Modern approaches to pharmacy practice in the international

practice

Organization of the pharmaceutical providing in the

international practice

Basic principles of organization of pharmaceutical aid for

population

Regulation of pharmaceutical activity

PLAN:

WHO: Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference.

International Health Conference, New York, 19–22 June, 1946 1946, 2:100.

Anderson S: The state of the worlds pharmacy: a portrait of the pharmacy profession.

Worley MM, Schommer JC, Brown LM, Hadsall RS, Ranelli PL, Stratton TP, Uden DL: Pharmacists' and patients' roles in the pharmacist-patient relationship: Are pharmacists and patients reading from the same relationship script? Research in Social and Administrative Pharmacy 2007, 3:47-69.

«ORGANIZATION OF PHARMACEUTICAL AID TO THE POPULATION» (part I) / Under ed. prof. Nemchenko A.S. - Kharkov, 2012.- Unit 1, p. 5-12.

«ORGANIZATION OF PHARMACEUTICAL PROVIDING OF THE POPULATION» / Under ed. prof. Nemchenko A.S., Zhirova I.V. - Kharkov, 2014.- p. 9-39, 76-86, 96-102, 116-120.

References

Basic principles

of organization of

pharmaceutical

aid for

population.

5

International practice

Germany

Features

• allowed to have only one

pharmacy;

• the owner of the pharmacy can be

only a pharmacist;

• medicines can be sold only through

a pharmacy (both prescription

drugs and OTC)

6

Features

• privacy (confidentiality) of the conversation between the patient

and pharmacist, provided the organization of sales area and

workplace of the pharmacist is guarantied by the law

• prescription to a pharmacy may come not only directly from the

patient, but also by e-mail

• all recipe data processed by the computer issuing a further

signature

Denmark

7

• basis of the activity of each pharmacy is the computer network

with data on each patient

• the total area of the pharmacy - not less than 100 m2.

• OTC medicines and related products - in the public domain.

• Prescription drugs are at the workplace pharmacist

USA

International practice

Features

The main principles for the development and

location of the pharmacy network

Maximum approximation of pharmaceutical care to the population

Norms walking (distance) between pharmacies

Regulation of the total number of pharmacies and the rationality of

their location

The distance between

pharmacies 200-400 m

provides sufficient availability

of pharmaceutical care

Portugal

Spain

Sweden

Minimum

distance

250 m

France - 2.3 pharmacies per 1000 km2

Greece - 70 pharmacies per 1,000 km2

Ukraine - 17 pharmacies per 1,000 km2

!

9

The main principles for the development and location of the pharmacy network

Availability of pharmaceutical care guarantees a certain standard number of inhabitants served by one pharmacy

norms of walking distance to establish the number of pharmacies in

accordance with the population of the region

The feasibility of opening new stores near existing

The average

quantity of people

served by

1 pharmacy

Greece 1143 France 2641 Italy 3563 Germany 3883 Finland 6599 Austria 6665 Hungary 4870 Poland 6094 Norway 12760 Denmark 17869

Ukraine

1 pharmacy serves 2200 inhabitants

Country Popula-tion

(millions

pers.)

Quantity

of

pharma-

cies

Quantity of

population for

1 pharmacy

Pharmac

y

network

Regulation of

pharmacy

location

GPP Market

($, bill.)

Austria 8,2 1 276 6 426 - + + 4,5

Great Britain 53 >11 000 4818 + - + 21,5

Denmark 5,5 316 17 405 + - + 3,2

Ireland 4,5 1 579 2 849 + - + 2,5

Spain 47 21364 2 199 - + + 22,7

Netherlands 16,7 1 980 8 434 + - + 7,5

Norway 5,0 692 7 225 + - + 3,4

Sweden 9,1 1 250 7 280 + + + 4,7

UKRAINE 45 >20000 2 198 + - - 3,9

Key indicators of pharmaceutical providing of population

A) The quantity of patients served by one pharmacy; B) the quantity of pharmacies per 1,000 square meters; B) pedestrian accessibility (distance); D) the quantity of pharmacies per 1,000 inhabitants.

Which of the regulations, which characterize the effective development and deployment of pharmacy, it is advisable

to install at the opening of new pharmacies in Ukraine:

TEST

А) Germany

Б) USA

В) Denmark

Г) GB

What country guarantees the confidence of the conversation between the patient

and pharmacist

TEST

Regulation of

pharmaceutical

activity.

Regulation

Regulation can be defined as any measure or intervention implemented under government authority that acts to control the behaviour of individuals or groups that come within the ambit of that authority. Regulation includes the primary laws and subordinate instruments developed by government and the rules issued by government and non-government agencies under delegated powers.

