Professional Documents
Culture Documents
GENERAL PRINCIPLES
CHAPTER
patient relationship. This allows him or her to gather the essential medical and social history needed to identify therapeutic problems, assess the patients knowledge about drug
therapy, and establish and evaluate therapeutic outcomes. This
information is essential to the design and implementation of a
pharmaceutical care plan that is specific to an individual patients needs. The provision of such ongoing, individualized
pharmaceutical care also encourages patients to use the pharmacist as a resource for drug therapy dilemmas. The third critical component of pharmaceutical care is formal documentation, not only of the pharmaceutical care plan, but also of all
clinical interventions and therapeutic outcomes. These
records enhance the continuity of care and can be used to facilitate communication with other providers involved in the
patients care.
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GENERAL PRINCIPLES
Knowledge
To establish an accurate patient record, the practitioner must
have a good understanding of the pathophysiology and clinical presentation of commonly encountered medical conditions so that he or she can correlate certain signs and symptoms with diseases. Pharmacists and other providers also must
have a clear understanding of the appropriate use of drugs that
are prescribed commonly to manage these diseases, including
a thorough knowledge of pharmacology, how drugs are used
to treat disease, and most important, the expected outcome of
the therapy. The remaining chapters throughout this textbook
provide knowledge for disease-specific interventions. This
chapter provides a framework for the application of knowledge in various patient care settings.
Name:
1-3
Date:
Mailing Address:
street
city
Height:
Gender:
state
Phone: (H)
Weight:
zip
(W)
HR:
BP:
Pregnancy Status:
Reactions:
Allergies:
Devises/Alerts:
Name/Strength
Directions
Purpose
Effectiveness
OTC USE: Check conditions for which you have used a non-prescription medication.
heartburn/GI upset/gas
drowsiness
headache
vitamins
weight loss
eye/ear problems
herbal products
diarrhea
cold/flu
organic products
hemorrhoids
allergies
other:
muscle/joint pain
sinus
rash/itching/dry skin
cough
sleeplessness
Name/Strength
Effectiveness
FIGURE 1-1 Patient history form. (Reprinted with permission from Patient history form. A Practical Guide
to Pharmaceutical Care, pp. 3637, 2003, by the American Pharmaceutical Association.)
responses to his or her comments. The patient should be encouraged to do most of the talking, while the interviewer carefully listens and observes.
In all interactions, the health care provider must treat the
patient with respect and must make every effort to ask questions and receive information in a nonjudgmental way (e.g.,
1-4
GENERAL PRINCIPLES
MEDICAL PROBLEMS: Have you experienced, or do you have: (circle Y or N)
known kidney problems?
frequent urinary infections?
difficulty with urination?
frequent urination at night?
known liver problems/hepatitis?
trouble eating certain foods?
nausea or vomiting?
constipation or diarrhea?
bloody or black bowel movements?
abdominal pain or cramps?
frequent heartburn/indigestion?
stomach ulcers in the past?
shortness of breath?
coughing up phlegm or blood?
chest pain or tightness?
fainting spells or passing out?
thumping or racing heart?
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
MEDICAL HISTORY: Have you or any blood relative had: (mark all that apply)
self
relative
self
relative
heart disease
stroke
kidney disease
mental illness
substance abuse
other
SOCIAL HISTORY: Please indicate your tobacco, alcohol, caffeine and dietary habits.
Nicotine Use
never smoked
packs per day for
years
stopped
year(s) ago
Caffeine Intake
never consumed
drinks per day
stopped
year(s) ago
Alcohol Consumption
never consumed
drinks per day/week
stopped
year(s) ago
Diet Restrictions/Patterns
number of meals per day
food restrictions:
OTHER INFORMATION/COMMENTS:
Pharmacist Signature
Date
and share it only with those providers who need this information to provide patient care. Additionally, clinicians must adhere to the regulations set forth by the Health Insurance
Portability and Accountability Act (HIPAA) of 1996, which
provides standards to protect the security and confidentiality
treatment records, prescriptions, and laboratory and test results. Further discussion of the HIPAA regulations is beyond
the scope of this chapter; consult the United States
Department of Health and Human Services website
(http://www.hhs.gov/ocr/hipaa/) for additional information.
The process of interviewing the patient, how to set the stage
for the interview, and the essential information to be gleaned
from the interview are outlined in Table 1-1.
Table 1-1
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Medical History
The medical history is essential to the provision of pharmaceutical care. It can be as extensive as the medical records that
are maintained in an institution or in a physicians office, or it
can be a simple patient profile that is maintained in a community pharmacy. The purpose of the medical history is to
identify significant past medical conditions or procedures;
identify, characterize, and assess current acute and chronic
medical conditions and symptoms; and gather all relevant
health information that could influence drug selection or dosing (e.g., function of major organs such as the GI tract, liver,
and kidney that are involved in the absorption and elimination
of drugs; height and weight, including recent changes in either; age and gender; pregnancy and lactation status; and special nutritional needs).
