Ulllted States Patent [19]
`Elsayed et al.
`
`[54] METHODS FOR DELIVERING A DRUG TO A
`PATIENT WHILE PREVENTING THE
`EXPOSURE OF A FOETUS OR OTHER
`CONTRAINDICATED INDIVIDUAL TO THE
`DRUG
`
`[75] Inventors: Marc Elsayed, BridgeWater; Bruce
`Williams, Flemington, both of N1
`
`_
`[73] Ass1gnee: Celgene Corporation, Warren, NJ.
`
`21 A l. N .: 09 143 569
`[
`1
`pp
`0
`/
`’
`[22] Filed:
`Aug. 28, 1998
`[51] Int Cl
`7
`......... ..
`.........................................
`.
`.
`gfsl'dclt', """ """""" " 600/300’ 600?
`1e
`0
`
`[
`
`]
`
`[56]
`
`A61N5/00
`~
`
`/338’ 376’
`’ 511 551_ 12’8/926_925’ 89$_898’
`’
`’
`’
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`US006045501A
`[11] Patent Number:
`[45] Date of Patent:
`
`6,045,501
`Apr. 4, 2000
`
`5,594,637
`5,619,991
`5,660,176
`
`1/1997 Eisenberg et al. .................... .. 600/300
`4/1997 Sloane .......... ..
`.. 600/300
`8/1997 Iliff ........................................ .. 600/300
`
`Primary Examiner—Cary O’Connor
`Assistant Examiner—Michael Astarino
`Attorney, Agent, or Firm—Woodcock Washburn KurtZ
`MackieWicZ & Norris LLP
`
`[57]
`
`ABSTRACT
`
`Novel methods for delivering a drug to a patient While
`preventing the exposure of a foetus or other contraindicated
`'d' ‘d
`1
`h d gE bd'
`P 'dd' h'h
`1n 1v1 ua tot e ru . m o iments are rov1 e mW 1c
`the involved prescribers, pharmacies and patients are regis_
`tered in one or more computer databases. Embodiments are
`also provided in Which registered patients receive counsel
`ing information concerning the risks attendant to foetal
`exposure to the drug. Male patients and female patients Who
`are not pregnant may, in certain circumstances, receive the
`drug.
`
`5,299,121
`
`3/1994 Brill et al. ............................ .. 600/301
`
`10 Claims, N0 Drawings
`
`CFAD VI 1003-0001
`
`

`

`6,045,501
`
`1
`METHODS FOR DELIVERING A DRUG TO A
`PATIENT WHILE PREVENTING THE
`EXPOSURE OF A FOETUS OR OTHER
`CONTRAINDICATED INDIVIDUAL TO THE
`DRUG
`
`2
`distribution channels. Also, because drug sharing may fre
`quently occur, such as among AIDS patients, Which may
`result in placing a fetus at risk, a program is needed Which
`can be used to educate men and Women about the risk of
`teratogenic drugs, such as thalidomide. The present inven
`tion is directed to these, as Well as other important ends.
`
`FIELD OF THE INVENTION
`
`The present invention relates to novel methods for deliv
`ering a drug to a patient. More particularly, the present
`invention relates to novel methods for delivering a terato
`genic or other potentially haZardous drug to a patient While
`preventing the exposure of a person, such as a foetus, to the
`drug When such exposure is contraindicated. The novel
`methods permit the distribution to patients of drugs, par
`ticularly teratogenic drugs, in Ways Wherein such distribu
`tion can or must be carefully monitored and controlled.
