Transcription
California Department of JusticeCURESPrescription Drug Monitoring ProgramFebruary, 2013CCSF DEFENDANTv. Purdue Pharma,EXHIBITet al. 3:18-CV-7591WAG-MDL-03277WAG-MDL-03277Admitted: 06/07/2022WAG-MDL-03277.00001
pdmpCURESThe mission of the California PrescriptionDrug Monitoring Program (PDMP) is toeliminate pharmaceutical drug diversion inthe state while promoting legitimate medicalpractice and quality patient care.211.WAG-MDL-03277.00002
pdmpCURESControlled Substance UtilizationReview and Evaluation System211.WAG-MDL-03277.00003
pdmpCURES1939The California Triplicate Prescription Program (TPP) was created in1939, capturing Schedule II prescription information.1997CURES was initiated, operating in parallel with the TPP’s AutomatedTriplicate Prescription System (ATPS) to evaluate the comparativeefficiencies between the two systems.1999CURES replaced the TPP/ATPS and began capturing Schedules IIthrough IV prescription information.2005TPP/ATPS decommissioned after Senate Bill (SB) 151 eliminated the triplicateprescription requirement for Schedule II controlled substances, making CURESpermanent.2009PDMP introduced as a searchable, client-facingcomponent of CURES.211.WAG-MDL-03277.00004
pdmpCURESRelevant Provisions of LawHealth Insurance Portability and Accountability Act (HIPAA)& Attendant Regulations42 U.S.C. §§ 1320d to 1320d-8, and 45 CFR 164, et seq.California Confidentiality of Medical Information ActCA Civil Code §§ 56 to 56.16California Information Practices ActCA Civil Code § 1798, et seq.CURES LegislationCA Health and Safety Code § 11165, et seq.211.WAG-MDL-03277.00005
pdmpCURESStatutory AuthorityCalifornia Health and Safety Code Section § 11165.1 (a) (1)A licensed health care practitioner eligible to prescribe Schedules IIthrough IV controlled substances or a pharmacist may provide a notarizedapplication . . . to access information stored on the Internet regarding thecontrolled substance history of a patient maintained within the Departmentof Justice, and the Department may release to that practitioner orpharmacist, the electronic history of controlled substances dispensed to anindividual under his or her care based on data contained in the CURESPrescription Drug Monitoring Program.211.WAG-MDL-03277.00006
pdmpCURESStatutory AuthorityCalifornia Health and Safety Code Section § 11165 (a)To assist law enforcement and regulatory agencies in their effortsto control the diversion and resultant abuse of Schedule II, ScheduleIII, and Schedule IV controlled substances the Department of Justiceshall maintain the Controlled Substance Utilization Review andEvaluation System (CURES) for the electronic monitoring of, andInternet access to information regarding, the prescribing anddispensing of Schedule II, Schedule III, and Schedule IV controlledsubstances by all practitioners authorized to prescribe or dispensethese controlled substances.211.WAG-MDL-03277.00007
pdmpCURESStatutory AuthorityCalifornia Health and Safety Code Section § 11165 (d)For each prescription for a Schedule II, Schedule III, or Schedule IVcontrolled substance, as defined in the controlled substances schedulesin federal law and regulations, specifically Sections 1308.12, 1308.13,and 1308.14, respectively, of Title 21 of the Code of FederalRegulations, the dispensing pharmacy or clinic shall provide the . . .information to the Department of Justice on a weekly basis and in aformat specified by the Department of Justice: . . .211.WAG-MDL-03277.00008
pdmpCURESStatutory AuthorityCalifornia Health and Safety Code Section § 11165 (c)CURES shall operate under existing provisions of law to safeguard the privacy andconfidentiality of patients. Data obtained from CURES shall only be provided toappropriate state, local, and federal persons or public agencies for disciplinary,civil, or criminal purposes and to other agencies or entities, as determined by theDepartment of Justice, for the purpose of educating practitioners and others inlieu of disciplinary, civil, or criminal actions.211.WAG-MDL-03277.00009
