Pharmacy Practice Standards Based on Science, Driven by Evidence

Transcription

1 Pharmacy Practice Standards Based on Science, Driven by Evidence Henri Manasse Jr., Ph.D., Sc.D. (Hon.), FIP Chair, FIPEd Steering Committee Professor and Dean Emeritus University of Illinois at Chicago, College of Pharmacy

2 Objectives of this session 1. Define and discuss terms 2. Establish the basis and rationale of standards 3. Review the basis of Standards as quasi-legal mechanisms for accountability 4. Present the Utility of standards in practice

3 Some distinctives Pharmacists are specifically (scientifically) educated and trained health professionals, who are charged by their national or other appropriate (e.g. state or provincial) authorities with the management of the distribution of medicines to consumers and to engage in appropriate efforts to assure their safe and efficacious use 1 1 According to Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services. WHO Technical Report Series, No. 961, Geneva: World Health Organization, 2011

4 Some distinctives Molecules become medicines when evidence-based pharmaceutical expertise is added. In turn, pharmacists optimise the effects of these medicines and ensure their quality, safety and responsible use.

5 Some distinctives All practicing pharmacists are obliged to ensure that the service they provide to every patient are of appropriate quality; Setting standards and defining terms is a means of clarifying and meeting that obligation.

6 Terms: Evidence Evidence = the available body of facts or information indicating whether a belief or proposition is true or valid; Belief Anecdote Observation Clinical Experience Controlled trials

7 Terms: Standards Standard = A required or agreed upon level of quality or attainment, used as a measure, norm, or model in comparative evaluations; FIP sets global pharmacy standards through professional and scientific guidelines, policy statements and declarations, as well as through its collaboration with other international organizations, including the World Health Organization (WHO) and other United Nations agencies; FIP encourages the adoption of necessary standards of health practice and focuses on topics relevant to professionals in developing, transitional and developed countries.

8 Terms: Standards One of FIP's tasks is to provide worldwide standards for pharmacy, via its: FIP Statement of Policy [ A paper setting out FIP's current, firm policy on a specific subject, usually a policy bearing on or a topic closely related to pharmacy; FIP indicates the policy that it is intended to pursue with other relevant international organisations. FIP expects its Member Organisations (and Predominantly Scientific Member Organisations if appropriate) to promote to other bodies, including governments when appropriate, nationally. FIP Statement of Professional Standards A paper setting out the standards FIP expects pharmacists to observe in discharging their professional responsibilities in one or more areas of practice.

9 Terms: Standards Joint Statements or Guidelines A statement between FIP and another international organisation, like the WHO or other health professional organisations: FIP/WHO Joint Guidelines on Good Pharmacy Practice - Standards for Quality Services (2011, Hyderabad); FIP/WHO Joint Statement on the role of Pharmacists in Tuberculosis Care and Control (2011, Hyderabad); WHO/FIP Joint Declaration on the Role of the Pharmacist in the Fight Against the HIV-AIDS Pandemic (1997, Vancouver); Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services. WHO Technical Report Series, No. 961, Geneva: World Health Organization, 2011.

10 Terms: Accountability Accountability = taking responsibility and the expectation of being able to justify actions or decisions. Pharmacists are health-care professionals whose professional responsibilities and accountabilities include seeking to ensure that people derive maximum therapeutic benefit from their treatments with medicines. This requires them to keep abreast of developments in pharmacy practice and the pharmaceutical sciences, professional standards and requirements, the laws governing pharmacy and medicines and advances in knowledge and technology relating to use of medicines.

11 Terms: Accountability 2012 Centennial Declaration of FIP: "Pharmacists and pharmaceutical scientists accept responsibility and accountability for improving global health and patient health outcomes by closing gaps in the development, distribution, and responsible use of medicines. Society can contribute to these objectives by supporting the advancement of pharmacy practice and the pharmaceutical sciences."

12 Terms: Quality Quality = The standard of something as measured against other things of a similar kind; the degree of excellence of something. Quality Services National pharmacy professional associations have a role in setting standards required for GPP, which includes a quality management framework and a strategic plan for developing services; In 2011, FIP and WHO adopted an updated version of Good Pharmacy Practice entitled "Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services

13 Terms: Quality Quality Products Pharmacists secure the quality of medicines (regulation, integrity of supply chain and alert to substandard/spurious/falsely- labelled/falsified/counterfeit medical products) Demonstrating quality by meeting standards -> certification Quality as an ethical and legal obligation of pharmacists

14 Terms: Certification Certification = Demonstrating accountability and meeting standards The Quality Care Pharmacy Program (QCPP) - quality assurance program developed by the Pharmacy Guild of Australia, for high level of service, staff empowerment and higher levels of productivity, to an improvement in business management as a result of properlydocumented processes, and to higher levels of customer satisfaction in the quality of the services that the pharmacy delivers. In order to assist community pharmacists to develop a Quality Manual in their pharmacies as required by the Belgian regulation, the Association Pharmaceutique Belge has developed an online tools called MyQualityAssistant ( Pharmacy can also have access to a benchmarking module where they can compare their status of implementing the Quality Manual with other community pharmacies at national level.

15 Terms: Professional Consensus Professional Consensus = an acceptable resolution that can be supported by the profession as a whole brought about through deliberation and examination of available values, attititudes, scientific evidence and professional commitments Consensus by definition requires compromise Consensus development requires an over-arching commitment to create an outcome that is ultimately best for the patient

16 Terms: Professional Consensus Basel Statement Global Conference on the Future of Hospital Pharmacy as part of the 68th Annual Congress of the International Pharmaceutical Federation (FIP) 348 hospital pharmacists representing 98 nations met in Basel, Switzerland to develop 75 consensus statements reflecting the profession's preferred vision of practice in the hospital setting ( "We believe that this historic consensus meeting will motivate all pharmacists, especially those in hospitals, to reconsider their practice and commit to improvements that will positively affect patient outcomes."

