Balancing the Scales- A Report on Barriers and Solutions to treat Pre-eclampsia and Eclampsia

Publication date: 2007

Balancing the ScaleS expanding treatment for pregnant Women With life-threatening hypertenSive conditionS in developing countrieS a report on Barriers and Solutions to treat pre-eclampsia & eclampsia www.engenderhealth.org Acknowledgments. 3 Executive.Summary. 4 I.Introduction. 6 II.Barriers.to.Compliance.with.International.Standards.of.Care. 10 III.The.Way.Forward:.Solutions.to.Expanding. Utilization.of.Magnesium.Sulfate. 12 References. 14 contentS ©.2007.EngenderHealth Cover.photo.credits.top.to.bottom:.A.Fiorente/EngenderHealth,.M.Tushman/EngenderHealth,.C.Svingen/EngenderHealth 3. Acknowledgments EngenderHealth.gratefully.acknowledges.the.John.D.and.Catherine.T.MacArthur. Foundation,.with.special.thanks.to.Ann.Blanc.and.Judith.Helzner.for.supporting. the.Workshop.on.Magnesium.Sulfate.for.the.Management.of.Pre-eclampsia.and. Eclampsia,.June.26–27,.2007,.which.provided.the.opportunity.to.bring.international. experts.together.to.address.this.major.public.health.issue.Special.thanks.go.to. Drs.Stephen.Kennedy.and.José.Villar.of.the.Nuffield.Department.of.Obstetrics. &.Gynaecology.at.Oxford.University.for.co-hosting.the.meeting. EngenderHealth.also.thanks.members.of.the.Technical.Advisory.Group,.who. provided.invaluable.input.to.the.meeting.content.and.attendees. Many.individuals.from.institutions.across.Africa,.Asia,.and.Latin.America.generously. shared.their.insights.on.pre-eclampsia.and.eclampsia.for.the.purposes.of.this.meeting. and.helped.create.a.road.map.for.the.journey.ahead.Although.their.names.are.too. many.to.mention,.we.are.indebted.to.them. Specific.writers.and.reviewers.of.this.report.included.Kelly.O’Hanley,.Theresa.Kim,. Katie.Tell,.and.Ana.Langer.EngenderHealth.also.thanks.Kathleen.McFarland,. Michael.Klitsch,.Tor.de.Vries,.Weronika.Murray,.and.Ariana.Souzis.for.their.diverse. contributions.to.the.final.report. October.17,.2007 acknoWledgmentS 4. Executive.Summary Giving.birth.should.be.a.time.for.celebration,.but.for.more.than.half.a.million.women. each.year—or.one.woman.every.minute—pregnancy.and.childbirth.end.in.death.and. mourning.Ninety-nine.percent.of.these.deaths.occur.in.the.developing.world,.and. tragically,.most.of.these.deaths.are.preventable. One.of.the.most.common,.yet.treatable,.causes.of.maternal.death.worldwide.is. pre-eclampsia—the.rapid.elevation.of.blood.pressure.during.pregnancy—which,.if. untreated,.can.lead.to.seizures.(eclampsia),.kidney.and.liver.damage,.and.ultimately,. death.The.World.Health.Organization.(WHO).estimates.that.at.least.16%.of. maternal.deaths.in.developing.countries.result.from.these.conditions.(UNDP/ UNFPA/WHO/World.Bank.Special.Programme,.2006).Thus,.approximately.63,000. pregnant.women.die.every.year.because.of.eclampsia.and.severe.pre-eclampsia,. which.are.also.associated.with.a.higher.risk.of.newborn.deaths. Pre-eclampsia/eclampsia.ranks.second.only.to.hemorrhage.as.a.specific,.direct. cause.of.maternal.death.In.some.countries,.such.as.Mexico,.pre-eclampsia.and. eclampsia.is.the.number.one.killer.The.risks.that.a.woman.faces.vary.greatly. depending.on.where.she.lives:.The.risk.that.a.woman.in.a.developing.country.will. die.of.pre-eclampsia/eclampsia.is.approximately.300.times.higher.than.that.for.a. woman.in.a.developed.country.While.the.use.of.magnesium.sulfate.has.become. the.mainstay.of.treatment.of.pre-eclampsia.and.eclampsia.in.the.vast.majority.of. developed.countries,.medications.such.as.diazepam.and.phenytoin.