`
`BACKGROUND OF THE INVENTION
`
`Thalidomide is a drug Which Was ?rst synthesiZed in
`Germany in 1957. Beginning in 1958, it Was marketed in
`many countries for use as a sedative, although it Was never
`approved for use in the United States. After reports of
`serious birth defects, thalidomide Was WithdraWn from all
`markets by 1962. HoWever, during the years it Was used, it
`Was found to be effective in treating erythema nodosum
`leprosum (ENL), a condition of leprosy, and the US. Food
`and Drug Administration (FDA) has made the drug available
`for this speci?c use via a program of the Public Health
`Service. More recently, investigators have found that thali
`domide may be effective in treating AIDS Wasting and
`aphthous ulcers occurring in AIDS patients. In addition,
`treatments for other diseases, such as a number of serious
`diseases including cancers, in?ammatory boWel diseases,
`Behcet’s Disease, rheumatoid arthritis, and macular
`degeneration, are also believed to be possible. The FDA has
`recently approved an application by Celgene Corporation,
`Which is the assignee of the present patent application, to
`market thalidomide for the treatment of ENL. The medical
`community anticipates that thalidomide Will be used for
`treatment of additional conditions and diseases, including
`those set forth above. HoWever, due to the severe teratogenic
`risk of thalidomide, methods are needed to control the
`distribution of this drug so as to preclude administration to
`foetuses. Methods for distribution of other potentially haZ
`ardous drugs are also needed to guard against improper
`provision to persons for Whom such drug is contraindicated.
`Previous methods for controlling the distribution of drugs
`have been developed in connection With Accutane
`(isotretinoin). Accutane, Which is a knoWn teratogen, is a
`uniquely effective drug for the treatment of severe,
`recalcitrant, nodular acne. A pregnancy prevention program
`Was developed, and the Slone Epidemiology Unit of Boston
`University designed and implemented a survey to evaluate
`these efforts. The survey identi?ed relatively loW rates of
`pregnancy during Accutane treatment, Which suggests that
`such a program can be effective. With more than about
`325,000 Women enrolled to date in the Accutane survey, it
`is also clear that such a large-scale study can be conducted.
`HoWever, enrollment in the Accutane survey is voluntary.
`Accordingly, assessing the representativeness of the Women
`Who have been enrolled in the survey has been problematic,
`and it has been dif?cult to determine Whether the survey
`results can be generaliZed to all female Accutane users.
`Thus, improved methods are needed Which are more
`representative of all users of a particular drug, such as
`thalidomide, Who obtain the involved drug through laWful
`
`SUMMARY OF THE INVENTION
`
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`The present invention is directed to methods for the
`delivery of potentially haZardous drugs, such as teratogenic
`drugs, to patients. In one embodiment of the invention, there
`are provided methods for delivering a teratogenic drug to
`patients in need of the drug While avoiding the delivery of
`said drug to a foetus comprising:
`a. registering in a computer readable storage medium
`prescribers Who are quali?ed to prescribe said drug;
`b. registering in said medium pharmacies to ?ll prescrip
`tions for said drug;
`c. registering said patients in said medium, including
`information concerning the ability of female patients to
`become pregnant and, optionally, the ability of male
`patients to impregnate females;
`d. retrieving from said medium information identifying a
`subpopulation of said female patients Who are capable
`of becoming pregnant and, optionally, male patients
`Who are capable of impregnating females;
`e. providing to the subpopulation, counseling information
`concerning the risks attendant to fetal eXposure to said
`drug;
`f. determining Whether patients comprising said subpopu
`lation are pregnant; and
`g. in response to a determination of non-pregnancy for
`said patients, authoriZing said registered pharmacies to
`?ll prescriptions from said registered prescribers for
`said non-pregnant registered patients.
`Another embodiment of the invention relates to methods
`for delivering a potentially haZardous drug to patients in
`need of the drug While avoiding the delivery of said drug to
`persons for Whom said drug is contraindicated comprising:
`a. registering in a computer readable storage medium
`prescribers Who are quali?ed to prescribe said drug;
`b. registering in said medium pharmacies to ?ll prescrip
`tions for said drug;
`c. registering said patients in said medium, including
`information concerning the likelihood of said patients
`having a condition Which contraindicates eXposure to
`the drug;
`d. retrieving from said medium information identifying a
`subpopulation of said patients Who have a condition
`Which contraindicates eXposure to the drug;
`e. providing to the subpopulation, counseling information
`concerning the risks attendant to eXposure to said drug;
`f. determining Whether patients comprising said subpopu
`lation have said condition; and
`g. in response to a determination that said patients do not
`have said condition, authoriZing said registered phar
`macies to ?ll prescriptions from said registered presi
`crbers for said registered patients for Whom said drug
`is not contraindicated.
