Rational Drug Use Supported by USAID Prescribing, Dispensing, Counseling and Adherence in ART...
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Transcript of Rational Drug Use Supported by USAID Prescribing, Dispensing, Counseling and Adherence in ART...
Rational Drug Use
Supported by USAID
Prescribing, Dispensing,
Counseling and Adherence in ART
Programs
Pharmaceutical Management Cycle
Selection
ProcurementManagement Support
Distribution
Use
Policy, Regulations, Laws
Definition of RDU
The rational use of drugs 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
Importance of RDU in the context of ART• ART is:
– Complex (a combination of many drugs)– a life treatment– Recent and in constant development
• An irrational drug use of ARVs results in the following:– Treatment failure – Rapid development of drug resistance– Increase of toxicity risk – Wastage of money
The promotion of RDU in the context of ART is a must from day one!
Rational Drug Use
Prescriber, Dispenser &
their workplaces
Drug Supply System
Patient & community
Many Factors Influence Use of Medicines
Policy, Legal and Regulatory framework
Diagnosis: Aspects that lead to Irrational Drug Use• Inadequate examination of patient• Incomplete communication between patient
and doctor • Lack of documented medical history• Inadequate laboratory Resources
Prescription: Types of Irrational Drug Use
• Under-prescribing
• Incorrect prescribing
• Extravagant prescribing
• Over-prescribing
• Multiple prescribing
Dispensing: Types of Irrational Drug Use• 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
ART Dispensing – Differences?
• Why is dispensing key for the success of ART programs?
• Are there significant differences between dispensing ARTs and other medicines?
ART Dispensing – Differences?
• A stock-out of one ARV in regimen result in the cessation of therapy until the drug is available again
• Time of taking medicines more important than for many other medicines
• Date of collection of medicines more important – reflects on adherence
• Accurate and complete record keeping is vital• Regimens more complex so knowledge of
treatment guidelines more important.
Adherence to HAART
• Goal of HAART (Highly Active Antiretroviral Therapy) is to suppress viral load in the blood to undetectable levels
• Adherence to treatment is critical to obtain full benefits of HAART:– maximal and durable suppression of viral
replication,– reduced destruction of CD4 cells, – prevention of viral resistance, – promotion of immune reconstitution– slowed disease progression.
Adherence vs Compliance
• Adherence: The act or quality of sticking to something; steady devotion; the act of adhering
The acceptance of an active role in ones health care
• Compliance: the act of yielding conforming, or acquiescing
Lack of sharing in the decision made between provider and client
How Much Adherence is Required for Optimal Results of HAART?
Adherence Viral load<400
>95% 81%
90-95% 64%
80-90% 25%
<70% 6%Paterson D.L et al 2000. ann. Int. medicine
Consequences of Poor Adherence• For the individual:
– Treatment failure: incomplete viral suppression, continued destruction of the immune system, disease progression
– Drug resistance: emergency of resistant viral strains – Limited future treatment options: more complex
treatment, more toxicity, uncertain prognosis• From a public Health perspective:
– Transmission of resistant virus (subsequent HAART failure)
• From a health economics perspective:– Negative impact on the established cost-benefit of
HAART – higher cost to the individual and ART program
SLEPTIN
AWAYFROM HOME
RAN OUT OF
PILLS
FELT ILL
FELT BETTERPILLS
DO NOT HELP
FEAR SIDE
EFFECTSDID NOT WANT
OTHERS TO SEE
FAMILY SAID NO TO MEDICATIO
N
FORGOT/ BUSY
DID NOT UNDERSTAND INSTRUCTION
S
MISSED DOSES
TAKING PILL
HOLIDAYS
UNABLE to CARE
FOR SELF
Adherence: Why do Patients Miss Doses? (Barriers to adherence 1)
Let’s find together a solution for your problem
•I am listening•You can trust me•I understand •I suggest…•What do you think?•I’ll explain to you how to take these medicines
Other Barriers to adherence
• Communication difficulties
• Literacy levels
• Inadequate knowledge of HIV disease
• Inadequate understanding of effectiveness of medications
• Lack of social support
• Discomfort with disclosure of HIV status
• Difficult life conditions
• Alcohol and drug use
• Depression and other psychiatric problems
• System barriers
Adherence Multi-disciplinary Roles• Same message from all!
