CHARTER OF FUNDAMENTAL RIGHTS OF THE
EUROPEAN UNION
 Everyone has the right of access to
preventive health care and the right to
benefit from medical treatment under the
conditions established by national laws
and practices.
 A high level of human health protection
shall be ensured in the definition and
implementation of all the Union's policies
and activities.
SITUATION – worldwide overview
 Increasing globalization of healthcare;
 Healthcare is becoming more and more
patient-focused;
 The gap in healthcare services between
developing and developed countries
(needs to be urgently addressed)
 The demand on limited resources (both
human and financial) - growing.
SITUATIONAL ANALYSIS
1) Population factors
 the population of the world will continue to
grow
(and its economy, prevalence of poverty ??)
 aging of populations
 difference in health distribution in
urban/rural developments.
SITUATIONAL ANALYSIS
2) Disease burden factors –
 leading causes of disease burden
continue to include a mix of
communicable and noncommunicable
diseases.
Variation exists between high-, low- and
middle-income countries.
SITUATIONAL ANALYSIS
3) Health system factors –
 cost
 accessibility
ability to provide high quality healthcare with
best possible outcomes
Note: growing healthcare worker shortages affecting
healthcare delivery around the
world.
SITUATIONAL ANALYSIS
4) Pharmaceutical industry and innovation
factors
5) Cooperation factors
SITUATIONAL ANALYSIS
 6) Pharmacy profession factors –
it is speculated that the number of trained
and competent pharmacists may be either
unavailable or inadequately distributed to
meet population needs.
This is a result of varying education
and training processes of pharmacists and
pharmaceutical scientists around the
world!
SITUATIONAL ANALYSIS
Healthcare systems
are realising the imperative role of the
pharmacist
through both experience and research
evidence.
The role of the pharmacist
The role of the pharmacist
 The role of the pharmacist:
“The seven-star pharmacist”
 WHO
The role of the pharmacist
1) CARE-GIVER - the pharmacist provides
caring services.
the pharmacist must view the
pharmacy practice as integrated in the
health care system and has to co-operate
with others health care professionals
The role of the pharmacist
2) DECISION-MAKER
 the appropriate, efficacious and cost
effective use of resources
The role of the pharmacist
3) COMMUNICATOR –
 the pharmacist is in an ideal position
between physician and patient
 Communication involves verbal, nonverbal,
listening and writing skills (soft
skills lecture)
The role of the pharmacist
4) LEADER
 Leadership involves:
 the ability to make decisions,communicate,
and manage effectively
 as well as compassion and empathy.
The role of the pharmacist
5) MANAGER
 effectively manage resources (human)
and information;
The role of the pharmacist
6) LIFE-LONG-LEARNER
 learning must be supported throughout
the pharmacist’s career.
The role of the pharmacist
7) Teacher
 responsibility to assist with the
education and training of future
generations of pharmacists.
the practitioner - gain new knowledge and
to fine-tune existing skills.
Seven or eight star pharmacist?
8) Researcher:
 sharing and documenting experiences,
the pharmacist
 „the evidence based“ care
GOOD PHARMACY PRACTICE
 The health of the public is fundamental
to the happiness and welfare of all
people.
GOOD PHARMACY PRACTICE
 Medicinal products are an essential and
critical part of health-care services in all
cultures and societies.
 The potential benefit of medicinal
products is often not realized — there is
a gap between the proven efficacy of
medicines demonstrated in clinical trials
and their actual effectiveness in
practice.
GOOD PHARMACY PRACTICE
The reasons for this gap include:
 problems with medicine selection and dosages,
 inappropriate administration of medicines
 medicine–medicine and medicine–food
interactions,
 lack of adherence by patients to prescribed
treatment,
GOOD PHARMACY PRACTICE
 „It has been estimated that the cost of
problems with the use of medicines is
equal to or greater than the cost of the
medicines themselves.“
 (Medicinal products are also increasingly expensive)
GOOD PHARMACY PRACTICE
 „All practicing pharmacists are obligated to
ensure that the service they provide to
every patient is of appropriate quality. GPP
is a means of clarifying and meeting that
obligation. “
 The aim: to assist in the promotion of the
provision of pharmaceutical care
 Complies with universal norms and values,
(in the private and public sector)
GOOD PHARMACY PRACTICE
 all pharmacists
 all pharmaceutical-related services
GOOD PHARMACY PRACTICE
 FIP adopted the guidelines for Good
Pharmaceutical Practice in Tokio on
September 5th, 1993
 FIP‘s idea: „Contribute to health
improvement and to help patients with
health problems to make the best use of
their medicines."
