1
Risk of harm to patients
Faculty of Medicine, Masaryk University
Public Health - VLVZ9X1c
Spring semester 2014
Name and Surname: Roye Mauthner
UCO: 365444
Email: 365444@mail.muni.cz
2
Introduction:
In our modern society and healthcare systems patients do not have anymore only one clinic,
hospital, physician, surgeon, pharmacist or other care providers. They have to move between
different healthcare providers and facilities. Along with the important advantages and
advanced abilities that a system such as this can offer, the constant dynamics and movements
of the patients may become a source of many problems we experience nowadays.
Discrepancy of methodologies for follow-up of patients and their health status, tracking
medications and lack of communication are the main causes for adverse events that place the
patients at risk for harm. [1]
Adverse events that lead to potential harm can occur in every possible setting starting from
first responses, transportation, examination and diagnosis process, treatment, and
rehabilitation settings.
Hospitalized patients and outpatients are exposed to many risk factors. In this article we will
sample and review some of these problematic aspects, risk factors and possible ramifications.
Organization and management of healthcare systems
As mentioned before, the dispersion of the healthcare services for one patient between
multiple health providers and entities constitutes practical issues of absence or lack of
necessary information to provide optimal care. [1]
Even within one hospital the system can be disorganized and abrupt. Urgent patient may visit,
all in one day, the emergency department, the medical admission unit, diagnostic laboratories,
operation theatres, and other specialized wards. Each of these places has a different personal
that the patient does not know and vice versa. The staff will not meet that patient again and
may not interact personally with others professionals responsible for his care.
3
The main media for communication is the clinical record and prescriptions charts. Therefore,
it is not surprising that errors arise in such a system. [2]
No universally recommended standards exist for proper medications history recording,
transfer and discharge documentation or follow-up registration.
Addressing weak points such as uniform follow-up and discharge documentation can be
suggested as one of the prevention measures for possible harm.
In the United States of America the National Patient Safety Goals exist, which supposed to
provide a national resolution for that matter.
With the aim to improve patient safety, today many healthcare services use computerized
prescriptions, documentation, medication review and reconciliation. Nevertheless, learning
how to use these systems and implementing them requires learning and transition period, in
which increased harm may be realized. It is necessary to create standardization and structure
the systems in a way that will ensure proper continuity of care in order to optimize the
treatments and eventually improve the survival and life quality of the patients [1].
Factor contributing to medical errors
A proper working and healing environment should be clear of distractions, noise or
interruptions. There is a key role for a good organization of the working space- ergonomics
[3].
Human errors are natural and cannot be eradicated completely. Nevertheless, efforts should
be made to avoid the predisposing factors such as fatigue, time- pressure, attending to
multiple patients at the same time [3-5]. Another main considerations should be given to
communications between the doctor, the patient and the other personal [6-8].
4
The patients have, in most medical care settings, a crucial role in the prevention of medical
errors and success of the treatment. For example, patients can decrease the incidences of
wrong side, wrong person and wrong operations from being performed [3]. Trying to create
trust with the patient, doctors prefer to hide their tendency to make errors and therefore the
person how might suffer the harm is unable to take part in the prevention of errors.
Compliance, communication and behavior are all key players in the success of the treatment
[2].
Medication adverse events
Two wide groups of errors are defined by psychiatrists: Mistakes- errors of knowledge and
planning; Slips or Lapses- errors made as a part of the execution of the plans. [2]
Errors of knowledge can be prevented by education. For example, physicians should be
educated that Warfarin interacts with many other drugs such as macrolide antibiotics and
azole antimycotics.
The World Health Organization personal formulary demonstrated an improvement in
prescribing, which reduced the planning errors significantly [9].
In order to address to the slips it is necessary to implement a checking system. It was
demonstrated in experimental studies that an independent checking can discover 90% of all
prescription errors [10]. For instance, clinical pharmacologists or ward pharmacists are
regarded by beginner doctors as a buffer between their pharmacological plan and patient
harm.
Insulin is being used increasingly in the United States of America and the United Kingdom. It
is the main recommended drug for glycemic control among type 1 and 2 diabetes mellitus
patients. Majority of the patients self- administrate the medication or assist a relative for that
5
purpose. Almost all adverse events occur due to acute secondary care outside the hospital,
while a small part arises in primary care settings under direct medical supervision [11, 12].
According to the US Pharmacopoeia MEDMARX reporting program 4,764 insulin
administration errors occurred during a two-year period. 320 of the incidents resulted in harm
to the patient (approximately 6.6%) [11].