`The methods described herein provide advantageous and
`effective means for monitoring, controlling and authoriZing
`the distribution of drugs to patients, particularly teratogenic
`drugs. The methods of the present invention include a
`variety of checks and controls Which serve to limit unau
`
`CFAD VI 1003-0002
`
`

`

`6,045,501
`
`3
`thoriZed and possibly inappropriate distribution of the drug.
`In the case of teratogenic drugs, the checks and balances
`may be particularly advantageous for preventing distribution
`of the drug to patients Whose use of the drug may pose an
`unacceptable risk of foetal exposure. Accordingly, the
`present methods may be advantageously used to avoid
`exposure of foetuses to teratogenic drugs, thereby avoiding
`the terrible birth defects Which may result from such expo
`sure.
`The invention is not limited to the distribution of terato
`genic drugs; other potentially haZardous drugs may also be
`distributed in accordance With embodiments of this inven
`tion and such drugs may be distributed in such a fashion that
`persons for Whom such drugs are contraindicated Will not
`receive them. These and other aspects of the invention Will
`become more apparent from the present description and
`claims.
`
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`4
`preferably, the avoidance rate is greater than about 75%,
`With an avoidance rate of greater than about 80% being still
`more preferred. In even more preferred embodiments, the
`avoidance rate is greater than about 85%, With an avoidance
`rate of greater than about 90% being yet more preferred. Still
`more preferably, the avoidance rate is greater than about
`95%. In particularly preferred embodiments, a teratogenic
`drug may be delivered to patients With substantially no
`delivery to foetuses (i.e., nearly 100% avoidance rate).
`The drug delivery methods of the present invention pref
`erably involve, inter alia, registering in a computer readable
`storage medium prescribers Who are quali?ed to prescribe
`the involved drug including, for example, teratogenic drugs.
`Once registered in the computer readable storage medium,
`the prescriber may be eligible to prescribe the drug to
`patients in need of the drug. Generally speaking, in order to
`become registered in the computer readable storage
`medium, the prescriber may be required to comply With
`various aspects of the methods described herein including,
`for example, providing patient education and counseling,
`and the like, as described in detail beloW. The registration of
`the prescriber in the computer readable storage medium may
`be achieved by providing the prescriber, for example, by
`mail, facsimile transmission, or on-line transmission, With a
`registration card or form, preferably together With appropri
`ate educational materials concerning, for example, the par
`ticular drug for Which the prescriber is being registered to
`prescribe, as Well as suitable methods for delivering the drug
`to the patient, including the drug delivery methods described
`herein. The prescriber Will preferably complete the registra
`tion card or form by providing information requested
`therein, and the registration card or form Will preferably be
`returned to the manufacturer or distributor of the drug, or
`other authoriZed recipient of the registration materials, for
`example, by mail, facsimile transmission or on-line trans
`mission. Information Which may be requested of the pre
`scriber in the registration card or form may include, for
`example, the prescriber’s name, address, and af?liation, if
`any, With one or more health care institutions. The prescrib
`er’s information in the registration card or form is then
`entered into the computer readable storage medium. It is
`contemplated that the registration of the prescriber into the
`computer readable storage medium may also be achieved,
`for example, by telephone. Suitable computer readable stor
`age media Which may be employed for registration of the
`prescribers (as Well as the pharmacies and patients, as
`discussed beloW) Will be apparent to one of ordinary skill in
`the art, once armed With the teachings of the present
`application.
