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Management & Leadership role of Pharmacists in
HIV & MCH care – towards achieving
Millenium Development Goals 4, 5 & 6.
Dr. Jaydeep Tank
MD, DNB, DGO, FCPS, MICOG.
FOGSI representative to the Consortium for Safe Abortion,
FIGO Project on Unsafe Abortion, PMNCH – WHO (Geneva).
Co Chair Reproductive Endocrinology Committee –
Asia Oceania Federation of Obstetrics and Gynecology (AOFOG)
Convener- Sub Committee on Unsafe Abortions – (AOFOG).
Ex Chairman MTP committee (FOGSI) 2004 - 09.
Member Advisory Committee for Operational Research on Safe abortion of the
Ministry of Health and Family Welfare - Government of India
Ashwini Maternity and Surgical Hospital,
Center for Endoscopy and IVF
Visiting Consultant for IVF- Akola, Jabalpur and Jalandar
A classic—something that
everybody wants to have read
and nobody wants to read.
~ Mark Twain ~
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The problem of HIV and MTCT
The problem of resources.
The treatment of HIV
The role of pharmacists
Role of partnerships
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The problem of HIV and MTCT
The problem of resources.
The treatment of HIV
The role of pharmacists
Role of partnerships
Margaret Heckler
“Dr. Robert Gallo of the National Cancer
Institute had isolated the virus
which caused AIDS,
It was named HTLV-III,
There would soon be a
commercially available test
for the virus”.
Margaret Heckler
Human Services Secretary
23rd April 1984
Dr. Robert Gallo
A global view of HIV infection
33 million people [30–36 million] living with HIV, 2007
In India…
• The first AIDS case in India was detected in 1986; since then HIV infection
has been reported in all states and union territories.
• The highest HIV prevalence rates are found in Maharashtra, Andhra
Pradesh and Karnataka in the south; and Manipur, Mizoram and Nagaland
in the north-east.1
• Four southern states (Andhra Pradesh, Maharashtra, Tamil Nadu and
Karnataka) account for around 63% of all people living with HIV in India.
HIV Sentinel Surveillance and HIV Estimation, 2006", NACO, 2007
• It is now thought that around 2.5 million people in India are living with
HIV.
UNAIDS/NACO/WHO, 6 July 2007
Children and HIV/AIDS
• Everyday about 1200 children under 15 years of
age become infected with the virus
• The majority acquire the virus before birth, during
pregnancy, delivery or when breastfed.
• Over 90% of new infections in infants occur
through MTCT.
• HIV/AIDS is particularly aggressive in children:
– ±50% of those infected and without treatment, die
before their second birthday.
Prophylaxis – current status
• Only 9% of HIV+ pregnant women in low/
middle income countries received ARV
prophylaxis in 2005.
• Only 7 countries provided ARV prophylaxis to
more than 40% of pregnant women in 2005
(Brazil, Argentina, Jamaica)
PMTCT – Possibilities
• High income countries have reduced infection rates at birth
to less than 2%.
• Cost for pediatric ARVs has been reduced to less than
US$0.16 or US$ 60.00 per year.
• Annual mortality rates due to AIDS among children began
to fall since 2003 due to scale up treatment and PMTCT.
PMTCT and MDG’s
PMTCT directly affects the achievement of three MDGs (to
be met by 2015):
• 4th MDG: Reduce by two thirds the mortality rate among
children under five
• 5th MDG: Reduce by three quarters the maternal mortality
ratio
• 6th MDG: Halt and begin to reverse the spread of
HIV/AIDS
Policy – ahead of its time
• United Nations Comprehensive Approach - 2003
• Universal Access of Prevention, Treatment and Care – G
8 at Gleneagles July 2005
• Abuja Call to Action 2005
• The Declaration of Commitment - UNGASS June 2001-
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The problem of HIV and MTCT
The problem of resources.
