Principles of Prescription Writing Nicholas G Popovich Ph.D., R.Ph. Professor and Head Department of Pharmacy Administration UIC College of Pharmacy

Principles of Prescription Principles of Prescription WritingWriting

Nicholas G Popovich Ph.D., R.Ph.Nicholas G Popovich Ph.D., R.Ph.Professor and HeadProfessor and Head

Department of Pharmacy AdministrationDepartment of Pharmacy AdministrationUIC College of PharmacyUIC College of Pharmacy

ObjectivesObjectives

Define a prescription and the classification Define a prescription and the classification of medicationsof medications

Compare and contrast the various Compare and contrast the various schedules of controlled substancesschedules of controlled substances

Compare and contrast a prescription Compare and contrast a prescription medicine and a non-prescription medicinemedicine and a non-prescription medicine

List the component elements of the List the component elements of the prescriptionprescription

Objectives cont’dObjectives cont’d

List the component elements of a List the component elements of a controlled substance prescriptioncontrolled substance prescription

Classify controlled drugs by their scheduleClassify controlled drugs by their schedule Describe writing conventions associated Describe writing conventions associated

with prescription writingwith prescription writing Provide examples of “look alike,” “sound Provide examples of “look alike,” “sound

alike” prescription medicines, including alike” prescription medicines, including trade namestrade names

Objectives cont’dObjectives cont’d

Provide examples of confusing Provide examples of confusing abbreviations used in prescription writingabbreviations used in prescription writing

Describe important prescription writing Describe important prescription writing precautions for traditional and controlled precautions for traditional and controlled substance prescriptionssubstance prescriptions

Define the “off label” use of a drugDefine the “off label” use of a drug

Prescription Order WritingPrescription Order Writing

Definition: A prescription is a written, Definition: A prescription is a written, verbal, or electronic order from a verbal, or electronic order from a prescriber (e.g., physician, dentist, prescriber (e.g., physician, dentist, podiatrist, nurse practitioner) to a podiatrist, nurse practitioner) to a pharmacist for a particular medication for pharmacist for a particular medication for a specific medication at a certain time.a specific medication at a certain time.

Classification of MedicationsClassification of Medications

Prescription= “legend” drug or medicationPrescription= “legend” drug or medication

Prescription product label reads: Prescription product label reads:

““Caution: Federal Law Prohibits Caution: Federal Law Prohibits Dispensing without a Prescription.” Dispensing without a Prescription.”

Types of PrescriptionsTypes of Prescriptions

GenericGeneric The nonproprietary name The nonproprietary name provided by the United States Adopted provided by the United States Adopted Name (USAN) CouncilName (USAN) Council syn. Chemical Namesyn. Chemical Name e.g., amoxicillin, fluoxetine, diazepam, aspirine.g., amoxicillin, fluoxetine, diazepam, aspirin

Brand NameBrand Name The proprietary name or The proprietary name or registered trademark name provided by registered trademark name provided by the pioneer (innovator) pharmaceutical the pioneer (innovator) pharmaceutical company who holds the patent on the company who holds the patent on the drugdrug e.g., Prozace.g., Prozac®®, Viagra, Viagra®®, Xanax, Xanax®®

Types of Prescriptions cont’dTypes of Prescriptions cont’d

CompoundedCompounded Requires the preparation Requires the preparation of one or more active ingredients with one of one or more active ingredients with one or more pharmaceutical necessities, e.g., or more pharmaceutical necessities, e.g., suspending agent, flavoring agent, to suspending agent, flavoring agent, to create a finished product.create a finished product.

For example, an oral compounded prescriptions may be For example, an oral compounded prescriptions may be used to facilitate the administration of a solid dosage form used to facilitate the administration of a solid dosage form that is not available in liquid form for patients unable to that is not available in liquid form for patients unable to swallow a solid dosage form.swallow a solid dosage form.

e.g., pediatric, geriatrice.g., pediatric, geriatric

Types of Prescriptions cont’dTypes of Prescriptions cont’d Control SubstanceControl Substance Distribution of certain Distribution of certain

medicines with abuse potential is controlled medicines with abuse potential is controlled through the through the Comprehensive Drug Abuse Comprehensive Drug Abuse Prevention and Control Act of 1970Prevention and Control Act of 1970

This Act is regulated and enforced by the federal This Act is regulated and enforced by the federal Drug Enforcement Agency (DEA)Drug Enforcement Agency (DEA) MDs must be registered with the DEA to MDs must be registered with the DEA to

prescribe those drugs under the control of this prescribe those drugs under the control of this act.act.

