Wydanie 2/2014
str. 35

Leki stosowane w terapii schorzeń narządu wzroku u kobiet w ciąży – aspekty praktyczne i prawne. Część I

Medications Used in Ocular Disorders Treatment in Pregnant Women – Clinical and Legal Issues. Part I

Katarzyna Mianowska, Dominika Mońdziel, Konrad Solarski, Daria Kęcik, Klaudia Półtorak, Dariusz Kęcik

Klinika Okulistyki I Wydziału Lekarskiego Warszawskiego Uniwersytetu Medycznego
Kierownik: prof. dr hab. n. med. Dariusz Kęcik

Summary: The Medical Profession Act of 1996 provides legislation regarding rules of conduct of doctors in Poland. Under above mentioned Act the due diligence is required for the introduction of optimal therapeutic management. It means – inter alia – that medicinal products should be used in compliance with the approved Short Product Characteristic (SmPC). Particular attention must be given to the Section 4.6 of Short Product Characteristic “Fertility, pregnancy and lactation” which encompasses the information on the use of a medicine in relation to reproduction. FDA pregnancy categories of drugs are not included into Polish SmPC thus these categories can be regarded as current state of medical knowledge, but not as approved by URPL documentation. SmPC of medicinal products containing the same chemical substance may vary, so trade names of products must be known. In this paper we will discuss legal issues and problem of drug substitution in the pharmacy.
Objective: to compare section 4.6 of SmPC of medicinal products containing the same chemical substance.
Methods: Comparison of section 4.6 of approved Short Product Characteristic of ophthalmological medicinal products (based on ATC classification). Part I includes S01A Antinfectives and S01B Antiinflamatory Agents.
Conclusions: SmPC of medical products containing the same chemical substance may vary, so from the legal point of view it is important to know the trade marks (because SmPC is approved for trade mark, not for the chemical substance).

Słowa kluczowe: ciąża, leki okulistyczne, Charakterystyka Produktu Leczniczego (ChpL).

Keywords: pregnancy, ophthalmological medications, Short Product Characteristic (SmPC).