 (Note: FIP - International Pharmaceutical Federation )
GOOD PHARMACY PRACTICE
 The revised version of this document was
endorsed by WHO in 1997
 Updates: 2009-2010, 2011
 2020 Vision
 …..
 (Note: WHO - World health organization)
GOOD PHARMACY PRACTICE
 GPP 2011:
„The practice of pharmacy 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 will be an established national
framework of quality standards and
guidelines."
GOOD PHARMACY PRACTICE
Good pharmacy practice =
guidelines developed to set up standards
GOOD PHARMACY PRACTICE
 These guidelines have been subsequently
adapted in a wide number of developed
countries
 Focus on differences between countries
(health care system,…)
 Where national standards exist – reviewed
to harmonize with GPP
GOOD PHARMACY PRACTICE
 Specific standards of GPP can be
developed only within a national pharmacy
professional organization framework.
 Who is responsible?
Pharmaceutical organizations
and
Governments
GOOD PHARMACY PRACTICE
 Level 1: Prepare, obtain, store, secure,
distribute, administer, dispense and dispose
of medical products
 Level 2: Provide effective medication therapy
management
 Level 3: Maintain and improve professional
performance
 Level 4: Contribute to improve effectiveness
of the health-care system and public health
GOOD PHARMACY PRACTICE
 Each level is structured in several parts
 For each part has been set the list of
minimum national standards
GOOD PHARMACY PRACTICE
Level 1: Prepare, obtain, store, secure,
distribute, administer, dispense and
dispose of medical products
 Function A: Prepare extemporaneous
medicinal products
 Function B: Obtain, store and secure
medicinal products
 Function C: Distribute medicinal
products
GOOD PHARMACY PRACTICE
 Function D: Administration of medicines,
vaccines and other injectable
medications
 Function E: Dispensing of medical
products
 Function F: Dispose of medicine
preparations and medical products
GOOD PHARMACY PRACTICE
Level 2: Provide effective medication therapy
management
 Function A: Assess patient health status
and needs
 Function B: Manage patient medication
therapy
 Function C: Monitor patient progress and
outcomes
 Function D: Provide information about
medicines and health-related issues
GOOD PHARMACY PRACTICE
Level 3: Maintain and improve professional
performance
 development strategies to improve
current and future performance
GOOD PHARMACY PRACTICE
Level 4: Contribute to improve effectiveness of
the health-care system and public health
 Function A: Disseminate evaluated information
about medicines and various aspects of self-
care
 Function B: Engage in preventive care
activities and services
 Function C: Comply with national professional
obligations, guidelines and legislations
 Function D: Advocate and support national
policies that promote improved health
outcomes
GOOD PHARMACY PRACTICE
 FIP endorsed The paper:
 “GPP in Developing Countries –
Guidelines for Implementation”
 September 1998
Recomendation for implementation in developing
countries
Main topics:
 Personnel
 Training
 Standards
 Legislation
1. Personnel
The idea :
 all people should have access to an
adequate pharmaceutical service
The goal:
Sufficient numbers of pharmacists
2. Training
The idea: Sufficient numbers of well
educated pharmacists
Realization – standard for:
 Education
1st step: to have graduate level
pharmacist,
2nd step: provide continuing education for
pharmacists (pharmacy technicians)
3. Standards
The goal :
 guarantee the integrity and quality of the
product, and minimise the risk of
dispensing errors
3.1. Standards for facilities
Clean, tidy, hygienic conditions
Adequate space, light
Appropriate condition for storage, dispensing
(including security)
Protection from exposure to excessive light,
haet
Appropriate equipment for dispensing,
praparing, manufacturing…
3.2. Standards for Dispensing
The goal:
 right patient the right medicine (see
seminar)
(Possible interaction are avoided, shelf time,
correct and clear instruction to the patient instruction
for use, warrings, adverse - side
effects…)
3.3. Standards for Containers
Sample of stepwise implementation:
Step 1: Air-tight, plastic wallet 
Step 2: Air-tight, rigid container 
Step 3: Air-tight container with child resistant
closure 
Step 4: Manufacture‘s original pack etc.
3.3. Standards for Containers
 Liquid pharmaceuticals – in
pharmaceuticals bottles
 Poisonous products – distinguishable
bottles
3.3. Containers
http://yaymicro.comwww. drkulichpharma.cz
3.4. Standards for Labeling
 The required minimum for the label
 Warning
 Standards for written information,
standards for pictograms as well!!
