29 research outputs found
Patient reporting of adverse drug events - a narrative review
PURPOSE: The aim of this review is to examine the role and experience with direct patient adverse drug reactions reports in the spontaneous reporting systems.MATERIAL AND METHODS: A computerized literature search or relevant English publications regarding the role and characteristics of direct patient reporting from 1996 to 2012 was completed in January 2013. The latest update in the search was performed from September to October 2013.RESULTS: The results show that direct patient reports could contribute to the pharmacovigilance system qualitatively as well as quantitatively. There are a lot of factors that influence patient participation such as personal characteristics, disease perception, and previous experience. Critical issue in the process is considered to be the noise effect on the signal generation.CONCLUSION: Inclusion of patients as a source of information will help to change the perspective of pharmacovigilance. The factors that affect the decision of the patient`s report of an adverse drug reaction and possible external influences that would shape their opinion and could affect the quality of reports are not well studied
Research and analysis of data on the pharmacovigilance system framework in the European Union
ΠΠΎΠ΄Π΄ΡΡΠΆΠ°Π½Π΅ΡΠΎ Π½Π° ΡΠΈΡΡΠ΅ΠΌΠ° Π·Π° ΠΏΡΠΎΡΠ»Π΅Π΄ΡΠ²Π°Π½Π΅ Π½Π° Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π°ΡΠ° Π±Π΅Π·ΠΎΠΏΠ°ΡΠ½ΠΎΡΡ Π΅ Π·Π°Π΄ΡΠ»ΠΆΠ΅Π½ΠΈΠ΅ Π½Π° Π²ΡΠΈΡΠΊΠΈ ΠΏΡΠΈΡΠ΅ΠΆΠ°ΡΠ΅Π»ΠΈ Π½Π° ΡΠ°Π·ΡΠ΅ΡΠ΅Π½ΠΈΠ΅ Π·Π° ΡΠΏΠΎΡΡΠ΅Π±Π° ΠΈ Π½Π° ΡΠ΅Π³ΡΠ»Π°ΡΠΎΡΠ½ΠΈΡΠ΅ ΠΈΠ½ΡΡΠΈΡΡΡΠΈΠΈ Π½Π° ΡΡΡΠ°Π½ΠΈΡΠ΅-ΡΠ»Π΅Π½ΠΊΠΈ. ΠΠ²ΡΠΎΠΏΠ΅ΠΉΡΠΊΠ°ΡΠ° Π°Π³Π΅Π½ΡΠΈΡ ΠΏΠΎ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π°ΡΠ° (ΠΠΠ) ΠΈΠ³ΡΠ°Π΅ ΠΊΠ»ΡΡΠΎΠ²Π° ΡΠΎΠ»Ρ Π½Π° ΠΊΠΎΠΎΡΠ΄ΠΈΠ½Π°ΡΠΎΡ Π½Π° Π²ΡΠΈΡΠΊΠΈ ΠΎΡΠ½ΠΎΠ²Π½ΠΈ ΠΏΡΠΎΡΠ΅ΡΠΈ Π² ΠΏΠΎΡΡ-ΠΌΠ°ΡΠΊΠ΅ΡΠΈΠ½Π³ΠΎΠ²ΠΎΡΠΎ Π½Π°Π±Π»ΡΠ΄Π΅Π½ΠΈΠ΅ Π½Π° Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½ΠΈΡΠ΅ ΠΏΡΠΎΠ΄ΡΠΊΡΠΈ. Π§ΡΠ΅Π· ΡΡΠ·Π΄Π°Π²Π°Π½Π΅ΡΠΎ Π½Π° ΡΠ΅Π΄ΠΈΡΠ° ΠΈΠ½ΡΠ΅Π³ΡΠΈΡΠ°Π½ΠΈ ΡΠΈΡΡΠ΅ΠΌΠΈ ΠΈ ΡΠΏΠΎΡΠΎΠ±ΠΈ Π·Π° Π²ΡΡΡΠ΅ΡΠ½Π° ΠΊΠΎΠΌΡΠ½ΠΈΠΊΠ°ΡΠΈΡ ΠΠΠ ΡΠ΅Π»ΠΈ ΠΎΠ±ΠΌΡΠ½Π° Π½Π° ΠΎΠΏΠΈΡ ΠΈ ΡΡΡΡΡΠ΄Π½ΠΈΡΠ΅ΡΡΠ²ΠΎ ΠΌΠ΅ΠΆΠ΄Ρ Π΅ΠΊΡΠΏΠ΅ΡΡΠΈΡΠ΅ ΠΎΡ Π²ΡΠΈΡΠΊΠΈ Π΄ΡΡΠΆΠ°Π²ΠΈ-ΡΠ»Π΅Π½ΠΊΠΈ Ρ ΡΠ΅Π» ΠΎΡΠΈΠ³ΡΡΡΠ²Π°Π½Π΅ Π½Π° Π²ΠΈΡΠΎΠΊΠΎ ΠΊΠ°ΡΠ΅ΡΡΠ²ΠΎ ΠΏΡΠΈ ΠΎΡΠ΅Π½ΡΠ²Π°Π½Π΅ΡΠΎ Π½Π° ΡΡΠ±ΡΠ°Π½ΠΈΡΠ΅ Π΄Π°Π½Π½ΠΈ.The maintenance of a pharmacovigilance system is a legal obligation of all marketing authorization holders and regulatory authorities in the member states. The European Medicines Agency (EMA) plays a key role as a coordinator of the main processes in the post-marketing surveillance of the medicinal products. With the creation of several shared systems and internal communication tools EMA aims at exchange of experience and collaboration between the experts of all member states in order to insure high quality data evaluation