(used.in.the. treatment.of.other.types.of.seizures,.including.epilepsy).have.become.more.widely. used.in.most.other.parts.of.the.world. Several.research.trials.have.identified.magnesium.sulfate.as.the.most.effective. treatment.for.preventing.the.onset.of.deadly.seizures.In.fact,.the.maternal.mortality. rate.was.reduced.by.55%.in.the.33-country.Magpie.Trial,.which.was.conducted.in. 1995.Similarly,.in.the.Collaborative.Eclampsia.Trial.(2002),.magnesium.sulfate.was. proven.to.be.more.than.twice.as.effective.at.preventing.recurrent.seizures.as.the.two. drugs.(diazepam.and.phenytoin).that.had.been.the.drugs.of.choice.for.this.problem. in.most.countries.Treating.mothers.with.magnesium.sulfate.improved.outcomes.not. only.for.mothers,.but.for.their.babies.as.well. While.these.findings.are.compelling,.the.research.in.itself.has.not.translated.into. national.health.policies.and.clinical.practices.in.many.parts.of.the.developing.world. Mothers.continue.to.die.from.the.lack.of.magnesium.sulfate—a.safe,.effective,.and. inexpensive.drug.Today,.magnesium.sulfate.is.still.not.available.in.the.hospitals. of.many.countries,.nor.is.it.on.the.countries’.essential.drug.lists.In.some.nations,. magnesium.sulfate.is.not.even.licensed.for.sale. Based.on.the.scientific.evidence,.WHO.identified.magnesium.sulfate.as.the.most. effective.and.low-cost.medication.for.treatment.of.pre-eclampsia.and.eclampsia. (WHO,.1994).Unfortunately,.magnesium.sulfate.continues.to.be.underutilized,. especially.in.countries.where.pre-eclampsia.and.eclampsia.remains.one.of.the. main.causes.of.maternal.mortality.and.morbidity. executive Summary 5. Executive.Summary In.light.of.the.above,.EngenderHealth.brought.together.international.health. experts.to.study.and.come.to.a.consensus.on.the.key.barriers.to.the.use.of.this. life-saving.tool.and.to.develop.a.road.map.to.improve.access.and.implementation. of.magnesium.sulfate.treatment.The.Workshop.on.Magnesium.Sulfate.for.the. Management.of.Pre-eclampsia.and.Eclampsia,.held.on.June.26–27,.2007,.in. Oxford,.England,.was.conducted.in.coordination.with.a.Technical.Advisory.Group,. which.served.as.an.advisory.body.overseeing.the.preparation.and.planning.for. the.workshop.The.Technical.Advisory.Group.included.representatives.from.the. following.agencies:.Columbia.University.(The.Averting.Maternal.Death.and. Disability.Program),.EngenderHealth,.the.London.School.of.Hygiene.and.Tropical. Medicine,.UNICEF,.the.University.of.Leeds,.the.University.of.Oxford,.and.the. World.Health.Organization.Workshop.attendees.included.technical.experts,. country-level.representatives.from.Ministries.of.Health.and.public.health.services,. and.representatives.from.universities.and.international.organizations.Given.the. complexity.of.the.issues,.the.Workshop.required.a.multidisciplinary.group.of. experts.representing.diverse.experiences.and.countries.Participants.represented.the. countries.of.Ghana,.India,.Malawi,.Mexico,.Nepal,.Nigeria,.Switzerland,.Thailand,. the.United.Kingdom,.and.the.United.States. This.historic.gathering.of.global.public.health.experts.identified.the.primary.barriers. to.expanding.access.to.magnesium.sulfate.in.developing.countries,.including: • lack of national priority and guidelines.In.countries.like.Nigeria,.Uganda,. and.Pakistan,.guidelines.mandating.magnesium.sulfate.use.do.not.exist,.and. only.about.half.of.the.world’s.countries.include.magnesium.sulfate.on.their. national.list.of.“essential.drugs.”. . •.lack of education and training.Many.clinicians.remain.unfamiliar.with. the.safety.and.effectiveness.of.magnesium.sulfate.and.continue.to.rely.on. other,.less.effective.and.riskier.drugs.Education.and.training.on.the.scientific. validity.and.treatment.protocols.are.needed. . •.Supply Shortage. Relative.to.other.health.conditions,.pre-eclampsia.and. eclampsia.affect.a.small.population.In.addition,.magnesium.sulfate.is. relatively.inexpensive.In.combination,.these.factors.leave.little.or.no. incentive.for.pharmaceutical.companies.to.make.magnesium.sulfate.more. widely.available. Based.on.these.conclusions,.EngenderHealth.and.the.University.of.Oxford.have. developed.a.