17 Terms: Professional Consensus World Health Professions Alliance Statement on Interprofessional Collaborative Practice was developed by consensus on effects of effective interprofessional collaborative practice: Improved access to health interventions and improved coordination between different sectors; A comprehensive, coordinated and safe health system that is responsive to the needs of the population; Efficient use of resources; Reduced incidence and prevalence of disability; Increased job satisfaction, with reduced stress and burnout of health professionals. WHPA works to improve global health and the quality of health services and facilitates collaboration among the health professions and other major stakeholders.

18 Terms: Professional Consensus

19 Terms: Reasonable Man Theory in Law Concept used in USA - refers to a test whereby a hypothetical person is used as a legal standard, especially to determine if someone acted with negligence. Reasonable man [woman] exercises care, skill, and judgment in conduct that society requires of its members for the protection of their own and of others' interests. Comparative standard for determining liability. Continuously asking in a comparable situation what would a reasonable person do? In patient care, this is a critical issue for pharmacists vis a vis a duty to warn and being your brother s/sister s keeper

20 Good Pharmacy Practice: Joint FIP/WHO Guidelines on GPP Standards for Quality of Pharmacy Services, 2012 Good pharmacy practice is the practice of pharmacy that responds to the needs of the people who use the pharmacists services; GPP describes key competencies that the pharmacy profession brings to the continuum of health care delivery in each country, in all settings and health care environments.

21 Good Pharmacy Practice: Joint FIP/WHO Guidelines on GPP Standards for Quality of Pharmacy Services, 2012 GPP sets professional standards requirements for pharmacists in all settings towards optimal, evidence-based care to be supported by national framework of quality standards and guidelines. Pharmacist: Put welfare of patients as the first and overall concern; Help patients make the best use of medicines; Supply of products of assured quality, provide appropriate information and advice to the patient, administration of medication, when required, and the monitoring of the effects of medication use; Promote responsible use of medicines; Collaborate with other health-care professionals.

22 Good Pharmacy Practice: Joint FIP/WHO Guidelines on GPP Standards for Quality of Pharmacy Services, 2012 GPP are organised around 4 major roles for pharmacists Role 1: Prepare, obtain, store, secure, distribute, administer, dispense and dispose of medical products Role 2: Provide effective medication therapy management Role 3: Maintain and improve professional performance Role 4: Contribute to improve effectiveness of the health-care system and public health For each role, a list of minimum national standards to be established have been set.

23 FIP Reference Paper on Good Pharmacy Practice in Community and Hospital Settings, First Edition, 2009 Describes key competencies that the pharmacy profession brings to the continuum of health care delivery in each country, in all settings and health care environments served as a basis for development of Good Pharmacy Practice: Joint FIP/WHO Guidelines on GPP Standards for Quality of Pharmacy Services, 2012

24 FIP Statement of Policy on Good Pharmacy Education Practice, 2000 To be effective health care team members, pharmacists need skills and attitudes enabling them to assume many different functions. The concept of the seven-star pharmacist was introduced by WHO and taken up by FIP in 2000 in its policy statement on Good Pharmacy Education Practice. Leader Caregiver Life-long learner Decision-maker Teacher Communicator Manager

25 FIP Good Pharmacy Practice in Developing Countries, 1997 Step-wise implementation of GPP Adequate pharmaceutical service is a vital component of heath care; Pharmacy environment varies widely from country to country or within a country (e.g. due to the fact that the number of pharmacists is less than desirable is some rural or urban areas); Applicable to different levels of practice - identifying the step = level of current practice and continually improve quality of pharmaceutical service based on the local need; Efforts to educate the public, policy makers and all health-care professionals about the services that can be offered by pharmacists and the benefits that can accrue from full use of their expertise and knowledge this increased awareness should also serve to raise public expectations and driving force for optimal standards of practice.

26 Changing the practice Population (unmet) needs Possible contributions of pharmacists Assessment of the legal framework Assessing need for Changing of the legal framework Assessment of workforce and education Assessing need for changing workforce / education Other components Change in infrastructure (Academic workforce ) Change in process (quality assurance)

27 FIP - leader of pharmacy at a global level FIP works to support the development of the pharmacy profession, through practice and emerging scientific innovations, in order to meet the world s health care needs and expectations. It is the policy of FIP and WHO to provide guidance to national pharmacy professional organizations regarding the development of their standards. The conditions of practice vary widely from country to country and each national pharmacy professional organisation is best able to decide what can be achieved and within what time-scale. There is a well-established rationale and imperative for changing pharmacy practice and education to meet national needs for responsible use of medicines

28 Engage with FIP 3 levels of membership Organisational Membership Individual membership Academic Institutional Membership Become a part of this worldwide network and benefit from all it has to offer! More info at:

29 FIP membership: 132 Member Organisations and 19 Observer organisations Including Philippine Pharmaceutical Association individuals gathered in 8 (practice) sections and 8 (sciences) special interest groups 29

30 Engage with FIP Join network 138 schools of pharmacy from 51 countries

31 Engage with FIP

32 Recommendations National pharmacy professional associations need to work together with their governing bodies and other health-care professional associations to support pharmacists in their countries through establishing national standards for scope and quality of pharmacy services and practice objectives Health-care system and public health demands a continuous maintenance of the competence of pharmacists as healthcare professionals who have up-to-date skills and expertise. Pharmacists are accepting greater responsibility for the outcomes of medicines use and are evolving their practices to provide patients with enhanced medicines-use services. This needs to be supported by provision of continuing professional development activities, including distancelearning programmes.

33 Thank you for your attention Questions? Comments?