1. P.J., a 45-year-old woman of normal height and weight,
states that she has diabetes. What questions might the practitioner ask of P.J. to determine whether type 1 or type 2 disease
should be documented in her medical history?
When questions such as these are combined with knowledge of the pathophysiology of diabetes, appreciation of the
typical presenting signs and symptoms of the disease, and understanding of the drugs generally used to treat both forms of
diabetes, meaningful pharmaceutical care can be provided.
Even simple assessments such as the observation of a patients
body size can provide information useful for therapeutic
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GENERAL PRINCIPLES
Table 1-2
Company
Web Site
Telephone Number
http://www.hcc-care.com/
888-727-5422
http://www.etreby.com/
800-292-5590
http://www.carepoint.com/
800-296-1825
Encounter by jASCorp
http://www.jascorp.com/
800-444-4498
http://www.qarx.com
816-525-6141
http://www.qs1.com
800-845-7558
Data compiled by Bill G. Felkey, Harrison School of Pharmacy, Auburn University. For more information, visit his website at http://pharmacy.auburn.edu/pcs/review/manage.htm
Drug History
After the initial visit, patients often present themselves to
community pharmacists in one of three ways: (1) with a selfdiagnosed condition for which nonprescription drug therapy
is sought, (2) with a newly diagnosed condition for which a
drug has been prescribed, or (3) with a chronic condition that
requires refill of a previously prescribed drug or the initiation
of a new drug. In the first and second situations, the practitioner must confirm the diagnosis using disease-specific questions as illustrated in Question 1. In the third situation, the
practitioner uses the same type of questioning as in the first
two situations; however, this time the practitioner needs to
evaluate whether the desired therapeutic outcomes have been
achieved. The practitioner must evaluate the information
gleaned during follow-up visits in the context of the history
and incorporate it into his or her assessment and pharmaceutical care plan. The goals of the therapeutic history are to obtain and assess the following information: the specific prescription and nonprescription drugs the patient is taking (the
latter includes over-the-counter [OTC] medications, botanicals, dietary supplements, recreational drugs, alcohol, tobacco, and home remedies); the intended purpose or indications for each of these medications; how (e.g., route, ingestion
in relation to meals), how much, and how often these medications are used; how long these agents have been taken or used
(start and stop dates); whether the patient believes any of
these agents are providing therapeutic benefit; whether the patient is experiencing or has experienced any adverse effects
that could be caused by each of these agents (idiosyncratic reactions, toxic effects, adverse effects); and allergic reactions
and any history of hypersensitivity or other severe reactions to
drugs. This information should be as specific as possible, including a description of the reaction, the treatment, and the
date of its occurrence.
2. P.J. has indicated that she is injecting insulin to treat her
diabetes. What questions might be asked to evaluate P.J.s use of,
and response to, insulin?
Social History
The social history is used to determine the patients occupation and lifestyle; important family relationships or other sup-
Work
Describe a typical work day and a typical weekend day.
Exercise
Describe your exercise habits. How often, how long, and
when during the day do you exercise? Describe how you
change your meals or insulin when you exercise?
Diet
How many times per day do you usually eat? Describe your
usual meal times.
What do you usually eat for each of your main meals and
snacks?
Are you able to eat at the same time each day?
What do you do if a meal is delayed or missed?
Who cooks the meals at home? Does this person understand your dietary needs?
How often do you eat meals in a restaurant?
How do you order meals in a restaurant to maintain a
proper diet for your diabetes?
Support Systems
Who else lives with you? What do they know about diabetes? How do they respond to the fact that you have diabetes? How do they help you with your diabetes management? Does it ever strain your relationship? What are the
issues that seem to be most troublesome? (Note: These questions apply equally to the workplace or school setting. Often,
the biggest barrier to multiple daily injections is refusal of
the patient to inject insulin while at work or school.)
Attitude
How do you feel about having diabetes?
What worries or bothers you the most about having diabetes? (Note: The patients demeanor and response to this
and other questions will cue the history taker to the issues
the patient considers most important. By addressing these
concerns first, the patient is encouraged to actively participate in his or her own care. This approach is likely to enhance the patient-provider relationship, which should
translate into improved care.)
