Satyajeet College Of Pharmacy, Mehkar.
To address the changes in health care and the needs of society related to medicines, we must redefine the profession of pharmacy. We have defined the next generation pharmacists (NGP) as “a health care provider and change agent on the inter professional health care team, personalizing medication use, managing safe and effective medication systems, and creating healthier communities.” Schools and colleges of pharmacy should thoroughly examine their curriculum to ensure it is preparing pharmacists for this future. By creating a vision for the NGP and implementing the best curriculum, we ensure that pharmacists of the future will be up to the challenge of our society’s health care needs. This is not the best era for traditionalists in pharmacy. So much of what I learned in pharmacy school no longer is relevant, or it has been supplanted with new technologies and health care approaches. The science of medicine, delivery of health care, extent of corporatization, and health care financing are far different from what we envisioned years ago. Add to that the greater availability of health care data in electronic medical records and information for the health consumer. However, these changes by no means lessen the need for pharmacists. In fact, given all the problems that people have with medicines, there is greater need than ever for pharmacists’ skills and knowledge.1,2 No one can say that problems related to preventable adverse drug events, medication errors, drug misuse and addiction, poor adherence, high medication expense, and counterfeit or adulterated medications have gone away. To address these problems and the reality of what has changed in health care will require that we redefine our profession. As a health care provider, it is necessary to be a change agent. The NGP change agent is a trusted leader with clear vision and goals who is a critical thinker and an excellent communicator. As a change agent the pharmacist must be able to recognize medication- related problems and also identify opportunities to solve them. A change agent knows how to effectively work with people to marshal collective wisdom and achieve common goals. This has been called “leading change” and refers to a book of the same name that provides a useful framework for achieving organizational change.4 The 8-step Kotter approach to change begins with the need to develop a sense of urgency. People are usually reluctant to make a change if they do not understand the reason why it is necessary. In our school, we have spent multiple training sessions on leading change and understanding the change process for the purpose of revising our curriculum.
Pharmaceutical Quality
As in most manufacturing processes, the quality of a final pharmaceutical product is determined by the starting materials, equipment, and technical know how that go into producing and packaging it. Unlike a steel bolt or a tailored suit, however, a medicine is a dynamic product whose color, consistency, weight, and even chemical identity change between manufacture and ultimate consumption. A medicine that passes all laboratory tests upon receipt may be useless within a few months if the packaging, storage, and transportation conditions are not maintained properly. The purpose of quality assurance in pharmaceutical supply systems is to help ensure that each medicine reaching a patient is safe, effective, and of appropriate quality. The quality of pharmaceutical products is ensured by the technical and managerial activities of the quality system, which includes evaluating pharmaceutical product documentation, performing or reviewing quality-control laboratory tests, and monitoring product performance. Managerial activities include selecting reliable suppliers, preparing contract terms, monitoring supplier performance, and per forming inspection procedures throughout the distribution network.
Pharmaceutical quality assurance framework
The following five elements are critical to achieving the expected treatment outcome. Using a pharmaceutical product to treat a patient presumes that the—
The first two items are product-specific issues, which are the most easily addressed technically, whereas items three and four are practitioner-specific and depend on the practitioners’ education, knowledge, and skill as well as the rigorous enforcement of performance standards. Item five is a patient-specific issue that depends on the patient’s knowledge and commitment and the patient’s access to services. The safety and effectiveness of an API may be established either through a review of historical usage, such as in the case of digoxin’s evolution from the foxglove plant (digi-talis purpurea), or through complex procedures established for new chemical entities, such as those described by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). After the safety and effectiveness of an API has been approved for marketing in an ICH market region, other regions of the world follow with little or no additional assessment. The ICH economic zones (European Union, Japan, United States) perform almost 100 percent of the pharmaceutical research and consume over 85 percent (by value) of the pharmaceutical products in the world. These regions allocate large amounts of resources to ensure the safety and effectiveness of APIs granted market authoriza- tion in their zones. Once the safety and efficacy have been established through these procedures, other regions do not have to expend the same level of resources to establish these attributes. However, other product-quality issues, including bioavailability and bioequivalence, content uniformity, impurities and degradation, and medicine safety (pharma covigilance), should be monitored on ongoing basis in all market zones. The complexity of globalized pharmaceutical markets and the difficulty in ensuring quality of imported products, including API, have been illustrated in headlines about deaths caused by adulterated products such as cough syrup in Peru and heparin in the United States—both tied to ingredients from China. As a result, the U.S. Food and Drug. Administration (FDA) seeks to increase its global presence to make monitoring foreign manufacturers easier and to strengthen its involvement with harmonization of pharma- ceutical standards (FDA 2010). In addition, the FDA wants to help build regulatory capacity in foreign counterparts. As part of that international effort, the agency has opened per- manent offices in a number of cities around the world and has entered into dozens of agreements with other drug regu- latory authorities (DRAs) to share inspection reports and other private information that can help improve the quality of pharmaceutical products worldwide. The pharmaceutical regulatory and quality assurance pro- cesses that should be addressed by a country’s DRA include(WHO 2004b)—
Defining and assessing pharmaceutical quality
