Federal Technical Vocational Education and Training

(FTVET) Agency
Internal Quality Assurance and Improvement Standards for
Pharmacy Program (Level II- IV)
First Edition
June 2015

Internal Quality Assurance and Improvement Standards for Pharmacy Program

Federal Technical Vocational Education and Training
(FTVET) Agency FTVET
Internal Quality Assurance and Improvement Standards for pharmacy
Program

First Edition

Internal Quality Assurance and Improvement Standards for Pharmacy Program

PREPARED BY
Fikirte Alemayehu, Federal Technical, Vocational Education and Training Agency (FTVET)
Asnake Ayechiluhim, Federal Technical, Vocational Education and Training Agency
(FTVET)
Simiret Mersha, Federal Technical, Vocational Education and Training Agency (FTVET)
Demissie Gonfa, Oromia Technical, Vocational Education and Training (TVET)
Tesfaye Hagos, Tigray Technical, Vocational Education and Training (TVET)
Assegid Samuel, Federal Ministry of Health (FMoH)
Engidasew G/Hana, Amhara Regional Health Bureau
Mulunesh Tesfa, Amhara Regional Health Bureau
Zerihun Ayenew, Oromia Regional Health Bureau
Anteneh Tesfaye, SNNPR Regional Health Bureau
Peter kueth, Gambella Regional Health Bureau
Equlinet Misganaw, Strengthening Human Resources for Health Project, Jhpiego
Yewlsew Assaye, Strengthening Human Resources for Health Project, Jhpiego
Ermias Mergia, Strengthening Human Resources for Health Project, Jhpiego
Mintiwab Gelagay, Strengthening Human Resources for Health Project, Jhpiego
Yohannes Assemu, Strengthening Human Resources for Health Project, Jhpiego
Bekalu Asaminew, Strengthening Human Resources for Health Project, Jhpiego
Abebe Kebede, Strengthening Human Resources for Health Project, Jhpiego
Mekuanent Zemene Ayalew, Teda Health Science College
Shimelis G/Wolde G/Giorgis, Dessie Health Science College
Mulugeta Mihrete Tefera, Bahirdar Health Science College
Mengesha Dirar Berhe, Dr. Tewelde Legesse Health Science College
Amanuel Godebo Godana, Hawasa Health Science College
Biruk Wogayehu Taddele, Arbaminch Health Science College
Tsegaw Shewakena Beshaewored, Debreberhan Health Science College

Internal Quality Assurance and Improvement Standards for pharmacy Program iii
ACKNOWLEDGMENT
This Internal Quality Assurance and Improvement Standard for Pharmacy TVET
Program was developed by FTEVET Agency Regional TVET Offices, Regional Health
Bureau and Regional Health Science Colleges in collaboration with Strengthening
Human Resources for Health Project. This document is made possible by the
generous support of the American people through the United States Agency for
International Development (USAID) under the Cooperative Agreement AID-663-A-12-
00008. The contents are the responsibility of TEVET and Regional Health Bureau and
do not necessarily reflect the views of USAID or the United States Government.

Internal Quality Assurance and Improvement Standards for pharmacy Program iv

ABBREVIATIONS

CPD: Continuing Professional Development

DVD: Digital Video Disk
ESDP: Education Sector Development Program
EOS: Ethiopian Occupational Standard
ETQF: Ethiopian TVET Qualifications Framework
FMOH: Federal Ministry of Health
IDP: Institutional Developmet Plan
ICT: Information Communication Technology
IT: Information Technology
IQA: Internal Quality Assurance
KSA: Knowledge, Skills, and Attitudes
NC: National Certification
RHB: Regional Health Bureau
RPL: Recognition of Prior Learning
SDL: Skills Development Laboratory
SOP: Standard Operating Procedure
TEC: Technology Enhanced Class
TLTQF: TVET Leaders’ and Trainers’ Qualifications Framework
TTLM: Training and Teaching Learning Materials
TTQL: TVET Teachers’ Qualification Level
TVET: Technical and Vocational Education and Training
USAID: United States Agency for International Development
VHS: Virtual Host Storage
WHO: World Health Organization

TABLE OF CONTENTS

Internal Quality Assurance and Improvement Standards for pharmacy Program v

Introduction.................................................................................................................................................... 1
1. Program Goals and Outcomes.......................................................................................................... 4
1.1. Program goals and outcomes ....................................................................................................... 4
1.2. Participation in the formulation of the program goals and outcomes ..................................... 5
1.3. Institutional autonomy and academic freedom ........................................................................... 5
1.4. Educational and training outcomes................................................................................................. 6
2. Governance, Leadership, and Administration .............................................................................. 8
2.1. Governance of the program ........................................................................................................... 8
2.2. Program leadership/coordinator ................................................................................................... 9
2.3. Administrative staff and management .......................................................................................... 9
2.4. Budget and resource allocation .................................................................................................. 10
2.5. Interaction with the health sector ................................................................................................. 11
3. Educational and Training Resources ........................................................................................... 12
3.1. Training halls/classrooms ............................................................................................................ 12
3.2. Office for staff ................................................................................................................................ 13
3.3. Skills development center/laboratory /demonstration room ................................................... 14
3.4. Clinical training facilities/practice sites/cooperative training ................................................... 15
3.5. It facilities........................................................................................................................................ 17
3.6. Library ............................................................................................................................................. 17
3.7. Trainees amenities ....................................................................................................................... 18
3.8. Financial resources....................................................................................................................... 19
4. Trainers and Support staff ................................................................................................................. 21
4.1. Institutional trainer ........................................................................................................................ 21
4.2. Clinical trainer (clinical instructor/ preceptor) ........................................................................... 22
5. Trainees Enrollment and Support Services ................................................................................. 24
5.1. Trainees enrollment ...................................................................................................................... 24
5.2. Trainees support systems ............................................................................................................ 25
5.3. Trainees representation ........................................................................................................... 26
6. Program Curriculum and Teaching, Training and Learning Materials ................................ 27
6.1. Program curriculum design and development .......................................................................... 27
6.2. Teaching-training and learning materials (ttlm) ........................................................................ 28
7. Outcome Based Training ................................................................................................................. 30
7.1. Institutional training ....................................................................................................................... 30
7.2. Cooperative training ..................................................................................................................... 31
Annex ............................................................................................................................................................. 36

Internal Quality Assurance and Improvement Standards for pharmacy Program vi

Annex I: List and number of pharmacy skill development center/laboratory
equipment’s/apparatus............................................................................................................................. 36
Annex II: list of pharmacy laboratory manuals for tvet pharmacy program...................................... 38
Annex III: list of textbooks and reference books for tvet pharmacy program................................... 39
Annex IV. Dictionaries and encyclopedias ........................................................................................... 42

Internal Quality Assurance and Improvement Standards for pharmacy Program vi

INTRODUCTION

The revised National TVET Strategy (2008) reflects an important paradigm shift which places quality
and relevance of TVET program is as its major priority. According to the strategy there is a call for
efforts to raise the quality of the Ethiopian workforce to international standards, to reverse the
previous marginalization of industrial professions in the TVET system, and to put a substantial focus
on building a culture of entrepreneurship and preparing people for self-employment.

The Education Sector Strategy Program (ESDP) III outlines a comprehensive development vision
for the TVET sector and allocated significant amount of money to improve teaching –learning
process, infrastructure and, strengthen quality assurance, and other quality improvement activities.

The Federal TVET Agency has shown the commitment to improve easy access and quality training
in Technical and Vocational Education and Training. To end this, thus, high quality TVET educational
and training programs that meet standard and performance in accordance with standards are
imperative and the cornerstone of quality assurance.

Increased public expectation for quality and ethical health care is necessitating changes in what
health professionals are taught and how they are taught. On the other hand, the increasing need to
train more health workers, coupled with rapid expansion in medical knowledge, presents a serious
challenge to the quality of education of health professionals, including anesthetists. Despite these
challenges, many HEIs training health care providers do not have well-functioning quality systems
that have been cascaded to the department level.