Adherence Message for the patient
Doctors Adherence Nurse
PharmacistFamily/ Friends
Counselor Social
Worker
Adherence to Antiretroviral Therapy in Adults: A guide for Trainers. Horizon/Population Council
Methods and Challenges of Measuring Adherence (2)• Self reports • Pill counts• Pharmacy records• Provider estimate• Pill identification test• Biological markers• Electronic devices• Measuring drug levels
Strategies and Tools to Enhance Adherence (1)
Pre-treatment strategies• Identification of potential non-adherent and
address the barriers to adherence before first ARV prescription
• Identification of adherence partners/buddy’s (Peer, friend, family)
• Identification of reminders/tools to help taking pills
Strategies and Tools to Enhance Adherence (2)• Treatment adherence-support
strategies– Generation of daily-due review/refill list and
‘flag’ absent patients– Referral to community-based Healthcare workers
and NGO’s– Use of Directly Administered Antiretroviral
Therapy, DAART– Use of incentives and enablers
Recap on Adherence
• A perfect adherence to ART is a must• 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
• Patient-tailored interventions are required• Family/friends, community: key factor in
improving adherence• Multidisciplinary approach towards adherence
is needed
HIV Nutrition
Nutrition Affects HIV:• Poor nutrition reduces ability to fight HIV and
O.I.s• Nutritional problems can affect drug compliance
HIV Affects Nutrition:• Metabolic changes and wasting• Reduced food consumption• Nutrient malabsorption
Affects
ART Nutrition
• ART Affects Nutrition– Drugs can decrease appetite (decrease food intake)
(AZT can cause nausea, GI disturbances may lead to reduced food intake)
– Drugs can cause metabolic changes Indinavir (can raise blood sugar) LPV/RTV (can worsen high
triglycerides or cholesterol levels – Drugs can cause vitamin disturbances (INH depletes Vit. B6)
• Nutrition Affects ART– Food can hinder or help drug absorption– Certain minerals can hinder drug absorption– Certain vitamins can help minimize drug side effects– Alcohol can exacerbate side effects of drugs
Affects
Nutrition and ARVsARV Food Effect Oral
Bioavailability
Nevirapine No effect > 90%
Efavirenz Absorption of tabs increased 79% with tabs and 51% with caps with high fat meal. (Avoid high fat meal)
42%
AZT, ZDV
None ( May be better tolerated with food. Fatty food may decrease bioavailability (AIDS 1990;4;229)
60%
d4T Stavudine3TC Lamivudine
NoneNone
86%86%
ddI Levels less than 19% with food (take two hours before and two hours after meals.)
30-40%
Nutrition and ARVs
• DdI’s absorption reduced by ~55% with food• Indinivair’s absorption is reduced 84% with food. • Food may increase the absorption of Saquinavir by
200%. • Grapefruit juice, increase absorption of Saquinavir by
40-100% ( inhibition of enzyme CYP3A4, which is responsible for its metabolism).
• Taking indinavir with a high fat meal reduces its absorption by about 77%.
• Indinavir taken in combination with ritonavir, food has no effect on the absorption of indinavir and it may be taken irrespective of meals.
ARV Therapy in PregnancySource: WHO• Eligibility criteria for starting HAART in
pregnancy will not differ from other adults • Default first-line regimen for all women will
include nevirapine. Avoid efavirenz.• All pregnant women with a CD4 <200
cells/mm3 should be started on ARVs after the first trimester
ARV Therapy in Pregnancy cont
• Pregnant women with CD4 counts between 200 and 350 CD4 cells/mm3 should be strongly considered for initiation of HAART after the 1st trimester, with therapy to be continued for life.
• Women who become pregnant while on ARVs should continue therapy without interruption, including during the first trimester.
• For pregnant women who test HIV-positive during labour, single-dose nevirapine will be used for PMTCT per guidelines.
