Интерпрофесионално и тимско континуирано образование на здравствени работници

The benefits of implementing interprofessional and team-based programs are well recognized. However, for interprofessional education to be effective and broadly implemented, the health professions, policymakers, insurers, academic institutions, health care providers, and regulatory bodies should embrace and adopt a new, interprofessional education framework. They should create a shared value and vision for interprofessional health professions’ education, research, and practice. This vision should be patient-oriented and contain a measurable component across the entire educational continuum, from admission into a health professional program through retirement. Such a framework would maximize and value the strengths of individual professions in the integrated delivery of high quality care. Finally, in creating a successful model, a series of questions should be considered: how best can team competence be measured, how should individual behavioral changes be documented when we think of individual rather than team-level changes, how do we create and measure performance criteria based on shared understanding and experience in the practice setting? Recommendations which are given emphasize that investing in research to evaluate the efficacy of continuing education and its impact on patient outcomes and the healthcare delivery system is inherent in this process. Key words: continuing education, health professional

Interprofessional and Team-Based Continuing Education for Health Professionals

The benefits of implementing interprofessional and team-based programs are well recognized. However, for interprofessional education to be effective and broadly implemented, the health professions, policymakers, insurers, academic institutions, health care providers, and regulatory bodies should embrace and adopt a new, interprofessional education framework. These stakeholders should create a shared value and vision for interprofessional health professions’ education, research, and practice. This vision should be patient-oriented and contain a measurable component across the entire educational continuum, from admission into a health professional program through retirement. Such a framework would maximize and value the strengths of individual professions in the integrated delivery of high quality care. Finally, in creating a successful model, a series of questions should be considered: how best can team competence be measured, how should individual behavioral changes be documented when we think of individual rather than team-level changes, how do we create and measure performance criteria based on shared understanding and experience in the practice setting? Within academic settings, there are more specific barriers including a lack of administrative support, financial and human resources for interprofessional education, conflicts in schedules and health professions’ curricula, and limitations to the time required to plan and implement faculty development for interprofessional learning. Finally, despite progress, there remains regulatory and professional barriers to achieving full and meaningful implementation of effective models. Recommendations which are given emphasize that investing in research to evaluate the efficacy of continuing education and its impact on patient outcomes and the healthcare delivery system is inherent in this process

Use of disinfectants and antiseptics in selected health institutions in Republic of Macedonia

Introduction - Intra-hospital or hospital infections are caused by organisms acquired during hospitalization of the patient and clinically manifest from 48 to 72 hours after their administration. Disinfection procedures, type and quantity of used disinfectant is directly related to the effects of their use. Objective – The aim of this study was to review of the use of antiseptics and disinfectants in selected hospitals in Republic of Macedonia over five years period, to make analysis of the amount of antiseptics and disinfectants consumed annually on each department in hospitals, to analyze of the total amount of consumed antiseptics and disinfectants in selected hospitals for five years and to compare the results to the microbiological data conducted periodically in each department in hospitals in Strumica, Ohrid, Veles, Stip and Kavadarci for five years. Materials and Methods - Data from the annual reports collected from hospitals in Strumica, Ohrid, Veles, Stip and Kavadarci over five years were used. Data from annual reports for disinfectants and antiseptics (Bactosal, Ecosal, Dezintal, Betadine, Hydrogen peroxide, Formaldehyde, Ethanol) used on the selected departments for gynecology, surgery and transfusion were collected. Data from annual reports collected from public health centers in Strumica, Ohrid, Veles, Stip and Kavadarci over five years were used. Routine testing period for microbiological controls in hospitals was 15 days. Results - The results indicate a significant reduction of contamination with conditionally pathogenic bacteria when disinfection is conducted according to the standardized procedures controlled by the IHI times established in each hospital from 2012. The number of conditionally pathogenic bacteria detected is reduced starting from 2012. The reduction of the quantity of disinfectant used is also noted from 2012. Conclusions - In general disinfectants and antiseptics are used optimally and correctly according to the needs of the hospitals investigated. The amount of disinfectants and antiseptics consumed comparing with the microbiological data indicates their rational utilization starting from 2012. Use of disinfectants according to the standardized procedures established by the IHI times allows current daily care for patients and staff in the hospitals investigated. The processed data from public health centers in Strumica, Ohrid, Veles, Stip and Kavadarci confirm the above and point out the precautions to be taken when conditionally pathogenic bacteria have been detected. It is pointed out the role of IHI times in the hospitals, as well as the role of hospital pharmacists. We would like to suggest the implementation of disinfection process validation as standardization measure as well as more often routine microbiological controls in the hospitals. Keywords - disinfectants, antiseptics, disinfectio

Analysis of used disinfectants in correlation with the occurrence and causes of hospital infections - a comparison of data for general hospital in Ohrid in the period 2009 to 2013