Pharmaceutical quality can be defined and tested in many ways. Quality standards are published periodically in pharmacopoeias and in some government publications, which provide detailed descriptions of pharmaceutical characteristics and analytical techniques. Standards may vary slightly from one pharmacopoeia to another, so a particular pharmaceutical may meet the standards of one pharmacopoeia and not those of another. When public standards have not been established, as is generally the case for newly marketed pharmaceuticals, analytical methods developed by the manufacturer and submitted as a part of the tender or marketing authorization requirements are usually applied. The major pharmaceutical manufacturing and exporting countries publish their own pharmacopoeias, and on a regional basis, the European Pharmacopoeia establishes standards that are enforced by the governments of the European Union and others that adopt them. The International Pharmacopoeia, published by the World Health Organization (WHO), the U.S. Pharmacopeia, and the British Pharmacopoeia are used frequently by public-sector pharmaceutical supply programs in developing countries. One important limitation of the European Pharmacopoeia is that it provides few specifications for individual dosage forms. The WHO International Pharmacopoeia (WHO 2008a) includes monographs on finished dosage forms, including antiretrovirals and newly developed antimalarial medicines. Analytical procedures in the U.S. Pharmacopeia tend to use complex and expensive technology, which may be beyond the reach of many developing countries. The European, Japanese, and U.S. pharmacopoeias are engaged in ongoing efforts to harmonize some of their standards, but progress is slow. Until common standards are finally achieved, purchasers must specify which dosage form standards are acceptable. For pharmaceutical procurement organizations, pharmaceutical quality is assessed as the product’s compliance with specifications concerning identity, purity, strength, potency, and other characteristics. Uniformity of the dosage form, bioavailability, and stability are important characteristics that are also considered in the specifications. Identity. The identity test should confirm the existence of the active ingredient(s) indicated on the label. This characteristic is generally the easiest to check. Purity. In addition to the API, most pharmaceuticals are made with ingredients added for bulk, consistency, or color that should not contain potentially harmful contaminants or microorganisms. The product should not have significantquantities of other products from cross-contamination.
A Global Need to Build Capacity and Assure Quality
Globally, pharmacy practice and education are undergoing unprecedented change as the role of the pharmacist as a provider of healthcare services is increasingly recognized, valued, and expanded. Many countries are, however, faced with critical shortages of pharmacy workforce (pharmacists and pharmacy technicians) and other healthcare professionals and workers. The World Health Organization has concluded that in many countries healthcare targets cannot be realized until capacity is built in the healthcare system. A primary focus in this regard is the development of an adequate and appropriate healthcare workforce, along with the academic and institutional infrastructure to deliver the required competency-based education and training. Many countries are introducing, expanding, or undertaking major reform of pharmacy education. Such developments must be accompanied by robust systems to assure the quality of the educational structures, processes and outcomes; the latter primarily being graduates who are competent and capable of performing safely and e!ectively in their practice setting and contributing to the delivery of healthcare.
The International Forum for Quality Assurance of Pharmacy Education
To promote and facilitate international dialogue and collaboration in the area of quality assurance1 of pharmacy education, the International Forum for Quality Assurance of Pharmacy Education (the “Forum”) was established in 2001. It operates under the auspices of the Academic Section of the International Pharmaceutical Federation (FIP), primarily as an informal network of individuals interested in the quality assurance and quality advancement of pharmacy education. The objectives of the Forum are: While developments in practice and education are reducing this diversity, current di!erences - on a global scale - are still considered to be fairly signi$cant. In many countries, quality assurance systems for pharmacy education are well-developed; in other countries, they are still emerging. Members of the Forum generally advocate that countries should have their own national system of quality assurance and standards for pharmacy education that re"ect contemporary and emerging pharmacy practice (within the overall system of healthcare delivery) and education, and meet the speci$c needs of the country. However, it is also believed that the principles and core elements for quality assurance of pharmacy education do not di!er signi$cantly - if at all - from country to country. Members of the Forum felt that countries seeking to establish or improve their system of quality assurance would bene$t from an internationally developed and adopted framework for quality assurance of pharmacy education and, furthermore, that the development of such a framework was an appropriate project for the Forum
Core Principles and Elements of Quality Assurance
Accordingly, it was decided to undertake a project to develop a global framework for quality assurance of pharmacy education (hereinafter referred to as the “framework”) that would incorporate core principles and elements considered essential for an elective approach to quality assurance. The first phase of the project, presented herewith, has addressed “professional” (pre-service or entryto-practice) education for pharmacists. It is recognized that the education of pharmacists around the world takes place in different academic settings but in this document it is largely assumed that such education would involve a degree program at a post-secondary (higher education) level. The principles of quality assurance outlined in the framework should, however, apply to all levels of formal education. It is proposed that a future exercise will address quality assurance for continuing education and continuing professional development for pharmacists. Recognizing the diversity referred to earlier, the development of a set of global standards for pharmacy education was not considered at this time, as has been done for medical education. The desirability and feasibility of such an undertaking may, however, be re-considered in the future. The authors of this document have tried to avoid being prescriptive, as the framework is intended more as a foundation that can be adapted and built upon to suit national needs, systems, and conditions. The framework focuses more on the elements that need to be included, and how these elements are applied in principle, rather than being specific or detailed. The framework does not advocate for any one overall model or system of quality assurance but, in some cases, comments on different approaches that exist and reports on emerging trends.
