Patient Safety

13 September 2019

Key facts
 The occurrence of adverse events due to unsafe care is likely one of
the 10 leading causes of death and disability in the world (1).
 In high-income countries, it is estimated that one in every 10
patients is harmed while receiving hospital care (2). The harm can be
caused by a range of adverse events, with nearly 50% of them being
preventable (3).
 Each year, 134 million adverse events occur in hospitals in low- and
middle-income countries (LMICs), due to unsafe care, resulting in 2.6
million deaths (4).
 Another study has estimated that around two-thirds of all adverse
events resulting from unsafe care, and the years lost to disability and
death (known as disability adjusted life years, or DALYs) occur in
LMICs (5).
 Globally, as many as 4 in 10 patients are harmed in primary and
outpatient health care. Up to 80% of harm is preventable. The most
detrimental errors are related to diagnosis, prescription and the use of
medicines (6).
 In OECD countries, 15% of total hospital activity and expenditure is a
direct result of adverse events (2).
 Investments in reducing patient harm can lead to significant
financial savings, and more importantly better patient outcomes (2).
An example of prevention is engaging patients, if done well, it can
reduce the burden of harm by up to 15% (6).

What is Patient Safety?

Patient Safety is a health care discipline that emerged with the evolving
complexity in health care systems and the resulting rise of patient harm in health
care facilities. It aims to prevent and reduce risks, errors and harm that occur to
patients during provision of health care. A cornerstone of the discipline is
continuous improvement based on learning from errors and adverse events.

Patient safety is fundamental to delivering quality essential health services.

Indeed, there is a clear consensus that quality health services across the world
should be effective, safe and people-centred. In addition, to realize the benefits of
Keselamatan Pasien adalah disiplin perawatan kesehatan yang muncul dengan
kompleksitas yang berkembang dalam sistem perawatan kesehatan dan
meningkatnya bahaya pasien di fasilitas perawatan kesehatan. Ini bertujuan
untuk mencegah dan mengurangi risiko, kesalahan dan bahaya yang terjadi
pada pasien selama pemberian layanan kesehatan. Landasan dari disiplin ini
adalah peningkatan berkelanjutan berdasarkan pembelajaran dari kesalahan dan
peristiwa buruk.

Keselamatan pasien sangat penting untuk memberikan layanan kesehatan

esensial yang berkualitas. Memang, ada konsensus yang jelas bahwa layanan
kesehatan berkualitas di seluruh dunia harus efektif, aman dan berpusat pada
orang. Selain itu, untuk merealisasikan manfaat perawatan kesehatan yang
berkualitas, layanan kesehatan harus tepat waktu, merata, terintegrasi dan
efisien.

quality health care, health services must be timely, equitable, integrated and
efficient.    

To ensure successful implementation of patient safety strategies; clear policies,

leadership capacity, data to drive safety improvements, skilled health care
professionals and effective involvement of patients in their care, are all needed.

Why does patient harm occur?

A mature health system takes into account the increasing complexity in health
care settings that make humans more prone to mistakes. For example, a patient
in hospital might receive a wrong medication because of a mix-up that occurs due
to similar packaging. In this case, the prescription passes through different levels
of care starting with the doctor in the ward, then to the pharmacy for dispensing
and finally to the nurse who administers the wrong medication to the patient. Had
there been safe guarding processes in place at the different levels, this error
could have been quickly identified and corrected. In this situation, a lack of
standard procedures for storage of medications that look alike, poor
communication between the different providers, lack of verification before
medication administration and lack of involvement of patients in their own care
might all be underlying factors that led to the occurrence of errors. Traditionally,
the individual provider who actively made the mistake (active error) would take
the blame for such an incident occurring and might also be punished as a result.
Unfortunately, this does not consider the factors in the system previously
described that led to the occurrence of error (latent errors). It is when multiple
latent errors align that an active error reaches the patient.

