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8 Monitoring Drug
Therapies
LEARNING OBJECTIVES
I dentify the skills needed to monitor patient drug G
iven specific monitoring parameters, organize patient
therapy. data appropriately.
List and describe each step in the monitoring process.
Identify the four types of monitoring data included
in the four-square monitoring method.
145
146 Clinical Skills for Pharmacists: A Patient-Focused Approach
Therapeutic
planning
takes about 10 days for phenytoin to reach steady state
Figure 8-1 Patient-Focused Care Cycle.
after therapy is initiated or the dose is changed; non
steady-state drug serum concentrations may be mislead-
ingly low and should not be used as the basis for routine
Box 8-1The SOAP-Based Planning Process
dosage adjustments. When developing the monitoring
1. Identify the problems plan, consider how long it takes for the expected ther-
2. Prioritize the problems apeutic response to appear and the time course for the
3. Select patient-specific drug and nondrug interventions development of adverse drug effects. Some adverse drug
4. Develop a monitoring plan effects are idiosyncratic and appear without warning;
SOAP, Subjective, Objective, Assessment, Plan.
patients need to report any new or unusual effects.
The monitoring plan must be thorough and complete,
yet practical given the patient setting and relative risks and
plan. For example, patients who begin antihypertensive benefits of the intervention. It is not possible to monitor
drug therapy initially require frequent monitoring (i.e., for every adverse effect documented for every drug; many
every 2 to 4 weeks) to assess the response to the drug ther- clinicians monitor patients closely for adverse effects that
apy. The drug dose often needs to be titrated up or other are reported to occur at a rate of 10% or higher or are less
medications need to be added to the regimen to achieve common but potentially life-threatening. For example,
the target blood pressure. Once the target blood pressure monitoring for rare potential adverse drug effects iden-
is achieved and the patients condition is stable, the fre- tifiable only on the electrocardiogram is reasonable for
quency of monitoring can be extended (i.e., every 6 to 12 a critically ill patient already undergoing continuous
months). Patients who begin oral anticoagulation therapy electrocardiographic monitoring but not a viable option
initially require weekly monitoring; the monitoring inter- for an ambulatory patient with no signs or symptoms of
vals are extended once the patients therapeutic regimen drug-associated cardiotoxicity. However, documenting
provides a stable and predictable therapeutic response. the baseline electrocardiographic findings and then peri-
The monitoring plan includes the monitoring inter- odically recording an electrocardiogram is a reasonable
vals for each monitoring parameter. Monitoring intervals approach for drugs with known but uncommon poten-
depend on what the specific target outcome is and how tially serious cardiovascular toxicities. It is also not possi-
quickly or slowly the target outcome is expected to be ble to specifically monitor for idiosyncratic or previously
achieved; what the pharmacokinetic properties (absorp- unidentified adverse drug effects. The pharmacist must be
tion, distribution, metabolism, elimination) of the medi- aware of the possibility of these types of potential adverse
cation are; and how long it takes for a potential adverse drug effects and solicit and assess all patient complaints
drug effect to appear. For example, the level of glycosyl- (e.g., ask the patient if he or she has experienced any-
ated hemoglobin (Hb A1C) changes slowly in response thing unusual since starting the medication).
to long-term glucose control and is routinely monitored
every 6 to 12 months. It may take several weeks for STEP 1DETERMINE SPECIFIC MONITORING
changes associated with pneumonia to resolve; repeating PARAMETERS
chest radiography within a few days of starting a course of
antibiotics is not appropriate unless the patient has signs All medication regimens have two possible outcomes:
and symptoms consistent with progressive pneumonia. 1. The medication regimen provides the expected
Drug-associated anaphylaxis typically occurs within min- therapeutic benefit for the patient.
utes to hours of the first dose; ambulatory patients may 2. The medication regimen does not provide the expected
be observed closely for a few hours after receiving the first therapeutic benefit or is otherwise harmful to the
dose then sent home with instructions to contact the pre- patient.