Study of the clinical pharmacist role in preparation and application of radiopharmaceuticals
ΠΡΠ²Π΅Π΄Π΅Π½ΠΈΠ΅: Π£ΠΏΠΎΡΡΠ΅Π±Π°ΡΠ° Π½Π° ΡΠΏΠ΅ΡΠΈΡΠΈΡΠ½ΠΈ ΡΠ°Π΄ΠΈΠΎΠ°ΠΊΡΠΈΠ²Π½ΠΈ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½ΠΈ ΠΏΡΠΎΠ΄ΡΠΊΡΠΈ ΠΈ ΠΌΠ΅Π΄ΠΈΡΠΈΠ½ΡΠΊΠΈ ΠΈΠ·Π΄Π΅Π»ΠΈΡ Π·Π° Π²ΠΈΠ·ΡΠ°Π»ΠΈΠ·ΠΈΡΠ°Π½Π΅ ΠΌΠΎΡΡΠΎΠ»ΠΎΠ³ΠΈΡΡΠ° Π½Π° ΠΎΡΠ³Π°Π½ΠΈ, ΡΠ΅Ρ
Π½ΠΈΡΠ΅ ΡΡΠ½ΠΊΡΠΈΠΈ ΠΈ Π΄ΠΈΡΡΡΠ½ΠΊΡΠΈΠΈ, ΠΊΠ°ΠΊΡΠΎ ΠΈ ΡΡΠ°Π΄ΠΈΡΠ°Π½Π΅ ΠΈ Π»Π΅ΡΠ΅Π½ΠΈΠ΅ Π½Π° Π·Π°Π±ΠΎΠ»ΡΠ²Π°Π½ΠΈΡ Π΅ ΡΠ½ΠΈΠΊΠ°Π»Π½Π° Π²ΡΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡ Π½Π° Π½ΡΠΊΠ»Π΅Π°ΡΠ½Π°ΡΠ° (ΡΠ΄ΡΠ΅Π½Π°ΡΠ°) ΠΌΠ΅Π΄ΠΈΡΠΈΠ½Π°. Π ΡΠΎΠ·ΠΈ ΠΏΡΠΎΡΠ΅Ρ Π²Π°ΠΆΠ½Π° ΡΠΎΠ»Ρ ΠΈΠΌΠ° ΡΡΠ°ΡΡΠΈΠ΅ΡΠΎ Π½Π° ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅Π½ ΡΠ°ΡΠΌΠ°ΡΠ΅Π²Ρ, ΠΊΠΎΠΉΡΠΎ Π΄Π° ΡΠ»Π΅Π΄ΠΈ ΠΈ ΠΊΠΎΠ½ΡΡΠΎΠ»ΠΈΡΠ° ΠΏΠΎΡΠ΅Π½ΡΠΈΠ°Π»Π½ΠΈΡΠ΅ ΡΠΈΡΠΊΠΎΠ²Π΅ ΠΊΠ°ΠΊΡΠΎ ΠΈ Π΄Π° ΡΡΠ΄Π΅ΠΉΡΡΠ²Π° Π·Π° ΠΎΠΏΡΠΈΠΌΠ°Π»Π½ΠΎΡΠΎ ΠΈΠΌ ΠΏΡΠΈΠ»ΠΎΠΆΠ΅Π½ΠΈΠ΅.Π¦Π΅Π»: Π¦Π΅Π»ΡΠ° Π½Π° ΠΏΡΠΎΡΡΠ²Π°Π½Π΅ΡΠΎ Π΅ Π΄Π° ΡΠ΅ ΠΏΠΎΡΡΡΡΡΡ Π²ΡΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡΠΈ Π·Π° ΠΎΠΏΡΠΈΠΌΠΈΠ·ΠΈΡΠ°Π½Π΅ ΠΏΡΠΎΡΠ΅ΡΠΈΡΠ΅ Π½Π° ΠΏΡΠΈΠ³ΠΎΡΠ²ΡΠ½Π΅ ΠΈ ΠΏΡΠΈΠ»Π°Π³Π°Π½Π΅ Π½Π° ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠΈ Π² ΠΊΠ»ΠΈΠ½ΠΈΡΠ½Π°ΡΠ° ΠΏΡΠ°ΠΊΡΠΈΠΊΠ° Π² ΠΡΠ»Π³Π°ΡΠΈΡ ΡΡΠ΅Π· ΡΡΠ°ΡΡΠΈΠ΅ΡΠΎ Π½Π° ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅Π½ ΡΠ°ΡΠΌΠ°ΡΠ΅Π²Ρ Π² ΠΌΡΠ»ΡΠΈΠ΄ΠΈΡΡΠΈΠΏΠ»ΠΈΠ½Π°ΡΠ½ΠΈΡ Π΅ΠΊΠΈΠΏ ΠΎΡ ΠΌΠ΅Π΄ΠΈΡΠΈΠ½ΡΠΊΠΈ ΡΠΏΠ΅ΡΠΈΠ°Π»ΠΈΡΡΠΈ Π² ΠΎΡΠ΄Π΅Π»Π΅Π½ΠΈΡΡΠ° ΠΏΠΎ ΠΡΠΊΠ»Π΅Π°ΡΠ½Π° ΠΌΠ΅Π΄ΠΈΡΠΈΠ½Π°.ΠΠ°ΡΠ΅ΡΠΈΠ°Π»ΠΈ ΠΈ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠ»ΠΎΠ³ΠΈΡ: ΠΡΠΎΡΡΠ΅Π½ΠΈ ΡΠ° Π»ΠΈΡΠ΅ΡΠ°ΡΡΡΠ½ΠΈ ΠΈΠ·ΡΠΎΡΠ½ΠΈΡΠΈ ΠΏΠΎ ΠΊΠ»ΡΡΠΎΠ²ΠΈ Π΄ΡΠΌΠΈ: ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠΈ, ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅Π½ ΡΠ°ΡΠΌΠ°ΡΠ΅Π²Ρ, Π½ΡΠΊΠ»Π΅Π°ΡΠ½Π° ΠΌΠ΅Π΄ΠΈΡΠΈΠ½Π°, Π΄ΠΎΠ±ΡΠΈ ΠΏΡΠ°ΠΊΡΠΈΠΊΠΈ, Π½Π°ΡΠΈΠΎΠ½Π°Π»Π΅Π½ ΡΡΠ°Π½Π΄Π°ΡΡ ΠΏΠΎ Π½ΡΠΊΠ»Π΅Π°ΡΠ½Π° ΠΌΠ΅Π΄ΠΈΡΠΈΠ½Π° ΠΎΡ Π½Π°ΡΡΠ½ΠΈΡΠ΅ Π±Π°Π·ΠΈ Π΄Π°Π½Π½ΠΈ: Scopus, Medline, Google Scholar, Springer, Embase ΠΈ Π΄Ρ. ΠΠ·Π²ΡΡΡΠ΅Π½ Π΅ Π°Π½Π°Π»ΠΈΠ· Π½Π° Π΄Π΅ΠΉΡΡΠ²Π°ΡΠΎΡΠΎ Π·Π°ΠΊΠΎΠ½ΠΎΠ΄Π°ΡΠ΅Π»ΡΡΠ²ΠΎ Π² Π Π΅ΠΏΡΠ±Π»ΠΈΠΊΠ° ΠΡΠ»Π³Π°ΡΠΈΡ, ΠΊΠΎΠ΅ΡΠΎ ΡΠ΅Π³Π»Π°ΠΌΠ΅Π½ΡΠΈΡΠ° ΠΈΠ·Π²ΡΡΡΠ²Π°Π½Π΅ΡΠΎ Π½Π° Π΄Π΅ΠΉΠ½ΠΎΡΡΠΈ Ρ ΡΠ°Π΄ΠΈΠΎΠ°ΠΊΡΠΈΠ²Π½ΠΈ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½ΠΈ ΠΏΡΠΎΠ΄ΡΠΊΡΠΈ, ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠΈ, ΡΠ°Π΄ΠΈΠΎΠ½ΡΠΊΠ»ΠΈΠ΄Π½ΠΈ Π³Π΅Π½Π΅ΡΠ°ΡΠΎΡΠΈ, ΠΊΠΈΡΠΎΠ²Π΅ ΠΈ ΡΠ°Π΄ΠΈΠΎΠ½ΡΠΊΠ»ΠΈΠ΄Π½ΠΈ ΠΏΡΠ΅ΠΊΡΡΡΠΎΡΠΈ, ΠΊΠ°ΠΊΡΠΎ ΠΈ ΡΠ΅Π³ΡΠ»Π°ΡΠΈΡΡΠ° Π½Π° ΠΎΠ±ΡΡΠ΅Π½ΠΈΠ΅ΡΠΎ Π½Π° ΡΠΏΠ΅ΡΠΈΠ°Π»ΠΈΡΡΠΈ, ΡΡΠ°ΡΡΠ²Π°ΡΠΈ Π² ΡΠ΅Π·ΠΈ Π΄Π΅ΠΉΠ½ΠΎΡΡΠΈ.