To err is human, and expecting flawless performance from human beings working
in complex, high-stress environments is unrealistic. Assuming that individual
perfection is possible will not improve safety (7). Humans are guarded from
making mistakes when placed in an error-proof environment where the systems,
tasks and processes they work in are well designed (8). Therefore, focusing on
the system that allows harm to occur is the beginning of improvement, and this
can only occur in an open and transparent environment where a safety culture
prevails. This is a culture where a high level of importance is placed on safety
beliefs, values and attitudes and shared by most people within the workplace (9).

The burden of harm

Every year, millions of patients suffer injuries or die because of unsafe and poor-
quality health care. Many medical practices and risks associated with health care
are emerging as major challenges for patient safety and contribute significantly to
the burden of harm due to unsafe care. Below are some of the patient safety
situations causing most concern.

Medication errors are a leading cause of injury and avoidable harm in health

care systems: globally, the cost associated with medication errors has been
estimated at US$ 42 billion annually (10).

Health care-associated infections occur in 7 and 10 out of every 100

hospitalized patients in high-income countries and low- and middle-income
countries respectively (11).

Unsafe surgical care procedures cause complications in up to 25% of patients.

Almost 7 million surgical patients suffer significant complications annually, 1
million of whom die during or immediately following surgery (12).

Unsafe injections practices in health care settings can transmit infections,

including HIV and hepatitis B and C, and pose direct danger to patients and
health care workers; they account for a burden of harm estimated at 9.2 million
years of life lost to disability and death worldwide (known as Disability Adjusted
Life Years (DALYs)) (5).
Diagnostic errors occur in about 5% of adults in outpatient care settings, more
than half of which have the potential to cause severe harm. Most people will
suffer a diagnostic error in their lifetime (13).

Unsafe transfusion practices expose patients to the risk of adverse transfusion

reactions and the transmission of infections (14). Data on adverse transfusion
reactions from a group of 21 countries show an average incidence of 8.7 serious
reactions per 100 000 distributed blood components (15).

Radiation errors involve overexposure to radiation and cases of wrong-patient

and wrong-site identification (16). A review of 30 years of published data on
safety in radiotherapy estimates that the overall incidence of errors is around 15
per 10 000 treatment courses (17).

Sepsis is frequently not diagnosed early enough to save a patient’s life. Because
these infections are often resistant to antibiotics, they can rapidly lead to
deteriorating clinical conditions, affecting an estimated 31 million people
worldwide and causing over 5 million deaths per year (18).

Venous thromboembolism (blood clots) is one of the most common and

preventable causes of patient harm, contributing to one third of the complications
attributed to hospitalization. Annually, there are an estimated 3.9 million cases in
high-income countries and 6 million cases in low- and middle-income
countries (19).

Patient Safety - a fundamental component for

Universal Health Coverage
Safety of patients during the provision of health services that are safe and of high
quality is a prerequisite for strengthening health care systems and making
progress towards effective universal health coverage (UHC) under Sustainable
Development Goal 3 (Ensure healthy lives and promote health and well-being for
all at all ages) (7).

Target 3.8 of the SDGs is focused on achieving UHC “including financial risk
protection, access to quality essential health care services, and access to safe,
effective, quality, and affordable essential medicines and vaccines for all.” In
working towards the target, WHO pursues the concept of effective coverage:
seeing UHC as an approach to achieving better health and ensuring that quality
services are delivered to patients safely (20).
It is also important to recognize the impact of patient safety in reducing costs
related to patient harm and improving efficiency in health care systems. The
provision of safe services will also help to reassure and restore communities’
trust in their health care systems (21).

WHO response
Resolution (WHA 72.6) on Patient Safety 

Recognizing that Patient Safety is a global health priority, the World Health
Assembly (WHA) adopted a resolution on Patient Safety which endorsed the
establishment of World Patient Safety Day to be observed annually by Member
States on 17 September.

1. Patient Safety as a global health priority

 https://mailchi.mp/who.int/wha-72-achievements-commitment-
accountability
 https://www.who.int/patientsafety/policies/global-health-priority/en/
 (WHA 72.6)

The purpose of World Patient Safety Day is to promote patient safety by

increasing public awareness and engagement, enhancing global understanding
and working towards global solidarity and action.