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GENERAL PRINCIPLES
Table 1-3
Recorda
Problem name: Each problem is listed separately and given an identifying number. Problems may be a patient complaint (e.g., headache),
a laboratory abnormality (e.g., hypokalemia), or a specific disease
name if prior diagnosis is known. When monitoring previously described drug therapy, more than one drug-related problem may be
considered (e.g., nonadherence, a suspected adverse drug reaction or
drug interaction, or an inappropriate dose). Under each problem
name, the following information is identified:
Subjective
Objective
Assessment
Plan
Medical problems can be drug-related including prescribing errors, dosing errors, adverse drug effects, adherence issues, and the need for medication counseling. Drug-related
problems may be definite (i.e., there is no question that the
problem exists) or possible (i.e., further investigation is required to establish whether the problem really exists). The
most commonly encountered types of drug-related problems
are listed in Table 1-4.2,3
The distinction between medical problems and drug-related problems sometimes is unclear, and considerable overlap exists. For example, a medical problem (i.e., a disease,
syndrome, symptom, or health condition such as pregnancy)
can be prevented, cured, alleviated, or exacerbated by medications. When assessing drug therapy, several situations could
exist: treatment is appropriate, and therapeutic outcomes have
Table 1-4
Drug-Related Problems
Wrong Dose
Prescribed dose too high (includes adjustments for renal and hepatic
function, age, body size)
Correct prescribed dose, but overuse by patient (overadherence)
Prescribed dose too low (includes adjustments for age, body size)
Correct prescribed dose, but underuse by patient (underadherence)
Incorrect, inconvenient, or less-than-optimal dosing interval (consider use of sustained-release dosage forms)
Adverse Drug Reaction
Hypersensitivity reaction
Idiosyncratic reaction
Drug-induced disease
Drug-induced laboratory change
Drug Interaction
Drugdrug interaction
Drugfood interaction
Druglaboratory test interaction
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GENERAL PRINCIPLES
ries of intermediate step-wise goals. In some situations, an intermediate goal may be that which is realistic within the context of the patients situation. For example, with peptic ulcer
disease the short-term goal is symptomatic relief, an intermediate goal is healing the ulcer, and a long-term goal is preventing recurrence of the disease.
These examples all relate to achieving a positive outcome
(i.e., ensuring that the therapy is effective). However, there are
other concurrent goals related to drug therapy: avoidance of
adverse effects, convenience (to improve adherence), and
cost-effectiveness. Although these latter three elements of the
therapeutic goal may not always be articulated, they are part
of every desired clinical outcome and must be considered
when evaluating a pharmaceutical care plan. The potential
benefits always should be balanced against the potential risks
of therapy. As an example, higher-than-average dosages may
be acceptable if the patient is not responding to usual
dosages and has not been experiencing side effects. The interventions necessary to achieve the specified clinical outcomes also are integral to the pharmaceutical care plan. The
following are examples of interventions in a pharmaceutical
care plan: reinstituting correct use of a prescription medication when it is being taken or used improperly; educating and
working with the patient to self-diagnose, evaluate, and solve
therapeutic problems; initiating nonprescription drugs, nondrug therapies, administration aids, or monitoring tools; recommending or prescribing prescription medications; reinforcing continuation of already prescribed medications; alerting
physicians to potential drug-related problems that can be
solved only through an alteration of the original prescription
(these include discontinuing the medication, prescribing an
alternative drug, altering the dosage or route of the current
medications, and adding other medications); and referring the
patient back to his or her primary care provider.
7. In Question 4, the subjective and objective data were considered for P.N., who has a BP of 140/100 mm Hg. What would
be some therapeutic objectives or desired clinical outcomes of
P.N.s treatment?
tension such as kidney damage, loss of eyesight, and the development of HF or other cardiovascular complications. This
latter objective is better defined than simply stating that the
goal is to prevent complications of his disease. As always,
unstated objectives are to avoid side effects and to make the
treatment regimen as simple and cost-effective as possible.
8. D.L. (see Question 5) presented to the ED with subjective
and objective data sufficient to support a diagnosis of cellulitis.
What would be some therapeutic objectives or desired clinical
outcomes of his treatment?
Short of a heart transplant, cure or eradication of the disease is impossible. A narrow therapeutic objective might be
to increase cardiac output. Obviously, there is more to treating HF than increasing cardiac output (See Chapter19, Heart
Failure). Also, this stated objective implies that invasive procedures can be performed to actually measure cardiac output.
This would be beyond the scope of most practitioners. A more
realistic statement of a therapeutic objective is to provide
symptomatic relief of HF, including increased exercise capacity, decreased SOB, and reduced ankle swelling. A longrange objective is to prolong the patients survival. The physicians objectives may be more specific and include reducing
neck vein distension, eliminating the S3 gallop rhythm, and
1-11
The following example of a SOAP note illustrates the importance of integrating the patients medical, therapeutic, and
social history into the design of a pharmaceutical care plan
(also see Chapter 50, Diabetes Mellitus).
Problem 1
Patient has been experiencing frequent hypoglycemia reactions.
