Consent forms for botulinum toxin and fillers

What the law says

Under the Croatian Patients' Rights Act, a patient has the right to accept or refuse a diagnostic or therapeutic procedure, and expresses acceptance by signing a consent form (Article 16). The form itself is set by an ordinance (NN 10/08) and is the legal minimum. Other EU countries have similar rules on informed consent.

A signature is only worth as much as the information behind it. Article 8 of the same Act gives the patient the right to be fully informed, among other things about the recommended procedures, the possible benefits and risks of having or not having them, and possible alternatives, in a way they can understand given their age, education and mental capacity.

What a consent form for toxin and fillers should cover

• Details of the patient, the clinic and the practitioner performing the treatment
• The treatment, the type of product and the areas treated
• Expected effect and approximate duration (for toxin usually a few months, for fillers depending on the product and area)
• Common side effects: swelling, redness, bruising, pain or tenderness at the injection site
• Rare but serious complications: for fillers, a blocked blood vessel with skin damage and, very rarely, loss of vision; for toxin, the effect spreading to nearby muscles (for example a drooping eyelid)
• Contraindications the patient was asked about: pregnancy and breastfeeding, allergies, infection at the treatment site, and for toxin neuromuscular disorders (such as myasthenia gravis)
• Alternatives, including the option of not having the treatment
• Aftercare and when to contact the clinic
• A statement that the patient could ask questions, the date and signatures

One generic form for every treatment is rarely enough. Toxin and fillers carry different risks, and the patient should sign for what is actually being done.

When to sign and who signs

Consent is signed before the treatment, never after. Ideally it is sent a day or two in advance, so the patient reads it at home and comes with questions, instead of signing in the chair a minute before the first injection.

For a minor, or a patient without legal capacity, the legal representative or guardian signs (Article 17).

Take a new consent when the treatment, product or area changes, or when something changes in the patient's health. Many clinics also renew consent once a year for repeat treatments.

Paper or electronic signature

Consent can be signed on paper or electronically. Under the EU eIDAS Regulation, an electronic signature cannot be denied legal effect solely because it is electronic (Article 25). How strong the evidence is still depends on the type of signature and what is kept with it: the document version, the time of signing, a record of when it was opened and signed, and a locked PDF that cannot be changed afterwards.

Agree with your legal adviser which signature and how much of an evidence trail you need. The rule is the same as on paper: the signed version stays exactly as it was signed, and the patient gets a copy.

Most common mistakes

• The same form for every treatment, without product or areas
• Consent signed after the treatment, or "just in case" at the end of the day
• Consent to use photos for marketing hidden as one tick box inside the treatment consent
• The patient never received a copy of what they signed
• After a template was changed, nobody knows which version the patient actually signed

How Injectly handles it

In Injectly, the clinic writes its consent documents once and links them to treatments. When an appointment is booked, the consent for that treatment is emailed to the patient, who signs it on their own phone. The signed status shows on the patient's record and in the day's schedule.

When a treatment requires consent, Injectly asks for it before documentation starts: send it by email, or confirm a signed paper consent. A signed consent is stored as a PDF that cannot be changed, with a record of when it was opened and signed, and the patient receives a copy by email.

Frequently asked questions

Sources

1. Croatian Patients' Rights Act (Zakon o zaštiti prava pacijenata, NN 169/04, 37/08), Articles 8, 16 and 17 (in Croatian)
2. Ordinance on the consent form and the form for refusing a procedure (NN 10/08, in Croatian)
3. Regulation (EU) No 910/2014 (eIDAS), Article 25
4. HALMED: summary of product characteristics, Alluzience (botulinum toxin type A), contraindications (in Croatian)