Re-registration is mandatory every three years.Re-registration is mandatory every three years.

*A partial listing of controlled substances is *A partial listing of controlled substances is demonstrated in demonstrated in Appendix A. Appendix A. Further Further examples of drugs by schedule are found at examples of drugs by schedule are found at http://www.dea.gov/pubs/scheduling.html

Types of Prescriptions cont’dTypes of Prescriptions cont’d

NewNew An original prescription order An original prescription order dispensed for the first time.dispensed for the first time.

RefillRefill A repeat dispensing of the original A repeat dispensing of the original prescription order.prescription order.

Usually, encompasses patients on maintenance therapy, Usually, encompasses patients on maintenance therapy, e.g., digoxin, phenytoin, lovastatin, potassium chloride.e.g., digoxin, phenytoin, lovastatin, potassium chloride.

Schedules of Controlled Schedules of Controlled SubstancesSubstances

Schedule ISchedule I No medical use with a high No medical use with a high abuse and dependence potentialabuse and dependence potential

A physician cannot write for this schedule of drugsA physician cannot write for this schedule of drugs e.g., LSD, Marijuana*, Heroin, Mescaline (Peyote), 1-(1-e.g., LSD, Marijuana*, Heroin, Mescaline (Peyote), 1-(1-

Phenylcyclohexyl)pyrrolidine (i.e., PCP).Phenylcyclohexyl)pyrrolidine (i.e., PCP).

**Twelve states have laws regulating the medical use of Twelve states have laws regulating the medical use of marijuana- AL, AZ, CA, CO, HI, ME, MD, MT, NV, OR, VT, WAmarijuana- AL, AZ, CA, CO, HI, ME, MD, MT, NV, OR, VT, WA


Schedule II Schedule II A written prescription is required for A written prescription is required for this schedule. However, there are no refills this schedule. However, there are no refills allowable.allowable. Only in an emergency situation is an oral order allowable Only in an emergency situation is an oral order allowable

and acceptable to the dispenser.and acceptable to the dispenser. Must be followed by a written prescription within 72 hours.Must be followed by a written prescription within 72 hours.

In some states (formerly IL), the physician must complete a triplicate In some states (formerly IL), the physician must complete a triplicate prescription form to prescribe Class II in ink.prescription form to prescribe Class II in ink.

The physician should write out the actual amount prescribed besides The physician should write out the actual amount prescribed besides giving an Arabic Number or Roman Numeral for the quantity.giving an Arabic Number or Roman Numeral for the quantity. This discourages forging or “alteration” of the prescription.This discourages forging or “alteration” of the prescription.

In Illinois, a written prescription for this schedule must be dispensed In Illinois, a written prescription for this schedule must be dispensed within 90 days, i.e., 3 months, of issuance or it expires.within 90 days, i.e., 3 months, of issuance or it expires. e.g., amphetamines, meperdine HCl, cocaine, secobarbital sodiume.g., amphetamines, meperdine HCl, cocaine, secobarbital sodium

Multiple Prescriptions for Schedule II Controlled SubstancesMultiple Prescriptions for Schedule II Controlled SubstancesDEA RuleDEA Rule

12/19/07 – Approved federal legislation to allow 12/19/07 – Approved federal legislation to allow prescriber to write >1 prescription (not more than prescriber to write >1 prescription (not more than a 90 day supply total) for CII controlled a 90 day supply total) for CII controlled substances in certain circumstances.substances in certain circumstances.▪▪ Legitimate medical purpose.Legitimate medical purpose.