Π Π΅Π·ΡΠ»ΡΠ°ΡΠΈ ΠΈ Π΄ΠΈΡΠΊΡΡΠΈΠΈ: ΠΡΠΈΡΠΊΠΈ ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ½ΠΈ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½ΠΈ ΠΏΡΠΎΠ΄ΡΠΊΡΠΈ (Π Π€ΠΠ) ΠΊΡΠΈΡΡ ΠΏΠΎΡΠ΅Π½ΡΠΈΠ°Π»Π΅Π½ ΡΠΈΡΠΊ ΠΎΡ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½ΠΈ Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡΠ²ΠΈΡ (ΠΠ) ΠΈ Π½Π΅ΠΆΠ΅Π»Π°Π½ΠΈ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½ΠΈ ΡΠ΅Π°ΠΊΡΠΈΠΈ (ΠΠΠ ). ΠΠΎΠ·Π½Π°Π²Π°ΠΉΠΊΠΈ Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠΈΡΡΠΈΠΊΠΈΡΠ΅ Π½Π° Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½ΠΈΡΠ΅ ΠΏΡΠΎΠ΄ΡΠΊΡΠΈ ΠΈ Π½Π° ΡΠ°Π΄ΠΈΠΎΠ°ΠΊΡΠΈΠ²Π½ΠΈΡΠ΅ ΠΠ, ΠΊΠ»ΠΈΠ½ΠΈΡΠ½ΠΈΡΠ΅ ΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈ ΠΈΠΌΠ°Ρ ΠΈΠ·ΠΊΠ»ΡΡΠΈΡΠ΅Π»Π½ΠΎ Π²Π°ΠΆΠ½ΠΎ ΠΌΡΡΡΠΎ Π² ΡΠ΅ΡΠ°ΠΏΠ΅Π²ΡΠΈΡΠ½ΠΈΡ ΠΈΠ»ΠΈ Π΄ΠΈΠ°Π³Π½ΠΎΡΡΠΈΡΠ΅Π½ ΠΏΡΠΎΡΠ΅Ρ ΠΊΠ°ΠΊΡΠΎ Π·Π° ΠΈΠ·Π±ΡΠ³Π²Π°Π½Π΅ΡΠΎ Π½Π° ΠΏΠΎΡΠΎΡΠ΅Π½ΠΈΡΠ΅ ΡΠΈΡΠΊΠΎΠ²Π΅, ΡΠ°ΠΊΠ° ΠΈ Π·Π° ΠΊΠΎΠ½ΡΡΠ»ΡΠΈΡΠ°Π½Π΅ Π½Π° ΠΏΠ°ΡΠΈΠ΅Π½ΡΠ° ΠΊΠ°ΠΊΠ²ΠΎ ΠΏΠΎΠ²Π΅Π΄Π΅Π½ΠΈΠ΅ Π΄Π° ΠΈΠΌΠ°, Π°ΠΊΠΎ Π½Π΅ΠΆΠ΅Π»Π°Π½ΠΈΡΠ΅ ΡΡΠ±ΠΈΡΠΈΡ Π½Π΅ ΠΌΠΎΠ³Π°Ρ Π΄Π° Π±ΡΠ΄Π°Ρ ΠΈΠ·Π±Π΅Π³Π½Π°ΡΠΈ ΠΈ/ΠΈΠ»ΠΈ ΡΠ° Π½Π°ΡΡΡΠΏΠΈΠ»ΠΈ. ΠΠΎΡΠ΅Π½ΡΠΈΠ°Π»Π½ΠΈ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½ΠΈ Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡΠ²ΠΈΡ Ρ ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ½ΠΈ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½ΠΈ ΠΏΡΠΎΠ΄ΡΠΊΡΠΈ ΡΠ° ΠΏΡΠΎΠΌΠ΅Π½ΠΈ Π² Π±ΠΈΠΎΠ»ΠΎΠ³ΠΈΡΠ½ΠΎ ΡΠ°Π·ΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΠ΅ Π½Π° Π Π€ΠΠ Π²ΡΠ² ΡΠΈΠ·ΠΈΠΎΠ»ΠΎΠ³ΠΈΡΠ½ΠΈΡΠ΅ ΠΊΠΎΠΌΠΏΠ°ΡΡΠΈΠΌΠ΅Π½ΡΠΈ, ΠΏΡΠΎΠΌΠ΅Π½Π΅Π½Π° Π°Π±ΡΠΎΡΠ±ΡΠΈΡ, ΡΡΠΊΠΎΡΠ΅Π½ΠΎ Π΅Π»ΠΈΠΌΠΈΠ½ΠΈΡΠ°Π½Π΅, ΡΠ°ΡΠΌΠ°ΠΊΠΎΠ»ΠΎΠ³ΠΈΡΠ½ΠΈ, ΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ½ΠΈ ΠΈ/ΠΈΠ»ΠΈ ΡΠΎΠΊΡΠΈΠΊΠΎΠ»ΠΎΠ³ΠΈΡΠ½ΠΈ Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡΠ²ΠΈΡ. ΠΡΠΊΠΎΠΈ Π Π€ΠΠ ΠΌΠΎΠ³Π°Ρ Π΄Π° ΡΠ΄ΡΠ»ΠΆΠ°Ρ ΠΈΠ»ΠΈ Π½Π°ΠΌΠ°Π»ΡΡ Π½Π°ΡΡΡΠΏΠ²Π°Π½Π΅ΡΠΎ ΠΈΠΌ Π² ΡΠ°ΡΠ³Π΅ΡΠ½ΠΈΡΠ΅ ΠΎΡΠ³Π°Π½ΠΈ ΠΈ Π΄Π° ΠΏΠΎΠ²Π»ΠΈΡΡΡ Π΄ΠΈΠ°Π³Π½ΠΎΡΡΠΈΡΠ½ΠΈΡΠ΅ ΠΈΠ»ΠΈ ΡΠ΅ΡΠ°ΠΏΠ΅Π²ΡΠΈΡΠ½ΠΈ ΡΠ΅Π·ΡΠ»ΡΠ°ΡΠΈ.ΠΠ°ΠΊΠ»ΡΡΠ΅Π½ΠΈΠ΅: Π£ΡΠ°ΡΡΠΈΠ΅ΡΠΎ Π½Π° ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅Π½ ΡΠ°ΡΠΌΠ°ΡΠ΅Π²Ρ ΠΏΡΠΈ ΠΏΡΠΈΠ³ΠΎΡΠ²ΡΠ½Π΅ΡΠΎ ΠΈ ΠΏΡΠΈΠ»ΠΎΠΆΠ΅Π½ΠΈΠ΅ΡΠΎ Π½Π° ΡΠ°Π΄ΠΈΠΎΠ°ΠΊΡΠΈΠ²Π½ΠΈ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½ΠΈ ΠΏΡΠΎΠ΄ΡΠΊΡΠΈ, ΡΠ°Π΄ΠΈΠΎΠ½ΡΠΊΠ»ΠΈΠ΄Π½ΠΈ Π³Π΅Π½Π΅ΡΠ°ΡΠΎΡΠΈ, ΠΊΠΈΡΠΎΠ²Π΅ ΠΈ ΡΠ°Π΄ΠΈΠΎΠ½ΡΠΊΠ»ΠΈΠ΄Π½ΠΈ ΠΏΡΠ΅ΠΊΡΡΡΠΎΡΠΈ Π±ΠΈ ΠΌΠΎΠ³Π»ΠΎ Π΄Π° ΡΡΠ·Π΄Π°Π΄Π΅ ΡΠ΅Π°Π»Π½Π° Π²ΡΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡ Π·Π° ΠΎΠΏΡΠΈΠΌΠΈΠ·ΠΈΡΠ°Π½Π΅ Π½Π° ΡΠ΅Π·ΠΈ ΠΏΡΠΎΡΠ΅ΡΠΈ, ΠΊΠ°ΠΊΡΠΎ ΠΈ ΠΏΠΎΠ΄ΠΎΠ±ΡΡΠ²Π°Π½Π΅ Π½Π° ΡΠ΅ΡΠ°ΠΏΠ΅Π²ΡΠΈΡΠ½ΠΈΡΠ΅ ΠΈ Π΄ΠΈΠ°Π³Π½ΠΎΡΡΠΈΡΠ½ΠΈ ΡΠ΅Π·ΡΠ»ΡΠ°ΡΠΈ Π·Π° ΠΏΠ°ΡΠΈΠ΅Π½ΡΠ° Π² ΠΊΠ»ΠΈΠ½ΠΈΡΠ½ΠΈ ΡΡΠ»ΠΎΠ²ΠΈΡ.Introduction: The use of a specific type of radioactive medicinal products and medical