Pharmacist's algorithm of actions in case of adverse reactions

Criteria for hazardous conditions requiring mandatory reporting

Within the framework of pharmacovigilance, a pharmaceutical worker bears professional responsibility for monitoring the safety of pharmacotherapy. There is a clear list of criteria upon which a side effect is classified as hazardous. Such conditions require mandatory official registration.

Conditions subject to strict recording include:

• Life threat: any side effects that pose an immediate danger to the patient's life at the time of their occurrence.
• Unexpected reactions: the development of adverse effects that have not been previously studied and are not described in the official instructions (package leaflet) of the medicinal product used.
• Severe consequences: adverse reactions whose severity led to the patient's temporary disability or required emergency or scheduled hospitalization.
• Clinical trials of new drugs: the occurrence of absolutely any, even minor, side effects when taking a new medicinal product if it is currently at the clinical trial stage.

Pharmacist's duties upon identifying hazardous reactions

If the patient's identified condition falls under the criteria of a hazardous one (life-threatening, undocumented, leading to hospitalization, or related to clinical trials), the pharmacist's algorithm of actions is strictly regulated. The specialist must perform the following steps:

1. Provide emergency pre-medical care. The primary task of a pharmaceutical worker is to stabilize the patient's condition upon the development of an acute or life-threatening reaction right in the pharmacy organization.
2. Document the case. After providing care, it is necessary to officially record the incident. To do this, the pharmacist is required to fill out the "Adverse Reaction Report Form" of a strictly established format.
3. Notify responsible persons. Information about a severe or atypical side effect must be promptly transmitted to the pharmacy management as well as to the patient's attending physician who prescribed this drug.

Tactics for non-hazardous and known side effects

Not every adverse event requires emergency measures, filling out Report Forms, and notifying management.

If the developed side effect is assessed as non-hazardous, and its manifestations are already described in the instructions (package leaflet) for the medicinal product, the algorithm of actions is significantly simplified. In such situations, it is sufficient for the pharmacist to conduct competent counseling and strongly recommend that the patient consult their attending physician. The physician, in turn, will assess the condition and, if necessary, adjust the pharmacotherapy regimen or drug dosage.

Briefly: answers to topical questions

Class and exam questions

What else to study on this topic

• Organization of the pharmacovigilance system in the Russian Federation
• Rules for providing first aid in a pharmacy
• Procedure for filling out the Adverse Reaction Report Form
• Differences between clinical trials and post-marketing surveillance

Other topics in "General Pharmacology"

Prepared by WhiteCoat Pro faculty in accordance with the medical school curriculum. For educational purposes only.