▪ ▪ Instruction on each prescription indicating earliest Instruction on each prescription indicating earliest date to date to dispense the prescription.dispense the prescription.

▪▪ This situation does not create an undue risk of This situation does not create an undue risk of diversion or diversion or abuse.abuse.

▪▪ Applicable state laws permit this practice including Applicable state laws permit this practice including Illinois.Illinois.

▪▪ Prescriber is in compliance with all other state and Prescriber is in compliance with all other state and federal federal laws.laws.


Schedule IIISchedule III Drugs in this schedule Drugs in this schedule have a moderate abuse and dependence have a moderate abuse and dependence potentialpotential

May be prescribed in writing or through a verbal order.May be prescribed in writing or through a verbal order. May be refilled up to five times within a six month May be refilled up to five times within a six month

interval from the date of issuance.interval from the date of issuance. e.g., glutethimide, chlorphentermine, phenmetrazine, e.g., glutethimide, chlorphentermine, phenmetrazine,

anabolic steroidsanabolic steroids


Schedule IVSchedule IV Drugs in this schedule are Drugs in this schedule are considered to have low abuse and low considered to have low abuse and low dependency potentialdependency potential

May be prescribed through writing and through a verbal May be prescribed through writing and through a verbal order.order.

May be refilled upto five times within a six month May be refilled upto five times within a six month interval from the date of issuance.interval from the date of issuance.

E.g., alprazolam (XanaxE.g., alprazolam (Xanax®®), pentazocine (Talwin), pentazocine (Talwin®®), ), flurazepam (Dalmaneflurazepam (Dalmane®®))


Schedule VSchedule V Drugs in this schedule have Drugs in this schedule have the least amount of abuse potential and the least amount of abuse potential and an unlikely dependencyan unlikely dependency

Consists primarily of medications that contain limited Consists primarily of medications that contain limited quantities of certain narcotic and stimulant drugs quantities of certain narcotic and stimulant drugs generally used as anti-tussives, antidiarrheals, and generally used as anti-tussives, antidiarrheals, and analgesicsanalgesics

Can be purchased OTC by the patient who signs a Can be purchased OTC by the patient who signs a registryregistry

e.g., Robitussin AC, Parepectolin, Kaopectolin PGe.g., Robitussin AC, Parepectolin, Kaopectolin PG

Nonprescription MedicationsNonprescription Medications

Can be purchased at pharmacies and retail Can be purchased at pharmacies and retail outlets without a prescription (outlets without a prescription (synsyn. Over-the-. Over-the-counter [OTC] products)counter [OTC] products)

To date, 99 drugs and/or drug dosage forms have To date, 99 drugs and/or drug dosage forms have been “switched” from prescription to OTC status been “switched” from prescription to OTC status (Note Appendix AA)(Note Appendix AA)

Besides South Africa, the US is the only country Besides South Africa, the US is the only country NOT to have a “third class” of drugs. That is, NOT to have a “third class” of drugs. That is, available through the pharmacist.available through the pharmacist. FL has a “pharmacist only” class of FL has a “pharmacist only” class of

medicationsmedications BTC being considered by FDABTC being considered by FDA

National Coordinating Council for Medication Error National Coordinating Council for Medication Error Reporting and Prevention (NCC-MERP) -- Founding Reporting and Prevention (NCC-MERP) -- Founding

MembersMembers

American Association of Retired Persons;American Association of Retired Persons;American Health Care Association;American Health Care Association;American Hospital Association;American Hospital Association;AMA; American Nurses Association; AMA; American Nurses Association; American Pharmacists Association; American Pharmacists Association; American Society of Health-System American Society of Health-System Pharmacists; FDA; GPIA; JCAHO; National Pharmacists; FDA; GPIA; JCAHO; National Association of Boards of Pharmacy; National Association of Boards of Pharmacy; National Council of State Boards of Nursing, Inc; Council of State Boards of Nursing, Inc; PhRMA; United States PharmacopeiaPhRMA; United States Pharmacopeia

NCC-MERP Recommendations to NCC-MERP Recommendations to Improve Error-Prone Aspects of Improve Error-Prone Aspects of

Prescription WritingPrescription Writing

All prescriptions must be legible. All prescriptions must be legible. Prescribers should move to a Prescribers should move to a direct, computerized, order entry direct, computerized, order entry system.system.Handwriting examples:Handwriting examples:

Can you read this?Can you read this?