The ultimate goal of IQA is to have a culture of quality care that ensures that quality is a focus of all
the activities of an institution at all levels and is incorporated into the everyday work of the whole
institutional community. A robust and transparent quality assurance system conveys confidence in
the quality of the provision of a TVET institution to its staff, to students, to employers, and to other
stakeholders.

In response, TVET Agency, in collaboration with the Federal Ministry of Health (FMOH) and Jhpiego
(under the Strengthening Human Resources for Health Project funded by the U.S. Agency for
International Development [USAID]), has developed this quality improvement standards for the
Pharmacy program.

Standards are desirable practices in educating anesthetists, and which incorporating well- recognized
and accepted principles of learning and institutional conditions for educational activities and are based
on scientific evidence, best practice, experts opinion and judgment and National policies, strategies,
guideline and legislation and therefore; there is a need for using and implementing of the standards.

Internal Quality Assurance and Improvement Standards for Pharmacy Program 1

USES OF STANDARDS
It is the opinion of TVET that the set of standards presented can be used nationally as a tool for
quality assurance and improvement of Pharmacy education. This could be done in different ways,
such as:
1. For education institutions (Pharmacy programs, schools, Colleges )
 Serve as a mechanism for internal quality assurance and improvement and in
Pharmacy education (basis for internal evaluation and quality improvement)
♦ Measuring their performance,
♦ Identifying the gaps,
♦ Identifying appropriate interventions to correct performance gaps
♦ Implement interventions and continually measure their progress using standards
2. For regulatory bodies
• Serve as bases for accreditation process to ensure and improve the quality of Pharmacy
education
♦ Self- assessment and evaluation,
♦ External audit –including site visit ,
♦ Feedback for institutions to correct error of facts and
♦ Accreditation decision- to accredit and to sanction Pharmacy program

3. Value added to the institution/ education

 Use and implementation of these standards is intended to add the following value for
institutions Create system /mechanism for internal quality assurance, regulation and
accountability
♦ Became a powerful tool or advocacy and resource mobilization to fill their gaps
♦ Attract the attention of policy makers and leaders to be involved and support
♦ Create opportunity to implement scientific evidences and best practices
♦ Create and facilitate quality to became regular, day-to-day and on-going function of
the Pharmacy education
♦ Reinforce continual individual & organizational learning

Internal Quality Assurance and Improvement Standards for Pharmacy Program 2

DEFINITIONS
The following terms are used frequently in this guideline. Hence it is important to define them to
enhance understanding of the document.
Areas are defined as broad components in the structure, process, and outcome of Pharmacy
education.
Sub-areas are defined as specific aspects of an area, corresponding to performance indicators.
Standards (one or more) are specified for each sub-area, using two levels of attainment, and each
standard is given a specific number. The standards are structured in 10 areas and 37 sub- areas.
Basic standard means that the standard must be met by every Pharmacy program/ unit and
fulfilment demonstrated during evaluation of the program/ unit. Basic standards are expressed by a
“must.”
Standard for quality improvement means that the standard is in accordance with international
consensus about best practice for Pharmacy program/ unit and basic Pharmacy education.
Fulfilment of or initiatives to meet some or all of such standards should be documented by Pharmacy
programs/ units. Fulfilment of these standards will vary with the stage of development of the
Pharmacy program/ unit, their resources, and educational policy. Even the most advanced
programs/ units might not comply with all standards. Standards for quality improvement are
expressed by a “should.”

Annotations are used to clarify, amplify, or exemplify expressions in the standards. It should be
strongly emphasized that the content of the annotations should not be seen as prescriptive for
institutions. The annotations do not add new criteria or requirements. The listing of examples in
annotations are in some cases exhaustive, in others not.

STRUCTURE OF STANDARDS
TVET has identified the following 09 areas and 30 sub-areas of operation, which will form the focus
points for a quality audit model at program-level in Ethiopian Health science colleges. They are closely
related to the focus areas the Agency has been using for the past couple of years. These areas are:

1. Program Goals and Outcomes

2. Governance, Leadership, and Administration
3. Educational Resources
4. Trainers and Support Staff
5. Trainees enrollment and Support Services
6. Program curriculum , Training , Teaching and Learning Materials
7. Outcome Based Training
8. Continual Quality Assurance
9. Health Extension service and technology transfer

Internal Quality Assurance and Improvement Standards for Pharmacy Program 3

1. PROGRAM GOALS AND OUTCOMES
1.1. PROGRAM GOALS and Outcomes

Basic Standards
The Pharmacy program must:

 Define its program goals and make them known to its constituency (B 1.1.1)

 Ensure that the goal of the program is in line with, and supportive of, the vision and
mission of the institutions and Technical Vocational Educational and Training(TVET)/
Regional health bureau (RHB) (B 1.1.2)

 Outline in its statement of program goals that the trained pharmacy professionals are:

♦ Competent at each level and capable of undertaking the role of pharmacy

professionals as defined by the Health Sector Ethiopian Occupational Standard
(EOS ) (B 1.1.3)

♦ Prepared and ready for each next level (B 1.1.4)

♦ Committed to lifelong learning (B 1.1.5)

 Ensure that the mission encompasses the needs of the community, the health care
system, and other aspects of social accountability (B 1.1.1)

Annotations

• Program goals/outcomes are general statements of what the program intends to

accomplish; they describe learning outcomes and concepts in general terms. They
should also be consistent with the mission of the program and institution.
• Constituency would include the leadership, staff, and students of the program as well as
other relevant stakeholders.
• Lifelong learning is the professional responsibility to keep up to date in knowledge and
skills through appraisal, audit, reflection, or recognized continuing professional
development (CPD). CPD includes all activities that undertake, formally and informally,
to maintain, update, develop, and enhance their knowledge, skills, and attitudes in
response to the needs of their patients.
• Social accountability would include willingness and ability to respond to the needs of
society, of clients, and the health and health-related sectors and to contribute to the
national and international developments in the pharmaceutical sector by fostering
competencies in pharmaceutical care, health care, pharmacy education, and research.

Internal Quality Assurance and Improvement Standards for pharmacy Program 4

This would be based on the program’s own principles and in respect of the autonomy
of health Science College. Social accountability is sometimes used synonymously with
social responsibility and social responsiveness. In matters outside its control, the
program would still demonstrate social accountability through advocacy and by
explaining relationships and drawing attention to consequences of the policy.

1.2. PARTICIPATION IN THE FORMULATION OF THE PROGRAM GOALS AND

OUTCOMES

Basic Standards

The Pharmacy program must:

 Ensure that its principal stakeholders participate in formulating program goals and
outcomes (B 1.2.1)

Quality improvement standards

The Pharmacy program should

 Ensure that the formulation of program goals and outcomes is based also on other
relevant stakeholders (Q 1.2.1)
Annotations

• Principal stakeholders include the trainees, college, Ministry of Education, professional

associations, Ministry of Health, Regional Health Bureaus (RHB), Federal Technical
Vocational and Educational Training (FTVET) Agency, Regional Technical Vocational
and Educational Training, Education Strategic Center, and the public.
• Other relevant stakeholders include community representatives, patient associations,
and partners.
1.3. INSTITUTIONAL AUTONOMY AND ACADEMIC FREEDOM
Basic Standards
The Pharmacy program must:
 Have autonomy to implement policies for which its program staff and administration
are responsible, especially regarding;

 Development and revision of the curriculum (B 1.3.1)

 Use of the allocated resources necessary for implementation of the curriculum

and (B 1.3.2)

 Conduct of internal assessments, staff recruitment/selection and employment

conditions. (B 1.3.3)
Internal Quality Assurance and Improvement Standards for pharmacy Program 5
Quality improvement standards

The pharmacy program should:

 Ensure freedom for its trainer and trainees

♦ In addressing the actual curriculum (Q 1.3.1)

♦ In exploring the use of new appropriate technology and disseminate the output (Q
1.3.2)
Annotations

• Institutional autonomy would include appropriate independence from government and

other counterparts (regional and local authorities, religious communities, private co-
operations, the professional unions and other interest groups) to be able to make
decisions about key areas such as revision of curriculum, institutional assessments, staff
recruitment/selection and employment conditions, and resource allocation.
• Academic freedom would include appropriate freedom of expression and freedom of
inquiry and promotion for trainers and trainees.

