Monitoring, Reporting,

and Communicating

ADR-Monitoring and Reporting

Programs
A comprehensive ADR-monitoring and
reporting program should be an
integral part of an organizations
overall drug use system.

One form concurrent(during drug

therapy) surveillance system is based
on reports of suspected ADRs by
pharmacists, physicians, nurses, or
patients.
Another form of concurrent
surveillance monitors for alerting
orders.

Alerting Orders
Are prescriptions which alert
pharmacists that an ADR may have
occurred and that an investigation
needs to be conducted.
Three types of Alerting Orders:
Tracer drugs
Abrupt discontinuation or decreases in
dosage of a drug
Stat orders for laboratory assessment
of therapeutic drug levels

Tracer Drugs
Tracer drugs are commonly used to
treat ADRs (e.g., orders for immediate
doses of antihistamines, epinephrine
and corticosteroids.
When tracer drugs are used, an ADR
may have occurred

Abrupt discontinuation or decreases

in dosage of a drug

The assumption being that the

discontinuation occurred because of a
negative reaction to the medication

Stat orders for laboratory

assessment of therapeutic drug
levels
Alerts the pharmacist that some
concern exists in the mind of the
prescriber that too much or too little
drug is in the patients system

One type of prospective (before drug

therapy) surveillance system focuses
on monitoring high-risk drugs or
patients with a high risk of ADRs

High-risk drugs:
Adrenergic agonist (IV) (e.g., epinephrine)
Adrenergic antagonist (IV) (e.g., propanolol,
metoprolol)
Anesthetics (e.g., Ketamine)
Antithrombotics (e.g., Warfarin, low molecular
weight Heparin)
Cardioplegic Solutions
Hypertonic Dextrose
Dialysis Solutions

High-risk drugs:
Epidural and intrathecal medications
Hypoglycemic Agents (P.O)
Inotropic Agents (e.g., digoxin, milrinone)
Insulin
Methotrexate for non-oncologic use
Sedatives (e.g., Midazolam)
Narcotics/ Opiates
Neuromascular blocking agents
(e.g., succinylcholine)

High-risk drugs:
Nitroprusside
Oxytocin
Potassium Chloride and Sodium Chloride for
injection
Promethazine (IV)
Radiocontrast agents
Total parental nutrition

Populations at greater risk for ADRs

are those with the most trouble
adjusting to the negative
consequences. Those include the
following:

Pediatric patients are at greater risk

because drug responses are less
predictable than with adults due to
pharmacokinetic variations.
This problem is aggravated because of
the lack of clinical trials conducted in
pediatric populations.

Elderly are at greater risk due to issues

of polypharmacy, multiple prescribers,
adherence problems, changes in renal
function and metabolism and greater
sensitivity to medications

Oncology patients commonly suffer

ADRs because they are exposed to
highly toxic therapeutic regimens and
often are immunocompromised.

What to do when ADRs

occur?
Prescribers, nurses and pharmacists
should be notified
~ Notification should be made to the
pharmacy surveillance program for
recording and analysis.
~Attempts should be made to
determine the cause/s of each
suspected ADR using the patients

medical and medication history, the

circumstances of adverse event, and
what might be found in any literature
review.
~Ideally, a systematic method for
assigning the probability of the
reported or suspected ADR (e.g.,
confirmed or definite, likely, possible
and unlikely) should be used to
categorize each ADR.

In case SERIOUS or UNEXPECTED ADRs

occur
It should be reported to the FOOD and
Drug Administration(FDA) or the drugs
manufacturer (or both).

Medication
Reconciliation

Medication Reconciliation
Is the process of resolving
discrepancies with what the
patient has been taking in the
past with what the patient should
be taking at the moment.

 Medication reconciliation is an
opportunity for pharmacist to use
their knowledge and skills to
enhance patient safety by
identifying and resolving drugrelated problems as patients
transition through out the
health care system

Reconciliation attempts to correct

problems such as:

Omissions in therapy
Medication Duplication
Errors in dosing
Potential drug interactions

Medication Reconciliation Process

1. Verification
~ The most up-to-date list of
medications currently being taken by
the patient within the hospital or other
institution is developed by using one
or more sources of information
brought to the institution

Sources of Information
pharmacy profile
medical records
patient or caregiver interview
patient medication

2. Clarification
~ The medication and dosages are
checked for appropriateness.
3. Reconciliation
~ Clinical decisions are then made
based upon a comparison of newly
prescribed medications against what
was prescribed previously

4. Transmission
~Therapy changes are
communicated to those people who
need to know about the changes
including providers on both end of
transition (e.g., hospital pharmacist
and community pharmacist,
surgeon, internist. This includes
providing the patient or caregiver
with a copy of final medication list.