2. World Patient Safety Day

Key strategic action areas

The Patient Safety and Risk Management unit at WHO has been instrumental in
advancing and shaping the patient safety agenda globally by focusing on driving
improvements in some key strategic areas through:

 providing global leadership and fostering collaboration between Member

States and relevant stakeholders
 setting global priorities for action
 developing guidelines and tools
 providing technical support and building capacity of Member States
 engaging patients and families for safer health care
 monitoring improvements in patient safety
 conducting research in the area
By focusing on these key areas to facilitate sustainable improvements in patient
safety, WHO aims to enhance patient experience, reduce risks and harm,
achieve better health outcomes and lower costs.

WHO initiatives to date

WHO's work on patient safety began with the launch of the World Alliance for
Patient Safety in 2004 and this work has continued to evolve over time. WHO has
facilitated improvements in the safety of health care within Member States
through establishment of Global Patient Safety Challenges. Each of the
Challenges has identified a patient safety burden that poses a major and
significant risk. The challenges thus far have been:

 Clean Care is Safer Care (2005); with the goal of reducing health care-
associated infection, by focusing on improved hand hygiene.
 Safe Surgery Saves Lives (2008); dedicated to reducing risks associated
with surgery.
 Medication Without Harm (2017); with the aim of reducing the level of
severe, avoidable harm related to medications globally by 50% over five
years.

WHO has also provided strategic guidance and leadership to countries through
the annual Global Ministerial Summits on Patient Safety, which seek to advance
the patient safety agenda at the political leadership level with the support of
health ministers, high-level delegates, experts and representatives from
international organizations.

WHO has been pivotal in the production of technical guidance and resources
such as the Multi-Professional Patient Safety Curriculum Guide, Safe Childbirth
Checklist, the Surgical Safety Checklist, Patient Safety solutions, and 5 Moments
for Medication Safety (available in print and in App form).

To promote global solidarity, WHO has also encouraged the creation of

networking and collaborative initiatives such as the Global Patient Safety Network
and the Global Patient Safety Collaborative. Recognizing the importance of
patients’ active involvement in the governance, policy, health system
improvement and their own care, the WHO also established the Patients for
Patient Safety programme to foster the engagement of patients and families.

References

1. Jha AK. Presentation at the “Patient Safety – A Grand Challenge for

Healthcare Professionals and Policymakers Alike” a Roundtable at the Grand
Challenges Meeting of the Bill & Melinda Gates Foundation, 18 October 2018
(https://globalhealth.harvard.edu/qualitypowerpoint, accessed 23 July 2019).

2. Slawomirski L, Auraaen A, Klazinga N. The economics of patient safety:

strengthening a value-based approach to reducing patient harm at national level.
Paris: OECD; 2017 (http://www.oecd.org/els/health-systems/The-economics-of-
patient-safety-March-2017.pdf, accessed 26 July 2019).

3. de Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester MA.
The incidence and nature of in-hospital adverse events: a systematic review.
Qual Saf Health Care. 2008;17(3):216–23.
http://doi.org/10.1136/qshc.2007.023622
https://www.ncbi.nlm.nih.gov/pubmed/18519629

4.National Academies of Sciences, Engineering, and Medicine. Crossing the

global quality chasm: Improving health care worldwide. Washington (DC): The
National Academies Press; 2018 (https://www.nap.edu/catalog/25152/crossing-
the-global-quality-chasm-improving-health-care-worldwide, accessed 26 July
2019).

5. Jha AK, Larizgoitia I, Audera-Lopez C, Prasopa-Plaizier N, Waters H, W Bates

D. The global burden of unsafe medical care: analytic modelling of observational
studies. BMJ Qual Saf Published Online First: 18 September 2013.
https://doi.org/10.1136/bmjqs-2012-001748
https://www.ncbi.nlm.nih.gov/pubmed/24048616

6. Slawomirski L, Auraaen A, Klazinga N. The Economics of Patient Safety in

Primary and Ambulatory Care: Flying blind. Paris: OECD; 2018
(http://www.oecd.org/health/health-systems/The-Economics-of-Patient-Safety-in-
Primary-and-Ambulatory-Care-April2018.pdf, accessed 23 July 2019).

