S P E C I A L I S T A N D M A S T E R S T U D I E S

Transcription

1 University Ss, Cyril and Methodius Skopje FACULTY OF PHARMACY S P E C I A L I S T A N D M A S T E R S T U D I E S Healthcare management and pharmacoeconomics Skopje, 2007

2 STUDY PLAN -Specialist Studies- -Master Studies MODULES AND SUBJECTS I KR II KR I I I I. Efficacious Healthcare Management Management Functions and Processes (6 Organizational Models (6 The Foundation of Public and Private Health Organizations (10 Business Plan Development (10 Products and Services Price Management (12 Human Resource Development and Management (6 II. Rational Healthcare Pharmaceutical Management Pharmacy and Clinical Practice Management (15 Pharmacy Foundation and Financing (10 Pharmacy and Clinical Practice Organization (15 Drug information (20 III. Pharmacoeconomics The Basics of Pharmacoeconomics (10 Pharmacoeconomic Methods (10 Pharmacoepidemiology (10 Pharmaceutical (Pharma) Marketing (10 Methodologies of Drug Price Determination (10 Economic Evaluation in the Healthcare System (10 IV. The Politics of Drug Provision The Organization of Drug Supply(10 Selection of Drugs (10 Distribution of Drugs (5 Stock Control and Planning 5 Rational Use of Drugs (10 Healthcare Legislation (10 6h 6h 12h 6h 50h 15h 15h 20h 60h 1KR 1KR 2KR 2KR 1KR 10K R 4KR 4KR 4KR 8KR 20K R 60h 5h h 2KR 2KR 2KR 15KR 1,5KR 1,5KR 15KR TOTAL (specialist studies) 1 30K 1 30KR 220hours 60KR K R I V

3 Master Studies In addition to the four modules of the specialist studies, the master studies include a fifth module and elaboration of a master thesis Modules and Subjects I KR II KR III KR IV V. National Drug Policy Systems of Health Insurance (15 International Organizations (10 International Contracts and Drug Regulations (15 Registrations and Licensing (10 Harmonization of the National Legislation with EU Directives (20 15h 15h 20h 70h 6KR 5KR 5KR 6KR 8KR 30KR Master s thesis 30KR TOTAL (master studies) 1 30KR 1 30KR 80h 30KR 30KR 290h 120KR SUBJECT PROGRAMS Module I. Efficacious Healthcare Management The teaching of all subjects is organized in cycles with a fixed number of hours for each subject through lectures, practice, preparation of seminar papers and organization of workshops. Testing and Grading: Seminar paper 30 points Colloquiums 30 points Exam 40 points SUBJECTS: I.1. Management Functions and Processes 1 st term (6 hours, 1KR) Aims: The goal of the subject is to introduce the students to the general concept of management as a complex process which directs individuals or groups to the realization of given plans, tasks and activities in order to accomplish the predetermined common goals. The complexity of the process is in the fact that it encompasses numerous different complementary sub-processes, such as planning, organization, control, management etc. Brief program: Introduction to the basic concepts of the healthcare management in order to create cadres skillful in healthcare management processes; learning the processes of planning, organization of the management systems, financing of the healthcare system and services. The goal of the sub-module is to educate the student in the ways of efficacious

4 management with the available resources and methods of management by objectives. The final objective is acquiring knowledge about defining and illustrating the fundamental concepts of healthcare economy, the elements which are an integral part of the applied concepts, such as: production potentials, production functions, average and marginal expenditures, demand and supply, consumer and producer, various types of markets etc. I.2. Organizational Models 1 st term (10 hours, 2KR) Aims: Introduction to the theory and practice of the organization of healthcare organizational models determined by the parameters of the structure and factors of given conditions. Brief program: The study of the basic, modified and modern organizational models of the public and private healthcare organizations as well as establishing the procedure which begins with the foundation of the healthcare organization and ends with its successful functioning in conditions of numerous legal, proprietor and structural changes. The teaching deals with linear, functional and sector organizational models which in a more complex form become a project, matrix and net organizational model. I.3. The Foundation of Public and Private Health Organizations 1 st term (10 hours, 2KR) Aims: Knowledge of the evaluation procedures for healthcare foundations grants for public and private health organizations with a special emphasis on the legal and financial restrictions and factors. Brief program: Defining the needs, strategic objectives and financial aspects of the foundation of public and private health organizations; the study of the legal regulations relevant for the foundation of these institutions with a special emphasis on the long-term concepts for the development of the health sector in the state and knowledge about the concepts of the identification of the needs, determination of the foundation and work costs as well as selection of the best sources of capital for financing the newly founded public and private health organizations. I.4. Business Plan Development 1 st term (10 hours, 2KR) Aims: Detailed knowledge of the meaning and procedures of a business plan development as a document which gives a detailed explanation of the business operations of the subject, his/her past work, current condition, future plans and objectives as well as the manner of accomplishing those objectives. Each business plan has an essential form which makes the generalization of the procedure and modifications which reflect the specificity of the subject and the individuality of the carrier of activities. Brief program: Theoretical and practical knowledge of the basics of a business plan, its content and forms. The teaching contents provide education for individual preparation of business plans, as a basis for an organizational and financial management in a health institution. A significant segment of this sub-model is the study and elaboration of a cash-