1.4. EDUCATIONAL and TRAINING OUTCOMES

Basic Standards

The Pharmacy program must:

 Have clearly defined educational and training outcomes that are in line with, and
supportive of, the program goals (B 1.4.1)

 Define the intended educational and training outcomes that trainees should exhibit upon
completion of training in relation to:

♦ Their achievements at each level regarding knowledge, skills, and attitudes (KSA)
(B 1.4.2)

♦ Their commitment to KSA in lifelong learning (B 1.4.3)

♦ The health needs of the community, the needs of the health care system, and other
aspects of social accountability (B 1.4.4)

 Ensure appropriate trainees conduct (ethics) with respect to fellow trainees , trainers
other health care personnel, and patients and their relatives (B 1.4.5)

 Make the educational and training outcomes of the known to the trainees and trainers
(B 1.4.6)

Internal Quality Assurance and Improvement Standards for pharmacy Program 6

Quality improvement standards

The Pharmacy program should:

 Review and suggest the outcomes periodically in consultation with principal

stakeholders to ensure that the educational and training outcomes are in line with the
needs of the health sector and the society (Q 1.4.1)
Annotation

• Education and training outcomes refers to statements of KSA that trainees are expected
to possess and demonstrate at the end of each training completion.
• Refer to annotations in 1.1 for lifelong learning
• Refer to annotations in 1.2 for principal stakeholders.

Internal Quality Assurance and Improvement Standards for pharmacy Program 7

2. GOVERNANCE, LEADERSHIP, AND ADMINISTRATION
2.1. GOVERNANCE OF THE PROGRAM

Basic Standards
The Pharmacy program must:

 Define its program structure and functions including its relationships within the
institution (B 2.1.1)

 Ensure the program is part of Institutional development plan (IDP) (B 2.1.2)

Quality improvement standards

The Pharmacy program should:

 In its program structures, set out the committee structure and reflect representation
from:

♦ Trainers (Q 2.1.1)

♦ Trainees (Q 2.1.2)

♦ Principal stakeholders (Q 2.1.3)

 Ensure transparency of the work of governance and its decisions (through notice board,
web information, disclosure of minutes, etc.) (Q 2.1.4)

Annotation

• Governance means the act and/or the structure of governing the program. Governance
is primarily concerned with participating in policy making process and implementing
policy, the processes of establishing general institutional and program policies, and also
with control of the implementation of the policies. The institutional and program policies
would normally encompass decisions on the mission of the pharmacy program,
curriculum, staff recruitment and selection policy, and decisions on interaction and
linkage with pharmaceutical practice and the health sector as well as other external
relations.
• IDP sometimes called strategic plan or long range plan, is document that guides the
institutions achievement, growth and allocation of the resource.

Internal Quality Assurance and Improvement Standards for pharmacy Program 8

2.2. PROGRAM LEADERSHIP/COORDINATOR

Basic Standards
The Pharmacy program must:

 Have a designated coordinator (trainer who has better performance, is at least TWO
level Higher than respective level and 1 years of experience in the related training
area) (B 2.2.1)

 Describe the responsibilities of its leadership for definition and management of the
pharmacy educational and training program (B 2.2.2)

Quality improvement standards

The Pharmacy program should:

 Periodically evaluate its program leadership in relation to achievement of its program

goals and intended educational and training outcomes (Q 2.2.1)

Annotation

• Program leadership refers to the positions and persons within the governance and
management structures being responsible for decisions on matters in education and
training of the program and would include program coordinator, , successors and other
committees.

2.3. ADMINISTRATIVE STAFF AND MANAGEMENT

Basic Standards
The Pharmacy program must:

 Have adequate support of administrative staff from the institution that are appropriate
to:

♦ Support implementation of its education and training program and related activities
(B 2.3.1)

♦ Ensure good management and resource deployment (B 2.3.2)

Quality improvement standards

The Pharmacy program should:

 Formulate and implement an internal program for quality assurance of the
management, including regular review (Q 1.1.1)

Internal Quality Assurance and Improvement Standards for pharmacy Program 9

Annotations

• Administrative staff in this document refers to the positions and persons within the
governance and management structures being responsible for the administrative support
to implementation of policies and plans and would—depending on the organizational
structure of the administration.
• Management means the act and/or the structure concerned primarily with the
implementation of the institutional and program policies including the economic and
organizational implications, i.e., the actual allocation and use of resources within the
program.

2.4. BUDGET AND RESOURCE ALLOCATION

Basic Standards
The Pharmacy program must:

 Have a clear line of responsibility and authority for resourcing the program, including a
dedicated educational and training budget (B 2.4.1)

 Allocate and use the resources necessary for the implementation of the curriculum and
distribute the educational and training resources in relation to educational and training
needs (B 2.4.2)

 Ensure that the budget allocation matches with trainees enrollment (B 2.4.3)

Quality improvement standards

The Pharmacy program should:

 Have autonomy to direct/control the budget and resources in order to achieve its
program goals and the intended educational outcomes of the curriculum (Q 2.4.1)

 Have a transparent system of responsibility and accountability in the allocation,

distribution, and use of the budget and other resources (Q 2.4.2)

 In the distribution of the resources, take into account development in

pharmaceutical sciences and health needs of the society(Q 2.4.3)

Internal Quality Assurance and Improvement Standards for pharmacy Program 10

2.5. INTERACTION WITH THE HEALTH SECTOR
Basic Standards

The Pharmacy program must:

 Have constructive interaction with the health and health-related sectors of society and
government (B 2.5.1)

 Formalize its collaboration (entering into formal agreements, stating content and forms
of collaboration, and/or establishing joint contact and coordination committees as well
as joint projects), including engagement of trainer and trainees , with partners in the
health sector (B 2.5.2)

Quality improvement standards

The Pharmacy program should:

 Periodically review its interaction with the health and health-related sectors (Q 2.5.1)
 Interact with health and health-related sectors based on principles of mutual benefit and
shared governance (Q 2.5.2)

Annotations

• Constructive interaction would imply exchange of information, collaboration, and

organizational initiatives that would facilitate education of pharmacy professionals so as
to equip them with the qualifications needed by society.
• The health sector would include the health care delivery system, whether public or
private, research institutions, and other sectors.
• The health-related sector would—depending on issues and local organization—include
institutions and regulating bodies with implications for health promotion and disease
prevention (e.g., with environmental, nutritional, and social responsibilities)
• Mutual benefit would mean both parties in agreement gain value out of the interaction.
For example, staff at the hospital is given educational opportunities at the same school.
• Shared governance would mean working together to make decisions for the good of both
parties involved.