“Call.to.Action”.that.calls.on.policy.makers.and.ministers.of.health.to. make.pre-eclampsia.and.eclampsia.a.higher.priority.and.to.set.national.guidelines. for.treatment.and.care,.based.on.WHO.guidelines.It.also.urges.decision.makers. and.international.and.national.health.organizations.and.agencies.to.help.make. magnesium.sulfate.more.available.and.affordable,.in.part.by.empowering.local. clinicians.with.education.and.training. 6. I.Introduction the cost of childbirth For.most.women.and.their.families,.giving.birth.should.be.a.time.for.celebration,. but.for.more.than.half.a.million.women.each.year—or.one.woman.every.minute— pregnancy.and.childbirth.end.in.death.and.mourning.(UNFPA,.2000).Ninety-nine. percent.of.maternal.deaths.occur.in.the.developing.world,.and.most.of.these.deaths. are.preventable.The.risk.of.death.and.disability.resulting.from.reproduction.reflects. the.enormous.disparities.in.maternal.health.care.between.industrialized.and.poor. nations.Indeed,.the.risk.of.a.woman’s.dying.as.a.result.of.pregnancy.or.childbirth. during.her.lifetime.is.about.one.in.seven.in.Afghanistan.or.Sierra.Leone,.while.it.is. only.one.in.30,000.in.Sweden.(Lawn,.Cousens,.&.Zupan,.2005). Although.the.reduction.of.maternal.mortality.was.adopted.by.the.global. development.community.as.one.of.the.Millennium.Development.Goals.and.is.a. stated.target.of.many.countries.and.international.institutions,.pregnancy-related. deaths.have.fallen.little.in.most.low-resource.countries.over.the.past.decades. The.lack.of.success.in.improving.pregnancy.outcomes.has.been.a.result.of.failing. health.systems,.as.well.as.of.insufficient.political,.financial,.and.social.commitment. to.the.issue. What are pre-eclampsia and eclampsia? Pre-eclampsia.is.a.rapidly.progressive.condition.that.can.lead.to.stroke,.kidney.or. liver.damage,.blood-clotting.problems,.and.pulmonary.edema.(fluid.in.the.lungs). The.diagnosis.of.pre-eclampsia.is.based.primarily.on.the.presence.of.hypertension. and.protein.in.the.urine.during.the.latter.stages.of.pregnancy.Eclampsia.is.defined. as.the.development.of.convulsions.or.coma.in.a.woman.with.pre-eclampsia.Pre- eclampsia.and.eclampsia.occur.much.more.commonly.in.first-time.pregnancies.and. appear.typically.with.minimal.or.no.warning.The.antenatal.onset.of.pre-eclampsia. and.eclampsia.is,.by.definition,.after.the.20th.week.of.pregnancy.However,.up.to. 25%.of.pre-eclampsia.and.eclampsia.cases.occur.after.delivery—usually.within.48. hours.postpartum.Some.women.with.pre-eclampsia.develop.eclamptic.seizures. Pre-eclampsia.and.eclampsia.can.also.result.in.perinatal.deaths.While.many.theories. have.been.suggested.to.explain.the.etiology.of.pre-eclampsia.and.eclampsia,.to.date. no.single.or.unifying.explanation.of.the.cause.exists.Unfortunately,.pre-eclampsia.is. not.preventable,.nor.is.its.onset.accurately.predictable. latest data for pre-eclampsia and eclampsia The.World.Health.Organization.(WHO).identifies.the.leading.causes.of.maternal. mortality.worldwide.as:.hemorrhage.(25%),.indirect.causes.(20%),.infections.(15%),. unsafe.abortion.(13%),.pre-eclampsia/eclampsia.(12%),.obstructed.labor.(8%),.and. other.direct.causes.(8%).Pre-eclampsia/eclampsia.ranks.second.only.to.hemorrhage. as.a.specific,.direct.cause.of.maternal.mortality.However,.these.global.averages. hide.important.variations.among.countries.For.instance,.in.Mexico,.pre-eclampsia/ eclampsia.is.the.number.one.cause.of.maternal.death.(Lozano.et.al.,.2005).In.2002,. there.were.approximately.4,152,000.cases.of.pre-eclampsia.and.eclampsia.that. resulted.in.63,000.deaths.worldwide.