FIP GOOD PHARMACY PRACTICE Thai GPP Quality Indicator workshop

Eeva Tersalmi MS in Pharm, pharmacy owner FIP Community Pharmacy section, secretary
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The reference document accepted in the FIP Council meeting in 2009 The revised FIP/WHO GPP policy guidelines accepted by FIP Council in 2010 The guidelines presented to the 45th WHO Expert Committee on spesifications for Pharmaceutical Preparations
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Thailand as a FIP pilot country for GPP implementation

2005-2007 pilot study for developing national standards 2007 Bangkok declaration on GPP in the community pharmacy settings by SEARPharm Forum 2008 Second SEARPharm Forum meeting

Contents of the revised version

Introduction Underlying philosophy Definition of GPP Requirements of GPP Setting standards for GPP Conclusions

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Introduction
Health of the public a basic value Poor access to quality medicines and trained health care professionals, high costs Gap between proven efficacy of medicines and their actual effectiveness in practice Patient safety Counterfeiting GPP document describes how pharmacists can improve access to health care, health promotion and the use of medicines on behalf of the patients that they serve
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Underlying philosophy
Mission of pharmacy practice is to contribute to health improvement and to help patients with health problems to make the best use of their medicines Readily available, identifying and managing health-related problems, health promotion, assuring effectiveness, preventing harm from medicines, making responsible use of limited health care resources
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DEFINITION
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

Requirements of GPP
Welfare of patients Make the best use of medicines Promotion of rational and economic prescribing and dispensing Relevant services which are defined and communicated (collaboration) Conditions: National standards for GPP should be spesified and adhered to by practitioners
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National level
Legal framework Workforce framework Economic framework

Setting standards
Quality management framework Strategic plan for developing services Needs of users and capacity of national healthcare system to support the servicees Baseline for practice Defining the roles of pharmacists based on needs analysis Functions in these roles, national standards including the activities based on processes Defined and measured by setting indicators of good practice
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Role 1, Prepare, obtain, store, secure, distribute, administer and dispose medical products
Prepare extemporaneous drug preparations and medical products Obtain, store and secure drug preparations and medical products Distribute drug preparations and medical products Administration of medicines, vaccines and other injectable medicines Dispose of drug pretarations and medical products

Role 2, Provide effective medication therapy management

Assess patient health status and needs Manage patient medication therapy Monitor patient progress and outcomes Provide information about medicines and health related issues

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Role 3, maintain and improve professional performance

Role 4, contribute to improve effectiveness of the health care system and public health
Disseminate evaluated information about medicines and various aspects of self care Engage in preventive care activities and services Comply with national professional obligations, guidelines and legislations Advocate and support national policies that promote improved health outcomes
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Plan and implement continuing professional development strategies to improve current and future performance

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Operations need structure to support the work Standardized actions organised in the form of processes We do not know if the structure is right if we do not evaluate it => indicators We do not know how the processes work if we do not measure them => indicators We do not know of outcomes if we do not measure them => indicators
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Next step - how to guarantee that Pharmacy practice is Good pharmacy practice

Quality management
Pharmacists and pharmacies have professional responsibilities set by customers and societies To provide services with are reliable, costeffective and which promote right medicine use and patient safety Quality management is the way to manage the work so that these responsibilities are fulfilled. Work is organised in processes to meet the legal requirements, standards and SOPs and based on ethical values, vision and mission.

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Weaknesses of pharmacies
The documentation is lacking The practice not based on evidence The effectiveness and efficacy of the services not evaluated The measuring system is weak => Political problems in showing the value of pharmacies in health care. Pharmacies needed for safe practices, adherence, self care support
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Different needs to measure

How the pharmacy copes with legal requirements => inspection by officials, society needs How the pharmacy copes with national/international requirements => relationship, membership. Political needs, customer and society needs, satisfaction with services, benchmarking possibility How the pharmacy copes with the owners own goals => auditing inside the pharmacy, profes-sional leadership, development of own work

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Donabedian
Structure working environment Processes what is done, all work in pharmacies, based on customer needs Outcomes results of action ECHO-model: economic, clinical, humanistic outcomes
NEED S

Indicators
Direct indicator: the system fulfills the requirement, example: pharmacy is licensed Indirect indicators: pharmacy has sources for information/expectation information is given Due to difficulties to measure final outcomes or their efficacy indirect indicators are sometimes needed. Example public health activities

SATISFACTI ON
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The system of indicators should

Show the areas where the pharmacy needs upgrading Show the perceptions of consumers Give a clear picture of other stakeholders views

Quality requirements for indicators

Validity; that the measurement instrument is measuring what is intended Reliability; that the measurement instrument is reliable and repeatable The auditing tool must be accessible, available, relevant, have functional integration and be cost-effective to apply

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Systems for measuring quality

ISO 9001:2008 EFQM model Continual improvement, model of Demian plan, do, check, act

Systems for measuring quality in Pharmacy Practice

Indicator based tool developed for Africa SEARPharm forum CPS set of indicators CPS set of indicators for pharmacy services Validation instruments developed in Malta Validation instruments for Switzerland benchmarking! Finnish quality indicators BSC-based Quality indicators in my own pharmacy ISO 9001:2008, ISO 14001:2004, OHSAS 18001:2007
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African indicators 2

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Process of indicator development in Malta

Baseline study: indentification of professional services offered from community pharmacies Quantification of the professional services offered from community pharmacies Quantitative community pharmacy model Internal validation tools External validation tools Evaluation of both => tool ready for use

Identification of the structures and processes

In Malta: dispensing process responding to symptoms Communication with the patient Other professional services The setting of the pharmacy : compliance with legal requirements and permits and staffing
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Process 1

Process 2

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Process 3

Process 4

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Process 5

External tools
Customer satisfaction Do I want to recommend this pharmacy? Health professional satisfaction Do we have collaboration which is beneficial? Officials satisfaction Are we ready to pay for the quality?

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Testing the tool

Applicability and practicality Validity: face and content validity criterion and construct validity need for golden standard! Reliability: correlation between 2 different measures, testing - retesting

Working group work

Identify the processes which should be measured Identify the right indicators for these processes Weight (score) these indicators Make a tool of the indicator Discussion of the applicability, practicality, validity and reliability Working method: think alone, discuss with another, present the ideas, screen the ideas, select the ideas.

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