VINNYTSIA NATIONAL MEDICAL UNIVERSITY by the Name of N.I Pirogov

Ministry of health OF Ukraine

VINNYTSIA NATIONAL MEDICAL UNIVERSITY by the name of N.I Pirogov.

Department of pharmacy

ORGANIZATION

AND ECONOMICS OF PHARMASY

Methodical recomendations

to self-preparation implementation of practical lessons

Module 1:"ORGANIZATION OF POPULATION PHARMACEUTICAL PROVIDING ".

Vinnytsia – 2014

Methodical instructions are designed for independent work of students on subject "Organization and Economy of Pharmacy" Module 1:"ORGANIZATION OF POPULATION PHARMACEUTICAL PROVIDING".Designed for practical self-preparation implementation to practical lessons for students IV course specialty "Pharmacy" and "Clinical Pharmacy".

Compilers: Cand.farm. science, as. Balitska O.P.

Methodical recommendations considered and approved at the meeting of the Department of Pharmacy

Protocol №______from______

Introduction

In the conditions of forming of market relations in Ukraine large attention is spared to professional preparation of specialists of pharmaceutical industry, from which is demanded not only the basic conception of organization of work of enterprises of all patterns of ownership (pharmacies and pharmaceutical firms) but also ability to be oriented in production situations which change constantly.

The methodical pointing send students to mastering of informative material for the themes of discipline, which represent the most essential questions of organization of work of pharmaceutical establishments.

The presented pointing is developed in accordance with the program from organization and economy of pharmacy for the students of specialty 7.110201 «Pharmacy» of higher pharmaceutical establishments of formation of Ukraine of the III – IV levels of accreditation.

In the methodical pointing information is pointed for the leadthrough of laboratory employments and mastering of practical skills: purpose of employment, list of theoretical questions, additional literature and list of test task which will allow a students to prepare students to practical lessons.

Topic 1.Types of regulating lists of drugs in system of health protection.

The aim of topic:

General: To master the principles of regulating lists of drugs in system of health protection.

To learn the basic types of regulating lists of drugs.

Concrete: To master the modern stateand problemsof providing the population of medicines and medical devices.

Theoretical questions on the practical lesson :

1. Modern stateand problemsof providing the population of medicines and medical devices.
2. The main task of forming of National medicinal policy.
3. Priority directions and programmatic task of forming.
4. Pharmaceutical education and staffing providing.
5. Providing of medicines quality.

Recommended literature:

1. National medicines policies – a review of the evolution and development processes// Joëlle M Hoebert, Liset van Dijk, Aukje K Mantel-Teeuwisse, Hubert GM Leufkens and Richard O Laing // Journal of Pharmaceutical Policy and Practice 2013, 6:5.
2. Effective drug regulation A multicountry study by MsSauwakon RatanawijitrasinMrEshetuWondemagegnehu World Health Organization.

2002, 142 p.

1. Access to Medicines and Drug Regulation in Developing Countries: a Resource Guide for DFID //Andy Gray. 2004,10 p.

Topic 2.Order of forming of the National List of essential (basic) drugs according to requirements of the World Health Organization.

The aim of topic:

General:To master the principles ofOrder of forming of National list of main drugs according to requirements of the World Health Organization.

Concrete:To learn the structure and content of the National List of essential (basic) drugs.To learn the regulations on the National List of Essential (vital) Medicines and Medical Devices. To learn the formulary system in medical institutions of Ukraine.

Theoretical questions on the practical lesson :

1. Structure and content of the National List of essential (basic) drugs.
2. Regulations on the National List of Essential (vital) Medicines and Medical Devices.
3. Formulary system in medical institutions of Ukraine.
4. System of state registration of prices of medicines and medical products.
5. Monitoring system of prices of manufacturers and suppliers of drugs and medical products, domestic production.
6. Monitoring system of world prices for drugs and medical products of foreign manufacture.

Recommended literature:

1. National medicines policies – a review of the evolution and development processes// Joëlle M Hoebert, Liset van Dijk, Aukje K Mantel-Teeuwisse, Hubert GM Leufkens and Richard O Laing // Journal of Pharmaceutical Policy and Practice 2013, 6:5.
2. Effective drug regulation A multicountry study by MsSauwakon RatanawijitrasinMrEshetuWondemagegnehu World Health Organization.
3. 2002, 142 p.
4. Access to Medicines and Drug Regulation in Developing Countries: a Resource Guide for DFID //Andy Gray. 2004,10 p.

Topic 3.Licensing of pharmaceutical activity in Ukraine and abroad.

The aim of topic:

General: To master the following;

- features of licensing of pharmaceutical activity in Ukraine.

- order of opening of pharmacy.

- description of structural subdivisions of pharmacy.

- organization of licensing of pharmaceutical activity in the countries of EС, USA, other countries.