The treatment of HIV
The role of pharmacists
Role of partnerships
Overall Strategic Approach
• Decentralized approaches:
– Sub national teams are responsible for the planning,
implementation and monitoring of PMTCT services,
including the training of service providers
• Continuous political commitment
• Incorporating whole family care with models such as
MTCT Plus – a package of HIV prevention, care,
support and treatment for mothers, children and their
families.
• The total population calculated for 1 March
2001 was 1,027,015,247, making the 2001
census the first to count more than a billion
Indians.
http://www.censusindia.net/results/resultsmain.html
• The population had risen by 21.34% compared
to the 1991 total.
http://www.censusindia.net/results/
• Although India occupies only 2.4% of the
world's land area, it supports over 17.5% of the
world's population 1.13 billion people.
• 31.8% of Indians are younger than 15 years of
age.
• As per the 2001 census, 72.22% of the people
live in more than 550,000 villages, and the
remainder in more than 2000 towns and cities.
• Till September 2004, around 633,108 doctors
were registered with different State Medical
Councils of India.
• This implies 1 doctor for 1622 persons (or 61
doctors per 100,000 populations) as against 1
doctor per 182 persons and 401 persons in the
United States and Australia respectively.
Serving the
reproductive needs of
Half a Billion
Women
The Possible solutions
• Strengthen capacity
• Increase the number of providers
Capacity
The Place of Private Health Care
• India spends less than 1 percent of its GDP on
health.
• Only Pakistan spends less among its South
Asian neighbors.
• Sri Lanka and Bhutan which are poorer than
India spend 6 percent and 10 percent
respectively of their GDP on health.
Gross underutilization of ‘free’ care
• In general, in India people depend more on the private sector
for health care than they do on the public sector.
• The private health sector in India is one of the largest in the
world: 80 percent of all qualified doctors, 75 percent of
dispensaries and 60 percent of hospitals in India belong to the
private sector
Narayan et al, 2003.
• According to the NFHS II, only 23.5 percent of urban
residents and 30.6 percent of rural residents choose to visit a
government health facility as their main source of health care
services.
Increase the number of providers
What has changed?
• Technology
• Demography
• Development of cadres of non physician
providers
• Physician perception
Who will be the “increased”
providers…
“The terms “non-physician” and “mid-level providers”
refer to a broad range of non-physician health
workers, including midwives, nurses, clinical officers,
physician assistants and paramedics, among others,
whose training and responsibilities differ from one
country to another, but who are involved in the
provision of reproductive health care or primary
health care services”
WHO 2003.
FOGSI’s position on
the inclusion of MLP’s
• Acknowledging the problem
• The gap between the number of providers
needed and the providers available
• Defining the MLP’s
• Setting standards for training
• Taking cognizance of the legal scenario
FOGSI is committed to…
• To introduce or change policies to facilitate MLPs to provide
care after receiving adequate training
• To capacity build the MLPs for ensuring continued and
sustainable services towards maintaining the quality of care and
services.
• To provide MLPs with sufficient educational materials.
• To ensure availability of up to date operational guidelines for the
MLPs to act as a quick reference.
• To ensure that the MLPs also promote and recognise the
reproductive and sexual rights of women.
The way forward….
• Safe and Effective Technology is available.
• The problem is reaching it to those who need it the
most
• Inadequate and Inequitable access
• Increase access by increasing the number of service
providers and build good quality capacity
• Partnerships with the government, NGO’s and other
stakeholders.
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The problem of HIV and MTCT
The problem of resources.
Management
The role of pharmacists
Role of partnerships
Issues for us…
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Universal Precautions
MTCT
Contraception and HIV
PEP
Abortion and HIV
Infertility and HIV
The UN PMTCT response
1.
Primary prevention interventions within services related to
reproductive health
2.
Appropriate counseling and support to women living with HIV to
enable them make an informed decision about their future
reproductive life, with special attention to preventing unintended
pregnancies.
3.
HIV testing be integrated in maternal child health units where ARVs
are provided to prevent infection being passed on to their babies
and also the woman’ s own health; and adequate counseling is
provided on the best feeding option for the baby.