`In accordance With the methods described herein, phar
`macies Which may ?ll prescriptions for the particular drug
`being prescribed including, for example, teratogenic drugs,
`are also preferably registered in a computer readable storage
`medium. The computer readable storage medium in Which
`the pharmacies are registered may be the same as, or
`different from the computer readable storage medium in
`Which the prescribers are registered. Once registered in the
`computer readable storage medium, the pharmacies may be
`eligible to dispense the involved drug to patients Who are in
`need of the drug. Generally speaking, in order to become
`registered in the computer readable storage medium, the
`pharmacy may be required to comply With various aspects of
`the methods described herein including, for example, reg
`istering the patient (preferably also in a computer readable
`storage medium), as Well as other aspects of the present
`methods, as described in detail beloW. As With the registra
`tion of the prescriber in the computer readable storage
`
`DETAILED DESCRIPTION OF PREFERRED
`EMBODIMENTS
`The present invention is directed generally to methods for
`the delivery of drugs, especially teratogenic drugs, to
`patients. The term “drug,” as used herein, refers to any
`substance Which is intended for use in the diagnosis, cure,
`mitigation, treatment or prevention of disease, or to affect
`the structure or function of the body. Generally speaking, the
`methods of the present invention may be desirably and
`advantageously used to educate and reinforce the actions
`and behaviors of patients Who are taking the drug, as Well as
`prescribers Who prescribe the drug and pharmacies Which
`dispense the drug. As used herein, the term “prescriber”
`refers to any individual Who are capable of prescribing
`drugs, including, for example medical doctors. Such educa
`tion and reinforcement of actions and behavior are often
`necessary to ensure proper prescribing and dispensing of the
`35
`drug, as Well as patient compliance With taking the drug. A
`Wide variety of educational materials may be employed to
`ensure proper prescribing, dispensing and patient compli
`ance according to the methods described herein, including,
`for example, a variety of literature and other materials, such
`as, for example, product information, educational brochures,
`continuing education monographs, videotapes and the like
`Which may describe the risks and bene?ts associated With
`taking the particular drug.
`The methods described herein may be advantageously
`employed for the delivery of a drug to a patient for Whom the
`drug is contraindicated. As used herein, the term “contrain
`dicated” refers to any condition in a patient Which renders a
`particular line of treatment, including the administration of
`one or more drugs, undesirable or improper. Thus, contrain
`dicated drugs include, for example, teratogenic drugs Whose
`administration, for example, to pregnant patients is impor
`tantly avoided due to the risks to the foetus. The methods of
`the present invention are especially advantageously
`employed for the delivery to a patient of a teratogenic drug.
`The delivery of a teratogenic drug to a patient may be
`advantageously achieved With the present methods While
`substantially (including completely) avoiding the delivery of
`the drug to a foetus (i.e., fetus). The term “substantially,” as
`used in reference to avoiding the delivery of a teratogenic
`drug to a foetus, generally means that there is an avoidance
`rate of delivering the drug to a foetus of greater than about
`50%. Preferably, the avoidance rate is greater than about
`55%, With an avoidance rate of greater than about 60% being
`more preferred. Even more preferably, the avoidance rate is
`greater than about 65%, With an avoidance rate of greater
`than about 70% being still more preferred. Yet more
`
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`CFAD VI 1003-0003
`
`

`

`6,045,501
`
`5
`medium, the registration of the pharmacy may be achieved
`by providing the pharmacy, for example, by mail, facsimile
`transmission, or on-line transmission, With a registration
`card or form, preferably together With appropriate educa
`tional materials concerning, for example, the particular drug
`for Which the pharmacy is being registered to dispense, as
`Well as suitable methods for delivering the drug to the
`patient, including the drug delivery methods described
`herein. The pharmacy may then have the registration card or
`form completed by providing the information requested
`therein, Which thereafter may be returned to the manufac
`turer or distributor of the drug, or other authoriZed recipient
`of the registration card or form, for example, by mail,
`facsimile transmission or on-line transmission. Information
`Which may be requested of the pharmacy in the registration
`card or form may include, for example, the pharmacy’s
`name, address, and affiliation, if any, With any health care
`institution such as, for example, hospital, health care
`organiZation, and the like. The pharmacy’s information in
`the registration card or form is then preferably entered into
`the computer readable storage medium. It is contemplated
`that the registration of the pharmacy into the computer
`readable storage medium may also be achieved, for
`example, by telephone.
