GOOD PHARMACY PRACTICE
SITUATION – worldwide overview
• globalization
• Healthcare patient-focused
• The gap: developing and developed countries
(needs to be urgently addressed)
• The demand on limited resources
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
• A high level of human health protection shall be ensured
SITUATIONAL ANALYSIS
1) Population factors
SITUATIONAL ANALYSIS
2) Disease burden factors –
SITUATIONAL ANALYSIS
3) Health system factors
SITUATIONAL ANALYSIS
4) Pharmaceutical industry and innovation factors
5) Cooperation factors
SITUATIONAL ANALYSIS
• 6) Pharmacy profession factors –
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 seven-star pharmacist”
• WHO
The role of the pharmacist
1) CARE-GIVER
The role of the pharmacist
2) DECISION-MAKER
The role of the pharmacist
3) COMMUNICATOR –
The role of the pharmacist
4) LEADER
The role of the pharmacist
5) MANAGER
The role of the pharmacist
6) LIFE-LONG-LEARNER
The role of the pharmacist
7) Teacher
• .
Seven or eight star pharmacist?
8) Researcher:
• „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
GOOD PHARMACY PRACTICE
The reasons for this gap include:
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
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
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,
3. Standards
The goal :
• guarantee the integrity and quality of the product, and minimise the
risk of dispensing errors
3.1. Standards for facilities
3.2. Standards for Dispensing
The goal:
• right patient the right medicine
3.3. Standards for Containers
3.3. Standards for Containers
• Liquid pharmaceuticals – in pharmaceuticals bottles
• Poisonous products – distinguishable bottles
3.5. Instruction to the patient
3.6. Standards for Records
• Maintained
3.7. Standards for Health information, patient counselling,
pharmaceutical care
3.8. Standards for Self medication
• Protocols to ensure that advice is accurate and appropriate
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
Application of Good pharmacy
practice
STANDARD OPERATING PROCEDURES and other documentation in pharmacy
practice
Good pharmacy practice
• The concept of GPP – adopted in many countries
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 in
the pharmacy pracitce
Standard Operating Procedures
• Help to assure quality and consistency of pharmacy service:
Provide an opportunity to fully utilize the skills of all team members;
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:
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
• How to perform the process of „compounding“
• Containers
• Labelling
• Storage
• Expiration date
• Tests
• Date - signature
• Up dates - signature
• Annulment – date - signature