4.
Better integration of HIV care, treatment and support for women
found to be positive and their families.
2003
HIV Infection in pregnancy
• Informed universal screening
– interventions can reduce maternal-to-child
transmission from 25-30% to less than 2%
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Confidentiality and disclosure
Antenatal monitoring and advise
Screening for fetal abnormalities
Look for complications of therapy.
HIV Infection in Pregnancy
General Principles of ARV Therapy
Nucleoside/nucleotide reverse transcriptase inhibitors
• reduce the growth of HIV
• Inhibit prolongation of DNA chain insert false nucleotide
• Zidovudine, lamivudine
Non nucleoside reverse transcriptase inhibitors
• keep HIV from making copies of itself
• Bind directly to reverse transcriptase preventing activity
• Nevirapine, efavirenz
Protease inhibitors
• prevent HIV from being formed
• Inhibit cleavage of viral packaging prior to viral release
• Indinavir, saquinavir mesylate, nelfinar mesylate
Livingstone, Curr Wom Health Rep, 2:245, 2002
How many antiretrovirals?
Single drug therapy
Polydrug therapy
Better safety profile
Can be continued as long
term therapy
Efficacious against MTCT –
CS may be offered
Reduces viral load to nearly
nil – CS not required
Simplicity
Effective for advanced
disease
Rs 7,000 to 8,500
Rs 21,000 to 24,000 plus
Single dose nevirapine
• The simplest of all PMTCT drug regimens was tested in the HIVNET 012
trial, which took place in Uganda between 1997 and 1999.
• This study found that a single dose of nevirapine given to the mother at the
onset of labour and to the baby after delivery roughly halved the rate of
HIV transmission.6 7
• As it is given only once to the mother and baby, single dose nevirapine is
relatively cheap and easy to administer.
• Since 2000, many thousands of babies in resource-poor countries have
benefited from this simple intervention, which has been the mainstay of
many PMTCT programmes.
Connor et al, NEJM 331(18), 3 November 1994
Guay et al, The Lancet 354(9181), 4 September 1999
When is single dose
nevirapine appropriate?
• Because of concerns about drug resistance and
relatively low effectiveness, there is now general
agreement that single dose nevirapine should be used
only when no alternative PMTCT drug regimen is
available. Whenever possible, women should receive
a combination of drugs to prevent HIV resistance
problems and to decrease MTCT rates even further.
• Nevirapine, however, is still the only single dose drug
available to prevent MTCT.
Optimize Labor Care
• Late rupture of membranes
• Avoid invasive procedures such as fetal
electrodes, scalp blood sampling
• Avoid traumatic or instrumental delivery
• Vaginal lavage with chlorhexidine is not
efficacious
• Elective LSCS
– With effective ART it may have a limited role.
• Breast Feeding
– If she takes no preventive drugs and breastfeeds
then the chance of her baby becoming infected is
around 20-45%.
Post Delivery Care
• Antibiotics, wound care, analgesics and
discharge as per routine
• If the mother chooses to breast feed, teach and
support her
• If the mother opts not to breast feed, suppress
lactation
Child’s Serostatus
• Child is HIV positive if :
– PCR is positive at any time after birth
– ELISA test is positive after 18 months age
• ELISA positive before 18 months does not mean that
baby is infected
• Timing of transmission by timing of PCR positivity:
 < 48 hours : antenatal
 48 hours to 7 days : intrapartum
 > 7 days : postnatal transmission
Contraception
• Condoms should be used even if the couple is
using other methods
• Hormonal methods are suitable for pregnancy
prevention
• In asymptomatic HIV positive patients, IUCD
is not contraindicated, but is best avoided
PEP
What is PEP?