scriber if symptoms develop. Isoniazid-associated hepato- Each outcome is assessed by questioning the patient to
toxicity develops slowly with continued exposure to the elicit subjective data and by obtaining quantifiable objec-
drug; liver function tests are performed before starting tive data, so that four distinct types of monitoring data
therapy to obtain a baseline and then repeated monthly can be collected:
during the 6-month course of therapy. Chemotherapy- 1. Subjective-therapeuticsubjective data for assessing
associated neutropenia occurs quickly and predictably; whether the medication regimen provides the expected
the complete blood count and differential are monitored therapeutic outcome
daily to identify if and when preventive interventions 2. Subjective-toxicsubjective data for assessing whether
(i.e., isolation, antibiotic prophylaxis) are indicated. It the medication regimen does not provide the expected
Chapter 8 Monitoring Drug Therapies 147
for each medication in the therapeutic regimen. This of ibuprofen for this patient. Most of the adverse effects
approach not only produces an organized and thorough documented for ibuprofen that are identifiable with objec-
monitoring plan but also provides a reminder of the rela- tive data occur at an incidence of less than 1% and require
tionships among the types of monitoring data and the invasive tests that would add significant cost to the care of
reasons for evaluating specific parameters. Experienced the patient if routinely monitored for. Thus, it would not be
clinicians work through this planning process mentally; reasonable to monitor the patients complete blood count,
students and less experienced clinicians may find writing liver function test results, or serum creatinine level unless
down each step a useful exercise as they develop compre- the patient was at increased risk for, or was experiencing,
hensive monitoring plans. adverse effects.
Example: Select appropriate subjective-therapeutic, subjective- The patient does not require follow-up with the prescriber
toxic, objective-therapeutic, and objective-toxic monitoring unless the ibuprofen fails to control the pain or the patient
parameters for a 25-year-old patient with a severe ankle sprain develops any of the potential adverse drug effects. The patient
for which ibuprofen 600 mg every 8 hours is prescribed. The should be instructed to contact the prescriber if the ibuprofen
patient has no other medical conditions. Her symptoms include does not control the pain within a couple of days or if the
throbbing pain that keeps her awake at night. Ibuprofen is ibuprofen upsets her stomach or if she experiences heartburn,
approved by the Food and Drug Administration (FDA) for the nausea, ankle swelling, itching or a rash, or ringing in the ears
treatment of inflammatory disorders, including mild to moder- or notices anything else unusual after starting the ibuprofen.
ate pain. Documented adverse effects and incidents reported
for ibuprofen include edema (3% to 9%), rash (3% to 9%), STEP 2INTEGRATE THE MONITORING PLAN
epigastric pain (3% to 9%), heartburn (3% to 9%), nausea
(3% to 9%), tinnitus (3% to 9%), headache (1% to 3%), ner- No integration is required if the patient is receiving just
vousness (1% to 3%), itching (1% to 3%), abdominal pain or one medication. However, most patients receive multiple
cramps (1% to 3%), decreased appetite (1% to 3%), constipa- drugs; therefore the individual medication monitoring
tion (1% to 3%), diarrhea (1% to 3%), flatulence (1% to 3%), plans must be integrated into one master monitoring
and a very long list of adverse effects with a reported incidence plan. One way to integrate the monitoring plan is to cre-
of less than 1%, including acute renal failure, agranulocytosis, ate a master list of subjective and objective monitoring
anaphylaxis, aplastic anemia, gastrointestinal bleeding, hal- parameters collated from each of the individual medica-
lucinations, inhibition of platelet aggregation, abnormal liver tion monitoring plans, noting all the reasons for moni-
function test results, leukopenia, pancreatitis, thrombocytope- toring any given parameter. For example, heart rate may
nia, and toxic epidermal necrolysis. be an objective monitoring parameter for the therapeutic
Subjective-therapeutic monitoring parameters: It is and toxic response to digoxin, the therapeutic response
reasonable to expect that the ibuprofen will reduce the pain, to procainamide, and the toxic response to theophyl-
although it will not necessarily decrease the pain enough to line. To monitor the heart rate, the pharmacist needs to
allow the patient to sleep through the night. Therefore, the measure the heart rate only once; however, the monitor-
subjective-therapeutic monitoring target outcomes include ing plan documents all the reasons why the heart rate is
decreased pain and sleeping through the night. These monitor- being monitored.
ing outcomes can be assessed by asking the patient how well
the ibuprofen works to reduce her pain and whether the pain is STEP 3OBTAIN DATA
reduced enough to let her sleep through the night.
Subjective-toxic monitoring parameters: Failure of Once the monitoring plan is created, monitor the patients
the ibuprofen to achieve the expected therapeutic outcome is response to therapy at the predetermined monitoring
recognized by the presence of persistent throbbing pain that intervals. Interview the patient or caregiver for subjec-
prevents the patient from sleeping through the night. These tive data. Obtain objective data from the patients medi-
monitoring outcomes can be assessed by asking the patient cal record, bedside flow sheets, and laboratory reports.
how well the ibuprofen works to reduce her pain and whether Document the data.