SUBJECTIVE
Patient reports episodes characterized by severe hunger,
tremors, and profuse sweating that are relieved by drinking
orange juice. Episodes occur twice weekly, generally in the
late afternoon. Patient often skips lunch to exercise. Patient
states that she uses 30 U of NPH insulin every morning
mixed with 30 U of regular insulin. She claims to never
miss a dose and takes her insulin at 8 AM each day.
OBJECTIVE
Occasional blood glucose values of 30 to 60 mg/dL in the
late afternoon, often followed by values 300 mg/dL before dinner and at bedtime.
ASSESSMENT
Total daily dose of insulin is high (1.2 U/kg). Morning
dose of NPH insulin may be excessive. May require multiple daily injections of insulin. Carbohydrate intake and exercise patterns erratic.
PLAN
Therapeutic Objectives
Initially, fasting blood glucose 140 mg/dL, postprandial blood glucose 180 mg/dL, all blood glucose concentrations 70 mg/dL.
No symptoms of hypoglycemia such as those noted
above under Subjective.
Patient to eat more regularly and carbohydrate intake to
be distributed appropriately throughout the day.
Patient to be able to predict time of peak NPH insulin activity and the relationship between carbohydrate intake
and insulin dosage.
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GENERAL PRINCIPLES
also must upgrade and update the patients database (i.e., the
patient profile). The community pharmacist could begin by
carefully reviewing the patient profile for all drugs currently
being taken by the patient; for drugs that have been taken previously, but are now discontinued; and for the apparent refill
frequency rates for regularly scheduled, routine medications
as well as for those medications with the potential for abuse.
The pharmacist should now be ready to generate a problem
list by identifying patient-specific, drug-related problems. The
pharmacist should prioritize the problems listed, with the
most important problem or the patients current complaint
(chief complaint) being ranked first, followed in an order
based on the pharmacists personal assessment of the severity
of the problems. The order of the pharmacists problem list
may be greatly different from that of the physician or nurse
because each has a different perspective when evaluating a patient. In some cases, an abbreviated problem list that includes
only the currently active problems or even a single problem
that is being given priority (e.g., specific suspected adverse
drug effect) can be developed. The risk of an abbreviated
problem list is that confounding variables from other problems may be overlooked, thus affecting the practitioners ability to assess the current problem accurately.
Although the community pharmacist in this scenario is not
likely to have access to the patients medical records, the pharmacist can formulate a problem list predicated on the most
likely indications for the drugs that the patient is taking.
When in doubt, the most valuable source of information can
be accessed (i.e., the patient can be interviewed). In a tactful
way, the practitioner can ask the patient about current medical
problems or why medical help was sought. One example is to
say, I see that you are taking digoxin. What did your physician tell you this medication was for? or Are you taking this
to help regulate your heartbeat or for heart failure? The exact phrasing of these sample questions needs to be adapted to
the patient and the professional style of the pharmacist.
Questions also should be asked to determine how well the patient thinks the drug is working and whether the patient has
experienced any problems. At the same time, the pharmacist
can ask the patient about medications that are obtained from
another pharmacy, nonprescription medications being used,
and any previous drug allergy experiences. Gathering of information may be expedited by using written history forms
for the patient to complete, but the importance of talking directly with the patient at the time of the initial filling of a prescription or when the patient is obtaining refills cannot be
overemphasized. Note that at this point, the practitioner is
gathering subjective data (i.e., information gleaned from the
patient) while preparing a problem list for the patient.
A helpful intermediate step in gathering objective data is
to link the patients drugs to one or more of his or her medical
problems (Table 1-5). This process aids in identifying drugs
that may have been prescribed for more than one indication or
drugs that are inappropriate (i.e., have no apparent indication). Drugs with multiple indications should be listed separately under each relevant problem. Some medications, such
as vitamins, analgesics, sedatives, antacids, and laxatives,
may be difficult to categorize. These nonprescription medications can be grouped under a general category such as general care, but these should not be ignored because overuse or
side effects can occur with these drugs as well. Alternatively,
Table 1-5
Problem a
Drugs Prescribed
Medical problem 1
(usually the chief complaint)
Medical problem 2
Drug A
Medical problem 3
Medical problem 4
Drug-related problem 1
Drug-related problem 2
a
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Drug B
Drug C
Drug B
Drug D
Drug E
No drug therapy
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GENERAL PRINCIPLES
No
Yes
Effective?
No
Yes
Yes
Yes
Adverse effect?
No
Is cost an issue?
Yes
Drug interactions?
Yes
Can regimen be
simplified?
Evaluate adherence
Can the patient or
caregiver administer
medications as
prescribed?
No
FIGURE 1-2 Medication evaluation algorithms. (Adapted from Newton P. The geriatric medication algorithm. A pilot study. J Gen Int Med 1994;9:164167.)
