Chapter 2

2.1 Literature review

Defining Patient safety

The IOM defines patient safety as "the prevention of damage to patients." The emphasis is

on a care delivery system that prevents errors, learns from those that do occur, and is based

on a safety culture that includes health care workers, organizations, and patients.

Despite the acknowledged potential of modern medicine to cure and mitigate illness, one of

the defining realizations of the 1990s was that hospitals were not safe places for recovery.

Instead, they were dangerous environments for patients. The growing interest in patient safety

is one key response to this understanding. It's becoming evident that patient safety has

evolved into a science with its own body of knowledge and expertise, and that it has the

potential to transform health care in the same way that molecular biology did. Patient safety

is currently recognized in many nations, thanks to the World Health Organization's World

Alliance for Patient Safety, which promotes global awareness.

2.2 components of patient safety

2.3 The global need for patient safety

With the publication of the seminal study To Err is Human: Building a Safer Health System

by the United States Institute of Medicine in 1999, the gravity of the problem of unsafe care

drew increasing public attention (Kohn et al, 1999). The paper extrapolated a death rate from

the prevalence of adverse events in US hospitals from two previous studies, estimating that at

least 44 000 and possibly as many as 98 000 individuals died each year in hospitals as a result

of medical errors. (panesar, SS, et.al). An organization with a memory was published by the

United Kingdom Department of Health in 2000 both investigations covered the topic of

health-care safety and harm, drew comparisons with other high-risk businesses, and were the

first to do so. An estimated 1 in 10 patients is subject to an adverse event while receiving

hospital care in high-income countries. Available evidence suggests that 134 million adverse

events are due to unsafe care that occur in hospitals in low- and middle-income countries,

contributing to around 2.6million deaths every year. (Elder NC, et.al, 2004). A recent

systematic review including studies from 21 different countries estimated that 2-3 patient

safety incidents occur per 100 primary care consultations, and 4% of them result in severe
harm (long-term physical or psychological problems or death) (Paneser SS et al, 2016). In

UK this would transform to 15000-22500 safety incidents per day, resulting in 600-900

patients being severely harmed per year. (Elder NC, et al, 2004). Previous studies are

heterogeneous in terms of the different aspects of patient safety examined, but also in terms

of countries in which they have been conducted (Australia, New Zealand, USA) with diverse

health systems (Dowell D, 2005). Patient safety is highly contextual, and findings cannot be

necessarily extrapolated across countries. Patients are ideally suited to reflect on the health

care they receive. According to the World Health Organization, focusing on patients opinions

for health care safety can contribute significantly to improving patient safety.

2.3.1 The global patient safety action plan 2021

Patient safety is essential in all situations where health care is provided. However, avoidable

adverse events, errors, and risks in health care continue to be major challenges for patient

safety around the world. (The global action plan). In 2019, the 72nd World Health Assembly

passed Resolution WHA72.6 on global action on patient safety, which demanded the creation

of a global patient safety action plan. The Seventy-Fourth Future Health Assembly endorsed

this global action plan in 2021, with the objective of "a world in which no one is injured in

health care and every patient receives safe and respectful treatment, every time,

everywhere."(World health organization, 2019). The goal of the action plan is to give all

stakeholders strategic direction for preventing avoidable harm in health care and improving

patient safety in various practice domains through policy actions on health service safety and

quality, as well as implementation of recommendations at the point of care. The action plan

lays out a framework for countries to build their own national patient safety action plans, as

well as aligning current strategic instruments for improving patient safety in all clinical and

health-related programs.
2.4 Medication without harm

The World Health Organization (WHO) is launching the third Global Patient Safety

Challenge, which will focus on pharmaceutical safety. It is based on WHO’s prior patient

safety concept, which states that errors are unavoidable and are exacerbated in large part by

weak health systems, thus the objective is to limit their frequency and impact. The Global

Ministerial Summit on Patient Safety in Bonn, Germany, launched the Challenge in March

2017. The launch presented a chance for leaders to drive change and work together to make a

genuine impact in the lives of patients, families, and frontline health workers by enlisting the

support of high-level delegates, ministers of health, and experts. This Challenge will build on

the knowledge gained in prior Challenges to drive a change process aimed at reducing patient

harm caused by hazardous pharmaceutical practices and medication errors. Everyone on the

planet will take medicines to prevent or treat illness at some point in their lives. Medicine has

forever changed our ability to live with disease and has extended our lives in general.

