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Transcript
Evaluation of Antiretroviral Therapy Followed by an Educational
Intervention to Increase Appropriate Use in Zimbabwe
Tisocki Klara, Sibindi Siboniso, Maguma Hercules, University of Zimbabwe
Problem Statement: The inappropriate use of antiretrovirals (ARVs) can
quickly lead to development of viral resistance, treatment failure, toxicities,
and waste of financial resources.
Objective: To evaluate physicians’ prescribing practices for ART for adult
HIV/AIDS patients in Zimbabwe; and to design and pilot-test an educational
intervention to increase the rational use of ARVs.
Design: Descriptive study based on retrospective data collection; and
before/after study based on self-administered questionnaires.
Setting and Population: Private physicians in Zimbabwe. Individual patient
data were collected on the following: patients’ assessment prior to starting
ART;
prescribing
patterns;
monitoring
for
efficacy/safety;
and
clinical/virological outcomes.
Intervention: The educational intervention comprised face-to-face training in
appropriate use of ART supported by printed materials designed and tested
in individual academic detailing visits to 13 physicians.
Outcome Measures: Individual patient data analysis in the above four
domains (assessment prior to ART; prescribing patterns; monitoring for
efficacy/safety of therapy; and clinical, virological outcomes); changes in
physicians’ knowledge about rational use of ARTs.
Results: 41% of patients had no record of any initial clinical evaluation and
only 6% of patients had all of the recommended laboratory tests performed.
Approximately half of the patients (56%) were initiated on triple therapy, and
34% on dual therapy. Thirty-eight percent of patients received regimens with
incorrect doses. Sequencing of ART frequently occurred from triple to dual
therapy, based mainly on the patient's financial status rather than on the
efficacy or safety profile of regimens. Opportunistic infections and HIV-related
malignancies were used primarily to monitor efficacy. Unfavorable
clinical/immunological outcomes were frequently present in patients receiving
dual or monotherapy. Evaluation of the effect of the educational intervention
showed an average 27.15% increase in knowledge, as evident from
comparison of
pre- and post-intervention questionnaires. The highest
increases were found in knowledge on drug interactions and adverse effects
of ART.
Conclusions: Irrational prescribing of ART by private practitioners, leading to
poor outcomes, were detected in the descriptive phase of this study.
Independent academic detailing supported by practical printed information
can be useful for improving use of ART and for the dissemination of evidence- 1
based clinical guidelines.
BACKGROUND &
SETTINGS
•
•
Zimbabwe has one of the world’s highest HIV
infection rate.
In the late 1990s physicians in Zimbabwe
started to prescribe ARVT to private sector
patients with widely varying standards.
•
ANTIRETROVIRAL THERAPY (ARVT) can
dramatically reduce HIV/AIDS related morbidity
and mortality
– BUT it has narrow therapeutic margin i.e.
unless it is initiated, monitored, maintained
and adjusted correctly, benefits may barely
outweigh potential risks.
•
POTENTIAL PROBLEMS OF ARVT in case of
irrational prescribing include:
– subtherapeutic effects and emergence of
viral resistance  treatment failure,
• Length of desired outcomes in individual
patient is reduced
• Efficacy of ARVs within the population is
reduced
– unnecessary toxicity,
– wastage of limited financial resources
• Affecting heavily surviving family
members
2
OBJECTIVES
I.
II.
To examine standards of providing
ARVT in Zimbabwean patients
receiving treatment in the private
health sector by investigating:
•
initiation,
•
monitoring and
•
evaluation of ARVT and
•
relevant patient outcomes
To design and pilot-test an
educational intervention promoting
the rational use of ARVs by
increasing the physician’s
knowledge about evidence-based
and rational use of ARVs
3
METHODS 1.
Objective I. Examine patterns of ARVT
Design: Descriptive study based on
retrospective data collection
Subjects: 14 physicians prescribing ARVT in
main urban centers (Bulawayo, Harare)
identified by a screening questionnaire
Data collection: January – February 2001
• individual patient data was retrospectively
extracted from medical records of 39 patients.
– Inclusion criteria: above 18 years, received at
least one ARV for at least a six months; data
available for the last 12 months.
– Exclusion criteria: ARVT given for prevention of
mother to child transmission or for post exposure
prophylaxis .
Data Collected:
– Clinical, laboratory and virological evaluation
before and during ARVT
– Initial ARV regimen and consequent changes
– Monitoring for efficacy and safety
– Clinical and immunological outcomes
See yellow data collection sheets in right corner.
Data analysis: descriptive statistics
4
METHODS 2.
Objective II.
Promote rational use of
ARVs by increasing
physicians’ knowledge
Design:
Pilot-test an educational intervention with preand post intervention assessment of
effectiveness
Intervention:
Academic detailing combined with distribution
of concise printed materials
– Single, structured face-to-face meeting
conducted by specially trained
pharmacist in physician’s surgery
– Concise information booklet
summarising evidence-based clinical
guideline recommendations
complemented with laminated desktop
info-cards See material in left corner of
poster
Subjects:
13 Physicians prescribing ARVT inthe private
health sector (Harare)
Assessment:
Multiple choice questions randomly divided
into pre and post tests that were administered
two weeks before and two weeks after the
intervention
Data analysis: comparison of pre and post
intervention scores
5
CLINICAL EVALUATION
BEFORE STARTING ARV
Clinical evaluation
1, 2, 3 and 4
1, 3 and 4
4 only
1 and 3
3 and 4
No evidence of
any clinical evaluation
No. of patients n=39
7
(18%)
4
(10%)
3
(8%)
3
(8%)
6
(15%)
16
(41%)
Key:
1 = weight
2 = chest x-ray
3 = examination of the oropharyngeal mucosa
4 =examination of skin and lymph nodes
Important observations:
• Only 18% patients received full clinical
evaluation as recommended
• 41% had no records of any clinical
examination
• Complete laboratory examinations incl.
