Analysis of information asymmetry in the instructions for medical use on the example of Enterol

Abstract

There may be variations in the texts of instructions for medical use of medicines (hereinafter – the instructions) containing the same active pharmaceutical ingredient, and registered in the pharmaceutical markets of different countries. First of all this applies to medicines manufactured in one country and distributed to other countries. Therefore, there are questions related to incorrect use of medicines due to the existing asymmetry of information. This problem is especially relevant in connection with tourist activity and labour migration. The aim of the study was to identify discrepancies in the instructions of Enterol, registered in different countries. The materials of the study were the registers of medicines in France, Ukraine, Belarus, Bulgaria, Poland, the Czech Republic and Russia, as well as the texts of instructions of Enterol (Biocodex, France), registered in the above countries. Methods of generalization, systematization, as well as contextual and comparative analysis were used. It was found that the original (French) instruction has two indications for the use of Enterol (treatment of acute diarrhea in children under 12 years old; prevention of antibiotic-associated diarrhea caused by Clostridium difficile or recurrence of diarrhea caused by Clostridium difficile), while Belarusian and Russian instructions have one indication. Polish instruction contains 5 indications, while Bulgarian and Czech – 8. The largest number of indications for the use of Enterol (11) is given in Ukrainian instruction. A contradictory information is in the sections «Therapeutic Indications», «Posology and method of administration», «Contraindications», «Undesirable effects», «Special warnings and precautions for use», including «Pregnancy and lactation». In the text of one instruction there is no information available in the text of another, and none of the instructions is identical to the instructions of Enterol, registered in France (country of manufacture). Actually, these information discrepancies, as well as the patient's perception of information, can lead to improper use of medicines and, as a consequence, drug-related problems. Thus, to minimize the asymmetry of information, the applicant during the registration of the drug must submit a notarized translation of the manufacturer's instructions.

Keywords

• probiotic
• instruction for medical use
• asymmetry of information