Rational Use of Medicines in ART Programs

Document Sample
Rational Use of Medicines in ART Programs Powered By Docstoc
					Rational Use of
Medicines in ART

  Bannet Ndyanabangi
 Washington DC, Oct. 2006
            Presentation Outline
At the end of this session, trainees should be able
  Define rational medicines use (RMU)
  Explain the importance of RMU in the antiretroviral
   therapy (ART) context including:
       the importance of good dispensing practices in the context of
       Importance of adherence to successful treatment outcomes
        in ART programs
       methods and strategies to improve adherence
  Identify factors that influence use of medicines
  Discuss strategies and interventions that can improve
Rational medicines use requires that patients
receive medications appropriate to their clinical
needs, in doses that meet their own individual
requirements for an adequate period of time, and
at the lowest cost to them and their community.
                         —WHO Conference of Experts
                                      Nairobi, 1985
 What Is the Importance of RMU in the
 ART Context?
 ART is—
    Complex (a combination of many medicines)
    Lifetime treatment
    Recent and in constant development
 Irrational use of ARVs results in—
    Treatment failure
    Rapid development of resistance
    Increase of toxicity risk
    Waste of money
            The promotion of RMU in the context
                of ART is a must from Day 1
The Medicines Use Process
Aspects of Irrational Use of Medicines(1)
  Diagnosing
     Inadequate examination of client/patient
     Incomplete communication between client/patient and
     Lack of documented medical history
  Prescribing
       Underprescribing
       Incorrect prescribing
       Extravagant prescribing
       Overprescribing
       Multiple prescribing
Aspects of Irrational Use of Medicines (2)
  Dispensing
      Incorrect interpretation of the prescription
      Retrieval of wrong ingredients
      Inaccurate counting, compounding, or pouring
      Inadequate labeling
      Unsanitary procedures
  Packaging
    Poor-quality packaging materials
    Odd package size, which may require repackaging
    Unappealing package
Aspects of Irrational Use of Medicines (3)

  Client/patient adherence
      Poor labeling
      Inadequate oral instructions
      Inadequate counseling to encourage adherence
      Inadequate follow-up or support of clients/patients
      Treatments or instructions that do not consider the
       client’s/patient’s beliefs, environment, or culture
Factors Influencing Use of Medicines
                 Policy, legal, and regulatory

dispenser, and       Rational use                Client/patient
    their                                             and
                     of medicines
 workplaces                                       community

                        supply system
The Medicines Use Process
Good Dispensing Practices

Ensure that—
 An effective form of the medicine is
  delivered to the right client/patient
 In the prescribed dosage and quantity
 With clear instructions
 In a package that maintains the potency of
  the medicine
ARV Dispensing – Differences?
 A stock-out of one ARV in a regimen causes a clinically
  unjustified change in regimen.
 Timing for when medicines are taken is more important
  than for many other medicines.
 Date of collection of medicines is important; it reflects on
 Appropriate and complete record-keeping is vital.
 Regimens are more complex, so knowledge of treatment
  guidelines is more important.
 need for access to up to date information and guidelines
  due to rapidly changing science and evolving data on
  drug interactions and Adverse drug reactions (ADRs).
Dispensing in such a crowded condition is unhealthy, confusing, and
compromises privacy

                                              What’s wrong here?

     Source: Photo by Gabriel Daniel
Confidential counseling booths

                                     Booth 1   Booth 2   Booth 3

   Source: Photo by Gabriel Daniel
Booth dispensing (indoor view) ensures privacy and
               minimizes mistakes

          Booth 1                    Booth 2   Booth 3

   Source: Photo by Gabriel Daniel
ART Dispensing Tool
 Links patient information and individual ART history to stock
  movement in a facility
 Maintains records for each patient receiving ART
     Tracks patient profile and medication history
 Generates key management reports, such as Monthly Patient
  Uptake Trends and Currently Active Patients per Regimen
 Cote d’Ivoire: 1 site
 Haiti: 4 sites
 Kenya: 20+ sites
 Namibia: 4 sites
 Rwanda: 5 sites
 Tanzania: 1 site
 Zambia: 17 sites
The Drug Use Process
        Defining Adherence (1)
 The extent to which a client’s/patient’s behavior
  coincides with the prescribed health care
  regimen as agreed upon through a shared
  decision-making process between the
  client/patient and the health care provider.
 Adherence involves a mutual decision-
  making process between client/patient and
  health care provider.
        Defining Adherence (2)

 Patient takes medicines correctly: right dose,
  right frequency, and right time.

 Patient is involved in deciding whether or not to
  take the medicines.

