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Verifying capacity is an essential element in gaining informed consent

January 26, 2022
Some helpful tips on how to assess an individual’s capacity.

A recent incident where a pharmacy team provided a COVID-19 vaccine injection to an individual without the consent of their legal guardian acts as a reminder about the importance of pharmacy teams assessing capacity as part of gaining informed consent before providing a service.

In the incident, an 18-year-old college student with developmental delays was encouraged by faculty and fellow students to get vaccinated against COVID-19. The student then visited a pharmacy on her own where she received her first dose of a COVID-19 vaccine. However, because of the student’s developmental delays, her parents act as her legal guardians. Due to the students’ other health issues, including severe allergies, her parents made the difficult decision to not have her vaccinated from COVID-19. Instead, they were getting their daughter tested for COVID-19 every 72 hours to allow her to attend her classes in person. Once the student received her vaccination, she texted her parents about it, much to their surprise.

Since receiving her vaccination, the student has experienced several health issues. Although it’s difficult to link these health issues to receiving a vaccine, the parents are understandably disappointed that they were not consulted before their daughter received the injection. The parents say that it would have been apparent to a pharmacy team member that she had developmental delays if they had engaged in conversation with her.

While pharmacy teams are under intense pressure to provide  more services to the public during the pandemic, pharmacists are still required to gain informed consent from patients before providing a treatment or procedure. Informed consent means the patient has agreed to undergo a treatment or procedure after the pharmacist has provided the patient with relevant information about the nature of the treatment or procedure(s), its benefits, potential risks and alternatives, and the potential consequences of refusal, in a manner the patient can understand.

Pharmacists are also required to assess an individual’s capacity as part of gaining informed consent. An individual who does not have the capacity to properly understand the risks and benefits of a proposed pharmacy service, including the potential long-term effects, cannot independently provide informed consent.

According to Alberta Health Services (AHS), having capacity means an individual can understand information important for making a decision and can appreciate the reasonable consequences of making or not making that decision. The pharmacist should consider whether the individual can

  • understand key information about the decision,
  • assess the pros and cons of a decision, and
  • make a decision based on their values.

Here are some tips to help pharmacists determine if an individual has capacity to provide informed consent:

  • Don’t assume a person is able to provide consent based solely on their age (i.e., an 18-year-old adult may not have capacity to provide informed consent).
  • Avoid asking “yes/no” questions during and assessment. It’s better practice to engage in a conversation with the individual. For example, instead of asking an individual, “Do you have any concerns about the vaccine?” a pharmacist might consider the following question: “What are your concerns about receiving the vaccine?” That might initiate a conversation that will put the pharmacist in a better position to verify if the individual has the capacity to provide informed consent.
  • For tips on the process to gain informed consent, refer to AHS’ Consent to treatment/procedure(s) policy.
  • For ideas on what to look for in adults who lack capacity, refer to AHS’ Consent to treatment/procedure(s) for adults with impaired capacity and adults who lack capacity.

Also remember that individuals under 18 years of age may be considered a mature minor and may be able—and have the capacity—to provide informed consent to a pharmacist for a procedure such as a COVID-19 vaccination. Refer to our Link article from May 26, 2021, for more information.