• The term “Post-exposure prophylaxis” or PEP refers to the
prophylactic use of antiretrovirals to prevent establishment of
HIV infection after an occupational exposure to HIV
Types of occupational exposures
• Percutaneous
– Needle stick
– Sharps injury
• Mucocutaneous
• Contact with skin which is abraded, chapped,
inflamed or an open wound
• Direct contact with concentrated HIV in a laboratory
• Isolated skin exposure
Risk of Transmission of Different Viruses
Following Accidental Needle Injury
• Hepatitis B virus
6-30%
• Hepatitis C virus
1.8%
• Human
Immunodeficiency Virus
0.3%
What Is The Risk?
Occupational
Percutaneous
0.3%
Mucous membrane
0.09%
Sexual transmission
0.018% to 3%
Mother to child
25%
Infected blood products
95%
Antiviral therapy 1998; 3 (Suppl 4): 45-47
Factors Influencing Risk
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Depth of injury
Size and type of needle
Device visibly contaminated with blood
Procedure involving a needle placed in artery or
vein
• Use of zidovudine
• Source patient’s viral load
How To Reduce Risk?
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Number of procedures
Double gloves
Gowns, facemasks, goggles. Care during procedures
where splattering of blood is anticipated
Use of impervious needle-disposal containers
Transport of samples in sealed containers
Universal precautions
Antiseptics effective against HIV
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Undiluted Savlon solution
Chlorhexidine
2% glutaraldehyde
Household bleach
Formalin 4%
Povidone iodine 2%
IPA, ethanol 70%
Dettol solution – no effect
Treatment Of Exposure Immediate Measures
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Use of soap and water to wash any wound or skin
Flush exposed mucous membrane with water
Report to the concerned authority
Counselling
Antiretroviral therapy
General Guidelines For PEP
• Therapy should be recommended after exposure
• Therapy should be initiated as soon as possible, preferably
within hours of exposure
• 2- and 3-drug regimens, based on level of risk
• Source patient’s HIV status unknown, decide on a case-to-case
basis
• Follow up counseling and HIV testing using ELISA
periodically for at least 6 months (baseline, 6 weeks, 12 weeks
and 6 months)
• Potential benefits should be weighed against potential risks
Basic regimen (28 days)*
Zidovudine 300 mg + lamivudine 150 mg (Duovir* 1 tab) bid
Or
Tenofovir disoproxil fumarate 300 mg + emtricitabine 200mg (Tenvir –
EM 1 tab) od
Or
Tenofovir disoproxil fumarate 300 mg (Tenvir) od + lamivudine 150mg
bid or 300mg od (Lamivir)
Alternative:
Stavudine 30/40 mg + lamivudine 150 mg (Lamivir-S 30/40 1 tab) bid
Or
Didanosine 250/400mg (Dinex-EC) od + lamivudine 150mg bid or
300mg od (Lamivir)
* Drugs listed are those available in India
Basic regimen plus:
Expanded regimen
(28 days)*
Preferred:
• Lopinavir 200 mg/ritonavir 50 mg (Lopimune 2 tabs) bid
Alternative:
• Atazanavir 400mg od
• If used with TDF: atazanavir 300mg od and ritonavir 100mg (Ritomune 1 tab)
bid
Or
• Indinavir 800 mg (Indivan 2 caps) and ritonavir 100 mg (Ritomune 1tab) bid
or Indinavir 800mg (2 caps) tid
Or
• Saquinavir 1000mg ( Maximune 2 tabs bid ) and ritonavir 100 mg (Ritomune
1 tab) bid
Or
• Nelfinavir 750 mg (Nelvir 3 tabs) tid
Or
• Efavirenz 600 mg (Efavir-600 1 tab) od at bedtime
* Drugs listed are those available in India
Enfuvirtide (90 mg (1 ml) twice daily by subcutaneous injection) to
be used only with expert consultation
Follow up of exposed cases
• Baseline HIV testing
• Follow up testing at 6 weeks, 3 months and 6 months by
ELISA
• Role of HIV DNA PCR – unclear. If done must be
confirmed by ELISA
PEP
• More and more patients with HIV infection continue to
seek treatment
• Greater number of needlestick injuries are expected to
occur
• The risk of HIV transmission is extremely small
• The availability of PEP should not preclude taking
universal precautions
Abortion in
women living with HIV
No woman is required
to build the world
by destroying herself.
