(12) United States Patent
`Williams et al.
`
`US006315720B1
`US 6,315,720 B1
`Nov. 13, 2001
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`(54)
`
`METHODS FOR DELIVERING A DRUG TO A
`PATIENT WHILE AVOIDING THE
`OCCURRENCE OF AN ADVERSE SIDE
`EFFECT KNOWN OR SUSPECTED OF
`BEING CAUSED BY THE DRUG
`
`(75)
`
`Inventors:
`
`Bruce A. Williams, Flemington;
`Joseph K. Kaminski, Hampton, both of
`NJ (US)
`
`(73)
`(*)
`
`(21)
`(22)
`(51)
`(52)
`(58)
`
`(56)
`
`Assignee:
`
`Celgene Corporation, Warren, NJ (US)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`USC 154(b) by 0 days.
`
`Appl. N0.:
`
`Filed:
`
`09/694,217
`Oct. 23, 2000
`
`Int. Cl.7 ..
`.................................................... .. A61B 5/00
`US. Cl.
`........................................ .. 600/300; 235/375
`Field of Search ................................... .. 600/300, 304,
`600/551; 395/202_210; 128/630; 706/23,
`2, 3; 235/375
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5,299,121
`5,594,637 *
`5,619,991 *
`5,660,176
`
`3/1994 Brill et a1. ......................... .. 600/301
`1/1997 Eisenberg et a1. ................. .. 395/202
`4/1997 Sloane ................................ .. 128/630
`
`8/1997 Iliff ..................................... .. 600/300
`
`12/1998 Mayaud ................................. .. 705/3
`5,845,255
`1/2000 Teagarden et a1. .
`705/3
`6,014,631
`6,045,501 * 4/2000 Elsayed et a1.
`. 600/300
`6,055,507
`4/2000 Cunningham
`.... .. 705/3
`6,063,026 * 5/2000 Schauss et al. ..
`. 600/300
`6,128,620
`10/2000 Pissanos et a1.
`707/102
`6,131,090 * 10/2000 Basso, Jr. et al.
`..... .. 706/23
`6,202,923 * 3/2001 Boyer et a1. ....................... .. 235/375
`
`* cited by examiner
`
`Primary Examiner—Eric F. Winakur
`Assistant Examiner—Nikita R Veniaminov
`(74) Attorney, Agent, or F irm—Woodcock Washburn KurtZ
`MackieWicZ & Norris LLP
`
`(57)
`
`ABSTRACT
`
`Improved methods for delivering to a patient in need of the
`drug, While avoiding the occurrence of an adverse side effect
`known or suspected of being caused by the drug are dis
`closed. The methods are of the type in Which prescriptions
`for the drug are ?lled only after a computer readable storage
`medium has been consulted to assure that the prescriber,
`pharmacy and patient have been properly registered in the
`medium before the patient is approved to receive the drug.
`Embodiments are provided Wherein the patients are assigned
`to risk groups based upon the risk that taking the drug Will
`lead to the side effect, and certain additional information,
`such as periodic surveys and diagnostic tests probative of the
`ongoing risk of the side effect developing are obtained
`before prescriptions for the drug are approved.
`
`32 Claims, No Drawings
`
`CFAD VI 1001-0001
`
`

`
`US 6,315,720 B1
`
`1
`METHODS FOR DELIVERING A DRUG TO A
`PATIENT WHILE AVOIDING THE
`OCCURRENCE OF AN ADVERSE SIDE
`EFFECT KNOWN OR SUSPECTED OF
`BEING CAUSED BY THE DRUG
`
`FIELD OF THE INVENTION
`
`The present invention relates to improved methods for
`delivering 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 in need
`of the drug, While avoiding the occurrence of knoWn or
`suspected side effects of the drug. The novel methods permit
`the distribution to patients of drugs, particularly teratogenic
`drugs, in Ways Wherein such distribution can be carefully
`monitored and controlled.