- international requirements and norms of EС to pharmaceutical activity.

Concrete:

- to learn the functions of licensing in the sphere of medications turnover ;

- to learn the socio-economic necessity of licensing of pharmaceutical activity;

- to learn procedure of licensing of pharmaceutical activity from retail realization of medications and IMP in Ukraine;

- to learn procedure of licensing of pharmaceutical activity from wholesale realization of medications and IMP in Ukraine;

- to learn procedure of licensing of pharmaceutical activity on the production of medications and IMP in Ukraine;

- to learn the basic tasks of pharmaceutical activity on macro- and microeconomic levels;

- to learn the order of organization and opening of pharmacy (pharmaceutical firms) as a legal person;

- to learn the order of organization and opening of structural subdivision of pharmacy;

- to learn composition and areas of apartments of pharmacies.

Theoretical questions on the practical lesson :

1.Order of opening of pharmacies and licensing of their activity.

2.Task and functions of pharmacies, classification of pharmacies.

3.Organizational requirements to activity of pharmacies.

4.Apartments of pharmacy and their equipments, minimum composition and area of apartments of pharmacies, depending on character of activity.

5.Procedure of licensing of pharmaceutical activity.

6.Organization of work of structural subdivisions of pharmacy.

Recommended literature:

1. Approaches to Valuation of Pharmaceutical Licensing Deals // Edited by Nigel Borshell and Taskin Ahmed.2012, 92 p.

Topic 4.Foreign experience of medical insurance system functioning.

The aim of topic:

General: To master the features of foreign experience of medical insurance system functioning.

Concrete:To learn the fundamentals of Health Insurance.To learn the main features of health insurance in the world.To learn the forms of organization of mandatory health insurance in foreign countries.

Theoretical questions on the practical lesson :

1. Fundamentals of Health Insurance.
2. Main features of health insurance in the world.
3. Forms of organization of mandatory health insurance in foreign countries.
4. Decentralized form of organization of mandatory health insurance in foreign countries.
5. Centralized form of organization of mandatory health insurance in foreign countries.
6. Collective and individual health insurance.
7. Major sources of health care financing.
8. Mixed form of organization of mandatory health insurance in foreign countries.

Recommended literature:

1. Disease Control Priorities in Developing Countries. 2nd edition// Jamison DT, Breman JG, Measham AR, et al., editors// Washington (DC): World Bank; 2006.
2. Options for reform of Commonwealth and State governance responsibilities for the Australian health system//Judith Dwyer and Kathy Eagar. 2008, 34 p.

Topic 5.Analysis of the market for voluntary health insurance in Ukraine.

The aim of topic:

General: To mastermarket for voluntary health insurancein Ukraine.

Concrete:To learn the benefits of voluntary health insurance.

To learn the purposeof voluntary health insurance.

To learn the tasksof voluntary health insurance.

To learn the list of services of insurance companies.

To make a revision of the health insurance market.

Theoretical questions on the practical lesson :

1. Benefits of voluntary health insurance.
2. Purpose of voluntary health insurance.
3. Tasks of voluntary health insurance.
4. Measures to improve the regulatory and methodological frameworkof insurance companies.
5. Feasibility of health insurance.
6. List of services of insurance companies.
7. Revision of the health insurance market.

Recommended literature:

1. Disease Control Priorities in Developing Countries. 2nd edition// Jamison DT, Breman JG, Measham AR, et al., editors// Washington (DC): World Bank; 2006.
2. Options for reform of Commonwealth and State governance responsibilities for the Australian health system// Judith Dwyer and Kathy Eagar. 2008, 34 p.

Topic 6.Organization of OTC-drugs sale.

The aim of topic:

General:To master organization of OTC – drugs sale in Ukraine and countries of EC, organization of pharmaceutical guardianship, the rules of responsible independent treatment as modern form of mutual relations between a patient and pharmacist. To get practical skills from placing of these preparations in a trading hall.

Concrete:

To learn classification of medications on different criteria.

To learn the order of organization of OTC – drugs handing out in Ukraine and abroad.

To learn requirements to OTC – drugs.

To learn rights and duties of druggist from handing out of medications without recipes.

To learn the rules of advertising of OTC – drugs.

To learn responsible self-treatment – pre-conditions of origin, essence, value.

Theoretical questions on the practical lesson :

1. Namebasicaims of applicationsofOTCpreparations.

2.SpecifythecriteriaoftakingofmedicinalpreparationstoOTC medicines.

3.Givedeterminationof OTC-preparations.

4.Basicrulesofresponsible self-treatment.

5.Givedeterminationofpharmaceuticalguardianship.

6.Describebasicclassificationsofmedicinalpreparations.

