World Patient Safety Day is observed for the first time on 17 September this year. The campaign led by the World Health Organization was endorsed by the 72nd World Health Assembly in May, where it was recognized that: ”the 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 under Sustainable Development Goal 3 (Ensure healthy lives and promote health and well-being for all at all ages)”.
72nd World Health Assembly, Global action on patient safety, WHA72.6, 28 May 2019
One of the hallmark objectives of Universal Health Coverage (UHC) is the provision of quality care to improve the health of those receiving it. The service delivery and patient safety is in turn an essential component of UHC, and is to a large extent what builds quality care. In the policy brief “Antimicrobial Resistance and Universal Health Coverage: What’s the deal?”, we spell out how heavily health systems rely on antibiotics, and that without effective antibiotics, the quality of care will be undermined.
Effective antibiotics and antibiotic resistance are interlinked with a number of important dimensions regarding patient safety:
- Infection prevention and control.
- Access to quality antibiotics.
- Diagnostics for infectious diseases.
- Non-communicable diseases.
Infection prevention and control as part of service delivery and safety
Within service delivery programs, aiming to provide quality care, there is a need for an increased importance to a basic set of services including: access to clean water, sanitation and hygiene, infection prevention and control, access to essential diagnostics, and access to essential medicines, including antibiotics.
Preventing and controlling the spread of infections in the community and in the health care settings is critical to reduce infectious diseases and antibacterial resistance. Healthcare-associated infections are a major contributor to complications, morbidity and mortality of hospitalized patients. Healthcare-associated infections are estimated to affect 7.6% of hospitalized patients in high-income countries and between 8.5-15.5% (data from low- and high-quality studies respectively) of patients in low- and middle-income countries.
About 4.5 million patients suffered from a hospital-acquired infection in the EU in 2017; of these, around 90,000 died and one third of these deaths were due to antibiotic resistant bacteria. The burden of these resistant infections is especially frequent in intensive care units and neonatal wards.
In a study supported by ReAct, serious consequences of within-hospital spread were noted in Vietnamese hospitals. At admission to the hospital, 32% carried carbapenem resistant bacteria, and after 8 days of treatment 82% of patients were carriers. Mortality in hospital-acquired infections is twice as high if the infection is caused by a carbapenem resistant bacterium.
Methicillin-resistant Staphylococcus aureus (MRSA) is increasingly spreading in health care settings. People infected with MRSA are estimated to be 64% more likely to die than people with a non-resistant S. aureus.
One of the primary ways to address healthcare associated infections and prevent harm to patients and health workers is through infection prevention and control. Preventing infections, creating and implementing infection prevention and control guidelines would be one of the cheapest and most effective ways to reduce the effects of antibiotic resistance.
Access to quality antibiotics
Having access to quality medicines is an important part of ensuring patient safety. Bacterial infections that are treatable with antibiotics cause 5.7 million deaths annually that could be avoided. This number can be contrasted with the 750,000 annual deaths caused by antibiotic resistance.
Shortages and unavailability of essential antibiotics increasingly happens in all parts of the world and is of immediate threat to the patient safety. By not being able to provide the correct treatment for an infection, it can aggravate disease severity and outcome with an increased risk of patient harm or even death. Shortage or unavailability of the first line treatment often leads to the use of antibiotics with broader spectrum, and contributes unnecessarily to resistance development. Shortages are also linked to substandard and falsified medicines, as they create a market opening for criminal actors. The root causes for shortages and unavailability differs, but are related to manufacturing and production business models as well as regulation and market authorization issues.
Poor quality antibiotics are a safety issue mainly related to a complete lack or too little of the active substance. Of the reported cases of substandard and falsified medicines, 17% are antibiotics and are only exceeded by antimalarial drugs. Potential consequences of the substandard drugs include more than 169,000 pneumonia deaths in children each year. The underlying causes of a complete lack or too little of the active substance in the drug can be either related to the actual production of the drug, or from degradation due to improper handling or storage. Unfortunately, it is almost impossible to know how much each of the causes contribute to the problem, and to what extent the causes can be attributed to maleficent actors, negligence or simply poor knowledge. But an important contributor is criminal activity, such as in recent cases of falsified antibiotics discovered first in Cameroon and later in Uganda and Kenya: no active ingredients were detected in the tablets, and packaging closely resembled the original.
