Valentina Marinković

The Development of Business Standardization and Integrated Management Systems

The Development of Business Standardization and Integrated Management Systems At the beginning of the 21st century, business standardization has been experiencing intense development, while technical standardization has been moved to the background. Globalization, the development and application of IT technology, the global economic crisis and severe conditions in business have only contributed to this development. Today, the most current standards to be applied are ISO 9000, 14000, 17000, 18000, 20000, 22000, 27000, 31000 and others. At this point the basic question that arises is how to apply these standards in an integrated fashion. Integrated management systems are the answer, which should connect at least two standards or at best all of them - from five to seven. This paper deals with the development of individual models of business standardization, and their integration in the design and implementation of IMS, from the viewpoint of quality management requirements, environmental protection, the safety and health protection of employees and some other demands. Razvoj Poslovne Standardizacije i Integrisani Sistemi Menadžmenta Početkom 21. veka, poslovna standardizacija je doživela intenzivan razvoj, potisnuvši tehničku standardizaciju u drugi plan. Globalizacija, razvoj i primena IT tehnologija, svetska ekonomska kriza i teški uslovi poslovanja samo su doprineli tom razvoju. Danas su najaktuelniji za primenu standardi serije ISO 9000, 14000, 17000, 18000, 20000, 22000, 27000, 31000 i drugi. U ovom trenutku osnovno pitanje koje se postavlja je kako ove standarde primeniti integrisano. Odgovor su integrisani sistemi menadžmenta koji bi trebalo da povežu najmanje dva standarda, a najbolje bi bilo da to budu svi - od pet do sedam. Ovaj rad se bavi razvojem pojedinačnih modela poslovne standardizacije, kao i njihovom integracijom u cilju projektovanja i primene IMS-a, iz ugla zahteva za upravljanje kvalitetom, zaštitu životne sredine i bezbednost i zaštitu zdravlja zaposlenih, kao i nekih drugih.

From experimental design to quality by design in pharmaceutical legislation

Quality by design (QbD) is a concept first outlined by Juran, who believed that quality could be planned and that most quality crises and problems relate to the way in which quality was planned in the first place. Experimental design is a powerful technique and tool for QbD, used for exploring new processes, gaining increased knowledge of the existing processes and optimizing these processes for achieving internationally competitive performance. It is also used for the investigation of relationship between parameters of ill-defined process. In this paper, the experimental design principles in pharmaceutical development and impact of these principles on pharmaceutical legislation have been reviewed. Also, slow implementation of QbD in pharmaceutical industries has been discussed. Pharmaceutical legislation is necessary for companies to continue benefiting from knowledge gained and to continually improve throughout the process lifecycle by making adaptations to assure that root causes of manufacturing problems are quickly corrected.

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.

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 applied for the rapid determination of loperamide hydrochloride in pharmaceutical formulation (Loperamide, Zdravlje-Actavis, Serbia) and in the presence of its acid degradation products.

Using Failure mode and Effects Analysis to reduce patient safety risks related to the dispensing process in the community pharmacy setting

HighlightsVarious failure modes compromising patient safety during the dispensing of medicines in community pharmacies were revealed.Corrective actions were developed to prevent dispensing errors, indicating considerable potential for risk reduction.Failure Mode and Effects Analysis is capable of improvement of patient safety during the dispensing in community pharmacies.

Using Prospective Risk Analysis Tools to Improve Safety in Pharmacy Settings: A Systematic Review and Critical Appraisal

OBJECTIVES This study aimed to review and critically appraise the published literature on 2 selected prospective risk analysis tools, Failure Mode and Effects Analysis and Socio-Technical Probabilistic Risk Assessment, as applied to the dispensing of medicines in both inpatient and outpatient pharmacy settings. METHODS A comprehensive search of electronic databases (PubMed and Scopus) was conducted (January 1990-March 2016), supplemented by hand search of reference lists. Eligible articles were assessed for data sources used for the risk analysis, uniformity of the risk quantification framework, and whether the analysis teams assembled were multidisciplinary. RESULTS Of 1011 records identified, 11 articles met our inclusion criteria. These studies were mainly focused on dispensing of high-alert medications, and most were conducted in inpatient settings. The main risks identified were transcription, preparation, and selection errors, whereas the most common corrective actions included electronic transmission of prescriptions to the pharmacy, use of barcode, and medication safety training. Significant risk reduction was demonstrated by implementing corrective measures in both inpatient and outpatient pharmacy settings. The main Failure Mode and Effects Analysis limitations were its subjectivity and the lack of common risk quantification criteria. CONCLUSIONS The prospective risk analysis methods included in this review revealed relevant safety issues and hold significant potential for risk reduction. They were deemed suitable for application in both inpatient and outpatient pharmacy settings and should form an integral part of any patient safety improvement strategy.