(WHO,.2005). i. introduction 7. I.Introduction the price of pre-eclampsia and eclampsia: how it affects “us” vs. “them” The.cumulative.risks.from.pre-eclampsia.and.eclampsia.are.many.times.higher.for.a. woman.in.a.developing.country.than.for.a.woman.in.a.developed.country.A.woman. in.a.developing.country.is.seven times more.likely.to.develop.pre-eclampsia.If.she. develops.pre-eclampsia,.she.is.three times.more.likely.to.progress.to.eclampsia.Should. she.develop.eclampsia,.she.is.up.to.14 times.more.likely.to.die.of.eclampsia—even. in.hospital.settings.Taken.together,.the.risk.of.dying.of.pre-eclampsia.and.eclampsia. is.approximately.300 times higher.for.a.woman.in.a.developing.country.than.for.a. woman.in.a.developed.country. Incidence of Pre-eclampsia The.incidence.of.pre-eclampsia,.the.precursor.to.eclampsia,.varies.greatly.worldwide. WHO.estimates.the.incidence.(or.number.of.new.cases).of.pre-eclampsia.to.be.seven. times.higher.in.developing.countries.(2.8%.of.live.births).than.in.developed.countries. (0.4%).(Dolea.et.al.,.2003). Progression of Pre-eclampsia to Eclampsia Only.a.relatively.small.proportion.of.all.women.with.pre-eclampsia.progress.to.the. more.potentially.deadly.eclampsia.However,.once.again,.a.pre-eclamptic.woman. in.a.developing.country.is.three.times.more.likely.to.progress.to.eclampsia.than.a. woman.in.a.developed.country.The.WHO.estimates.that.eclampsia.develops.in. 2.3%.of.pre-eclamptic.women.in.the.developing.world,.compared.with.0.8%.of. pre-eclampsia.cases.in.developed.countries. Challenges to Defining the Problem: Variations in Death Rates from Eclampsia Reliable.statistics.about.women.dying.due.to.eclampsia.are.difficult.to.obtain.because. of.the.poor.quality.of.vital.statistics.registration.systems.and.hospital.records.in.many. developing.countries.In.addition,.a.sizable.number.of.deliveries.take.place.at.home,. and.thus.there.are.no.records.at.all.for.these.births.Therefore,.data.on.women.who. die.from.eclampsia.are.only.available.from.a.limited.number.of.countries.(see.Table.1,. below).Nevertheless,.it.is.clear.that.the.case.fatality.rates.for.eclampsia.vary.greatly. across.countries,.with.the.risk.of.death.from.eclampsia.being.much.higher. in.developing.countries.than.in.developed.ones. table 1: case fatality rates for eclampsia in select countries Source:.World.Health.Organization.2003.Evidence.and.information.for.policy. Geneva.These.data.are.drawn.exclusively.from.hospital-based.studies. country caSe fatality rate year(S) . Burkina.Faso. 15.7%. 1992–1995 . Niger. 5.9%. 1997 . South.Africa. 21.2%. 1994–1995 . South.Africa. 26.3%. 1996–1997 . Peru. 8.0%. 1991–1997 . Thailand. 3.3%. 1988–1997 . United.Kingdom. 1.8%. 1992 8. I.Introduction magnesium Sulfate: the evidence-Based Solution While.there.is.no.cure.for.pre-eclampsia.and.eclampsia,.treatment.measures.can. prevent.and/or.reduce.maternal.and.perinatal.death.and.disability.The.currently. prescribed.management.of.pre-eclampsia.and.eclampsia.originated.in.the.early. 1900s.In.1925,.Lazard.published.a.preliminary.report.in.the.American Journal of Obstetrics and Gynecology.describing.the.effectiveness.of.magnesium.sulfate. for.treating.pre-eclampsia.and.eclampsia.(Lazard,.1925).The.use.of.magnesium. sulfate.went.on.to.become.the.standard.treatment.of.pre-eclampsia.and.eclampsia. in.the.United.States.The.results.did.not.translate.globally,.and.other,.less-effective. medications,.such.as.diazepam.and.phenytoin.