Collaborative Development of the Framework
To maximize the value and global applicability of the framework, input has been sought and received from as many countries as possible. The document, therefore, has drawn from the experience and perspectives of many countries with di!erent systems of quality assurance. In developing the framework, every e!ort has been made to focus on common elements, and to avoid bias and the use of terminology, principles, and speci$cs that may not be universally applicable. However, in order to improve the readability of the document and to avoid the repeated inclusion of multiple terms to cater for all possible systems, certain terminology has been adopted. Such terminology should be interpreted broadly and, as deemed necessary, the context of its use is described in the glossary or in foot notes. Readers are requested to apply the principle behind the term even if di!erent terminology or systems apply in their own situation. Translation of the framework into multiple languages is also planned.
Defining the pharmacist’s role and contribution in health care
The pharmacy profession has a long and proud tradition, and pharmacists – playing many different roles - are valued, trusted, and respected members of their communities. The role and contribution of pharmacists in the overall context of health care delivery is, however, changing dramatically on a global level. The changes can be summarised as pharmacists’ focus on assuming a greater responsibility for the safe, effective and responsible use of medications by patients and populations, with the main goal of optimising therapeutic outcomes. Additionally, pharmacists are assuming key roles in health promotion, disease prevention and the management of systems and resources associated with health care delivery. These developments, such as medication therapy management, evidence-based pharmacy, collaborative practice, independent prescribing, and rational and responsible use of medicines, require clinical and communication skills, decision-making and critical thinking, leadership, innovation and research abilities. They have been well described in FIP documents, such as the Global Competency Framework (2012) [4], Pharmacy Vision for 2020 (2011) [5], Good Pharmacy Practice Standards for Quality of Pharmacy Services (1993, 1997, 2011) [6] and Statement of Professional Standards on Pharmaceutical Care (1998) [7]. On a global basis, countries are at many different stages in this transition, and even within countries there may be differences in the degree to which change has been effected. Cultural, historical, and political factors also impact the rate of these changes. Changes in the education of pharmacists and regulation of pharmacy practice have paralleled these developments. As medication therapy has become more complex, more accessible, and used in more diverse patient populations (including a greater proportion of elderly patients), patient safety issues and accountability for outcomes of therapy have become a greater focus of attention. Consumers and governments alike are demanding higher standards and seeking assurances of service quality and patient safety. As nations seek to improve standards for health care delivery, greater attention is being paid to the quantity and quality of health care practitioners, including the systems in place to assure the quality of education a
Developing a national, profession-wide vision for pharmacy practice and education
Recognising the many benefits that can accrue to society through the optimal use of pharmacists in health care delivery, many countries are undergoing (or planning to undergo) major transformation of pharmacy education. They are examining the roles and responsibilities that pharmacists can and should have in the delivery of health care services, and articulating the competencies that are required to effectively perform these roles and responsibilities. They are considering what levels, models, and duration of education and training are needed to ensure that pharmacists achieve these competencies before entering practice, and, importantly, maintain and enhance them throughout their professional careers. Educators and policy makers are considering education from a standpoint of “fitness for purpose” for current needs and priorities in the health care system as well as for the desired and anticipated expanded roles and responsibilities in the future. In most cases, one country’s model of education cannot be adopted by another country without appropriate adaptation to suit local needs and circumstances. Among other things, educational outcomes, competencies to be achieved, curricular content and structure will need to be modified. It is essential that such strategic discussions do not take place in isolation. All stakeholders who have an interest and role to play should be involved so that a profession-wide consensus and vision can be successfully articulated, pursued, and achieved. Moreover, the discussions should be conducted in the context of national needs and priorities, and should take into account all required resources and the implications of the proposed changes. A clear, appropriate, realistic and achievable national vision for pharmacy education and practice should be developed through a collaborative effort. This vision and process should be integral to the development of a National Drug Policy. Any professional arena involves a complex and dynamic interplay between practice, regulation, and education. As the regulatory sector exists to serve and protect patients and the public interest, societal needs and expectations are accounted for by “regulation” in this representation. At different times, it is likely that developments, innovations, or initiatives in one area will lead or drive change in others as depicted in Figure 2. For example, at times new regulation may be required to bring about needed changes in practice, while at other times beneficial innovations in practice may force changes to be made in regulation. Traditionally, education has been a strong driver of change in practice, but sometimes it may lag behind and be disconnected from the needs and realities of practice. Quality assurance systems that proactively engage with practice, education and regulation can also be drivers for quality advancement in education. At the same time, however, it is important to ensure that at no stage do any of the “gaps” depicted above get too wide, thereby creating a disconnect, which may lead to tensions, dissatisfaction or frustration. If, for example, pharmacy educators have a vision for pharmacy practice and education and implement a model that is not supported by practitioners and/or regulators, graduates may become disillusioned if the practice or regulatory environment does not allow them to practice in the manner conveyed by the academic programme.