the pain is reduced enough to let her sleep through the night. Document the monitoring data in organized, easily
A reasonable monitoring strategy for potential drug-associated assessable formats. Flow sheets work well for document-
adverse effects in this ambulatory patient with no other medi- ing large amounts of objective data; brief sequential notes
cal conditions would be to ask her if the ibuprofen upsets her work well for documenting subjective data. Many phar-
stomach or causes heartburn, nausea, ankle swelling, itching macists prefer to create their own customized monitoring
or a rash, or ringing in the ears. Less common side effects such forms or computer files that provide a structured format
as pancreatitis would not be routinely monitored for but would to organize the types of data they routinely monitor in
be identified if the patient reported new symptoms. their practice settings. Some pharmacists use institution-
Objective-therapeutic parameters: There are no rea- specific monitoring forms or computer files that have
sonably available objective data for assessing the beneficial been developed and agreed on by consensus. Figures
effects of ibuprofen for this patient. Daily imaging studies 8-3 and 8-4 are examples of medication flow sheets, and
(e.g., magnetic resonance imaging [MRI]) might identify mea- Figures 8-5 through 8-7 are examples of objective data
surable reduction in swelling, which might be associated with flow sheets. Some pharmacists prefer to use commercial
less pain, but would be exceedingly expensive and completely patient tracking software available via smart phones, per-
unjustifiable for this patient. sonal data assistants (PDAs), or wireless computer tech-
Objective-toxic parameters: There are no reasonably nologies. Because of the increasing availability of wireless
available objective data for assessing the lack of benefit Internet access and small portable handheld computers,
Chapter 8 Monitoring Drug Therapies 149
Case Study
Jack Campbell, a 69-year-old white male with a diagnosis Subjective-toxic monitoring parametersThe patients
of right- and left-sided congestive heart failure, complains of symptoms will not improve and may worsen if captopril
swollen feet, shortness of breath when walking more than half therapy does not provide the expected therapeutic ben-
a block, nonproductive cough that is worse at night, and occa- efit. The patient also may experience a variety of annoy-
sional leg cramps. He has gained 30 lb over the past 3 months ing or potentially harmful side effects from captopril
and notes that all his clothes are too tight. He props himself therapy.
up with three pillows when sleeping. The goal of therapy is to Objective-therapeutic monitoring parametersA variety of
improve the patients quality of life by improving cardiac func- laboratory and other tests are used to monitor improve-
tion and controlling symptoms. His new medication regimen ment in cardiac function. Improvement in cardiac func-
includes digoxin (Lanoxin) 0.25 mg daily, furosemide (Lasix) tion may not be immediately evident after initiation of
40 mg daily, captopril (Capoten) 25 mg three times daily, and treatment but may be noted after long-term drug admin-
potassium chloride (Slow-K) 8 mEq three times daily. istration.
Objective-toxic monitoring parametersA variety of labo-
Digoxin Monitoring Parameters (Figure 8-8) ratory and other tests are used to monitor for lack of
Subjective-therapeutic monitoring parametersThe patients improvement in cardiac function or potentially harmful
symptoms will diminish or resolve if digoxin therapy side effects from captopril therapy.
provides the expected therapeutic benefit of improved
cardiac function. Potassium Chloride Monitoring Parameters (Figure 8-11)
Subjective-toxic monitoring parametersThe patients symp- Subjective-therapeutic monitoring parametersThe patient
toms will not improve and may worsen if digoxin therapy is receiving supplemental potassium to prevent hypokale-
does not provide the expected therapeutic benefit. The mia resulting from the furosemide therapy. Because this is
patient also may experience a variety of annoying or preventive therapy, no subjective parameters are avail-
potentially harmful side effects from digoxin therapy. able to evaluate the desired outcome of supplemental
Objective-therapeutic monitoring parametersA variety of potassium therapy.
laboratory and other tests are used to monitor improve- Subjective-toxic monitoring parametersThe patient may
ment in cardiac function. Improved cardiac function may develop symptoms of hypokalemia if potassium supple-
not be immediately evident after initiation of treatment mentation is inadequate. Conversely, if potassium
but may be apparent with long-term drug therapy. supplementation is excessive, the patient may experience
Objective-toxic monitoring parametersA variety of labo- symptoms of hyperkalemia.
ratory and other tests are used to monitor for lack of Objective-therapeutic monitoring parametersThe goal of
improvement in cardiac function or potentially harmful therapy is to maintain an appropriate serum potassium
side effects from digoxin therapy. level with supplemental therapy.