(used.in.the.treatment.of.other.types. of.seizures,.including.epilepsy),.were.more.widely.used.in.other.countries.to.treat. pre-eclampsia/eclampsia. Evidence of Effectiveness Treating Eclampsia In.1995,.more.research.confirmed.the.superiority.of.magnesium.sulfate.for.the. treatment.of.eclamptic.seizures.compared.to.other.medications.The.Collaborative. Eclampsia.Trial.compared.the.relative.effectiveness.of.the.three.most.popular. treatments.(magnesium.sulfate,.diazepam,.and.phenytoin).for.the.treatment. of.eclampsia.(Eclampsia.Trial.Collaborative.Group,.1995).Women.treated.with. magnesium.sulfate.had.a.52%.and.67%.lower.recurrence.of.convulsions.than. those.treated.with.diazepam.and.phenytoin,.respectively. During.the.Collaborative.Eclampsia.Trial,.treatment.packs.were.prepared.for.the. clinicians.to.treat.women.participating.in.the.study.The.packs.contained.magnesium. sulfate.(prepackaged.for.recommended.standard.dosing),.calcium.gluconate. (an.antidote.for.toxicity.from.magnesium.sulfate),.supplies.for.intravenous.and. intramuscular.administration,.record.sheets.to.record.clinical.monitoring.findings,. and.a.protocol.sheet.that.also.included.guidelines.for.other.aspects.of.relevant.care. Evidence of Effectiveness Treating Pre-eclampsia Although.the.Collaborative.Eclampsia.Trial.provided.compelling.evidence. about.the.superiority.of.magnesium.sulfate.for.treatment.of.eclamptic.seizures,. questions.remained.about.the.effectiveness.of.magnesium.sulfate.for.the.treatment. of.pre-eclampsia. In.2002,.a.randomized,.placebo-controlled.study.enrolled.more.than.10,000. women.from.33.countries.to.address.this.issue.(Altman.et.al.,.2002).Known.as. the.Magpie.Trial,.the.landmark.study.enrolled.12.times.more.women.than.any. previous.pre-eclampsia.study.to.compare.the.efficacy.of.magnesium.sulfate.to. placebo.The.Magpie.Trial.determined.that.when.magnesium.sulfate.was.given.to. women.with.pre-eclampsia,.it.lowered.the.chance.of.seizure.by.58%.Following.the. Magpie.Trial,.magnesium.sulfate.was.placed.on.the.WHO.essential.drugs.list,.and. as.a.result,.many.countries.began.full.use.of.the.drug,.such.as.the.United.Kingdom. “no woman in this day and age should die from eclampsia simply because of where she happens to live. it’s a tragedy, because we have an effective, low-cost, and safe solution.” – dr. ana langer, engenderhealth the [eclampsia] treatment packs are “a simple, relatively cheap, and effective way of ensuring that magnesium sulfate is always readily at hand. in developing countries, the problem is the familiar one of maintaining a regular supply of any essential drug. in developed countries, the issue is getting rapid access to a drug that is only rarely required.” – dr. leila duley, chair, obstetric epidemiology, university of leeds. 9. I.Introduction Improving Neonatal Outcomes Perinatal.outcomes.for.women.treated.with.magnesium.sulfate.for.pre-eclampsia. and.eclampsia.have.been.studied.in.recent.years.Cochrane.Review.articles.reported. better.outcomes.for.babies.of.mothers.who.received.magnesium.sulfate.for. eclampsia.than.for.those.who.received.diazepam.or.phenytoin.Specifically,.the.vigor. of.the.babies.(five.minutes.after.birth).was.greater.and.the.chances.of.a.long.hospital. stay.in.an.intensive.care.unit.were.lower.in.the.magnesium.sulphate–treated.group. than.in.the.diazepam-treated.group.Similarly,.maternal.magnesium.sulfate.treatment. was.associated.with.fewer.neonatal.admissions.to.a.special.care.unit,.a.shorter. duration.of.stay.(in.days).in.the.neonatal.care.unit,.and.fewer.neonatal.deaths.when. compared.with.maternal.treatment.with.phenytoin.(Duley.et.al.,.2003a;.Duley.et.al.,. 2003b). Current Clinical Guidelines The.positive.research.data.from.the.Magpie.Trial.led.institutions.including.the.WHO,. the.American.College.of.Obstetricians.and.Gynecologists.(ACOG),.and.the.Royal. College.of.Obstetricians.and.Gynaecologists.