7. Name the task of the department of OTC realization of pharmacy.

8. Organization of OTC realization of medicinal preparations in foreign countries.

9. Basic principles of placing of OTC medications in the hall of service of pharmacy.

10. Description of domestic list of medications which are released without recipes from pharmacies.

11. What is merchandising use connected with while OTC realization of medical preparations.

12. Name the basic requirements to advertising of drugs.

13.The European method of approaching OTC advertisement.

Recommended literature:

1. OVER-THE-COUNTER MEDICATIONS: USE IN GENERAL AND SPECIAL POPULATIONS, THERAPEUTIC ERRORS, MISUSE, STORAGE AND DISPOSAL //A Resource from the American College of Preventive Medicine. -2011, 10 p.
2. Analysis of the Movement of Prescription Drugs to Over-the-Counter Status //PATRICIA HARRINGTON, BSC Pharm, MSC CLIN Pharm, and MARVIN D. SHEPHERD, PhD //Journal of Managed Care Pharmacy JMCP November/December 2002 Vol. 8, No. 6 //

Topic 7.Conception of self-treatment.Pharmaceutical guardianship.

The aim of topic:

General:.To master organization of self-treatment.To master organization of basic principals of Pharmaceutical guardianship.

Concrete:To learn the basic rules of responsible self-treatment.

To learn the basic rules ofpharmaceutical guardianship.

To learn the basic requirements to advertising of drugs.

Theoretical questions on the practical lesson :

1. Basic rules of responsible self-treatment.

2. Give determination of pharmaceutical guardianship.

6. Describe basic classifications of medicinal preparations.

7. Name the task of the department of OTC realization of pharmacy.

8. Organization of OTC realization of medicinal preparations in foreign countries.

9. Description of domestic list of medications which are released without recipes from pharmacies.

10. What is merchandising use connected with while OTC realization of medical preparations.

11. Name the basic requirements to advertising of drugs.

12.The European method of approaching OTC advertisement.

Recommended literature:

1.OVER-THE-COUNTER MEDICATIONS: USE IN GENERAL AND SPECIAL POPULATIONS, THERAPEUTIC ERRORS, MISUSE, STORAGE AND DISPOSAL //A Resource from the American College of Preventive Medicine. -2011, 10 p.

2.Analysis of the Movement of Prescription Drugs to Over-the-Counter Status //PATRICIA HARRINGTON, BSC Pharm, MSC CLIN Pharm, and MARVIN D. SHEPHERD, PhD //Journal of Managed Care Pharmacy JMCP November/December 2002 Vol. 8, No. 6 //

Topic 8. Price determination of different medical forms..

The aim of topic:

General:.To get the practical skills on acceptance of prescriptions on medications of the individual making, their registration, giving out from pharmacies, rules of fixing the price of cost of medications of pharmacy production.

Concrete:

To learn a tariff for making of medications as historical and socio-economic categories.

To learn determination and account of tariffs on making of medications.

To learn the rules of fixing the price of cost of different medical samples of writing (solutions, powders, supozitories, extracts and decoctions, ointments, liquid medical forms which are prescribed as drops and etc.).

To learn organization of workplace of pharmacist on the receiving the prescriptions and giving out of drugs of the individual making.

To learn the methods of registration on making.

To learn the equipment of shopfloors for making of extemporal drugs.

To learn the features of work with poisonous, narcotic, psychotropic medications and precursors of the list №1.

Theoretical questions on the practical lesson :

1. Features on prescription drugs that are made in pharmacies.

2. Organization of working place of pharmacist from prescriptions receiving

3. The main mistakes of doctors at writing prescriptions on extemporaneous preparations.

4. Common rules of fixing the price of prescriptions on the individual medical forms.

5. Structure of tariff, their nature and significance.

6. Features of fixing the price of prescriptions on the individual medical forms:

- liquids for external and internal application, eyeing drops, solutions for injection;

- powders, suppositories and ointments;

- waters extractions

- ethyl alcohol and alcoholic solutions.

7. Methods of journal recipes registration.

8. Methods of receipt recipes registration.

9. Equipment of assistant room

10. General rules of making of medications

11. Features of work with poisonous, narcotic and psychotropic matters and precursor of list №1

13. Registration for handing out of medical forms, made in pharmacies

14. Name and /or composition of medications.

Recommended literature:

1. Characteristics and Types of Price Discrimination//Fritz Machlup//

397 - 440).

Topic 9.Normative-legal base which regulate object-quantitative drugs account.Turnover of narcotic, psychotropic drugs and precursors regulation on the international and state levels.

The aim of topic:

General: To purchase system knowledges and practical skills from organization of appeal of narcotic, psyhotropic medications, prekursorson the international and state levels.