Component Elements of the Component Elements of the PrescriptionPrescription

HeadingHeading Physician’s name, practice Physician’s name, practice address and telephone number, DEA address and telephone number, DEA numbernumber

Date prescription is writtenDate prescription is written

Patient InformationPatient Information Name, address, age Name, address, age (esp., if for a pediatric or geriatric patient)(esp., if for a pediatric or geriatric patient)

Component Elements of the Component Elements of the PrescriptionPrescription

Body of the Prescription (Note: Exhibit)Body of the Prescription (Note: Exhibit) RRXX Take Thou. Take Thou. Name of the prescribed drug or Name of the prescribed drug or

drug product. Also included is the strength of the drug product. Also included is the strength of the medication, the number or quantity of the medication, the number or quantity of the prescribed drug in addition to the dosage formprescribed drug in addition to the dosage form

DO NOT use abbreviations for drugs prescribed unless DO NOT use abbreviations for drugs prescribed unless the abbreviation is official, e.g., SSKI (Saturated the abbreviation is official, e.g., SSKI (Saturated Solution of Potassium Iodide), NSS (Normal Saline Solution of Potassium Iodide), NSS (Normal Saline Solution), HCTZ (Hydrochlorothiazide), NTG Solution), HCTZ (Hydrochlorothiazide), NTG (Nitroglycerin), MTX (Methotrexate)(Nitroglycerin), MTX (Methotrexate)

Avoid “unofficial” abbreviationsAvoid “unofficial” abbreviations

Component Elements of the PrescriptionComponent Elements of the Prescription- Body of the Prescription (cont’d)- Body of the Prescription (cont’d)

SigSig Signatura (i.e., Mark Thou). Signatura (i.e., Mark Thou). Directions for use, e.g., one cap every 8 Directions for use, e.g., one cap every 8 hrs.hrs. Avoid “Avoid “ut dictumut dictum” or “as directed.” Units ” or “as directed.” Units

should be spelled out rather than writing “U.”should be spelled out rather than writing “U.” Latin abbreviations (Appendix B) are Latin abbreviations (Appendix B) are

acceptable as well as plain Englishacceptable as well as plain English Commonly confused Latin abbreviations Commonly confused Latin abbreviations

include: include: qdqd, , qodqod RefillsRefills “N” times or NR. Leaving this “N” times or NR. Leaving this

section blank implies that the prescription section blank implies that the prescription is non- refillable.is non- refillable.

Dangerous AbbreviationsDangerous Abbreviations

AbbreviationAbbreviation Intended MeaningIntended MeaningUU UnitsUnitsµgµg MicrogramsMicrogramsQ.D.Q.D. Every dayEvery dayQ.O.D.Q.O.D. Every other dayEvery other dayMS, MSOMS, MSO44,, Morphine sulfate or Morphine sulfate or

MgSOMgSO44 magnesium sulfate?magnesium sulfate?

More Dangerous More Dangerous Abbreviations Abbreviations

SC or SQSC or SQ SubcutaneousSubcutaneousTIWTIW Three times a weekThree times a weekD/CD/C Discharge; discontinueDischarge; discontinueHSHS Half strength; Half strength;

bedtime?bedtime?cccc Cubic centimetersCubic centimetersAU, AS, ADAU, AS, AD Both ears, leftBoth ears, left

ear, right earear, right ear I.U.I.U. International unitsInternational units


Generic AuthorizationGeneric Authorization Physician signature on Physician signature on the “dispense as written” or “may substitute” linethe “dispense as written” or “may substitute” line

““No Child Resistant Packaging” No Child Resistant Packaging” AuthorizationAuthorization All legend drugs intended for oral All legend drugs intended for oral use must be dispensed by the pharmacist to the use must be dispensed by the pharmacist to the patient in containers having safety closures unless patient in containers having safety closures unless the prescribing physician or the patient specifically the prescribing physician or the patient specifically requests otherwise.requests otherwise. A request for a non-child resistant container may be A request for a non-child resistant container may be

applied to a single prescription or to all of the patient’s applied to a single prescription or to all of the patient’s dispensed medications.dispensed medications.