devices is a unique opportunity of Nuclear medicine for visualization the morphology of organs, their functions and dysfunctions as well for staging and treatment of diseases. Very important role in this process has the clinical pharmacist through monitoring and control of a potential drug related risks and assistance for ensuring optimal application of this specific kind pharmaceuticals.Objective: To explore a various opportunities for optimize the preparation and application processes of radiopharmaceuticals in clinical setting in Bulgaria through the participation of a clinical pharmacist in the multidisciplinary team of healthcare specialists in the Nuclear medicine departments.Materials and methodology: The systematic review of literature data is based on key words: radiopharmaceutical, clinical pharmacist, nuclear medicine, good practices, national standard of nuclear medicine in the following bibliographic databases: Scopus, Medline, Springer, Embase, and others. The analysis is performed grounded on the current legislation of the Republic of Bulgaria, which regulates activities pertaining to radioactive pharmaceutical products, radiopharmaceutical, radionuclide generators, kits, radionuclide precursors, as well as the educational regulations for all experts participating in such activities.Results and discussions: All radiopharmaceutical medicinal products (RPMP) hide potential risk of drug interactions (DI) and adverse drug reactions (ADR). The expertise of a clinical pharmacist plays an important role in the therapeutic and diagnostic processes and is applicable to avoiding potential risks, consulting the patient regarding their behavior in the event such risks cannot be avoided or have already taken place. Potential DI with RPMP present changes in the biological distribution of the radiopharmaceuticals in the physiological compartments, changed absorption, accelerated elimination, pharmacological, pharmaceutical and/or toxic interactions. Some RPMP can extend or reduce their accumulation in the targeted organs and influence the diagnostic and therapeutical results.Conclusion: The participation of a clinical pharmacist in the preparation and application of radioactive medicinal products, radionuclide generators, kits, and radionuclide precursors as a part of the healthcare team can present a real opportunity for the optimization of such processes, as well as the improvement of the diagnostic and therapeutic outcomes of the patients in a clinical setting
E-Detailing: Keyways for Successful Implementation of Digital Technologies in the Pharmaceutical Marketing