~ Rabbi Sofer ~
Almost all abortion-related deaths are
preventable
When abortion is performed by qualified
people using correct techniques in
sanitary conditions, it is one of the safest
medical procedures
Reproductive Health Strategy
• Safe sex practices and monogamous
relationship
• Pap smear screening
• Prevention of unwanted pregnancy
– Condom use
– Hormonal contraception or IUD
• Termination of unwanted pregnancy
Do women with HIV seek abortion?
• Nowrosjee Wadia Maternity Hospital
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Study period 1993 to 2003
Number of patients tested: 116031
Number of patients HIV positive : 1508 (1.31%)
Number of HIV positive patients undergoing MTP : 76
(4.35%)
• Reasons for low MTP rates
– Opt to continue pregnancy
– Late registration and testing
Reproductive rights
• Same rights and privileges as any other woman
• Pregnancy termination is permitted under the
same provisions as per the MTP Act
• Decisions about pregnancy continuation or
termination are based on unbiased, nondirective counseling
Medical factors influencing the MTP
decision
• Women on HAART especially if Efavirenz
(Category D) is part of the regimen
• Co-morbidity that may endanger maternal life
Medical agents after one year in
INDIA
• More than 1 million tablets of
Mifepristone from a single company
Data from Zydus Cadila
Market Growth % of Mife - Miso
Nov' 06
Misoprostol
Dec'05
Mifepristone
Dec'04
0
20
40
60
80
100
120
% Growth
ORG MARG Data
Courtesy Sun Pharma
“A revolution without a rebellion”
Chris Sutton
Medical abortion : legal aspects
• 7 weeks of pregnancy
• Ultrasound not necessary
• Valid consent
– Without coercion or undue influence
– Minors
• Back up facilities at a recognized MTP center;
should also be equipped to manage biomedical
waste effectively
The “informal” sector
• While 60% of chemists were aware of mifepristone,
only 35% of outlets stocked the drug.
• Chemists reported an average of two customers per
week for mifepristone and four customers per week
for misoprostol.
• Chemists said 90% of sales were to non-physicians
and that the majority of customers were men.
• Most sales were reported to be to those carrying a
prescription, but over-the-counter sales were also
reported in a small number of cases.
Ganatra Bela, Manning Vinoj, Pallipamulla Suranjeen Prasad, 2005,
Ipas, New Delhi, India.
Medical abortion :
regimen till 9 weeks pregnancy
• 200 mg Mifepristone
• 48 hours later 400 micrograms of Misoprostol
vaginally
• Follow up after 15 days to ensure
completeness
Additional measures
• No evidence of drug interactions between either drug
and HAART
• Adding antibiotics ?
– Evidence of lower genital tract infection
– Prolonged bleeding (>7days)
– Low CD4 count
• Pain relief
– Spasmolytics (Tramadol)
– Avoid NSAIDs especially if low platelet count associated
with HIV
Instructions to patient
• Disposal of sanitary pads in a safe manner
– No evidence of environmental HIV transmission
– Report if heavy bleeding, pain, fever, no bleeding
in first 48 hours after Misoprostol
• Avoid intercourse
Medical v/s Surgical Abortion
• Advantages
– Surgical and anesthesia risk minimized
– Demedicalization
– Privacy
• Disadvantages
– More number of visits
– Available only till 7 weeks of pregnancy
• Disposal of biomedical waste should not be a
consideration
Post abortion counseling
• Medical abortion is not
– A alternative to contraception
– An “over-the-counter” abortion
• Discuss sexual health issues and reinforce the
reproductive health strategy
Infertility and HIV
• For couples discordant for HIV infection who
wish to conceive, appropriate advice should be
given to optimise the chance of conception
while minimising the risk of sexual
transmission.
• In vitro fertilisation (IVF) is now considered to
be ethically acceptable for couples with
subfertility.