Table 1-6
Monitoring Questions
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The problem list for both medical and drug-related problems now has been finalized, and considerable subjective and
objective data have been reviewed. After the listed problems
have been assessed for severity and acuity, a plan can be developed. As previously presented, the plan should include
both therapeutic objectives and an educational component for
each of the defined medical or drug-related problems. The
immediate emphasis may be on short-term therapeutic objectives, but the clinician also should formulate intermediate and
long-term objectives from the beginning.
The therapeutic objectives, of course, include the correction of possible drug-related problems. After considering all
potential corrective actions, the clinician ultimately must
choose the one option that is best for the patient. The process
of merely identifying several possible solutions to a problem
without being able to prioritize and select what seems to be
the best option does not benefit the patient. If a change in therapy is necessary or if there is sufficient concern to warrant
contacting the prescriber, the recommended solution to the
problem must be clearly defined and include a specific alternative drug, route of administration, dose, and frequency of
administration. Furthermore, the pharmacist must be prepared to justify the reasoning behind his or her recommendations (i.e., provide supporting evidence). If more cost-effective alternatives are available, the pharmacist will need to
work with both the patient and the prescriber to change the
therapy.
A plan for ongoing monitoring also needs to be established
for the patient. The ongoing plan should contain specifics
about what parameters will continue to be monitored for efficacy, side effects, appropriateness of dosage, and adherence to
treatment. The clinician will have to decide how often monitoring for these parameters will be necessary. It also is helpful to anticipate possible future complications (e.g., changes
in disease control, future complications of the disease) that
may necessitate a change in the dosage or drug of choice. For
example, if a diabetic patient develops decreased visual acuity and worsening renal function, the therapeutic plan may
have to be altered by using larger print on labels, recommending a magnifying attachment for the patients insulin syringes, and adjustment of the dosage of one or more of the patients drugs. Finally, issues for future counseling also need to
be considered, taking into consideration the level of sophistication of the individual patient (i.e., education plan).
Inpatient Pharmacy Setting
12. W.G. has just been hospitalized in a large medical center
where the pharmacist has access to the medical chart, nursing
record, medication administration record, and a computer that
directly links to the clinical laboratory. The pharmacists at this
facility assess the patients drug therapy and routinely provide
clinical pharmacokinetic monitoring. How would the pharmacist
approach W.G. differently in this clinical setting compared with
the pharmacist in Question 11 who worked in a community
pharmacy?
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GENERAL PRINCIPLES
confusing because two different agents are involved (tioconazole versus miconazole) and the dosage forms are different (a
cream versus suppository). There are also differences in how
long each drug is to be used (1 day for tioconazole and 7 days
for this particular form of miconazole). S.F. may be asking the
question because she simply is curious, but more likely, she is
indirectly asking the pharmacist to diagnose a problem and to
recommend a therapy. Moreover, the treatment may be for her,
or it may be for someone else. The pharmacist should ask several questions and mentally develop a problem list before recommending therapy.
The only approved indication for nonprescription vaginal
antifungal products is the treatment of a recurrent candidal
vaginal infection. Therefore, the pharmacist needs to gather
subjective and objective data to verify the existence of this
problem in S.F. or in whomever will be using the product. As
a minimum, the pharmacist should inquire about symptoms
(e.g., vaginal itching or burning, inflammation, a cottagecheeselike discharge) and confirm that previous symptoms
were diagnosed by a physician. Possible questions to ask are:
Will you be using this product or will someone else? What
symptoms are you having? Describe the discharge. Have
you been treated for this problem before? How were you
treated before? Have you ever used either of these two products? Was the drug effective last time?
At least two other important questions should be asked:
What other medications are you taking? and Is it possible
that you are pregnant? The answer to the first question will
help identify other possible medical problems to add to the
problem list as well as possible drugs that could be the cause
of her infection (e.g., antibiotics or oral contraceptives). If she
is pregnant, referral to her obstetric provider is indicated.
14. At this point, an initial assessment can be made about
whether S.F. has a recurrent vaginal yeast infection. Assume for
the moment that the diagnosis is confirmed and S.F. is not taking
any other medications and has no other medical problems. What
is the therapeutic goal of her treatment, and what is the next step
for the pharmacist to take?
Establishing Priorities
15. How are priorities decided regarding which patients
should be monitored and when the pharmacist should intervene?
Ideally, all patients should be monitored closely and interventions made in every instance that an actual or potential
problem is identified. For the pharmacist working in a specialized unit (e.g., a bone marrow transplant unit), it may be
feasible to monitor all patients with the same level of intensity
because the number of patients may be relatively small and
the underlying problem is similar for all the patients. On the
other hand, pharmacists practicing on a general medicine
ward, at a nursing home, or in a busy community pharmacy
have a greater diversity and larger volume of patients, making
universal monitoring impractical. Thus, criteria need to be established to determine which patients need to be monitored
more extensively. Although there are no absolute rules on how
to set priorities, the following guidelines might be helpful.