E-detailing describes the use of IT tools for promotional activitiesβdelivering information for pharmaceutical products to customers (health professionals, medical personnel, and patients). It includes using electronic channels to interact with customers, as well as electronic support for sales reps in their everyday work. It is a strong and potential tool in the pharmaceutical marketing. This chapter describes the advantages and the challenges in the use of e-detailing
Ethical Aspects of Vulnerable Group of Patients in Clinical Trials
The current publication aims to review and analyse the ethical aspects and regulations to protect the category of vulnerable patients, as defined in the European legislation. These patients need special protection and require more detailed approach throughout the clinical trialsβ life cycle
Questionnaire Survey Among Hospital Pharmacists On The Effects Of The Change In The Legislation Regulating Clinical Trials In Bulgaria
Π£ΡΠ°ΡΡΠΈΠ΅ΡΠΎ Π½Π° Π±ΠΎΠ»Π½ΠΈΡΠ½ΠΈΡΠ΅ ΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈ Π² ΠΏΡΠΎΠ²Π΅ΠΆΠ΄Π°Π½Π΅ΡΠΎ Π½Π° ΠΊΠ»ΠΈΠ½ΠΈΡΠ½ΠΈ ΠΈΠ·ΠΏΠΈΡΠ²Π°Π½ΠΈΡ Π΅ Π²Π°ΠΆΠ½ΠΎ, Π·Π° Π΄Π° ΡΠ΅ ΠΎΡΠΈΠ³ΡΡΠΈ ΠΊΠ°ΡΠ΅ΡΡΠ²ΠΎ ΠΈ ΠΏΡΠΎΡΠ»Π΅Π΄ΠΈΠΌΠΎΡΡΡΠ° ΠΏΡΠΈ ΡΡΡ
ΡΠ°Π½Π΅Π½ΠΈΠ΅ΡΠΎ, ΡΠ°Π·ΠΏΡΠ΅Π΄Π΅Π»ΡΠ½Π΅ΡΠΎ ΠΈ ΠΎΡΡΠ΅ΡΠ½ΠΎΡΡΡΠ° Π½Π° ΠΈΠ·ΠΏΠΈΡΠ²Π°Π½ΠΈΡ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½ ΠΏΡΠΎΠ΄ΡΠΊΡ (IMP). ΠΠ°Π΄ΡΠ»ΠΆΠΈΡΠ΅Π»Π΅Π½ ΡΠ΅ΠΊΡΡ, ΡΠ΅Π³ΡΠ»ΠΈΡΠ°Ρ ΡΠΎΠ·ΠΈ ΠΏΡΠΎΡΠ΅Ρ, ΡΡΠ°Π½Π° ΡΠ°ΡΡ ΠΎΡ ΠΌΠ΅ΡΡΠ½ΠΎΡΠΎ Π±ΡΠ»Π³Π°ΡΡΠΊΠΎ ΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ½ΠΎ Π·Π°ΠΊΠΎΠ½ΠΎΠ΄Π°ΡΠ΅Π»ΡΡΠ²ΠΎ ΠΏΡΠ΅Π· 2015 Π³. ΠΡΠ΅Π· ΠΏΠΎΡΠ»Π΅Π΄Π½ΠΈΡΠ΅ Π³ΠΎΠ΄ΠΈΠ½ΠΈ ΠΌΠ½ΠΎΠ³ΠΎ ΠΏΡΠΎΠΌΠ΅Π½ΠΈ ΠΏΠΎ ΠΎΡΠ½ΠΎΡΠ΅Π½ΠΈΠ΅ Π½Π° ΡΠ°Π·ΠΈ ΡΠ΅Π³ΡΠ»Π°ΡΠΈΡ ΠΌΠΎΠ³Π°Ρ Π΄Π° Π±ΡΠ΄Π°Ρ Π½Π°Π±Π»ΡΠ΄Π°Π²Π°Π½ΠΈ ΠΏΡΠΈ ΠΏΡΠΎΠ²Π΅ΠΆΠ΄Π°Π½Π΅ΡΠΎ Π½Π° ΠΊΠ»ΠΈΠ½ΠΈΡΠ½ΠΈ ΠΈΠ·ΠΏΠΈΡΠ²Π°Π½ΠΈΡ. ΠΠΎΠ»Π½ΠΈΡΠ½ΠΈΡΠ΅ ΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈ ΡΠ° ΠΎΡΠ³ΠΎΠ²ΠΎΡΠ½ΠΈ Π·Π° ΡΠΏΡΠ°Π²Π»Π΅Π½ΠΈΠ΅ΡΠΎ Π½Π° ΠΈΠ·ΡΠ»Π΅Π΄ΠΎΠ²Π°ΡΠ΅Π»ΡΠΊΠΈΡΠ΅ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½ΠΈ ΠΏΡΠΎΠ΄ΡΠΊΡΠΈ, ΠΊΠ°ΠΊΡΠΎ Π΅ Π΄Π΅ΡΠΈΠ½ΠΈΡΠ°Π½ΠΎ ΡΠΏΠΎΡΠ΅Π΄ ΠΠΎΠ±ΡΠ°ΡΠ° ΠΊΠ»ΠΈΠ½ΠΈΡΠ½Π° ΠΏΡΠ°ΠΊΡΠΈΠΊΠ°. Π’Π΅ ΠΈΠΌΠ°Ρ ΠΆΠΈΠ·Π½Π΅Π½ΠΎΠ²Π°ΠΆΠ½Π° ΡΠΎΠ»Ρ Π²ΡΠ² Π²ΡΡΠ·ΠΊΠ° Ρ ΠΊΠ»ΠΈΠ½ΠΈΡΠ½ΠΈΡΠ΅ ΠΈΠ·ΠΏΠΈΡΠ²Π°Π½ΠΈΡ, ΠΊΠΎΠΈΡΠΎ ΡΠ° Π΄Π° Π·Π°ΡΠΈΡΡΡ ΡΡΠ°ΡΡΠ½ΠΈΡΠΈΡΠ΅, ΠΌΠ΅Π΄ΠΈΡΠΈΠ½ΡΠΊΠΈΡΠ΅ ΡΠΏΠ΅ΡΠΈΠ°Π»ΠΈΡΡΠΈ ΠΈ Π΄ΠΎΠ²Π΅ΡΠΈΠ΅ΡΠΎ, ΠΊΠ°ΡΠΎ Π³Π°ΡΠ°Π½ΡΠΈΡΠ°Ρ, ΡΠ΅ ΠΏΡΠΎΡΡΠ²Π°Π½ΠΈΡΠ΅ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π° ΡΠ° ΠΏΠΎΠ΄Ρ
ΠΎΠ΄ΡΡΠΈ Π·Π° ΡΠΏΠΎΡΡΠ΅Π±Π° ΠΈ ΡΠ΅ ΡΠ½Π°Π±Π΄ΡΠ²Π°Ρ, ΠΎΠ±ΡΠ°Π±ΠΎΡΠ²Π°Ρ, ΡΡΡ
