Appropriate Prescribing of Medications:
`An Eight-Step Approach
`
`MADELYN POLLOCK, M.D., University of Kansas Medical Center, Kansas City, Kansas
`ORALIA V. BAZALDUA, PHARM.D., University of Texas Health Science Center at San Antonio, San Antonio, Texas
`ALISON E. DOBBIE, M.D., University of Texas Southwestern Medical School at Dallas, Dallas, Texas
`
`A systematic approach advocated by the World Health Organization can help minimize poor-
`quality and erroneous prescribing. This six-step approach to prescribing suggests that the phy-
`sician should (1) evaluate and clearly define the patient’s problem; (2) specify the therapeutic
`objective; (3) select the appropriate drug therapy; (4) initiate therapy with appropriate details
`and consider nonpharmacologic therapies; (5) give information, instructions, and warnings;
`and (6) evaluate therapy regularly (e.g., monitor treatment results, consider discontinuation of
`the drug). The authors add two additional steps: (7) consider drug cost when prescribing; and
`(8) use computers and other tools to reduce prescribing errors. These eight steps, along with
`ongoing self-directed learning, compose a systematic approach to prescribing that is efficient
`and practical for the family physician. Using prescribing software and having access to electronic
`drug references on a desktop or handheld computer can also improve the legibility and accuracy
`of prescriptions and help physicians avoid errors. (Am Fam Physician 2007;75:231-6, 239-40.
`Copyright © 2007 American Academy of Family Physicians.)
`
`▲ Patient information:
`A handout on using medi-
`cines wisely, written by
`the authors of this article,
`is provided on page 239.
`
`In 2001, persons in the United States
`
`younger than 65 purchased a mean of
`10.8 prescription drugs and those 65 or
`older purchased a mean of 26.5 prescrip-
`tion drugs.1 With that level of prescribing, it is
`not surprising that errors occur. Minimizing
`such errors through a systematic approach is
`recommended by national and international
`authorities2-5 and has drawn the attention
`of consumer advocates.6 Review each of the
`following clinical scenarios for potential pre-
`scribing errors, and consider if you have a
`strategy for avoiding such errors in your own
`prescribing. All of the scenarios take place
`during a typical day at a family practice office;
`scenarios 1 through 4 are phone messages
`given to you by the nurse and scenario 5 is a
`patient in the waiting room.
`Scenario 1: A five-year-old boy who had
`pink eye and a clear ocular discharge was
`started on antibiotic drops four days ago and
`initially improved, but today the redness
`and irritation has returned.
`Scenario 2: A patient seen yesterday for a
`sleep-depriving cough was started on anti-
`biotics, but the cough still kept her awake
`last night.
`Scenario 3: A generally healthy 70-year-old
`
`woman who takes nonsteroidal anti-inflam-
`matory drugs (NSAIDs) for her osteoarthritis
`now reports ankle edema. In your absence, a
`colleague had started her on a calcium channel
`blocker for newly diagnosed hypertension.
`Scenario 4: A 20-year-old woman with
`sinus pain who was prescribed a fluoroquin-
`olone by the overnight call physician called
`this morning to request a cheaper alternative
`medication.
`Scenario 5: A 29-year-old woman has pre-
`sented to the office. She is obese, has type 2
`diabetes, and is reporting elevated blood pres-
`sures measured at home and at work. You are
`considering starting her on an angiotensin-
`converting enzyme inhibitor.
`This article summarizes and adapts the
`recommendations from the World Health
`Organization’s (WHO) Guide to Good Pre-
`scribing.2 The use of these guidelines should
`help physicians to minimize prescription
`errors and improve prescribing quality.
`
`Step 1. Evaluate and Clearly Define  
`the Patient’s Problem 
`In scenario 1, the child treated with antibiotic
`drops likely had a viral conjunctivitis that did
`not need specific treatment.7 If the child has
`
`
`Downloaded from the American Family Physician Web site at www aafp org/afp. Copyright © 2007 American Academy of Family Physicians. For the private, noncomme cial
`use of one individual user of the Web site. All other rights reserved. Contact copyrights@aafp.org for copyright questions and/or permission requests.
`
`Biogen Exhibit 2188
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 6
`
`

`

`SORT: KEY RECOMMENDATIONS FOR PRACTICE
`
`Clinical recommendation
`
`Evidence
`rating
`
`References
`
`Use a systematic approach to prescribing to decrease errors, help
`patients avoid adverse events, and improve intended outcomes.