Intra-hospital or nosocomial hospital infections mean infections that develop in hospitals or are caused by microorganisms acquired during the hospitalization of the patient, and clinically are manifested from 48 to 72 hours after admission at earliest. To achieve the goal in reducing and prevention of these infections, within the hospital hygiene, many processes and procedures that should be routinely carried out in the hospital are included

Intra-hospital infections in relation to use of disinfectants and antiseptics in selected health institutions in Republic of Macedonia

Introduction - Intra-hospital infections are clinically manifested from 48 to 72 hours after the infection. Objective – The aim of this study was to review of the use of antiseptics and disinfectants in selected hospitals in Republic of Macedonia over five years period in relation to appearance of intra-hospital infections. Materials and Methods - Data from hospitals and public health centers in Strumica, Ohrid, Veles, Stip and Kavadarci over five years were used. Results - The results indicate that the amount of disinfectants and antiseptics consumed comparing with the microbiological data indicates their rational utilization starting from 2012. and significant reduction of contamination with conditionally pathogenic bacteria. Conclusions - In general disinfectants and antiseptics were used optimally and correctly according to the needs of the hospitals investigated. We would like to suggest the implementation of disinfection process validation as standardization measure as well as more often routine microbiological controls. Keywords: disinfectants, antiseptics, disinfectio

Development and validation of a method for the simultaneous determination of 20 organophosphorus pesticide residues in corn by accelerated solvent extraction and gas chromatography with nitrogen phosphorus detection

The method for simultaneous determination of 20 organophosphorus pesticide residues in corn samples has been developed and validated. For the extraction of organophosporus pesticide residues from the samples, the accelerated solvent technique with the mixture of dichloromethane: acetone (1:1, V/V) was used. Clean up was done using liquid – liquid extraction with n – hexane, followed by solid phase extraction on primary secondary amine adsorbent, and elution with the mixture of acetone: toluene (65:35). The determination of the pesticides was carried out by gas chromatography with nitrogen phosphorus detection. Separation and quantitative determination of the analytes were performed on a fused silica capillary ZB-35 column (30 m x 0.25 mm i.d. x 0.25 μm, Phenomenex). The recovery was investigated in blank corn samples fortified with mevinphos, diazinon, dimethoate, bromofos-methyl, chlorfenvinphos, fenamiphos, ethion and phosalone at 5 ng/g, 10 ng/g, 15 ng/g , 20 ng/g and 25 ng/g, respectively and with methacrifos, phorate, etrimfos, parathion-methyl, pirimiphos - methyl, fenitrothion, chlorpyrifos, malathion, parathion, bromofos-ethyl, phosmet and azinphos-methyl at 10 ng/g, 20 ng/g, 30 ng/g, 40 ng/g and 50 ng/g, respectively. The recovery ranged from 76.0% to 112.0%. Repeatability expressed as relative standard deviation (RSD) was less than 8.2%. Linearity expressed as correlation coefficient (R2) ranged from 0.9935 to 0.9996. Measurement uncertainty (Ux) was lower than 14.2% for all tested pesticides. The limits of quantification (LOQ) were bellow 5 ng/g for all tested pesticides. The satisfactory Z-score results of international proficiency tests confirm good analytical performances of the developed method. Keywords: Organophosporus Pesticide Residues, Gas Chromatography, Accelerated Solvent Extraction, Solid Phase Extractio

Documentation as an integral part of quality assurance in the pharmaceutical industry

The basic rules in any Good Manufacturing Practice indicate that the drug manufacturer must keep proper documentation and records. The documentation helps to build a detailed picture of the functioning of the processes within the pharmaceutical industry, and thus provides a basis for planning improvements that will be implemented in the future. Good manufacturing practice (GMP), which is part of quality assurance, ensures that products are consistently manufactured and controlled according to quality standards and according to their intended use. Good manufacturing practice is primarily aimed at reducing risk when performing activities that are involved in pharmaceutical production and control. Good manufacturing practice is a regulatory requirement. Regulatory bodies during their inspections of production sites, often spend a large part of the inspection time in the review of the documentation and records made by the manufacturer. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product. Effective documentation makes good visualization of the quality assurance system. Clearly written procedures prevent errors resulting from spoken communication, and clear documentation permits tracing of activities performed. Documents must be designed, prepared, reviewed, and distributed with care and must be approved, signed, and dated by the appropriate competent and authorized persons. Records must be kept at the time each action is taken and in such a way that all activities concerning the development, production and the quality control of products are traceable. Storage of critical records must at secure place, with access limited to authorized persons. The storage location must ensure adequate protection from loss, destruction, or falsification, and from damage due to fire, water, etc. Good Documentation Practice (GDocP) is a pharmaceutical industry term. Good Documentation is an integral part of the Good Manufacturing Practice and it is essential for the integrity of data collection and reporting for supporting development, registrations, commercialization, and life-cycle management of pharmaceutical products. Documents are a mirror to show actual image of any pharmaceutical industry. Such measures that collectively and individually ensure documentation, whether paper or electronic, is attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate. ‘If it’s not written down, then it didn’t happen!’ Keywords: documents, records, Good Manufacturing Practice, Quality Assuranc