pdmpCURESStatutory AuthorityCalifornia Health and Safety Code Section § 11165 (c) [Continued]Data may be provided to public or private entities, as approved by the Departmentof Justice, for educational, peer review, statistical, or research purposes, providedthat patient information, including any information that may identify the patient,is not compromised. Further, data disclosed to any individual or agency asdescribed in this subdivision shall not be disclosed, sold, or transferred to any thirdparty.211.WAG-MDL-03277.00010
pdmpCURESCurrent System CURES stores and reports Schedule II, III and IVprescription dispensation data reported by dispensers to DOJ. Pharmacists are required to report dispensations of Schedules IIthrough IV controlled substances at least weekly. In order to reflect exactly what dispensers report to DOJ, thedepartment does not touch or modify dispenser-reported data. Presently, the database contains over 100 million entries ofcontrolled substance drugs that have been dispensed in California.211.WAG-MDL-03277.00011
pdmpCURESCurrent System Use of the PDMP by prescribers and dispensers for prescriptionabuse prevention/intervention is voluntarily. In FY 11/12, the program responded to 1,063,952 requests. Provides registered prescribers and dispensers with 12-monthPatient Activity Reports (PAR). CURES/PDMP information can assist health practitioners identify,intervene, and deter abuse and diversion of Schedule II through IVcontrolled substances.211.WAG-MDL-03277.00012
PDMP Training & Technical Assistance CenterpdmpCURESStatus of Prescription Drug Monitoring Programs (PDMPs)* To view PDMP Contact information, hover the mousepointer over the state DC1MDNC759OK—- {7 TNARVAK/MSALGATXFL Operational PDMPsapU Enacted PDMP legislation, butprogram not yet operationalLegislation PendingResearch 5 current 36 or April 10. 2013WAG-MDL-03277.00013
PDMP Training & Technical Assistance CenterpdmpCURESPrescription Drug Monitoring Program (PDMP) Agency TypesVTMEWAitMTORIDNHMARICTCPWYPA-------- NJDEOHNVUT. CAX7AKAZCO1NM[wlwdygte I1 TX ailhegKSVADCKYMDNCFLJ Pharmacy Board / Licensing Agency Health I Human Services / Substance AbuseU Law EnforcementCurentasofApril 4. 2013WAG-MDL-03277.00014
pdmpCURESDentistsMedical PhysiciansOptometristsOsteopathic PhysiciansPhysician AssistantsPodiatristsRegistered NurseMidwives (Furnishing)Registered NursePractitioners 174,33838,293212,631PDMP Registrants(as of 8/13/13)17,508211.WAG-MDL-03277.00015
pdmpCURES8.23%211.WAG-MDL-03277.00016
pdmpCURESPage 1 a 3NEJM2)wNEW ENGLANDJOURNAL cf MEDICINEThePerspectiveMedication Reconciliation for Controlled Substances — An "Idcal"Prescription-Drug Monitoring Program.1 1 RluelD. vu Lesis kyecn, M LN F-il .1 Pen sr 1 A »3 1-701: Are 21.29*2504 w T03"NVLIMp12M1 *Thallrced States sir the iestofanepdencofmieuseofpreeermton ovoce ad re-ated ceatha. Eetvee1 1997 2CD7Leuse Speseplinnpsiuidsmpemhar quzznipnd.l and t has remma rJnar that tha isk ofaonia rurlon is corvalsted wththe quanut, : dieae 3rups be 1g preecnbed.3 Trie i cerallcalior o' osuid prescribng cas ce alzibizled to a leigitened fucaisenpan mranapamsnt, refactad in sich developnents ss E Jo *t Comnal mrardate Um pen be saseased s6 5 Alsi V reuse of pan szores x nessuie parinr: sabsinci 1, and an cxtoition of re irgicatiorstor I0g-19Tr opizid treatnent to ircludchroiic vor-carcar-related Min lr tks new model, phgsielaeg dentals, and furse prac. ibnets — rathei Ili2"1 duusy cuilels anJsreeideslers — pay cromnerironE 11 esoslaung anua J8E. Paredosice ». there are EIMU:eneDJe preaaurea :o Ircrease oplsdpiescibirg fax ‘leberefit sfin: Aul sabierisand: rodicolt"prthosskeof cubie heahb.As health care provids sttnistnto balance Ueae mand.s. we H Je. aJscuale f: muIE Mon’ese gresuib 1g5 ius 1953, faderal cgsltknhzs supzorme the fomation of se:5-hased preccrpdior-drag Tonkpring progrems(PDMPzi :back rreserizing o: conirolle- slb*lances La tie pie Interiet ru, zuet sogam: had miled effects. avirg : dhe lag r mpimerent in epaitina with peper secumen:s:on, the abzence cf oft-hours acoese 10 the prograns. and the vols-Lare na. re orimpnrfirg. Nya rinan proz-ams. arn hannfiting frret manrwed inamst ard nupasad fuinding 42 stetescirrenty have operscinnaPDMPe, ard 6 hae* eacled legiskslinn In iderveln:: anrgrairs *The Vu-ite I cus Cfier of Na coil Drug Gortro Polizs. he Conters for D scaso Covrol ard Pre-antion ad re Food and Dr JQAirrinalration siggeel Lval acle-bassed PDAAPs aloud ba exzanded." Y l mary elir.dare. are unnxare nftear pregurm andtho Jseemog ztatas ad spedisi: es 5 Reesarer exa ninirg tre erect ol trots mor t Ing sgalarie 18s bben liinile-d sy# vur atanu ard cals cn af seie PDu P dnzigris An statce norcloc, «« or ctoe tho r PPMAPs, 7 in worthc le teanalyze Lne ourranl . king fegarding ilve ieelulnezs arid sierzedul churseleietizs cithe oxefing progrars na as tz enbandaIha impeet (se tebk).unreel evalator e* a new pa: ent wth ahorc peincan be diffcu’. withoJt a tomtrelensive painnatagerrent rozord. Altioigh rey nn solay 0 tre patets ris:or is qverlly accaptatle and wellir enuun ed, i. ras leud xcnge1D)." inisprescrih 1g Firthatror. prinary car providre wto enbracemha rendeato tespelents erunc pain Ble Tsxedw.I yuidliressugyesliny . jze ufpali iprevirkr agromans (pir sorttacts"tand ur iedrag scwring. Some chesicars meyfaCraractersics afanIleral -! 9 Flwipr.gsbrOfunzuoell"DNl‘ resdilyslere it users Icegns alabenari drag-abcurereit behievar.A uerehtloinliririanz ard patinnts is the opportur te intervere irrmecately aen sberant betew* w hrat ected end while-ih peter 13 inIheirizdiczslreltrig. In ad: lien, a PDAAmayidnetfynmient, whoserpervng epings and ar alrun ** complicaliove hemn cvlypl ainacy.Web-xake PDIMPs sst rraris of the vupknisthat l ni)d ear er. fax-bsred srstms, out1he, also raise rew sentemz. tn erecand sJrvey or orescricere, reszoroeris cted cariers to use or FCMPs thal inclixlr:2 "lime and "acx: issuns’ Ixit netzorrputer avsilab ite 1569 gmot). r’otecl ** 50389, a ample log-or.whh iser-apsofed psazworda viewTyne PrinlviowClass P-inl1e-,Ad3:1/2013WAG-MDL-03277.00017
pdmpCURESDrs. Perrone and Nelson noted barriers to today’sPDMPs include: Time and access issues. Complicated application and notarization procedures Prescribers will have to be educated about PDMPs ifvoluntary compliance is to be improved and routineuse encouraged.211.WAG-MDL-03277.00018
pdmpCURESCURES Outreach CURES staff can assist prescribers anddispensers with the registration process bypersonally accepting applications directly fromindividual prescribers and dispensers in lieu ofthe notarization requirement for groups of 20. CURES staff can also provide CURESinformational presentations and answerquestions concerning the CURES program.211.WAG-MDL-03277.00019
pdmpCURESRegistration ProcessThe registration process is initiated electronically via a web-based application form.HTTP://OAG.CA.GOV/CURES-PDMPState of California Department of JusticeKamala D. HarrisOffice of the Attorney GeneralAttorney GeneralAG Home PagePDMP ApplicationTools & ResourcesBNE LocationsGuidelines to CombatingRx Drug Abuse & FraudHealth Information Privacy(HIPAA Guidelines)FAQ'sRegisterForgot PasswordLoginPDMP RegistrationCalifornia Prescription Drug Monitoring Program (PDMP)The California Prescription Drug Monitoring Program (PDMP). CURES, is committed toassisting in the reduction of pharmaceutical drug diversion without affecting legitimatemedical practice and patient care.The CURES