Implementation of Telepharmacy Services in Community Pharmacy – Pharmacists’ Perspective in Republic of Serbia

This systematic literature review aimed to provide an overview of the characteristics and methods used in studies applying the Disability-Adjusted Life Years (DALY) concept for infectious diseases within European Union (EU)/European Economic Area (EEA)/European Free Trade Association (EFTA) countries and the United Kingdom. Electronic databases and grey literature were searched for articles reporting the assessment of DALY and its components. We considered studies in which researchers performed DALY calculations using primary epidemiological data input sources. We screened 3,053 studies of which 2,948 were excluded and 105 studies met our inclusion criteria. Of these studies, 22 were multi-country and 83 were single-country studies, of which 46 were from the Netherlands. Food- and water-borne diseases were the most frequently studied infectious diseases. Between 2015 and 2022, the number of burden of infectious disease studies was 1.6 times higher compared to that published between 2000 and 2014. Almost all studies (97%) estimated DALYs based on the incidence- and pathogen-based approach and without social weighting functions; however, there was less methodological consensus with regards to the disability weights and life tables that were applied. The number of burden of infectious disease studies undertaken across Europe has increased over time. Development and use of guidelines will promote performing burden of infectious disease studies and facilitate comparability of the results

Upravljanje rizikom u farmaciji na osnovu ISO 31 000

Risk management process has been originally applied in finance, but it has been developed very fats in the other parts of industry. Pharma business is notified as an area of high risk, so the standards that describe risk management processes (GMP, ISO 14001, OHSAS 18001) have been already implemented in the majority of pharmaceutical companies. In this paper the guidelines on principles ad implementation of risk management according the model ISO 31000 in pharma business have been done. Standard ISO 31000 has arrived 'just in time', because of integrated processes in risk management in pharma business regarding safety and quality of medicines, as well as risk management in Environmental, Health and Safety area.Zahtevi za upravljanja rizikom su se prvo javili u finansijama, ali su se brzo pojavili i u ostalima granama industrije. Polazeći od činjenice da je farmaceutsko poslovanje rangirano kao oblast visokog rizika, standardi koji opisuju procese, odnosno imaju specifične zahteve za upravljanje rizikom (GMP, ISO 14001, OHSAS 18001) su već implementirani u većini kompanija koje se bave proizvodnjom lekova. U ovom radu prikazani su osnovni principi i smernice za upravljanjem rizika po modelu ISO 31000, uz osvrt na farmaceutsku delatnost, sa posebnim akcentom na spoljašnje faktore koji utiču na procese upravljanje rizikom. Standard ISO 31 000 je došao u pravi čas, jer će pomoći da se u farmaceutskom poslovanju integrišu sve aktivnosti u upravljanju rizikom, bilo da se odnose na kvalitet leka i bezbednost pacijenta, bilo da se odnose na zaštitu životne sredine i bezbednosti na radu

Comparison of antioxidant and antimicrobial activities of extracts obtained from Salvia glutinosa L. and Salvia officinalis L.

Antioxidant and antimicrobial activities as well as total phenols and flavonoids contents of Salvia glutinosa L. (glutinous sage) and Salvia officinalis L. (sage) extracts were studied. Methanol and aqueous ethanol (70% v/v) were used for extraction of bioactive compounds, both in the presence and the absence of ultrasound, from herb and the spent plant material remaining after the essential oil hydrodistillation. The ratio of plant material to extracting solvent was 1:10 g/ml. Antioxidant and antimicrobial activities of the extracts were found to depend on the type of plant material and the extraction conditions. The plant materials from which essential oil had been recovered were proven to be valuable raw materials for making various herbal preparations

Paclitaxel as an anticancer agent: isolation, activity, synthesis and stability

Paclitaxel is isolated from the Pacific yew. It can be obtained from the European yew, but only after chemical modification of the isolated compound by a semi-synthesis procedure. The procedure for total synthesis of paclitaxel is very complicated, involving multiple steps, and the yields of paclitaxel are meagre. This substance is also a metabolite of certain kinds of fungus. The microbiological pathway for producing paclitaxel compared with isolation from plant material involves shorter procuction times but a small yield. Cyclodextrins are usually used for improving the solubility of paclitaxel in aqueous media, with polymeric and other substances added. Paclitaxel has anticancer activity and use for preparing the formulations intravenously administrated to patients with tumors. The paclitaxel concentration in these formulations is determined using validated HPLC methods

Analiza nivoa poslovne standardizacije u svetu i kod nas

The development and implementation of standardized management system (SMS) has allowed that today we are talking about business standardization, as the new model of good business practices applied worldwide. ISO 9000 was the forerunner, and today is the basis of business standardization. This can be said for ISO 9001: 2015, which was edited on September 15, and he will bring new models for other SMS. This paper provides a detailed analysis of the certification process in the world, Europe, the West Balkans and Serbia on various aspects, for seven standardized management systems for 2012/2013. year, and the first example of the application the new QMS model in Serbia.Razvoj i primena standardizovanih menadžment sistema (SMS) je omogućila da danas govorimo o poslovnoj standardizaciji, kao novom modelu dobre poslovne prakse, primenjene širom sveta. Serija ISO 9000 je bila preteča, a danas je osnova poslovne standardizacije. To se može reći i za ISO 9001:2015, koji je izašao 15. septembra, a on će doneti nove modele i za ostale SMS. Ovaj rad daje detaljnu analizu stanja sertfikacije u svetu, Evropi, Zapadnom Balkanu i Srbiji, po različitim osnovama, za sedam standardizovanih menadžment sistema za 2012/2013. godinu, kao i prvi primer primene novog QMS-a u Srbiji

First-order UV-derivative spectrophotometry in the analysis of omeprazole and pantoprazole sodium salt and corresponding impurities

