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While being treated, patients hope that their health-related problems will be appropriately handled and healthcare professionals trust that their procedures, equipment, and training should be used in good working order and in the proper way. However, sometimes an incident occurs.

A patient safety incident (in this manual referred as an incident) is an event or circumstance which could have resulted, or did result, in unnecessary harm to a patient. Incidents can arise from either unintended or intended acts. ₁

An incident can be: 

• a near miss – An unplanned event that had the potential to result in injury, illness or damage – but fortunately it did not. ₂
• a no harm incident – reaching the patient but causing no discernible harm (e.g., infusing a wrong unit of blood, which was not incompatible). 
• an adverse event (harmful incident) – incident that results in harm to a patient (disease, injury, suffering, disability, or death). ₁

The occurrence of healthcare incidents may depend on different situations. First of all, it is important to highlight the distinction between “violation”, “negligence” and error. An error is a failure to carry out a planned action as intended or application of an incorrect plan. Thus, it is unintentional. On the contrary, a violation is a deliberate deviation from an operating procedure, standard or rule. ₁ Patient neglect is defined when healthcare professional flops in attending to the patient needs.₃

A Term’s Glossary with a comprehensive list of concepts regarding Patient Safety and the Second Victim phenomenon can be downloaded below (attachments):

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1. World Health Organization. The conceptual framework for the international classification for patient safety – final technical report. Geneva: World Health Organization; 2009. 
2. EU-OSHA. Near misses – OSHwiki | European Agency for Safety and Health at Work. Retrieved April 3, 2023, from
   https://oshwiki.osha.europa.eu/en/themes/near-misses
3. Reader TW, Gillespie A. Patient neglect in healthcare institutions: A systematic review and conceptual model. BMC Health Serv Res. 2013;13(1). 

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The magnitude of the problem of unsafe care was first evidenced by the Institute of Medicine report To err is human, published in 1999. The estimates produced indicated that between 44k and 98k of people died in hospitals each year because of medical errors, values comparatively higher than the mortality resulting from breast cancer and AIDS.₁ 

In the last years, several epidemiologic studies have continued to raise awareness to the patient safety field, also allowing the definition of priorities of action. As data has been more widely collected, more evident is the idea that the unsafe actions are a feature of virtually every aspect of healthcare. 

• Every year between 8 and 12% of the people admitted to hospitals and around 2% of those in primary care in the European Union (EU) suffer from an adverse event (AE) while receiving healthcare, many of which are preventable. 

• The European Barometer indicates that 53% of EU citizens think that patients could be harmed by hospital care.

In recent years, the focus of various studies has been the economic burden of safety failures covering both direct costs due to resource wastage and indirect costs due to loss of productivity in the population.

• In high-income countries, up to 15% of hospital expenditure can be attributed to safety failures ₂. 

• The consequences of preventable AEs to the EU amount have been calculated to a loss of 1.5 million disability-adjusted life years (DALYs), also resulting in an annual cost in the range of 17–38 billion euros.₃

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1. Institute of Medicine. To err is human: Building a Safer Health System. Washington, DC: The National Academies Press; 2000. 650p. 
2. Organization WH. Global Patient Safety Action Plan 2021-2030 Towards eliminating avoidable harm in health care. Geneva: World Health Organization; 2021. 
3. Agbabiaka TB, Lietz M, Mira JJ, Warner B. A literature-based economic evaluation of healthcare preventable adverse events in Europe. Int J Qual Heal Care. 2017;29(1):9–18

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In the late 90’s, the publication of To err is human ₁ generated global awareness about patient safety. A publication from British NHS: An organisation with a memory ₂ also highlighted the magnitude of the problem in the United Kingdom. Both reports recognized that error was a routine during the delivery of healthcare and stressed that healthcare organizations were having a poor performance to tackle this problem; some other risk-prone industries like aviation seemed much more advanced on their efforts, and the need of cultural change of healthcare organizations was stated.

Since then, a global movement has grown around patient safety, with the involvement of important organizations like the World Health Organization (WHO), the Agency for Healthcare Research and Quality (AHRQ) and the Organisation for Economic Development (OECD).

– In 2004 the WHO launched the World Alliance for Patient Safety, a working partnership between WHO and external experts, with the aim of facilitate the development of patient safety policy and practices in Member States. This work led, on subsequent years, to the launching of Global Patient Safety Challenges, each of them identifying a major risk for patient safety and setting an agenda for research and improvement, developing frontline interventions, and partnering with countries to disseminate and implement the interventions. Thus far, the three Global Patient Safety Challenges were: 

• 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.

– Another remarkable initiative from WHO was Patients for Patient Safety program, led by individuals who had suffered harm from health care or by their family members.

– The World Patient Safety Day, which is marked every year on 17 September, was established by the 72_nd World Health Assembly in May 2019 highlights a global patient safety priority.  In 2020 the COVID-19 pandemic stressed the importance of protecting those who care, therefore the slogan was “Safe healthcare providers, safe patients”. The Charter Health Worker Safety: A Priority for Patient Safety ³ was presented, calling for action to ensure health worker safety and patient safety. One of the main topics is dedicated to the healthcare workers mental health and psychological wellbeing.

– In August 2021 the Global Patient Safety Action Plan 2021–2030 -Towards eliminating avoidable harm in health care was launched, setting out a vision of a “world in which no patient is harmed in healthcare, and everyone receives safe and respectful care, every time, everywhere” and a goal of achieving the maximum possible reduction in avoidable harm because of unsafe care. 

– Patient safety is central to the implementation of the United Nations Sustainable Development Goals (SDGs), especially SDG3 (“Ensure healthy lives and promote wellbeing for all at all ages”) and achievement of universal health coverage (target 3.8).

Patient safety as a priority in Europe: 

In European countries, significant improvements to provide safer care for patients have been introduced in health systems seeking to ensure that procedures and treatments are being performed correctly and in a timely and effective way. Although the organisation of health systems and the delivery of healthcare remain a national competence, the EU plays an increasingly important complementary and supporting role in health and the impact of its actions on policies, healthcare delivery, and patient safety is highly significant. The EU has made legislation, recommendations, and funded projects to assure patient safety and mutual sharing and learning between Member States.

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1. Institute of Medicine. To err is human: Building a Safer Health System. Washington, DC: The National Academies Press; 2000. 650 p. 
2. Donaldson L. An organisation with a memory: Report of an Expert Group on Learning from Adverse Events in the NHS Chaired by the Chief Medical Officer. London: The Stationery Office; 2000. 
3. Organization WH. Charter: health worker safety: a priority for patient safety. Gevena: World Health Organization; 2020.

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