ΡΠ°Π½ΡΠ²Π°Ρ ΠΈ ΠΈΠ·ΠΏΠΎΠ»Π·Π²Π°Ρ Π±Π΅Π·ΠΎΠΏΠ°ΡΠ½ΠΎ ΠΈ ΠΏΡΠ°Π²ΠΈΠ»Π½ΠΎ. ΠΠ° Π±Π°Π·Π° Π½Π° Π½Π°ΠΏΡΠ°Π²Π΅Π½ΠΈΡ Π°Π½Π°Π»ΠΈΠ· Π½Π° Π΄Π°Π½Π½ΠΈΡΠ΅ ΠΎΡ Π°Π½ΠΊΠ΅ΡΠ°ΡΠ°, ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½Π° Ρ ΠΌΠ°Π³ΠΈΡΡΡΡ-ΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈ, ΠΊΠΎΠΈΡΠΎ ΡΠ° ΡΠΏΡΠ°Π²ΠΈΡΠ΅Π»ΠΈ Π½Π° Π±ΠΎΠ»Π½ΠΈΡΠ½ΠΈ Π°ΠΏΡΠ΅ΠΊΠΈ, ΠΌΠΎΠ³Π°Ρ Π΄Π° ΡΠ΅ Π½Π°ΠΏΡΠ°Π²ΡΡ ΡΠ»Π΅Π΄Π½ΠΈΡΠ΅ ΠΈΠ·Π²ΠΎΠ΄ΠΈ: 1. ΠΠ°Π±Π»ΡΠ΄Π°Π²Π° ΡΠ΅ ΡΠ²Π΅Π»ΠΈΡΠ°Π²Π°Π½Π΅ Π½Π° Π±ΡΠΎΡ Π½Π° ΠΊΠ»ΠΈΠ½ΠΈΡΠ½ΠΈΡΠ΅ ΠΈΠ·ΠΏΠΈΡΠ²Π°Π½ΠΈΡ, Π² Π΅ΠΊΠΈΠΏΠΈΡΠ΅ Π½Π° ΠΊΠΎΠΈΡΠΎ ΡΠ΅ Π²ΠΊΠ»ΡΡΠ²Π°Ρ ΠΌΠ°Π³ΠΈΡΡΡΡ-ΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈ. 2. Π‘ΡΠ·Π΄Π°Π΄Π΅Π½ΠΈ ΡΠ° Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΈΡΠ΅ ΡΡΠ»ΠΎΠ²ΠΈΡ ΠΎΡ ΡΡΡΠ°Π½Π° Π½Π° Π»Π΅ΡΠ΅Π±Π½ΠΈΡΠ΅ Π·Π°Π²Π΅Π΄Π΅Π½ΠΈΡ Π·Π° ΡΡΡ
ΡΠ°Π½ΡΠ²Π°Π½Π΅ Π½Π° ΠΈΠ·ΠΏΠΈΡΠ²Π°Π½ΠΈΡΠ΅ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½ΠΈ ΠΏΡΠΎΠ΄ΡΠΊΡΠΈ Π² Π±ΠΎΠ»Π½ΠΈΡΠ½Π°ΡΠ° Π°ΠΏΡΠ΅ΠΊΠ° ΠΏΡΠΈ ΠΏΡΠΎΠ²Π΅ΠΆΠ΄Π°Π½Π΅ΡΠΎ Π½Π° ΠΊΠ»ΠΈΠ½ΠΈΡΠ½ΠΈ ΠΈΠ·ΠΏΠΈΡΠ²Π°Π½ΠΈΡ. 3.Β Β Β ΠΠ°Π³ΠΈΡΡΡΡ-ΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ΅, ΡΠΏΡΠ°Π²ΠΈΡΠ΅Π»ΠΈ Π½Π° Π±ΠΎΠ»Π½ΠΈΡΠ½ΠΈ Π°ΠΏΡΠ΅ΠΊΠΈ, ΡΠ΅ ΡΡΠ²ΡΡΠ²Π°Ρ ΡΠ²Π΅ΡΠ΅Π½ΠΈ ΠΈ Π΄ΠΎΠ±ΡΠ΅ ΠΏΠΎΠ΄Π³ΠΎΡΠ²Π΅Π½ΠΈ Π·Π° Π°ΠΊΡΠΈΠ²Π½ΠΎ ΡΡΠ°ΡΡΠΈΠ΅ Π² ΠΏΡΠΎΠ²Π΅ΠΆΠ΄Π°Π½Π΅ΡΠΎ Π½Π° ΠΊΠ»ΠΈΠ½ΠΈΡΠ½ΠΈ ΠΈΠ·ΠΏΠΈΡΠ²Π°Π½ΠΈΡ.The participation of hospital pharmacists in the conduction of clinical trials is important in order to have quality and traceability of storage, dispensing and accountability for the investigational medicinal product (IMP). A mandatory section regulating this process became a part of the local Bulgarian pharmaceutical legislation in 2015. During the last years, many changes in regard to this regulation can be followed in the conduct of clinical research. Hospital pharmacists have become the responsible ones for IMP management as defined in the Good Clinical Practice. They have a vital role in relation to clinical research, which is to safeguard participants, healthcare professionals and trust by ensuring investigational medicinal products are appropriate for use and are procured, handled, stored and used safely and correctly. The following conclusions can be drawn from the analysis of the data from the survey conducted with master pharmacists who are managers of hospital pharmacies: 1.Β Β Β There is an increase in the number of clinical trials involving master pharmacist teams. 2.Β Β Β The necessary conditions have been created by the medical establishments to store the tested medicinal products in the hospital pharmacy and to carry out clinical trials. 3.Β Β Β Master pharmacists and hospital pharmacy managers feel confident and well prepared to participate actively in clinical trials
Ad hoc study of the role of hospital pharmacists in clinical trials in Bulgaria