The most frequent errors reported were omission errors that lead to hyperglycemia and
improper dose or quantity which lead to either hyper- or hypo-glycaemia [12].
In a research recently conducted in the United Kingdom, 16,600 insulin errors were identified.
24% were reported as harmful to the patients. 18 incidents resulted in fatal and sever
ramifications, while 1,042 were classified as moderate harm. Errors occurred during all stages
from prescription errors (17%), dispensing (10%) and administration (61%). The main error
types concluded in that research were wrong dose, omitted or delayed insulin and wrong
product of insulin [11].
Usage of out-of-date medications or other medical products may be harmful. The chemical
composition and potency of an expired drug may decrease its effectiveness. Storage in
inappropriate conditions like in a car exposed to direct sunlight and high temperature or
humid bathroom cabin can also alter the properties of the medication, even if it did not reach
its expiration date. Some healthcare systems and governments implemented take-back
programs for disposal of expired medications [13].
The risks are highly preventable and in order to achieve this it is necessary for both regulators
and healthcare providers to work together. Regulators are responsible for similar names,
6
labels and packaging, while the healthcare providers need to ensure properly safe settings for
insulin use.
Post-discharge guidance and patient education regarding proper administration of drugs,
routine checkups, regular tests and situations requiring professional medical attention are now
acknowledged as important millstones of harm prevention;
In the United Kingdom, the National Health Service (NHS) Institute For Innovation and
Improvement launched the ‘Think glucose program’- Inpatient care for diabetic people,
reduces the length of stay and allows to free more time to treat the increasing numbers of
diabetic patients. The program provides a package of products with learning and support
materials to improve awareness, better education and ultimately prevent harm (Annex 1) [14,
36].
The independent double check system entails two professionals each checking a component
of the work stages. For example, a pharmacist will perform dose calculation, dispense and
prepare the drug and eventually compare it to the prescription. Then the nurse will check
independently the medication order, calculate the dose and compare the results with the
prepared dispassion. The rationale behind this system is that it is less probable for two
independent people to do the same mistake [15].
Hospital acquired infections
‘Healthcare-associated infections (HAI) are defined as infections not present and without
evidence of incubation at the time of admission to a healthcare setting’ [16]
‘Most infections that become clinically evident after 48 hours of hospitalization are
considered hospital-acquired. Infections that occur after the patient is discharged from the
7
hospital can be considered healthcare-associated if the organisms were acquired during the
hospital stay’ [16]
Clostridium difficile is a gram-positive spore-forming bacterium that may colonize the
intestine if the normal microflora is modified or damaged.
Contact with healthcare workers, other patients and hospital environment can lead to exposure
to C. difficile spores. Clostridium difficile infection (CDI) may occur after administration of
antibiotic therapy, if the patient is unable to produce a proper antibody immune response to
the pathogenic toxin produced by the bacteria. Patients who are able to produce adequate
immunological response can revert to an uncolonized status or become carriers without any
symptoms with further protection against the pathogen.
Infected patient may manifest with a wide range of clinical pictures starting from
asymptomatic infection through diarrhea and some other severe syndromes such as fever,
abdominal pain, leukocytosis. A severe form of CDI can be manifested as
Pseudomembranous colitis with possible further complications of toxic megacolon,
perforation, sepsis and eventually death [17, 18].
Antibiotics are widely used nowadays and often administrated empirically as a substitution
for expensive and long lasting laboratory tests. Disrupting the gut microflora, antibiotic drugs
play an important role in the development of CDI. Strains of C. difficile that are resistant to
the antibiotics thrive in the intestine and lead to the possible manifestations mentioned above
[19].
In the past C. difficile strains were resistant to Clindamycin, but susceptible to
Fluoroquinolones. Nowadays new strains are resistant to Gatifloxacin and Moxifloxacin
(fourth generation of fluoroquinolones) [20, 21].
8
Although not all cases of CDI are associated with antibiotic therapy, it still constitutes as the
main risk for this infection [22]. All types of antibiotics are related to development of CDI,
nevertheless some has higher risk to do so. For example, Clindamycin, Cephalosporin and
now also Fluoroquinolones [19, 21, 23-25].
Many healthcare centers, such as Virginia Manson Hospital in Seattlle, already begun to
apply specific projects to reduce antibiotics errors and risk of CDI and MRSA (MethicillinResistant
Staphylococcus Aureus) [26].
A very careful and attentive treatment, considering the ramifications of antibiotic therapy may
help with the prevention of this kind of infections. A complete and thorough investigation,
including microbiological cultures, of the possible primary complaint may serve as a doorkeeper
for such healthcare-associated infections.