Medicines, on the other hand, can cause substantial injury if used wrongly, monitored

insufficiently, or as a result of an error, accident, or a breakdown in communication. Humans

rarely make mistakes because of neglect, as evidenced by experience from other high-risk

industries and WHO's long-standing work with experts in health care safety. Instead, human

beings make mistakes because of the systems, processes, and procedures that they work with.

2.5 Role of patients in patient safety

The patient’s perspective ought to be a key component of any quality improvement strategy.

Quality from the patient’s perspective includes access to care, responsiveness and empathy,

good communication, clear information provision, appropriate treatment, relief of symptoms,

improvement in health status and, above all, safety and freedom from medical injury. Coulter

and Ellins, 2007). There have been few studies of patients’ views on the safety of health care

or the risk of medical errors, but some evidence from the US indicates a significant level of

awareness of safety issues among the general population. For example, in a national

telephone survey carried out in 1997 by Louis Harris and Associates on behalf of the

National Patient Safety Foundation, 42% of respondents disagreed with the proposition that

the current healthcare system had adequate measures in place to prevent medical mistakes,

and 42% indicated that they or their close friends and relatives had experienced a medical

mistake. (Louis H, 1997). Patients are usually thought of in a passive way as the victims of

errors and safety failures, but there is considerable scope for them to play an active part in

ensuring that their care is effective and appropriate in preventing mistakes and assuring their

own safety (WHO, 2017). It is, of course, important not to place an additional burden of

responsibility on people who are already anxious and vulnerable because of injury or serious

illness. However, most clinical encounters are not times of crisis for patients and additional

involvement in their treatment should not be a burden. (Dowell, D, et.al, 2005). When

patients are seriously ill it may be even more important to take their views and wishes into

account, either by involving them directly or by using family members as surrogate decision

makers. Instead of treating patients as passive recipients of medical care, it is much more

appropriate to view them as partners or co-producers with an active role in their care which

needs to be recognized and enhanced (Mockford C, et,al, 2012).

 Box 1

The patient’s role in promoting safety The patient is involved in:

• Helping to reach an accurate diagnosis.

• Deciding on appropriate treatment or management strategy.

• Choosing a suitably experienced and safe provider.

• Ensuring that treatment is appropriately administered, monitored and adhered to.

• Identifying side effects or adverse events quickly and taking appropriate action.

2.5.1Engage patients and families as partners in safe care

Safe health care should be seen as a basic human right. As health care is predominantly a

service, it is always co-produced with the users. Achieving safe care requires that patients be

informed, involved and treated as full partners in their own care. (Stille CJ, et.al,2007). In

many parts of the world, this happens much less than it should. Patients, families and

caregivers have a keen interest in their own health and that of their communities. Patient

safety depends on their full involvement as the users of the health care system and the people

who are most familiar with the entire patient journey. Patients and families should be

involved at every level of health care, ranging from policy-making and planning, to

performance oversight, to fully informed consent and shared decision-making at the point of
care. Patients, families and communities have essential contributions to make in patient

safety. (Coulter, A, Ellins J 2007)

Empowering patients to take an active role in their own health care has been nationally and

internationally identified as a key factor in the drive to improve health services for the patient

(Wilson, R at.el, 2012). Patients can play an important role in the reduction of patient safety

incidents (defined by the UK’s National Patient Safety Agency (NPSA) as unintended or

unexpected incidents which could have or did lead to harm for one or more patients receiving

NHS funded care). At most stages of care there is the opportunity for the patient to

contribute, for example, helping avoid medication errors and the monitoring of adverse

events (Syed.S at.el, 2008). There are currently a number of national and international

initiatives which support this view, which aim to facilitate patient involvement in safety.

(Vincent C, Amalberti R, 2016). However, the acceptability of such interventions from the

patients’ perspective remains unknown.

Engaging patients in the safety of the care delivered to them, however, should not be taken to

mean that the patients should carry the ultimate responsibility for the safety of the care that

they receive. Patients can only function as a safety ‘buffer’ (often, the very last one) in

addition to those in the healthcare system that are already in place. In other words, patients

should not feel that if they do not wish or are unable to contribute to their own safety they

will, as a result, receive substandard care. Equally, the responsibility of delivering safe care

remains in the hands of the health care professionals. (Dixon-Woods. M,2010).

Involving patients in safety represents a specific instance of the wider concept of patient

participation in health care. Preliminary studies on patient perceptions of errors in primary

care suggest that it is unlikely that patients will view safety issues in a different way to more

generic concerns about the quality of health care, (Nolan TW, 2000) though engagement in
safety will carry some specific challenges. These may include the fact that some safety-

related patient behaviours may be perceived by patients and clinicians alike as challenging

clinicians’ professionalism. In addition, while in other areas of patient involvement in health

care, patient involvement has been well documented (e.g. patient involvement in TDM),

patient involvement in safety is an emerging field of interest with limited evidence.

