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PHAR 5 – Chapter 6: Medication Safety

Adverse drug events

Medication misadventures  ADRs that result in an injury – large or small –
 iatrogenic hazards or incidents associated with indicated preventable or unpreventable – due to the use or lack of
drug therapy resulting in patient harm that can be intended use of a drug
attributable to error, immunologic response, or  expected, well known reactions to medications that are
idiosyncratic response severe enough to require extensive medication
Drug-related problems
 events associated with drug therapies hamper optimal Drug-related morbidity
patient health  failure of a drug to achieve its intended health outcome
 medication errors, ADRs, ADEs, and side effects due to unresolved DRPs

Medication errors Sentinel events

 negative outcomes  unexpected incidents resulting in death or the potential
 not all DRPs are medication errors for serious physical or psychological injury
 may or may not cause adverse consequences because  they signal the need for immediate investigation and
some mistakes have no clinical effects response

Classification based on their impact on patients Latent injuries

No Error A Capacity to cause error  propensity or predisposition for harm during the process
Error, No harm B Did not reach patient of care that actually does not result in patient injury
C Reached patient: No harm
D Reached Patient and monitored to Potential injuries
cause no harm to patient
 mistakes in prescribing, dispensing, or medication
Error, Harm E Temporary harm: required Intervention
administration that have the potential to cause an injury
F Temporary Harm: required
hospitalization but did not, either by luck or because they were
G Permanent Patient Harm intercepted
H Required intervention to sustain Life Errors of commission
Error, DEATH I Resulted in patient’s death  occur when the patient receives either a correct drug or
an incorrect drug

Classification based on where they exist within the medication Preventing medication errors
use system  keep up with the medication literature for drug error
information and take action for prevention
Prescribing Wrong drug Correct drug, Wrong dose,  verify the accuracy of new prescription, data, monitor for
wrong patient form or route
Transcribing Illegible Misinterpretation Omission errors and near misses, make corrections as needed,
and and report errors to external reporting programs
interpretation  patient identifies should be verified using bar codes
Dispensing Wrong Error in Error in drug
patient or preparation or utilization
 patient should be educated about ways to prevent
drug calculation review medication errors
Administration Wrong drug, Incorrect handling Failure to  patient should be engaged in managing their own
and monitoring dose, route, or storage, missed review a medication regimens
administratio dose prescribed
n, time, regimen for  electronic prescribing should be used
infusion rate appropriaten  trivial warnings to prescribed and pharmacists should be
avoided in medication decision-support systems
 prescription filling technology needs to be assessed and
Adverse drug reactions
 DRPs that are unexpected, unintended, undesired, or
 monitor patients for high risk side effects
excessive responses
 review patient medication records especially when
 may or may not be the result of medical error
transitioning between types of care
» allergic reactions: immunologic hypersensitivities to
» 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
Principles of quality improvement Medication reconciliation
 the status quo is unacceptable  process of resolving discrepancies with what a patient
 safety can be enhanced by improving the core processes has been taking in the past with what the patient
of the medication use system should be taking at the moment
 safety errors must be patient-centered  correct problems such as omissions in therapy,
 quality must be assured medication duplications, errors in dosing, and
 solutions to safety problems should address, not potential drug interactions
individuals  conducted each time a patient transitions across
departments or locations
PDSA Cycle of Safety Improvement
 Plan – plan your small change
 Do – implement this small change
 Study – what impact did this small change have?
 Act – make another small change

ADR monitoring and reporting programs

 Alerting orders
- alert pharmacists that an ADR may have occurred
and that an investigation needs to be conducted
1. “tracer” drugs – 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 – less predictable pharmacokinetics
2. elderly patients – poly pharmacy, multiple prescribers,
adherence problems, change in renal function and
metabolism, greater sensitivity to medications
3. oncology patients – exposed to highly toxic
therapeutic regimens and immunocompromised