`Discontinue use of abbreviations and non-English characters in
`prescription writing.
`Provide patient education at the time of prescribing to improve
`patient adherence to pharmacotherapy.
`23, 24
`C
`Use electronic prescribing tools to prevent errors caused by drug
`
`interactions and poor handwriting.
`
`C
`
`C
`
`C
`
`2, 10
`
`13
`
`18
`
`A = consistent good-qualitv patient-oriented evidence; 8 = inconsistent or limited-quality patient-oriented evi-
`dence; C = consensus, disease-oriented evidence, usual practice, expert opinion, or case series. For information
`about the SORT evidence rating system, see page 149 or http://www.aafp.org/afpsort xml.
`
`
`
`
`
`become sensitive to the prescribed medication,
`his recurrent symptoms represent morbidity
`related to an unnecessary prescription.
`In scenario 4,
`it
`is assumed that
`
`the
`
`woman with sinus pain was diagnosed with
`a bacterial infection over the telephone on
`the basis of a symptom, rather than as part
`of an examination. Prescribing a quinolone
`to a woman of childbearing age exposes her
`child to serious teratogenic side effects if
`she turns out to be pregnant. Defining the
`problem clearly as “sinus pain in a woman of
`childbearing age” might have led to a more
`appropriate management course.
`
`Step 2. Specify the Therapeutic
`Objective
`
`Specifying the therapeutic objective allows
`physicians to direct prescribing to a clear goal
`with expected outcomes. This can be illus-
`trated using several of the clinical scenarios.
`In scenario 5, which involves the woman
`
`with diabetes and the added diagnosis of
`hypertension, one clear therapeutic objective
`would be to obtain sustained blood pressure
`readings of less than 130/80 mm Hg.8
`In scenario 2, which involves the patient
`with nocturnal cough,
`the objective of
`restoring sleep was not met with the anti-
`biotic prescription; the antibiotic was most
`likely unneccessary.9 For the woman with
`sinus pain (scenario 4), even if an antibiotic
`was necessary, prescribing a medication that
`the patient could not afford clearly missed
`the therapeutic objective.
`Other common examples of nonspecific
`prescribing include using benzodiazepines
`for insomnia without investigating the cause,
`and using analgesics without diagnosing the
`
`underlying source of pain. Setting clear ther-
`apeutic goals is particularly important
`in
`conditions that have treatment objectives that
`vary depending on risk factors (e.g., dyslipid-
`emia in patients with or without diabetes).
`
`Step 3. Select the Appropriate
`Drug Therapy
`
`The WHO guide suggests that physicians
`develop a formulary of personal drugs
`(P-drugs).2 P-drugs are effective, inexpensive,
`well-tolerated drugs that physicians regu-
`larly prescribe to treat common problems.
`Detailed guidance on developing a personal
`formulary can be found in the WHO manual,
`which is available at http://whqlibdoc.who.
`int/hq/1994/WHO_DAP_94.1l.pdf.2 The
`STEPS (Safety, Tolerability, Effectiveness,
`Price, Simplicity) framework also can help
`with building a P-drug formulary.lo
`The P-drug and STEPS approaches can
`be shown using the example of the woman
`with diabetes and the added diagnosis of
`hypertension presented in scenario 5. Generic
`formulations of hydrochlorothiazide (Esid-
`rix), lisinopril (Zestril), metoprolol succinate
`(Toprol XL), and metoprolol tartrate (Lopres-
`sor) are all potential P-drug medications.