7. Systems Approach. In: Patient Safety Network [website]. Rockville (MD):

Agency for Healthcare Research and Quality; 2019
(https://psnet.ahrq.gov/primers/primer/21, accessed 23 July 2019).

8. Leape L. Testimony before the President’s Advisory Commission on Consumer

Production and Quality in the Health Care Industry, November 19, 1997.

9. Workplace Health and Safety Queensland. Understanding safety culture.

Brisbane: The State of Queensland; 2013
(https://www.worksafe.qld.gov.au/__data/assets/pdf_file/0004/82705/understandi
ng-safety-culture.pdf, accessed 26 July 2019).

10. Aitken M, Gorokhovich L. Advancing the Responsible Use of Medicines:

Applying Levers for Change. Parsippany (NJ): IMS Institute for Healthcare
Informatics; 2012 (https://ssrn.com/abstract=2222541, accessed 26 July 2019).

11. Report on the burden of endemic health care-associated infection worldwide.

Geneva: World Health Organization; 2011
(http://apps.who.int/iris/bitstream/handle/10665/80135/9789241501507_eng.pdf?
sequence=1, accessed 26 July 2019).

12. WHO guidelines for safe surgery 2009: safe surgery saves lives. Geneva:
World Health Organization; 2009
(http://apps.who.int/iris/bitstream/handle/10665/44185/9789241598552_eng.pdf?
sequence=1, accessed 26 July 2019).

13. Singh H, Meyer AN, Thomas EJ. The frequency of diagnostic errors in
outpatient care: estimations from three large observational studies involving US
adult populations. BMJ Qual Saf. 2014;23(9):727–31.
https://doi.org/10.1136/bmjqs-2013-002627
https://www.ncbi.nlm.nih.gov/pubmed/24742777

14. Clinical transfusion process and patient safety: Aide-mémoire for national
health authorities and hospital management. Geneva: World Health Organization;
2010 (http://www.who.int/bloodsafety/clinical_use/who_eht_10_05_en.pdf?ua=1,
accessed 26 July 2019).

15. Janssen MP, Rautmann G. The collection, testing and use of blood and blood
components in Europe. Strasbourg: European Directorate for the Quality of
Medicines and HealthCare (EDQM) of the Council of Europe; 2014
(https://www.edqm.eu/sites/default/files/report-blood-and-blood-components-
2014.pdf, accessed 26 July 2019).

16. Boadu M, Rehani MM. Unintended exposure in radiotherapy: identification of

prominent causes. Radiother Oncol. 2009; 93(3):609–17.
https://doi.org/10.1016/j.radonc.2009.08.044
https://www.ncbi.nlm.nih.gov/pubmed/19783058
17. Shafiq J, Barton M, Noble D, Lemer C, Donaldson LJ. An international review
of patient safety measures in radiotherapy practice. Radiother Oncol.
2009;92:15-21 https://doi.org/10.1016/j.radonc.2009.03.007

18. Fleischmann C, Scherag A, Adhikari NK, et al. Assessment of Global

Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and
Limitations. Am J Respir Crit Care Med 2016; 193(3): 259-72.
https://doi.org/10.1164/rccm.201504-0781OC
https://www.ncbi.nlm.nih.gov/pubmed/26414292

19. Raskob E, Angchaisuksiri P, Blanco N, Buller H, Gallus A, Hunt B, et al.

Thrombosis: A major contributor to global disease burden. Thrombosis Research.
2014; 134(5): 931–938
(https://www.sciencedirect.com/science/article/pii/S0049384814004502,
accessed 23 July, 2019).

20. Proposed programme budget 2020–2021. Seventy-Second World Health

Assembly, provisional agenda item 11.1. Geneva: World Health Organization;
2019 (http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_4-en.pdf, accessed 23
July 2019).

21. Patient safety- Global action on patient safety. Report by the Director-
General. Geneva: World Health Organization; 2019
(https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_26-en.pdf, accessed 23
July 2019).