Involving stakeholders in assuring and advancing the quality of pharmacy education
Just as all stakeholders should be involved in the development and adoption of a profession- wide vision for pharmacy practice and education, so too should a broad spectrum of stakeholders be involved in the quality assurance of pharmacy education. This key responsibility should not be the exclusive domain of any one sector. Importantly, professional organizations need to take pride and ownership in the education of future practitioners and assume some of the responsibility for assuring quality outcomes. Within all quality assurance systems, strategies should be in place to ensure that opportunity exists for all key stakeholders to have input and, furthermore, that such input is meaningfully considered. The major stakeholders are identified in Figure 3. From a political and regulatory standpoint, the government and, where applicable, other specific authorities responsible for the practice of pharmacy have the duty to protect the interests and wellbeing of the public. This requires them to assure that pharmacists receive appropriate education and training and are competent to deliver the range of services permitted in their defined scope of practice. Completion of an approved programme of study is a standard pre-requisite for licensure or registration as a pharmacist. Invariably, as substantial (or sole) contributors to the financing of higher education, governments have another reason to desire quality outcomes from their “investment” in education for national development. In most countries, for these and other reasons, governments – either directly or indirectly through a statutory body – have traditionally taken on the responsibility for quality assurance of pharmacy education. Indications are that government-based systems remain the most pervasive, though the system may be exercised through reliance on private professional entities. There is, however, a growing trend towards non-governmental systems that are more closely aligned with the pharmacy profession. The institutions that offer pharmacy education – universities, schools, or colleges (hereinafter generically referred to as “institutions” or “schools”) should play a key role in assuring the quality of education. Both students’ and academic staff members’ assessments, evaluation and improvement of the curriculum, implementing innovations, involving preceptors in the academic programme, development of students’ competency lists, and implementing contemporary teaching methodologies are some of the essential components of the quality assurance process. Students’ feedback can also influence quality, but cannot provide the full scope of required perspectives. The interests of members of the academic staff, other staff, and administrators in these schools, as well as other affiliated organizations and individuals should also be protected and advanced through an effective quality assurance system. This is particularly important when greater attention may be given to the interests of other programmes at an institution that are subject to external quality assurance or accreditation processes. Schools benefit from a standardised, external evaluation of their programme and an objective, frank assessment of the adequacy of resources for each aspect of the educational mission, which lead to quality improvements. The profession as a whole, as it seeks to advance and better serve society and its members, relies heavily on the quality assurance system to maintain the integrity of the educational process and ensure the competence, professionalism, and leadership of future practitioners. For this reason, in many countries, professional bodies – either directly or through input to accreditation agencies – are now taking a more active role in the quality assurance of pharmacy education. Ultimately, however, it is the general public and patients – as the final users of the wide ranging services provided directly and indirectly by pharmacists – that benefit most from the system that assures the quality of education and training provided to pharmacists. Increasingly, it is becoming policy and practice that lay members of the public (e.g., patients’ representatives) are involved in some way in the quality assurance of education and regulation of the practice of health care professionals.
Development of a national, profession-wide vision for pharmacy practice and education
Recognizing the many benefits that can accrue to society through the expanded use of pharmacists in healthcare delivery, many countries are undergoing (or planning to undergo) a major reform of pharmacy education. They are examining the roles and responsibilities that pharmacists can and should have in the delivery of healthcare services, and articulating the competencies that are required to electively carry out these roles and responsibilities. They are considering what level, model, and duration of education and training is needed to ensure that pharmacists achieve these competencies before entering practice and maintain and enhance them thereafter. Educators and policy makers are considering education from a standpoint of “fitness for purpose” for current needs and priorities in the healthcare system as well as desired expanded roles and responsibilities for the future. In most cases, one country’s model of education cannot be adopted by another country without appropriate adaptation to suit local needs and circumstances; among other things, educational outcomes and competencies to be achieved and curricular content and structure will need to be modified. Any professional arena involves a complex and dynamic interplay between practice, regulation, and education. At different times, it is likely that developments or initiatives in one area will lead or drive change in others as depicted in Figure 1. For example, at times new regulation may be required to bring about needed changes in practice, while at other times beneficial innovations in practice may force changes to be made in regulation. Traditionally, education has been a strong driver of change in practice, but sometimes it may lag behind the needs of practice. Quality assurance systems that proactively engage with practice, education and regulation can also be drivers for quality advancement in education. At the same time, however, it is important to ensure that at no stage do any of the “gaps” depicted above get too wide, thereby creating a disconnect, which may lead to tensions, dissatisfaction or frustration. If, for example, pharmacy educators have a vision for pharmacy practice and education and implement a model that is not supported by practitioners and/or regulators, graduates may become disillusioned if the practice or regulatory environment does not allow them to practice in the way they have learned.
The Philosophy and Purpose of Quality Assurance in Pharmacy Education
Considering different models for quality assurance
Governments have traditionally been responsible for the quality assurance of education for health care professionals through a department or ministry (such as health or education) or a more focused agency of government established specifically for the purpose. Other models exist where quality assurance falls under the responsibility of a national pharmacy organisation or institutions self-regulate. In some countries, such as, Australia, Canada, and the United States of America, more independent and autonomous agencies have been established, either in terms of a government mandate or in some other way overseen by and/or accountable to government. Such agencies maintain a large degree of independence and autonomy in decision-making and operations. The latter model represents a growing trend, and would include agencies who classify their quality assurance system as one of accreditation. Some countries collaborate on a regional basis to quality assure pharmacy education using a common set of standards, policies and procedures. However the system is structured, the possibilities for “conflict of interest” should be removed or appropriately managed. In some countries, for professional degree programmes such as pharmacy offered at institutions of higher education, quality assurance can occur at two levels – the institutional/ university level and the specific programme level. In the former, the agency evaluates all aspects of the institution, including all programmes or degrees offered. In the latter, the respective quality assurance body or agency (hereinafter referred to as the “agency”) only evaluates the professional degree programme and directly related aspects of the institution or school. This Framework is presented from the perspective of programme level quality assurance. While it is acknowledged that many different systems for quality assurance exist around the world - likely each with its advantages and disadvantages - the general merits of one system over another are not discussed in this Framework. This is primarily because the principles and core elements of quality assurance that the Framework articulates can apply to any system of quality assurance.
