an “older” person, in her upper 70s. She is, however, or at least until now has been, quite healthy and vital and very active>>elective orthopedic procedure. That procedure went well but had a significant and unpredictable complication>>Receiving intravenous fluid per protocolin a corner room far from the nurses’ station or anyone’s frequent attention, my loved one was put into fluid overload and pulmonary edema. She was discovered in this condition in the morning not by the medical staff, but by a family member. Subsequently, receiving a diuretic in the ICU to correct the fluid overload, our patient was put into a state of acute fluid depletion, dropping her blood pressure to a potentially lethal 40mm Hg. This was discovered by another family member. This is not because of lack of human decency, but because hospitals are routinely under-staffed, the staff on hand are overworked and overwhelmed, and all concerned have “alarm fatigue.” There are alarms sounding in the ICU at almost all times. Like the boy who cried wolf, they are prone to induce not the intended emergency response, but selective inattention.
A medication error can occur at any step of the medication use process. Some ADEs are associated with medication errors and all potential ADEs are medication errors (fig 1). Minor errors that have little or no potential for harm are not considered potential ADEs—for example, a dose of non-critical medication such as docusate is given several hours late—but are considered to be medication errors. If the incident has the potential to harm a patient—for example, a dose of critical medication such as an intravenous antibiotic is not given—it is considered both a medication error and a potential ADE. A potential ADE is a medication error with the potential to cause an injury but which does notactually cause any injury, either because of specific circumstances, chance, or because the error is intercepted and corrected—for example, an order is written for an overdose of medication but the error is intercepted by the pharmacist. An ADE is an injury due to a medication—for example, cough due to angiotensin converting enzyme (ACE) inhibitors is considered an ADE. ADEs may or may not result from medication errors—for example, cough due to an ACE inhibitor in a patient without a history of ACE inhibitor induced cough is not the result of a medication error, while a medication error has occurred if the patient has a prior history of ACE inhibitor induced cough. A preventable ADE is an injury that is the result of an error at any stage in the medication use—for example, a coma due to an overdose of a sedative. A non-preventable ADE is an injury due to a medication where there is no error in the medication process—for example, an allergic reaction in a patient not previously known to be allergic to the medication. These are also known as adverse drug reactions, or nonpreventable reactions due to side effects or allergic reactions. An ameliorable ADE is an injury of which the severity or duration could have been substantially reduced if different actions had been taken—for example, sexual dysfunction lasting for several months while taking a selective serotonin reuptake inhibitor. A non-ameliorable ADE is an injury in which there is no current reasonable way to reduce the severity or duration—for example, bradycardia after the first usual dose of b blocker.
Adverse Drug Reaction Advisory Committee (ADRAC): Australia Agency for Healthcare Research and Quality (AHRQ): USA American Society of Consultant Pharmacists (ASCP): USA American Society of Healthcare Risk Management (ASHRM): USA American Society of Health-system Pharmacists (ASHP): USA Association of Perioperative Registered Nurses (AORN): USA Australian Capital Territory Health (ACT Health): Australia Australian Council for Safety and Quality in Health Care (ACSQHC): Australia Australian Patient Safety Foundation (APSF): Australia British Medical Association (BMA): UK Canadian Institute for Health Information (CIHI): Canada Commission for Healthcare Improvement (CHI): UK Commonwealth Department of Health and Aging: Australia ECRI (formerly the Emergency Care Research Institute): USA
In late 1999, the Institute of Medicine published To Err is Human: Building a Safer Health System, a landmark report that brought the nation’s attention to the 98,000 deaths due to patient safety failures. At least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented, according to estimates from two major studies. They have been estimated to result in total costs (including the expense of additional care necessitated by the errors, lost income and household productivity, and disability) of between $17 billion and $29 billion per year in hospitals nationwide. ( the institute but on the 1984 Harvard Medical Practice Study and the 1992 Utah and Colorado Study) . For the Harvard Study this gives a 3.7% overall adverse event rate x 58% attributable to management error (Leape et al. 1991) x 13.6% of adverse events resulting in death (in fact 13.6% was the rate for all adverse events rather than adverse events due to error (Brennan, Leape, Laird, Hebert, Localio, Lawthers, Newhouse, Weiler, & Hiatt 1991)), giving a total of 98,000 deaths per annum. For the Utah/Colorado Study this gives a 2.9% overall adverse event rate x 53.3% preventable x 6.9% of preventable adverse events resulting in death, giving a total of 35,835 deaths per annum, which does not reconcile with the lower figure of 44,000 quoted in the Institute of Medicine report and elsewhere. It appears in fact that the report accidentally transposed the overall adverse event rates of the 2 studies, giving Harvard a 2.9% rate and Utah/Colorado a 3.7% rate
They then place the estimate derived from these heterogeneous studies in a “ranking” of causes of death in the US to make their argument that it is the third leading cause. These two steps are both precarious. The four studies on which they appear to base their estimate on use different methodologies and wildly varying definitions that Makary and Daniel collapse into their vividly-titled construct of “preventable lethal adverse event”. It is not clear how the “point estimates” they derive were calculated, but it is notable that the denominators across the studies are not comparable and no confidence intervals are reported. A further problem with the estimate is more subtle. Making the field of patient safety all about death has risks. Just as most deaths do not involve medical error, most medical errors do not produce death—but they can still produce substantial morbidity, costs, suffering and distress. Drawing attention only to death as the focus of patient safety efforts risks drawing resources away from many settings of care – including almost all non-hospital environments – where death is not the most relevant outcome.