Internal Quality Assurance and Improvement Standards for pharmacy Program 11

3. EDUCATIONAL AND TRAINING RESOURCES
3.1. TRAINING HALLS/CLASSROOMS

Basic Standards
The Pharmacy program must:

 Have training halls/classrooms for group, tutorial, and seminar activities with adequate

space (1.4m2/trainees for group/tutorial and 1.6m2/trainees for seminar) (B 3.1.1)

 Ensure that the rooms are equipped with:

♦ Sufficient and comfortable chairs and tables (movable armchairs and/or chairs with
tables (B 3.1.2)

♦ Clean projection wall/screen (B 3.1.3)

♦ Writing board with different colors of marker and board cleaner (B 3.1.4)

 Ensure that the rooms are well-illuminated (words written in pencil can be read from
any corner of the room, and screen-projected words, pictures, and videos seen clearly
without reflection from every corner) (B 3.1.5)

 Ensure that the rooms have adequate ventilation (open windows and /or AC, fans) (B
3.1.6)

 Have functional toilets separate for males and females near the classroom (B 3.1.7)

 Have regular cleaning schedule and follow-up for the facility (B 3.1.8)

 Have a built-in overhead projector and/or LCD (liquid crystal display) with computer (B
3.1.9)
 Have a water source around /near the classroom (B 3.1.10)

Quality improvement standards

The Pharmacy program should have:

 A “smart” classroom (Q 3.1.1)

 Regular/scheduled facility inspection and maintenance services (B 3.1.2)

Annotation

• Smart classroom: A smart classroom is a traditional, lecture-style teaching space that

has available technological equipment that can be used to aid and enhance instruction
of a course. The traditional smart classroom is equipped with the basic technology that

Internal Quality Assurance and Improvement Standards for pharmacy Program 12

will enable trainees, and/or teachers to connect their laptops to the video projector or to
play a VHS (virtual host storage)/DVD (digital video disk) movie. The new standard TEC
(technology- enhanced classroom) model includes:

• A DVD/VHS combo

• RCA video and audio input

• Laptop VGA (video graphics array) and audio input

• Network connectivity

• Amplifier and speakers

• High-powered projector (3,000 lumens)

• Permanent projector screen (powered or pull-down

3.2. OFFICE FOR STAFF

Basic Standards
The Pharmacy program must have

 A office for coordinator equipped with:

♦ Printer, scanner and photocopy machine (B 3.2.1)

♦ Telephone (B 3.2.2)
♦ Conference (meeting) table with chairs (B 3.2.3)

 Have an office for teaching and administration staffs with adequate space

(2.0m2/person) (B 3.2.4)

 The office for staff must be equipped with:

♦ Computers with Internet access for each teaching staff (B 3.2.5)

♦ Chairs and tables with drawers (B 3.2.6)

♦ File cabinet and bookshelf (B 3.2.7)

♦ Nearby toilets, separate for males and females (1 toilet for 20 instructors) (B 3.2.8)

Quality improvement standards

The Pharmacy program should have:

 A regular maintenance schedule for office equipment (Q 3.2.1)

Internal Quality Assurance and Improvement Standards for pharmacy Program 13

3.3. SKILLS DEVELOPMENT CENTER/LABORATORY /DEMONSTRATION ROOM

Basic Standards

The Pharmacy program must:

 Have a skills development center/laboratory (SDL) to practice dispensing and

Packaging of Pharmaceutical Products, Compounding of Small Scale Pharmaceutical
Products, quality control and rational use of complementary and alternative medicine
(Traditional Medicine) (B 3.3.1)

 Have SDL management guideline/policy (B 3.3.2)

 Ensure a learning environment that is safe for staff, students, and patients (B 3.3.3)

 Ensue that each the SDL/demonstration room has:

♦ Adequate space for skill demonstration, practice, and discussion (2.2m2/student)

(B 3.3.4)

♦ An adequate (1:6 ratio) supply of functional anatomic models, simulators, and

mannequins to learn essential competencies (see Annex I) (B 3.3.5)

♦ Adequate consumable medical supplies (see Annex I) (B 3.3.6)

♦ A dedicated office (B 3.3.7)

♦ Safety manuals, posted safety precautions, a fire extinguisher, an emergency

shower, and infection prevention equipment (B 3.3.8)

♦ Uninterrupted water and power supply (B 3.3.9)

♦ An adequate number of movable chairs, tables for each station, a labeled shelf with
locks, dust bins in all the stations, and storage (B 3.3.10)
♦ Audiovisual aids including video sets (B 3.3.11)

♦ Adequate illumination and ventilation (B 3.3.12)

♦ Adequate and up-to-date learning materials (reference books, checklists for all
skills, standard operating procedures [SOPs], wall charts, posters, flow charts, and
electronic learning resources) (See Annexes I and III) (B 3.3.13)

♦ A regular cleaning schedule and follow-up for the facility (B 3.3.14)

Internal Quality Assurance and Improvement Standards for pharmacy Program 14

Quality improvement standards

The Pharmacy program should:

 Ensure that the skills lab is properly organized and managed by a dedicated skills lab
manager (Q3.3.1)

 Be accessible for students’ independent practice 24/7 (B 3.3.2)

 Have a system for tracking all materials and equipment after each practice (B 3.3.3)

 Have a central research lab (core lab) where the staff and trainees, undertake research
activities (B 3.3.4)

 Have a facility to house animals for the courses offered by the program and for research
(B 3.3.5)

 Have a regular maintenance schedule for the laboratory facility and equipment (B 3.3.6)

 Recruit standard patient (B 3.3.7)

Annotation

• A safe learning environment would include provision of necessary information; protection

from harmful substances, specimens, and organisms; laboratory safety regulations; and
safety equipment.
3.4. CLINICAL TRAINING FACILITIES/PRACTICE SITES/COOPERATIVE
TRAINING

Basic Standards
The Pharmacy program must:

 Have clinical practice guideline (B 3.4.1)

 Define appropriate clinical/practicum sites selection criteria that encompass but are not
limited to:

♦ Having an adequate client caseload and case mix as per the core competencies (B
3.4.2)

♦ Having sufficient staff who are willing to be preceptors (B 3.4.3)

♦ A range of clinical practice sites (primary, secondary, tertiary levels) (B 3.4.4)

♦ A practice standard of practical training facilities that matches what is taught in the
school (B 3.4.5)

Internal Quality Assurance and Improvement Standards for pharmacy Program 15

 Have a sufficient number and variety of practicum sites for pharmacy practice
experiences including sites for practice on

♦ Pharmaceutical manufacturing and compounding (B 3.4.6)

♦ Regulatory affairs (B 3.4.7)

♦ Pharmacy administration and supply chain management (B 3.4.8)

♦ Community pharmacy services (B 3.4.9)

♦ Hospital/health center pharmacy services(B 3.4.10)

♦ Pharmacy marketing services(B 3.4.11)

♦ Hospital pharmacy services (B 3.4.12)

♦ Pharmaceutical quality control services (B 3.4.13)

 Ensure the availability of necessary resources for giving the trainees adequate clinical
experience, including national service delivery guidelines, personal protective
equipment, learning tools (log books, checklists, SOPs), and other essential equipment
(B 3.4.14)

 Ensure easy accessibility of clinical practice sites including transport facilities to distant
sites (B 3.4.15)

Quality improvement standards

The Pharmacy program should:

 Periodically assess the quality of sites and preceptors in light of achieving curricular
needs and identify potential additional sites when needed (Q 3.4.1)

 Discontinue relationships with the sites that do not maintain the preset quality criteria
and are unable to do so after implementation of a remediation plan (Q 3.4.2)

 Ensure that the clinical practice sites have discussion rooms (Q 3.4.3)

 Ensure that the clinical practice site have a mini-library with essential reference books
and guidelines in the clinical practice site (Q 3.4.4)
 Use accredited clinical practice sites (Q 3.4.5)

Internal Quality Assurance and Improvement Standards for pharmacy Program 16

3.5. IT FACILITIES
Basic Standards
The Pharmacy program must:

 Ensure trainees have access to computers with internet connectivity; one computer for
three trainees (B 3.5.1)

 Have electronic educational resources available (B 3.5.2)

 Formulate and implement a policy that addresses effective use and evaluation of
appropriate information and communication technology (ICT) for education (B 3.5.3)

Quality improvement standards

The Pharmacy program should:

 Have subscriptions to educational websites/resources for staff and students’ use (Q

3.5.1)

 Ensure that the IT center is accessible for trainees independent learning (outside of
working hours) (Q 3.5.2)
 Have regular/scheduled IT facility inspection and maintenance services (Q 3.5.3)
 Establish e-library (Q 3.5.4)