The first-order UV-derivative spectrophotometry, applying zero-crossing method was developed for the determination of omeprazole (OM), omeprazole sulphone (OMS), pantoprazole sodium salt (PANa), and N-methylpantoprazole (NPA) in methanol-ammonia 4.0% v/v, where the sufficient spectra resolutions of drug and corresponding impurity were obtained, using the amplitudes D-1(304), D-1(307), D-1(291.5) and D-1(296.5), respectively. Method showed good linearity in the ranges ( mug ml(-1)): 1.61-17.2 for OM; 2.15-21.50 for OMS; 2.13-21.30 for PANa and 2.0-20.0 for NPA, accuracy and precision (repeatability and reproducibility). The experimentally determined values of LOD (mug ml(-1)) were 1.126; 0.76; 0.691 and 0.716 for OM, OMS, PANa and NPA, respectively. The obtained values of 2.91% w/w for OMS and 3.58% w/w for NPA in the presence of their parent drug, by applying the method of standard additions, point out the usage of the proposed method in stability studies. Zero-crossing method in the first-order derivative spectrophotometry showed the impurity-drug intermolecular interactions, due to the possible intermolecular hydrogen bonds, confirmed by divergences of experimentally obtained amplitudes for impurities OMS and NPA in comparison to expected values according to regression equations of calibration groups

Densitometric determination of omeprazole, pantoprazole, and their impurities in pharmaceuticals

A method has been developed for separation of omeprazole and pantoprazole, and their impurities omeprazole sulfone and N-methylpantoprazole, by HPTLC. The mobile phase chloroform-2-propanol-25% ammonia-acetonitrile, 10.8 + 1.2 + 0.3 + 4 (v/v), enables good resolution of large excesses of the drugs from the possible impurities. Regression coefficients (r > 0.998), recovery (90.7-120.0%), and detection limit (0.025-0.05%) were validated and found to be satisfactory. The methods is convenient for quantitative analysis and purity control of the compounds

Impact analysis of the implemented quality management system on business performances in pharmaceutical-chemical industry in Serbia

International quality management standard (QMS) ISO 9001 became widely accepted as a framework for product and/or services quality improvement. There are recent research conducted in order to define relationships and effects between the applied QMS and financial and/or non-financial business parameters. The effects of the applied pharmaceutical quality system (PQS) on the business performances in Serbian pharmaceutical-chemical industry are analyzed in this paper using multivariate linear regression analysis. The empirical data were collected using a survey that was performed among experts from Serbian pharmaceutical-chemical industrial sector during 2010. An extensive questionnaire was used in the survey, grouping the questions in eight groups: Implementation of pharmaceutical quality system (AQ), Quality/strategy planning (QP), Human resource management (HR), Supply management (SM), Customer focus (CF), Process management (PM), Continuous improvement (CI), and Business results (BR). The primary goal of the research was to analyze the effects of the elements of first seven groups (AQ, QP, HR, SM, CF, PM, and CI) that present various aspects of the implementation of PQS, on the elements of business results (BR). Based on empirical data, regression relations were formed to present the effects of all considered elements of PQS implementation on the business performance parameters (BR). The positive effects of PQS implementation on the business performances such as the assessment of performance indicators, continual products and/or services quality improvement, and efficient problem solving, are confirmed in the presented research for the Serbian pharmaceutical-chemical industrial sector. The results of the presented research will create a room for the improvement of the existing models in application, and for attracting interested parties that aim to commence this business standardization process. Hence, implementation of PQS is not only the regulatory requirement or advertising movement, but very important issue for the development and improvement of business performances

Determination of carvedilol and its impurities in pharmaceuticals

A reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for separation of carvedilol and its impurities from Karvileks tablets. The best separation was achieved on a 100 mm x 4.6 mm, 5 mu m particle size, Chromolit RP 8e column. Use of acetonitrile-water, 45:55 (v/v), adjusted to pH 2.5 with formic acid, as mobile phase at a flow rate of 0.5 mL min(-1) enabled acceptable resolution of carvedilol, in large excess, from possible impurities, in a short elution time. UV detection was performed at 280 nm. Linearity, accuracy, precision, selectivity, and robustness were validated and found to be satisfactory. Overall, the proposed method was found to be highly sensitive, suitable, and accurate for quantitative determination of carvedilol and its impurities in dosage forms and in raw materials

QUANTITATIVE ANALYSIS OF LOPERAMIDE HYDROCHLORIDE IN THE PRESENCE ITS ACID DEGRADATION PRODUCTS

The aim of this work was to develop a new RP–HPLC method for the determination of loperamide hydrochloride in the presence of its acid degradation products. Separation of loperamide from degradation products was performed using ZORBAX Eclipse XDB C-18, column with a mobile phase consisting of 0.1 % sodium-octansulphonate, 0.05% triethylamine, 0.1 % ammonium hydroxide in water:acetonitrile (45:55 v/v). The mobile phase was adjusted to pH 3.2 with phosphoric acid. The method showed high sensitivity with good linearity over the concentration range of 10 to 100 μg cm-3. The method was successfully applied to the analysis of a pharmaceutical formulation (Loperamide, Zdravlje-Actavis, Serbia) containing loperamide hydrochloride with excellent recovery. The loperamide hydrochloride degradation during acid hydrolysis and kinetics investigation was carried out in hydrochloric acid solutions of 0.1, 1.0 and 1.5 mol dm-3, at different temperatures (25 and 40 °C), by monitoring the parent compound itself. The first order reaction of loperamide degradation in acid solution was determined. The activation energy was estimated from the Arrhenius plot and it was found to be 38.81 kJ mol-1 at 40 °C. The developed procedure was successfully applie