CLINICAL AND BIOCHEMICAL CHARACTERISTICS IN WOMEN WITH POLYCYSTIC OVARIAN SYNDROME IN THE REGION OF POLLOG, REPUBLIC OF MACEDONIA

Polycystic ovary syndrome (PCOS) is a common endocrine disorderand is a major cause of an ovulatory infertility. The main objective is toestimate the prevalence of PCOS in the region of Pollog, Republic ofMacedonia and to assess some clinical and biochemical parameters inpatients with PCOS in comparison with normal women as control.Rotterdam criteria is used to evaluate 70 women diagnosed with PCOS,compared to 30 age matched controls to assess the clinical and biochemicalabnormalities that occur in PCOS patients. All statistical analysis is doneusing SPSS (version 19.0). A P-value < 0.05 is considered statisticallysignificant. Mean age in PCOS group is 25.11 ± 3.32, and 25.10 ± 3.91 in thecontrol group. BMI of the women with PCOS is significantly higher than inthe control group. Menstrual cycle abnormalities are observed in 71.4% ofPCOS patients, and ultrasonographic appearance of polycystic ovaries isreported for all PCOS cases. Hirsutism (FG 8-9) is present in 42.9 %,hirsutism (FG 10-14) in 50% and 7.1% showed hirsutism (FG>15). Werecorded significantly higher serum levels of luteinizing hormone (LH), totaltestosterone (TT), and insulin, while the serum levels of sex hormonebinding globuline (SHBG) and follicular stimulating hormone (FSH) aresignificantly lower than in the control group. By analyzing the clinical andbiochemical characteristics of our studied population of patients with PCOS,we can conclude that the majority of our patients expressed all threediagnostic features of PCOS (hyperandrogenism, menstrual abnormalities,and ultrasound findings of polycystic ovaries)

SPECTRUM OF INFECTIOUS DISEASES AND ANTIBIOTIC USAGE IN A PAEDIATRIC OUTPATIENT DEPARTMENT

The main objective of this study is to analyze the spectrum of infectious diseases in paediatric population and to study the antibiotic usage and selection of the dosage forms in children taking treatment in the outpatient department of the paediatric hospital in Tetovo. A retrospective study was undertaken during 01 January – 30 June of 2012. Drug data and patient characteristic data were computed using Ms. Excel 2007. Among the total number of 3778 patients analyzed during the period of six months, 1463 (38.7 %) of them were prescribed antibiotics, male patients were 829 (56.7%) and female patients were 634 (43.3 %). The majority of patients given antibiotics were aged >1 - ≤ 3 years (49.1 %). Incidence of infections was found to be 89.3% (1306 patients), of which upper respiratory tract infections (69.7%) were common among 1020 patients followed by lower respiratory tract infections in 234 (16.0%) cases. Cephalosporins were the commonest antibiotics prescribed (43.6%), among which cefaclor was the leading antibiotic prescribed in 283 (19.3 %) the total patients. Benzathine phenoxymethylpenicillin was the most common antibiotic prescribed in upper respiratory tract infections (23.8%) followed by cefaclor (19.7%). Syrups were the common dosage forms prescribed for all patients in the paediatric age group followed by capsules

OVERVIEW ON GENERICS POLICIES AND PHARMACEUTICAL PRICING IN THE EUROPEAN COUNTRIES AND THE REPUBLIC OF MACEDONIA

Continued growth of spending on drugs in Health care, especially in the public sector encouraged initiatives for reforms in the system of determining the prices of medicines. These initiatives that were undertaken, were primarily aimed at reducing the cost of drugs but parallel to become a generic medications simultaneously promoting an adjustment of reimbursement procedures in the pharmaceutical sector. The policies for the regulation of the pharmaceutical market come as a response to health care classical market failures. This article will focus on the features, implementation and impact of these policies in some EU member states. Most EU countries, apply the external reference system of prices, whereupon the price of a certain medication is determined based on the price of the same product in other countries. On the other hand, in twenty other EU member states, prices are determined by comparing the prices of the same products according to chemical, pharmacological or therapeutic grouping. The reference pricing system has been adopted by governments as a mechanism to reduce the costs in the public health care system. By setting a price limit, competition among producers has been stimulated