3.6. LIBRARY
Basic Standards
The Pharmacy program must

 Have access to a library with:

♦ A qualified librarian, an assistant, catalogue clerks, and other subordinates (B 3.6.1)

♦ A seating capacity to accommodate 25% of the total number of trainees at a time

(B 3.6.2)

♦ A separate reading room for instructors (B 3.6.3)

♦ A catalogue system, adequate illumination and ventilation and be free from sound
pollution (B 3.6.4)

♦ A nearby functional toilet with a water supply (B 3.6.5)

♦ Signs posted for appropriate behaviors (silence, no food and drinks, no smoking)
(B 3.6.6)

♦ A schedule showing library working hours posted at the entry point (B 3.6.7)

Internal Quality Assurance and Improvement Standards for pharmacy Program 17

♦ An adequate supply of recent textbooks (in a ratio of 1:5 students) and reference
materials (in a ratio of 1:15 students) relevant to the courses taught (See Annex II)
(B 3.6.8)

♦ Access to up-to-date and peer-reviewed journals (local and international) (B 3.6.9)

♦ Copies of relevant and updated national service delivery guidelines and protocols
on priority health issues in the country (See Annex III) (B 3.6.10)

Quality improvement standards

The Pharmacy program should:

 Have an automated library system (system for recording and cataloging material and
for ensuring the security of materials) (Q 3.6.1)

 Have a system to take feedback from users and update its services on a regular basis
(Q 3.6.2)
 Have 24/7 access to library services (Q 3.6.3)

Annotations

• Catalogue system is a search and discovery tool that provides results from the library's
online and print collections in a single search. It includes titles of printed books, journals,
manuscripts, letters, and other material available at the library as well as links to the full
text of millions of journal articles and digital images of graphics/illustrations and
manuscripts.
• Automated library system: Library automation is the application of ICTs to library
operations and services. The functions that may be automated are any or all of the
following: acquisition, cataloging, public access, indexing and abstracting, circulation,
serials management, and reference.

3.7. TRAINEES AMENITIES

Basic Standards
The Pharmacy program must:

 Have an entity/unit responsible for trainees, support, addressing academic, social,

financial and personal needs (B 3.7.1)

 Ensure safe and adequate trainees facilities including lounges, catering, trainees
housing (if possible), and sports and recreational facilities (B 3.7.2)

Internal Quality Assurance and Improvement Standards for pharmacy Program 18

 Allocate resources (budget, facilities, and qualified personnel) for trainees support
programs (B 3.7.3)

 Ensure the availability of a trainees clinic, counseling, and social support units at
institution level (B 3.7.4)

 Ensure that the different facilities on campus are accessible to trainees with disabilities
(B 3.7.5)

Quality improvement standards

The pharmacy program should:

 Have regular/scheduled facility inspection and maintenance services (Q 3.7.1)

 Have a trainees complex providing a variety of services (Q 3.7.2)
 Ensure safe and adequate student housing and catering service(Q 3.7.3)

Annotation

• Addressing social, financial, and personal needs would mean support in relation to social
and personal problems and events, health problems, and financial matters and would
include access to health clinics, immunization programs, and health/disability insurance
as well as financial aid services in the form of bursaries, scholarships, and loans.

3.8. FINANCIAL RESOURCES

Basic Standards
The Pharmacy program must:

 Deploy financial resources to:

♦ Support all aspects of the goals and strategic plan and ensure stability in the delivery
of the program (B 3.8.1)

♦ Allow effective faculty and support staff recruitment, retention, and development (B
3.8.2)

♦ Maintain and improve physical facilities, equipment, and other educational and
research resources (B 3.8.3)

♦ Measure, record, analyze, document, and distribute assessment and evaluation

activities (B 3.8.4)

♦ Ensure experiential learning and preceptors support for smooth curriculum

implementation (B 3.8.5)
Internal Quality Assurance and Improvement Standards for pharmacy Program 19
Quality improvement standards

The Pharmacy program should:

 Develop and maintain a broad base of financial support, including a program to acquire
extracurricular funds through endowment income, consultancy services, grants,
provision of continuing education, and other fundraising mechanisms (Q 3.8.1)

 Secure a budget for innovation in education, research, and other scholarly activities (Q
3.8.2)

 Allocate an uncommitted reserve of finance/budget to address unexpected issues (Q

3.8.3)

Internal Quality Assurance and Improvement Standards for pharmacy Program 20

4. TRAINERS AND SUPPORT STAFF
4.1. INSTITUTIONAL TRAINER
Basic Standards
The Pharmacy program must:

 Ensure implementation of trainer recruitment and development according to TVET

leaders’ and trainers’ qualifications framework (TLTQF)/RHSCs legislation (B 4.1.1)

 Implement a ratio of trainers to trainees of 1:25 for institutional training (B 4.1.2)

 Ensure that the number of trainers assigned for skills labs and cooperative training is
in line with the specific profession requirements and local context (B 4.1.3)

 Require the following qualifications of the trainer :

♦ C- level and above trainer - to train level I & III training (B 4.1.4)
♦ B –level (Bachelor degree) and above trainer- to train level I to IV training (B 4.1.5)
♦ A- level (Master’s degree) trainer- to train level I to V training (B 4.1.6)

 Ensure the trainers carryout the following role and responsibilities

♦ Facilitator, TTLM and curriculum developer, advocator, counselor, coordinator,

institutional Assessor, supervisor (B 4.1.7)

 Ensure Trainers implement Health sector extension service and technology transfer
(B 4.1.8)

 Implement a ratio of full-time and part-time teaching trainers (80% and 20%,
respectively) (B 4.1.9)

 Ensure that availability of contract document for each part-time trainer (B 4.1.10)

 Ensure that each trainer has a t technical update training in the field of instruction (30
CEU/year) (B 4.1.11)

 Assign a trainer for skills lab assistant with Level IV and above. (B 4.1.12)

 Have a system for orienting and mentoring of new trainers (B 4.1.13)

 Have a trainer performance evaluation system

♦ Carried out regularly using standard format (B 4.1.14)

♦ Is performed by peers, students and department head(B 4.1.15)

♦ Is specific and timely provision of constructive feedback(B 4.1.16)

Internal Quality Assurance and Improvement Standards for pharmacy Program 21

♦ Has documented result to be used for decision making and staff development (B
4.1.17)

Quality improvement standards

The pharmacy program should:

 Formulate and implement performance based incentive for trainers(Q 4.1.1)

 Develop and implement trainer retention policy (Q 4.1.2)

4.2. Clinical Trainer (Clinical instructor/ preceptor)

Basic Standards

The pharmacy program must:

 Use guideline/criteria for selection of Clinical Trainer (Clinical instructor/ preceptor)

who are working at practice sites and providing service (B 4.2.1)
 Ensure that the Clinical Trainer (Clinical instructor/ preceptor)

♦ Undertake occupational assessment and being competent to the respective level

(B 4.2.2)

♦ Have methodology training for clinical teaching (B 4.2.3)

♦ Are at least equivalent to the level of training with minimum of 2 years of service in
the specific area(B 4.2.4)

♦ Have the following minimum qualifications

• C- level and above trainer - to train level I & III training (B 4.2.5)
• B –level (Bachelor degree) and above trainer- to train level I to IV training (B
4.2.6)
• A- level (Master’s degree) trainer- to train level I to V training (B 4.2.7)

 Ensure that the Clinical Trainer (Clinical instructor/ preceptor -to-trainees, ratio for
the practice experience is sufficient (1:20) to provide individualized instruction,
guidance, and supervision. (B 4.2.8)

Quality improvement standards

The Pharmacy program should:

 Establish a mechanism to support clinical trainer’s CPD as educators and practitioners

in line with their responsibilities in the program (Q 4.2.1)
 Implement incentive and recognition mechanisms for the preceptors (Q 4.2.2)

Internal Quality Assurance and Improvement Standards for pharmacy Program 22

Annotations
• TVET Trainer is defined as an instructor, developer, facilitator or supervisor who is
qualified to facilitate the activities and programs of a particular occupation.
o C-level trainer is a holder of a National Certification (NC) of at least Level I up to
III,IV,V and a Trainers Methodology Certification C (TMC) to prove that he / she is
competent to deliver a training program.
o B-level trainer is who possesses TVET Trainers Qualification (TTQL) B and NC
Level-I up to IV and also TMB.
o A level trainer is who possesses TVET Trainers Qualification Level (TTQL) A and NC
Level I up to V and also TMA.

o Clinical Trainer (Clinical instructor/ preceptor refers to qualified pharmacist or

druggist who is working on full-time basis in the respective experiential practice sites
and have signed a formal agreement with the education and training institutions to
coach the students.