`Except for metoprolol tartrate, all of these
`drugs can be administered once daily. Lisino-
`pril offers both blood pressure control and
`prevention of diabetic complications,ll but it
`is contraindicated if the patient is not using a
`reliable form of birth control. It also is more
`
`expensive than hydrochlorothiazide. Meto-
`prolol reduces blood pressure and diabetic
`complications.‘1 However, metoprolol tar-
`trate requires twice-daily dosing, which can
`affect adherence, and metoprolol succinate is
`
`232 American Family Physician
`
`www.aafp.org/afp
`
`Volume 75, Number 2 I Irmuary 15, 2007
`
`Page 2 of 6
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`

`

`Appropriate Prescribing
`
`TABLE 1
`
`STEPS Framework: An Example of How to Select a Personal Drug
`(P-Drug) for a Patient
`
`Drug"
`
`Safety
`
`Tolerabi/ity
`
`Effectiveness
`
`Price
`
`Simplicity
`
`Hydrochlorothiazide
`(Esidrix)
`Lisinopril (Zestril)
`Metoprolol tartrate
`(Lopressor)
`Metoprolol succinate
`(Toprol XL)
`
`F
`
`Vt
`F
`
`F
`
`F
`
`F
`F
`
`F
`
`F
`
`SF
`SF
`
`SF
`
`SF
`
`SF (once daily)
`
`SF (once daily)
`F (twice daily)
`
`SF (once daily)
`
`F
`
`U
`
`STEPS = Safety, Tolerability, Effectiveness, Price, and Simplicity; F = favorable; SF = strongly favorable; V = varies in
`safety and price depending on specific patient diaracteristics and local costs; U = unfavorable.
`
`*—All of these drugs are available in generic form.
`T—Lisinopril would get a U rating for safety if the patient was a female of childbearing age who was pregnant or
`not using reliable birth control.
`Information from reference 10.
`
`typically more expensive. Hydrochlorothia-
`zide is the cheapest, but it does not carry the
`extra benefit of avoidance of diabetic compli-
`cations. A STEPS assessment (Table 11°) will
`balance the convenience, effectiveness, and
`
`benefit of each drug for a particular patient.
`This analysis may lead to different drug selec-
`tions for different patients.
`In scenario 3, which involves the patient
`with osteoarthritis, inappropriate prescrib-
`ing may have been harmful. Her hyperten-
`sion may be a side effect of the NSAID she
`was receiving, and her ankle edema could
`be a side effect of the antihypertensive she
`was receiving. Perhaps the NSAID should
`have been discontinued and an adequate
`dose of acetaminophen, taken three or four
`times daily, should have been prescribed for
`her pain rather than adding another medi-
`cation and inducing a second side effect.
`This example illustrates that it is important
`to consider a patient’s age, chronic disease
`status, and other medications currently
`being taken before choosing a treatment.
`
`Step 4. Initiate Therapy with
`Appropriate Details and Consider
`Nonpharmacologic Therapies
`
`legible, and
`Prescriptions should be clear,
`written in plain English. The National
`
`Coordinating Council on Medication Error
`Reporting and Prevention recommends
`eliminating most abbreviations for medica-
`tion instructions, such as qd (daily), qid
`(four times daily), and qod (every other day).
`They also recommend eliminating abbrevia-
`tions for drug names, such as M804 (mor-
`phine sulfate).12 To be effective, prescribers
`should eliminate nonstandard abbreviations
`
`that are easily misread, such as non-English
`characters (e.g., p).l3 Using plain English for
`all prescription writing allows the patient to
`read and draw attention to any errors.”
`Prescriptions should include specific indi-
`cations for anticipated duration of therapy.
`For example, write out “as needed for severe
`back pain” instead of using the abbrevia-
`tion pm (as needed). Adding the state-
`ment, “instructions in Spanish please,” to
`the prescription (perhaps implemented as a
`check box on the prescription form) offers a
`safety net for physicians and pharmacists to
`reduce prescribing errors for Spanish-speak-
`ing patients.” Patients taking complex pre-
`scriptions like prednisone tapers may need
`additional written instructions, as may visu-
`ally impaired patients who have difficulty
`reading medicine bottle labels. Physicians
`should consider
`reducing transcription
`errors by prescribing electronically.“l4
`
`Ianuary 15, 2007 I Volume 75, Number 2
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`
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`

`Appropriate Prescribing
`
`Nonpharmacologic therapy remains an
`important treatment option. In scenario 5,
`the woman with diabetes and the added
`
`zole (Flagyl), staying out of the sun when
`taking tetracycline, and the possibility of
`sexual side effects with selective serotonin
`
`Avoid using abbreviations
`for medication instructions,
`
`such as qd (daily), qid
`(four times daily), and qod
`(every other day).
`
`diagnosis of hypertension may not need
`medication if she loses weight and exercises.