Age and Gender
The dosages of medications should be reviewed for children
younger than 12 years of age and adults older than 65 because
of smaller body size and possible impaired drug clearance or
enhanced sensitivity to drug effects. Women of childbearing
age should be evaluated more closely if possible teratogenic
drugs are prescribed.
Number of Medications Prescribed or Number of Doses Per Day
People receiving multiple medications should be monitored
more closely for duplication of therapy, potential adverse
drug effects, and possible drug interactions. Complicated
drug regimens should be evaluated for the possibility of using
sustained-release preparations or combination products to improve adherence.
Drugs With a High Risk for Adverse Drug Effects
or Drug Interactions
Pharmacists should develop a list of key drugs within their
practice that trigger a more in-depth review when they are
encountered. This list could include drugs such as anticoagulants, digoxin, metered-dose inhalers, oral corticosteroids,
insulin or oral hypoglycemics, aminoglycosides, and anticonvulsants. Drugs with a high potential for triggering drug
1-17
interactions include enzyme inhibitors and inducers, anticonvulsants, cimetidine, macrolide antibiotics, fluoroquinolones,
and serotonin reuptake inhibitors.
Target Diseases
As with the drug examples just listed, drug therapy of some
patient populations needs to be monitored more closely. This
will have to be tailored to an individuals specific practice site
and may change over time. For example, one may wish to develop a specialty interest in patients with asthma, diabetes,
hypertension, or dyslipidemia. For 6 months or a year, a pharmacist could target all patients with asthma using more than
one canister of a metered-dose -agonist inhaler per month to
receive special counseling and intervention. In some cases,
disease state management protocols (collaborative drug therapy agreements) can be developed with local prescribers to
help the target population treat their condition more effectively.6 During the following year, different screening criteria
could be established, such as all patients with hypertension
who fail to refill their prescriptions within 2 weeks of their
next scheduled refill.
High-Cost Drugs
The most cost-effective therapy always should be considered.
Pharmacists practicing in acute care settings may closely
screen and monitor orders for high-cost agents (e.g.,
hematopoietic growth factors, intravenous immune globulin,
and intravenous antifungal agents) to ensure usage is consistent with criteria developed by the institution. In the community setting, pharmacists might target prescriptions for brand
name drugs when therapeutically equivalent generic alternatives are available. Additionally, patients filling separate prescriptions for high-cost agents available in combination formulations may realize significant cost-savings by switching to
the combination product. For example, an asthmatic patient
whose condition is well controlled with fluticasone (Flovent)
88 g BID and salmeterol (Serevent) 50 g BID will reduce
drug costs and simplify the regimen (2 versus 6 puffs per day)
by switching to the combination fluticasone/salmeterol formulation (Advair 100/50).
Altered Drug Clearance
In practice settings where laboratory values are available for
monitoring, all patients with an elevated serum creatinine
should be assessed for renally eliminated drugs that may need
dosage adjustment. For patients with evidence of hepatic insufficiency (elevated bilirubin and hepatic aminotransferase
concentrations, reduced albumin) dosage adjustments are
more complicated because these endogenous biomarkers are
not reliable in predicting alterations in hepatic drug clearance.8
However, derangements in these tests suggest the possibility of
liver dysfunction and should place the clinician on alert for
more closely monitoring drugs that rely on the liver for elimination or are potentially hepatotoxic. Similarly, patients taking
drugs with well-established pharmacokinetic monitoring parameters, such as aminoglycosides, carbamazepine, digoxin,
phenytoin, and vancomycin, should be monitored closely.
Allergy
Patients whose drug profile indicates a drug allergy should be
screened to make sure that no cross-reacting drugs have been
1-18
GENERAL PRINCIPLES
ordered. If possible, the patient should be consulted to ascertain the nature of the allergy and a notation made in his or her
medical or pharmacy record regarding the clinical presentation of the allergy.
Prescriber Contact
The next level of priority setting is to determine when to contact a prescriber. This requires establishing a balance between
patient safety, convenience, and the time available for both the
pharmacist and prescriber. Any situation that represents potential harm to the patient (e.g., a newly identified adverse
drug effect, a well-documented drug interaction, a dosing error) must be acted on immediately. Switching to less costly
drugs or more convenient regimens also should have a high
priority, but sometimes can be postponed until a more convenient time. If the pharmacist practices in the patient care area,
it is easier to sense when the prescriber is stressed and, thus,
postpone an intervention until a more convenient time. The
pharmacist should not confront the prescriber in front of his
or her peers, so it is prudent that he or she make an intervention during a private one-on-one consultation as opposed to
during rounds or in a crowded room. If the same prescriber
has several potential problem patients, it may be best to intervene on the most pressing issues and leave the others to another time. When a good working relationship has been established with the prescriber, it may be possible to schedule a
time to review all of his or her patients in a collegial fashion.