The Food Control Authority of Geneva and researchers from the University Hospital of
Geneva, Switzerland, tested chicken meat delivered to the central kitchen of the hospital
which prepares more than 8,000 meals a day. They discovered that about 86% of the sampled
meat was positive for Extended-Spectrum Beta-Lactamase producing E. coli bacteria.
Although E. coli is a physiological component of the human intestinal microflora, it can cause
urinary tract infections and even more severe invasive infections in susceptible patients [27].
In light of these disturbing findings, a serious attention should be given to food hygiene in
health care facilities.
Patient falls
The second most common adverse event after medication errors is hospital falls. Due to its
high incidence rate it is defined by the Medicare & Medicaid Services and as a known
hospital-acquired condition (2012) and falling incidents reductions was defined by the Joint
9
Commission (2011) as a national priority goal. Falling incidents may occur and inflict injury
in any age. Nevertheless, old adults have higher chance to get injured these incidents [28].
Sometimes a previous falling incident might cause fear of falling and altered mobility, which
is increasing the probability to further falling [29].
An integrative study published on 2012 identified evidence- based possibilities to prevent
falling incidents; environment and equipment interventions and maintenance, armbands and
signs in the room and on doors, education and communication, safety rounds, patient aids,
multidisciplinary consultation and collaboration [30, 31].
Surgery of wrong site
'Wrong site of surgery is a broad term that encompasses surgery performed on the wrong
body part, wrong side of the body, wrong patient or at the wrong level of the correctly
identified anatomical side' [3].
A survey conducted among Ophthalmologists in Scotland concluded that preventive
recommendations to avoid such mistakes are not being implemented in practice. It was
identified that lack of communication and verbal verification of the correct side in the
operating theatre was the main reason for such an error [32, 33].
Prevention of wrong side surgery could be achieved by developing mandatory protocols and
guidelines that will include all personal involved: surgical, anesthesia, nursing, theatre staff
and the patient.
The WHO launched in 2008 the "Safe Surgery Saves Lives". It is a very effective checklist
(annex 2) [35] composed of three parts according to the preoperative stages: Sing-in- is before
induction of anesthesia, Time-out- after induction and before the surgical incision, Sign-outduring
or after the wound closure but before the patient is transported out of the theatre [3].
10
Discussion:
The constant movements of the patients between health care entities may become a source of
many problems we evident today. Mismatch resulted from different methods for follow-up of
health state, tracking medications and lack of communication are the main causes for adverse
events, placing the patients at risk for harm [1].
Potential harm can present itself in every possible setting starting from first responses,
transportation, examination and diagnosis process, treatment, and rehabilitation settings.
From the aspect of the organization and management of healthcare systems, the most
significant weak point is the dispersion of the healthcare services for one patient between
multiple health providers and entities [1]. Unfortunately, there are no unified and universal
standards for proper medications history recording, transfer and discharge documentation or
follow-up registration.
Many healthcare services use computerized prescriptions, documentation, medication review
and reconciliation. It is our belief that it is necessary to create standardization and structure
the systems in a way that will ensure proper continuity of care.
Medication adverse events can be divided into Mistakes- errors of knowledge and planning;
or Slips or Lapses- errors made as a part of the execution of the plans. [2]
Errors of knowledge can be prevented by education. Such an example is the WHO personal
formulary, which reduced the planning errors significantly [9].
Slips may be prevented by a checking system. A serious consideration should be given to fact
that some studies that demonstrated a strong preventability only by implementing an
independent checking of prescriptions [10].
Hospital acquired infections are 'Infections not present and without evidence of incubation at
the time of admission to a healthcare setting' [16]. Antibiotic drugs play an important role in
11
the development of CDI and MRSA Infections. Therefore their use should be limited and
used empirically only in their relevant indications. Otherwise, responsible consideration of the
ramifications of antibiotic therapy should be made. A complete and thorough investigation,
including microbiological cultures, of the possible primary complaint may serve as a doorkeeper
for such healthcare-associated infections.
The second most common adverse event after medication errors is hospital falls. Falling
incidents reductions was as a national priority goal in the USA.
Some preventive measure can be taken in order to achieve this goal; environment and
equipment interventions and maintenance, armbands and signs in the room and on doors,
education and communication, safety rounds, patient aids, multidisciplinary consultation and
collaboration [30, 31].
Lack of communication and verbal verification of the correct side in the operating theatre was
the main reason for Surgery of wrong site [32, 33].
Prevention of wrong side surgery could be achieved by implementing mandatory protocols
and guidelines that will include all personal involved in the operation and the patient himself.