`
`BACKGROUND OF THE INVENTION
`
`Many bene?cial drugs are knoWn or suspected of produc
`ing adverse side effects in certain individuals. These side
`effects may be manifest in the patient taking the drug, in a
`foetus (i.e. fetus) carried by the patient, or in a recipient (or
`foetus carried by a recipient) of the bodily ?uids of the
`patient. In some cases, administration of the drug may be
`acceptable in some patients, but absolutely contraindicated
`in other patients. For example, drugs knoWn or suspected of
`causing birth defects if taken by a pregnant Woman (i.e.
`teratogenic drugs), may nonetheless be bene?cial for treat
`ing certain conditions. HoWever, because of the teratogenic
`properties of the drug, administration to pregnant Women
`must be avoided. Other drugs are knoWn Which may be
`bene?cially employed in the general population, but must be
`avoided by individuals having a certain preexisting
`condition, or those concurrently taking certain other
`medication(s), due to adverse side effects Which may
`develop in those individuals.
`One such drug Which is knoWn to produce adverse side
`effects, but Which may nevertheless be bene?cially
`employed in certain patients is thalidomide. 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 Admin
`istration (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 thalidomide 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 neoplastic diseases including
`cancers, 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 thali
`domide 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.
`In this regard, US. Pat. No. 6,045,501, to Elsayed et al.,
`provides methods for delivering a drug to a patient While
`preventing the eXposure of a foetus or other contraindicated
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`individual to the drug. According to the methods of this
`patent, prescriptions for the drug are ?lled only after a
`computer readable storage medium has been consulted to
`assure that the prescriber is registered in the medium and
`quali?ed to prescribe the drug, that the pharmacy is regis
`tered in the medium and quali?ed to ?ll the prescription for
`the drug, and the patient is registered in the medium and
`approved to receive the drug. Improvements to this method
`may be useful, hoWever, to minimiZe and simplify the
`demands on the pharmacy, thereby improving compliance
`With the system of distribution, and reducing the risk that the
`drug Will be dispensed to a contraindicated individual.
`Methods for monitoring and educating patients to Whom
`a drug is distributed 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 sug
`gests 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. Enrollment in the Accutane survey is voluntary,
`hoWever. 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, an improved survey is needed Which Would be
`representative of all users of a particular drug, such as
`thalidomide, Who obtain the drug through legal distribution
`channels. There are also no mechanisms provided to assure
`compliance With the program or to limit distribution of the
`drug to participants in the survey.
`Because drug sharing may frequently occur among AIDS
`patients, Which may result in placing a foetus at risk, a
`program is needed Which can be used to educate men and
`Women about the risk of teratogenic drugs, such as thalido
`mide. In addition, a system is needed for the controlled
`distribution of a drug, in Which of all users of the drug,
`including prescribers, pharmacies, and patients, may be
`accountable for their compliance With methods that may be
`established to minimiZe the risk that a contraindicated
`individual Will be eXposed to the drug. The present invention
`is directed to these, as Well as other important ends.
`
`SUMMARY OF THE INVENTION
`
`The present invention is directed to improved methods for
`delivering a drug to a patient in need of the drug, While
`avoiding the occurrence of an adverse side effect knoWn or
`suspected of being caused by the drug, of the type in Which
`prescriptions for the drug are ?lled only after a computer
`readable storage medium has been consulted to assure that
`the prescriber is registered in the medium and quali?ed to
`prescribe the drug, that the pharmacy is registered in the
`medium and quali?ed to ?ll the prescription for the drug,
`and the patient is registered in the medium and approved to
`receive the drug. In one embodiment of the invention, there
`are provided improved methods comprising the steps of:
`a. de?ning a plurality of patient risk groups based upon a
`prede?ned set of risk parameters for the drug;
`b. de?ning a set of information to be obtained from the
`patient, Which information is probative of the risk that
`such adverse side effect is likely to occur if the drug is
`taken by the patient;
`
`CFAD VI 1001-0002
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`

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`US 6,315,720 B1
`
`3
`c. in response to the information set, assigning the patient
`to at least one of the risk groups; and
`d. entering the risk group assignment in the medium
`before the patient is approved to receive the drug.