Categories of regulation

Economic regulations

intervene directly in market decisions

Social regulations

protect public interests such as health and safety, the environment and social

cohesion

Administrative regulations

are administrative and paperwork requirements through which

governments collect information and impact on individual decision making

through the requirement for licensing et cetera

The Organization for Economic Cooperation and Development (OECD) identifies

The State Board of Pharmacy issues regulations which pharmacists must follow to assure the public health, safety and welfare.

The practice of pharmacy within each state is regulated by the laws of the state, including the regulation of licensure for pharmacy practice.

Pharmacist is one of the most regulating profession

GRP

GLP

GCP

GMP

GDP

GPP

Good X Practice (GXP)

Development of the medicines

Good procurement practices (GPPP) - recommended in procurement of pharmaceutical products for the budget

Good storage practices of pharmaceutical products (GSP) - special arrangements necessary for the proper storage and transportation of pharmaceutical products

! Good practice prescribing medicinal drugs (requires implementation in Ukraine)

Good practices on pharmacovigilance (GPvP) - principles and rules that relate to the collection, monitoring, information, audit, storage, analysis and publication of data on pharmacovigilance to guarantee their quality and reliability

Good regulatory practice (GRP) Order of the Ministry of Health of Ukraine from 28.05.2013, № 247

principles and rules of regulatory activities, which are used by the Ministry, the competent authorities and expert agencies to ensure the efficacy, safety, quality and availability of drugs

The main regulatory functions (9):

• licensing of production, wholesale and retail trade, import;

• certification of drug production;

• inspection of production;

• audits of institutions and organizations that conduct preclinical studies and clinical trials, and pharmacosupervision system audits;

• State registration of drugs, in Vol. h. examination of materials for these drugs; state control of drug quality;

• control over promotion (promotion) drugs on the market;

• advertising controls drugs;

• pharmacosupervision of medicine safety.

Good Laboratory Practice generally refers to a system of management controls for laboratories and research organizations to ensure the consistency and reliability of results as outlined in the OECD Principles of GLP and national regulations.

GLP applies to non-clinical studies conducted for the assessment of the safety of chemicals to man, animals and the environment. The internationally accepted definition is as follows:

Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived.

Good Laboratory Practice

Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds.

Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates.

Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation (ICH), an

international body that defines standards, which governments can transpose into regulations for clinical trials involving human

subjects.

Good Manufacturing Practice or GMP (also referred to as 'GMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products.

The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world.

Good Manufacturing Practice

GMP is designed to help assure the quality of drug products by ensuring several key attributes, including correctness and legibility of recorded manufacturing and control documentation. Data transfers must be performed in specific ways to avoid mistakes (e.g., writing down a reading on a balance and requiring a second person to also check the balance reading to assure accuracy). Methods have been developed to make this process easier (e.g., links between equipment and central data storage facilities for direct transfer of important data).

GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs, intended for human consumption.

GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

Good Distribution Practice or GDP deals with the guidelines for the proper distribution of medicinal

products for human use.

The International Pharmaceutical Federation first adopted the guidelines for Good Pharmaceutical Practice in 1993. Conscious of the need to help developing countries achieve GPP, the FIP Community Pharmacy Section Executive Committee established a working group to produce guidelines in this area in 1992. The paper, entitled “GPP in Developing Countries – Guidelines for Implementation”, was endorsed by the FIP CPS Executive Committee in September 1998.

Good Pharmaceutical Practice

GPP is the practice of pharmacy that responds to the needs of the people who use the pharmacists’ services to provide optimal, evidence-based care. To support this practice it is essential that there be an established national framework of quality standards and guidelines.

Good Pharmaceutical Practice

The promotion of health;

The supply of medicines, medical devices, patient self-care;

Improving prescribing and medicine use by pharmacists’ activities.

The GPP Guidelines are based on the pharmaceutical care given by pharmacists. The guidelines

recommend for national standards to be set:

Providing of control of quality of the compounding data, given to the druggist.

Creations of formularies on medicines.

Providing of the mutual understanding of doctors and druggists in the process of

work with the individual recipes.

Estimations of data on the use of medicines in the medical and pharmaceutical

practice.

Estimations of advertising materials on medicines.

Distributions of information on the official channels.

Educational program developments for the workers of health protection.

The uses of the reference books, present at disposal of druggists.

Providing of confidentiality of the information, touching patients.

