Vaccine Nonadherence on the Rise

Risk management for physician practices includes informed consent, shared decision-making, and documentation.

By Sharon Hall, RN

Physicians and health care professionals in the U.S. are seeing a notable increase in patients refusing recommended vaccinations. Rising refusal rates, entrenched hesitancy, and declining immunization coverage have become major challenges in clinical practice.

Since a nonadherent patient may subsequently develop an illness or experience a worsening of their condition, it is important to be able to follow the patient’s care in case the patient files a malpractice claim for a missed or delayed diagnosis. Lack of informed consent is an allegation in 30-35% of malpractice claims nationwide, so it is vital that the patient’s decision to decline recommended care is carefully documented.

Informed consent and vaccinations

While there is no federal requirement for informed consent relating to vaccinations, the National Childhood Vaccine Injury Act requires the physician (or physician assistant or nurse practitioner) to deliver a vaccine information sheet that includes both the benefits and risks associated with certain vaccinations. As WSMA members are no doubt aware, recent federal recommendations for childhood vaccines have changed and differ from those recommended by our regional authority, the West Coast Health Alliance. The alliance, which includes Washington, California, Hawaii, and Oregon and is endorsed by physician professional organizations in those states, continues to support vaccine recommendations from the American Academy of Pediatrics. The Washington State Department of Health offers guidelines for immunizations and vaccines on its website, along with guidance for health care practitioners.

Prior to vaccine administration, provide sufficient information and obtain consent from the child, patient, or state legal representative. We recommend a well-documented informed consent, including the rationale for the vaccine, risks, and benefits for the vaccine, as well as for declining the vaccine and its alternatives. This can be done using the vaccine information sheet, unless that form does not include state requirements or has not been updated with current information on the vaccine to be given.

Recordkeeping recommendations include:

• Documentation that the vaccine information sheet was distributed, including the edition date and the date the information sheet was provided.
• The name, address, and title of the health care worker who administered the vaccine.
• The date of administration.
• The vaccine manufacturer, along with the lot number of the vaccine used.

Elements of informed consent

Components of a valid consent include adequate information, absence of coercion, decision-making capacity by the patient, and the patient’s consent.

Informed consent typically includes the following information:

1. Patient condition or disease.
   • Whether the procedure is diagnostic or therapeutic.
   • Expected outcome with and without treatment.
2. Rationale for recommended treatment or procedure.
3. Benefits.
   • Evidence in favor of procedure.
   • Prevention of deterioration of the patient’s condition.
   • Longer survival for the patient.
   • Further treatment recommendations.
4. Complications and risks.
   • Usual risks associated with the recommended treatment or procedure.
   • Possible complications, taking into consideration the patient’s comorbidities.
   • Serious risks, up to and including death.
5. Alternatives, including nontreatment.
   • Risks and benefits of alternatives.
   • Risks and benefits of nontreatment.

Since not all patients have the same level of literacy, it is important that explanations of care be provided in simple, plain language, using lay terminology in place of medical jargon. Requesting that a patient repeat back the information allows for opportunities to address any misunderstandings.

Discussion of treatment options should include, but not be limited to, those covered by the patient’s insurance. While cost may play a factor in a patient’s ultimate decision, if an available option may be in the patient’s best interests, it should be included in the informed-consent discussion. We recommend reminding the patient to check with their insurer to determine what services are covered.

The patient may benefit from other information, as well, including details about recovery time, additional follow-up care, and costs. The informed-consent discussion can be supplemented with printed information that is available for many conditions and treatment options.

Shared decision-making

Shared decision-making is an approach that facilitates the highest ethical standard for the informed-consent process. The use of this process may be guided by state law or regulations. The Agency for Healthcare Research and Quality, part of the U.S. Department of Health and Human Services, offers a five-step shared approach to the decisionmaking process:

1. Enlisting the patient’s participation and encouraging patient involvement.
2. Assisting the patient in exploring treatment options while explaining the risks and benefits of each option, including no treatment.
3. Recognizing the patient’s values and preferences, taking patient priorities into consideration.
4. Reaching a decision together.
5. Evaluating the patient’s decision, assessing whether their decision is reasonable based upon their values.

Moving from informed refusal to informed declination

Informed refusal is a health care industry phrase used to describe a patient’s decision to decline to follow the order or recommendation of a physician, physician assistant, or nurse practitioner. This phrase tends to reflect the perspective of the practitioner rather than that of the patient; in fact, even the words “informed refusal” may result, consciously or unconsciously, in negative value judgments from the practitioner’s perspective, which in turn may impact the patient. On the other hand, using the term informed declination aligns with patient autonomy, is patient-centric, and will likely support an organization’s mission, vision, and values, which are generally written with a focus on the patient.

Documentation of informed declination

There may be circumstances in which a patient’s declination cannot be successfully addressed. In these instances, Physicians Insurance recommends that the patient be provided with information concerning the possible consequences of declining treatments, procedures, or recommendations or plans. Discuss and document the patient’s reasoning. Explore alternatives and actions taken to help address the patient’s thought processes, and document the patient’s response. If the patient states that their declination is due to a lack of understanding, incorporate audiovisual or multimedia materials, and document this.

Documentation of the declination should state:

• That the patient has declined the recommended care.
• The patient’s reasons for declination.
• That the consequences of declination have been explained to the patient in plain language, and that the patient understood the risks of their decision.
• That the patient’s signature was obtained on an informed declination form.

In the event that the patient is uncooperative, the signature of a witness to the discussion should be obtained and documented in the medical record.

Sharon Hall, RN, MPH, ARM, is a senior clinical risk consultant with Physicians Insurance.

This article was featured in the March/April 2026 issue of WSMA Reports, WSMA’s print magazine.