce, Research, & Economic Development.  My name is Linda Glass, M.D., F.A.A.P.  and I am a pediatrician the Managing Partner of Pediatric Associates of Lewiston. I am speaking in opposition to L.D. 456, An Act to Increase Access to Vaccinations.

Pediatric immunizations have been the subject of an immense amount of research regarding the safety, efficacy, longevity, and potential risk and benefits profile. Pediatric immunizations undergo evaluation and approval by four separate entities: the FDA ((Food and Drug Administration), the CDC (Centers for Disease Control), the ACIP (American College of Immunization Practices), and the AAP (American Academy of Pediatrics). This process is meant to assure the public that pediatricians are committed to administering immunizations to their children in the safest way possible. This is necessary in an atmosphere where anti-pharma sentiments are high. While pharmacists may have knowledge of drugs, dosages, interactions, and side effects – their pediatric pathophysiology and disease knowledge is limited. In addition, their training for injecting is brief, and does not address the significant amount of issues that arise while administering immunizations to certain populations (particularly pediatric patients).

There are several safety concerns associated with the injections that are routinely give to pediatric patients:

  1. The immunization is obtained from a source that provides mercury free products that have been manufactured, stored, and transported properly (strict temperature controls are necessary);
  2. Strict temperature storage on site until the immunization is used (requires specific refrigerators and thermometers);
  3. An understanding of age – specific/vaccine -specific recommendation for injection sites, injection technique (IM or SQ), needle size, needle length, diluent-base mixing, needle change techniques, etc;
  4. An understanding of possible side effects, and troubleshooting adverse reactions (simple to VAERS level concern);
  5. The ability to safely administer immunizations – being prepared for pediatric reactions to injections – often unpredictable and unpleasant (e.g. running, screaming, biting, hitting);
  6. The knowledge to screen pediatric patients for contra-indications to immunization administration (fever is the most common concern, but there are many others);
  7. The ability to verify the appropriate vaccine schedule/intervals specific to each patient;
  8. The ability to verify that an administered vaccine has not been previously given and is not available to the pharmacist for viewing;
  9. Proper documentation of immunizations (lot, date of expiration, injection site, maintaining count balance), documenting 24-hour temperature maintenance; and
  10. Documenting immunization in the public registry – IMMPACT.

**In large pediatric offices, there is an Immunization Officer who is responsible to oversee the safety of the vaccines that are administered to the patients. This is a full - time position in large practices.

This proposal affects the current model for the patient centered medical home. Pediatric care in the 21st century is focused on providing care for the whole child in a patient centered medical home. The goal is to pair with families to provide the standards for pediatric care as per the America Academy of Pediatrics, as well as engage individual services unique to each patient and family to meet their health care needs. The foundations of this care are the periodic examinations where the pediatric provider has the time and opportunity to discuss many aspects of a pediatric patient’s care, and develop a plan for the family that will meet the unique needs presented.  The relationship a family has with a medical home is important in teaching parents and their children to seek the best health care possible, and sets the standard for a pediatric patient to grow into an adult that continues that relationship with their adult provider, and seeks that same level of care for their own children. Years of research have taught us that preventative care is the best way to decrease health care costs, and patient centered medical home is a model for such care.

Allowing any provider to administer vaccines and thereby possibly discouraging parents from scheduling the recommended periodic examinations for their children establishes a behavior that may well lead into adulthood. While the technical aspect of learning to inject a medication is not difficult (lay people are taught this skill), safe and effective vaccine administration is much more than learning a simple technique, and represents a significant part of our preventative care in the patient centered medical home. Immunizations without periodic medical visits is not preventative care – the health risk just shifts.

Better ways to increase immunizations include: 1) offices recalling patients who miss appointments; 2) actively reaching out to patients to schedule preventative care visits; 3) helping with transportation; and 4) remembering to check immunizations at every visit (some children who are seen for sick visits can have immunizations, and should if behind).

This bill, an attempt to ensure that more children have access to vaccinations, instead puts children at risk by failing to take into consideration all of the factors and possibilities that go into a child’s full spectrum of health care. For that reason I ask you to vote “Ought not to Pass” on LD 456. I would be happy to address any questions you may have.