system is designed to identify and deter drug abuse and diversion throughaccurate and rapid tracking of Schedule li through IV controlled substances. It is a valuableinvestigative, preventive and educational tool for law enforcement, regulatory boards,educational researchers, and the healthcare community.The Department of Justice PDMP system allows pre-registered users including licensedhealthcare prescribers, pharmacists authorized to dispense controlled substances, lawenforcement, and regulatory boards to access real time patient prescription historyinformation to better identify and prevent the abuse of prescription drugs. The role of thePDMP entrusts that-well informed prescribers and pharmacists can and will use theirprofessional expertise to evaluate their patients care and assist-those patients who may beabusing controlled substances.In order to obtain access to the PDMP System you must submit a registration formelectronically. Please be sure to complete the correct form: BNE.Admin BNE Analyst DOJ InvestigatorLaw Enforcement AgencyNon-BNE SupportPharmacistPractitionerRegulatory BoardIn addition, prescribers and pharmacists must follow up their registration by submittingnotarized copies.of their Government ID, Drug Enforcement Administration (DEA)Registration, and State Medical License or State Pharmacist License to the Bureau ofNarcotic Enforcement (BNE). P.O. Box 160447, Sacramento, CA 95816, or forgo the notaryand present documents in person at any one of our regional office locations and our BNEpersonnel will validate and collect your supporting documentation.HelpVersion 1.0.0.9Select the appropriate registrationform according to profession:BNE AdminBNE AnalystDOJ InvestigatorLaw Enforcement AgencyNon-BNE SupportPharmacistPractitioner6Regulatory Boardce(1NOTE: You must call the regional office ahead of‘time and make an appointment prior tohaving your documents validated by BNE personnel.WAG-MDL-03277.00020
pdmpCURESRegistration (Continued)(eaState of California Department of JusticeOffice of the Attorney GeneralAG Home PagePDMP ApplicationKamala D. HarrisAAttorney GeneralForgot PasswordRegisterLoginHelpVersion 1.0.0.9PDMP Registration: PractitionerrAccount InformationApplication Instructions —Would you like to receive Notifications/Alerts?: *To submit this application, complete the following steps:ONo OYesStep 1: Complete the on-line application form then click the 'Submit' button.Must create your own Individual answers and not answers that areStep 2: Upon successful submission of this form, you will see a confirmationagency sanctionedpage with additional instructions for completing the registration process.Question *Important NotesAnswer *I In what city or town was your first job?Indicates Required Fields[ in what city or town was your first job?Question *For assistance, contact the Help Desk at (916) 319-9274 orpmp registration@doj.ca.govQuestion *AnswerIn what city or town was your first job?Last Name ‘First Name ‘Date of Birth mm/dd/yyyyE-Mail Address *Re-Enter E-mail Address *Contact Phone *State Medical Licensei *NPI#re9Other DegreeDegree *Answer ‘Question ‘[ in what city or town was your first job?Application ValidationOther Specialty( — Select One —Answer *[ In what city or town was your first job?Applicant Information:Specialty *Answer ‘Question ‘Your E-Mail Address will be used for communicating account information andsystem notifications. It is therefore very important that this be an E-Mail Addressthat only you have access to and is not accessible by others. If this condition isnot met your registration will be denied.JeanType the two words:1 — Select One —VI C FtaaSBama.Re CAPTCHAAddress InformationThe CAPTCHA feature requires that youenter both words exactly as they appear,separated by a space. If you cannot readboth words simply click the