Embracing the concepts and elements of quality assurance
Quality assurance might often be perceived simply as a system of external review by an entity not directly involved in the programme being evaluated; however, a comprehensive quality assurance system should incorporate many more elements and promote a specific culture within the institution whose programme is being evaluated. One of the key foundations of any quality assurance system is (collectively) the indicators, standards or criteria by which quality is defined. All quality assurance systems should be based on well- articulated standards that clearly state their purpose and expectation. Such standards should be:
National standards should ensure that core educational and other programmatic outcomes and impact (as defined by the profession) are achieved while still allowing for innovation and mission-related differences to exist between schools and programmes. The objective of a quality assurance system for professional education is not to assure that all institutions or schools are identical or that they do things in exactly the same way; rather it is to assure that specific outcomes and impact on the profession are achieved and that core quality elements are established and maintained. Quality can be articulated in five main domains - Context, Structure, Process, Outcomes and Impact, expanded on in more detail in Section B. Also central to the quality assurance system and agency are rigorous and stringently applied policies and procedures that assure consistency, impartiality, fairness, and integrity of the evaluation and decision-making process. Such policies and procedures should also be developed through a transparent process (allowing and encouraging stakeholders’ input as appropriate), validated, and made available publicly. External evaluation should ideally incorporate a “peer review” process, involving individuals with qualifications, expertise, and experience commensurate with those being evaluated, as well as evaluators who bring other necessary perspectives and experience, such as pharmacy practice and regulation. If those participating in the evaluation are respected colleagues, the system is more likely to achieve credibility and a greater level of acceptance. Quality assurance should involve initial evaluation, with periodic but regularly scheduled follow up evaluations. This is to ensure ongoing compliance with existing or revised standards or criteria, especially in view of the dynamic nature of professional education and other environmental changes. Typically, approval or a statement of compliance with standards is given for a defined or maximum period of time (a quality assurance “cycle” or “term”). If deficiencies or problems are identified, the standard (or maximum) term may be shortened. Furthermore, certain restrictive conditions may be imposed. Interim monitoring or reporting may be required, and timeframes may be set for remediation of deficiencies. Some quality assurance systems have annual audits, monitoring or reporting requirements. These make use of standardized data, indicators or benchmarks that can serve as early warning signals or highlight potential quality-related problem areas. Increasingly, quality assurance systems are incorporating a greater element of self-assessment, whereby institutions undertake a comprehensive, broad-based exercise in introspection to make their own assessment of compliance with the established standards or criteria. In this way, the institution is encouraged to identify areas in which it needs to improve and to develop and implement plans and strategies to rectify any deficiencies. This approach is also intended to promote a culture of assessment and continuous quality improvement (CQI) within the institution, such that - to a large extent - the institution assumes responsibility for its own, ongoing quality assurance and quality improvement. Ideally, the external quality assurance agency should be regarded as a partner, facilitator, consultant and collaborator in the process, rather than a “policeman” trying to catch an institution doing something wrong. Finally, the policies and procedures of the quality assurance agency should also provide for an appeals process - through which the decisions or actions of the agency can be questioned or challenged if the institution feels aggrieved in any way - and ensure that the institution’s right to “due process” is protected.
Quality Criteria and Quality Indicators for Pharmacy Education
The Quality Criteria for Pharmacy Education describe the principles and core elements for quality assurance. They address to the outcomes, structure and process of pharmacy education. Developed through open international consultations since 2001 by the International Pharmaceutical Federation (FIP) Forum for Quality Assurance of Pharmacy Education, the Criteria are part of a broader framework that provides guidance for the development of quality assurance systems. The Criteria serve as a tool to facilitate the establishment of quality assurance and standards in countries where no such formal systems exist or in the continuous quality improvement of existing systems.
Educational outcomes and competencies
Quality assurance standards for professional programs in pharmacy should be competency- based. The competencies that must be achieved by graduates through the professional degree program curriculum should be clearly stated by the school. Such competencies should include pharmacy specific competencies as well as general competencies that apply to all healthcare professionals, such as ethical, caring and evidence-based practice, cultural competence, application of quality improvement principles, use of information technologies, and working in interdisciplinary and inter professional teams. In broad terms, the competencies that need to be achieved by pharmacists fall into three main areas: provision of patient-care services at the individual and population levels; management of systems and resources; and promotion of public health. The competencies should be identified through profession-wide consensus, thereby redirecting the national vision for pharmacy practice and education, and should be appropriate to current and future national healthcare needs with regard to services provided by pharmacists. Practitioners (from all practice settings), regulators, educators, and consumers of pharmacy services should all contribute to the identification of professional competencies. The competencies should be used to guide the development of student learning outcome expectations for the curriculum. To anticipate future professional competencies and recognizing that no professional degree program can teach pharmacists everything that they will need to know and do throughout their professional careers, educational outcomes statements should incorporate the development of the skills and attitudes necessary to become self-directed, lifelong learners.
Evaluation of achievement of mission-related outcomes
Student learning and curricular effectiveness
As a component of its overall evaluation plan (see Paragraph 3.3), the school should develop and undertake assessment activities to collect data regarding the attainment of desired student learning outcomes. The assessment activities should employ a variety of valid and reliable measures systematically and sequentially throughout the professional degree program. The school should use the results obtained from analysis and interpretation of assessment data to improve student learning and the achievement of the professional competencies. The school should systematically evaluate and validate its curricular structure, content, organization, teaching and learning methodologies, and outcomes. The school should use the results of such evaluation and data from assessment of student learning for continuous improvement of the curriculum and its delivery.