 Compliance is the patients’/clients’ doing what
  they have been told by the doctor/pharmacist.
  Consequences of Poor Adherence
 For the individual—
   Treatment failure
   Drug resistance
   More complex treatment, more toxicity, more uncertain
 From a public health perspective—
   Transmission of resistant virus (subsequent ART
 From a health economics perspective—
   Negative impact on the established cost benefit of ART
   Increased morbidity and mortality
     Factors Influencing Client/Patient

    Disease                                                                  Client/patient
 characteristics                         Adherence                             –provider

            Treatment                                                      Clinical
             regimen                    Client/patient                     settings

Source: Horizons/Population Council, International Centre for Reproductive Health, and Coast Provincial
General Hospital, Mombasa, Kenya. 2004. Adherence to Antiretroviral Therapy in Adults: A Guide for
Trainers. Nairobi: Population Council.
   How Much Adherence Is Required for Optimal
               Results of ART?

       % Adherence to PI                               % of Clients/Patients
           Therapy                                     with Virologic Failure
                       >95                                               21.7
                  90–94.9                                                54.6
                  80– 89.9                                               66.7
                  70–79.9                                                71.4
                    <70                                                  82.1
Virologic failure is defined as an HIV RNA level greater than 400 copies/ml at the last
clinic visit.
Source: Paterson, D. L, et al. 2000. Adherence to Protease Inhibitor Therapy and Outcomes in Patients with
HIV Infection. Annals of Internal Medicine 133:21–30.
         Viral Load Suppression and Adherence
                      NNRTI vs PI

    Adherence by                NNRTI Group,
                                                                  PI Group, %
     Pill Count, %                    %

       94 to 100                        ~90                               ~65

        74 to 93                        ~ 75                              ~60

        54 to 73                        ~ 60                              ~30

        0 to 53                         ~30                               ~12

    After a median 9.1 months of follow-up, most people on NNRTI therapy had a viral
     load below 400 copies/mL even with adherence as low as 54%, while substantially
     fewer PI takers had viral loads that low if their adherence was shaky (Table)
    Source: Bangsberg, D.R, 2006. Less than 95% Adherence to Nonnucleoside Reverse-
     Transcriptase Inhibitor Therapy can lead to Viral suppression. Clinical Infectious Diseases;
Methods of Measuring Adherence (1)
   Self-reporting
   Pill counts
   Pharmacy records
   Provider estimate
   Pill identification test
   Electronic devices—MEMS (medication events
    monitoring system)

 Biological markers—Viral load
 Measuring medicine levels—TDM
         Strategies and Tools to
         Enhance Adherence (1)
Pretreatment strategies—
  Identify the potentially nonadherent client/patient and
   address the barriers to adherence during counseling
   before first ARV prescription.
  Identify an adherence partner or buddy, or a peer
  Ask the client/patient to demonstrate adherence ability.
  Identify reminders or tools to help in taking pills.
          Strategies and Tools to
          Enhance Adherence (2)
Ongoing treatment strategies—
  Generate daily-due review and refill list, and ―flag‖
   absent clients/patients.
  Refer to community-based health care workers and
  Use DAART or modified DOT (practiced at health
   centers, CBOs, or at client’s/patient’s home).
  Use incentives and enablers (e.g., having income-
   generating projects for caregivers, providing transport
   on clinic days, or providing food).
Strategies and Tools to Enhance Adherence (7):
     Example from the Khayelitsha cohort,
            Western Cape, S. Africa*

Promoting Adherence
    Disclosure
    Pill boxes
    Support groups
    Treatment assistants
    Trust in clinic staff and belief in treatment efficacy
Associated with Poor Adherence
  Competing priorities – changes in social circumstances/employment
  stress/depression
  New partners/ non-disclosure
  Men leaving alone
  Alcohol
 More than 75% of patients still in care after 48 months, 16% on second line.

 *Source: MSF, presented at ICASA, Abuja , Nigeria, 2005, Abstract No.1562
Strategies to Improve Use of Medicines*
         Educational                                           Managerial
  Inform or persuade                                Guide clinical practice
   – Health providers                                 – Information systems/STGs
   – Consumers                                        – Medicine supply/lab capacity

                                               Use of

           Economic                                          Regulatory
  Offer incentives                                  Restrict choices
   – Institutions                                    – Market or practice controls
   – Providers and clients/patients                  – Enforcement
*WHO, Dept. Essential Drugs and Medicines Policy
 Changing a Medicine Use Problem
 An Overview of the Process
                                     1. EXAMINE
                                 Measure Existing
                                Quantitative Studies)