The pharmacist should clarify the patient’s desires, obtain The pharmacist should clarify the patient’s desires, obtain and file a signed waiver request, and maintain the and file a signed waiver request, and maintain the information in the prescription computer for future information in the prescription computer for future reference.reference.

Exception: Nitroglycerin (NTG) containing products.Exception: Nitroglycerin (NTG) containing products.


SignatureSignature Legible Legible in indelible pencil or in indelible pencil or pen. Signature selectionspen. Signature selections:: May substitute_______________________May substitute_______________________ Dispense as written___________________Dispense as written___________________

• DEA NumberDEA Number If necessary and, usually, If necessary and, usually, within the heading of the prescription within the heading of the prescription blank along with the physician’s practice blank along with the physician’s practice informationinformation

Writing ConventionsWriting Conventions

For compounded prescriptions, For compounded prescriptions, when when units are not given, solids are assumed to be units are not given, solids are assumed to be in in gramsgrams (g) and liquids in (g) and liquids in millilitersmilliliters (ml). (ml). Never write a decimal without a zero preceding it, Never write a decimal without a zero preceding it, e.g., e.g.,

0.15 g Clindamycin HCl. This helps to minimize an error in 0.15 g Clindamycin HCl. This helps to minimize an error in translationtranslation

Never write a decimal with a zero following it, Never write a decimal with a zero following it, e.g., e.g., Propylene Glycol 6.0, Propylene Glycol 6Propylene Glycol 6.0, Propylene Glycol 6

e.g., e.g., RRxx Clindamycin HClClindamycin HCl 0.150.15

Propylene GlycolPropylene Glycol 66

Lavacol qsadLavacol qsad3030

Sig: Sig: Apply to affected area Apply to affected area twice dailytwice daily

Writing Conventions (cont’d)Writing Conventions (cont’d)

Sometimes a vertical line is used for the Sometimes a vertical line is used for the decimal point, although, decimal point, although, conceivably, it conceivably, it could be confused as a number one.could be confused as a number one.

________e.g., Re.g., Rxx ChlorpheniramineChlorpheniramine0 l 0020 l 002

AspirinAspirin0 l 3250 l 325

Dispense Caps #12Dispense Caps #12

Sig: One capsule Sig: One capsule po po four times daily four times daily for allergy and for allergy and painpain


Liquid household measuresLiquid household measures Milliliter = mlMilliliter = ml 1 teaspoonful = 5 ml1 teaspoonful = 5 ml 1 tablespoonful = 15 ml1 tablespoonful = 15 ml 2 tablespoonfuls = 30 ml (approximately 2 tablespoonfuls = 30 ml (approximately

one ounce)one ounce) 8 fluid ounces ~ 240 ml8 fluid ounces ~ 240 ml One pint = 16 fluid ounces = 473 mlOne pint = 16 fluid ounces = 473 ml One quart = 32 fluid ounces = 946 mlOne quart = 32 fluid ounces = 946 ml One gallon = 4 quarts = 8 pints = 3750 mlOne gallon = 4 quarts = 8 pints = 3750 ml gttsgtts = drops (e.g., oral, ophthalmic, ear, = drops (e.g., oral, ophthalmic, ear,

topical)topical)


Solid weightsSolid weights mcgmcg == microgrammicrogram mgmg == milligrammilligram gg == gramgram grgr == grain (old apothecary system grain (old apothecary system

reserved reserved for “older,” traditional for “older,” traditional medications). medications).