According to the document of WHO national good pharmacy practice standards are necessary for:

a pharmacist's first concern in all settings is the welfare of patients.

the core of the pharmacy activity is the supply of medications and other health care products of assured quality, appropriate information and advice for the patient, and monitoring of the effects of use.

an integral part of the pharmacist's contribution is the promotion of rational and economic prescribing and of appropriate use of medicines.

the objective of each element of pharmacy service is relevant to the patient, is clearly defined and is effectively communicated to all those involved.

Good pharmacy practice requires that

The guidance contains recommendations to four basic directions GPP: 1. Personnel 2. Education of personnel 3. Standards GPP 4. Legislation and national medicinal policy.

Recommendations

Professionalism should be the main philosophy underlying practice, although it is accepted that economic factors are also important.

Continuous teaching and in-plant training of employees Perfection of knowledge on basic (vitally important) medicines, on

rational prescribing medicines and possibilities of replacement of original preparations by reproduced medicines (by generic)

Teaching of personnel how to help general practitioners in regard to the rules of the correct purpose of medicines

Teaching of personnel, how to give recommendations to the patients about the application of medicines

Teaching to the methods of the data processing about the application of medicines

Teaching to the methods of the data processing about the purpose of medicines

Necessary qualification of personnel

accepting of recipes and providing of the mutual understanding between doctor and pharmacist;

estimation of recipe by pharmacist; conducting of the procedures, necessary for

preparation of the medications written out; grant in the accessible form to the patient or person,

taking care of it, sufficient writing and verbal information, allowing to obtain a maximal benefit from the medical treatment;

watching of results of the conducted medical treatment;

documenting of professional activity.

The good pharmacy practice PRESCRIPTION MEDICINES PROVIDING

Prescription medicines sales Every country must define for itself the own minimum requirements

of GPP taking into account the local features.

Examples of types of activity

Accept of recipes. Verification of recipe by pharmacist. Communication with the doctor,

writing out a recipe. Selection of the prescribed

preparations. Labeling. Medicine quality control. Delivery of medicine. Replacement LS. Urgent providing. Recommendations on compensation

of charges.

Examples of minimum requirements

A pharmacy must secure, that a patient understood and could use information, indicated on label

Making medicines in pharmacy: Purchase of raw material. Estimation of composition of ingredients written

in prescription. Making of preparations. Conduct of document (accounting). Packing and labeling. Verification (validation). Medicine quality control.

Examples of types of activity

The good pharmacy practice

Purchase and inventory control:

Examples of types of activity

Determination and support of assortment of goods.

Organization and turn of supplies. Inventory control. Choice of supplier/wholesaler. Order of medicines. Delivery of medicines. Receipt of medicines. Storage of medicines. Safety of medicines. Writing and return. Review. Utilization of the used

pharmaceutical products and pharmaceutical wastes

Examples of minimum requirements

A pharmacy is under an obligation to document its level of providing of services to the population.

A pharmacy must have continuous registration records of errors in consideration of supplies.

A pharmacy must have the system, securing, that there were no overdue products on shelves.

A pharmacy must have a worked order of formal acceptance, treatment and utilization of the returned medicines.

Purpose: to secure, that the proper preparation in the correct dose and medicinal form was got by exactly that patient, for which it is intended.

To the vacation of medicines the following requirements are produced (are

transferred arbitrarily): A concrete patient must get necessary medicine. It follows not to assume the possible co-operations of medicines. Quality and safety of medicines must be saved and be supported during

the indicated expire term. A patient must get the correct and clear pointing in order to secure the

adequate and safe application of given medicines with the optimum benefit for patient and in accordance with the purpose of medical treatment.

It follows a patient to be given at least basic information on the application of medicines, to warn about the possible side effects, if such are present, and to tell that it is needed to do, if concrete events will happen.

Vacation (Sales) of medicines

Purpose: to secure a presence of the proper apartments, on the base of which services will be provided.

For the grant of pharmaceutical services and products there must be the

special apartments, which are separated from other types of activity/services and products, on purpose guarantee safety and quality of products, thus taking to the minimum risk of the erroneous in providing of medicines. The question is about the following requirements (are transferred arbitrarily):

Cleanness of apartment. Adequate space. The proper terms for storage, packing, vacations and

distributing of medicines (including safety measures). Adequate illumination. Defence medicines from the excessive influence of light and

temperature — if it is necessary to keep in refrigerator. Presence of the equipment, proper to the executable tasks. Presence of basic reference books. Possibility of instructing, advising of patients.

Apartments

Ending

Changes creates

opportunities…..

as well as problems….

Thinking Globally…. Acting Locally