(RCOG).to.recommend.the.use.of. magnesium.sulfate.as.the.first-line.treatment.for.pre-eclampsia.and.eclampsia.Their. recommendations.specify.correct.dosing.and.administration.and.also.emphasize.the. importance.of.monitoring.to.ensure.safety. Recommendations.for.the.care.of.a.woman.with.pre-eclampsia/eclampsia.extend. beyond.simply.the.proper.administration.of.magnesium.sulfate.Current.guidelines. address.appropriate.laboratory.tests.for.blood.count.and.liver.and.kidney.function. RCOG.and.ACOG.also.specify.the.need.for.treatment.of.severely.elevated.blood. pressure.with.an.antihypertensive.medication.to.prevent.nonseizure.complications. For.more.specific.guidelines.on.the.management.of.pre-eclampsia.and.eclampsia,. visit.WHO.at.www.who.int/,.ACOG.atd.www.acog.org,.or.RCOG.at. www.rcog.org.uk. 10. II.Barriers.to.Compliance.with.International.Standards.of.Care transforming evidence to practice The.presence.of.magnesium.sulfate.within.a.country.and.distribution.of.the.drug. to.facilities.are.basic.prerequisites.for.complying.with.international.guidelines.for. pre-eclampsia.and.eclampsia.care.Despite.compelling.data.about.magnesium. sulfate.as.the.first.choice.for.treatment,.the.drug.remains.inaccessible.to.millions.of. women.in.developing.countries.For.example,.in.the.United.Kingdom,.since.1991,. the.use.of.magnesium.sulfate.in.cases.of.pre-eclampsia.rose.from.2%.to.100%. By.contrast,.in.many.developing.countries,.magnesium.sulfate.is.still.unavailable.or. underutilized,.and.other.anti-seizure.medications.continue.to.be.used.preferentially. over.magnesium.sulfate.These.facts.indicate.that.although.research.findings.are. essential.to.improve.clinical.practices,.they.are.not.sufficient.to.change.health.policies. and.routine.clinical.care. Although.some.studies.have.attempted.to.understand.why.this.evidence.has.not. translated.into.changes.in.practice,.there.had.never.been.a.specific.forum.to.address. this.issue.head.on.The.Workshop.on.Magnesium.Sulfate.for.the.Management.of. Pre-eclampsia.and.Eclampsia,.held.in.June.2007.in.Oxford,.was.conducted.to.identify. the.key.barriers.to.expanding.access.to.magnesium.sulfate,.including.country- specific.barriers,.and.to.develop.solutions.to.address.them.The.experts.attending. the.meeting.identified.the.following.key.barriers.to.translating.knowledge.about. magnesium.sulfate.into.policies.and.practice. key Barriers Lack of National Priority and Guidelines In.countries.such.as.Nigeria.and.Pakistan,.national.guidelines.mandating.magnesium. sulfate.use.do.not.exist.And.only.about.half.of.all.countries.in.the.world.include. magnesium.sulfate.on.their.national.list.of.“essential.drugs.”.Where.national. guidelines.do.exist,.facilities.and.clinicians.are.sometimes.under.no.obligation.to. follow.them.In.many.cases,.each.facility.develops.and.follows.its.own.policies. . Lack of Education and Training Many.clinicians.are.unfamiliar.with.the.safety.and.effectiveness.of.magnesium. sulfate.and.continue.to.rely.on.other,.less-effective.and.riskier.drugs.Health.care. providers.and.administrators.may.be.reluctant.to.adopt.a.practice.with.which.they. have.had.little.experience.or.one.that.requires.intensive.monitoring.for.a.condition. that.is.relatively.infrequent. In.addition,.few.clinicians.or.policy.makers.in.developing. countries.are.aware.of.the.concept.of.evidence-based.medicine.or.know.about.the. findings.from.the.Magpie.Trial.In.some.countries,.experts.report.that.the.utilization. of.magnesium.sulfate.is.viewed.as.being.appropriate.only.at.highest.functional. facilities.