Amendment 1 Attachment 3_FMOH Final Completed ME document May 2020.pdf

PHARMACY SERVICES, PHARMACEUTICALS SUPPLY

CHAIN & MEDICAL DEVICE MANAGEMENT

MONITORING AND EVALUATION FRAMEWORK

PARTICIPANT‟S TRAINING MANUAL

November, 2019

Addis Ababa, Ethiopia

I

APPROVAL STATEMENT OF THE MINISTRY

The Federal Ministry of health of Ethiopia has been working towards standardization and institutionalization of In-Service Trainings (IST) at national level. As part of this initiative the ministry developed a national in-service training directive and implementation guide for the health sector. The directive requires all in-service training materials fulfill the standards set in the implementation Guide to ensure the quality of in-service training materials. Accordingly, the ministry reviews and approves existing training materials based on the IST standardization checklist annexed on the IST implementation guide.

As part of the national IST quality control process, this pharmacy services, pharmaceutical supply chain & medical device management monitoring and evaluation framework IST training package has been reviewed based on the standardization checklist and approved by the ministry in November , 2019.

Assegid Samual Cheru

Human Resource Development Directorate

A/ Director

Federal Ministry of Health, Ethiopia

II

Foreword

The Federal Ministry of Health (FMOH) has been working to ensure equity and quality of health services across the country. As part of these efforts, the ministry is also exerting concerted efforts to improve accessibility and quality of pharmaceutical products, services and medical device management. It is widely known that, the sector is growing in line with the overall growth and transformation plan of the country and the sector is being guided by the health sector transformation plan (HSTP).

Pharmaceutical supply chain, pharmacy service and medical device management activities are an integral part and a cross cutting activity of the health care system. Managing these activities is a key for fulfilling client satisfaction with regards to obtaining the right diagnostic, treatment and pharmaceuticals with right quantity and right condition, at right cost, at the required time, for the right client. Therefore, the purpose of this M&E plan is to strengthen the pharmaceuticals supply chain management, pharmacy service and medical device management of the country to ensure uninterrupted quality healthcare services for the ultimate customers. This M&E training manual will help FMOH to build the capacity of health professionals working at different levels of the health system so as to properly manage pharmaceuticals supply chain management (SCM), pharmacy service and medical device. The M&E training manual is developed by the

Pharmaceutical & Medical device Directorate (PMED).

Thus, the development of this training manual is an important step to address knowledge, skill and attitude gaps to implement developed M&E framework. As the development of this manual is a significant achievement, it would be meaningful only if the M&E framework of all stakeholders engaged in pharmacy and medical device management is built on this common framework. I would like to take this opportunity to thank all who participated in the development of this training manual.

Regasa Bayisa (BPhram, MSC)

Director, Pharmaceutical and Medical device Directorate

Federal Ministry of Health

III

Acknowledgments

The Federal Ministry of Health would like to express its gratitude and appreciation to all participants and their respective institutions who were involved in this document preparation for their unreserved efforts and commitment. The shared technical knowledge and experiences have produced a comprehensive

M&E training manual for implementation of simple, coordinated and effective results-based national

M&E system for data management, dissemination and utilization of strategic information for pharmaceutical supply chain management, pharmacy service and medical device.

The support and commitment of the members of the technical team at the Ministry of Health and partner organizations are also very well acknowledged. Their active participation and engagement in the development process have been the driving force to the completion of this document successfully.

Sincere appreciation is extended to the following members of the technical team whose support was central to the development, coordination and finalization of the M&E training manual:

Name Organization

Azeb Fisseha JSI/AIDS Free

Edessa Diriba FMOH

Elias Geremew GHSC- PSM

Fikresilessie Alemu GHSC- PSM

Kirubel Minsamo Haramaya University

Mahdi Abdella FMOH

Megersa Kebede FMOH

Meseret Adugna FMOH

Meseret Zerihun JSI/AIDS Free

Mohammedaman Jemal FMOH

Nebyou Habtamu GIZ

Seid Ali CHAI

Solomon Abdellah FMOH

Sufyan Abdulber FMOH/UNFPA

Tadesse Waktola FMOH

Yosef Wakwoya GHSC-PSM/ORHB

Zerihun Ketema FMOH

The Federal Ministry of Health would also like to thank the Deutsche Gesellschaft für Internationale

Zusammenarbeit (GIZ) and Clinton health Access Initiative (CHAI) for their generous financial and technical support for the successful development of this training manual.

Finally, we would like to acknowledge USAID‘s Global Health Supply Chain Program-Procurement and supply Management project (USAID/GHSC-PSM), JSI/AIDS Free, UNFPA and Oromia Regional Health

Bureau (ORHB) for their significant technical support throughout the development process.