Note for these one grain is equal to 60 Note for these one grain is equal to 60 mgmg. . Otherwise, one grain = 64.8 mg.Otherwise, one grain = 64.8 mg.e.g., nitroglycerin, 1/150 gr, 1/200 gr, 1/400 e.g., nitroglycerin, 1/150 gr, 1/200 gr, 1/400

gr;gr;

phenobarbital, ¼ gr., ½ gr.,1 gr.; phenobarbital, ¼ gr., ½ gr.,1 gr.;

thyroid ¼ gr, ½ gr, 1 gr.thyroid ¼ gr, ½ gr, 1 gr.


Be very cautious about drug names that Be very cautious about drug names that “sound/look” alike (Appendix C).“sound/look” alike (Appendix C).

http://www.nacds.org/wmspage.cfm?http://www.nacds.org/wmspage.cfm?

parm1=1915parm1=1915

Avoid using “unofficial” abbreviations for Avoid using “unofficial” abbreviations for drugs/drug product names, e.g., PCN drugs/drug product names, e.g., PCN (Penicillin), SMX-TMP (Sulfamethoxazole-(Penicillin), SMX-TMP (Sulfamethoxazole-Trimethoprim), TCN (Tetracycline), KCl Trimethoprim), TCN (Tetracycline), KCl (Potassium Chloride), MOM (Milk of (Potassium Chloride), MOM (Milk of Magnesia). If confused, contact the Magnesia). If confused, contact the pharmacist.pharmacist.

Prescription Writing SuggestionsPrescription Writing Suggestions

Intended to ensure Intended to ensure patient safety and patient safety and minimizeminimize pharmacist intervention on pharmacist intervention on behalf of the prescriber and the patient.behalf of the prescriber and the patient.

Keep all prescription blanks in a Keep all prescription blanks in a safe safe place out of patient reachplace out of patient reach. This avoids . This avoids the temptation and disappearance of the temptation and disappearance of blanks. Further, this procedure minimizes blanks. Further, this procedure minimizes the number of prescription pads in use.the number of prescription pads in use.

Use a separate prescription blank for Use a separate prescription blank for eacheach prescribed medication. prescribed medication.


Ensure that refill directions are Ensure that refill directions are included on included on everyevery prescription. prescription. Is it Is it refillable or not? refillable or not?

If refillable, indicate the number of times If refillable, indicate the number of times or the duration of time that refills are or the duration of time that refills are authorized. It will save the prescriber time authorized. It will save the prescriber time and interruptions in the long run. Legally, and interruptions in the long run. Legally, aside from refill limitations associated with aside from refill limitations associated with controlled substances, a prescription refill controlled substances, a prescription refill for a conventional, non-controlled for a conventional, non-controlled medication has a medication has a one yearone year expiration time. expiration time.


Attempt to make the prescription Attempt to make the prescription order alteration proof.order alteration proof.

Use Use indelible pencil or inkindelible pencil or ink and for and for controlled controlled substances write the number and spell it substances write the number and spell it outout. Otherwise, for example, a “X. Otherwise, for example, a “XIIII” can be ” can be forged to read “XXX.” forged to read “XXX.” Use the same pen or Use the same pen or indelible pencil for the entire prescription. indelible pencil for the entire prescription. If a mistake is made, e.g., number of If a mistake is made, e.g., number of tablets, cross out the mistake, write/print tablets, cross out the mistake, write/print “error” above it, and then initial it.“error” above it, and then initial it.


Avoid writing a prescription for a large quantity Avoid writing a prescription for a large quantity of drug unless it is absolutely determined that of drug unless it is absolutely determined that such a quantity is necessary.such a quantity is necessary.

For an anticipated chronic medication, it is better to For an anticipated chronic medication, it is better to start with a lower number at first in the event that the start with a lower number at first in the event that the patient cannot tolerate it because of side effects. patient cannot tolerate it because of side effects. Think also of the economic considerations. Insurance Think also of the economic considerations. Insurance plans will limit the amount to one to three months at plans will limit the amount to one to three months at most.most.

When an institutional prescription blank is used, When an institutional prescription blank is used, the prescriber should the prescriber should clearlyclearly print his/her name, print his/her name, address, DEA registration number on the blank.address, DEA registration number on the blank.