Labeling - pictograms
 Samples of misinterpretation:
Cultural differences in pictogram:
 U.S.: Eiffel tower
 Japanese: Japan tower
 U.S: Scared
 Japanese: Cold
3.5. Instruction to the patient
Step 1: Verbal 
Step 2: Verbal plus hand-written and affixed to the
container 
Step 3: Verbal plus printed and affixed to the
container 
Step 4: Step 3 plus additional verbal counselling,
supplementary written information
3.5. Instruction to the patient
3.6. Standards for Records
 Records of all dispensed medicinal
products – patient, name and strength of
medicine, dosage, quantity of supplied,
date of dispensing….
 Maintained in a system (manual or
computerised) – easy retrieval patient
information
3.7. Standards for Health information, patient
counselling, pharmaceutical care
Provide health promotion literature 
Provide an area suitable for delivering of
basic information, counselling and
pharmaceutical care 
Provide a separate room for these
activities
3.8. Standards for Self medication
 Protocols to ensure that advice is
accurate and appropriate
3.8. Standards for Self medication
Greiner A.N., Meltzer E.O.: Pharmacologic rationale for treating allergic and nonallergic
rhinitis,
The Journal of Allergy and Clinical Immunology, Volume 118, Issue 5 , Pages 985-996,
November 2006
3.9. Standards for Products
 Legal mechanisms to ensure quality,
safety, efficacy of medicines
4. Legislation
 The legislation for pharmacy practice must
be practical, enforcable
 The legislation controls almost all above
 Needed: independent bodies to control all
aspects of medicine registration,
distribution,..
4. Legislation
 Set up: National drug policy
To ensure equitable access to safe and
effective drug of good quality.
References:
 www.fip.org
Guidlelines for pharmacy practice
Good pharmacy practice in developing
countries
STANDARD OPERATING PROCEDURES and other
documentation in pharmacy practice
Good pharmacy practice
 The concept of GPP – adopted in many
countries
 The GPP standards: all practising
pharmacists and other healthcare
professionals providing a
pharmaceutical-related service to
patients.
GPP in CZ
In the CZ:
 Decree No 84/2008 Coll., on good
pharmaceutical practice, detailed
conditions of handling pharmaceuticals in
pharmacies, healthcare facilities and other
operators and facilities supplying medicinal
products, as amended
(FIP GPP Level 1: Prepare, obtain, store,
secure, distribute, administer, dispense and
dispose of medical products, Level 2: Provide
effective medication therapy management)
GPP in CZ
Education and Qualification:
 Act No. 95/204 Coll. ,on the Conditions for Acquiring and Recognising
Professional Qualifications and Specialised Qualifications to Perform
the Professions of a Physician, Dentist, and Pharmacist
 Act No. 96/2004 Coll., on the Conditions for Acquiring and Recognising
Professional Qualifications to Perform Non-medical Health Care
Professions and to Perform Activities relating to Health Care Provision
and on the Amendment to Some Related Acts (the Act on Non-medical
Health Care Professions)
 Rules of Czech chamber of pharmacists
(Level 3: Maintain and improve professional performance, Level 4:
Contribute to improve effectiveness of the health-care system and public
health)
Standard Operating Procedures
 SOPs needed in the GPP
 All ativities in the pharmacy - It is
possible to describe in the SOP
 staff
 prescription problem solving
 SOPs for laboratory..
Standard Operating Procedures
 Help to assure quality and consistency
of pharmacy service:
Provide an opportunity to fully utilise the
skills of all team members;
Help to avoid confusion over who does
what (role clarification);
What is it?
 Standard Operating Procedure (SOP) is a
set of written instructions that document a
routine or repetitive activity, followed by an
organization .
 SOPs are an integral part of a successful
quality control system
 Development and use of SOPs minimizes
variation and promotes quality
Limatation
SOPs are of limited value if:
 not written correctly
 are not followed
SOP in CZE pharmacy practice
 SOPs for all repeated activities
 Technological prescription (master
formula sheet, SOP for preparing of
medicinal products) - Required for
repeated preparing of medicinal
products
GPP in CZE
Technological prescription for preparing :
 Medicinal product – „name“
 Ingredients
 Preparing directions
 Containers
 Labelling
 Storage
 Expiration date
 Tests
 Date - signature
 Up dates - signature
 Annulment – date - signature