IV

Acronyms

DIS Drug Information Service

DTC Drug and Therapeutics Committee

EHRIG Ethiopian Hospitals Reformation Implementation Guideline

EHCRIG Ethiopian Health Centre‘s Reformation Implementation Guideline

FMOH Federal Ministry of Health

HSDP Health Sector Development Plan Health Facility

HSTP Health Sector Transformation Plan

IPLS Integrated Pharmaceutical Logistic System

M&E Monitoring and Evaluation

ME Medical device

MEMS Medical device Management System

PMED Pharmaceutical & Medical device Directorate

RHB Regional Health Bureau

SOP Standard Operating Procedure

STG Standard Treatment Guideline

WoHO Woreda Health Office

ZHD Zonal Health Department

V

List of Tables

Table 1: Benefits and beneficiaries of Compassionate and Respectful Care ------------------------- 4

Table 2: Components indicators in the PS, SC and ME management indicators ------------------- 48

Table 3: List of Pharmacy Services Indicators and the Corresponding type of Data Collection

Method --------------------------------------------------------------------------------------------------------- 50

Table 4: Exercise 1 on medical device management indicators --------------------------------------- 76

Table 5: Exercise 2 on medical device management indicators --------------------------------------- 76

Table 6: Data Quality Dimensions ------------------------------------------------------------------------- 86

Table 7: Reporting hierarchy, frequency and schedule of public health facilities and administrative health units ---------------------------------------------------------------------------------- 91

Table 8: Stepwise approach to implement M&E framework ---------------------------------------- 103

VI

List of Figures

Figure 1: Qualities of compassion

Figure 2: Monitoring and Evaluation Framework for Pharmaceutical Supply Chain, Pharmacy

Service and Medical device Management

Figure 3: Schematic diagram of Medical device management indicators

Figure 4: Pharmaceutical Supply Chain, Pharmacy Service and Medical device Management

M&E Indicators Report Flows

VII

Table of contents

APPROVAL STATEMENT OF THE MINISTRY ........................................................................ I

Foreword ......................................................................................................................................... II

Acknowledgments ........................................................................................................................ III

Acronyms ...................................................................................................................................... IV

List of Tables ................................................................................................................................. V

List of Figures ............................................................................................................................... VI

Table of contents.......................................................................................................................... VII

Introduction to the Manual ............................................................................................................ X

Core competency ......................................................................................................................... XII

Course Syllabus ......................................................................................................................... XIII

Course Schedule ....................................................................................................................... XVII

Chapter One: Caring, Respectful and Compassionate Healthcare Service

1. Introduction to Compassionate, Respectful and Caring (CRC)

1.2. Healthcare Ethics

1.2. Principles and Standards of Compassionate Care

1.3. Respectful care

1.4. Compassionate leader

Chapter Two: Overview on Pharmacy and Medical device Management Chapter Standards

2.1. Introduction

2.2. Hospital Operational Standards for Pharmacy Services

2.3. Health Center Operational Standards for Pharmacy Services

2.4. Operational Standards for Medical Device Management

Chapter Three: Basics of Monitoring and Evaluation

3.1 Introduction

3.2. Basic terminologies of M&E

3.3. Purposes of Monitoring and Evaluation

3.4. M&E framework

VIII

Chapter Four: Indicators to Measure Pharmacy Service, Supply Chain and Medical device

Management

4.1. Introduction

4.2. Components of the Indicators

4.3. Pharmacy Service Indicators

4.4. Pharmaceuticals Supply Chain Management Indicators

4.5. Medical device Management Indicators

4.6. Pharmacy Services, Supply Chain and Medical device Management Cross Cutting (CC)

Indicators

4.7. Generation, aggregation, dissemination and reporting

Chapter 5: Data Management

5.1. Introduction to data management

5.2. Data management principles

5.3. Data quality dimensions & its impact on decision making

5.3.1. Data quality

5.3.2. Data quality dimensions

5.3.3. Possible sources of poor Data quality at various levels

5.3.4. Impact of data quality on decision making

5.4. Validating M & E indicators for decision making

5.5. Flow of M and E reports and schedule

5.6. Utilization of PS, PSCM and MEM ME report

Chapter Six: Performance monitoring, Feedback Mechanisms and Motivation

6.1. Introduction

6.2. Performance monitoring

6.3. Feedback mechanisms

6.4. Motivation

Chapter 7: Roles and responsibilities of Stakeholders

7.1. Introduction

7.2. Stakeholders for M & E framework

7.3. Roles and responsibilities of stakeholders

7.3.1. FMOH/RHBs

IX

7.3.2. ZHDs/WoHOs

7.3.3. Health facilities

CHAPTER 8: PLANNING AND GETTING STARTED

8.1. Introduction

8.2. Stepwise approach to establish M&E system

ANNEX

Annex 1. Registration formats for Pharmacy Service indicators

Annex 2. Registration formats for supply chain indicators

Annex 3. Registration and Reporting Formats for Medical device Management

Annex 4. M&E Implementation plan

X

Introduction to the Manual

The Federal Ministry of Health (FMOH) is leading a sector wide reform to improve accessibility and quality of health services. The country has implemented successive Health Sector

Development Plans (HSDPs) since 1997 in four phases each for five years, which have contributed a lot in addressing the priority healthcare needs of the population. The country has now embarked upon its fifth plan, namely, the health sector transformation plan (HSTP) which covers 2015 – 2020, aims to transform the health sector so as to further improve equity, coverage and utilization of essential health services, improve quality of health care, and enhance the implementation capacity of the health sector at all levels of the system.