5 flow in the work of a healthcare unit and development of a business plan in the existing conditions of the applied budget system of the public health organizations. I.5. Products and Services Price Management 1 st term (12 hours, ) Aims: Defining price systems through determining the key components of the systems of healthcare financing and the legal administrative and market regulations. Brief program: The subject explains the procedures which are characteristic of the Government actions, employers and patients and their influence on the price policy and costs as its product. The education will enable the projection of the potential cost consequences which are the result of the sum of changes in the financing policy and providing health protection. In addition to studying the financial aspects of the price structure, the students will learn other influential factors, such as the economic and political conditions, organizational objectives and strategies, operational approaches, traditions and competencies. Practice: This part of the subject concerns a critical analysis of the price policy in the health system financing of two countries selected by the leader of the Module. I.6. Human Resources Development and Management 1 st term (6 hours, 1 KR) Aims: The subject introduces the students to the meaning of the human potential in the realization of health services. The cadre planning is an integral part of the overall planning process of an organization. The whole process is under a direct influence of external and internal factors as well as the underlined objectives. Brief program: The basic activity is connected to the systems of employment, control, evaluation and reward. The final objective is to educate cadres that will define the new profile of healthcare professionals with the following characteristics: a provider of services capable of making decisions, a professional with managerial capabilities, a leader, skillful communicator capable of transferring knowledge. Practice: Elaboration of biographies, conducting an interview procedure, and preparation of annual evaluation and reward programs. Module II. Rational Healthcare Pharmaceutical Management The teaching of all subjects is organized in cycles with a fixed number of hours for each subject through lectures, practice, preparation of seminar papers and organization of workshops. Testing and Grading: Seminar paper 30 points Colloquiums 30 points Exam 40 points SUBJECTS:

6 ii.1. Pharmacy and Clinical Practice Management Aims: The subject Pharmacy and Clinical Practice Management provides knowledge about the meaning of the managerial processes in the healthcare system and health organizations. The goal is to determine the role of the pharmacist in the health environment and develop his/her abilities for interaction and education of the patients in a manner that will enable improvement of the use of the prescribed therapy and provide and process information to the healthcare professionals and society as a whole in order to improve the health of the population and individual. Brief Program: The candidates study the concept of defining the manager s role as well as the pharmacy and clinical practice management. In addition, they learn the goals of the established health system, including the pharmaceutical system, cadre management, development policy and health technology. Special attention is given to the methods of solving organizational failures through simulation models of selected priorities and interventions, The subject also deals with the communication skills in the pharmaceutical practice as well as the processes of building relations with the Health Insurance Fund and Ministry of Health. II.2. Pharmacy Foundation and Financing 1 st term (10 hours, 4 KR) Aims: The study of the legal regulations of pharmacy foundation and financing in conditions of diverse ownership structure Brief Program: The subject introduces the student to the evolution of variables which determine the foundation and financing of pharmacies. More precisely, the content of the subject encompasses the definitions for the location, purchasing power of the population, current and future competition, legal restrictions, availability of educated labor power, the founder s capital potential and systems of financing the work of the Pharmacy. The question concerning the system of financing the pharmacies is elaborated through two basic models of concluded contracts with the Health Insurance Fund and the system of self-financing. Practice: The concepts applied in the pharmacy work of the EU countries are studied and projected through a system of simulations. II.3. Pharmacy and Clinical Practice Organization 1 st term (15 hours, 4 KR) Aims: Introduction to the modern concepts of clinical and pharmaceutical work as a part of the overall health protection. Elaboration of the innovative organizational models characterized with net models of internal and external links. Brief Program: The subject studies the internal solutions of the organization, based on the principles of Good Pharmacy Practice, the Pharmaceutical Services section of the Health Protection and offers solutions for the processes that provide the best possible services in the modern health organizations and pharmacies, distribution of drugs, development of galenicals and self-treatment. III.4. Drug information