A further interface of essential communication is the medical rounds. An adequate interaction
among the staff and with the patient is critical for obtaining important real-time information
about the status of the patient and his complaints. A proper quality of communication during
the rounds allows also the multidisciplinary team to develop a coordinated plan of treatment
and is more likely to achieve involvement from the side of patient [34].
12
We can manage errors with potential harm to patient in three main points of time:
Avoid errors: Stopping the errors before they occur. Tight adherence to guidelines and safety
protocols, with no exceptions or room for interpretations.
Trap errors: Early detection of errors when they occur is the most important process of
prevention of same future mistakes or slips. Learning from our errors and implementing the
preventive measures in the guidelines is a necessary trait.
Manage errors: Reduction of the effect of the errors that occurred and were not caught.
Creating incident reports and analysis of soft spots in the system is a key component of better
prevention [2].
13
Conclusion:
A proper working and healing environment has a key role in the prevention of adverse events.
Human errors are natural and cannot be eradicated completely. Nevertheless, efforts should be
made to avoid the predisposing factors. Communications between the doctor, the patient and
the other personal is essential for reducing risk of harm.
The patients have, in most medical care settings, a large part in the prevention of medical
errors, complications and success of the treatment.
14
References:
[1] Thompson-Moore, LIEBL M. G.: Health care system vulnerabilities: Understanding
the root causes of patient harm. Am J Health-Syst Ph [online]. 2012-02-17, vol. 69, issue 5,
p. 431-436.
[2] Ferner, Robin E. An agenda for UK clinical pharmacology: Medication errors. British
Journal of Clinical Pharmacology [online]. 2012, vol. 73, issue 6, p. 912-916.
[3] Hanchanale, Vishwanath, AmrithRaj, Motiwala H. and Karim O. M. A. Wrong site
surgery! How can we stop it?. Urology Annuals [online]. 2014, vol. 6, issue 1, p. 57.
[4] F. Boutros, DA Redelmeier. Effects of trauma cases on the care of patients who have chest
pain in an emergency department. J Trauma 2000. 48:649-53.
[5] EA Flynn, KN Barker, JT Gibson, RE Pearson, BA Berger, et al. Impact of interruptions
and distractions on dispensing errors in an ambulatory care pharmacy. Am J Health Syst
Pharm 1999; 56:1319-1325.
[6] Lingard L, Reznick R, Espin S, Regehr G, DeVito I. Team communications in the
operating room: Talk patterns, sites of tension, and implications for novices. Acad Med 2002;
77:232-237.
[7] JCAHO protocol to prevent wrong-site surgery is endorsed. Qual Lett Healthc Lead 2004;
p. 16:13.
15
[8] Mulloy DF, Hughes RG. Wrong-site surgery: A preventable medical error. In: Hughes
RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville:
Agency for Healthcare Research and Quality; 2008. p. 381.
[9] de Vries TPGM, Henning RH, Hogerzeil HV, Fresle DA. Guide to Good Prescribing – A
Practical Manual. HO/DAP/94.11. Geneva:World Health Organization, 1994.
[10] Kirwan B. A Guide to Practical Human Reliability Assessment. London: Taylor &
Francis, 1994.
[11] Cousins D., Rosario C., Scarpello J. Insulin, hospitals and harm: a review of patient
safety incidents reported to the National Patient Safety Agency. Clinical medicine
(London, England) [online]. 20110201, vol. 11, issue 1, p. 28 - 30.
[12] United States Pharmacopoeia. Insulin errors a common problem.Patient Safety CAPS
link. Section 1. USP medication analysis. Rockville, MD: USP, 2003.
[13] S. Lister. Don't Be Tempted to Use Expired Medicines. U.S. Food and Drug
Administration. http://www.fda.gov/drugs/resourcesforyou/specialfeatures/ucm252375.htm
(last accessed on June 2014).
[14] NHS Institute for Innovation and Improvement. Think glucose.
www.institute.nhs.uk/quality_and_value/think_glucose/welcome_to_the_website_for_thinkgl
ucose.html (Last accessed on June 2014).
16
[15] Independent Double Checks: Undervalued and Misused: Selective use of this
strategy can play an important role in medication safety. Institute for Safe Medication
Practices June 2013. https://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=51
(Last visited on June 2014)
[16] Haidee T Custodio: Hospital-Acquired Infections. Updated: 2014
http://emedicine.medscape.com/article/967022-overview#aw2aab6b2b2 (last accessed on
June 2014).