(such.as.facilities.with.an.intensive.care.unit).because.of.the.misperception. that.women.receiving.magnesium.sulfate.require.very.complex.monitoring. Supply Shortage Relative.to.other.health.conditions,.pre-eclampsia.and.eclampsia.affect.a.small. population.In.addition,.the.drug.itself.is.relatively.inexpensive.In.combination,.these. factors.leave.little.or.no.incentive.for.pharmaceutical.companies.to.make.magnesium. sulfate.more.widely.available. ii. BarrierS to compliance With international StandardS of care 11. II.Barriers.to.Compliance.with.International.Standards.of.Care Lack of Comprehensive, Country-by-Country Data Solid.data.about.the.availability.of.magnesium.sulfate.are.generally.lacking.in.many. countries,.and.the.data.that.do.exist.often.present.a.challenging.picture.For.example,. 2003.national.surveys.in.Ghana.and.Rwanda.reported.that.only.7%.and.25%.of. facilities.offering.delivery.services.stocked.magnesium.sulfate.(respectively).In.2005,. the.drug.was.entirely.absent.from.a.teaching.hospital.in.Nigeria.Sevene.et.al.(2005). conducted.a.case.study.in.Mozambique.and.Zimbabwe.to.examine.the.reasons.why. magnesium.sulfate.continues.to.be.unavailable.in.these.countries.The.factors.identified. included:.insufficient.demand.for.the.drug.by.physicians;.poor.communication.between. clinicians.and.pharmacists;.complex.mechanisms.of.drug.approval,.acquisition,.and. distribution;.priority.given.to.drugs.used.at.all.levels.of.the.health.system;.and.limited. drug.budgets. Financial Cost The.cost.of.magnesium.sulfate.and.the.hospital.care.involved.with.providing.it. were.seen.as.an.impediment.to.its.use.in.some.countries.The.problem.of.cost.was. reflected.in.the.discrepancies.between.private.and.public.facilities.in.their.ability.to. stock.magnesium.sulfate.The.cost.of.magnesium.sulfate.also.differs.depending.on. the.country.While.generally.inexpensive.across.most.countries,.it.is.more.expensive. in.places.such.as.in.Nigeria,.than.other,.less.favorable.drugs. Weak Health Systems Without.a.stable.health.system,.any.intervention,.including.one.that.is.relatively.easy. to.administer.with.clinical.training,.will.not.succeed.It.is.critical.to.ensure.that.any. training.or.program.with.magnesium.sulfate.is.offered.in.the.context.of.a.functional. health.system,.where.providers.are.able.to.participate.in.job.training.and.adopt.new. practices,.where.the.procurement.and.distribution.systems.are.effective,.where.norms. and.institutional.quality.protocols.are.in.place,.and.where.facilities.are.reasonably.well- equipped.It.is.also.important.that.interventions.like.magnesium.sulfate.are.provided.as. part.of.a.package.of.emergency.obstetric.care.and.in.the.context.of.a.comprehensive. reproductive.health.approach.that.addresses.women’s.inextricably.linked.needs,. including.family.planning. Dr.Bissallah.Ahmed.Ekele,.Professor.and. Chair.of.the.Department.of.Obstetrics. and.Gynecology.at.Usmanu.Danfodiyo. University,.recounted.that.when.he. graduated.from.medical.school,.he.knew.far. more.about.the.so-called.“lytic.cocktail”—. a.potentially.deadly.treatment—than.about. magnesium.sulfate.for.the.management.of. pre-eclampsia.and.eclampsia.In.his.clinical. textbooks,.where.magnesium.sulfate.was. mentioned,.providers.were.advised.to.use. the.drug.with.discouragingly.great.caution,. due.to.the.various.myths.associated.with. its.use.The.drug.diazepam.has.also.been. very.popular.in.the.management.of.pre- eclampsia.and.eclampsia.in.Nigeria,.despite. the.proven.high.recurrence.of.eclamptic. fits.associated.with.the.drug.Similar.to. other.countries,.provider.knowledge.of.and. training.about.magnesium.sulfate.is.very. limited.And.the.cost.is.prohibitively.high. compared.with.other,.less.favorable.drugs. Also,.in.many.communities,.the.culture. demands.that.women.deliver.at.home.or.at. their.parents’.house,.which.prohibits.women. from.accessing.life-saving.medical.care.in. a.timely.manner. overcoming harmful practiceS in nigeria 12. III.The.Way.Forward:.Solutions.to.Expanding.Utilization.of.Magnesium.Sulfate Based.on.these.conclusions,.EngenderHealth.and.the.University.of.Oxford.developed. a.