7 1 st term (20 hours, 8 KR) Aims: The study of the meaning of the information systems which represent a sum of the procedures and equipment projected, built, managed and maintained for the purpose of collecting, storing and displaying more information relevant for a given group of users and their work; the meaning and role of the drug information centers and providing drug information. Brief Program: Theory: Introduction to drug information, evidence-based medicine; evidence-based pharmacy; drug information centers; providing drug information; ethical aspects of drug information; methods of monitoring drug use; pharmaceutical practice Practice: Knowledge and organization of a drug information center; introduction to information and communication programs; use and evaluation of the professional literature; qualitative and quantitative measures for monitoring drug consumption; prevalence and incidence. Module III: Pharmacoeconomics The teaching of all subjects is organized in cycles with a fixed number of hours for each subject through lectures, practice, preparation of seminar papers and organization of workshops. Testing and Grading: Seminar paper 30 points Colloquiums 30 points Exam 40 points SUBJECTS: III.1. The Basics of Pharmacoeconomics 2 nd term (10 hours, 2 KR) Aims: The goal of the subject is to provide specific knowledge about the cost-benefit analysis of drug use within the restrictive factors, such as the existing financial resources and potential new sources of financing the supplies. The teaching contents encompass the terms and basic methodology of the economic evaluation, determination of the models for minimizing costs and identification, monitoring and comparison of the clinical and economic results of drug use. The end point of the subject program is to enable the use of a costbenefit analysis in an optimal allocation of the available means for health protection. III.2. Pharmacoeconomic Methods 2 nd term (10 hours, 2 KR) Aims: Detailed knowledge of the methods used for the identification, measuring and comparing costs with the clinical, economic and humanitarian results in providing pharmaceutical services and products. The subject elaborates four basic approaches in the methodology of pharmaceutical studies, including cost analysis vs. effectiveness, cost minimization, defining cost vs. benefit and cost vs. usefulness of the product/service.

8 III.3. Pharmacoepidemiology 2 nd term (10 hours, 2 KR) Aims: The study of the basic principles of pharmacoepidemiology and defining the models and studies with applicative use in order to rationalize drug use. The subject also elaborates various approaches in the evaluation of the development of new drugs, new drug formulations, the use of drugs and their price and effect. Special attention is given to the methods of discovering and monitoring side effects, risk/benefit evaluation in a given therapy, monitoring the use of drugs in the population and establishing a relationship between pharmacoepidemilogy and the pharmacy and therapeutics committees and regulatory organs. For this purpose, the methods of designing databases, their identification, analysis and functional application of pharmacoepidemiology in the pharmaceutical practice is also included in the subject program. III.4. Pharmaceutical (Pharma) Marketing 2 nd term (10 hours, 3 KR) Aims: The study of the general and specific marketing elements in pharmacy and business activities related to drug sales and services, therapy and health improvement. Abbreviated content: The subject introduces the students to the modern concepts of marketing functions, research of the drugs and services market, building of price policy as a prerequisite for a competitive participation on the markets and establishing distributive channels for drugs and services supply and sale. A special attention is given to the postmarketing of drugs, health promotion through pharmaceutical marketing in public pharmacies and the information technologies used in the promotion, sale and distribution of drugs. Practice: Evaluation of a concrete marketing campaign of a drug producer and distributer. III.5 Methodologies of Drug Price Determination 2 nd term (10 hours, 3 KR) Aims: The study of the basic systems of drug price determination and methodology used for the support of the drug policy in the EU countries. Brief Program: A detailed study of the producers and pharmacies conduct in the drug price determination based on the production costs, government policy and influence, development, market demands, drug specifics and market segmentation. The program also includes the study of the systems of reference prices, systems in which the prices are determined on the basis of production cost data, determination of the price with reference to a group of countries on the same level of economic development and systems of drug price determination with profit control. III.6. Economic Evaluation in the Healthcare System 2 nd term (10 hours, 3 KR) Aims: The study of various methodology models of economic evaluations through the concept of cost determination in health protection. Brief Program: The study program includes making decisions based on cost-benefit and cost-effectiveness analyses as well as cost analyses related to health protection, which may

9 appear as a result of the accounting system, refund system and range-economies as well as a method of statistical analysis sample and medical practice. The sub-module enables the students to acquire the basic knowledge of and practical experience in the statistical methods used in the evaluation of health protection and health economics. Module IV. The Politics of Drug Provision The teaching of all subjects is organized in cycles with a fixed number of hours for each subject through lectures, practice, preparation of seminar papers and organization of workshops. Testing and Grading: Seminar paper 30 points Colloquiums 30 points Exam 40 points SUBJECTS: IV.1. The Organization of Drug Supply 2 nd term (10 hours, 3 KR) Aims: Practical implications of the concept of Essential Drugs and selection criteria; the use of generic names (INN) Abbreviated Content: The study of the organization of processes and the system which provides efficacious and transparent drug supply, drug financing and selection, quantification of the demands, suppliers selection, making decision for the selection of offers; introducing the procedures for offers, preparing the documentation for the participation in offers, making supply contracts, ABC analysis in the control of stocks and the monetary and natural units in the calculation of drug use. The subject also includes the existing systems of drug supply in the EU countries as well as the countries of former SFRY. IV.2 Selection of Drugs 2 nd term (10 hours, 2 KR) Aims: The study of the criteria for drug selection with special emphasis on the Essential List of Drugs, therapeutic guides and formularies as well as sources of information. Abbreviated Content: Training the candidates for performing drug selection in order to decrease the morbidity and mortality of the most common diseases. Development and application of programs for establishing the policies and technical development of national resources (National drug policy, approach to ELL, quality and safe rational use). The study of the key principles of good pharmaceutical supply practice. A review of the selection of drugs, determining the necessary quantities, supply methods, financial means, specifications and contracts. IV.3. Distribution of Drugs 2 nd term (5 hours, 1,5 KR)