Applying this rate of preventability to the total number of hospital deaths in the US each year produces an estimate of about 25,200 deaths annually that are potentially avoidable among hospitalized patients in the US—roughly 10-fold lower than the estimate advanced by Makary and Daniel. Moreover, two of these studies [4, 6] make the point that roughly half of patients who probably had a preventable death were in their last six months of life – unlike the tens of thousands of people each year in the US who die in car accidents, shootings, or commit suicide (some of the causes of death that Makary and Daniel argue account for less mortality than does medical error).
Makary and Daniel recently gained widespread publicity with their estimate that medical error constitutes the 3rd leading cause of death in the US. As editors of BMJ Quality and Safety and researchers of long-standing in patient safety and quality of care, we appreciate the urge to draw attention to this area. But it is critical that the claims made to secure attention are well-founded. We worry that this estimate is not. First, the estimate fails the plausibility test. Of around 2.5M deaths in the US each year, approximately 700,000 occur in hospital. We – and many clinicians and researchers - find it very hard to believe that one in 10 of all US deaths, or a third of inpatient deaths (the 251,454 estimated by Makary and Daniel) result from “medical error”. Second, the authors of the article do not provide any sort of formal methodology. Their estimate seems to rely on extrapolating preventable death rates from those reported in other studies. They then place the estimate derived from these heterogeneous studies in a “ranking” of causes of death in the US to make their argument that it is the third leading cause. These two steps are both precarious. The four studies on which they appear to base their estimate on use different methodologies and wildly varying definitions that Makary and Daniel collapse into their vividly-titled construct of “preventable lethal adverse event”. It is not clear how the “point estimates” they derive were calculated, but it is notable that the denominators across the studies are not comparable and no confidence intervals are reported. The authors call for death certificates to include an extra field asking whether a preventable complication stemming from the patient’s medical care contributed to the death. The practical details of how this might be achieved are scant. Causes listed on death certificates already represent educated guesses much of the time, as not many patients die of diagnoses supported by gold standard tests during life (or autopsy results after death) Moreover, the doctor who pronounces death (and thus fills out the death certificate) may be ill-placed to know whether the patient experienced a preventable complication in care. But, suppose we sidestepped these practical issues (and put aside questions of resources) to implement a system whereby at least two clinicians not based at the hospital where death occurred undertake an independent medical record review and then discuss the case in order to reach consensus about whether or not medical error had likely contributed to death. As it turns out, this approach has been implemented in research settings on at least three occasions.[4-6] In all of these studies, the authors sampled deaths from multiple institutions and asked trained reviewers to look over the cases to identify possible quality of care problems and to make a judgment about the preventability of death. In all three studies, reviewers estimated that around 3% to 5% of deaths were ‘probably preventable’ (a greater than 50% chance that optimal care would have prevented death). The largest and most recent of these studies reported that trained medical reviewers judged 3.6% of deaths to have at least a 50% probability of avoidability. Applying this rate of preventability to the total number of hospital deaths in the US each year produces an estimate of about 25,200 deaths annually that are potentially avoidable among hospitalized patients in the US—roughly 10-fold lower than the estimate advanced by Makary and Daniel. The Makary and Daniel claim that medical error accounts for more than 250,000 deaths per year therefore stands in contrast to the results of several robust studies performed using the type of review they say is needed for medical error to be listed on a death certificate. Moreover, two of these studies [4, 6] make the point that roughly half of patients who probably had a preventable death were in their last six months of life – unlike the tens of thousands of people each year in the US who die in car accidents, shootings, or commit suicide (some of the causes of death that Makary and Daniel argue account for less mortality than does medical error). A further problem with the estimate is more subtle. Making the field of patient safety all about death has risks. Just as most deaths do not involve medical error, most medical errors do not produce death—but they can still produce substantial morbidity, costs, suffering and distress. Drawing attention only to death as the focus of patient safety efforts risks drawing resources away from many settings of care – including almost all non-hospital environments – where death is not the most relevant outcome.
http://qualitysafety.bmj.com/content/22/10/809 YLL= number of death* estimated life expectancy YDL=number of incidence* disability weight* average duration of the case until remission or death
Economic evaluations allow for establishing the link between the resources deployed (cost of public interventions) and the results achieved, and are essential for improving accountability and transparency of resource use in the healthcare system.
