Monitoring and reporting of medication errors By Tsneem Tagelsir Khider Medication safety
What is medication error? Error Failure of a planned action to be completed as intended
Medication error Any preventable event that may cause or lead to inappropriate medication use or to patient harm while the medication is in the control of
the health care professional, patient, or consumer Patient safety incidents Patient safety incident is a term used by PSOs (patient safety organization) when referring to an
event or circumstance that could have resulted, or did result, in unnecessary harm to a patient. The harm can be caused by a range of errors or adverse events. In developing countries, the probability of patients being harmed in hospitals is higher than it is in industrialized nations.
Medication incidents The term medication incident is used by PSOs
when an adverse event is linked to the use of a medicine. A medication incident can be described as any undesirable experience that a patient has while taking a medicine, but which may not be related to the medicine. Medication error (ME) is a commonly used
term which has a similar meaning. ERRORS IN HEALTH CARE: A LEADING CAUSE OF DEATH AND INJURY
statistics Health care in the United States is not as safe as it should be--and can be. As many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented.
Medication errors cause at least one death every day and injure approximately 1.3 million people annually in the United states. It has been estimated that 18.7 - 56% of all
adverse events that occur among hospitalized patients result from medication errors that would be preventable. ( Europe, 2003) TRUE STORIES
HEPARIN FATALITY!!! A two years old child condition was critical, and she required renal dialysis and an intravenous infusion of heparin to prevent clotting.
During the infusion, the child received a large overdose of heparin, which led to cerebral bleeding and subsequent brain death The overdose occurred due to an infusion pump setting error that was not detected
during a verbal checking process. The wrong dose of heparin infused for about 5 hours before the error was noticed Promethazine Extravasation ISMP Medication
Safety Alert! Extravasation leading to amputation has occurred
Burden of medication errors on public health Medical errors have been estimated to result in total costs : additional care necessitated by the errors,
lost income household productivity, cost between $17 billion and $29 billion per year in hospitals nationwide. Errors also are costly in terms of loss of trust
in the health care system by patients and diminished satisfaction by both patients and health professionals. Examples of medication error incidents
Dispensing error Medicine preparation error Administration error Monitoring error Ensuring safe medication practice requires an
understanding of human factors (the reasons why humans make errors), and that healthcare products and systems should be designed to minimize the risks of MEs harming patients. Published research indicates that MEs occur frequently but that not all errors cause harm
or have the potential to cause harm. It is important to understand what is meant by the terms ME, ADE and adverse drug reaction (ADR) when reviewing published literature Adverse Drug Event (ADE): An injury
resulting from medical intervention related to a drug. Adverse drug reactions (ADRs): are defined as any response to a drug which is harmful and unintended, including lack of efficacy, which occurs at doses normally used
for the prophylaxis, diagnosis or therapy of disease. Medication errors (ME): such as overdose, and misuse and abuse of a drug, are also of interest because they may result in an ADR.
an adverse drug reaction is harm directly caused by the drug at normal doses, during normal use. How does an ADR differ from a side effect or allergy?
an allergy is an adverse drug reaction mediated by an immune response (e.g., rash, hives). A side effect is an expected and known effect of a drug that is not the intended therapeutic outcome.. It has been recommended that this term should generally
be avoided in favor of adverse drug reaction. CASES EXAMPLS Medication error resulting in no harm
A 25 kg child with no prior history of penicillin allergy was prescribed 250 mg orally of amoxicillin suspension twice daily (morning and evening) for 7 days. On the seventh day, the child inadvertently received a morning
dose of 500 mg instead of 250 mg. The child did not suffer any negative consequences from the error. A preventable ADE (medicationrelated harm due to error A 74 year old female with acute leg
pain presented to the emergency department. She has a history of sleep apnea. She has no previous history of opioid use. Prescriber ordered hydromorphone 2 mg IV. Patient found unresponsive in
respiratory distress with SP O2 at 70. Naloxone administered A Non-preventable ADE (medication-related harm not due to error) A 37 year old patient diagnosed with an
infection for which amoxicillin and clavulanate potassium is a clinically reasonable choice. Patient has used amoxicillin and other antibiotics in past without adverse effects. Prescriber ordered amoxicillin and clavulanate potassium 500 mg every 12 hours. After
taking 3 doses, patient experienced rash and facial swelling. He was transported to the emergency department and treated. ME detected through MIC phone calls from March- Jul 2017:
Organizations involved in medication error prevention International level 1 World Health Organization
A- The pharmacovigilance programme. B- Patient safety. 2-The World Alliance for Patient Safety 3-International Medication Safety Network National level
1-Patient safety organizations 2-National pharmacovigilance centres 3-Poison control centres 4-Local level 5-Hospitals 6-Consumer and patient organizations
Identifying and reporting medication errors: Why to report medication errors? Medication errors have significant implications on
patient safety. Error detection through an active management and effective reporting system discloses medication errors and encourages safe practices. What Information to Report?