Critical Appraisal of Reimbursement List in Bosnia and Herzegovina

One of the most challenging issues in health systems of middle-income countries is unequal access to medicines. When it comes to determining prices and reimbursement, different frames of price regulation and distributionmargins, variousmethodological approaches, and tools for assessing the eligibility of costs for the insured are used (Jakovljevic et al., 2016a). Most countries in the European Union (EU) decided to regulate prices, at least when it comes to reimbursement lists (Rosian et al., 1998; Freemantle et al., 2001; Mrazek, 2002; Mossialos et al., 2004, 2006; Mossialos and Oliver, 2005; Vogler et al., 2005, 2008, 2009, 2011, 2015; Vogler and Habimana, 2014; Walley et al., 2005; Habl et al., 2006; Kazakov, 2007). Health legislation is one of the key elements in national and international activities related to health, as it plays a major role in development of a comprehensive support for individual and community health (Salihbasic, 2011). The different and complex constitutional division as well as arrangement of price regulation in the healthcare system in BH causes huge losses. Because of lack of uniform legislation in this field and huge diversification in decision-making there is no adopted and unique methodology in price determination thus the key role in price determination in each entity have decision-makers involved in process. The article’s objective is to critically assess the methodological quality of decision-making process and Bosnian legislation for price determination as well as the reimbursement policy. Bosnian authority strives toward for regulation of prices according to external referent prices model, so this article also presents and outlines clear benefits that could be achieved if the method of price determination is homogenized between each entity according to referent prices especially in terms of price deviation outlined in this article. Health system in Bosnia and Herzegovina (B&H) has fully divided jurisdiction between two entities and State District (Federation of Bosnia and Herzegovina, Republic of Srpska, and the Brcko District of B&H) further divided in entity Federation of B&H to 10 Cantons. This complex structure follows the administrative, constitutional frame of B&H which consist of two entities, State District and 10 Cantons in entity Federation of B&H. There is no single segment in this area, which would be a part of the jurisdiction of BH’s state level authorities except for the BH’s Law on Medicines and Medical Devices and the Agency for Medicines and Medical Devices1. Jurisdiction of the Agency for Medicines and Medical Devices at the state level is reflected in conducting the process of registration of medicines and medical devices. In the Federation of B&H, the jurisdiction over the health sector is divided between the federal government and the Cantons, which means that the health sector is organized at the cantonal level and coordinated at the federal level (Salihbasic, 2011). As a part of the commitment

An approach to TQM evaluation in pharma business

Purpose – The purpose of this paper is to explore the good practice (GxP) and standardised management system integration within total quality management (TQM) paradigm in pharmaceutical sector in Serbia. Also, the impact of all interested parties on quality management has been assessed. Design/methodology/approach – The cross-sectional study was performed, including different stakeholders within the pharmaceutical sector in Serbia: manufacturers, distributors, big pharma representative offices, as well as national regulatory authority. A survey instrument was developed, consisted of 16 questions, which were organised into four groups: questions in relation to implementation of ISO 9001, implementation of good distribution practice/good manufacturing practice, integration of management systems, and impact on TQM and business excellence. Total number of participants was 121. Findings – Standardised management systems (ISO 9001, ISO 14001, OHSAS 18001) support companies to improve business environment and management sustainability, but this survey indicated that it was ranked at the lower level then GxP, for pharmaceutical sector in Serbia. Although pharmaceutical companies has faced many challenges in recent years, the survey revealed high level of confidence in quality management systems, as well as the necessity of various management systems integration. Originality/value – The perception of TQM by the experts in pharmaceutical companies and regulatory authority is wider than the common TQM definition. From pharmaceutical point of view, TQM is a holistic approach to long-term success of organisation, oriented to all interested parties, with focus on a public health. Risk-based approach in new revision of both ISO and GxP will facilitate integration process towards TQM and business excellence.

Towards medicines regulatory authorities' quality performance improvement: value for public health

The purpose of this article is to explore the possibility of implementing total quality management (TQM) principles in national medicines regulatory authorities in Europe to achieve all public health objectives. Bearing in mind that medicines regulation is a governmental function that serves societal objectives to protect and promote public health, measuring the effective achievement of quality objectives related to public health is of utmost importance. A generic TQM model for meeting public health objectives was developed and was tested on 10 European national medicines regulatory authorities with different regulatory performances. Participating national medicines regulatory authorities recognised all TQM factors of the proposed model in implemented systems with different degrees of understanding. An analysis of responses was performed within the framework of two established criteria-the regulatory authoritys category and size. The value of the paper is twofold. First, the new generic TQM model proposes to integrate four public health objectives with six TQM factors. Second, national medicines regulatory authorities were analysed as public organisations and health authorities to develop a proper tool for assessing their regulatory performance. The paper emphasises the importance of designing an adequate approach to performance measurement of quality management systems in medicines regulatory authorities that will support their public service missions.

Undiagnosed Hyperglycaemia and Hypertension as Indicators of the Various Risk Factors of Future Cardiovascular Disease Among Population of Serbian Students

Summary A number of risk behaviours, such as smoking, overweight, excessive alcohol intake, insufficient physical activity, excessive and frequent intake of salt, reduced fruit and vegetable intake, increased fat intake, which constitute living habits of an individual can influence the occurrence of hypertension and hyperglycaemia. The changing of these lifestyles can reduce the risk of developing prehypertension and prediabetes. The survey was conducted at student’s campuses. The respondents were subjected to the height, weight, blood glucose and blood pressure. Respondents filled in previously created questionnaire that was approved by the Ethics Committee for Biomedical Research Faculty of Pharmacy, University of Belgrade. The percentage of respondents with a glucose value above the reference value was 14.6% (n=19), 2.4% (n=3) had values greater than 7 mmol/L without being diagnosed with diabetes, and accordingly, 2.4% (n=3) had elevated HbA1c values (above 42 mmol/mol or 6.0%). The percentage of respondents with elevated systolic and diastolic blood pressure was 14.9% and 7.4% respectively. Regarding calculated risk scores, they showed parallel increase with increas-ing of BMI (HPS), systolic and diastolic pressure (OHS), and glucose concentration (OPS). When analysing all the factors that could cause the later development of diabetes, which is associated with hypertension as well, it is observed that the student population is very much exposed to those factors. The results of this study cannot be representative for the general population of students, but they can provide recommendations for further research.