Diagnostics for infectious diseases
A correct diagnosis is the basis for any decision in health care delivery, and infectious diseases face a special challenge as it is not sufficient to identify the disease, but also the organism that causes the disease. Improper use of antibiotics is a common result of a poor diagnosis and thus drives the development of antibiotic resistance. According to a paper published in 2006, universal availability of an optimal diagnostic test for bacterial pneumonia could annually prevent 404 million unnecessary antibiotic treatments and 400,000 lives of children below five years in Africa, Asia and Latin America.
The quality of laboratory supplies used in the diagnostic tests is an important underlying factor that must be taken into account. As an example, antibiotic disks for susceptibility testing have shown to give highly variable results from some manufacturers, this made EUCAST to issue a warning about the quality of these disks. This variability goes in both directions, leading to both falsely susceptible and falsely positive results. Similar to antibiotics, the quality of supplies may also deteriorate if not stored properly.
Non-communicable diseases that rely on antibiotic treatment
Infections are a frequent complication among patients undergoing surgical procedures. For example, in gastro-intestinal surgery, between 9-23% of surgeries resulted in a surgical site infection, with the higher rates found in resource constrained settings. The risk of infections after surgery has prompted the use of prophylactic antibiotics, and many medical implants, such as hip replacements are imbued with antibiotics to prevent later foreign-body infections.
Transplantations are especially prone to have infection-related complications, even after the initial surgical site infections. In addition to being major surgical procedures, the patients’ immune systems are commonly suppressed in order to protect the transplant, with the side-effect of increased vulnerability to infectious diseases. Studies indicate that up to 68% of liver transplant recipients experience an infection, most of these within two months of surgery.
The importance of using aseptic surgical procedures and that antibiotics should not be seen as a way to compensate for procedural deficits cannot be stressed enough.
Advanced medical treatments, such as cancer therapies, have made the health care increasingly dependent on antibiotics. The safety of cancer patients relies on the ability to treat infections related to immunosuppression following from chemotherapy or radiation therapy, and surgical procedures to remove tumours. Patients with haematological malignancies are among those most affected due to severe neutropenia where up to 60% of deaths were related to an infection, and 50% of deaths among patients with solid tumours. The infections in cancer patients are often caused by several species of bacteria simultaneously. In a news story in Bloomberg, a physician active in India describes the horrible dilemma for patients and their families: cancer drugs may cure the cancer – but an infection may kill you during the treatment.
Key areas of concern to secure patient safety
- Access to safe, effective and affordable antibiotics is one of the important cornerstones for the achievement of universal health coverage.
- Antibiotic resistance is itself a patient safety issue that should be more seriously addressed.
- Antibiotic resistance not only undermines healthcare service delivery and quality of care, but for all aspects of health systems.
- Infection prevention and control would be one of the cheapest and most effective ways to reduce healthcare associated infections and the effects of antibiotic resistance.
A conservative estimate that includes resistance to antibiotics (also in tuberculosis), but which excludes drug resistant HIV, extrapolated from four data sources:
a) Phumart, P. et al. Health and Economic Impacts of Antimicrobial Resistant Infections in Thailand: A Preliminary Study. J. Health Sys. Res. 6, 352–360 (2012).
b) Centers for Disease Control and Prevention – CDC. Antibiotic resistance threats in the United States. (2013).
c) European Centre for Disease Prevention and Control – ECDC, European Medicines Agency – EMA. The bacterial challenge: time to react. A call to narrow the gap between multidrug-resistant bacteria in the EU and development of new antibacterial agents Luxembourg: EUR-OP. (2009).
d) World Health Organization – WHO. Global Tuberculosis report. (2007)
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