Structure
Mission, goals and values of the school
The school of pharmacy should have a statement that expresses its mission, goals, and values in the areas of teaching, research and scholarly activity, service to the community,2 contribution to pharmacy practice, and advancement of the profession. The mission and goals should redirect and align with the national (profession-wide) vision for pharmacy practice and education to ensure that graduates are appropriately educated and trained to deliver pharmacy services that meet current and future societal needs and expectations. The mission and goals should redirect a commitment to continuous quality improvement and should be specific, measurable and realistic so that progress toward their achievement can be evaluated. The school of pharmacy (and the university in which it is located, if applicable) may have some unique aspects to its mission and objectives, but these should not otherwise compromise the achievement of required programmatic outcomes and compliance with quality criteria (standards). Progress towards achievement of the mission and goals should be measured and evaluated on a regular basis, and follow-up action initiated as required. The school should strive to provide an environment and culture that promotes professional and ethical behaviour, and harmonious relationships among administrators, faculty, preceptors and students. Faculty, administrators, and preceptors should be committed to developing professionalism and fostering leadership in students and to serving as mentors and positive role models for students. The school should support the participation of administrators, faculty preceptors, and students in local and national pharmacy, and other professional organizations, as appropriate. The school should implement strategies and programs to broaden the professional horizons of students in areas such as c inquiry, scholarly concern for the profession, the relevance, methodology and value of research, and postgraduate education and training.
Organization, administration, leadership, and communication
The Director of the school or professional degree program
Working with other university administrators, the Director of the school or program (such as the Dean or equivalent) should provide leadership to the school of pharmacy and assume primary responsibility for ensuring the quality of the professional degree program. The Director should have appropriate qualifications and experience to provide leadership in all mission-related areas, ensure communication with all stakeholders, secure adequate resources, and be able to unite and inspire administrators, faculty, , preceptors, and students toward achievement of the mission and goals. The leadership s of the Director should be evaluated on a regular basis using a broad-based approach. Services provided directly or indirectly by the institution, usually aimed at promoting health improvements within the community, or other related community engagement and outreach projects Organizational structure The school should be organized and to facilitate the accomplishment of its mission and goals. Within university policies, members of the school administration should have lines of authority and responsibility, foster organizational unit development and collegiality, and appropriately allocate resources. The efficiency and electiveness of the organizational structure should be evaluated to ensure that it properly supports the achievement of the mission and goals. If the school organizes its faculty into sub-units, such as departments or divisions, sub-unit goals and objectives should be established that align with the mission and goals of the school. The electiveness of each organizational unit should be evaluated on the basis of its goals and objectives and its contribution to the professional program and overall mission. The periodic review of the administrative leaders of the school should include input from other administrators, faculty, students, and preceptors.
Committees Faculty committees and faculty meetings
should be part of the system of governance of the school. Faculty committees should be established to address key components of the mission and goals. Examples could include curriculum committee, assessment committee, strategic planning committee, research committee, and admissions committee. Where appropriate, committees should include sta!, students, alumni,3 preceptors, and pharmacy practitioners.
Collaborative Relationships
Within the University Where the school is part of a university (or other academic structure), it is essential that cordial and collaborative working relationships exist between the school and university administration, and between the school and other schools, colleges or departments of the university. This is primarily to ensure that the school advances its mission and goals and receives adequate $nancial, physical (teaching and research), faculty, sta!, student, practice site, preceptor, library, technology, and administrative resources and services. Within the policies and procedures of the university, the school should have a large measure of autonomy regarding its own policies, procedures and operations. Areas in which the school should have a large measure of autonomy include: programmatic evaluation; development and delivery of the curriculum; development of school policies and procedures; student enrollment; student admission and progression; and faculty and sta! recruitment, retention, development, and evaluation.
Other Collaborative Relationships
The school - with the full support of the university, if applicable - should develop collaborative relationships and partnerships with stakeholders outside the university to support and advance its mission and goals. Examples of areas for collaboration could include: academic; research and other scholarly activities; pharmacy practice; and community service. Stakeholders include employers, regulatory agencies, professional bodies, scientific societies, research institutions, community and patient groups and other institutions. There should be active relationships between the school and the health and science related sectors of society and government.
