Prioritising informed consent

14 December 2022

Community pharmacies are the cornerstone of Australia’s healthcare system and hundreds of thousands of people flock to pharmacies every day for lifesaving advice and services. It’s a huge responsibility, and one that is taken very seriously.

Guild Insurance knows pharmacist are run off their feet.

“We live in challenging times and while serving your community is satisfying and rewarding, we know the demand for your services keeps rising. It can be easy, in peak customer times, to let what feels like administrative tasks come second to helping people,” the company says.

“We’ve worked with your colleagues at the Pharmacy Guild of Australia to create this guidance for how to provide your customers with the informed consent they need to make decisions about their health, and to protect from complaints and claims made against you.”

Informed consent

Ahpra defines informed consent in the Code of Conduct as “a person’s voluntary decision about healthcare that is made with knowledge and understanding of the benefits and risks involved”.  Therefore, you should always seek out informed consent prior to your treatment or assessment of a patient or customer.

Informed financial consent

Additional to their treatment or assessment, patients and customers should also give their informed financial consent.  This means they need to be provided with information about the expected cost of treatment before treatment commences.

Insurance and informed consent

Informed consent can feature in professional indemnity insurance claims against pharmacists in a couple of ways. Evidently, patients may claim they wouldn’t have given consent if they were fully informed.  Here are a few examples:

Stephen is unhappy after receiving a vaccine at a pharmacy. Allegedly, he was not made aware of the risks when he consented to the vaccine.  He claims that the treatment was negligent and has resulted in harm or suffering. He adds that if he’d known of the possible risks, he wouldn’t have consented.

Alice is distraught after her influenza vaccine. She thought it was funded under NIP and was unaware of the administration fee. She claims had she known about this she would not have consented. 

Having the informed consent conversation

Informed consent requires a conversation between the pharmacist and the patient prior to assessment and treatment.

The conversation must:

  • detail the recommended assessment and treatment as well as alternative treatment options
  • include the expected benefits of that treatment
  • provide information about the risks of the treatment
  • allow time for the patient to ask questions
  • be held in language that can be understood by the patient - this means practitioners should avoid technical clinical language
  • take place in a private area where the patient will feel comfortable being open and honest about their health circumstances
  • be tailored to that individual patient and their unique clinical needs.

Recording informed consent

Pharmacists must make a record of the patient’s informed consent.  The record needs to show what treatment options and risks were discussed as well as any questions asked by the patient.  The record should also show what the patient consented to.

Informed consent forms

Forms can’t replace conversations. An area of confusion is a signed patient form, they are seen as a quick way of obtaining informed consent. However, they are often used inappropriately.  A conversation with a pharmacist provides better opportunities for informed decision-making.

Signed forms aren’t a requirement, but they do provide additional evidence if allegations ever arise. A few examples: 

Cindy filled out a consent form for a vaccine before she had the opportunity to make an informed decision. As a result, Cindy had not provided informed consent. The patient should sign a form after the discussion with the pharmacist. 

Nigel filled out a pre-screening form for a vaccine and signed his name. He was unaware he signed a consent form because they were integrated documents. As a result, Nigel had not provided informed consent. Forms that serve two purposes should not be combined.

Pharmacies should have procedures in place to provide patients with the opportunity to give informed consent to each unique treatment and assessment. 

Informed consent and vaccination in pharmacy

It is important that the pharmacist must obtain informed consent after having an interaction with the patient prior to administering the vaccination. A signed consent form isn’t required, but you should have some form of written evidence, like a clinical record. Without this, there’s no proof that you had a conversation.  Ideally, the process for administering a vaccine would follow these 4 steps.

  1. Provision of a pre-screening form entailing personal details and a separate summarised consumer information on the vaccine, including the price of service.
  2. The patient and pharmacist have a conversation, providing an opportunity for further questions. The pharmacist should direct the conversation to meet the requirements for informed consent.
  3. The patient provides verbal consent for the pharmacist to record. A signed, written informed consent is recommended.
  4. The pharmacist can then feel confident to administer the vaccine.

As always, Guild Insurance is here to help you. Find out more by contacting your Account Manager, or head to RiskHQ for more insights.

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Page last updated on: 16 December 2022