To have successful health programs, ensuring sustainable availability of medicines, medical supplies, and equipment and strengthened pharmacy service is very crucial. To this end, different initiatives such as Drug and Therapeutics Committee (DTC), Auditable Pharmaceuticals

Transaction and Service (APTS), Clinical Pharmacy (CP), Drug Information Service (DIS), Integrated Pharmaceutical Logistic System (IPLS), Medical device Management System

(MEMS), etc. have been undertaken by the Federal Ministry of Health in collaboration with key partner organizations.

Subsequently, it‘s essential to have implementable monitoring and evaluation (M&E) framework that supports in the continuous improvement of Pharmacy Service (PS), Supply Chain (SC) and medical device management (MEM) performance.

In Ethiopia, however; the M&E system for PS, SC, and MEM lacked standardization and was implemented in a fragmented manner. Recognizing this, the FMOH, through Pharmaceuticals and Medical device Directorate (PMED) and in collaboration with partners, has developed national M&E framework and this training manual.

The aim of the training manual is to assist the FMOH, EPSA, RHBs, ZHD, Woreda Health

Offices, health facilities, donor agencies and development partners in implementing M&E framework for evaluating performance and identifying the factors which contribute to service delivery outcomes.

XI

Formal training needs assessment has not been conducted for this course; nevertheless, program performance assessment from reports and review meetings showed a huge gap in knowledge, skill, practices and attitude in the area of M&E which can be filled by in-service training.

To effectively implement the new M&E system, it was found necessary to develop a training course to build the capacity of relevant healthcare professionals. Accordingly, this M&E training is intended to equip professionals with adequate knowledge, skills, and attitude to carry out routine and periodic monitoring and evaluation of Pharmaceuticals and medical device management activities wherein data generated thereof are used for the decision making.

The training material contains Participant‘s Manual, Facilitator‘s Guide and PowerPoint

Presentations. The training course considers participants as the focus of the learning process and as such activities in the sessions are designed to be more trainee-focused.

XII

Core competency

Apply the concept of National monitoring and evaluation framework in the field of PS, SC and ME Management

Perform baseline organizational assessment using the national Pharmaceutical SCM, PS, and ME monitoring and evaluation Indicators

Organize the necessary data required for monitoring and evaluation of PS, SC and ME

Management Indicators

Compute indicators to measure PS, SC and ME activities to determine the level of performance

Apply the result of performance evaluation and feedback to building organizational capacity and development learning

Communicate Effectively the result of performance evaluation to the next level according to the reporting standard

Provide Compassionate, Respectful and Caring(CRC) healthcare service to patients

The core competencies have the following knowledge, attitude and skill attitude components

Knowledge

Apply the Pharmacy and MEM chapter standards in to the respective level of healthcare facility

Monitor & evaluate PS, SC, and ME management activities in the respective level of healthcare facility

Compute Indicators to measure PS, SC, and MEM activities

Skill

Demonstrate a Compassionate, Respectful and Caring(CRC) healthcare service to patients

Collect and organize data related to PS, SC and ME management activities for analysis and decision-making.

Analyze and Interpret Indicators used to measure PS, SC, and MEM activities

Deliver information for decision making

Provide effective feedback

Communicate effectively in the healthcare system

XIII

Attitude

Maintain effective documentation system in the area of Pharmaceutical SCM, PS and ME management of respective health facility

Adhere to National Pharmaceutical SCM, PS and ME monitoring and evaluation Indicators

Advocate Compassionate, Respectful and Caring(CRC) healthcare service in respective level of facility

Maintain responsibility and accountability for the quality and timeliness of work and reporting

Course Syllabus

Course Description

This 3-day training course is designed to enable trainees to understand and implement National

Pharmacy Service, pharmaceutical Supply Chain and Medical device Management Monitoring and Evaluation Framework.

Course Goal

To produce competent, compassionate and committed Health and related professionals working at various level of health service delivery to implement the National Pharmacy Service, pharmaceutical Supply Chain and Medical device Management Monitoring and Evaluation

Framework.

Participants learning objective

At the end of this course participants will be able to:

Demonstrate CRC health care service delivery

Discuss the Operational Standards for Pharmacy Services and Medical device

Management

Identify and compute Indicators used to Measure Pharmacy Service, Supply Chain and

Medical device Management activities

Apply the basic concept of Monitoring and Evaluation into Pharmacy and Medical device Management sector

XIV

Discuss the principles and importance of Data Management and its impact on decision making

Describe the importance of performance monitoring, effective Feedback Mechanisms and motivation in performance improvement

Figure out the Roles and responsibilities of stakeholders

Training Methods

Individual Reflection

Interactive lecture

Demonstration

Group exercise

Pair exercise

Brainstorming

Question and answer

Individual and group reading

Experience sharing

Role play

Home take assignments

Matching Exercise

Individual Exercise

Learning Materials and Resources

Participant manual

Facilitator guide

PowerPoint presentations

LCD Projector

M&E framework

White board and markers

Computer

Flipchart and Markers

Masking tape

XV

Participant Selection Criteria

Pharmacy Professional

Biomedical Professionals

Health Information Technicians

Monitoring and Evaluation Experts

Other health professionals working in the area

Facilitator / Trainer Selection Criteria

Course material developing technical team

Pharmacists

Biomedical Engineers

Monitoring and evaluation expert

Methods of Evaluation

A. Trainees Evaluation

Formative o Direct observation with feedback o Group activities and presentations o Individual reflections for questions o Pretest

Summative o For basic training

Post-test - 100% o For TOT training

Teach back:- 50%

Post-test:- 50%

B. Course Evaluation

Daily evaluation

End of training evaluation

Participant oral feedback

XVI

Certification Criteria

For Basic Training, a trainee is eligible for certification if and only if he/she:

Attend 100% of the course

Score 70% and above on summative assessment

For TOT Training, a trainee is eligible for certification if and only if he/she:

Attend 100% of the course

Score 80% and above on summative assessment

Course Duration

Three days

Suggested Class size

Suggested training class size: shall not be more than 25 participants per training venue.