`As noted above, the drug delivery methods described
`herein also preferably involve the registration of the patient
`in a computer readable storage medium. As discussed beloW,
`the registration of the patient is preferably carried out by the
`registered pharmacy at the time of the patient’s initial visit
`to the pharmacy. The computer readable storage medium in
`Which the patients are registered may be the same as, or
`different from the computer readable storage medium in
`Which the prescriber and/or pharmacy is registered. Once
`registered in the computer readable storage medium, the
`patient in need of a particular drug including, for example,
`a particular teratogenic drug, may be eligible to receive the
`drug. Generally speaking, in order to become registered in
`the computer readable storage medium, the patient may be
`required to comply With various aspects of the methods
`described herein. In preferred form, the pharmacy Will
`typically have a registration form ?lled out for the patient,
`Which includes information on the patient, such as the
`patient’s name, mailing address, date of birth, and the like.
`Information on the prescribing prescriber and dispensing
`pharmacy, such as the information described above for the
`registration thereof, may also be desirably entered on the
`patient registration form. The completed form may then be
`forWarded to the manufacturer or distributor of the drug, or
`other authoriZed recipient of the registration form, for
`example, by mail, facsimile transmission or on-line trans
`mission. It is contemplated that the registration of the patient
`into the computer readable storage medium may also be
`achieved, for example, by telephone.
`In accordance With the methods of the present invention,
`the delivery of the drug to the patient may involve the
`folloWing steps. As a prelude to prescribing and dispensing
`the drug to the patient, the prescriber and the pharmacy are
`registered in one or more appropriate computer readable
`storage media, as described above. If the prescriber is not
`registered in the computer readable storage medium, the
`prescriber Will be ineligible to prescribe the drug. Similarly,
`if the pharmacy is not registered in the computer readable
`storage medium, the pharmacy Will be ineligible to dispense
`the drug.
`In the course of an examination of a patient, including
`patients suffering from one or more diseases and/or disor
`ders such as, for example, erythema nodosum leprosum
`
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`(ENL), the prescriber may determine that the patient’s
`condition Would be improved by the administration of a drug
`such as, for example, a teratogenic drug, including thalido
`mide. Prior to prescribing the drug, the prescriber preferably
`counsels the patient, for example, on the various risks and
`bene?ts associated With the drug. For example, the pre
`scriber preferably discusses the bene?ts associated With
`taking the drug, While also advising the patient on the
`various side effects associated thereWith. Thus, a patient
`Who may acquire or impart a condition or disease for Which
`the drug is contraindicated is preferably counseled by the
`prescriber on the dangers associated thereWith. For example,
`in the case of teratogenic drugs, the prescriber preferably
`counsels the patient on the dangers of exposing a foetus to
`the teratogenic drug. Such counsel may be provided
`verbally, as Well as in Written form. In preferred
`embodiments, the prescriber provides the patient With lit
`erature materials on the drug for Which a prescription is
`contemplated, such as product information, educational
`brochures, patient instruction videos, and the like. Thus, in
`the case of methods involving teratogenic drugs, the pre
`scriber preferably provides patients With literature
`information, for example, in the form of the aforesaid
`product information, educational brochures, patient instruc
`tion videos, and the like, Warning the patient of the effects
`of the drug on foetuses.
`With particular reference to counseling provided in con
`nection With teratogenic drugs, the prescriber preferably
`counsels female patients that such drugs must never be used
`by pregnant Women. If the patient is a female of child
`bearing potential (i.e., a Woman Who is capable of becoming
`pregnant), the prescriber preferably counsels the patient that
`even a single dosage of certain teratogenic drugs, such as
`thalidomide, may cause birth defects. Accordingly, the
`patient is preferably counseled to avoid sexual intercourse
`entirely, or if sexually active, to use appropriate forms of
`contraception or birth control. For both male and female
`patients, the prescriber preferably provides counsel on the
`importance of using at least tWo forms of effective birth
`control methods, With one form preferably being a highly
`effective hormonal method, and the other from preferably
`being an effective barrier method. The patients are prefer
`ably counseled to use the birth control methods for a period
`of time prior to and during treatment With the teratogenic
`drug, as Well as for a period of time after treatment With the
`drug has been terminated. In preferred embodiments, the
`patient is counseled to use at least tWo forms of birth control
`for at least about 4 Weeks prior to initiation of treatment,
`during treatment, and for at least about 4 Weeks after
`treatment has been terminated. It may be desirable for the
`prescriber to personally provide female patients Who are
`capable of becoming pregnant With a contraceptive device or
`formulation.
