PHAR 5 – Chapter 6: Medication Safety

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

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, medication
duplications, errors in dosing, and potential drug interactions
 conducted each time a patient transitions across departments or
locations