PHAR 5 – Chapter 6: Medication Safety

Adverse drug events

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
Drug-related problems
 events associated with drug therapies hamper optimal
patient health
 medication errors, ADRs, ADEs, and side effects
 ADRs that result in an injury – large or small –
preventable or unpreventable – 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
Drug-related morbidity
 failure of a drug to achieve its intended health outcome
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
Error, No harm B Did not reach patient
C Reached patient: No harm
D Reached Patient and monitored to
cause no harm to patient
Error, Harm E Temporary harm: required Intervention
F Temporary Harm: required
hospitalization
G Permanent Patient Harm
H Required intervention to sustain Life
Error, DEATH I Resulted in patient’s death
 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

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
ess
avoided in medication decision-support systems
 prescription filling technology needs to be assessed and
Adverse drug reactions
improved
 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
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
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 your small change
 Do – implement this small change
 Study – what impact did this small change have?
 Act – make another small change
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

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
effect.
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
The role of the pharmacist has always been to ensure that
patients receive the appropriate medication in an acceptable
dosage forms that facilitates safe administration and improved
outcomes
Medication Distribution Methods
1. Floor stock system
 consisted of individual storage area on each
nursing unit where medications were kept prior to
nurse preparing them to administer to patients
 medications were largely unsecured
 pharmacist’s role
- place bulk containers of medications in
the unit storage area -> Drug room
- there were multiple doses in each bottle
to supply all patients receiving the drug
on the nursing unit
 nurse’s role
- prepare the patient-specific medications
for both oral and IV use
- would read the physician order, go into
the drug room to select the drug and
prepare it, and then administer it to the
patient
- would request new medication (for new
orders) to be stocked in the nursing unit
 other characteristics
- pharmacist would never see the
physician order
- pharmacist would stock the medications
- it required minimal pharmacy resources
- it was assumed to be safe
- patients were charged for the drugs
administered to them or were billed a
daily fee (per diem) for the drugs
2. Patient prescription system
 Involved the pharmacist to a greater extent by
requiring a review of the patient order
 Physician writes>nurse transcribes>pharmacist
prepares
 Pharmacist prepares a 2 to 5 day supply of
medications for the patient
 Patients are charged for the medications
dispensed
 Pharmacist’s role
- Review the patient order
- Place only limited judgement on whether
it was correct or appropriate to the
patient
 Nurse’s role
- Store the medication in the nursing unit
- Prepare the individual dose for the
patient
- Contact pharmacist to send refills
3. Unit dose system
 Pharmacy-coordinated method dispensing and
controlling medications in health care institutions
 Medications contain in unit dose packages,
dispensed in ready-to-administer form and not
more than 24-hour supply being delivered
 Pharmacists dispenses patient-specific
medications to be administered, not prepared, by
the nurse
 Advantages
- Reduction in medication errors
- Decrease in total cost of medication-
related activities
- More efficient use of pharmacy and
nursing personnel
- Improved drug control and drug use
monitoring
- More accurate patient billing for
medications
- Greater control by pharmacists over
work patterns and scheduling
- Reduction of inventories maintained on
nursing units
 Other characteristics
- Placed pharmacists front and center in
the medication use cycle
- Required pharmacists to review every
medication order prior to dispensing
- Duplicate carbon copies were provided
to pharmacists to prevent transcription
errors
- Required the pharmacy to have and
maintain a patient medication profile
- Carts are filled by technicians and
checked by pharmacists
 Process:
1. Medication orders written and sent to
pharmacy
2. Pharmacist receives and reviews order
3. Order is entered into the drug profile
4. Order is filled by tech and checked by
pharmacist
5. Medication is set to floor by courier, by
pneumatic tube, or with nurse
6. New order is recorded into the MAR
(medication administration record)
7. On the unit, nurse checks the medication
against the patient’s MAR
8. Nurse administers the medication to the
patient
9. Nurse records when and how the drug was
administered on the patient’s MAR
Medication delivery from pharmacy to patient care unit
Medication category
Stable scheduled medications A 24-hour supply is kept in a
Unstable scheduled
medications
Scheduled IV/TPN solutions
PRN medications
Controlled medications
STAT (immediately)
medications
Emergency medications
Investigational medications
Delivery/storage method
patient- specific bin on the
medication cart in the unit
Automatic delivery of
medications to the unit 1 hr
before administration time
Automatic delivery of
medications to the unit before
administration time
A limited supply is kept in a
patient-specific bin on the
medication cart
A limited patient- specific
supply is secured in an
automated dispensing cabinet
or in a medication cart
Delivered by the pharmacy in
response to a request form
the unit
Emergency drug kits are
located on units and replaced
by the pharmacy in response
to a request from the unit
Per investigational drug
protocol

Models of UDS
a. Centralized
 Emanates from the pharmacy (centralized
location)
 All processes occurs in the main pharmacy –
order processing, drug packaging, cart fill, and
medication dispensing
 Advantage:
 All resources can be localized into one
area
 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
institution
 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
satisfaction
 Better professional relationships
between pharmacy and the departments
 Separation of clinical services
 Fewer dispensing errors
 Decreased need for floor stock
medications