Participant-Trainer Composition

6:1(six participants to one trainer)

Training Venue

The training will be conducted at the nationally recognized IST centers/CPD providers having appropriate facilities, trainers, and attachment health facilities.

XVII

Course Schedule

Training on Pharmacy Services, Pharmaceutical Supply Chain and Medical device

Management Monitoring and Evaluation

Organized by: _______________________________________________________

Venue: ________________ Date: _________________

Day One Topic Trainer Facilitator

8:00-8:30 am Registration

8:30-9:00 am Welcoming and Introductory activities

9:00-9:20 am Pre-test

9:20-10:45 am Chapter 1: Introduction to CRC

10:45-11: am Tea Break Organizer

11:00-12:30 Chapter 2: Overview on pharmacy and MEM chapter standards

12:30-2:00 pm Lunch Break

2:00-3:30 pm Chapter 3: Monitoring and Evaluation Basics

3:30-3:45 pm Tea Break Organizer

3:45-4:15 pm Chapter 4: Indicators to measure PS, SC, and ME

Management activities: Introduction

4:15-5:20 pm Chapter 4: Indicators to measure PS

5:20-5:30 pm Day 1 Evaluation

Day Two Topic Trainer Facilitator

8:30-8:40 am Recap of Day One

8:40-10:00am Chapter 4: Indicators to measure PS

10:00-10:15 am Tea Break Organizer

10:15 -12:05pm Chapter 4. Indicators to measure PSC

12:05 – 12:30 Chapter 4. Indicators to measure MEM and CC

12:30-2:00 pm Lunch Break

2:00-3:30 pm Chapter 4. Indicators to measure MEM and CC

3:30-3:45pm Tea Break Organizer

3:45-4:45 pm Chapter 4. Indicators collection and aggregation tool

4:45 – 5:20 pm Chapter 4: Practical Exercise on Indicators

5:20-5:30 pm Day 2 Evaluation

Day Three

Topic Trainer Facilitators

8:30-8:40 am Recap of Day 2

8:40-10:30 am Chapter 4: Practical Exercise on Indicators

10:30-10:45 am Tea Break Organizer

10:45-12:30 am Chapter 5: Data Management

12:30-2:00 pm Lunch Break

2:00-3:00 pm Chapter 6: Performance monitoring, Feedback

Mechanisms and motivation

XVIII

3:00-3:40 pm Chapter 7: Roles and responsibilities of stakeholders

3:40-3:55 pm Tea Break Organizer

3:55- 4:25pm Chapter 8: Planning and Getting started

4:25 – 5:30 pm Post-test, Final Evaluation, Closing/Certification

Chapter One: Caring, Respectful and Compassionate Healthcare

Service

Allocated Time: 85 minutes

Chapter Description: This chapter is designed to equip healthcare professionals and senior management in health facilities to increase core competencies of compassionate, respectful, holistic, scientifically and culturally acceptable care for patients and their families.

Chapter Objective: By the end of this chapter the participants will be able to describe

Compassionate, Respectful and Caring (CRC) healthcare service delivery

Enabling Objectives: By the end of this chapter participants will be able to:

• Describe Compassionate, Respectful and Caring (CRC)

• List principles of health care Ethics

• Discuss components of compassionate care

• Explain principles of respectful care

• Discuss characteristics of Compassionate leader

Chapter Outline:

Introduction to CRC

Healthcare Ethics

Compassionate care

Respectful care

Compassionate leader

Summary

1. Introduction to Compassionate, Respectful and Caring (CRC)

Activity 1.1: Individual reflection

What is Compassionate, Respect and Caring (CRC)?

Time: 5 minutes

1.1. Definition of CRC

Compassion (ሩህሩህ)

Compassion is a feeling of deep sympathy and sorrow for the suffering of others accompanied by a strong desire to alleviate the suffering. Therefore, we can say it is being sensitive to the pain or suffering of others and a deep desire to alleviate the suffering.

Respectful (ተገልጋይን የሚያከብር)

Respectful is the kind of care, in any setting, which supports and promotes, and does not undermine a person‘s self-respect, regardless of any differences.

Caring (ተንከባካቢ)

Caring is an intensification of the affective dimension of empathy in the context of significant suffering. It is coupled with effective interventions to alleviate that suffering.

Compassionate, respectful and caring (CRC) - means serving patients, being ethical, living the professional oath, and being a model for young professionals and students. It‘s a movement that requires champions who identify with their profession and take pride by helping people.

Activity 1.2: Pair discussion

Why CRC a transformational agenda?

