HIV Drug Interactions and Antiretroviral (ARV) Therapeutic Drug by rub18840

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									                            HIV Drug Interactions and Antiretroviral (ARV) Therapeutic Drug 5.8
                            Monitoring (TDM) Registry: Attaining Compliance With Clinical
                            Laboratory Improvement Act (CLIA) and the Health Insurance Portability
                            and Accountability Act (HIPAA)
                             J. Slish, L. Catanzaro, L. Esch, F. Lliguicota, R. DiFrancesco, G. Morse
                            Laboratory for Antiviral Research School of Pharmacy and Pharmaceutical Sciences, University at Buffalo,
                            The State University of New York




                       Abstract                                                             Methods                                    HIV Drug Interactions                                  Concentrations versus                                                                     Drug Interactions and
HIV Drug Interactions and Antiretroviral (ARV) Therapeutic Drug                                                                        and Antiretroviral TDM                                     Antiretroviral                                                                          TDM Data Report
Monitoring (TDM) Registry: Attaining Compliance With Clinical                     HIPAA Mandated Exclusion
Laboratory Improvement Act (CLIA) and the Health Insurance
Portability and Accountability Act (HIPAA).                                              Identifiers                                         Registry                                                                                                                                           Form
J. Slish, L. Catanzaro, L. Esch, F. Lliguicota, R. DiFrancesco, G.
Morse. Laboratory for Antiviral Research, University at Buffalo (UB)
                                                                                                                                          Site Registers on HIV
School of Pharmacy and Pharmaceutical Sciences, New York, USA.            • Names                 •   Certificate/license number            Pharmacotherapy
Key Words: Therapeutic Drug Monitoring, Antiretrovirals, Drug             • Geographic info (city,•   VIN and Serial number                     Network
Interactions, CLIA, and HIPAA                                               state, zip)           •   License plate number
                                                                                                                                          (www.hiv.buffalo.edu)
                                                                          • Elements of dates •       Device identifiers
Background: The HIV Drug Interactions and TDM Registry is a
clinical research initiative designed to examine adherence, drug                                  •   Web URLs
interactions and antiretroviral (ARV) plasma concentrations in H  IV-     • Telephone number •        IP address number
infected subjects. The Clinical Laboratory Improvement Act (CLIA )        • Fax number                                                    Site obtains informed
                                                                                                  •   Biometric identifiers
and Health Insurance Portability and Accountability Act (HIPAA)
mandate that such operations follow a standard set of guidelines.         • E-mail address        •   Full face photo image               consent and registers
                                                                          • Social Security       •   Comparable photo images                    subject
Methods: The UB Laboratory for Antiviral Research (UBLAR) has
developed a laboratory program to measure and report ARV                    number                •   Unique identifying number
concentrations that is compliant with CLIA regulations. The validation
of the method was executed in accordance with the FDA Guidance for        • Medical record                                                 Lab sends kit to site,
Chromatographic Methods (2001). UBLAR also established a secure ,                                                                                                        Later goal
database -driven Internet application to provide users a mechanism for    • Prescription number                                           site returns sample for
data collection and allow submission of plasma samples while              • Health plan                                                            assay
maintaining HIPAA compliance. Specimens and the associated data
collected do not contain any of the 18 patient identifiers mentioned in     beneficiary number                                                                            Pharmaco -
the HIPAA regulations. Specimens are uniquely identified by a             • Account number                                                                                 genetics
combination of a random, confidential clinician code and a sample
accession number. To comply with HIPAA regulations and ensure                                                                                                            Viral genetics
patient confidentiality and data protection, UBLAR has implemented                                                                         Lab provides assay
policies and procedures that will reduce the probability of data
corruption on both personal and networked computer systems. A                                                                            result and interpretation
retrospective analysis of the initial 2 2 0 subjects was performed to                                                                          of PK result
assess the site registration, data entry and lab results components
                          -1
between 2-11 -99 and 10 -2002. Samples were collected at trough
or at designated times post-dosing.
                                                                                 HIPAA Compliant
Results: From 220 subjects (158 male, 50 female, and 12 unknown),                                                                             Database for
302 plasma samples and 10 cerebral spinal fluid samples were
submitted for analysis by 11 sites. Subject demographics (%) were                     Form                                                 Population Analyses
Caucasian (42), African American (30), Hispanic (8), Asian (1), Native
American (2) and other (18).          Median plasma concentrations
(mcg/mL) are as follows: amprenavir 1.83, efavirenz 3.29, indinavir        • Specimens and the associated data collected
3.19, lopinavir 1.48, nelfinavir 2.01, saquinavir 0.638, and ritonavir       do not contain any of the 18 patient identifiers
0.192 (ritonavir boosting regimens only). Laboratory inspections             mentioned in the HIPAA regulations.
conducted in November 2002 have yielded a two -year certification
period.
                                                                           • Specimens are uniquely identified by a
Conclusion: The Registry has been successfully implemented and
the site registration, data entry and ARV assay mechanism are well           combination of a random, confidential clinician                   CLIA Methods                                   Individual Antiretroviral
integrated. CLIA and HIPAA compliance have been achieved.                    code and a sample accession number.
Improvements in database and software design have been made to
safeguard the integrity of the data.                                                                                                                                                                  Results
                                                                                                                                   • All laboratory operations are conducted in
                                                                                                                                     accordance with the Clinical Laboratory
                                                                                                                                     Improvement Act (CLIA) requirements as                     Antiretrovirals (n)            Concentration Range              Median Concentration
                                                                                                                                                                                                                                     mcg/mL                          mcg/mL
                                                                                                                                     applied to the Therapeutic Drug Monitoring                                                     (n<LOQ)