Interventions over the telephone are less desirable because it
is difficult to judge how busy the individual is at the time of
the phone call. Nonurgent communication to inform the
physician of an intervention or to make suggestions for
change can be made by notes sent by a fax machine, written
in the chart, or by formal letters.
The data given are insufficient to definitively state the diagnoses at this time. The most likely use for the nitrofurantoin
is a urinary tract infection, probably cystitis or urethritis. The
metronidazole could have been prescribed for a trichomonal
infection, for bacterial vaginosis, or as an adjunct for anaerobic bacterial coverage. Given the dosage prescribed and the
general circumstances, the most likely indication is bacterial
vaginosis. Upon questioning V.C., these conclusions are confirmed. She claims good adherence to the metronidazole (she
will take her last dose tonight), notes no side effects, and
states that her vaginal itching and discharge are decreased, but
now she has some burning on urination. Thus the problem list
is as follows:
Problem
Drugs
Problem
Drugs
1. Nausea, vomiting, GI
bleeding
2. Volume depletion, hypokalemia
3. Resolving urinary tract infection
Ranitidine,
prochlorperazine
D512NS, KCl
Nitrofurantoin 100
mg BID
None
None
It is possible that V.C. also has underlying gastroesophageal reflux disease (GERD). This is not listed as a separate problem, although it may contribute to her primary
problem.
19. Are any drug-related problems present that should be
added to this list? Make an assessment regarding the likelihood
of any of the problems that could be drug induced.
1-19
Drugs
Phenytoin (causative)
Phenytoin and/or
prochlorperazine
(?causative)
Fluorouracil, leucovorin
Prochlorperazine
Fluoxetine
Hydrochlorothiazide
Phenytoin
Phenytoin (causative)
1-20
GENERAL PRINCIPLES
This is an example of a patient getting too much of the correct drug. In other words, phenytoin is an appropriate drug for
D.G.s seizure disorder and, for a long time, has provided the
desired therapeutic objective of good seizure control. Possible
causes for the new onset of toxicity include an inappropriately
prescribed dosage, overadherence, possible purposeful overdose (e.g., suicidal gesture), changes in drug metabolism, or a
possible drug interaction. A laboratory error can be ruled out
because a subsequent phenytoin serum concentration also was
high and D.G.s clinical complaints are compatible with
phenytoin toxicity. Finally, it is possible that the symptoms are
D.G. claims good adherence and says she has not taken any
extra doses. It is possible that she is an unreliable historian,
but she has taken the drug at the same dosage for many years
without previous complications. Colon cancer commonly
metastasizes to the liver, raising the suspicion of hepatic involvement and possibly impaired phenytoin metabolism, but
her liver function tests are all normal and she has no evidence
of jaundice. There are no reported drugdrug interactions between phenytoin and fluorouracil or leucovorin and she has
tolerated three previous cycles of chemotherapy with only
mild nausea, so it is unlikely that the recent course of chemotherapy is causing the elevated phenytoin level. Phenothiazines (including prochlorperazine) have been reported to
increase and in some cases decrease serum phenytoin levels
by an unknown mechanism,9 and it is possible that the prophylactic antiemetic therapy may have a causal role. However,
a prochlorperazinephenytoin interaction seems less likely
considering D.G. did not experience these symptoms during
the previous two cycles. D.Gs symptoms began 5 days after
starting fluoxetine, suggesting the possibility of a drugdrug
interaction. Indeed, there have been numerous case reports of
phenytoin toxicity observed in previously stable patients following the initiation of fluoxetine.9,10 This interaction is
thought to be caused by fluoxetine-mediated inhibition of cytochrome P450 2C9 (CYP2C9), a key hepatic microsomal enzyme involved in the metabolism of phenytoin. The time
course between the initiation of antidepressant therapy and
the development of symptoms strongly suggests a fluoxetine
phenytoin interaction as the cause of D.G.s altered mental
status and worsening neurologic function. D.G.s other drug
hydrochlorothiazide should not be contributing to the phenytoin toxicity because she has taken it for many years without
problems.
Therapeutic Goals
25. What is the desired therapeutic outcome relative to D.G.s
phenytoin toxicity?
1-21
9/13; 5 PM
Problem 1: Possible phenytoin toxicity
S
63-year-old female admitted with head injury resulting from fall secondary to dizziness. Pt reports a 2-day history of fatigue and blurred vision.