`A patient with chronic headaches may
`respond to relaxation training,15
`and a patient with insomnia
`may improve with better sleep
`hygiene.16 Studies have shown
`that physicians often write pre-
`scriptions of doubtful benefit
`because of perceived pressure
`to prescribe medications. How-
`ever, these perceptions may be
`inaccurate. Asking a patient directly about
`therapeutic goals may shed light on his or
`her willingness to use nonpharmacologic
`options when available.17
`
`Step 5. Give Information, Instructions,
`and Warnings
`
`Physicians should educate patients about
`the intended use, expected outcomes, and
`potential side effects for each prescribed
`medication.18 Although it is impossible to
`describe each side effect for a given medica-
`tion, it is important to address the common
`and the rare but serious ones. Physicians
`must describe how the medication should
`
`(and should not) be administered, including
`any important relationships to food, time of
`day, and other medications being taken by
`the patient.
`In scenario 5,
`
`the woman with diabe-
`
`tes and the added diagnosis of hyperten-
`sion should be informed that lisinopril will
`reduce her blood pressure, protect her kid-
`neys, and could cause a rare but serious
`reaction called angioedema that demands
`immediate medical attention. She should
`
`also know that approximately one in
`15 patients experiences cough with or with-
`out altered taste sensation. When communi-
`
`cating risk, use absolute numbers (e.g., one
`in 15), rather than percentages, probabili-
`ties, odds, or likelihoods, to make it easier
`
`for the patient to understand.
`Physicians also may want to highlight
`special drug-related information such as
`avoiding alcohol when taking metronida-
`
`reuptake inhibitors. Explaining that certain
`side effects are time-limited can help pre-
`vent a patient from discontinuing a needed
`therapy.l4 Patients can demonstrate their
`understanding of the medication by repeat-
`ing back pertinent information. At the end
`of the visit, the prescriber should ensure that
`the patient knows when to return for moni-
`toring and whether therapy continues after
`this single prescription.
`
`Step 6. Evaluate Therapy Regularly
`
`Systematically reviewing medications at
`every visit allows the prescriber to monitor
`treatment effectiveness and reduce prob-
`lems, particularly in older patients who
`are most susceptible to polypharmacy.19 A
`medication review may include revisiting a
`diagnosis, evaluating possible side effects,
`searching for drug interactions, and ceasing
`unnecessary medications. For example, an
`antihypertensive may be discontinued after
`a patient loses weight, or an NSAID for back
`pain may be stopped after continued exercise
`and physical therapy.
`A review also helps avoid the prescribing
`cascade, which involves a physician add-
`ing additional drugs to a patient’s regimen
`to treat side effects of other medications.20
`
`the patient’s ankle edema
`In scenario 3,
`may be a side effect of the calcium chan-
`nel blocker that was prescribed to treat her
`hypertension. The hypertension may be a
`side effect of her pain medication. Planning
`regular monitoring for certain medications
`is important. In scenario 5, if the patient is
`on lisinopril, she will need follow-up serum
`chemistries to assess for hyperkalemia or
`increased serum creatinine.
`
`Step 7. Consider Drug Cost
`When Prescribing
`
`to consider cost as
`Physicians often fail
`an important prescribing factor.21 Among
`Medicare beneficiaries, 56 percent use pre-
`scription medications costing more than
`$500 per year, and 38 percent require medi-
`cations costing $1,000 or more per year.22
`
`234 American Family Physician
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`
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`Page 4 of 6
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`

`

`In one study, two thirds of older patients
`planned to underuse their medications
`because of cost.” Even for patients not
`requiring chronic medications, filling a pre-
`scription that costs the equivalent of several
`days’ pay can be an unpleasant shock.
`Asking about a patient’s access to a med-
`ical prescription card can help to avoid
`formulary conflicts and delays in start-
`ing therapy. Prescribing and drug reference
`software can inform physicians and patients
`about medication costs and coverage on the
`insurance company’s formulary (Table 2). A
`local pharmacist also can suggest alterna-
`tives that decrease cost.
`
`Step 8. Use Computers and Other
`Tools to Reduce Prescribing Errors
`
`Optimal use of the first seven guidelines
`requires a working knowledge of current
`medications and keeping up to date on new
`drugs. The sources described in Table 2 pro-
`vide more objective, evidence-based data than
`pharmaceutical representatives or advertise-
`ments. Given the pace of change in phar-
`macotherapeutics, physicians
`should use
`continuously updated software for their hand-
`held or desktop computers and are strongly
`advised to consider using electronic prescrib-
`ing programs.23’24
`Physicians also can access therapeutic
`guidelines from sources like the National
`Guideline Clearinghouse, which can be
`found at http://www.guidelines.gov. These
`sources provide clear statements about the
`strength of evidence supporting their recom-
`mendations. Evidence indicates that many
`new medications offer little or no benefit over
`
`drugs that may already be in a personal for-
`mulary. More than 10 percent of new drugs
`on the market in the last 25 years have earned
`a black box warning or have been withdrawn
`from the market. For this reason, physicians
`should not prescribe new medications until
`they have been demonstrated to be safer or
`more effective at improving patient-oriented
`outcomes than existing drugs.”