[17] Kyne L, Warny M, Qamar A, Kelly CP. Asymptomatic carriage of Clostridium difficile
and serum levels of IgG antibody against toxin A. N. Engl. J. Med. 342(6), p. 390–397
(2000).
[18] Shim JK, Johnson S, Samore MH, Bliss DZ, Gerding DN. Primary symptomless
colonisation by Clostridium difficile and decreased risk of subsequent diarrhoea. Lancet
351(9103), p. 633–636 (1998).
[19] Matteo Bassetti, Giovanni Villa, Davide Pecori, Alessandra Arzese and Mark Wilcox.
Epidemiology, diagnosis and treatment of Clostridium difficile infection. Expert Rev.
Anti Infect. her. 10(12), (2012) p. 1405-1423.
[20] McDonald LC, Killgore GE, Thompson A et al. An epidemic, toxin gene-variant strain
of Clostridium difficile. N. Engl. J. Med. 353(23), p. 2433–2441 (2005).
17
[21] Johnson S, Samore MH, Farrow KA et al. Epidemics of diarrhea caused by a
clindamycin-resistant strain of Clostridium difficile in four hospitals. N. Engl. J. Med.
341(22), p. 1645–1651 (1999).
[22] Bartlett JG. Clinical practice. Antibiotic associated diarrhea. N. Engl. J. Med. 346(5), p.
334–339 (2002).
[23] Loo VG, Poirier L, Miller MA et al. A predominantly clonal multi-institutional outbreak
of Clostridium difficile-associated diarrhea with high morbidity and mortality. N. Engl. J.
Med. 353(23), p. 2442–2449 (2005).
[24] Muto CA, Pokrywka M, Shutt K et al. A large outbreak of Clostridium
difficileassociated disease with an unexpected proportion of deaths and colectomies at a
teaching hospital following increased fluoroquinolone use. Infect. Control Hosp. Epidemiol.
26(3), p. 273–280 (2005).
[25] Gaynes R, Rimland D, Killum E et al. Outbreak of Clostridium difficile infection in a
long-term care facility: association with gatifloxacin use. Clin. Infect. Dis. 38(5), p. 640–
645 (2004).
[26] Case studies: making hospitals safer. Nursing Management - UK [online]. 20140501,
vol. 21, issue 2, p. 11.
[27] Hospital food safety measures reduce risk of contaminated hospital food. Healthcare
Purchasing News [online]. April 2014, vol. 38, issue 4, s. 8-8.
18
[28] Murphy a Brenda. Mobility/Activity Circles: A Quality Improvement Effort to
Reduce Falls. MEDSURG Nursing [online]. 20131101, vol. 22, issue 6, p. 365-369.
[29] Dykes, P., Carroll, D., Hurley, A., Benoit, A., Lipsitz, S., et al. (2010). Fall prevention in
acute care hospitals. Jama-J Am Med Assoc, 304 (17), p. 1912- 1918.
[30] Spoelstra, S., Given, B., & Given, C. (2012). Fall prevention in hospitals: An integrative
review. Clinical Nursing Research, 21(1), p. 92-112.
[31] Degelau, J., Belz., M., Gungum, L., Flavin, P., Harper, et al. (2012). Falls (acute care),
prevention of. Institute for Clinical Systems Improvement. Retrieved from
https://www.icsi.org/guidelines__more/catalog_guidelines_and_more/catalog_guidelines/cata
log_patient_safetyreliability_guidelines/falls/ (last accessed on June 2014).
[32] Importance of side marking in ophthalmic surgery. Surgeon (Edinburgh University
Press) [online]. 20090401, vol. 7, issue 2, p. 82-85.
[33] The National Association of Theatre Nurses (NATN). Safeguards for Invasive
Procedures: The Management of Risks (1998). NATN Harrogate, Yorkshire. [Replacing
Theatre Safeguards (1998) The Medical Defence Union (MDU), Medical Protection Society
(MPS), Medical and Dental Defence Union of Scotland (MDDUS), NATN and the Royal
College of Nursing (RCN)].
19
[34] Royal College of Physicians, Royal College of Nursing. Ward rounds in medicine:
principles for best practice. London: RCP, 2012.
[35] Annex 2: Safe Surgery Save life- WHO checklist.
http://www.who.int/patientsafety/safesurgery/ss_checklist/en/ (last accessed on June 2014).
[36] Annex 1: NHS Think glucose program.
http://www.institute.nhs.uk/images/documents/ThinkGlucose%20promotional%20posters.pdf
(last accessed on June 2014).
Annex 1: NHS Think glucose program.
20
Annex 2: Safe Surgery Save life- WHO checklist.
21