PMH significant for stage III colon cancer, seizure disorder since childhood (seizure free for 25 years), hypertension, and recently diagnosed
depression. Patient taking Dilantin (phenytoin) 300 mg Q HS; hydrochlorothiazide 25 mg Q am; Prozac (fluoxetine) 20 mg Q am (started 1
week ago); and prochlorperazine 10 mg Q 6 hr PRN nausea. Has not taken any extra doses. Denies use of any OTC medications or other nonprescribed drugs. Completed fourth cycle of chemotherapy (5-FU and leucovorin) 3 days ago.
Pt with supratherapeutic phenytoin levels and symptoms consistent with phenytoin toxicity. The temporal relationship between initiation of
fluoxetine for depression and the new onset CNS symptoms suggests a possible drugdrug interaction. Fluoxetine is a known inhibitor of cytochrome P450 2C9 (a key hepatic enzyme involved in the metabolism of phenytoin) and cases of phenytoin toxicity have been reported in
previously stable patients following the initiation of fluoxetine. Patient reports taking medications as prescribed and denies intentional overdose. Other medications in the regimen (hydrochlorothiazide, prochlorperazine, 5-FU, leucovorin) are unlikely to be contributing as she has
tolerated these agents in the past without problems.
Consider temporarily discontinuing phenytoin and monitoring for further seizure activity. Suggest measuring serum phenytoin every 27 days
until the concentration falls below 15 mg/mL, then reinstate phenytoin at 300 mg PO Q HS. Monitor for dizziness, blurred vision, ataxia, and
nystagmus. Suggest discontinuing fluoxetine as this agent is likely causing the elevated phenytoin level. Consider citalopram, mirtazapine, or
venlafaxine for the treatment of depression as these agents are unlikely to inhibit the metabolism of phenytoin or lower the seizure threshold.
Although not appropriate acutely, given her long seizure-free period, D.G. may be a candidate for withdrawal of anticonvulsant therapy. Given
her age, she is at increased risk for phenytoin-induced folate deficient anemia, osteopenia, and peripheral neuropathy. Consider further evaluation to determine if gradual tapering and withdrawal of anticonvulsant therapy is appropriate. Please call for further questions. Will follow.
Thank you for the consult.
Signature, Pharm.D.
A, assessment; CNS, central nervous system; NKDA, no known drug allergies; O, objective; OTC, over the counter; PE, physical examination; PMH, past medical history; Pt, patient; R, recommendation; S, subjective; WNL, within normal limits.
1-22
GENERAL PRINCIPLES
After phenytoin is restarted, a follow-up serum concentration should be obtained 1 week later. D.G. should be observed
for further signs of toxicity (ataxia, nystagmus, dizziness) and
for seizure control. Weekly monitoring of phenytoin serum
concentrations may be needed for the next month until a
steady state is achieved. If seizures recur, the dosage should
be increased or another therapy started. D.G. will require follow up to assess her response to antidepressant therapy and
counseled that the beneficial effects of treatment may not be
realized for up to 4 to 6 weeks after initiating therapy.
problem. Recommendations for drugs should include the specific dose for the patient, the route, and the dosage frequency.
The practitioner should include parameters that he or she
would recommend for monitoring to ensure efficacy of the
treatment regimen, prevention of toxicity, and the assessment
of adherence. The practitioner should also be sure to include
how often it is recommended that the parameters be monitored. The SOAP format is desirable for the medical record,
although the P (plan) may be changed to R (recommend) if it
seems more logical.
29. Using D.G.s case, how would you formulate your consult
note for D.G.s medical record?
At the top of the note, the current date, time, and name of
the problem being addressed should be included. The body of
the note should be in the SOAP format, and the practitioner
should sign his or her name at the end. Common abbreviations and incomplete sentences often are used to keep the
length of the note manageable. A formal consult written as a
letter may be more formal, including full sentences and fewer
abbreviations. See Table 1-7 for the note written in D.G.s
chart.
REFERENCES
1. Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm
1990;47:533.
2. Cipolle R et al, eds. Pharmaceutical Care Practice.
New York: McGraw-Hill, 1998.
3. Rovers JP et al, eds. A Practical Guide to
Pharmaceutical Care. 2nd Ed. Washington, DC:
American Pharmaceutical Association, 2003.
8. Verbeeck RK, Horsmans Y. Effect of hepatic insufficiency on pharmacokinetics and drug dosing.
Pharm World Sci 1998;20:183.
9. Drug Interaction Facts. St. Louis, MO: Wolters
Kluwer Health, 2004.
10. Spina E, Perucca E. Clinical significance of pharmacokinetic interactions between antiepileptic and
psychotropic drugs. Epilepsia 2002;43:37.