Benefits from paperless computer system validation in pharmaceutical industry

Computer Systems Validation (CSV) is a process used to ensure that a computer-based systems will produce information or data that meet a set of defined requirements. If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended. Computer system validation checks the effectiveness and the efficiency with which the system is meeting the purpose for which it was designed. The concept of validation was first proposed by Ted Byers and Bud Loftus in the mid-1970s to improve the quality of pharmaceutical products. Currently, in the pharmaceutical manufacturing industry, validation plays a vital role in producing high-quality pharmaceutical products that meet good manufacturing practice (GMP) guidelines. (Singh et al., 2018). Paperless validation is an electronic process of ensuring that a computer-based systems are compliant to the requirements. All steps of the validation process are registered in digital documents, or items, rather than on paper. By not using a single sheet of paper, the paperless validation presents many benefits to companies, professionals, and the environment. One of them is to convert a most common, system validation such as ERP (Enterprise Resource Planning), which usually uses almost 2,500 sheets of paper, converting it into ‘zero paper’. (https://fivevalidation.com/paperless-systems-validation-2/, 2022

Implementation of chromatography data system in a quality control laboratory in the pharmaceutical industry

Chromatography is one of the main analytical techniques, especially in regulated analytical laboratories, where chromatographic analyses can comprise up to 80% of the total analytical workload. The Chromatography Data System is computer system with specialized software installed on it, which collects and analyzes chromatography results from instruments connected to the system. Today, when we operate with electronic records, the possibility of changing or copying the contents of electronic records, without leaving any visible trace of the change, is extremely high. To ensure the integrity of the data, the regulatory authorities require the computer systems validation in accordance with their requirements. The CDS systems are intended for use within regulated laboratories in pharmaceutical and related industries. The role of these systems in the R&D and QC is within Good Manufacturing Practice (GMP). The implementation and validation of CDS systems is carried out to validate key functions of the system and later to bring the system to end users. Computerized Systems Validation is a process used to test, validate and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable. This procedure is applied to GxP computerized system applications used at any point in the research, clinical testing, manufacturing, distribution and storage processes. Examples might include: Chromatography Data System (CDS), Laboratory Information Management System (LIMS), Laboratory Instrument Systems (LIS), Clinical Trial Monitoring Systems, PLC for Controlled Packaging Equipment Supervisory Control and Data Acquisition (SCADA), Distributed Control System (DCS), Enterprise Resource Planning (ERP) Systems, Manufacturing Execution System (MES), Batch Record System, Building Management Systems (BMS), Spreadsheets. In the pharmaceutical industry, the most widely used method is to follow the GAMP 5 guidelines and break the process down into its life cycle phases. As a basic starting point for identifying the process of validating a computerized system, V-model methodology approach to validation is used, which is the most widespread within the area of computer-based system validation in the pharmaceutical industry. In addition, there are a lot of supporting processes or activities that take place across the phases of the life cycle such as risk management, document management, repair activity, security management, etc and you should include them when visualizing the process. Keywords: chromatography, CDS, validation, computer system

Determination of some volatile compounds in fruit spirits produced from grapes (Vitis Vinifera L.) and plums (Prunus domestica L.) cultivars

Fruit spirits contain a large array of volatile compounds among which the important role from toxicological aspect besides ethanol has methanol, aliphatic esters and fusel alcohols. This study evaluates the content of ethanol, ethyl acetate, methanol, isopropyl alcohol (2-propanol), n-propyl alcohol (propan-l-ol), isobutyl alcohol (2-methylpropan-1-ol), n-butyl alcohol (1-butanol), isoamyl alcohol (3-methyl-1-butanol) and n-amyl alcohol (pentan-1-ol) in different grapes and plum brandies industrially produced at Republic of Macedonia. Gas chromatography (GC) with flame ionization detection (FID) was applied for the characterization of all investigated volatile compounds. The obtained results revealed that the highest methanol content was present in the samples of plum brandy, which is mainly due to the higher content of pectin in the raw material. The most important higher alcohols of grape and plum brandies were found to be: n-propyl alcohol, isobutyl alcohol and isoamyl alcohol. In all the analyzed samples of grape and plum brandies, the most abundant was isoamyl alcohol which content ranged from 50.3 to 290.7 mg/100 mL a.a. Comparing the results with the data from the literature, it can be concluded that the concentrations of all investigated volatile compounds in the samples of grape and plum brandies are commonly acceptable. Keywords: Fruit Spirits, Gas Chromatography (GC), Methanol, Ethyl Acetate, Fusel Alcohol