Time: 5 minutes

1.1.1. Why CRC a Transformation agenda?

Helping health professionals‘ to become compassionate and respectful practitioners remains a major challenge for the healthcare. Compassionate and respectful care is not only morally and financially essential, but it is required in many countries through national legislation and/or national health policy.

The notion that healthcare services must be expanded beyond the prevention of morbidity or mortality is only one aspect of the agenda. It must encompass respect for patients‘ basic human rights, including respect for patients‘ autonomy, dignity, feelings, choices, and preferences. It must include choice of companionship wherever possible.

Taken from the United Nations human rights declaration, ‗All human beings are born free and equal in dignity and rights.‘ The Ethiopian constitution of human rights article 25 and 26 states that the rights to equality and privacy.

In the Ethiopian health system, there are many health professionals who have dedicated their entire career to public service and are respected by the public they serve. However, a significant proportion of health professionals see patients as just ‗cases‘ and do not show compassion. Lack of respect to patients and their families is also a common complaint.

A three-year report of the Ethics Committee and relevant documents in Addis Ababa showed that

39 complaints were related to death of the patient and 15 complaints were about disability. The committee verified that 14 of the 60 claims had an ethical breach and/or negligence and other study also indicated that forwarding bad words, shouting on patients, mistreatment, insulting and hitting of clients are some of unethical practices showed by the health professionals.

Studies showed the need for CRC

Lack of role models in many health facilities.

Measuring the worth of a profession by how much it pays.

Senior physicians cancel their outpatient clinics without informing their patients.

Elective surgeries get cancelled.

Admitted patients are by default getting the care they need from relatives.

Nurses, for various reasons, have limited their role to providing injections and securing

IV lines.

Proper counseling during dispensing of drugs is also becoming a rarity.

The quality of lab tests and the quality assurance process that lab professionals have to take before issuing results is not practiced as expected.

Lack of compassion, respect and care is the common source of grievances in health facilities.

1.1.1. The Benefits of CRC

Table 1: Benefits and beneficiaries of Compassionate and Respectful Care

1.1.2. National Strategy and Approach of CRC

The development of caring, respectful and compassionate health workers requires a multi-pronged approach in order to make CRC as a culture, self-driven inner motive and a legacy that the current generation of practitioners leaves to their successors.

NATIONAL STRATEGY AND APPROACHES FOR CRC

Reforming the recruitment of students for health science and medicine programs.

Improving the curriculum of the various disciplines.

Ownership and engagement of the leadership at all levels of the system.

Inspirational leadership that aims to create an enabling environment.

National, regional and facility level ambassadors.

An advocacy campaign through mass media will also be launched to project positive images of health professionals.

Patients and the general public will also be engaged in this movement.

An annual health professional recognition event will be organized

Putting in place a favorable legislative framework to reinforce CRC which would include regulation on patients’ rights and responsibilities (PRR)

Measurement of health care providers on CRC

Comprehensive projects will be designed.

Conducting national assessment related to CRC.

Provision of continuous CRC trainings.

Engagement and ownership of professional associations.

Experience sharing from national and international best practices.

1.2. Healthcare Ethics

1.2.1. Principles of Health Care Ethics

Activity 1.3: Individual reflection

What is Ethics?

What is Health Care Ethics?

Time: 5 Minutes

Ethics:

Ethics is derived from the Greek word ethos, meaning custom or character. Ethics is the study of morality, which carefully and systematically analyze and reflect moral decisions and behaviors, whether past, present or future. It is a branch of philosophy dealing with standards of conduct and moral judgment.

Health Care Ethics:

It is a set of moral principles, beliefs and values that guide us to make choices about healthcare.

The field of health and healthcare raises numerous ethical concerns, including issues of health care delivery, professional integrity, data handling, use of human subjects in research and the application of new techniques.

Ethical principles are the foundations of ethical analysis because they are the viewpoints that guide a decision. There are four fundamental principles of healthcare ethics.

1. Autonomy

2. Beneficence

3. Non-malfeasance

4. Justice

A. Autonomy

Autonomy is the promotion of independent choice, self-determination and freedom of action.

Autonomy implies independence and ability to be self-directed in one‘s healthcare. It is the basis of self-determination and entitles the patient to make decisions about what will happen to his or her body.

Case one:

A 49-year-old client with diabetic finding came with right foot second finger gangrene to a hospital. The surgeon decided that the finger should be removed immediately. But the patient refused the procedure.

Question: How should the surgeon handle this case?

B. Beneficence

Beneficence is the ethical principle which morally obliges health workers to do positive and rightful things. It is ―doing what is best to the patient‖. In the context of professional-patient relationship the professionals are obliged to always and without exception, favor the wellbeing and interest of their patients.

Case two:

Ms. X was admitted to adult surgical ward with severe excruciating right flank pain with presumptive diagnosis of renal colic. Nurse Y was the duty nurse working that day. The physician who saw her at OPD did not write any order to alleviate the pain.

Question: What should the attending nurse do for Ms. X?

C. Non-malfeasance

The principle refers to ―avoid doing harm‖. Patient can be harmed through omitting or committing interventions. When working with clients, healthcare workers must not cause injury or distress to clients. This principle of non-malfeasance encourages the avoidance of causing deliberate harm, risk of harm and harm that occurs during the performance of beneficial acts.