Concrete: To learn classification of narcotic facilities, psyhotropic matters and prekursors. Government control of appeal of narcotic medications, psyhotropic matters and prekursors. To learn organization of appeal of narcotic (psyhotropic) medications and special compounding forms № 3 in state and communal pharmacy compositions and bases: rule acquisition, acceptance, storage, vacation and account. To learn organization of leadthrough of utilization and eliminations of off-grade medications, which narcotic (psyhotropic) matters, prekursors, enter in the complement of. To learn responsibility for violation of the set rules of appeal of narcotic facilities, psyhotropic matters and prekursors. To learn the features of registration and order of acceptance of prescription, which contain narcotic facilities, prekursors, psyhotropic facilities. To learn setting of norms of vacation of narcotic facilities, psyhotropic matters and prekursors from pharmacies.

Theoretical questions on the practical lesson :

1. A concept is about narcotic, psyhotropic medications and prekursors.

2. Classification of narcotic facilities, psyhotropic medications and prekursors.

3. Normative-legal base which regulate object-quantitative drugs account.

3. Organization in subject- quantitative account on the international and state levels

4. Concept of public policy in the sphere of combating with illicit trafficking of narcotic drugs, psychotropic substances and precursors.

6The purpose and objectives of the Concept.

7. Organizational and legal measures against illicit trafficking of narcotic drugs, psychotropic substances and precursors.

8. Measures to prevent the illicit use of narcotic drugs and psychotropic substances.

9. International cooperation in the sphere of fight against illicit traffic of narcotic drugs, psychotropic substances and precursors.

Recommended literature:

1. Narcotic Drugs and Psychotropic Substances Act //Available in Estonian: + ELDD. Available in English (may not be updated): .
2. Report of the International Narcotics Control Board for 2012.-UNITED NATIONS New York, 2013.
3. International Narcotics Control Strategy Report Volume I //Drug and Chemical Control//March 2011, 588 p.

Topic 10. Turnover of narcotic (psychotropic) drugs and special prescription forms N3 organization in state and communal pharmaceutical warehouses and bases.

The aim of topic:

General: To purchase system knowledges and practical skills from organization of appeal of narcotic, psyhotropic medications, prekursors.

Concrete: To learn classification of narcotic facilities, psyhotropic matters and prekursors. Government control of appeal of narcotic medications, psyhotropic matters and prekursors. To learn organization of appeal of narcotic (psyhotropic) medications and special compounding forms № 3 in state and communal pharmacy compositions and bases: rule acquisition, acceptance, storage, vacation and account.

Theoretical questions on the practical lesson :

1. A concept is about narcotic, psyhotropic medications and prekursors.

2. Classification of narcotic facilities, psyhotropic medications and prekursors.

3. Order and receipt from pharmacy compositions (bases) of narcotic facilities, psyhotropic matters and precursors.

4. Organization in subject- quantitative account in establishments of guard of health.

6 Storage of narcotic, psyhotropic matters and precursors in pharmacies.

7 Rule of excerption of prescriptions on the special jars of form № 3 and to vacation after them of medications.

8 Rule of excerption of narcotic, psyhotropic matters and precursors on the compounding forms

№ 1 and to vacation after them.

9. Order of vacation of narcotic facilities, psyhotropic matters and precursors from pharmacies.

10. Order of acceptance of prescriptions, vacation of medications, which contain narcotic facilities, psyhotropic drugs and precursors.

11. Design of prescriptions on medications for patients with the protracted and chronic diseases.

12 Order of storage, account and elimination of compounding forms №3.

13. Order of providing of oncologic patients narcotic medications in the conditions of permanent establishment on to the house.

Recommended literature:

1.Narcotic Drugs and Psychotropic Substances Act //Available in Estonian: + ELDD. Available in English (may not be updated): .

3.Report of the International Narcotics Control Board for 2012.-UNITED NATIONS New York, 2013.

4.International Narcotics Control Strategy Report Volume I //Drug and Chemical Control// March 2011, 588 p.

5. Order of MZ of Ukraine from 19.07 2005 360 "About claim of Rules of excerption of prescriptions and requirements - orders on medications and wares of the medical setting, Order of vacation of medications and wares of the medical setting, from pharmacies and them structural subdivisions, Instructions about the order of storage, account and elimination of compounding forms and requirements, - orders" from with changes and additions.

Topic 11. Features of special prescription forms storage, account and utilization.

The aim of topic:

General:To master organization ofstorage of special prescription forms, their account and utilization.

Concrete:To learn organization of leadthrough of utilization and eliminations of off-grade medications, which narcotic (psyhotropic) matters, prekursors, enter in the complement of. To learn responsibility for violation of the set rules of appeal of narcotic facilities, psyhotropic matters and prekursors. To learn the features of registration and order of acceptance of prescription, which contain narcotic facilities, prekursors, psyhotropic facilities. To learn setting of norms of vacation of narcotic facilities, psyhotropic matters and prekursors from pharmacies.