`The improved methods described herein provide advan
`tageous and effective means for monitoring, controlling and
`authoriZing the distribution to patients of drugs knoWn or
`suspected of causing adverse side effects. The methods of
`the present invention include a variety of checks and bal
`ances Which serve to limit unauthoriZed and possibly inap
`propriate distribution of the drug. These methods are par
`ticularly applicable to distribution of teratogenic drugs, in
`Which case 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 that a foetus carried by the patient or a recipient of the
`bodily ?uids of the patient Will be exposed to such drugs.
`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 exposure.
`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.
`
`DETAILED DESCRIPTION OF PREFERRED
`EMBODIMENTS
`The present invention is directed generally to methods for
`the delivery of drugs knoWn or suspected of causing an
`adverse side effect, 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. The term “side effect” refers to any
`abnormality, defect, mutation, lesion, degeneration or injury
`Which may be caused by taking the drug. The side effect may
`be one Which is likely to arise in the patient or in a foetus
`(i.e., fetus) carried by the patient. The side effect may also
`be one Which is likely to arise in a recipient of the bodily
`?uid of the patient, or foetus carried by such recipient. The
`term “likely to arise” means that the side effect knoWn or
`suspected of being caused by the drug may be expected to
`occur at a higher incidence rate in a particular individual or
`group of individuals.
`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 a 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 is capable of
`prescribing drugs, including, for example, a medical doctor.
`Such education and reinforcement of actions and behavior
`are often necessary to ensure proper prescribing and dis
`pensing of the drug, as Well as patient compliance With
`taking the drug. AWide variety of educational materials may
`be employed to ensure proper prescribing, dispensing and
`patient compliance 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 and
`measures Which may be taken to avoid those risks.
`
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`The methods described herein may be advantageously
`employed to avoid delivery of one or more drugs knoWn or
`suspected of causing an adverse side effect to a patient for
`Whom the drugs may be contraindicated. As used herein, the
`term “contraindicated” 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. This condition may be preexisting, or may
`develop While the patient is taking the drugs, including
`conditions Which may result directly or indirectly from
`treatment With the drugs. Thus, contraindicated drugs
`include, for example, teratogenic drugs Whose
`administration, for example, to pregnant patients is impor
`tantly avoided due to the risks to the foetus. Drugs may also
`be considered “contraindicated,” as the term is used herein,
`if use of a drug by patients Who are also taking another drug
`is knoWn or suspected of producing an adverse side effect in
`those patients, or in a foetus carried by such patients.
`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) avoid
`ing the delivery of the drug to a foetus. 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 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 completely no delivery to foetuses (i.e., 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
`
`CFAD VI 1001-0003
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`US 6,315,720 B1
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`5
`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, and/or through the use of an
`integrated voice response system. Suitable computer read
`able storage 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 Who are quali?ed to ?ll prescriptions for the par
`ticular drug being prescribed including, for example, terato
`genic 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 reg
`istered in the computer readable storage medium, the phar
`macies 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, registering the patient (preferably also in a
`computer readable storage medium), ensuring that the
`patient complies With certain aspects of the drug delivery
`methods, as Well as other aspects of the present methods, as
`described in detail beloW. As With the registration of the
`prescriber in the computer readable storage 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 educational 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 pro
`viding the information requested therein, Which thereafter
`may be returned to the manufacturer 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 af?liation,
`if any, With any health care institution such as, for example,
`a hospital, health care organiZation, and the like. The phar
`macy’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 and/or through
`the use of an integrated voice response system.
