For The Defense, October 2010 - DRI Today

D R U G A N D M E D I C A L D E V I C Etry. Verification of an Onsolis prescriptionfrom a registered provider is required andchecked against a database, and the drugis delivered to a patient via courier onlyafter the patient participates in a telephoniccounseling session. See Questions andAnswers About Onsolis (fentanyl buccalsoluble film) (July 16, 2009), http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInfoConsider the undeniablevalue of a plaintiff’s signedacknowledgement of adrug’s risks in front ofa jury or in support ofa dispositive motion.rmationforPatientsandProviders/ucm172039.htm;see also Ned Milenkovich, FDA- MandatedREMS Now In Force In PharmaceuticalIndustry, Drug Topics, Oct. 8, 2009.As a practical matter, a drug’s REMSmay have a two-edged blade. Requiringspecialized training, certification, or participationin registry programs may detersome physicians from prescribing medicationsthat would otherwise significantlybenefit certain patients. On the other hand,consider the undeniable value of a plaintiff’ssigned acknowledgement of a drug’srisks in front of a jury or in support of a dispositivemotion. Moreover, a physician whoparticipated in special training or held acertification would likely provide valuabletestimony concerning his or her awarenessof a drug’s risk profile, the compelling reasonsfor prescribing it to a plaintiff, and thecounseling that a patient received aboutthe drug’s risks consistent with obtaininginformed consent.Consumer Medication InformationConsumer medication information, sometimesabbreviated “CMI,” is another potentialconsumer source of risk and warningsinformation. As with a medication guide,consumer medication information is typicallyprovided to a consumer attached42 n For The Defense n October 2010to the bag containing a new prescription.Consumer medication information is usuallyprepared by an outside vendor ratherthan a pharmacy or a drug’s manufacturer.Although it is typically based on the FDAapprovedlabeling, consumer medicationinformation is not approved or regulatedby the FDA.In 1996, Congress enacted EffectiveMedication Guides, Public Law 104-180,Title VI, Sec. 601, 110 Stat. 1593 (1996).Public Law 104-180 established a series ofstaggered benchmarks for patients so thatthey would receive “useful written patientinformation” with their prescriptions: 75percent were to receive this useful informationby 2000 and 95 percent by 2006.The statute took the additional and unusualstep of prohibiting the FDA from regulatingthe format and content of consumermedication information while a committeeconsisting of consumer organizations,pharmaceutical manufacturers, health careprofessionals, consumer medical informationdevelopers, and others developed recommendations.The committee issued areport in 1996, “Action Plan for the Provisionof Useful Prescription Medicine Information,”delineating criteria for consumermedical information to meet the law’sgoals. Studies conducted by the NationalAssociation of Boards of Pharmacy evaluatedprogress toward the target goals. Thestudies released in 2002 found that whileconsumer medication information generallyreached the target proportion of theconsuming public, the “usefulness” of thatinformation lagged. In 2006, the FDA wasasked to take a more active role in meetingthe law’s objectives. Consequently, in July2006, the FDA published a guidance, “UsefulWritten Consumer Medication Information(CMI),” which is available at theFDA’s website. Ctr. for Drug Evaluation andResearch, U.S. Food & Drug Admin., http://w w w.fda.gov /downloads / Drugs / GuidanceComplianceRegulatoryInformation/ Guidances/ucm080602.pdf.The guidance considers written informationaccompanying a prescription “useful”when it reflects the components andformatting elements of the 1996 actionplan and its content is consistent with themost recent version of the manufacturer’slabeling. Specifically, “useful” consumermedication information should be scientificallyaccurate, unbiased, specific, comprehensive,understandable to consumers,and current.A follow- up study released in 2008 foundthat 94 percent of consumers received consumermedication information with newprescriptions, but only 75 percent of theCMI “met the minimum criteria for usefulness.”Thus, while these results fall shortof the 2006 target, the study did showthat the vast majority of consumers doreceive useful written information withtheir prescriptions.For your discovery planning, note thatmany retail pharmacies can reproduce theparticular consumer medication informationor medication guide that accompanieda particular prescription at a particulartime. Consider serving discovery to thevendor that produced a pharmacy’s consumermedication information if necessaryto obtain copies of the information that aplaintiff would have received.ConclusionToday there is an unprecedented amountof information available to a consumerregarding prescription pharmaceuticals.Not surprisingly, much of the availableinformation concerns the drug risks.Through patient package inserts, medicationguides, consumer medication information,and some of the REMS procedures,consumers are receiving user- friendly,patient- oriented information about therisks and benefits associated with prescriptionmedications. Effective marshallingand presenting the warnings that were provideddirectly to a plaintiff, perhaps manytimes, in many different forms, over manymonths or years, may make the differencein a pharmaceutical product liabilitycase. Ironically, in 2006, the AmericanPharmacy Association published PatientSafety Implications on Implementation ofthe Current FDA- Mandated MedicationGuide Program, which raised the concernsthat consumers may be overloaded with toomuch information from medication guides,patient package inserts, and consumermedical information, and that the directto-consumer information tended to placetoo much emphasis on risk. Id. at 7–11.What a wonderful problem for a defenselawyer to have.