10 Aims: Designing a system of drug storage and distribution; medical auxiliary materials and equipment, inventory planning and control; resources for distributive management. Abbreviated content: Introducing the concept of drug distribution management through a quality management whose elements are defined by the principles of good distributive practice. A special attention is given to the question of cadres as a part of the distributive chain, the documentation which follows the process and the planning of the space and equipment necessary for the distributive activities. IV.4. Stock Control and Planning 2 nd term (5 hours, 1,5 KR) Aims: Cost analysis and monitoring; the potentials of the private sector; selection between evidence and substitution. Abbreviated content: The study of controlling functions in management, processes, documentation, equipment and other activities related to drug storage. At the same time, the goal is to introduce the candidates to the Guidelines for Creating Protocol Documents,, elaboration of special measures considered suitable for the procedures of storage and transport of active pharmaceutical substances and final drugs. The content also includes the element of economic planning of stocks from the point of view of managing financial and other resources indispensable for the system of regular drug supply. IV.5. Rational Use of Drugs 2 nd term (10 hours, 3 KR) Aims: Defining the rational use of drugs and the adverse impact of the irrational use of drugs. Abbreviated content: Introducing the candidates to the basic concepts of improvement and rationalization of drug use in the focus of which is the patient and the study of the means for the realization of the policy which includes clinical leaders of good practice, the policy of the health institution and practice and the evaluation of drug prescription and information about drugs. The candidates are trained for making decisions, the application and monitoring of the disease management directives and rational use of drugs. IV.6. Healthcare Legislature 2 nd term (10 hours, 3 KR) Aims: The study of the National Drug Policy, including defining the goals and future trends in the development. The subject also introduces the students to the basic systems of health insurance and the existing international organizations responsible for creating and enforcing the global drug policy. Special attention is given to international contracts and drug regulations, procedures for drug registration and licensing and the element of harmonization of the national legislature with the EU directives. Module V. National Drug Polcicy The teaching of all subjects is organized in cycles with a fixed number of hours for each subject through lectures, practice, preparation of seminar papers and organization of workshops.

11 Testing and Grading: Seminar paper 30 points Colloquiums 30 points Exam 40 points V.1. Systems of Health Insurance 3 rd term (15 hours, 6 KR) Aims: Notion, meaning, functions and goals of the health system. Abbreviated Content: The course includes the study of health systems and subsystems; the development of health systems and health technology; creating good and just health systems, measuring the realized goals and knowledge about the problems in the health management systems, the organizational forms and creating the policy and development strategy. V.2. International Organizations 3 rd term (10 hours, 5 KR) Aims: International organizations: goals and benefits Abbreviated Content: Knowledge of the organizational display, functions and goals of the international organizations; membership and possibilities for a more efficacious health management and drug supply. V.3. International Contracts and Drug Regulations 3 rd term (15 hours, 6 KR) Aims: Establishing legal regulations (rules issued by the Government) for medical preparations. Abbreviated Content: Introducing strategic documents, EU, STO and FDA directives, institutions and regulations. V.4. Registrations and Licensing 3 rd term (10 hours, 5 KR) Aims: Introduction to the national pharmaceutical regulation Abbreviated content: The study of the requirements for the quality of new active substances and preparations, preclinical and clinical examinations, abbreviated procedures for drug registration, radiopharmaceutical preparations, medical devices, expert opinion and expert report on the procedure for drug registration and turnover, defects in the application, patent protection and the right to ownership, procedures for drugs developed with high/bio technology, guides to quality, drug safety and efficacy. V.5. Harmonization of the National Legislation with EU Directives 3 rd term (20 hours, 8 KR) Aims: Acquiring knowledge about the legislation of the pharmaceutical sector in other countries of the region and EU and harmonization of the national legislation with EU directives.

12 Abbreviated Content: nema VI. Preparation of the Master s Thesis The preparation of the master s thesis is in the IV term and it carries 30 KR.