      4. FOLLOW UP                     Improve                2. DIAGNOSE
    Measure Changes                    Diagnosis            Identify Specific
        in Outcomes                                       Problems and Causes
(Quantitative and Qualitative                           (In-depth Quantitative
         Evaluation)                                    and Qualitative Studies)

                                      3. TREAT
                                Design and Implement
                                  (Collect Data to
                                Measure Outcomes)
Changing a Medicine Use Problem
PEP at Coast Provincial General Hospital
 Coast Provincial General Hospital (CPGH) is a
  700-bed capacity hospital
 ART commenced in June 2003
 By April 2004 : PEP problem
Changing a Medicine Use Problem
PEP at Coast Provincial General Hospital

Examine and measure existing practices
 The pharmacy staff at CPGH examined the pharmacy
  records and measured PEP practices
 Key findings—
    The number of PEP cases treated for occupational
     exposure and following rape was low.
    The number of clients/patients returning to complete
     the PEP course was low.
    Inappropriate regimens were being prescribed for
     pediatric clients/patients.
Changing a Medicine Use Problem
PEP at Coast Provincial General Hospital

Identify the problem and underlying causes (1)
 The number of PEP cases treated for occupational
  exposure and following rape was low because—
    Staff and clients/patients were unaware of the
     purpose and availability of PEP and did not know how
     to access it
    Reluctance to test for HIV
    Fear of potential side effects
    Untrained staff offering PEP
    Confidentiality issues
Changing a Medicine Use Problem
PEP at Coast Provincial General Hospital

Identify the problem and underlying causes (2)
 The number of clients/patients returning to complete the
  PEP course was low because of—
    Side effects particularly with indinavir (IDV)

    Reluctance to test for HIV

    Inadequate counseling to support adherence

    Traumatized state of rape survivors
Changing a Medicine Use Problem
PEP at Coast Provincial General Hospital
Identify the problem and underlying causes (3)
 Inappropriate regimens were being prescribed for
  pediatric clients/patients because of—
    Absence of local and national guidelines at the time
    Untrained staff
    Lack of availability of appropriate medicines
Changing a Medicine Use Problem
PEP at Coast Provincial General Hospital
Treat, design, and implement (1)
 Training on the importance, availability, and how to
  prescribe and access medicines for PEP
 Review of regimens and standardization of clinical
  management of PEP
    PEP—standard regimens for low-risk exposure and
     high-risk exposure
    Appropriate client/patient follow-up schedule
    Appropriate regimen and dosing schedule for pediatrics
Changing a Medicine Use Problem
PEP at Coast Provincial General Hospital

Treat, design, and implement (2)
 Development and dissemination of flowcharts
  and SOPs for PEP logistics at the hospital
 Make starter packs for PEP available at
  emergency/casualty pharmacy to treat
  exposures occurring outside of working hours
 Written pediatric dosing schedules for PEP made
  available at the pharmacy and the pediatric HIV
Changing a Medicine Use Problem
PEP at Coast Provincial General Hospital

Follow up and measure changes in outcomes
 Number of adult PEP clients/patients increased
  following the two training sessions.
 More cases of pediatric PEP have been
 A larger percentage of the PEP clients/patients
  are completing the PEP course.
 Adult and pediatric PEP prescribing has
 Recap: Dispensing in ART Programs

 Dispensing is a critical part of ART programs.
 Good dispensing practices enhance—
    Client/patient adherence, satisfaction, and treatment
 Training, adequate resources (HR infrastructure, reference
  materials supplies etc), SOPs, good record keeping, user
  friendly tools and supervision encourage good dispensing
 All prescription errors should be reviewed, and the causes
  should be identified and corrected.
        Recap: Adherence to ART
 Excellent adherence is key to successful ART
 The consequences of poor adherence are poor
  health outcomes and increased health care costs.
 Adherence is a dynamic process that needs to be
  followed up.
 Client/patient-tailored innovative interventions are
  required and must fit into the sociocultural context
  of each setting.
 Family, friends, and community are key factors in
  improving adherence.
 A multidisciplinary approach toward adherence is
Recap Rational Use of Medicines (1)

 The promotion of RMU in the context of
  ART is a must from Day 1.
 There are many challenges to ART RMU at
  the diagnosis, prescribing, dispensing, and
  client/patient-use levels.
 Pharmacy staff have a key role to play in
  promoting ART RMU at all levels.
Recap Rational Use of Medicines(2)

 RMU interventions need to be targeted, based
  on evidence, locally appropriate, and
  implemented by a multidisciplinary team.

 Combining different interventions improves their