`As noted above, the drug delivery methods described
`herein also preferably involve the registration of the patient
`in a computer readable storage medium. 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. Generally speaking, in order to become regis
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`tered in the computer readable storage medium, the patient
`may be required to comply With various aspects of the
`methods described herein. The registration of the patient
`may be carried out by the registered pharmacy, for example
`at the time of the patient’s initial visit to the pharmacy. It has
`been found, hoWever, that it may be more ef?cient, and
`better compliance With the methods of the present invention
`may be provided, if registration of the patient is carried out
`by the registered prescriber of the drug at the time the initial
`prescription is generated.
`In preferred form, the prescriber Will typically have a
`registration card or form ?lled out for the patient, Which
`includes information on the patient, such as the patient’s
`name, sex, 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 card or form. The completed card or
`form may then be forWarded to the manufacturer or dis
`tributor of the drug, or other authoriZed recipient of the
`registration form, for example, by mail, facsimile transmis
`sion or on-line transmission. Where registration is by mail or
`facsimile, entry of the registration into the computer read
`able storage medium may preferably include the use of
`optical character recognition (OCR) softWare. It is also
`possible that the registration of the patient into the computer
`readable storage medium may also be achieved, for
`example, by telephone and/or through the use of an inte
`grated voice response system.
`Preferably, information Will also be collected from the
`patient that may be probative of the risk that a knoWn or
`suspected side effect Will occur if the drug is taken by the
`patient. This information may then be compared With a
`prede?ned set of risk parameters for the drug, Which in turn
`de?ne a plurality of risk groups, so that analysis of the
`information Will permit assignment of the patient to at least
`one of the risk groups. Preferably, this risk group assignment
`is then also entered into the computer readable storage
`medium. This assignment may be performed by the
`prescriber, Who may then include the risk group assignment
`on the patient’s registration card or form, or may be per
`formed by another individual, such as a nurse, technician, or
`of?ce personnel, Who preferably interprets the information
`and assigns the patient to one of the risk groups, accordingly.
`As discussed above, it is preferable that a plurality of risk
`groups, each based upon a prede?ned set of risk parameters,
`be established for the drug Which is to be administered. As
`Will be evident to those of skill in the art, the risk parameters
`to be considered and the risk groups de?ned by those
`parameters, Will be based upon factors Which in?uence the
`risk that a knoWn or suspected adverse side effect Will occur
`if the patient receives the drug, and Will vary depending
`upon the drug in question. Where the drug is a teratogenic
`drug, for example, such risk parameters may include ele
`ments Which Would impact the risk of a foetus being exposed
`to the drug, such as the age, sex and reproductive status of
`the patient. For example, a ?rst risk group may comprise
`female patients of child bearing potential; a second risk
`group may comprise female patients of non-child bearing
`potential; a third risk group may comprise sexually active
`male patients; and a fourth risk group may comprise sexu
`ally inactive male patients. Additionally, there may be a risk
`group established for patients to Whom administration of the
`drug may be strictly contraindicated, and patients assigned
`to such a group Will not be approved to receive the drug. For
`other drugs, different factors, such as those in?uencing the
`likelihood that certain preexisting conditions may exist, or
`
`CFAD VI 1001-0004
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`US 6,315,720 B1
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`7
`the likelihood of certain other drugs being used concomi
`tantly With the prescribed drug, may de?ne the relevant risk
`parameters.
`By assigning each patient to a risk group, the steps that
`Will be taken to minimize the chance that the drug is
`dispensed to a contraindicated patient, and to minimiZe the
`risk that a knoWn or suspected adverse side effect Will occur,
`can be tailored to suit the circumstances of that particular
`patient. For example, depending upon Which risk group a
`patient is assigned to, additional information may be col
`lected from the patient. As discussed more fully beloW, such
`additional information may be in the form, for example, of
`a patient survey. Such additional information may also
`include the results of certain diagnostic tests Which have
`been performed. Based upon the additional information, the
`patient’s risk group assignment may then remain the same,
`or the patient may be assigned to a different risk group,
`Which may in turn require that further additional information
`be collected from the patient.