The Curriculum
The curriculum for the professional degree program should support the preparation of graduates with the competencies needed to enter pharmacy practice in any setting (as described in 1.1) and contribute to the profession of pharmacy throughout their career. The curriculum should provide a thorough foundation (knowledge base) in the biomedical, pharmaceutical, social, behavioral, 3 Graduates of the program or school administrative, and clinical sciences, and a range of pharmacy practice experiences4 that integrate, apply, reinforce, and advance the knowledge, skills, attitudes, behaviors and values developed through the other components of the curriculum. The curriculum should develop in graduates the ability to integrate and apply learning to the present and future practice of pharmacy. Graduates should be prepared (educated/trained) to be agents of change and contribute to the advancement of the profession. The professional degree program should satisfy the educational requirements for licensure (or registration) as a pharmacist, and meet the requirements of the university and applicable education authorities for the degree (or other credential) awarded. The structure and duration of the program, including the number of academic credits awarded and the mix of required and elective courses, should be appropriate to the educational outcomes and competencies to be achieved by graduates. Practice experiences should be undertaken at approved practice sites under the supervision of appropriately experienced and trained preceptors, who serve as practitioner-educators. Criteria for the selection of preceptors and practice sites should be established and implemented. The objectives for each pharmacy practice experience and the responsibilities of the student, preceptor, and practice site should be and mutually agreed. At a level appropriate to the education and experience of the student and in accordance with pharmacy practice regulations, practice experiences should include direct interaction with diverse patient populations in a variety of practice settings and provide opportunities for communication and collaboration with other healthcare professionals
Resources
Faculty, and preceptors
The school should have a sufficient number of qualified full-time faculty and! to electively deliver and evaluate the professional degree program, while providing adequate time for faculty development, research and other scholarly activities, service, and pharmacy practice (for applicable faculty). The full-time faculty and staff may be complemented by part-time and voluntary faculty, staff and preceptors. Adequate support and technical sta! resources should be provided to allow elective and efficient operation of the school. Adequate strength of the faculty and staff should be ensured through capacity planning and recruitment and retention strategies. Members of the faculty and staff, individually and collectively, should be committed to the school’s mission and goals, and respect their colleagues and students. Members of the faculty should possess the required professional and academic expertise, have contemporary knowledge and abilities in current educational philosophy and techniques, and be committed to the advancement of the profession and the pursuit of research and other scholarly activities. The school should foster and support the professional development of its faculty, preceptors commensurate with their responsibilities in the program. The school should ensure that policies and procedures for faculty recruitment and retention, promotion and tenure5 (if applicable) are established and applied in a consistent manner. The school should ensure that the faculty composition, including any contributions from other relationships (internal and external to the school or institution) encompasses the relevant disciplines within the biomedical, pharmaceutical, social/behavioral/administrative, and clinical 4 Practice experiences (also referred to as practice-based learning or experiential education) in the healthcare professions have been shown to promote competence by teaching students how to integrate and apply knowledge in practice settings, learn from role models and experience interdisciplinary and interprofessional team approaches to the provision of healthcare services. As a result of such experiences, students have demonstrated an increase in empathy towards people with illnesses, have greater and professional identity, and have learned electively from the knowledge, attitudes, values, behaviours, and judgments of experienced practitioners. The school should foster an environment that encourages contributions by the faculty to the development and transmission of knowledge and should contribute to the advancement of knowledge and to the intellectual growth of students through scholarship. Faculty should be encouraged and supported to be actively involved in the governance of the school and associated academic institutions (e.g., through involvement on committees), in professional and scienti$c societies, and in community service. The school should identify preceptors who will be positive role models for students; who practice ethically and with compassion for patients; accept personal responsibility for patient’s health outcomes; have professional training, experience, and competence commensurate with their position; have a desire to
educate others; and have an aptitude to facilitate learning and evaluate the achievement of required competencies.
Financial Resources
With the support of the university, the school should develop and maintain a broad base of financial support to ensure that it has the financial resources necessary to provide a stable environment in which the school and program can develop and accomplish its mission and goals. Within the policies of the university, the school should have a measure of autonomy in its use and allocation of financial resources, and it should operate with a budget that is planned, developed, and managed in accordance with sound and accepted management practices. Where applicable, the university administrators responsible for the pharmacy program should have a clear understanding of the resource needs of the professional degree program, such as the need to support scholarship and research and the requirements of the library, educational resources and experiential education.
Physical Facilities
The school should have adequate and appropriate physical facilities to achieve its mission and goals. The physical facilities should meet legal standards; be safe, well maintained, and adequately equipped; provide a desirable, comfortable, and safe environment for teaching and learning, and facilitate interaction among administration, faculty, and students. Facilities should include o#ces, lecture rooms, small classrooms, facilities for individual and small group study by students, student activity areas, information and communication technologies (with appropriate data security and recovery systems), and other equipment and instrumentation to support administration, teaching, research and other scholarly activities. Equipment should be up-to-date and well maintained.
Facilities for pharmacy practice experiences
To support pharmacy practice experiences in the curriculum and to collaboratively advance the patient care services of pharmacy practice experience sites, the school should establish and implement criteria for the selection of an adequate number and mix of practice facilities. The respective responsibilities, commitments, and expectations of the school and the practice site regarding the education and evaluation of students should be agreed and, ideally, formalized in a written agreement or contract. Such an agreement should also address student-related matters such as health and safety issues, professional conduct expectations, and liabilities.
Library and learning/educational resources
The school should ensure access for all faculty, preceptors, and students to a library and other learning/educational resources that are sufficient to support the professional degree program and to provide for research and other scholarly activities in accordance with the school’s mission and goals. The school should fully incorporate and use these resources in the teaching and learning processes. In this regard, the school should provide organized programs to teach faculty, preceptors, and students the use of the library and other learning/ educational resources. To foster improvement, student, preceptor, and faculty opinions should be sought and evaluated regarding the adequacy of and access to library and learning/ educational resources.
Process
Planning
The school should develop, implement, and regularly revise a strategic plan to facilitate the advancement and achievement of its mission and goals. The strategic plan should be developed through an inclusive process that seeks input and review from administrators, faculty, staff, preceptors, students, alumni and other stakeholders as needed. The plan should have the support of the university administration, where applicable. The plan should be based on an examination of present and projected environmental, professional, and programmatic factors; it should assess strengths, weaknesses, opportunities, and threats relevant to the school (SWOT analysis); and include a review of the school’s mission statement, goals, and values.