Patient engagement has been shown to improve HIV treatment adherence (Menichetti J, at.el

2017).The purpose of patient engagement is to involve patients in treatment decision-making,

allowing patients and physicians to make shared medical decisions (Aurelie Lucette GI,

2015). Peer-based programs, provider training and mentorship, task shifting, and community-

based treatment programs have all been demonstrated to increase patient engagement [9]. In a

region where system-level barriers exist, such as inconvenient clinic hours, high provider

workload, poor patient-provider communication and relationship skills, lack of continuity of

patient-provider relationships, provider burnout, and low provider motivation, more

evidence-based approaches are needed (Finset A, 2017), (McMillan SS, Kendall E, at.el

2013).

2.6 Patient safety in Africa

In eastern Mediterranean and African study, a third of patients who suffered harmful effects

due to unsafe care died.14% sustained a permanent disability, 16% were moderately harmed,

and 30% were left with minimal harm. Conclusions made showed that 34%of the incidents

resulted from therapeutic errors, 19% from surgical mistakes and 9% obstetrics (patient

safety in developing and transitional countries, 2011).

A recent study done in Nigeria showed that 26.4% patient safety incidents were due to

incorrect ART prescribed, 19.8% due to potential drug to drug interactions and 16.6% were

due to inappropriate medications. Among studies done on 68 HIV patients (Sonak D, et al,

2008), it showed that at least one error in the initial HIV regimen occurred in 72 % of the

patients and 56 % resulted in severe discomfort or clinical detoriation.

In 2014, the Human Immunodeficiency Virus (HIV) infected approximately 5.51 million

persons in South Africa (Statistics South Africa, 2014). Since 2009, the government of south

Africa has developed a variety of initiatives aimed at increasing access to antiretroviral

therapy (ART) for specific groups of HIV patients. The most recent guidelines recommend

starting ART as soon as the patient's CD4+ count reaches 500 cells/l. The recommendations'

goals are to ensure that persons living with HIV receive the appropriate treatment at the right

time, to improve clinical results, to minimize morbidity from tuberculosis (TB)/HIV co-

infection, to reduce HIV incidence, and to avoid fatalities from AIDS (NDoH, 2014). As a

result, the supply and demand for ART have grown, raising the price. As a result, both the

supply and demand for ART have increased, raising the risk of severe medication reactions

(ADRs). ADRs contribute to increased health-care expenditures by increasing patient

morbidity, mortality, and hospitalization (Manikum & Suleman, 2012).

2.7 Patient safety in Zimbabwe

There are limited resources provided on the internet for patient safety in people living with

HIV in Zimbabwe. According to the 2015 quality assurance and quality improvement policy

under the Ministry of Health and Child Care, the policy states that all patients are not to be
harmed or injured when receiving patient care. Chief Director of Curative Services, Dr.

Maxwell Hove, speaking on behalf of Zimbabwe at the present 74th World Health Assembly,

reaffirmed the Ministry of Health and Child Care's commitment to prioritize patient safety as

a core component of its services. "We applaud the Global Patient Safety Action Plan 2021–

2030, which we feel will go a long way toward closing country gaps." Dr. Hove added, "We

also feel that safe infrastructure, technologies, and medical equipment are critical factors to

ensuring patient safety." Patient safety, according to the Chief Director of Curative Services,

necessitates a collaborative multisector effort in the provision of water, and a dedicated

department has been established to address this issue.

“World Patient Safety Day is now an annual event celebrated on 17th of September,

established by the 72nd World Health Assembly, in May 2019, with the adoption of

resolution WHA72.6 on ‘Global action on patient safety’. “The resolution recognizes patient

safety as a global health priority whose origin is firmly grounded in the fundamental principle

of medicine of: – First, do no harm. Setting the tone that no one should be harmed in the

process of delivering care,” said the Deputy Minister of Health. “This year’ theme, Health

Worker Safety: A Priority for Patient Safety, recognises a very important prerequisite to

patient safety that is a safe and healthy health worker.

Dr Mangwiro pointed out that past practices were skewed towards patients and neglecting the

health workers and stated that the new thrust was aimed striking a balance between the two

by further engaging patients.