Non-malfeasance also means avoiding harm as consequence of good.

Case Three:

Mr ―X‖ is admitted to internal medicine ward with cardiac failure. The physician admitted Mr ―X‖ and prescribed some medication which should be given regularly by the ward nurse. A nurse in charge of the ward does not give a patient medication timely and appropriately.

Question: What should the ward nurse do for Mr ―X‖

Time: 5 Minutes

D. Justice

Justice is fair, equitable and appropriate treatment. Justice refers to fair handling and similar standard of care for similar cases; and fair and equitable resource distribution among citizens. It is the basis for treating all clients in an equal and fair way. A just decision is based on client need and fair distribution of resources. It would be unjust to make such decision based on how much he or she likes each client.

Example:

Resource scarcity is the common issue in healthcare settings. For example, there may be only one or two neurosurgeons and many patients on the waitlist who need the expertise of these neurosurgeons. In this case we need to serve patients while promoting the principle of justice in transparent way. Example, the rule of first come first serve could be an appropriate rule.

Justice requires the treatment of all patients equally, irrespective of their sex, education, income or other personal backgrounds.

1.2.2. Confidentiality and informed consent.

Confidentiality

Confidentiality in healthcare ethics underlines the importance of respecting the privacy of information revealed by a patient to his or her health care provider, as well the limitation of healthcare providers to disclose information to a third party. The healthcare provider must obtain permission from the patient to make such a disclosure.

The information given confidentially, if disclosed to the third party without the consent of the patient, may harm the patient, violating the principle of non-malfeasance. Keeping confidentiality promotes autonomy and benefit of the patient.

The high value that is placed on confidentiality has three sources:

Autonomy: personal information should be confidential, and be revealed after getting a consent from the person

Respect for others: human beings deserve respect; one important way of showing respect is by preserving their privacy.

Trust: confidentiality promotes trust between patients and health workers.

The right of patient to confidentiality

All identifiable information about a patient's health status, medical condition, diagnosis, prognosis and treatment and all other information of a personal kind must be kept confidential, even after death. Exceptionally, family may have a right of access to information that would inform them of their health risks.

Confidential information can only be disclosed if the patient gives explicit consent or if expressly provided for in the law. Information can be disclosed to other healthcare providers only on a strictly "need to know" basis unless the patient has given explicit consent.

All identifiable patient data must be protected. The protection of the data must be appropriate to the manner of its storage. Human substances from which identifiable data can be derived must also be protected.

Exceptions to the requirement to maintain confidentiality

Routine breaches of confidentiality occur frequently in many healthcare institutions.

Many individuals (physicians, health officers, nurses, laboratory technicians, students, etc) require access to a patient‘s health records in order to provide adequate care to that person and, for students, to learn how to practice care provision.

Care providers routinely inform the family members of a deceased person about the cause of death. These breaches of confidentiality are usually justified, but they should be kept to a minimum and those who gain access to confidential information should be made aware of the need not to spread it any further than is necessary for descendants benefit.

Where possible, patients should be informed ahead that such a breach might occur.

Many countries have laws for the mandatory reporting of patients who suffer from designated diseases, those deemed not fit to drive and those suspected of child abuse.

Care providers should be aware of the legal requirements to be able to disclose patient information. However, legal requirements can conflict with the respect for human rights that underlies healthcare ethics. Therefore, care providers should look carefully at the legal requirement to allow such an infringement on a patient‘s confidentiality and assure that it is justified.

Case four:

An HIV-positive individual is going to continue to have unprotected sexual intercourse with his spouse or other partners.

Question: 1. How do you manage such an individual?

2. Discuss situations that breach confidentiality.

Ethiopia Council of ministers‟ regulation 299/2013, Article 77 Professional Confidentiality

Informed Consent

Informed consent is legal document whereby a patient signs written information with complete information about the purpose, benefits, risks and other alternatives before he/she receives the care intended. It is a body of shared decision making process, not just an agreement. Patient must obtain and being empowered with adequate information and ensure that he/she participated in their care process.

For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision. These terms are explained below:

A. Voluntary: the decision to either consent or not to consent to treatment must be made by the person him or herself, and must not be influenced by pressure from medical staff, friends or family. This is to promote the autonomy of the patient.

B. Informed: the person must be given all of the information in terms of what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments and the consequences of not doing the treatment. This will help to avoid harm—patients may harm themselves if they decide based on unwarranted and incorrect information.

C. Capacity: the person must be capable of giving consent, which means they understand the information given to them, and they can use it to make an informed decision.

General principle of Informed consent

Should be given by a patient before any medical treatment is carried out. The ethical and legal rationale behind this is to respect the patient‘s autonomy and their right to control his or her life.

The basic idea of personal autonomy is that everyone‘s actions and decisions are his or her own.

The principles include:

1. Information for patients

2. Timing of consent process

3. Health Professionals responsibility for seeking consent

4. Decision making for incompetent patients

5. Refusal of treatment

Ethiopia Council of minister‟s regulation 299/2013, Article 52 Patient‟s informed consent

1.2.3. Preventive ethics in the aspect of CRC

What is preventive ethics?