Enrollment management
The number of student enrolled in the program should be managed in alignment with available physical, financial, faculty, staff, practice site, preceptor, student services and other administrative resource.
Evaluation and assessment
The school should establish and implement an evaluation plan or ongoing comprehensive system of evaluation that assesses achievement of the mission, goals and objectives. The evaluation should measure the extent to which the desired outcomes of the professional degree program (including assessments of student learning and evaluation of the effectiveness of the curriculum, which are covered in more detail in Paragraph 1.2.1) are being achieved. Likewise, the extent to which the desired outcomes of research and other
scholarly activities, service, and pharmacy practice programs are being achieved should be measured. Assessment and evaluation activities should involve a broad range of stakeholders – both internal and external to the school – such as faculty, preceptors, students, alumni, regulators, employers, and consumers. Not only should the performance of students in the program be assessed and evaluated but efforts should also be made to evaluate the performance of graduates once in practice, including their professionalism, leadership and electiveness as agents of change in the profession. The school should use the analysis of process and outcome measures for continuous development and improvement of the school and professional degree program.
Academic policies and procedures
The school should produce and make available to students and prospective students criteria, policies, and procedures for admission to and progression in the professional degree program. Admission materials should clearly state the prerequisites for admission to the program (such as prior education, training or experience, knowledge, skills, or attitudes), academic expectations for the program, and professional standards for graduation. The school should have the final responsibility for enrollment and selection of students (quantitatively and qualitatively). Where permitted by university and school policies, the school should produce and make available to students and prospective students transfer credit and course-waiver policies, based on rational procedures and defensible assessments. The school should produce and make available to students and prospective students criteria, policies, and procedures for academic progression, academic probation, remediation, missed course work or credit, dismissal, re-admission, rights to due process, and appeal mechanisms. The school should have a system for monitoring student performance (based on formative assessments of learning outcomes) that provides for the early detection of academic difficulty. The school should provide student services, such as tutorial support, faculty advising and remediation programs for students experiencing academic difficulty. As a component of its evaluation system, the school should regularly assess the criteria, policies, and procedures for admission and progression to ensure the selection of students who have the greatest potential for academic success in the professional degree program, and the ability to achieve the professional competencies and enter practice in a variety of settings.
Student representation and input
The school should consider student perspectives and include student representation, where appropriate, on committees, in policy-development bodies, and in assessment and evaluation activities. The school should have a student representation/governance structure as well as suitable committees (for example, a student/faculty relations committee) to develop student leadership and professionalism, to ensure a forum for student dialogue, and to ensure adequate communication of student opinions and perspectives. Instruments and techniques, such as course evaluations, focus groups, meetings with the program Director or other administrative leaders, and exit interviews should be systematically employed to obtain student perspectives on faculty, curriculum, student services, and other aspects of the professional degree program. The assessment data so obtained should be systematically analyzed, interpreted, and used to improve all aspects of the program. The school should share with students the aggregate results and outcomes of their participation in program evaluation and improvement.
Student assessment methodologies
Assessment methodologies and criteria should be defined. These should be documented and evaluated against the educational outcomes they aim to measure. Assessment data can be used for curricular improvement to examine how the assessment methods promote learning and could be further developed to improve the alignment with educational outcomes.
Faculty, staff and preceptor development and evaluation
The school should have or provide support for an elective continuing professional development program for full-time, part-time, and voluntary faculty, preceptors and staff consistent with their responsibilities in the professional degree program. The school should review the performance of faculty, staff and preceptors on a regular basis. Criteria for performance review should be commensurate with responsibilities in the professional degree program. The faculty and staff evaluation process should be annual, involve self-assessment, and include appropriate input from peers, supervisors, and students.
CONCLUSION
Quality assurance of pharmacy education is essential to support the preparation of competent pharmacists and the ongoing development of the pharmacy profession; ultimately it enhances the services provided by pharmacists and pharmaceutical scientists and improves patient safety and medication-related outcomes. Quality assurance must be a primary focus of educational institutions and all key stakeholders. As outlined in its Statement of Policy on Quality Assurance of Pharmacy Education [3], it is the belief of FIP that in order to support the development of an adequate and appropriate pharmacy workforce and the academic and institutional infrastructure to deliver the required competency-based education and training, each country should have its own standards-based system for the quality assurance of pharmacy education.
The Quality Assurance system should:
Against this background, FIP recommends and encourages national governments, regulatory and quality assurance organizations to establish or enhance systems for quality assurance of pharmacy education that are based on standards or criteria of quality, and policies and procedures, which have been developed with broad stakeholder involvement, and provide opportunity for ongoing stakeholder involvement, including the public. This Framework is offered to support and guide such efforts. Through its Education Initiative, FIPEd, specifically the Quality Assurance Domain, as well as open to collaboration, networking and sharing best practices quality assurance of pharmacy education.
REFERENCES
Sanket Kakade*, Sachin Chalge, Vinod Chaware, Dr. Shivshankar Mhaske, Tejas Sharma, Quality Assurance in Pharmacy Education: Preparing the Next Generation of Pharmacists, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 1, 1006-1025. https://doi.org/10.5281/zenodo.14638485
10.5281/zenodo.14638485