PURPOSE: The aim of our research is to study the role and responsibilities of the hospital pharmacists in conducting clinical trials in Bulgaria.MATERIAL AND METHODS: A special questionnaire was developed in the Faculty of Pharmacy, MUSofia. A total number of 30 hospital pharmacies were contacted and included in the study. Three of them refused to take part in the survey. The interview was via phone and included 4 questions (3 closed and 1 open). Mainly the head hospital pharmacy manager of the participating health institutions was interviewed.RESULTS: Analysis of the results shows that current practice in Bulgaria allowed hospital pharmacists to be involved in clinical trials but this case is not prevalent. The majority of the trials, conducted in our country that includes hospital pharmacies were with narcotic investigational products, which according to the specific local legislation can only be located at the site of the hospital pharmacy in a special metal shelf box. However there are lots of trials conducted without participation of hospital pharmacist/research pharmacist.CONCLUSION: The participation of the hospital pharmacist can be extended - to help manage adverse events, monitor the effect of the drugs under the study and awareness for the drug-to-drug interactions. There are protocols where apart from the investigational product - there are non-drugs under the study, i.e. placed on the market which should be dispensed at the beginning of the trials during the washout period and again here is the place for the research pharmacist to control these non-investigational products
Study of pharmacy students` attitudes for scientific researches and/or academic career in Bulgaria
PURPOSE: To determine the attitudes towards participating in research projects among students at the Faculty of Pharmacy, Medical University Sofia.MATERIAL AND METHODS: A questionnaire was devised and distributed during the final compulsory project meeting to the group of pharmacy students enrolled in the scientific project in the beginning of 2012-2013 academic year.RESULTS: Among the 16 students included in the field research experiment study, 15 responded, with an overall response rate of 93.75%. Twenty percent of the students had previously participated in some form of research activity during their master degree education. Thirty three percent of all students surveyed expressed interest in participating in future research during their study and after graduation.CONCLUSION: The pharmacy students sampled reported interest in research, with a minority of the studentsΒ planning to participate in extracurricular research activities during their university education, and many hoping to be involved in research throughout their future career. However, only a small number of studentsΒ were interested in pursuing research through completing a PhD program
Marketing authorization procedures with negative opinion from EMAβtendencies and novelties in 2021β2022