refreshbutton, which looks like two arrows In acircle, next to the CAPTCHA words andyou will be prompted with two new words.Application CertificationFirst AddressBusiness NameStreet Address *Phone#*City *County *State * Zip *DEA# *User AgreementsThe California Prescription Drug Monitoring Program (PDMP), CURES, is0committed to assisting in the reduction of pharmaceutical drug diversionwithout affecting legitimate medical practice and patient care. The CURESasystem is designed to identify and deter drug abuse and diversion through accurate and rapid tracking of Schedule II through IV controlled substances. ,Please check all options that apply to this location * Business Location Home Location Listed on DEA CertificateI certify the facts stated above are true to the best of my knowledge.I accept the terms and conditions of the User Agreements. I CERTIFY/AGREE TO THE ABOVE *For assistance, contact the Help Desk at (916) 319-9274 orpmp 7.00021
pdmpCURESRegistration (Continued)ADDITIONAL REGISTRATION PROCESS STEPS:Print registration confirmation and have notarized.Respond to e-mail verification request.Mail notarized application & required supporting documentsto CA DOJ.Required Documentation:Notarized applicationCopy of government-issued identificationCopy of Medical License (Pharmacy or Regulatory License)Copy of Drug Enforcement Administration RegistrationApproval NotificationC 8WAG-MDL-03277.00022
pdmpCURESPatient Activity Report (PAR)https://pmp.doj.ca.gov/pdmp/index.doState of California Department of JusticeKamala D. Harris&Office of the Attorney GeneralAttorney GeneralAG Home PagePDMP Home PageTools & ResourcesPatient Activity ReportChange PasswordWelcome to the PDMP ApplicationHELP Prescribing and dispensinghistory of Schedule II-IVcontrolled substances. Registered prescribers anddispensers can quickly reviewa patient’s controlledsubstance history. Enables a prescriber toidentify and prevent drugabuse through accurate &rapid tracking.LogoutLogged in.BNE LocationsGuidelines to CombatingRx Drug Abuse & FraudHealth Information Privacy(HIPAA Guidelines)FAQ’s—CURESThe California Prescription Drug Monitoring Program, CURES, is committed to assisting in thereduction of pharmaceutical drug diversion without affecting legitimate medical practice andpatient care. The CURES program, restructured in 2003 and evolved from the CaliforniaTriplicate Prescription Program following numerous legislative enactments.The CURES system is designed to identify and deter drug abuse and diversion throughaccurate and rapid tracking of Schedule II through IV controlled substances. It is a valuableinvestigative, preventive and educational tool for law enforcement, regulatory boards,educational researchers, and the healthcare community.The Prescription Drug Monitoring Program system allows pre-registered users includinglicensed healthcare prescribers and pharmacists authorized to dispense controlled substances,law enforcement, and regulatory boards to access real time patient prescription historyinformation to better identify and prevent the abuse of prescription drugs. The role of thePrescription Drug Monitoring Program entrusts that well informed prescribers and pharmacistscan and will use their professional expertise to evaluate their patients care and assist thosepatients who may be abusing controlled substances.Dissemination or distribution of this information to anyone other than the registered user isstrictly prohibited. Disciplinary, civil or criminal actions will be taken by the Department of Justiceand/or appropriate Regulatory Board.-Notifications & AlertsDateNotification07-26-2010CURES ALERT 00907-26-2010CURES ALERT 01007-26-2010CURES ALERT 01107-26-2010CURES ALERT 01207-26-2010CURES ALERT 013e.WAG-MDL-03277.00023
