Prescribing

Objectives
 List steps clinicians can take to adopt a rational approach to drug therapy
 Understand why medication errors result from faulty systems not faulty people
 List the reasons why medication errors occur as described by the Institute for
Safe Medication Practices (ISMP)
 Recall the components of a legal prescription and how each component
communicates different information to both patients and dispensing personnel
 Describe practical ways to improve adherence to a prescribed regimen
 Discuss the impact of the Controlled Substances Act on prescribing habits
 List and describe the FDA’s pregnancy categories for drugs
 State Latin abbreviations for prescriptions in common use today and recall
abbreviations to be avoided
Emergence of Rational Prescribing
 WHO asked prescribers to create personal formularies containing frequently
used, effective medications in a manner that assures they have:
o Defined the problem
o Addressed a specific therapeutic objective
o Ensured that medication is safe and effective for the patient under
consideration
o Informed the patient about the risks and benefits of the medication
o Monitored the results of the treatment
o Stopped the drug when the treatment period is over
Medication Errors
 Medication errors are often caused by
o Failed communication
o Poor drug distribution practices (mail)
o Complex or poorly designed technology
o Access to drugs by nonpharmacy personnel (samples)
o Dose miscalculations
o Lack of information about the patient (no history)
o Allowing the patient to leave without checking his or her
understanding of therapy
Institute of Safe Medication Practices (ISMP)
 Look-a-like-Sound-a-like lists
 High Alert Medications
 Tall Man Lettering
 National Reporting System for Errors
Prescription Writing
Minimize Errors
 All prescription documents must be legible; verbal orders should be minimized
 Prescription orders should include a brief notation of purpose unless
considered inappropriate by the prescriber
 All prescription orders should be written in the metric system except for
therapies that use standard units, such as insulin 
 Prescribers should include age and, when appropriate, weight of the patient on
the prescription or medication order
 Medication orders should include drug name, exact metric weight or
concentration, and dosage form
 When a dosage strength is indicated
o Leading zero should always be used for the decimal expression of a
quantity less than one (e.g., 0.5 g)
 o Terminal zero should never be used after a decimal because of the risk
of tenfold errors in drug strength and dosage (e.g., 5 g instead of 5.0 g)
 Prescribers should avoid the use of abbreviations, including those for drug
names and Latin directions for use
o Never use: u for unit, qd  for daily
Components
 Full name of patient & address
 Date of Prescription
 Drug Name
 Dosage and form (Subscription)
 Directions of use (Signa)
 Route of administration
 Amount of drug to be dispensed
 Signature of Person authorized to prescribe
 Name and Address of Prescriber
 DEA Number if a controlled substance
Conscientious Prescribing
 Patient factors (age, sex, weight, culture, etc.)
 Disease factors
 Drug factors
 Social factors
 Knowledge factors
 Third-party factors
 Government and learned society factors
 Collaborating colleagues
Ten Questions to Ask
 Have I selected the most appropriate drug and drug dosage?
 Have I weighed all the risks and benefits to my patient?
 Have I addressed the need to monitor the effects of this medication?
 Am I fully informed about this patient’s condition, other medications,
comorbidities, allergies, and adverse events with other medications?
 Have I made the prescription as legible to the pharmacist as it is to me?
 Have I done all I can to assure the patient will be compliant?
 Have I considered what the medication will cost the patient?
 Have I considered the health literacy of my patient?
 Have I involved my patient in a shared decision-making process?
 Have I done all I can to minimize risks and increase patient safety?
AMA Principles of Conservative Prescribing
Think beyond drugs
 Seek non-drug alternatives as first, rather than last, resort
 Treat underlying causes, rather than solely treating symptoms
 Look for prevention opportunities, rather than exclusively focusing on
established disease or symptom amelioration
More strategic prescribing
 Defer immediate drug treatment whenever possible and desirable
 Use only a few drugs; learn to use them well
 Avoid drug switching without compelling evidence-based reasons
 Be skeptical about “individualizing” therapy when trials suggest little evidence
of benefit in the studied cohort
 Be cautious about telephone or e-mail prescribing
 Whenever possible, start only one new drug at a time
Heightened adverse effects vigilance
 Maintain a high index of suspicion for adverse drug effects
  Educate patients about potential adverse effects to ensure more timely
recognition
 Be alert to clues of drug withdrawal symptoms masquerading as disease
“relapses”
Caution and skepticism regarding new drugs
 Learn about new drugs and new indications from unbiased sources and
colleagues with reputations for conservative prescribing
 Do not rush to use new drugs; new adverse effects often emerge later
 Be certain that drugs improve clinical outcomes, rather than solely modifying
surrogate markers
 Do not stretch indications away from trial-based evidence.
 Avoid seduction by elegant pharmacology or physiological mechanisms in the
absence of demonstrated clinical outcomes benefit
 Beware of selective reporting or presentation of studies
Shared agenda with patients
 Do not reflexively succumb to patients’ requests for new drugs they have heard
advertised or recommended
 Avoid prescribing additional drugs for “refractory” problems, failing to
appreciate possible nonadherence
 Obtain accurate medication histories to avoid prescribing drugs that were
previously used unsuccessfully
 Discontinue drugs that are not working or are no longer needed
 Work with and promote patients’ desires for conservative therapies
Weigh long-term, broader impacts
 Think beyond short-term effects; consider longer-term benefits and risks.
 Seek better prescribing systems, such as computerized physician order entry
and reliable laboratory monitoring, rather than new drugs as ways to improve
pharmacotherapy
Pharmacotherapeutics
Kinds of Therapy
 Acute
 Empiric
 Maintenance
 Palliative
 Prophylactic
 Replacement
 Supportive
 Supplemental
Acute
 Improve life threatening or serious condition
 Intensive drug therapy implemented in acutely ill patients
 Often used to sustain life or treat disease
o ICU
o ER
o Cardiac resuscitation
o Septic Shock
Empiric
 Give until other tests prove another therapy is appropriate
 Example
o Pt presents with a fever of unknown cause, productive cough
o Obtain culture of sputum
o Start antibiotic empirically until culture results come back
Maintenance
 Prevent progression of the disease
 Maintain a condition
 Examples
o Insulin for DM
o Anti-hypertensives to control HTN
o Control chronic illness
o Cholesterol control
Palliative
 Reduce the severity of a condition or pain
 Make patient as comfortable as possible
 Example
o Pain control for cancer patients
o Oxygen for pulmonary disease
Prophylatic
 Prevent a disease or condition
 Examples
o Antibiotic prior to dental surgery
o Antibiotic prior to orthopedic procedure
o Anticoagulant prior to abdominal/ortho surgery
Replacement
 Provide chemicals missing by the patient
 Examples
o Electrolytes
o Total parenteral nutrition
Supportive
 For condition other than primary disease
 Example
o Maintains integrity of body functions while patient is recovering from
illness or trauma
o IV fluids to prevent dehydration
o Blood for anemia or blood loss
Supplemental
 Avoid deficiency
 Example
o Vitamin and Mineral supplements
Case Study
 TD is a 6-year-old boy, who returned to school a day or so after a family
vacation at Grandma and Grandpa’s cottage on a lake. He has had a bit of a cold
for the past three days but now the school nurse has called to have the boy
picked up as he is complaining of severe sore throat, enough to cause him to
cry. Upon examination, you note the child is febrile, has normal vital signs, and
is not playful. You examine him and see that his tonsils are dark red with some
exudates. You obtain a culture and agree that antibiotic treatment is best. The
doctor prescribes Rx: Amoxicillin 250mg/5ml i tsp po qid x 5 days # 120ml