Information about costs and effectiveness of these practices is crucial for making evidence-based decisions to allocate limited resources for improving patient safety. They range from producing cost estimations (how much different AEs and/or safety practices cost) to appraising the costs and the effectiveness of different interventions taking into account alternative uses of resources
Established March 18th 2017 http://www.spsc.gov.sa/about/
Costs of ADRs
Patient safety: an economic
Sinaa Alaqeel MSc, PhD
How Hospitals Kill Our Loved Ones And Conceal It
Source: Katz, D. The Huffington Post, 2017
“Hospitals kill our loved ones at
times, despite hard work and good
intentions, and conceal it even from
themselves. It hides in plain sight; it
is business as usual. It is the
business of each of us to do all we
can to defend our loved ones from
that. It is the business of all of us to
Relationship between adverse drug events (ADEs), potential ADEs, and medication errors
T Morimoto et al. Qual Saf Health Care 2004;13:306-314
A dose of non-critical medication such
as docusate is given several hours late
A dose of critical medication such as
an intravenous antibiotic is not given
An injury due to a medication—for
example, cough due to angiotensin
converting enzyme (ACE) inhibitors
A coma due to an overdose of a
An injury of which the severity or duration could
have been substantially reduced if different
actions had been taken
160 websites of organisations
involved in medication safety were
searched 33 organisations have
one or more definitions for
medication safety related terms.
Qual Saf Health Care 2005;14:358–363.
Multiplicity of medication safety terms, definitions
and functional meanings: when is enough enough?
• 44,000—98,000 deaths/year as a result
of medical errors that could have been
• 8th leading cause of death in US
• National Costs: $17 to $29 billion
251 454 deaths/ year
3rd leading cause of death in the US
Total number of US hospital admissions in 2013
was 35 416 020
0.71 of admissions with a preventable lethal
The proportion of avoidable deaths,
defined as those with at least a 50%
probability of avoidability, in view of
trained medical reviewers, was 3.6% (95%
confidence interval 3.0% to 4.3%)
JAMA 2001 Jul 25;286(4):415-20.
Estimating hospital deaths due to medical errors:
preventability is in the eye of the reviewer.
22.7% of active-care patient deaths were
rated, on a 5-point scale, as at least
possibly preventable by optimal care,
with 6.0% rated as probably or definitely
Avoidability of hospital deaths and association with
hospital-wide mortality ratios: retrospective case
record review and regression analysis
Preventable deaths due to problems in care in English
acute hospitals: a retrospective case record review
Reviewers judged 5.2% (95% CI 3.8% to
6.6%) of deaths as having a 50% or
greater chance of being preventable.BMJ Qual Saf. 2012;21:737-45
Incidence of adverse events in public and
private hospitals in Riyadh: The ADESA study
• 4 hospitals in Riyadh (1 teaching, 2 governmental, 1 private)
• Incidence were identified by pharmacists and reviewed by a clinicians
• 3985 patients were followed
• 1531 incidence were identified (245 AED, 677 PADEs, 609 ME with
• The incidence of ADEs was 6.1 per 100 admission (95%CI 5.4-6.9)
BMJ Open 2016
Disability-adjusted life-years (DALYs) lost and
source of the DALYs, in 2009
BMJ Qual Saf 2013;22:809–815.
*All DALY numbers are in thousands.
DALY=Years of life lost due to premature death+ Years lost due to disability
Studies that provide an estimation of the cost of adverse events/medication
Studies that evaluate the cost of different strategies for preventing adverse
Studies which consider both costs and benefits of a given patient safety practice, compared with the status
quo situation or at least one alternative strategy
Studies that evaluate the benefit of different strategies for preventing adverse events/medication
Evaluation of the economic burden
Complete economic evaluations
Evaluation of the cost of patient safety practices
Evaluation of outcomes of patient safety practices
Economic evaluation in patient safety: a literature
review of methods
Databases: MEDLINE, NHS EED, and Econlit Plus a manual search of the reference lists of relevant papers
Period: 2000 -2010
Language: English and French
Evaluation of the economic burden (incremental costs) of AEs
(n=18): these studies provide an estimation of the cost of AEs
without looking at the cost of interventions for preventing
Evaluation of the cost of patient safety practices (n=3): these
studies evaluate the cost of different strategies for preventing
AEs without establishing the cost of these safety problems
Complete economic evaluations (n=12): which consider both
costs and benefits of a given patient safety practice, compared
with the status quo situation or at least one alternative
BMJ Qual Saf 2012;21:457-465.