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, Occurs consequent but in excess
Predictable of drug primary pharmacological
Type B Bizarre, Occurs different (idiosyncratic) to
Unpredictable known drug pharmacologic
effect. Usually due to patient’s
genetic defect or immunological
response. Of qualitative nature
Type C End-of-use Occurs by sudden stoppage of
chronic drug use due to existing
adaptive changes.
Type D Delayed Occurs after long period of time
even after drug stoppage
Chapter 7: medication distribution systems  Pharmacy-coordinated method dispensing and
controlling medications in health care institutions
The role of the pharmacist has always been to ensure that  Medications contain in unit dose packages,
patients receive the appropriate medication in an acceptable dispensed in ready-to-administer form and not
dosage forms that facilitates safe administration and improved more than 24-hour supply being delivered
outcomes  Pharmacists dispenses patient-specific
medications to be administered, not prepared, by
Medication Distribution Methods the nurse
 Advantages
1. Floor stock system - Reduction in medication errors
 consisted of individual storage area on each - Decrease in total cost of medication-
nursing unit where medications were kept prior to related activities
nurse preparing them to administer to patients - More efficient use of pharmacy and
 medications were largely unsecured nursing personnel
 pharmacist’s role - Improved drug control and drug use
- place bulk containers of medications in monitoring
the unit storage area -> Drug room - More accurate patient billing for
- there were multiple doses in each bottle medications
to supply all patients receiving the drug - Greater control by pharmacists over
on the nursing unit work patterns and scheduling
 nurse’s role - Reduction of inventories maintained on
- prepare the patient-specific medications nursing units
for both oral and IV use  Other characteristics
- would read the physician order, go into - Placed pharmacists front and center in
the drug room to select the drug and the medication use cycle
prepare it, and then administer it to the - Required pharmacists to review every
patient medication order prior to dispensing
- would request new medication (for new - Duplicate carbon copies were provided
orders) to be stocked in the nursing unit to pharmacists to prevent transcription
 other characteristics errors
- pharmacist would never see the - Required the pharmacy to have and
physician order maintain a patient medication profile
- pharmacist would stock the medications - Carts are filled by technicians and
- it required minimal pharmacy resources checked by pharmacists
- it was assumed to be safe  Process:
- patients were charged for the drugs 1. Medication orders written and sent to
administered to them or were billed a pharmacy
daily fee (per diem) for the drugs 2. Pharmacist receives and reviews order
2. Patient prescription system 3. Order is entered into the drug profile
 Involved the pharmacist to a greater extent by 4. Order is filled by tech and checked by
requiring a review of the patient order pharmacist
 Physician writes>nurse transcribes>pharmacist 5. Medication is set to floor by courier, by
prepares pneumatic tube, or with nurse
 Pharmacist prepares a 2 to 5 day supply of 6. New order is recorded into the MAR
medications for the patient (medication administration record)
 Patients are charged for the medications 7. On the unit, nurse checks the medication
dispensed against the patient’s MAR
 Pharmacist’s role 8. Nurse administers the medication to the
- Review the patient order patient
- Place only limited judgement on whether 9. Nurse records when and how the drug was
it was correct or appropriate to the administered on the patient’s MAR
 Nurse’s role
- Store the medication in the nursing unit
- Prepare the individual dose for the
- Contact pharmacist to send refills

3. Unit dose system

Medication delivery from pharmacy to patient care unit
Medication category Delivery/storage method
Stable scheduled medications A 24-hour supply is kept in a
patient- specific bin on the
medication cart in the unit
Unstable scheduled Automatic delivery of
medications medications to the unit 1 hr
before administration time
Scheduled IV/TPN solutions Automatic delivery of
medications to the unit before
administration time
PRN medications A limited supply is kept in a
patient-specific bin on the
medication cart
Controlled medications A limited patient- specific
supply is secured in an
automated dispensing cabinet
or in a medication cart
STAT (immediately) Delivered by the pharmacy in
medications response to a request form
the unit
Emergency medications Emergency drug kits are
located on units and replaced
by the pharmacy in response
to a request from the unit
Investigational medications Per investigational drug

Models of UDS
a. Centralized
 Emanates from the pharmacy (centralized
 All processes occurs in the main pharmacy –
order processing, drug packaging, cart fill, and
medication dispensing
 Advantage:
 All resources can be localized into one
 Drug inventory can be minimized
 Disadvantage:
 Pharmacist is not able to directly
interact with the physician and nurse
 Clinical service is limited
b. Decentralized
 There are pharmacy satellites located throughout the
 Order is routed to a designated satellite, processed by
the pharmacist and dispenses the first dose of
medication directly to the nursing station
 Pharmacists are closely located to patient care areas
 There is still a need for a centralized pharmacy
 Advantages:
 Faster order filling
 Increased physician and nursing
 Better professional relationships
between pharmacy and the departments
 Separation of clinical services
 Fewer dispensing errors
 Decreased need for floor stock