`Male patients Who are being prescribed a teratogenic drug
`are preferably counseled to use condoms every time they
`engage in sexual relations, since many teratogenic drugs
`may be found in semen. Male patients are also preferably
`counseled to contact their prescriber if they have sexual
`intercourse Without a condom, and/or if it is believed that
`they may have caused a pregnancy. As With female patients,
`it may be desirable for the prescriber to provide male
`patients Who are capable of impregnating female patients
`With a contraceptive device or formulation. Other advice
`relative to birth control that the prescriber may provide to the
`patient Would be apparent to one skilled in the art, once
`armed With the teachings of the present application. If the
`prescriber Who is prescribing the teratogenic drug is
`
`CFAD VI 1003-0004
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`

`6,045,501
`
`7
`unaware of certain aspects of the available forms of birth
`control and the advantages and disadvantages associated
`thereWith, the patient should be referred to a prescriber Who
`is knowledgeable on such matters, prior to be being pre
`scribed the involved drug. Generally speaking, as discussed
`beloW, counseling on teratogenecity, birth control, and the
`like is preferably given only to female patients Who are
`capable of becoming pregnant, or to male patients Who are
`capable of impregnating female patients. In this manner,
`unnecessary counseling, for example, to Women Who are no
`longer of child-bearing age or men Who are incapable of
`impregnating Women, may be avoided.
`With further reference to methods involving teratogenic
`drugs, it is also preferred that the prescriber advise the
`patient to not share the drug With anyone else, and particu
`larly that the drug should be kept out of the reach of children
`as Well as Women of child-bearing potential. In the case of
`female patients, particularly female patients of child-bearing
`potential, the prescriber should give the patient a pregnancy
`test, preferably a serum pregnancy test, prior to and during
`treatment With the teratogenic drug. To begin receiving the
`teratogenic drug and to continue taking the drug, female
`patients of child-bearing potential should continue to have
`negative pregnancy tests. The patient is also preferably
`counseled by the prescriber to discard or return to the
`prescriber, pharmacy, manufacturer or distributor any
`unused portion of the prescribed drug.
`As Would be apparent to one of ordinary skill in the art,
`once armed With the teachings of the present application,
`one or more aspects of the counseling described above may
`be applicable, in certain circumstances, for drugs other than
`teratogenic drugs.
`In addition to receiving counseling on the drug being
`prescribed, including counseling, for example, on birth
`control, and prior to receiving a prescription for the drug, the
`methods of the present invention preferably involve requir
`ing the patient to ?ll out an informed consent form Which is
`signed by the prescriber, as Well as the patient. The pre
`scriber should retain a copy of the informed consent form for
`his/her records. By ?lling out and signing an informed
`consent form, the patient acknoWledges that he/she under
`stands the risks associated With taking the drug. In the
`informed consent form, the patient preferably agrees to
`behave in a manner Which is consistent With the prescriber’s
`counsel. For example, in cases involving, for example,
`teratogenic drugs, the patient may agree to use at least one
`form of birth control, With female patients agreeing to use at
`least tWo forms of birth control. In preferred embodiments
`involving teratogenic drugs, female patients preferably
`agree also to undergo pregnancy testing, preferably serum
`pregnancy testing, before, during and after treatment With
`the teratogenic drug. Female patients preferably Will also
`acknoWledge that, at the time they are being prescribed the
`drug, especially teratogenic drugs, they are not pregnant,
`they Will immediately stop taking the drug if they become
`pregnant, and they Will not try to become pregnant for at
`least 4 Weeks after treatment With the drug is terminated.
`Female patients, especially female patients for Whom a
`teratogenic drug Will be administered, preferably further
`agree to contact their prescriber if they Wish to change one
`or more of the birth control methods being used and to have
`an additional pregnancy test if a menstrual period is missed.
