Anaphylactic shock: legal aspect

The article describes the legal consequences of a patient having an allergic reaction to injected drugs, and provides an overview of the current regulatory documents of the Ministry of Health of Ukraine, which regulate the procedure for a medical institution to act in the event of a severe allergic reaction in a patient.

Yulia Marchenko, senior lawyer at Medconsulting LLC (Ukraine)

WHAT YOU NEED TO KNOW ABOUT ANAPHYLACTIC SHOCK

In modern aesthetic medicine, various invasive techniques play a significant role, which are becoming increasingly widespread and are in demand among clients. Unfortunately, such methods not only provide excellent results, but are also fraught with complications, among which, in terms of severity of consequences, one of the most significant is the patient’s allergic reaction to the drug and, as a possible consequence, anaphylactic shock.

It should be remembered that anaphylactic shock, although a rather rare disease, is by no means unique: in developed countries, 4-5 cases of anaphylactic shock are recorded annually for every 100 thousand population. In Ukraine, according to the Department of Post-Registration Surveillance of the State Expert Center of the Ministry of Health of Ukraine, 121 cases of anaphylaxis were recorded for the period from January 1, 2011 to December 31, 2013. If a client experiences a severe allergic reaction (even shock), it is very important to act correctly not only from a medical but also a legal point of view, keeping in mind the possible liability.

Cases of severe complications and numerous complaints after cosmetic interventions are sometimes due to the low level of qualifications of specialists. There are often cases when complex medical procedures (mesotherapy, peelings, injection contouring, administration of botulinum toxin preparations) are carried out by personnel who have no medical education at all or who have not undergone appropriate training. All methods of influence that affect the entire body or violate the integrity of the skin (chemical and other types of peels, mesotherapy, the introduction of fillers or botulinum toxin preparations) should only be carried out under the supervision of a specialist. The provision of medical cosmetology services without the appropriate permits or by a person who does not have the appropriate medical education can be equated to illegal medical activities (Article 138 of the Criminal Code) and, if consequences arise for the patient, is punishable by correctional labor for up to two years or imprisonment for up to three years.

HOW TO PROTECT YOURSELF

As paradoxical as it sounds, you need to prepare in advance for the onset of an unexpected severe allergic reaction. According to the licensing conditions for economic activities in medical practice, which were approved by Resolution of the Cabinet of Ministers of Ukraine dated March 2, 2016 No. 285, the licensee is obliged to ensure the availability, accessibility and completeness of first aid kits for the provision of emergency medical care (clause 20, clause 13 of the licensing conditions). It would be useful to provide a first aid kit in case of anaphylactic shock and work out with the staff of the medical center the procedure for action in case of its occurrence (conduct a practical lesson, for example).

Today, the issue of anaphylactic shock and the procedure for dealing with its occurrence is regulated by a number of orders of the Ministry of Health of Ukraine (hereinafter referred to as the Ministry of Health). The main (and newest) among them is order No. 916 dated December 30, 2015 “On the approval and implementation of medical and technological documents for the standardization of medical care for drug allergies, including anaphylaxis” (hereinafter referred to as Order of the Ministry of Health No. 916). If we summarize the recommendations of the order, then the procedure that must be followed comes down to simple steps:

1. Questioning all patients before prescribing the drug.
2. If necessary, provide emergency assistance.
3. Registration of adverse drug reactions (in the patient’s record, as well as notification of this using special cards) in accordance with current legislation.

Also continue to operate (albeit partially):

• Order of the Ministry of Health dated July 3, 2006 No. 432 “On approval of protocols for the provision of medical care in the specialty “allergology”;
• Order of the Ministry of Health and the Academy of Medical Sciences of Ukraine dated April 2, 2002 No. 127/18 “On organizational measures for the introduction of modern technologies for the diagnosis and treatment of allergic diseases.”

In the case of providing assistance to children, you can also take into account the order of the Ministry of Health dated December 27, 2005 No. 767 “On approval of protocols for the diagnosis and treatment of allergic diseases in children.”

3 STEPS TO YOUR PROTECTION

Step No. 1: patient survey

From a legal point of view, an important element of the doctor’s protection is the mandatory questioning of the patient. Examples and recommendations for the form of the questionnaire are established by order of the Ministry of Health No. 916. If, when filling out such a questionnaire, the patient intentionally or unintentionally hides the fact that he has allergic reactions, then the doctor’s position in court will be much better, since in this case the doctor was not able to foresee similar situation.

Step No. 2: providing emergency assistance

Within the framework of this article, we will not dwell in detail on the actual algorithm for providing emergency care - it is described in detail in the order of the Ministry of Health No. 916. But we would like to emphasize separately that, even if first aid was provided very successfully and the patient feels much better, it is imperative to call emergency medical team (this requirement is also stated in Order No. 916). It is necessary to call a team even when the patient himself refuses further help.

If this is not done and the patient’s health condition worsens, the person who provided the service will be held responsible. A criminal case may be initiated against a medical worker under Art. 140 of the Criminal Code of Ukraine – “Unsatisfactory performance of professional duties by a medical worker.” In accordance with the article, there is improper performance by a medical worker of his professional duties, that is, although the doctor performs his professional duties, but not in the manner required by the rules, instructions and other regulations.

In such a situation, it is considered that a crime has been committed if, as a result of failure to perform or improper performance of professional duties, grave consequences have occurred for the patient. It is the fact that the emergency team was not called that can be regarded by the court as improper performance by the medical worker of his duties.

Step #3: registration of adverse drug reactions

An important element of the doctor’s protection in future proceedings will be official notification of the patient’s adverse reaction to the drug. Notification occurs on the basis of the order of the Ministry of Health dated December 27, 2006 No. 898 “On approval of the Procedure for the implementation of pharmacovigilance.”

It is necessary to report any adverse reactions to medicinal products registered in Ukraine, including herbal products. It is worth reporting adverse reactions even if the doctor is not sure that this particular drug caused it. That is, when reporting adverse reactions, the doctor does not necessarily have to be sure of the existence of a cause-and-effect relationship between the use of the suspected drug and the occurrence of allergies.

To provide information, use a special form of message card according to Form 137/u, approved by the same order No. 898, which contains information about the patient, a description of the adverse reaction (time of occurrence, course of treatment, examination results, risk factors and other data), as well as the name and address of the person who can be contacted if clarification of the message details is necessary. Information about all non-serious adverse reactions must be submitted within 15 days, and about all serious adverse reactions - within 48 hours to the Department of Post-Marketing Surveillance of the State Enterprise "State Expert Center of the Ministry of Health of Ukraine" (by mail, fax, e-mail or by filling out an electronic form at center website).

Article taken from the magazine "Les Nouvells Esthetiques Ukraine" 3/2017