• Qualifications of trainer would mean appropriateness of the high-level trainings relevant

to the Unit of Competency described in the EOS.
• Cooperative training refers to an instructional delivery of education and training that
combines health institutions and school training based on a curriculum collaboratively
designed and implemented by health institution and respective institutions.

Internal Quality Assurance and Improvement Standards for pharmacy Program 23

5. TRAINEES ENROLLMENT AND SUPPORT SERVICES
5.1. TRAINEES ENROLLMENT
Basic Standards
The Pharmacy program must:

 Ensure that the enrollment policy/guideline is in line with the national and regional
enrollment decision and cut off point (B 5.1.1)
 Implement additional enrollment criteria to enroll trainees according to the program
and health sector needs (B 5.1.2)

 Have a written enrollment policy/guideline for trainees that specifies:

♦ Rationale, process of trainees, enrollment and minimum acceptance criteria/

enrollment requirement according to the EOS (B 5.1.3)

♦ Existence of an entity responsible for trainees, selection and admission that ensures
transparency and fairness (B 5.1.4)

♦ The process and criteria for enrollment of students with specials needs (B 5.1.5)

♦ The process for transfer of trainees from other institutions (B 5.1.6)

♦ The size of trainees intake in relation to its capacity and resource at all stages of
the program (B 5.1.7)

♦ Be represented on the screening and selection committee/entity of the institution (B

5.1.8)

♦ A system for appeal for enrollment decisions (B 5.1.9)

 Ensure that trainees enrollment process is transparent, free from discrimination, and
in accordance with institutional polices and all applicable codes of laws (B 5.1.10)

 Ensure that trainees, have a trainees handbook that clearly indicates

♦ Enrollment policy/guideline (B 5.1.11)

♦ Trainees support systems and how to access them (B 5.1.12)

♦ Rights, responsibilities, and obligations of trainees in the institution and cooperating

training site (B 5.1.13)

♦ Appeal system (B 5.1.14)

♦ School profile: brief history, organizational structure, etc. (B 5.1.15)

Internal Quality Assurance and Improvement Standards for pharmacy Program 24

Quality improvement standards

The Pharmacy program should:

 State the relationship between trainees, selection, the mission of the educational and
training program, and desired qualities of training completers (Q 5.1.1)
 Periodically review the enrollment policy/guideline and trainees, intake in line with
academic success of the trainees, and the needs of the society(Q 5.1.2)
Annotations

• Enrollment policy would imply adherence to possible national regulation as well as

adjustments to local circumstances. If the pharmacy school does not control the
enrollment p o l i c y , it would demonstrate responsibility by explaining relationships
and drawing attention to consequences, e.g., imbalance between intake and teaching
capacity.
• Enrollment criteria should include interest, pre-requisite knowledge and skills,
background education, physical fitness, national exam grade requirements, and criteria
for upgrading trainees, selection.
• The health needs of the society would include consideration of intake according to
gender, ethnicity, and other social requirements (socio-cultural and linguistic
characteristics of the population), including the potential need for a special recruitment,
admission, and induction policy for underprivileged trainees, and minorities.

5.2. TRAINEES SUPPORT SYSTEMS

Basic Standards
The Pharmacy program must:

 Ensure that the trainees have access to the following services:

♦ Counseling on training , health, and social issues that could otherwise affect their
success in the program (B 5.2.1)

♦ Trainees support addressing the training (e.g., remedial support and peer-assisted
learning. (B 5.2.2)

♦ Basic clinic services (B 5.2.3)

 Have a mechanism for trainees, to appeal on matters related to trainees, support

services (B 5.2.4)

 Ensure support to extracurricular activities like trainees associations, council, sport,

Internal Quality Assurance and Improvement Standards for pharmacy Program 25

gender, HIV and green TVET .etc…. (B 5.2.5)

Quality improvement standards

The Pharmacy program should:

 Provide career guidance and advice on progression after completing the program (Q
5.2.1)

 Have a system/mechanism to evaluate and ensure the adequacy, effectiveness, and

safety of the available trainees, support services(Q 5.2.2)
 Support establishment of charity clubs(Q 5.2.3)
Annotations
• Addressing social, financial, and personal needs would mean support in relation to social
and personal problems and events, health problems, and financial matters and would
include access to health clinics, immunization programs, and health/disability insurance
as well as financial aid services in forms of bursaries, scholarships, and loans..

5.3. TRAINEES REPRESENTATION

Basic Standards
The Pharmacy program must:

 Formulate and implement a policy that ensures participation of trainees, representatives

and appropriate participation in all matters relevant to trainees (B 5.3.1)

Annotations

• Participation of trainee’s representatives would include trainee’s self-governance and

representation on the quality of training, assessment process, and other relevant bodies,
as well as social activities and local health care projects.

Internal Quality Assurance and Improvement Standards for pharmacy Program 26

6. PROGRAM CURRICULUM AND TEACHING, TRAINING AND
LEARNING MATERIALS
6.1. Program curriculum design and development

Basic Standards
The Pharmacy Program curriculum must:

• Be developed based on occupational standards (B 6.1.1)

• Reflect the specific context and conditions of occupational learning, respective
relevant aspect of training delivery such as disparate target groups and their
characteristics, mode of delivery, regional conditions and availability of training
resources (B 6.1.2)
• Contain the contextual (knowledge-based), skills (performance-based) and
attitudes (behavioral-based) requirement of the unit of competence. (B 6.1.3)
• Reflect learning , progression, assessment and practice until competent (B 6.1.4)
• Follow the principle of modularization (structuring the content into a set of
comptencies). (B 6.1.5)
• The learning module or modules (if there are several) of a unit of competence be
self-contained. (B 6.1.6)
• Covers the following two main components
o TVET-Program Design(B 6.1.7)
o Learning Modules(B 6.1.8)
• The Program Design must include
o TVET-Program Title (B 6.1.9)
o TVET-Program Description(B 6.1.10)
o TVET-Program Learning Outcomes(B 6.1.11)
o Duration of the TVET-Program (B 6.1.12)
o Qualification Level and Certification(B 6.1.13)
o Target Groups(B 6.1.14)
o Entry Requirements(B 6.1.15)
o Mode of Delivery(B 6.1.16)
o TVET-Program Structure(B 6.1.17)
o Institutional Assessment (B 6.1.18)
o Teacher’s Profile(B 6.1.19)
o Learning Modules(B 6.1.20)

Internal Quality Assurance and Improvement Standards for pharmacy Program 27

o Resource Requirements(B 6.1.21)
• The Learning Module Design must include
o TVET-Program Title(B 6.1.22)
o Module Code and Title(B 6.1.23)
o Nominal Duration (B 6.1.24)
o Module Description(B 6.1.25)
o Learning Outcomes(B 6.1.26)
o Module Contents(B 6.1.27)
o Learning Methods(B 6.1.28)
o Assessment Methods and Criteria(B 6.1.29)
o Resource Requirements(B 6.1.30)
• Follow practical Steps in the design and Development of Outcome Based Curriculum
(B 6.1.1)
• Groups of trainers must periodically review and update the curriculum at appropriate
intervals and based on revised EOS by the sector , emerging evidence and the
needs of the society, students’ performance assessment results, and feedback from
trainees, and other stakeholders (B 6.1.31)