Preventive Ethics is a systematic application of ethical principles and values to identify and handle ethical quality gaps, dilemmas, challenges and errors to appropriately and fairly. It could be carried out by an individual or groups in the health care organization to identify prioritize and systematic address quality gaps at the system level.

Why is preventive ethics important for CRC healthcare workers?

First and foremost, the CRC health workforce, patients, families and the community at large should have a common understanding that the experience of illness and the practice of medicine lead to situations where important values and principles come to conflict and ethical dilemmas and challenges arise everywhere. Moreover, the CRC health worker should always understand the context in which She/he operates (like the services, the clients, the providers, values, norms, principles, culture, religions, socio-economic-geographic…) as the way in which ethical dilemmas are handled vary from case to case and place to place.

Preventive ethics helps the CRC health workforce to predict, identify, analyze, synthesize and manage ethical dilemmas, challenges and errors to make the appropriate and fair decisions.

Hence, preventive ethics enhances honesty and transparency between healthcare workers, patients, families and relevant others to make a deliberated joint decision. Moreover, it inspires mutual understanding and trust amongst the healthcare provider, recipient and the community at large.

Preventive ethics brings all efforts together productively and leads to the satisfaction of clients, providers and the community even if when the decisions are sometimes painful and outcomes are negative.

1.2.4. Ethics and law as enablers of CRC

The Relation between Ethics and Law

Activity 1.4: Individual reflection

What is the relationship between ethics and law?

Ethics as discussed in the previous sessions, is considered as a standard of behavior and a concept of right and wrong beyond what the legal consideration is in any given situation.

Law is defined as a rule of conduct or action prescribed or formally recognized as binding or enforced by a controlling authority. Law is composed of a system of rules that govern a society with the intention of maintaining social order, upholding justice and preventing harm to individuals and property. Law systems are often based on ethical principles and are enforced by the police and Criminal justice systems, such as the court system.

Ethics and law support one another to guide individual actions; how to interact with clients and colleagues to work in harmony for optimum outcome; provision of competent and dignified care or benefits of clients/ patients. Ethics serves as fundamental source of law in any legal system;

and Healthcare ethics is closely related to law. Though ethics and law are similar, they are not identical.

Often, ethics prescribes higher standards of behavior than prescribed by law; and sometimes what is legal may not be ethical and health professionals will be hard pressed to choose between the two. Moreover, laws differ significantly from one country to another while ethics is applicable across national boundaries.

The responsibilities of healthcare professionals and the rights and responsibilities of the patient is stipulated in legal documents of EFMHACA like regulation 299/2013, directives and health facility standards.

1.2. Principles and Standards of Compassionate Care

1.2.1. Qualities of compassionate care

Compassion can be defined as: ―sensitivity to the suffering of self and others with a deep wish and commitment to relieve the suffering‖.

Developing more compassion can be a way to balance emotions to increase the well-being of patients, healthcare professionals and facilitation of healthcare delivery. For patients, compassion can help prevent health problems and speed-up recovery. Compassion can improve staff efficiency by enhancing cooperation between individuals and teams and between patient and healthcare professionals.

Activity 1.5: Individual reflection

Can compassion be trained and learned?

Time: 2 Minutes

Qualities of Compassionate Care

Figure 1: Qualities of compassion

Role play on qualities of compassionate care:

Instructions:

One participant will take the role of a healthcare provider and another participant will take the role of a mother [with limited mobility] of a sick child with a feeding problem. Other participants should observe and note the discussion.

Roles

Healthcare provider

A mother (with limited mobility) of a sick child:

Situation:

A mother with limited mobility brings her 3-month-old baby girl with cough and fever to the outpatient clinic. The healthcare provider seemed tired. By the time the mother enters the examination room, he was talking with his subordinate about last night‘s football game. He had already noticed her but did not let her to sit. Her child was crying and she was trying to quiet her.

All of a sudden the healthcare provider shouted loudly at the mother to quiet her child or they would have to leave.

While waiting and calming her child, the mother told the healthcare provider that her child is very sick and needs an urgent care. While facing to his friend, the healthcare provider told the mother that he would see her child in five minutes.

After waiting for 10 minutes, the healthcare provider started to examine the child and felt sad about the condition of the child; apologized to her for having let her wait so long. The healthcare provider evaluated the child gently, gave the child a proper treatment, reassured the mother, and the child went home better.

Discussion Questions

Did the health provider demonstrate the characteristics of compassion?

If not, what are the areas /conversation that show poor characteristics of compassion?

If yes, what are the areas /conversation that show good characteristics of compassion?

Time: 25 minutes

1.2.2. Elements of compassionate care

According to researches the key elements of compassionate care has categories, each contains theme and subthemes.

a) Virtue: It is described as ‗‗good or noble qualities embodied in the character of the health care provider

b) Relational space: is defined as the context and content of a compassionate encounter where the person suffering is aware of and is engaged by, the virtues of the health care provider.

The category of relational space comprised two themes.

Patient awareness which describes the extent to which patients intuitively knew or initially sensed health care provider capacity for compassion.