JUST THE FACTS - include a factual description of what happened, how it happened, why it happened and the patient outcome Include names of products if the event involves a problem with labeling or packaging Include any additional patient monitoring or testing performed
or medications administered as a result of the event What Did We Learn from the Data? Lesson Learning Cycle Error / Near Miss
Monitoring of implementation Recognize Error / Near Miss
System-wide corrective / preventive action Report Error / Near Miss
Analyze Error / Near Miss Down with Blame, Up with Safety The culture of error and blame became selfdefeating: Errors were underreported, so the
facilities had no opportunity to review them and improve on existing systems. sometimes it is easy sometimes its not!!!!!!!!!!!
methods for collecting and reporting MEs 1- Identifying MEs through individual case safety reports The yellow card and other individual case safety reporting forms. The information contained in the yellow card and in other forms of ICSRs is of great value for PVCs in establishing a causal relationship between the observed adverse effect and the medicine.
At a minimum, an ICSR should contain information on the following (Uppsala Monitoring Centre, 2012): the patient adverse event suspected drug(s) all other drugs used (including self-medication)
risk factors name and address of reporter. ( yellowcard.mhra.gov.uk) Recently, the scope of pharmacovigilance has widened in some countries to include identification of MEs.
2- The P method The P method requires a yes or no or notapplicable or unknown response to each of the 20 criteria to be completed for each ADR
Detecting medication errors in practice Different approaches have been set up in response to the difficulty of getting clinicians to voluntarily report MEs.
Another big challenge has been to develop methods that can detect any failure in the medication-use system even if the ME does not reach the patient (potential ADE) The methods most commonly used are:
Incident report review Patient chart review Direct observation Interventions by pharmacists ADE trigger tools.
These methods are complementary, and none of them is able to detect all the medication incidents that occur, given the considerable complexity of the medication-use system
Analyzing medication error incident reports ME reports can be summarized and prioritized for action using categories listed by the Institute for Safe Medication Practices (2006). The most useful categories for initial analysis and prioritization are:
patient outcome medication use process medication problem therapeutic group or individual medicine Root cause analysis (qualitative analysis)
Reports of MEs that have caused (or have the potential to cause) serious harm should be analyzed to understand their contributory factors and root causes. Contributory factors are those which affect the performance of individuals whose actions may
have an effect on the delivery of safe and effective care to patients, and hence the likelihood of a patient safety incident occurring Care delivery problems are due to the direct provision of care
Service delivery problems are failures identified during the analysis of the patient safety incident Understanding human factors will help to address two myths of human performance in health care.
The perfection myth. The punishment myth. Like all myths, these two are untrue. Wide acceptance of these myths by the health-care community leads to systems where medication errors are likely to occur.
System barriers to prevent medication errors Medicines use systems have various barriers to prevent harm to patients. Barriers include medicine regulations and standard
operating procedures describing how medicine-related tasks should be undertaken, e.g. use of special documentation and information technology for prescribing, dispensing, administering and monitoring medicines, and independent checking by a second HCP, as well as restricted access to medicines, and defined
professional training and competences, among others. The Swiss cheese model to describe barriers intended to prevent errors Summary
Anyone should feel comfortable in reporting a medication error and not fear disciplinary action. Incident reports should not be used for disciplinary purposes but to improve systems and processes. Managers who use incident reports for disciplinary purposes run the risk of increased failures to report
errors and the same mistakes being made again and again. To err is human, but errors can be prevented. Safety is a critical first step in improving quality of care.
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