                                                                                                                                     sections.

                    Objectives                                                                                                     • As such, procedures, processes and actions
                                                                                                                                     within the laboratory must be executed with
                                                                                                                                                                                                    APV (64)                     0.073 -13.13   (5)                    1.83



                                                                                                                                     the following components in place:
  • Establish a confidential website for site                                                                                                                                                       EFV (53)                     0.157 -13.00   (4)                    3.29

    registration.                                                                                                                  •   Proficiency Testing     • Calibration and
  • Develop a CLIA-compliant assay and a                                                                                               Program                   Control
    HIPAA-compliant registration mechanism                                                                                         •   Procedures for            Procedures                          IDV (56)                    0.061 -16.15   (3)                    3.19


  • Implement a limited-center pilot program to                                                                                        Specimen                • Remedial Action                                                                                                                     Summary
    test outcomes of the TDM process.                                                                                                  Submission and            Policies
  • Develop a reporting process so that sites                               Drug Interactions and                                      Handling                • Required                           LPV (76)                     0.111 -12.06   (24)                   1.48
                                                                                                                                                                                                                                                                                       • CLIA and HIPAA compliance have been
    receive TDM results with a limited                                                                                             •   Procedures for All        Personnel                                                                                                               achieved for the confidential website
    pharmacologic assessment.                                             TDM Data Collection Form                                     Records and Test          Qualifications                                                                                                          registry.
                                                                                                                                       Reports                 • Documented                         NFV (19)                     0.344 -7.32 (2)                       2.01
  • Standardize an approach to collect
    adherence and concurrent medications                                                                                           •   Test Requisition          Personnel                                                                                                             • Currently, twenty-six sites have registered
    information.                                                                                                                       Requirements              Responsibilities                                                                                                        to participate.
                                                                                                                                                                                                   RTV (114)                     0.117 -7.54 (47*)                    0.192*
                                                                                                                                   •   Test Method/            • Patient Test
                                                                                                                                       Equipment/                Management                                                                                                            • Antiretroviral plasma concentrations were
                                                                                                                                       Instrumentation/          Procedures                                                                                                              measured for PIs and efavirenz.
                                                                                                                                                                                                     SQV (3)                     0.140 -4.37 (0)                      0.638
                                                                                                                                       Reagents/ Materials     • Comparison of
                                                                                                                                       Standard Operating        Test Results to                                                                                                       • Some early patients had TDM
                                                                                                                                       Procedures                Reference                                                                                                               concentrations below assay detection
                   Background:                                                                                                     •   Quality Control and       Methods
                                                                                                                                                                                               Total Assays reported
                                                                                                                                                                                                      (385)
                                                                                                                                                                                                                           * ritonavir boosting regimens only
                                                                                                                                                                                                                                                                                         indicating the need to intensify adherence
                                                                                                                                       Policy                                                                                                                                            interventions.
 The HIV Drug Interactions and TDM Registry is a                                                                                                               • Personnel
 clinical research initiative designed to examine                                                                                  •   Procedure Manual          Assessment
 adherence, drug interactions and antiretroviral                                                                                   •   Performance               Program
                                                                                                                                                                                              Summary of samples collected over prescribed dosing
 (ARV) plasma concentrations in HIV-infected                                                                                           Specifications,         • Communications               intervals
 subjects. The Registry goals and objectives                                                                                           Equipment                 and Complaint
 were presented at the 3rd International Workshop                                                                                      Maintenance, and          Investigation
 on Clinical Pharmacology of HIV Therapy. This                                                                                         Function Checks           Procedures