Every year the European Medicines Agency conducts scientific assessment of numerous applications for marketing authorization of new medicines via centralized procedure. Relatively few of them are being rejected yearly because of insufficient evidence of quality, efficacy or safety. The current study analyzes the period July 2021βJune 2022 in terms of the most frequent reasons for rejection of marketing authorization applications. For the same period, we take a look at the specific procedures for granting accelerated market access laid in the European pharmaceutical regulation. Their role in treatment of unmet medical needs and threats to global health status is pointed out.
AD-HOC study of pharma companies` willingness to conduct PASS/PAES studies in Bulgaria
Introduction: According to the contemporary data very little part of the developed and clinically tested molecules reach the market. Before being authorized for human use, during the clinical trials, the medicinal product is tested in many different ways. Bulgaria is one of the most preferred countries for conducting clinical trials. According to the current regulation the post-authorization studies are divided into two types - PASS (safety studies) and PAES (studies of efficacy) - also known as phase 4 of the clinical trials, taking place in the real clinical practice with patients. Their aim is identification, quantifying and assessment of the importance of the risks, linked to the use of a medicinal product in the clinical practice.Methodology: A questionnaire composed with the aim to assess the willingness of the pharmaceutical companies in Bulgaria to conduct PASS/PAES has been carried out. Subjects of the study were pharmaceutical companies and representatives of marketing authorization holders (MAH) in Bulgaria - innovative companies, members of the Association of the research-based pharmaceutical manufacturers in Bulgaria (ARPharM) and generic companies, members of the Bulgarian generic pharmaceutical association (BgPharmA).Results: Currently in international perspective half of the questioned pharmaceutical companies and two of the generic ones conduct PASS with total number of studies varying between 1 and 20 studies per company. Only one of the innovative companies conducts PAES. Nowadays only one of the questioned innovative companies has current PASS and PAES in Bulgaria.Conclusion: The results of the conducted study show that from regulatory and logistic point of view in Bulgaria all the required conditions for conduction of PASS and PAES are present. Although this legal tool is not yet widely popularized in the activities of the regulatory authority and MAHs, the existing conditions have the potential to speed up the development of this sector of the pharmaceutical industry