pdmpCURESPatient Activity Report (PAR)AaotyaState of California Department o/JusticeOffice of the Attorney GeneralAG Home PagePDMP Home PageTools & ResourcesKamala D. HarrisAttorney GeneraleoanuseePatient Activity ReportChange PasswordHELPLogoutLogged in, My Dr.Patient/Client Activity Report* Indicates Required FieldsPatient Activity ReportTheft or Loss of Prescriptio isFAQ'sClientFirst Name*Last Name*Date of Birth*mm/dd/yyyyGender (AddressCityZip StatePeriod in Months* [3#Search ModeSearch Mode Partial match Exact match*1 I certify, under the penalty of perjury, that I am a licenced healthcareprovider and I am authorized to obtain the above mentioned patient'sdispensed controlled substance history.(Search) (Reset)WAG-MDL-03277.00024
pdmpCURESiePatient Activity Report (PAR)Patient Activity ReportChange PasswordHELPPatient/Client Activity ReportRevise SearchSearch Results 1Last NameMiddle InitialsFirst NameDOB BODROB09-07-1961)rBODROB09-07-196 ) BODROB09-07-196 9Generate ReportAddress2119 TAMIE LN.SAN JOSE . CA. 951302119 TAMIE LANESAN JOSE , CA. 951302119 TAMIE LNSAN JOSE , CA. 95120!eset adSave CommentsView/Print ReportView/Print Consolidated ReportResetA,WAG-MDL-03277.00025
pdmpCURESPatient Activity Report (PAR)01/17/2013 11:19Department of Justice - Bureau of Narcotic EnforcementControlled Substance Utilization Review & Evaluation SystemCONFIDENTIALDOCUMENTPATIENT/CLIENT ACTIVITY: CONSOLIDATED REPORTPrescription Drug Transaction Details:Number of Hits: 9Date Filled First Name Last Name 01/01/2013JOHNOOE05/23/1960End Date: 01/17/2013Start Date: 01/17/2012AddressDrug NameForm Str2560 COLLEGE WAY.SACRAMENTO, CA95821VICODINTAB2560 COLLEGE WAY.SACRAMENTO, CA958212560 COLLEGE WAY.SACRAMENTO, CA95821APAP/HYDROCODONEBITART RATETABXANAXTAB2560 COLLEGE WAY.SACRAMENTO, CA95821VICODIN2560 COLLEGE WAY.SACRAMENTO, CA958212660 COLLEGE WAY.SACRAMENTO, CAAPAP/HYDROCODONEBITART RATE2560 COLLEGE WAY.SACRAMENTO, CA958212560 COLLEGE WAY.SACRAMENTO, CA958212560 COLLEGE WAY,SACRAMENTO, 5MG500MG-5MGAPAP/HYDROCODONEBITART RATE500MG-5APAP/HYDROCODONEBITART RATETABVICODINTAB500MG-5MG1000MG-5MGQty PHY Name104060609030WALGREENS#610CVS/PHARMACYPHY#Dr.'S DEA # Dr.’s Name RX#PHY12345AB5678909PHY 12345 AB5678909WAL-MART#926PHY12345 AB5678909TARGET#261PHY 12345 AB5678909WALGREENS#100PHY 12345 34SMITH, JOHNSMITH, JOHNSMITH, JOHNSMITH, H, JOHN04247940 4PHY 12345 AB567B909SMITH, JOHN02434960PHY 12345 AB5678909SMITH, JOHN02795765SMITH, JOHN025496072SMITH, JOHN026496033PHY 12345 AB5678909PHY 12345 AB5678909Disclaimer: The Patient Activity Report (PAR) is compiled from information maintained in the Department of Justice’s Controlled Substance Utilization Review and Evaluation System (CURES) The CURES maintainsSchedule II, Schedule III and Schedule IV prescription information that is received from California Pharmacies and is therefore only as accurate as the information provided by the Pharmacies. If data was submitted witherrors or have unknowns within a field, it will not be displayed within this report.01/17/2013 11:19 PSTPage 1WAG-MDL-03277.00026
pdmpCURESPatient Activity Report (PAR)REPORT INFORMATION Date prescription wasfilled Prescription number Drug namePrescriber name/DEAnumber Drug quantity andstrengthPharmacyname/pharmacy licensenumber Number of refillsremaining Patient name Patient date of birth Patient address 211.WAG-MDL-03277.00027
pdmpCURESCURES Program ContactsCalifornia Department of JusticePDMP/CURESP.O. Box 160447Sacramento, California 95816Phone: (916) 227-3843FAX: (916) 227-4589Email: MDL-03277.00028
pdmpCURESQUESTIONS?Thank You!211.WAG-MDL-03277.00029
CURES Prescription Drug Monitoring Program February, 2013 WAG-MDL-03277 WAG-MDL-03277.00001 CCSF v. Purdue Pharma, et al. 3:18-CV-7591 Admitted: 06/07/2022 WAG-MDL-03277. 211. p CURd ES mp . CURES/PDMP information can assist health practitioners identify, intervene, and deter abuse and diversion of Schedule II through IV .