Prescription Writing Suggestions Prescription Writing Suggestions for Controlled Substancesfor Controlled Substances

Again, this is intended to ensure patient Again, this is intended to ensure patient safety and minimize pharmacist intervention safety and minimize pharmacist intervention on behalf of the prescriber and the patient.on behalf of the prescriber and the patient.

Use a separate prescription blank for each Use a separate prescription blank for each substance prescribed.substance prescribed.

Maintain only a Maintain only a minimumminimum stock of controlled stock of controlled substances in the medical bag, and it should be substances in the medical bag, and it should be taken by the physician while away from the taken by the physician while away from the automobile. Keeping the medical bag locked in the automobile. Keeping the medical bag locked in the automobile trunk is not always an effective automobile trunk is not always an effective deterrent. deterrent.


During the drug history, if a patient concedes that During the drug history, if a patient concedes that he/she has received a controlled substance he/she has received a controlled substance prescription from another physician, consult that prescription from another physician, consult that physician or the hospital records, and/or examine physician or the hospital records, and/or examine the patient to decide if a controlled substance the patient to decide if a controlled substance should be prescribed. should be prescribed.

Do not allow the patient to dictate the controlled Do not allow the patient to dictate the controlled substance, if any, to be prescribed. The patient substance, if any, to be prescribed. The patient may be “doctor shopping.” may be “doctor shopping.”

Maintain an accurate record of controlled Maintain an accurate record of controlled substance products dispensed as required by the substance products dispensed as required by the Controlled Substances Act.Controlled Substances Act.


A prescription order blank should only be used for A prescription order blank should only be used for writing the prescription. writing the prescription.

Do not use it to write a note and/or information Do not use it to write a note and/or information for the patient. An unscrupulous drug dealer or for the patient. An unscrupulous drug dealer or abuser could erase the information easily and use abuser could erase the information easily and use

the blank to forge a prescription drugthe blank to forge a prescription drug. .


The prescriber should use the pharmacist as a The prescriber should use the pharmacist as a valuable resource when needed. Also, assist the valuable resource when needed. Also, assist the pharmacist when he/she inquires to verify pharmacist when he/she inquires to verify information about a prescription order. A information about a prescription order. A corresponding responsibility/liabilitycorresponding responsibility/liability rests with rests with the pharmacist who dispenses the prescription the pharmacist who dispenses the prescription order. order.

Telephone the nearest DEA field office to secure Telephone the nearest DEA field office to secure and/or furnish information. The call is held in and/or furnish information. The call is held in strictest confidence. strictest confidence.

Unlabeled (Unlabeled (synsyn Off-Label) Off-Label) Use (Indication)Use (Indication)

Serendipitous observations (e.g., decreased Serendipitous observations (e.g., decreased migraine headache attacks while maintained on migraine headache attacks while maintained on β-blockers for cardiovascular therapy; sildenafil β-blockers for cardiovascular therapy; sildenafil citrate clinically evaluated for lowering blood citrate clinically evaluated for lowering blood pressure demonstrating use for erectile pressure demonstrating use for erectile dysfunction) and therapeutic interventions of dysfunction) and therapeutic interventions of physicians have led to medicines being physicians have led to medicines being prescribed for unlabeled use for which prescribed for unlabeled use for which the drug the drug has not been approved by the FDAhas not been approved by the FDA. .

The off-label use is supposed to be based upon a The off-label use is supposed to be based upon a rational scientific theory, expert medical opinion, rational scientific theory, expert medical opinion, or evidence based on sound clinical trial(s). or evidence based on sound clinical trial(s).

•

Unlabeled (Unlabeled (synsyn Off-Label) Off-Label) UseUse

Commonly used for depression, cancer, HIV/AIDS, Commonly used for depression, cancer, HIV/AIDS,

dermatological disorders, and migrainedermatological disorders, and migraine..

Common in the pediatric population—danger Common in the pediatric population—danger ↑ AEs.↑ AEs.

In 2001, ~73% off label prescriptions were not In 2001, ~73% off label prescriptions were not supported by scientific evidence.supported by scientific evidence.