`When evaluating new drug studies, phy-
`sicians should look for evidence that the
`
`new drug also improves patient-oriented
`outcomes more than older drugs, and not
`
`Appropriate Prescribing
`
`TABLE 2
`
`Resources for Better Prescribing*
`
`Web sites
`
`American Family Physidan STEPS collection, http://www.aafp.org/afp/
`steps (free access)
`MerckMedicus, http://www.merckmedicus.com (free access)
`The Medical Letter, http://www.medicallettemrg (requires a subscription)
`Prescriber's Letter, http://www.prescriberslettercom (requires a subscription)
`
`Software for handheld computers
`Johns Hopkins Antibiotic Guide, http://hopkins-abxguide.org (free access)
`Epocrates, http://www.epocrates.com (free and some sections require
`subscription)
`Tarascon Pharmacopeia, http://www.tarascon.com (requires a subscription)
`Davis Drug Guide for Physicians, http://www.skyscape.com (requires a
`subscription)
`Thompson Micromedex, http://www.micromedex.com (requires a
`subscription)
`
`STEPS = Safety, Tolerability, Effectiveness, Price, and Simplicity.
`*—inclusion of resources in this table dam not represent an endorsement by the
`American Academy of Family Physicians.
`—
`
`just more than placebo. Physicians should
`be wary of the influence of the sample closet.
`Studies have shown that access to samples
`can influence choices independent of good
`clinical judgment.2"27
`
`Members of various family medicine departments
`develop articles for 'Clinical Pharmacology." This is
`one in a series coordinated by Allen F. Shaughnessy,
`Pharm.D.,and Andrea E. Gordon, M.D., Tufts University
`Family Medicine Residency, Malden, Mass.
`
`The Authors
`
`is associate professor in the
`MADELYN POLLOCK, M.D.,
`Department of Family Medicine at the University of Kansas
`Medical Center, Kansas City, and associate medical direc-
`tor for the Kansas Foundation for Medical Care in Topeka.
`She received her medical degree from the University of
`Texas Health Science Center at Houston. Dr. Pollock com-
`pleted a family medicine residency at McLennan County
`Medical Education and Research Foundation and an
`academic medicine fellowship at the Faculty Development
`Center, both in Waco, Tex.
`
`is associate profes-
`ORALIA V. BAZALDUA, PHARM.D.,
`sor and director of pharmacy education in the Family
`Medicine Residency Program at the University of Texas
`Health Science Center at San Antonio. She is a board-cer~
`tified pharmacotherapy specialist and received her doctor
`of pharmacy degree from the University of Oklahoma
`College of Pharmacy in Oklahoma City. Dr. Bazaldua
`completed a primary care specialty residency at
`the
`
`Ianuary 15, 2007 I Volume 75, Number 2
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`
`American Family Physician 235
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`Page 5 of 6
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`

`Appropriate Prescribing
`
`University of Colorado School of Pharmacy and at kaiser
`Permanente, both in Denver.
`
`AliSon E. DoBBiE, M.D., is the vice chair of and a profes-
`sor in the Department of Family and Community Medicine
`at the University of Texas Southwestern Medical School
`at Dallas. She received her medical degree from the
`University of Glasgow in Scotland and completed her fam-
`ily medicine residency in Edinburgh, Scotland. Dr. Dobbie
`also completed a fellowship in academic medicine at the
`Faculty Development Center in Waco, Tex.
`
`Address correspondence to Madelyn Pollock, M.D.,
`University of Kansas Medical Center, Dept. of Family
`Medicine, 3901 Rainbow Blvd., MS# 4010, Kansas
`City, KS 66160 (e-mail: madelyn.pollock@gmail.com).
`Reprints are not available from the authors.
`
`Author disclosure: nothing to disclose.
`
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`236  American Family Physician
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`www.aafp.org/afp
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`Volume 75, Number 2 ◆ January 15, 2007
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`Page 6 of 6
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