`Female patients, especially female patients to be treated With
`teratogenic drugs, Will preferably agree also to not breast
`feed While being treated With the drug.
`Male patients Who are being prescribed the drugs accord
`ing to the methods described herein, especially teratogenic
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`drugs, Will preferably agree to avoid having unprotected
`sexual relations With a Woman, particularly a Woman of
`child-bearing potential during treatment With the drug. In
`doing so, male patients Will preferably further agree to use
`a condom during sexual relations With a Woman, With latex
`condoms being preferred. Both male and female patients
`Will also preferably agree to not share the drug With anyone,
`and to acknoWledge that they cannot donate blood While
`taking the drug, With male patients agreeing also to not
`donate sperm While taking the drug. In addition, the patients
`Will preferably agree to take part in a con?dential patient
`survey, for example, before, during and after treatment With
`the drug. The patient survey provides information, for
`example, to the prescriber, manufacturer and/or distributor
`of the drug, as Well as any group or body Which may be
`established to generally provide oversight on the distribution
`of the drug, on information regarding the general lifestyle of
`the patient, including detailed information on the patient’s
`sexual behavior. In this manner, the survey may assist in
`identifying patients Who engage in risky behavior, as Well as
`patients Who are non-compliant With the methods described
`herein. Such risky behavor and/or non-compliance may lead
`to a suspension or intervention of the patient’s treatment
`With the drug, With re-education being provided to the
`patient.
`The information obtained from the survey is preferably
`also entered into the computer readable storage medium.
`Once entered into the computer readable storage medium,
`the prescriber, manufacturer and/or distributor of the drug
`may be able to glean therefrom information regarding the
`level of risk associated With the administration of the
`involved drug to the various patients. Accordingly, it may be
`possible to identify, from among the entire population of
`registered patients, one or more subpopulations of patients
`for Which the involved drug may be more likely to be
`contraindicated. For example, it may be possible to identify
`a subpopulation of female patients Who are capable of
`becoming pregnant and/or a subpopulation of male patients
`Who are capable of impregnating female patients. Preferably,
`the counseling information discussed above relating to expo
`sure of a foetus to a teratogenic drug may then be addressed
`primarily to this subpopulation of patients.
`If the risk is considered to be acceptable, the patient may
`continue to receive the drug, using the methods described
`herein. If the risk is considered to be unacceptable, addi
`tional counseling may be provided to the patient or, if
`necessary, treatment of the patient With the involved drug
`may be terminated, With alternate treatment modalities being
`provided. In preferred embodiments, female patients Will
`agree to complete a patient survey at least once every month,
`With male patients agreeing to complete a patient survey at
`least once every three months.
`After the patient has received counseling as described
`above, and has also ?lled out and signed an informed
`consent form, and it is determined that the drug Which is to
`be prescribed is not contraindicated for the patient (such as,
`for example, a negative pregnancy test in the case of female
`patients for Whom a prescription is desired for a teratogenic
`drug), the prescriber may prescribe the drug to the patient.
`In preferred embodiments of the present invention, the
`amount of the drug Which is prescribed to the patient is for
`a limited amount, preferably no more than about 28 days.
`Re?lls for the drug Will not be permitted Without a reneWal
`prescription from the prescriber, as discussed in detail
`beloW. In order to have the prescription ?lled, the patient
`preferably presents the prescription and the informed con
`sent form to a pharmacy Which has been registered, as
`
`CFAD VI 1003-0005
`
`

`

`9
`discussed above. It is contemplated that the patient may
`bring the prescription to an unregistered pharmacy. If so, the
`pharmacy may take steps to become registered, for example,
`by immediately contacting the manufacturer of the drug.
`Once registration of the pharmacy is completed, the distri
`bution procedure described herein may resume, per the
`discussion hereinafter. Of course, this may introduce a delay
`into the prescription process, and the patient may desire to
`take the prescription for the drug to an alternate, registered
`pharmacy. If the patient does not present a completed
`informed consent form to the pharmacy, the prescript