“Patient Safety Day commemorations today assists us in advancing and shaping the patient

safety agenda by focusing and driving improvements in some key strategic areas through

engaging patients and families for safer health care monitoring improvements in patient

safety,” said Dr Mangwiro. Permanent Secretary in the Ministry of Health, Air Commodore
Dr Jasper Chimedza weighed in and noted that some deaths occur due to errors which results

in long term impact on the patient. “Some studies suggest that Zimbabwe record as many as 1

000 deaths annually as a result of errors or preventable harm. Not every case of harm results

in death, yet they can cause long term impact on the patient’s physical health, emotional

heath, financial well-being, or family relationships,” said the Health Secretary.

Dr Chimedza spelt out Ministry of Health’s commitment to address health workers’ safety

which translates into patient safety. “At MoHCC (Ministry of Health), we believe patient

safety has to be addressed and must start with addressing health workers’ safety. A safe

worker is a pre-requisite for a sustained safe working environment and ultimately the safety

of the client who in most cases is the patient,” said Dr Chimedza. “On 17 September, we

celebrate World Patient Safety Day because we realise quality health care, the first step is to

do no harm, yet in hospitals in low- and middle- income countries globally, every year, there

are 134 million adverse events due to unsafe care, contributing to 2.6 million lives lost,” said

World Health Organisation Representative, Dr Midzi who delivered a key message of the

WHO Regional Director for Africa, Dr Matshidiso Moeti. Dr Midzi stated that health

workers were also at risk of being infected whilst discharging their duties with figures

standing at 41 000 during this COVID-19 era. “In WHO Africa Region, more than 41 000

health workers have been infected with COVID-19, accounting for 3.8% of all reported

cases,” said Dr Midzi. The celebrations were coordinated by Ministry of Health and Child

Care Director for Quality Assurance and Improvement, Musiwarwo Chirume.

(http://www.mohcc.gov.zw).

2.8 Methodology

Methodology is the study of different methods in research. There are two main types of

research design which are quantitative and qualitative. Quantitative research design’s overall

structure is mainly based on the scientific method whereby the researcher forms a hypothesis
,collects data based on the problem on investigation ,analyzes it thereby deducing whether the

hypotheses is true or false. It also focuses more on the size, frequency and quantity. Besides

quantitative research, there is also qualitative which mainly focuses on the experiences or

quality or meaning of a certain situation /problem. Qualitative data is obtained mainly from

interviews, focus groups, participant observation and examining past records

(documentation). Moreover qualitative methods are more flexible as compared to quantitative

methods, hence greater spontaneity is achieved between the researcher and the participant.

Interviews are mainly conducted when sensitive topics, experiences and perceptions are being

aired out. (Family health international, 2017). The main advantage of conducting interviews

are that they are cheap and are not time consuming , however there might be a bias by the

participant , when he or she says something that is expected of .When one desires to generate

a broad overview, focus groups will be the best method of data collection focusing on a group

of people with a certain characteristic .During the interview, open ended questions are asked

in order to get clear meanings and explanations .Participant observation is mainly used by

just observing participants’ behavior in their usual acts. However if participants feels that

they are being noticed there might start to act in a certain way which could also leads to bias.

Cross sectional, case control and cohort are study designs mainly used under quantitative

research as they use statistical data to test for hypotheses. A cross sectional survey can be

used in qualitative research as it can be used to gather information on a population at single

time. Usually interviews and questionnaires are used as methods of data collection. It is

relatively cheap, quick, simple to carry out and analyze. Interviews are normally used to

obtain specific information from an interviewee and usually includes structured or

standardized interview questions. Normally it is used when some of the information is known

and there is need to gain more in-depth insight. (Family health international, 2017).
Under cross sectional survey, one can also make use of questionnaires as a method of data

collection, which produce both qualitative and quantitative information. The main

disadvantage of questionnaire might be of language barrier hence one has to use the language

that would be understood by the respondents. However cross-sectional surveys are prone to

bias, and are weak in investigating causality. The other type of a study design is case series,

individual case reports are collected describing some interesting observations that occurred in

small number of patients, it is very useful in formulating research hypotheses and suggestive

risk factors. A qualitative cross-sectional design will be used for this study because it

captures data at a specific point in time, cheap and it does not require a lot of time. (Family

health international, 2017).

Thematic analysis is a flexible method of analyzing qualitative data that involves reading

through a data set such as transcripts from focus group discussions and in depth interviews. It

is also used in identifying patterns in meaning across the data. When using thematic analysis,

the first step is to familiarize with the data from audio files and transcribing them. The second

step involved is creating initial codes that represent the meanings and patterns in the data.

The next steps includes collating codes with supporting data and grouping codes into themes.

The final steps includes reviewing and revising themes by ensuring that each theme has

enough data to support them and is distinct. (Braun and Clarke, 2006)