HIV in Children & Adults is not the same • Control of viral replication in younger children
is poor due to immature immune systems– Higher levels of HIV RNA reached(2mths) persist for
1yr. Decline over next few yrs.• Infants have a substantial risk of developing
AIDS even with high CD4 values• In contrast to adults, immunologic & virologic
predictors of progression in asymptomatic HIV-infected children and infants, are not well defined
• Current surrogate markers are not specific enough to differentiate slow progressors from rapid progressors in childhood
Children Under-represented in ART programs• Of 12,000 patients on HAART in MSF Programs
only 700 (6%) Children below 15 years• Mombasa RPM Plus/FHI and Horizons program
(August 2004) Adults 186 Children 14 (7.5%)• Namibia (August 2004) Adults 1679 Children
166 (9%)• Haiti 7.2% used for projection.• Vietnam 5% used for projection• WHO 3x5 targets aim at 10-15% of patients on
ART as infants and Children
Clinical, Psychosocial, Programmatic Obstacles for Paediatric ART • Obstacles to testing children for HIV• Lack of expertise on paediatric ARV management, especially
‘when to start’: – Clinical staging non-specific– Prognostic tests poor in young children– Logistics of family clinic approach
• ART Availability– Cost of individual drugs– Lack of appropriate paediatric formulations and Fixed Dose
Combinations– Not a priority for pharmaceutical companies
• Lack of advocates for children
Obstacles to HIV Testing in Children• By families and care-givers
– fear, stigma, other priorities (Diagnosis of HIV in a child usually implies the mother is infected even if she is well)
• By health professionals– lack expertise to recognise clinical HIV– see no benefit in testing– lack counselling expertise for families
• Lack of diagnostic tests for young children under 18 months (PCR for firm diagnosis)
• Disclosure issues (older children)
Obstacles in Clinical Management• Decision when to start ART
– lack of good laboratory predictors of HIV progression in younger children
– Laboratory tests for prediction scarce
• Differences in disease patterns in resource-poor settings
– Lack of specificity of many conditions (new 4-stage WHO guide coming up)
• More overlap with commonly seen infectious diseases
• Major effect of malnutrition (predicts mortality independent of CD4 counts)
Antiretroviral Drugs for Children
• Lack of affordable and appropriate antiretroviral drugs and formulations for Children
• Lack of expertise among health workers to deliver care
• As in most areas of medicine availability of treatments for children lags behind that for adults
– Lack of incentives to manufacture pediatric formulations – Difficulties (perceived and real) in undertaking research in
children– Lack of pediatric research expertise among health
professionals– Practical difficulties in making and testing appropriate
formulations drugs for children
Obstacles for Pharmaceutical Companies• Big Pharma:
– No financial incentives to develop Ped. Formulations (market small and largely in developing world)
– Regulatory and prequalification procedures: perceived high risk of doing research in children discourages production of pediatric ART
– Extension of patent (carrot by FDA); Big stick (failure to grant adult licence-being proposed by EU)
• Generic Companies:– Also need a business case– Lack of expertise and research ‘know-how’– Pre-qualification issues
• Demand Forecasting
Obstacles - Pre-Qualification
• “National and or international regulatory and prequalification procedures may discourage the production of specific paediatric ART formulations”
• WHO requirements – Shelf-life studies– Dissolution studies– Bio-equivalence Studies – PK studies in children
Some Barriers to Adherence in Children• Lack of liquid formulations of some drugs• High volume• Poor palatability• High pill burden• Frequent daily dosing requirements• Dietary restrictions and toxicity.• Stigma issues: disclosure to family, friends,
school• Adherence depends on caregivers (usually old
grandparents)
Challenges
• Appropriate simple ART formulations and combinations relevant to resource–poor settings urgently needed
– Industry interest and accelerated PK research
• Integration of adult and paediatric treatment and care: FAMILY APPROACH
• Applying and Scaling-up what we already know:– Cotrimoxazole prophylaxis– Nutritional support
• Training in paediatric and family-based care for HIV• Strengthen links between access to treatment and
operational research to answer important questions about natural history and response to ART
3WHO, Dept. Essential Drugs and Medicines Policy
Strategies to Improve Use of Drugs3
Economic: Offer incentives– Institutions– Providers and patients
Managerial: Guide clinical
practice– Information
systems/STGs– Drug supply / lab
capacity
Regulatory: Restrict choices– Market or practice
controls– Enforcement
Use of Medicine
s
Educational: Inform or persuade– Health providers– Consumers
To Achieve Optimal Treatment Outcomes, Patients Need to:• Understand the diagnosis and correctly
assess its potential impact• Be interested in their health and believe in
the efficacy of the prescribed treatment• Find ways of using the medication that are
not more troublesome than the disease
1. EXAMINEMeasure Existing
Practices(Descriptive
Quantitative Studies)
2. DIAGNOSEIdentify Specific
Problems & Causes(In-depth Quantitative & Qualitative Studies)
3. TREATDesign & Implement
Interventions (Collect Data to
Measure Outcomes)
4. FOLLOW UPMeasure Changes
in Outcomes (Quantitative & Qualitative
Evaluation)
improveintervention
improvediagnosis
Changing a Drug Use Problem: An Overview of the Process
Drug Procurement
Drug Procurement and Rational Drug Use: What is the influence of one on another?
Rational Drug Use
•Drug Quality Problems•Unreliable suppliers•Poor forecasting/bad quantifications•Inefficient distribution system•Poor inventory Management
•Incomplete/incorrect patient record keeping•Inadequate dispensing•Bad counseling•Irrational Prescriptions•Incorrect Diagnosis•Absence of Formulary•Absence of STG