 presentation further defines the details required
 to make the Registry operational within
 regulatory realms. The UBLAR has established                                                                                                                Results Patient Demographics
 the HIV Pharmacotherapy Network Website
 (www.hiv.buffalo.edu) as a means of fostering a
 multicenter exchange of information and the                                                                                                           Race      Caucasian
                                                                                                                                                                              African
                                                                                                                                                                                      Hispanic Asian
                                                                                                                                                                                                      Native
                                                                                                                                                                                                              Unreported                                                                          Conclusions
                                                                                                                                                                             American                American
 performance of clinical research.
                                                                                                                                                                                                                                                                                       • The Registry has been successfully
                                                                                                                                                     Percent
 The Clinical Laboratory Improvement Act (CLIA)                                                                                                                     42          30        8         1                  2                  17                                             implemented and the site registration, data
                                                                                                                                                       (%)
 and Health Insurance Portability and                                                                                                                                                                                                                                                    entry and antiretroviral assay mechanisms
 Accountability Act (HIPAA) mandate that such                                                                                                                                                                                                                                            are well integrated.
                                                                                                                                                     Percent
 operations follow a standard set of guidelines.                                                                                                                    33          20        6         1                  2                  12
                                                                                                                                                      Male
                                                                                                                                                                                                                                                                                       • Improvements in database and software
 The CLIA standards promote good laboratory                                                                                                                                                                                                                                              design have been made to safeguard the
 practices and assure reliable laboratory results                                                                                                    Percent                                                                                                                             integrity of the data.
                                                                                                                                                                     9          10        2         0                  0                    5
 and documentation/records. Regulations under                                                                                                        Female
                                                                                                                                                                                                                                                                                       • Additional adherence interventions have
 these guidelines define requirements for
 personnel, procedures, and policies. A                                                                                                                                                                                                                                                  been incorporated prior to TDM sampling
                                                                                                                                                                                                                                                                                         to avoid measuring undetectable
 laboratory performing assays and reporting                                                                                                                                                                                                                                              specimens.
 results, which are used to treat, diagnose, or
 manage a patient’s care, require certification by
 CLIA.
                                                                                                                                               Drug Interactions And TDM Data Report Form                                                                                              • A network of clinical sites is evolving that
                                                                                                                                                                                                                                                                                         will provide a larger patient database to
                                                                                                                                                                                                                                                                                         facilitate population modeling.
 HIPAA standards are designed to ensure the
 privacy of individually identifiable health                                                                                                  •   To comply with HIPAA regulations and ensure patient confidential ity and data protection,
                                                                                                                                                                                                                                                                                       • The registry has been utilized to apply for
 information by establishing conditions for its use                                                                                               UBLAR has implemented policies and procedures that will reduce the probability of data
                                                                                                                                                                                                                                                                                         additional funding to support expanded
 and disclosure by a health plan, healthcare                                                                                                                 corruption on both personal and networked computer systems.                                                                 research involving drug interactions and
 clearinghouse, and certain healthcare providers.                                                                                                                                                                                                                                        TDM of antiretrovirals.
 Eighteen identifiers have been named which
 must be excluded from transfer of data outside
 protected source documentation.

								
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