Infertility and HIV
• Where a woman who is HIV negative has an HIV-positive
partner, the risk of transmission to the woman, estimated as
approximately 1:500 per sexual act, can be reduced by limiting
sexual intercourse to around the time of ovulation.
• For HIV discordant couples where the woman is HIV positive,
the couple should be advised on how to perform artificial
insemination at the time of ovulation
Infertility and HIV
To date there have been no seroconversions in
women inseminated with washed sperm.
Infertility and HIV
• IVF is now considered ethically acceptable in
view of vertical transmission rates of less than
2% and increased life expectancy for parents
taking HAART.
• HIV positive men with low sperm counts may
be offered intracytoplasmic sperm injection
following sperm washing.
Life is not about how
many breaths you take
but about moments
that take your breath away
Will Smith in Hitch
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The problem of HIV and MTCT
The problem of resources.
Management
The role of pharmacists
Role of partnerships
Role of the Pharmacist
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Review prescriptions
Recommend changes to regimen
Monitor adherence to treatment
Remove barriers to treatment
Manage adverse effects
Monitor drug interactions
Pharmacovigilance
Manage drug supply
Adherence- Strategies
• Encourage clients to bring ARVs at each visit
to the Pharmacy –
• Encourage clients not to take any over-thecounter medications• Counseled on how to take ARVs correctlytiming of doses, with or without meals
• Emphasize the importance of taking ARVssuppression of HIV
Adherence- Strategies
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Do pill counts
Provide pill boxes ( supplied by drug companies):
Relate possible side effects
Liaise with multidisciplinary team members if a
problem arises e.g. drowsiness, shift worker. May
warrant change in regimen.
• Encourage support of family member or friend.
• Be a very good listener.
Pharmacovigilance
• To detect unknown adverse reactions and
interactions
• To detect increases of frequency of (known)
adverse reactions
• To identify risk factors/mechanisms underlying
adverse reactions
Managing Drug Supply
• To ensure adequate and continuous supply of
ARVs
• To prevent stock outs
• To liaise with local Pharmaceutical companies
• Inventory control, including reducing expired
stock
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The problem of HIV and MTCT
The problem of resources.
Management
The role of pharmacists
Role of partnerships
“Let us not
underestimate the
Problem,
But let us also not
overestimate our capability
to do something about it.”
Barrack Obama
24 / 11/ 2008
• The overall objective is to increase the
contribution of HCP Associations to national
MNCH plans through a strengthened
participation in policy and programme
development and an increased alignment of
activities to the national targets regarding the
achievement of MDGs 4 and 5 (reducing child
mortality by 2/3 and maternal mortality by ¾
by 2015).
Task 1: Selection of Priority Actions
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Advocacy
Planning
Human Resources
Organizational Strengthening
Quality Improvement
Project management Committee
• Chairman: Praful Sheth.
• Nominated Focal Point: Jaydeep Tank.
• Members
– 2 Representatives from each association.
• Rotate each meeting through the associations.
Advocacy
Task 1
• (a) Problems associated with advocacy and why is it a top priority.
– No coherent and integrated strategy.
– All stakeholders do not have an equal voice.
– Health planning is not done by professionals.
• (b) How will capacity building in this activity contribute to achievement of
MDGs 4 and 5?
– Self evident and as below
• (c) Who will benefit most and how?
– Strengthen maternal – perinatal, neonatal and child health in the community as
well as facility.
– Integrated and continued care.
Quality Improvement
Task 1
• (a) Problems associated with Quality Improvement and why is it a top priority.
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Quality in public health sector needs urgent attention.
Unregulated health care.
Practical standards for different settings.
Quality as a culture does not exist in health care training
(b) How will capacity building in this activity contribute to achievement of MDGs 4
and 5?
– Self evident and as below
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(c) Who will benefit most and how?
– Strengthen maternal – perinatal, neonatal and child health in the community as well as
facility.
– Integrated and continued care.
The trouble with so many of us
is that we underestimate
the power of simplicity.
We tend to mistake
movement for achievement.
~ Robert Stuberg ~