 Which of the following defines the type of therapy prescribed here?

o Acute
o Empiric
o Maintenance
o Prophylactic
 The doctor prescribed Rx: Amoxicillin 250mg/5ml i tsp po qid x 5 days # 120ml
 What is the inscription component on the prescription?
o Name & strength
 o Amoxicillin 250mg/5ml
 What is the Subscription?
o Quantity to be dispensed
o Dispense # 120ml
 What is the Signa?
o Instructions to the RPh to give to pt- how to take
o i tsp po qid x 5 days
 What do the abbreviations mean?
o Tsp
o Po
o Qid
o #120ml
FDA Pregnancy Categories
 Category A
o Adequate and well-controlled studies have failed to demonstrate a risk
to the fetus in the first trimester of pregnancy (and there is no
evidence of risk in later trimesters)
 Category B
o Animal reproduction studies have failed to demonstrate a risk to the
fetus and there are no adequate and well-controlled studies in
pregnant women
 Category C
o Animal reproduction studies have shown an adverse effect on the fetus
and there are no adequate and well-controlled studies in humans, but
potential benefits may warrant use of the drug in pregnant women
despite potential risks
 Category D
o There is positive evidence of human fetal risk based on adverse
reaction data from investigational or marketing experience or studies
in humans, but potential benefits may warrant use of the drug in
pregnant women despite potential risks
 Category X
o Studies in animals or humans have demonstrated fetal abnormalities
and/or there is positive evidence of human fetal risk based on adverse
reaction data from investigational or marketing experience, and the
risks involved in use of the drug in pregnant women clearly outweigh
potential benefits

Federal Control of Medications - The Controlled Substances Act

Pop Quiz
 It is legal to consume recreational marijuana in Colorado, the same as it is to
use for medicinal purposes in Florida

 True or False
 The Controlled Substances Act (CSA) places all substances which were in some
manner regulated under existing federal law into one of five schedules.  This
placement is based upon the substance’s medical use, potential for abuse, and
safety or dependence liability
Factors affecting Schedule
 Its actual or relative potential for abuse.
 Scientific evidence of its pharmacological effect, if known.
 The state of current scientific knowledge regarding the drug or other substance.
 Its history and current pattern of abuse.
 The scope, duration, and significance of abuse.
 What, if any, risk there is to the public health.
  Its psychic or physiological dependence liability.
 Whether the substance is an immediate precursor of a substance already
controlled under this subchapter
Schedules
 Schedule I (C-1): High potential for abuse, No accepted medical use in the
United States
o Example: Heroin
 Schedule II (C-II): High potential for abuse; physical and psychological
dependency
o Prescriptions must be written in ink or typed and signed by clinician.
o Verbal orders must be confirmed in writing within 72 hours and given
only in true emergencies.
o No refills.
o Example: Oxycodone
 Schedule III (C-III): Some potential for abuse; moderate psychological
dependency
o Prescriptions may be oral or written
o Up to five renewals are permitted within 6 months
o Example: Hydrocodone
 Schedule IV (C-IV): Low potential for abuse, limited psychological and physical
dependency
o Prescriptions may be oral or written
o Up to five renewals are permitted w/ in 6 months
o Example: Ambien
 Schedule V (C-V): Subject to state/local regulation; may be sold Rx or OTC
o Prescriptions may not be required
o Example: Lomotil