OVERVIEW ON GENERICS POLICIES AND PHARMACEUTICAL PRICING IN THE EUROPEAN COUNTRIES AND THE REPUBLIC OF MACEDONIA

Continued growth of spending on drugs in Health care, especially in the public sector encouraged initiatives for reforms in the system of determining the prices of medicines. These initiatives that were undertaken, were primarily aimed at reducing the cost of drugs but parallel to become a generic medications simultaneously promoting an adjustment of reimbursement procedures in the pharmaceutical sector. The policies for the regulation of the pharmaceutical market come as a response to health care classical market failures. This article will focus on the features, implementation and impact of these policies in some EU member states. Most EU countries, apply the external reference system of prices, whereupon the price of a certain medication is determined based on the price of the same product in other countries. On the other hand, in twenty other EU member states, prices are determined by comparing the prices of the same products according to chemical, pharmacological or therapeutic grouping. The reference pricing system has been adopted by governments as a mechanism to reduce the costs in the public health care system. By setting a price limit, competition among producers has been stimulated

Legal Regulation and Critical Analysis for an Effectively Treatment of Pharmaceutical Waste

The extermination and proper disposal of pharmaceutical wastes from expired and unused medications remains a disputable issue due to their specific nature and characteristics. Even though the hazards from these wastes are already well known in terms of environment and human health, people still treat them as usual wastes. At a national level, in many countries the management of pharmaceutical and medical wastes has been one of the main objectives in order to protect people's health and the environment. Even though many legal regulations exist in this respect, there has not been a single law that would clearly explain the procedures of returning medicines, ways of selection, treatment and extermination of pharmaceutical wastes. This paper aims at analyzing the practices of pharmaceutical waste management and treatment in some European countries as well as a review of the legislation and official guidelines in managing these kinds of wastes and protecting the environment and human health. A suitable treatment and management of expired medications and other similar wastes would be in the interest of public health in the first place, as well as in the interest of healthcare institutions and other bodies engaged in environment protection

Legal Regulation and Critical Analysis for an Effectively Treatment of Pharmaceutical Waste

The extermination and proper disposal of pharmaceutical wastes from expired and unused medications remains a disputable issue due to their specific nature and characteristics. Even though the hazards from these wastes are already well known in terms of environment and human health, people still treat them as usual wastes. At a national level, in many countries the management of pharmaceutical and medical wastes has been one of the main objectives in order to protect people's health and the environment. Even though many legal regulations exist in this respect, there has not been a single law that would clearly explain the procedures of returning medicines, ways of selection, treatment and extermination of pharmaceutical wastes. This paper aims at analyzing the practices of pharmaceutical waste management and treatment in some European countries as well as a review of the legislation and official guidelines in managing these kinds of wastes and protecting the environment and human health. A suitable treatment and management of expired medications and other similar wastes would be in the interest of public health in the first place, as well as in the interest of healthcare institutions and other bodies engaged in environment protection

Legal Regulation and Critical Analysis for an Effectively Treatment of Pharmaceutical Waste

The extermination and proper disposal of pharmaceutical wastes from expired and unused medications remains a disputable issue due to their specific nature and characteristics. Even though the hazards from these wastes are already well known in terms of environment and human health, people still treat them as usual wastes. At a national level, in many countries the management of pharmaceutical and medical wastes has been one of the main objectives in order to protect people's health and the environment. Even though many legal regulations exist in this respect, there has not been a single law that would clearly explain the procedures of returning medicines, ways of selection, treatment and extermination of pharmaceutical wastes. This paper aims at analyzing the practices of pharmaceutical waste management and treatment in some European countries as well as a review of the legislation and official guidelines in managing these kinds of wastes and protecting the environment and human health. A suitable treatment and management of expired medications and other similar wastes would be in the interest of public health in the first place, as well as in the interest of healthcare institutions and other bodies engaged in environment protection