• Communicate and ensure that the curriculum is available to staff, students, and
other stakeholders (B 6.1.32)

• Prepare and implement schedule that indicates dates of registration, , cooperative

training , assessment , module ends, vacation, completion , and other major events
(B 6.1.33)
6.2. Teaching-Training and Learning materials (TTLM)
Basic Standards

The Pharmacy program TTLM Must:

• Directly related to the occupational standards and the curriculum(B 6.2.1)
• Designed by the teacher to fit local condition and appropriate to intended trainees (B
6.2.2)
• Designed in a way that address all the learning outcomes within one learning module
(B 6.2.3)
• Include Trainers guide, Learning guide and Assessment package(B 6.2.4)
• Follow the recommended Steps in Formulating Learning Guides, teacher guide,
assessment package (B 6.2.5)
• Learning guide must be given to trainees at the beginning of the each Learning

Internal Quality Assurance and Improvement Standards for pharmacy Program 28

Outcome /Unit of Competence(B 6.2.6)

Annotation

• Curriculum is a comprehensive description about all relevant aspects of a TVET

Program, including TVET Program Design and Learning Modules. A plan incorporating
a structured series of intended learning outcomes and associated learning experiences.
Curricula are based on the applicable Ethiopian Occupational Standard (EOS) the TVET
Program is addressing.
• Occupational standard defines the competences that a person or individual must
possess to be able to perform and be productive in the world of work. It is composed of
units of competence that define a particular scope of work resulting in a product, service
or decision
• Training, Teaching and Learning Materials (TTLM) are all types of materials suitable or
specifically designed and developed to support occupational learning processes - and
thus - helping to achieve the desired learning outcomes.
• The Learning Guide is either a self-contained or resource-based packet of information
and learning activities
• Occupational Assessment is Process of determining if the person possessed the
required competences stated in the occupational standard.
• Competence : The possession and application of knowledge, skills and attitudes to
perform work activities to the standard expected in the workplace

Internal Quality Assurance and Improvement Standards for pharmacy Program 29

7. OUTCOME BASED TRAINING
7.1. Institutional training

Basic Standards
The Pharmacy program institutional training must:

• Driven by competences written to the national occupational standards and address

the basic competency/elements set by occupational standard(B 7.1.1)
• Allows for learners to enter and exit programs and receive an award for modules
attained at any point (B 7.1.2)
• Allows for recognition of prior learning (RPL) (B 7.1.3)
• Be modular and provides opportunity for right mix of on and off the job(B 7.1.4)
• Training materials are directly related to the units of competence and the learning
modules(B 7.1.5)
• Adapt instructional media, TTLM and assessment according to the trainees needs
(B 7.1.6)
• Instructional media is individualized, self-paced instruction allowing the trainee to
learn and move along independently without much or constant direction, correction
and instruction from the teacher. (B 7.1.7)
• Have an assessment policy/ guideline that clearly define
o A range of assessment method used for formative and summative
assessment (B 7.1.8)
o Frequency and timing (B 7.1.9)
o Promotion, repetition, re-admission(B 7.1.10)
o A system for appeal of assessment result (B 7.1.11)
o Quality assurance process of assessment practice (B 7.1.12)
• Conduct formative and summative assessment (B 7.1.13)
• Perform institutional assessment level by level to make ready for national l
assessment(B 7.1.14)
• Assessment of learners is based on performing competences required by a specific
learning outcome and by the occupational standard as a whole(B 7.1.15)
• Have linkage with the health sector for training completers(B 7.1.16)

Internal Quality Assurance and Improvement Standards for pharmacy Program 30

7.2. Cooperative training

Cooperative training of Pharmacy program must fulfill the following implementation phases

The preparation Phase (B 7.2.1)

• Inspection of cooperative training sites and identify the available site appropriate
to the training
• Create awareness about cooperative training among institutions, practice sites
and other concerned bodies
• Create partnership and preparing joint action plan addressing training concerns
• Signing of MoU
• Assessing and capacitating clinical trainers/ preceptors and TVET Trainers by
fulfilling their skill gap
• Conducting Methodology training for clinical trainers/ preceptors
• Prepare training plan by both TVET trainer and clinical preceptors

Implementation Phase (B 7.2.2)

• Assigning clinical training coordinator and trainers

• Assigning trainees by level and occupation
• Use Training material (curriculum and Training, Teaching and Learning Materials
(TTLM)
• Conduct training as per unit of competencies
• Conducting assessment as per Unit of Competency before proceeding to the
succeeding Unit of Competency by industry trainers(clinical preceptors)
• Conduct Occupational assessment at the end of level/program at the practical
site
The monitoring and evaluation phase (B 7.2.3)

• Monitoring the training progress by TVET and Industry leaders/ coordinators/

• Assess the results
• Make correction as required
• Report writing
Annotations

• Cooperative training: is provided in cooperation between employers and a TVET

institution. Cooperative training usually takes the form of training at a public or private
TVET institution for part of the time and in the health institutions for the other part of the
Internal Quality Assurance and Improvement Standards for pharmacy Program 31
program duration

• Clinical Trainer (Clinical instructor/ preceptor) refers to qualified Pharmacist or druggist

who is working on full-time basis in the respective experiential practice sites and have
signed a formal agreement with the education and training institutions to coach the
students.

• Formative and summative assessment: formative assessment is assessment used to

improve trainees, learning and performance by giving feedback, while summative
assessment is used to decide if the trainees has to move to the next stage of learning.
Both should be conducted on a continual basis.

Internal Quality Assurance and Improvement Standards for pharmacy Program 32

8. CONTINUAL QUALITY ASSURANCE

Basic Standards

The Pharmacy program must:

 Have a functional internal quality assurance system/Health science educational

development center (HSEDC) leading the quality assurance system with clearly
defined duties/responsibilities and lines of communication (B 8.1)

 Allocate an adequate budget to the quality assurance unit to carry out its responsibilities
(B 8.2)

 Assign a qualified person to coordinate the system (minimum of 2 years of teaching

experience, training in educational quality assurance, and training and assessment of
health care providers) (B 8.3)

 Conduct quality assessment using the internal quality standard tool (at least Bi-
annually) and develop and implement clear strategies/work plans to fill the gaps
identified (B 8.4)

 Have a system for regular curriculum evaluation and review (at least every year) (B
8.5)

 Seek external quality audit and verification by TVET /RHB or peer institutions and work
on the recommendations given to ensure continual quality (B 8.6)

 Ensure duties and responsibilities within cluster institutions according to the clustering
guideline

♦ Sharing cooperative training experience (B 8.7)

♦ Share resource and skills, common assessment center(B 8.8)

♦ Upgrading trainers and clinical preceptors skills (B 8.9)

♦ Create employment opportunity(B 8.10)

♦ Transfer of technology (B 8.11)

Quality improvement standards

The Pharmacy program should:

 Have a well-organized, functional, and vibrant internal quality assurance system that is
responsible for monitoring and evaluation of input, process, output, outcome and impact
of the educational and training program (Q 8.1)
Internal Quality Assurance and Improvement Standards for pharmacy Program 33
 Systematically seek, analyze, and respond to trainers and trainees, feedback (Collect
trainees, and trainer comments using structured questionnaire or suggestion book, take
corrective action, and document) (Q 8.2)

 Conduct external verification by peer institutions/schools every 2 years (Q 8.3)

 Conduct review meetings with representatives from practice sites, industries, and
professional bodies annually to evaluate the effectiveness of learning experiences (Q
8.4)

 Develop the structure, governance, and management of the organization to cope with
changing circumstances and needs and, over time, accommodate the interests of the
different groups of stakeholders (Q 8.5)

Internal Quality Assurance and Improvement Standards for pharmacy Program 34

9. HEALTH EXTENSION SERVICE AND TECHNOLOGY
TRANSFER

Basic standards

9.1. Health Extension Service

The pharmacy program must:

 Ensure the implementation of Health Extension Service so that

• Identify level and type of occupation of Health professionals in the health care
service (B.9.1.1)

• Identify skill gap of health professionals based on occupational standard

(B.9.1.2)

• Fill the identified skill gaps based on the four Industry extension packages
(KAIZEN, Technical skill, Technology and Entrepreneurship) to improve
service delivery and competiveness (B.9.1.3)

• Assess their performance (B.9.1.4)

9.2. Technology Transfer

The pharmacy program must

• Conduct Value chain analysis (B.9.2.1)

• Identify appropriate technology (B.9.2.1)

• Develop document (B.9.2.3)

• Prepare prototype (B.9.2.4)

• Conduct pilot test (B.9.2.5)

• Transfer new technology (B.9.2.6)

 Allocate a sufficient budget to Transfer new Technology to the community (B.9.3)

Internal Quality Assurance and Improvement Standards for pharmacy Program 35

ANNEX
ANNEX I: LIST AND NUMBER OF PHARMACY SKILL DEVELOPMENT
CENTER/LABORATORY EQUIPMENT’S/APPARATUS

Ser. Equipment/Apparatus Quantity/ Description

No. Volume
1. Analytical balance At least 2 Digital or manual
2. Beakers of different size At least 10 of 50 ml/100 ml/250 ml
3. Bottles 15 each 50 ml/100 ml
4. Capsule filling 1
5. Conical flasks at least 10 of 50 ml/100 ml/250 ml/1,000 ml/2,000

6. Disintegration apparatus 1 h l
7. Dissolution apparatus 1
8. Distillation apparatus At least 2
9. Erlenmeyer flask 5 100 ml
10. Evaporating dish At least 5 each porcelain/glass
11. Filter papers Different pore size
12. Funnel At least 5
13. Funnels 8 Different size
14. Glass rods 10
15. Hot air oven 1
16. Hot plates 2
17. Iodine flask 2
18. Measuring cylinder of At least 10 of 10ml, 50 ml/100 ml/250 ml/1,000 ml
different size each

19. Microscope with stage 1

micrometer

20. Mortar and pestle At least 5 porcelain/glass; 125 ml/250 ml

each of different
material and

21. Ointment jars 15 Different sizes

22. Ointment tile At least 5
23. Refrigerator 1
24. Refrigerator 1
25. Sieve, different mesh 1 each for Particle size analysis + 180µm/
sizes stated
250µm for compounding
purposes

26. Soxhlet apparatus At least 2

27. Spatula At least 5 each stainless steel; flexible rigid

36
Internal Quality Assurance and Improvement Standards for pharmacy Program
28. Suppository molds At least 5 each 1 g/2 g/4 g
29. Tablet machine 1
30. Test tube rack 5
31. Test tubes 50
32. Thermometer 5
33. Thermostatic oven 1
34. Volumetric flasks At least 2 of 50 ml/100 ml/250 ml/1,000 ml
35. Water bath 1
36. Water distiller 1

37
Internal Quality Assurance and Improvement Standards for pharmacy Program
ANNEX II: LIST OF PHARMACY LABORATORY MANUALS FOR TVET PHARMACY
PROGRAM

No. Manuals

1. Lab manuals for dispensing and Packaging of Pharmaceutical Products having

at least 120 experiments
2. Lab manuals for Compounding of Small Scale Pharmaceutical Products having
at least 120 experiments
3. Lab manuals for practicing pharmacognostic techniques for rational use of
complementary and alternative medicine (Traditional Medicine), having at least
40 experiments and at least 10 visits to nearby traditional healer

38
Internal Quality Assurance and Improvement Standards for pharmacy Program
ANNEX III: LIST OF TEXTBOOKS AND REFERENCE BOOKS FOR TVET PHARMACY
PROGRAM
No. Course List List of Reference Books Required for the Year of
Course Publication
1 Compounding • United States Pharmacopoeia (USP) Most recent
• British Pharmacopoeia (BP) edition
• Connors (A Textbook of
Pharmaceutical Analysis)
• Scherimer RE. (Modern Methods of
Pharmaceutical Analysis)
• Pharmaceutics: The Science of
Dosage Form Design (Aulton)
• Handbook of Pharmaceutical
Excipients (Kibb
• Pharmaceutical Dosage Forms and
Drug Delivery Systems(Ansel’s)
2 Enhancing rational use of • Ali M. (Text Book of Most recent
traditional medicine and Pharmacognosy) edition
operating its dispensary • Wallis (Text Book of Pharmacognosy
and Phytochemistry)

3 Application of • Goodman and Gillman Most recent

Pharmacology Pharmacological Basis of edition
Therapeutics
• Katzung Basic and Clinical
Pharmacology
• Koda Applied Therapeutics, and Any
therapeutic and clinical pharmacy
book and any pharmacology book

39
Internal Quality Assurance and Improvement Standards for pharmacy Program
4 Procuring and storing • Pharmacy Management – Essentials
pharmaceutical products , for All Practice Settings (Desselle Most recent
Distributing and Zgarrick) edition
pharmaceutical products • Principles of Accounting National
Maintaining Drug and Health Policies of Ethiopia
pharmaceutical ward stock • Managing Access to Medicines and
and Dispensary stock Health Technologies
control • Managing Drug Supply (Management
Sciences for Health/WHO)

5 Hair, Beauty and Cosmetic • Breuer. Cosmetic Science Most recent

Products and Services edition

6 Assisting prescription • Pharmaceutical Calculations (Zatz Most recent

preparation and Teixeira) edition
• Pharmaceutical Calculations(Aniesl)

7 Medical Supplies • Medical Supplies and Laboratory Most recent

Equipment and Reagents Reagents (Pharmaceuticals Fund and edition
Supply Agency)
8. Extemporaneous Product • Remington Pharmaceutical Sciences Most recent
Master Work Sheet and • British Pharmacopeia(BP) edition
Labels • United States Pharmacopeia(USP)

• Food, Medicine and Health Care

9. Assisting hospital Administration and Control Most recent
pharmacy practice Authority Legislation and Regulation edition
• EPA Code of Ethics
• Hospital Pharmacy (Stephens)
• Updated standards for different levels
of health facilities and the different
pharmacy practice areas

40
Internal Quality Assurance and Improvement Standards for pharmacy Program
10. Leading workplace • Communication Skills for Most recent
communication Pharmacists (Berger) edition
• Drug Information: A Guide for
Pharmacists (Malone)
• Health Care Informatics (Bill)

11. Health and Nutritional • Modern Nutrition in Health & Most recent
Products and Services Disease (Shils) edition
• Krause’s Food, Nutrition and Diet
Therapy
12. Complying with infection • Occupational health and safety
control policies encyclopaedia, volume 2. ILO,
Geneva,.
• World Health Organization.
Managing medical wastes in
developing countries: a report of
consultation on medical wastes Most recent
management in developing countries, edition
WHO,
• WHO/PEP/RUD/94.1. WHO,
• World Health Organization.
Management of Hazardous waste.
Wh R i l bli i E

41
Internal Quality Assurance and Improvement Standards for pharmacy Program
ANNEX IV. DICTIONARIES AND ENCYCLOPEDIAS

A. PROGRAM/SUBJECT-SPECIFIC DICTIONARIES

Year of Number of
No List of Dictionaries Remarks
Publication Copies per 50
.
Students or 1
Class
1. Medical dictionary Latest 2
2. Pharmaceutical dictionary Latest 2

B. PROGRAM/SUBJECT-SPECIFIC ENCYCLOPEDIAS

Year of Number of Copies per

No List of Encyclopedias Remarks
Publication 50 students or 1
.
Class

1. Martindale Latest 5
2. Encyclopedia on general Latest 1
matters

42
Internal Quality Assurance and Improvement Standards for pharmacy Program
43