CD4, TLC, VL, LFT, FBC was performed in
only 2 patients (6%)
6
INITIAL AND CURRENT ARVT
REGIMEN
Initial regimen
Current regimen
50%
45%
40%
% of patients
35%
30%
25%
20%
15%
10%
5%
0%
2NRTI + 1PI
2NRTI +
1NNRTI
1NRTI + 1PI
2NRTI'
DDI + HYU
Important observations:
• Patients were frequently switched to dual
therapy with NRTI+PI or 2NRTI
combinations or to quasi monotherapy
with DDI+hydroxyurea
7
PRESCRIBING OF ARVs
Incorrect dose of ARVs was found in total of 15
patients (38%), examples:
– AZT (67% of effective dose prescribed ),
occurred in 7 pts.
– underdosing of SQV (22% of effective
dose prescribed) occurred in 2pt.
– Double dose of DDI
•
Interactions:
– co-administration of Indinavir and
Rifampicin
•
Irrational combinations i.e.
– AZT + hydroxyurea, 3TC+ hydroxyurea
•
irrational first-line therapy i.e.
– Didanosine + hydroxyurea combination
•
irrational sequencing i.e.
– Patients were frequently switched from
triple to dual then monotherapy
– DDI+ HYU was the current therapy for 7
pts. (18%)
8
CLINICAL AND
IMMUNOLOGICAL OUTCOMES
OUTCOME
No. of Pt.
DRUG REGIMEN
1, 7 and 3
8 (21%)
2NRTI's + 1PI or
2NRTI's+1NNRTI
1 and 4
8 (21%)
2NRTI's + 1PI
1NNRTI+1PI;
1 NRTI + 2NNRTI
1 only
2 and 4
6 and 3
4 only
4 and 5
2
1
2
6
12
2NRTI's + 1PI
DDI and HYU
2NRTI's and 1PI
2NRTI's
DDI and HYU,
2NRTI's
(6%)
(3%)
(5%)
(15%)
(15%)
Key:
1 = Undectateble viral load;
3 = CD4 count>350cells/mm3
5 = Clinically unwell with OIs
7 = clinically well
2 = High viral load,
4 = CD4 count <350cells/mm3
6 = Low viral load <10000cop/ml,
Important observations:
• Desired outcomes (undetectable VL, high
CD4, clinically well) was found generally in
pts on triple ARV regimens
• Dual or monotherapy often resulted in
poor outcomes in spite of ARVT
9
EDUCATIONAL
INTERVENTION
• Structured academic detailing was developed
delivering key messages regarding:
– Goals of and starting ARVT
– Choices for ARVT and potential drug
interactions
– Monitoring adherence and side effects
– When to change therapy
– Use of hydroxyurea in ARVT
– Use of antiretrovirals for PMTCT
• Single face-to-face academic detailing session
lasted approx. 30 to 90 min. were delivered to 15
physicians. Some physician requested a second
visit from the pharmacist.
• This was combined with printed educational
material to facilitate access to information and reinforce key messages
• Assessment of the effect of the educational
intervention (based on 10 phsysicians
completeing the full study) showed an average
27.15% increase in knowledge og physicians.
• The highest increases were found in knowledge
on drug interactions and adverse effects of ART. 10
DISCUSSION
• Though small in numbers, Zimbabwean patients
living with HIV/AIDS trying to access ARVT in the
private health sector.
• In spite of continued use of antiretrovirals in
majority of patients immunological and clinical
outcomes were poor, possibly due to irrational
choices and poor monitoring
• ARVT has rapidly evolved in the last decade and
physicians were often poorly informed about the
latest evidence-based clinical guidelines and on
how to optimize ARVT.
• In addition, the high cost of the therapy often
forces patient-physician decisions towards
irrational choices or sequencing in ARVT.
• Academic detailing delivered by pharmacist and
combined with evidence-based information on
ARVT from reliable, independent sources was
well received and appreciated by physicians.
• Locally generated information can be well-focused
and specific for ARVs available on the market in
Zimbabwe.
11
SUMMARY
•
•
•
Wide variations were found in prescribing,
monitoring and evaluation of ARVT in the
private health sector in Zimbabwe.
Consequently, patient outcomes were also
varied considerably, with poor results for the
majority.
Academic detailing by the pharmacist
combined with provision of printed information
increased physician’s knowledge on ARVT.
RECOMMENDATIONS
•
•
•
Comprehensive training of prescribers is
urgently needed in order to achieve maximum
possible benefits while minimising risks from
ARVT.
Pharmacists providing locally developed and
focused information can be valuable resource
in prescriber’s education.
Reduction in prices of ARVs and necessary
tests is stills needed. Even though
international public procurement prices fell
dramatically this often does not translate into
real affordability for patients in the private
health sector. High prices can continue to
force irrational choices or poor adherence
defeating the main goals of ARVT.
12