Principles and methods for isolation and preparation of plasma preparations containing platelets (PR) - how to improve the purpose and effectiveness

The clinical use of platelet-rich plasma (PRP) is based on increasing the concentration of growth factors and the secretion of proteins that can maximize the healing process at the cellular level. PRP is an autologous biological material, that involves minimal risk of immune reactions and transmission of infectious and contagious diseases, and it is widely used to repair musculoskeletal lesions and skin. Despite the great potential for applicability, the implementation of therapeutic inclusion of PRP as a clinical alternative has become difficult due to the lack of studies related to the standardization of production techniques, application conditions, and/or insufficient description of the adopted procedures. Currently, platelet-rich plasma therapy (PRP) is widely used and continues to grow for a variety of clinical applications. Along with its development, there are various options in the way of obtaining PRP, automatic or manual, while one of the most reliable methods according to the literature is the method of double centrifugation. Therefore, it is necessary to establish standard criteria to be met to obtain high-quality PRP, as well as several studies to determine the appropriate platelet concentration for different clinical applications. In this context, this paper aims to discuss some methodological aspects used to obtain PRP, as well as to discuss the bioactive properties of PRP and to point out its therapeutic use in various fields of regenerative medicine. Additionally, current techniques, critical points, technology for PRP preparation, and a review of the present deficiencies of this therapy that will need to be overcome if widely accepted, are described

Quality Audits - Viewpoints of Auditing in the Pharmaceutical Industry

In the pharmaceutical industry, audits are an essential part of the institutions’ quality management system ensuring compliance with regulatory expectations, supporting products quality assurance and customer satisfaction. Depending on the category of the audit, it is usually performed by the qualified group of professionals assigned by management for this intention, external or regulatory agency. This review covers the main viewpoints of auditing in the pharmaceutical industry including its goals, objectives and benefits, mandatory regulatory standards and principles of auditing along with the role and responsibilities of the auditor and their code of conduct during an audit. It outlines the management of an audit program with the main methods of gathering audit information and the key stakeholders of the quality audit. It also emphasises a five-phase process which includes audit planning and preparation, conducting fieldwork, audit reporting, and following up on corrective action plans. In brief, this is a structured summary on the entire process of an audit and the importance of creating an environment of good relationship between stakeholders, employees and auditors in delivering values to audit activities of any size

Overview of the Regulatory Framework for Radiopharmaceuticals

Radiopharmaceuticals are products that have the particularity of combining two very restrictive regulatory requirements depending on two different authorities: that of the drug in the pharmaceutical sense and that of a radioactive source linked to a specific authorization system. Radiopharmaceuticals are a new reality in the pharmaceutical industry and are considered to be an indicator of modern medicine and the technological industry. The exponential increase in their use is attributed to their dual use as diagnostic and therapeutic agents. They represent a group of pharmaceutical preparations, which contain radionuclides with short half-lives and are mainly administered intravenously. Maximum care should be taken during their production, distribution, storage, and disposal because their radiant nature is a concern for both patients and medical staff. All stages of production must be done by the requirements of Good Manufacturing Practice. Therefore, radiopharmaceuticals must meet the requirements of the pharmaceutical regulator, the same as those of the nuclear regulator. The largest number of regulatory bodies in the world have different perspectives in terms of their production, distribution, transportation, storage, and disposal. However, in developed countries, the regulator of radiopharmaceuticals is in its infancy. In this article, we will shed light on the various regulatorylimitationsimposedbythesestatutes, emphasizing that these regulations are therefore likely to evolve in the years to come and to demonstrate the importance of their development, proper use, and perspective