A literature-based economic evaluation
of healthcare preventable adverse events
• The cost of preventable adverse events is
estimated to be between 1.1 and 2.43% of total
health expenditure, 17–38 billion Euros in 2015.
• The total annual DALYs were calculated as 3.5
million DALYs, of which 1.5 million were assumed
to have been preventable.
Sources of data: MEDLINE, EMBASE and CINAHL were searched for studies in Europe estimating cost of adverse
events (AEs) and PAEs (2000–March 2016). Using data from the literature, they estimated PAE costs based on
national 2013 total health expenditure (THE) data reported by World HealthOrganization
International Journal for Quality in Health Care, 2017, 29(1), 9–18
Comparative economic analyses of patient safety
improvement strategies in acute care: a systematic
Databases: MEDLINE Plus a manual search of the reference lists of relevant papers
Period: 2000 -2011
Strategies: 15 patient safety target conditions and six improvement strategies was conducted..
Complete economic evaluations (n=5): that reported a total
of seven comparisons based on at least one clinical
effectiveness study of adequate methodological quality
BMJ Qual Saf 2012;21:448-456.
Pharmacist-led medication reconciliation, the Keystone ICU
intervention for central line-associatedbloodstream infections,
chlorhexidine for vascular catheter site care, and standard
surgical sponge counts were economically attractive strategies
for improving patient safety
A systematic review of observational studies evaluating
costs of adverse drug reactions
Databases: MEDLINE, Cochrane Library, and Embase
. 22 cohort studies (71.0%), 7 case–control studies (22.6%), and
2 studies based on pharmacovigilance databases of
spontaneously reported ADEs (6.4%).
A total of 29 (93.5%) studies evaluated “direct health care
costs”, and two studies (6.5%) issued both “direct and indirect
health care costs”
The costs of ADEs related to any drug occurring in
nonhospitalized patients has been estimated from €702.21 to
Clinicoecon Outcomes Res. 2016; 8: 413–426.
The costs of ADEs that occurred during hospitalization varied
from €943.40 to €5,972.74
How are the costs of drug-related morbidity measured?:
a systematic literature review.
Databases: CINAHL, EMBASE and MEDLINE
29 studies included
18 studies measured either the total or attributable costs
of drug-related morbidity, while 7 studies estimated the
increased costs using matched controls or regression analyses.
Drug Saf. 2012 Mar 1;35(3):207-19
6 studies measured costs from a payer perspective, while the
other 23 measured costs to the hospital.
1 study included costs resulting after discharge, and discounted
future costs, while the remaining 28 studies measured costs
during the initial admission only and involved no adjustment
for timing of costs.
Direct and indirect costs for adverse drug events
identified in medical records across care levels, and their
distribution among payers
Sample and setting: a random sample of 5025 adults in a Swedish county
methods: 1) based on resource use judged to be caused by ADEs, and 2) as costs attributable to ADEs by
comparing costs among individuals with ADEs to costs among matched controls.
Costs for resource use caused by ADEs were €505 per patient
with ADEs (95% confidence interval €345-665), of which 38%
were indirect costs.
Res Social Adm Pharm. 2016 Nov 19.
Compared to matched controls, the costs attributable to ADEs
were €1631, of which €410 were indirect costs.
The local health authorities paid 58% of the costs caused by
Burden of hospitalizations related to adverse drug events
in the USA: a retrospective analysis from large inpatient
Data sources: Healthcare Cost and Utilization Project's Nationwide Inpatient Sample dataset for the years
2008 to 2011
Methods: patients with ADE based on 537 Classification of Diseases-9 codes.
The total hospitalizations with ADE to be 9 440 757 patients
(6.28% of total) from 2008 to 2011
Pharmacoepidemiol Drug Saf. 2017 Feb 24
Steroids (14.49%), antineoplastic drugs (13.06%),
anticoagulants (11.33%), nonsteroidal anti-inflammatory drugs
(8.78%), and opiates/narcotics (6.48%) were the five most
common causes of ADE.
Patient with ADE stayed 1.89 days [95% confidence interval (CI)
(1.79-1.99); p < 0.001] longer, incurred $1851.44 [95%CI
($1613.90-$2088.96), p < 0.001] higher
• Economic evaluation of ADEs is still a neglected necessity
• Economic evaluations of better quality
• Economic evaluation of wider perspective