PHAR 5 – 5 – Chapter Chapter 6: Medication Safety Medication misadventures iatrogenic hazards or incidents associated with indicated drug therapy resulting in patient harm that can be attributable to error, immunologic response, or idiosyncratic response *idiosyncratic response: response that is peculiar to an individual (ex. Paracetamol is safe to most people but for some, it can trigger an increase in blood pressure)
Drug-related morbidity failure of a drug to achieve its intended health outcome due to unresolved DRPs Sentinel events unexpected incidents resulting in death or the potential for serious physical or psychological injury they signal the need for immediate investigation and response Latent injuries propensity or predisposition for harm during the process of care that actually does not result in patient injury Potential injuries mistakes in prescribing, dispensing, or medication administration that have the potential to cause an injury but did not, either by luck or because they were intercepted Errors of commission occur when the patient receives either a correct drug or an incorrect drug Errors of omission result in the patient failing to receive drugs that can be beneficial
Drug-related problems events associated with drug therapies that can do or hamper optimal patient health medication errors, ADRs, ADEs, and side effects
Medication errors errors or mistakes in the medication use process that may result in negative outcomes not all DRPs are medication errors may or may not cause adverse consequences because some mistakes have no clinical effects
Classification based on their impact on patients no error: A: circumstances or events that have the capacity to cause error no harm: B: an error occurred but the error did not reach the patient C: an error occurred that reached the patient but did not cause the patient harm D: an error occurred that reached the p atient and required monitoring to confirm that it re sulted in no harm to the patient and/or required intervention to preclude harm harm: E: an error occurred that may have contributed to or resulted in temporary harm to the patient and required intervention F: an error occurred that may have contributed to or resulted in temporary harm to the patient and required initial or prolonged hospitalization G: an error that may have contributed to or resulted in permanent patient harm H: an error occurred that required intervention necessary to sustain life death: I: an error occurred that may have contributed to or resulted in the patient’s death »
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Preventing medication errors keep up with the medication literature for drug error information and take action for prevention verify the accuracy of new prescription, data, monitor for errors and near misses, make corrections as needed, and report errors to external reporting programs patient identifies should be verified using bar codes patient should be educated about ways to prevent medication errors patient should be engaged in managing their own medication regimens electronic prescribing should be used trivial warnings to prescribed and pharmacists should be avoided in medication decision-support systems prescription filling technology needs to be assessed and improved monitor patients for high risk side effects review patient medication records especially when transitioning between types of care
Principles of quality improvement the status quo is unacceptable safety can be enhanced by improving the core processes of the medication use system safety errors must be patient-centered quality must be assured solutions to safety problems should address, not individuals
PDSA Cycle of Safety Improvement Plan – Plan – plan plan your small change Do – Do – implement implement this small change Study – Study – what what impact did this small change have? Act – Act – make make another small change
Classification based on where they exist within the medication use system
PRESCRIBING
Wrong drug
TRANSCRIBING AND INTERPRETATION DISPENSING
Illegible
ADMINISTRATION AND MONITORING
Wrong drug, dose, route, administration, time, infusion rate
Wrong patient or drug
Correct drug, wrong patient Misinterpretation
Wrong dose, form or route Omission
Error in preparation or calculation Incorrect handling or storage, missed dose
Error in drug utilization review Failure to review a prescribed regimen for appropriateness
Adverse drug reactions DRPs that are unexpected, unintended, undesired, or excessive responses to a drug that require some type of medical response or resulting a negative outcome may or may not be the result of medical error allergic reactions: immunologic hypersensitivities to drugs idiosyncratic reactions: abnormal responses drugs that are peculiar to individuals) side effects: expected, well-known reactions that require little or no change in patient management drug withdrawal symptoms, drug-abuse syndromes, accidental poisonings, and drug overdose complcations
ADR monitoring and reporting programs Alerting orders prescriptions which alert pharmacists that an ADR m ay have occurred and that an investigation needs to be conducted 1. “tracer” drugs – commonly – commonly used to treat ADRs (antihistamines, epinephrine, and corticosteroids) 2. abrupt discontinuation or decrease in dosage of a drug 3. stat orders for laboratory assessments of therapeutic drug levels
At risk of ADRs 1. pediatric patients – patients – less less predictable pharmacokinetics 2. elderly patients – patients – poly poly pharmacy, multiple prescribers, adherence problems, change in renal function and metabolism, greater sensitivity to medications 3. oncology patients – patients – exposed exposed to highly toxic therapeutic regimens and immunocompromised
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Adverse drug events ADRs that result in an injury – injury – large large or small – small – preventable preventable or unpreventable – unpreventable – due due to the use or lack of intended use of a drug expected, well known reactions to medications that are severe enough to require extensive medication management
Actions taken after ADRs 1. prescribers, nurses, pharmacists should be notified 2. determine the cause/s using the patient’s medical and medication history 3. determine the circumstances after the adverse events and what might be found in any literature review 4. assign the probability of the reported or suspected ADR and categorize 5. serious or unexpected ADR should be reported to FDA or manufacturer (or both)
Types of ADRs type A : augmented, predictable at times
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occurs consequent but in excess of drug primary pharmacological effect. Of quantitative nature Hemorrhage -> Warfarin type B: bizarre, unpredictable occurs different (heterogenous/idiosyncratic) to known drug pharmacologic effect. Usually due to patient’s genetic defect or immunological response. Of qualitative nature Thermodynamic -> Quinidine Type C: end-of-use Occurs by sudden stoppage of chronic drug use due to existing adaptive changes. Withdrawal syndrome -> Morphine Type D: delayed Occurs after long period of time even after drug stoppage Teratogenicity -> Retinoids Carcinogenicity -> tobacco smoking -
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Medication reconciliation process of resolving discrepancies with what a patient has been taking in the past with what the patient should be taking at the moment correct problems such as omissions in therapy, me dication duplications, errors in dosing, and potential drug interactions conducted each time a patient transitions across departments or locations
