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Analysis of Extemporaneously Compounded Nasal Preparations Prescribed by Latvian Otorhinolaryngologists and General Practitioners and Comparison with German Formulations

Author(s):  Kiselova Olga, Maurina Baiba, Sidlovska Venta

Issue:  Nov/Dec 2020 - Volume 24, Number 6
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Abstract:  It has been reported that sinusitis and rhinitis are included in the list of most common diagnoses made by general practitioners. Even though treatment of diseases of the nasal cavity and paranasal sinuses requires many manufactured medicines, several European countries, as well as the U.S. and Australia, still prescribe extemporaneous prescriptions for nose conditions. Germany created standardized compounded preparation monographs. Monographs allow prescription and preparation of medicines containing such active ingredients and combinations of active ingredients, the use of which is evidence-based. Latvia does not have any standardized compounded preparation monographs. The purpose of this survey was to analyze the active ingredients, combinations of active ingredients, and excipients of the extemporaneous prescriptions intended for administration to the nasal cavities which were prescribed by Latvian otorhinolaryngologists and general practitioners and to find out how many active ingredients are most often compounded in the analyzed dosage forms. To understand whether the extemporaneous formulations prescribed in Latvia are evidence based, they were compared with German formulations. A database was created entering data on all the prescriptions prepared in the selected pharmacies in 2017 to summarize information on extemporaneous prescriptions. The prescriptions prescribed by Latvian otorhinolaryngologists and general practitioners were selected and compared with German formulations. Data from 17 Latvian pharmacies were collected, and 1094 prescriptions of nasal preparations were analyzed. In preparation of nasal drops, 15 bulk drug substances and 10 manufactured preparations were used; in preparation of semi-solid nasal preparations, 14 bulk drug substances and 15 manufactured preparations were used. The analyzed prescriptions contained active ingredients and excipients currently used in Germany, as well as active ingredients and excipients, the use of which, in Germany, is limited or impermissible in the preparation of nasal preparations. More than 70% of analyzed nasal preparations contained two or more active ingredients. Several nasal drops prescribed in Latvia need isotonization to avoid damage to nasal mucosa.

Related Keywords: Olga Kiselova, PharmD, Baiba Maurina, PhD, Venta Sidlovska, PhD, sinusitis, rhinitis, intranasal preparations, nasal preparations, otorhinolaryngologists, general practitioners, nose, nasal cavity, paranasal sinuses, dosage forms, Latvia, excipients, Germany, Deutscher Arzneimittel-Codex Neus Rezeptor-Formularium, DAC/NRF, active pharmaceutical ingredients, drug combinations, nasal drops, silver proteinate, packaging, adverse effects, camphor, menthol

Related Categories: EAR NOSE THROAT, DOSAGE FORMS/DRUG CARRIERS

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