The FDA makes clear that it neither has, nor The FDA makes clear that it neither has, nor desires, the authority to compel physicians to desires, the authority to compel physicians to adhere to only “official” labeled indications. adhere to only “official” labeled indications. Simply, experience has demonstrated that the Simply, experience has demonstrated that the official indications “lag” behind scientific official indications “lag” behind scientific knowledge and the scientific/medicalknowledge and the scientific/medical literature. literature.


A Supplemental New Drug Application (NDA) may A Supplemental New Drug Application (NDA) may be filed by the drug manufacturer when approval be filed by the drug manufacturer when approval is sought for an additional indication for a drug is sought for an additional indication for a drug already approved for another indication. It has already approved for another indication. It has been estimated that 40% of all prescriptions are been estimated that 40% of all prescriptions are written for indications for which a Supplemental written for indications for which a Supplemental NDA has not been filed. While this process is less NDA has not been filed. While this process is less demanding, drug manufacturers do not want to demanding, drug manufacturers do not want to invest the time, energy, and $$ to do so. invest the time, energy, and $$ to do so.

Consequently, this has resulted in 75 to 90% off-Consequently, this has resulted in 75 to 90% off-

label prescribing for infants and children. The label prescribing for infants and children. The caveatcaveat is less than desirable dosing and warnings is less than desirable dosing and warnings for the pediatric patient with increased incidence for the pediatric patient with increased incidence of adverse effects.of adverse effects.

Single Patient Single Patient Compassionate UseCompassionate Use

A FDA-requested mechanism for a A FDA-requested mechanism for a physician to use a drug in a single patient, physician to use a drug in a single patient, usually in a desperate situation when usually in a desperate situation when there is no response to other therapies or there is no response to other therapies or in which there is no approved or in which there is no approved or recognized treatment available.recognized treatment available.

Single Patient Single Patient Compassionate UseCompassionate Use

Approval for a compassionate use may be sought Approval for a compassionate use may be sought in the following situations when a(n):in the following situations when a(n): IND is in effect, but the drug is still in the early stages of IND is in effect, but the drug is still in the early stages of

testing.testing. IND is in effect, but the intent of the drug use is not for IND is in effect, but the intent of the drug use is not for

the purpose described in the IND.the purpose described in the IND. drug has an IND, but it is not marketed.drug has an IND, but it is not marketed. drug has had previous FDA approval but has been drug has had previous FDA approval but has been

withdrawn from the market because of questions withdrawn from the market because of questions regarding its safety.regarding its safety.

drug is being investigated or marketed outside of the drug is being investigated or marketed outside of the US, but no IND is in effect within the US.US, but no IND is in effect within the US.

Often, the FDA will permit the proposed use Often, the FDA will permit the proposed use under a commercial sponsor’s IND or under a new under a commercial sponsor’s IND or under a new IND filed by the physician in behalf of an IND filed by the physician in behalf of an identified patient. identified patient.

ReferencesReferences

Scott SA. “The Prescription,” in Scott SA. “The Prescription,” in Remington: Remington: The Science and Practice of PharmacyThe Science and Practice of Pharmacy, 21st , 21st Edition, A. Gennaro, Chairman, Editorial Edition, A. Gennaro, Chairman, Editorial Board and Editor, Lippincott Williams and Board and Editor, Lippincott Williams and Wilkins, Baltimore MD, 2005, pp. 1823-Wilkins, Baltimore MD, 2005, pp. 1823-1839.1839.

http://www.dea.gov/pubs/scheduling.html

http://www.nacds.org/wmspage.cfm?par m1=1915m1=1915

Updated: March 24, 2010Updated: March 24, 2010

Acknowledgement:Acknowledgement: Examples scanned from Examples scanned from

materials prepared by thematerials prepared by the Institute for Safe Medication Institute for Safe Medication

PracticesPractices

ISMP, Warminster, PAISMP, Warminster, PAMichael Cohen, PresidentMichael Cohen, President

Documents

Principles of Prescription Writing Nicholas G Popovich Ph.D., R.Ph. Professor and Head Department of Pharmacy Administration UIC College of Pharmacy