Objective-toxic monitoring parametersObjective monitor-
Furosemide Monitoring Parameters (Figure 8-9) ing parameters for supplemental potassium therapy are
Subjective-therapeutic monitoring parametersThe patients limited.
symptoms will decrease or resolve if furosemide therapy
improves cardiac function by decreasing intravascular Integrated Monitoring Plan
volume. The integrated subjective parameters monitoring plan is
Subjective-toxic monitoring parametersThe patients shown in Box 8-4. The integrated objective parameters mon-
symptoms will not improve and may worsen if furose- itoring plan is shown in Box 8-5. The drugs in the therapeu-
mide therapy does not provide the expected therapeutic tic regimen are prescribed for the management of congestive
benefit. The patient also may experience a variety of heart failure. Therefore a great deal of duplication occurs
annoying or potentially harmful side effects from furose- among the monitoring plans. However, the pharmacist needs
mide therapy. to know the multiple reasons for monitoring each parameter.
Objective-therapeutic monitoring parametersA variety of For example, blood pressure is an important therapeutic and
laboratory and other tests are used to monitor improve- toxic monitoring parameter for several of the drugs in the
ment in the fluid overload status of the patient. Some medication regimen.
improvement in cardiac function may occur as a result of Monitor the patient frequently (e.g., weekly) for initial
diuretic therapy. response to therapy, then less frequently (e.g., every 6
Objective-toxic monitoring parametersA variety of labo- months) as the patients condition stabilizes. The patient
ratory and other tests are used to monitor for lack of should weigh himself daily and contact the prescriber if he
improvement in cardiac function or potentially harmful has gained more than 1.0 to 1.5 lb. The serum potassium
side effects from furosemide therapy. concentration and renal function should be assessed 1 to
2 weeks after changing the dose of the captopril or potas-
Captopril Monitoring Parameters (Figure 8-10) sium. The serum digoxin concentration should be assessed
Subjective-therapeutic monitoring parametersThe patients 1 to 2 weeks after changing the dose and at least annually
symptoms will decrease or resolve if captopril therapy if the patients condition is stable. Therapeutic monitoring
provides the expected therapeutic benefit of improved is an ongoing process. Modify the therapeutic regimen and
cardiac function. monitoring plan according to the patients response.
Chapter 8 Monitoring Drug Therapies 151
Susceptibilities
Date Site Grams Stain Organism(s) Sensitive Resistant Box 8-3Guidelines for Altering Drug Therapy
If the regimen is ineffective, change the drug if:
1. The patient received an adequate trial of the drug.
2. The patient received an adequate dosage of the
drug.
3. The patient adhered to the prescribed or
recommended regimen.
If the regimen is associated with life-threatening side
effects, discontinue the drug.
If the patient will not adhere to the prescribed or
recommended regimen because of unacceptable side
effects, discontinue the drug.
If the regimen is effective but the patient has non
life-threatening side effects and is willing to continue
Figure 8-7 Microbiology Flow Sheet. the drug, minimize the side effects:
1. Modify the dosage.
2. Change the drug administration time.
If the regimen is effective and the patient has no drug-
associated side effects, continue the current regimen.
Subjective-Therapeutic Objective-Therapeutic
Swelling of feet Heart size on CXR Subjective-Therapeutic Objective-Therapeutic
Looser-fitting clothing Edema on CXR
Weight Swelling of feet Heart size on CXR
SOB and DOE
Ejection fraction Looser-fitting clothing Edema on CXR
Exercise tolerance
Improved R-wave progression SOB and DOE Weight
Sleeps with fewer pillows
Normalization of R-S Able to sleep with fewer pillows Ejection fraction
Cough
T-wave inversion Cough Improved R-wave progression
Normalization of R-S
T-wave inversion
Figure 8-8 Digoxin Monitoring Plan. Examples of subjective Figure 8-9 Furosemide Monitoring Plan. Examples of subjec-
and objective monitoring parameters for digoxin. tive and objective monitoring parameters for furosemide.
152 Clinical Skills for Pharmacists: A Patient-Focused Approach
Subjective-Toxic Objective-Toxic
Nausea Serum potassium <3.5 mEq/L
Subjective-Toxic Objective-Toxic Vomiting Flattened T wave
Diarrhea Widened Q-R-S complex
Swelling of feet Heart size on CXR Bad taste Peaked T waves
Tighter-fitting clothing Edema on CXR Abdominal discomfort Flattened or inverted T waves
SOB and DOE Weight Palpitations U waves
Exercise tolerance Ejection fraction Lethargy
More problems sleeping Poor R-wave progression Weakness
Persistent dry cough Abnormal R-S Muscle cramps
Dizziness T-wave inversion
Itching Elevated temperature Figure 8-11 Potassium Chloride Monitoring Plan. Examples
Maculopapular or morbilli- Eosinophilia of subjective and objective monitoring parameters for potassium
-form rash Proteinuria chloride.
Dysgeusia Serum creatinine
Serum BUN
Blood pressure
WBC with differential