Engaged care giving which refers to tangible indicators of health care provider compassion in the clinical encounter that established and continued to define the health care provider-patient relationship over time.

c) Virtuous Response: It is the ―Enactment of a virtue toward a person in suffering,‘‘ and it is both an individual category and an overarching principle of care that functions as a catalyst to the three core categories of compassionate care giving: ‗‗seeking to understand, relational communicating, and attending to needs‘‘ The category of virtuous response contain three broad themes within it:

Knowing the person refers to the extent to which healthcare providers approached their patients as persons and view their health issues and suffering from this point of view.

Seeing the person as priority involves healthcare providers‘ ability to priorities patient needs, setting aside their own assumptions and healthcare system priorities in the process.

Beneficence refers to healthcare providers wanting the best for the patient, informing the three more targeted core categories of compassionate care giving.

d) Seeking to Understand: refers to healthcare providers trying to know the patient as a person and his or her unique needs.

The need to understand a person‘s desires and tailor his or her care is identified by most patients as a fundamental feature of compassion.

Seeking to Understand the Person.

Seeking to Understand the needs of the Person e). Relational Communication: is an important element of compassion identified by patients consisting of verbal and nonverbal displays conveyed by the healthcare provider‘s engagement with the person suffering.

There are four specific themes and associated subthemes that convey compassion within clinical communication:

Demeanor (‗‗being‘‘)

Affect (‗‗feeling for‘‘)

Behaviors (‗‗doing for‘‘)

Engagement (‗‗being with‘‘)

Attending to Needs

It refers to ‗‗a timely and receptive desire to actively engage in and address a person‘s multi-factorial suffering‘‘. Attending to patients‘ needs has three interrelated themes:

Compassion-Related Needs: refers to the dimensions of suffering that patient feel compassion: physical, emotional, spiritual, familial and financial.

Timely refers to addressing suffering in a ‗‗timely‘‘ manner.

Action refers to the initiation and engagement of a dynamic and tangible process aimed at alleviating suffering. Compassion is more action.

1.2.3. Principles of compassionate care

Activity 1.6: Individual reflection

What are the principles of compassionate care?

The universal principles of compassion will help us know one another in a more meaningful way where we discover one another respectfully. They create the conditions that allow a person who is suffering to experience the healing power of compassion.

I. Attention: is the focus of healthcare provider. Being aware will allow the healthcare provider to focus on what is wrong with a patient; or what matters most to the patient.

II. Acknowledgement: is the principle of what the healthcare professional says. The report of the examination or reflection on the patient‘s message. Positive messages of acknowledgment are buoyant; they let someone know that you appreciate them as a unique individual.

III. Affection: is how healthcare providers affect or touch people. Human contact has the ability to touch someone‘s life. It is the quality of your connection, mainly through warmth, comfort, kindness and humor. Affection brings joy and healing.

IV. Acceptance: is the principle of being with mystery – how you stand at the edge of your understanding or at the beginning of a new experience, and regard what is beyond with equanimity. It is the quality of your presence in the face of the unknown, in the silence. Like the sun in the north at midnight, acceptance welcomes the mysteries of life and is at peace with whom we are and where we are, right now. It is the spirit of Shalom.

The principle of acceptance is: being at peace with the way things are allows them to change.

1.2.4. Threats to compassionate care

There are factors preventing compassion and compassionate behavior for individual members of staff, teams and units and health facility. Most research discusses compassion at the individual level. In general, the most common threats for compassionate care are:

Compassionate fatigue: Physical, emotional and spiritual fatigue or exhaustion resulting from care giving that causes and a decline in the caregivers‘ ability to experience joy or feel and care for others.

A form of burnout, a kind of ―secondary victimization‖ what is transmitted by clients or patients to care givers through empathetic listening.

Unbalanced focus between biomedical model (clinical training) and person: Effective clinical care is clearly fundamentally important, but human aspects of medicine and care must also be valued in training and in terms of how to be a good healthcare professional.

Stress, depression and burnout:

Self-reported stress of health service staff is reported greater than that of the general working population.

Burnout (or occupation burnout) is a psychological term referring to general exhaustion and lack of interest or motivation to work.

Overall health facility context: Attention by senior managers and health facility boards to achieve financial balance that affects priorities and behaviors of staff in health facility.

Addressing Threats of compassion

Overcoming compassion fatigue

Developing an inner compassionate self

Compassion to yourself

Teaching compassion to professionals through, training and education

Dealing with staff stress and burnout

Dealing with wider health facility context

1.3. Respectful care

1.3.1. Definition of Concepts of Respectful and Dignified Care

Activity 1.7: Pair discussion

1. Can you share us your experience with regard to respect and dignity in the health care setting?

2. What does respectful care mean to you?

Time Allowed: 5 minutes

Definition of Dignity (ልእልና )

The word dignity originates from two Latin words: ‗dignitus‘ which means merit and ‗dignus‘ meaning worth. It is defined from two perspectives:

Dignity is a quality of the way we treat others.

Dignity is a quality of a person‘s inner self.

Types of Dignity

There are four types of dignity: dignity of human being, personal identity, merit and moral status.

a) Dignity of human being

This type of dignity is based on the principle of humanity and the universal worth of human beings their inalienable rights-which can never be taken away.

b) Dignity of personal identity

This form of dignity is related to personal feelings of self-respect and personal identity, which also provides the basis for relationships with other people.

c) Dignity of merit

This is related to a person‘s status in a society.

d) Dignity of moral status

This is a variation of…