`In accordance With the present invention, the monitoring
`of tWo, three or more drugs either administered to or
`proposed for administration to a patient may also be accom
`plished in order to avoid or diminish the likelihood of the
`occurrence of one or more side effects. Thus, combinations
`of drugs Which, When administered to an individual patient,
`may give rise to an increased likelihood of side effects, may
`be registered in a computer readable storage medium, and
`the patient’s risk group assignment may be re?ective of this
`increased risk. Aphysician is registered to prescribe at least
`one of the drugs for a patient and a pharmacy is registered
`to ?ll such prescription. In this Way, through assignment of
`such patient to one or more risk groups, the avoidance of
`harmful drug interactions may be attained.
`It is preferred that for any given risk group, there may be
`de?ned a predetermined additional set of information Which
`is to be collected from the patient. This additional set of
`information may be obtained prior to the initial dispensation
`of the drug to the patient and/or may be obtained from the
`patient on a periodic basis. This information may include
`information not previously obtained from the patient, or may
`simply reiterate previously asked questions, and repeat diag
`nostic tests Which Were conducted previously. The informa
`tion may relate to the patient’s conduct, or may relate to the
`patient’s past or ongoing medical treatment, such as other
`procedures or medication Which the patient may have
`received or is still receiving. For example, the additional set
`of information may be in the form of a survey or question
`naire regarding the patient’s behavior and compliance With
`risk avoidance measures and may thus be probative of
`Whether the risk of occurrence of an adverse side effect has
`increased, decreased or remained the same. Based upon the
`responses by the patient, the patient’s risk group assignment
`may, if appropriate, be changed accordingly. Alternatively,
`Where side effects Which are knoWn or suspected of being
`caused by a combination of drugs, the questions asked of the
`patient may be probative of the likelihood that the patient
`may take such a combination of drugs. Similarly, Where
`sharing of drugs by the patient may be a matter of concern,
`the survey may be probative of the risk that the patient may
`be sharing the haZardous drug With another, and hence
`increase the risk that a contraindicated individual may
`receive the drug.
`The additional information may also include the results of
`certain diagnostic tests Which have been performed on the
`patient. Such diagnostic tests may be probative, for example,
`of the risk of exposure of a foetus to a teratogenic drug, may
`test for the presence of a risk factor for the adverse side
`
`10
`
`15
`
`25
`
`35
`
`45
`
`55
`
`65
`
`8
`effect of concern, or may be probative of the onset of that
`side effect. Where the use of combinations of more than one
`drug are knoWn or suspected of causing an increased risk of
`the occurrence of a side effect, the diagnostic testing may
`include testing for the presence of one or more of those
`drugs, or evidence of the use by the patient of such other
`drugs. Additionally, diagnostic tests may be probative of the
`concentration of one or more drugs, including the prescribed
`drug or drugs, to assure that appropriate dosing is main
`tained.
`Such diagnostic testing may be conducted on any bodily
`?uid or Waste product of the patient, including the blood,
`serum, plasma, saliva, semen or urine, as Well as the feces.
`Diagnostic testing may also be performed on a biopsy of any
`tissue of the patient or may include genetic testing, Which
`may be indicative of a genetic predisposition to a particular
`adverse side effect. Other forms of diagnostic testing, such
`as diagnostic imaging, or tests Which may be probative of
`the proper functioning of any tissue, organ or system are also
`contemplated. Preferably, the additional information and/or
`diagnostic test results are obtained and entered in the com
`puter readable storage medium before the patient is
`approved to receive the drug. Additionally, Where the infor
`mation indicates that the risk of the adverse side effect
`occurring outWeighs the potential bene?t of the drug, the
`patient may be assigned to a risk group that Will preclude
`approval of dispensation of the drug to that patient.
`In accordance With the methods of the present invention,
`therefore, the delivery of the drug to the patient may involve
`the folloWing steps. As a prelude to prescribing and dispens
`ing 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
`(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. In embodiments of
`the invention Wherein the prescriber assigns the patient to a
`speci?c risk group, the disclosure is preferably tailored to
`that risk