“Call.to.Action”.that.calls.on.policy.makers.and.ministers.of.health.to.make.pre- eclampsia.and.eclampsia.a.higher.priority.and.to.set.national.guidelines.for.treatment. and.care.based.on.WHO.guidelines.It.also.urges.decision.makers.and.international. and.national.health.organizations.and.agencies.to.help.make.magnesium.sulfate. more.available.and.affordable,.in.part.by.empowering.local.clinicians.with.education. and.training.The.recommendations.for.interventions.to.expand.the.use.of. magnesium.sulfate.are:. Ensure Widespread Availability of Eclampsia Treatment Packs One.specific.and.urgently.needed.step.is.to.promote.the.use.of.“eclampsia. treatment.packs”.(such.as.those.used.in.the.Eclampsia.Collaborative.Trial).to. ensure.ready.access.and.appropriate.utilization.of.the.drug.in.all.facilities.offering. delivery.services.and.to.increase.the.likelihood.of.the.drug’s.correct.and.safe.use. The.introduction.of.emergency.packs.could.serve.as.a.training.aid.to.update.key. health.professionals.about.current.clinical.guidelines.for.management.of. pre-eclampsia.and.eclampsia. Expand Training and Education to All Health Professionals All.health.professionals.(including.family.and.emergency.room.physicians,. anesthetists,.nurses,.midwives,.medical.officers,.and.pharmacists).need.to.be. appropriately.trained.in.the.care.of.women.with.eclampsia.and.severe.pre-eclampsia,. including.the.use.of.magnesium.sulfate. Increase Political Commitment to Address Pre-eclampsia/Eclampsia, in Country and Globally All.stakeholders.concerned.about.women’s.health.are.urged.to.take.measures.to. prevent.deaths.due.to.pre-eclampsia.and.eclampsia.This.would.include.working.to:. • Add.magnesium.sulfate.to.essential.drug.lists.and.ensure.registration,. universal.availability,.and.appropriate.use.in.all.countries. • Develop.country-specific.standards.of.care.drawing.from.WHO’s.guidelines. and.best.practices.to.share.with.national.and.international.colleagues.and. organizations. • Obtain.local.support.and.identify.local.champions,.such.as.health.care. providers.and.politicians. Disseminate Research to Advocate for Increased Utilization and Access Various.champions.for.the.issue,.such.as.researchers.or.professional.organizations,. can.bring.the.results.of.their.research.to.a.wider.audience,.such.as.publishing. articles.that.call.for.updating.clinical.practices.in.national.or.regional.journals.The. information.could.then.be.used.to.convince.central.health.authorities.and.hospital. administrators.to.make.changes.in.clinical.practices.Estimating.the.cost.savings.from. the.use.of.magnesium.sulfate.resulting.in.shorter.maternal.and.newborn.hospital. stays.would.represent.a.powerful.advocacy.tool.to.influence.local.and.national. policy.makers. iii. the Way forWard: SolutionS to expanding utilization of magneSium Sulfate We have moved from: “evidence from both developed and developing countries suggests that deaths associated with hypertensive disorders of pregnancy are the most difficult to prevent” to “we have cost-effective interventions that have been proven to solve a significant proportion of the mortality from eclampsia. We now need the resources to take those interventions to women who need it most.” – dr. harshad Sanghvi, Jhpiego 13. III.The.Way.Forward:.Solutions.to.Expanding.Utilization.of.Magnesium.Sulfate Conduct Country-Specific Research Each.country’s.pharmaceutical.situation,.political.environment,.and.health.care.system. are.unique.Data.collected.about.a.country.in.one.region.often.cannot.be.generalized. to.other.contexts.For.the.purposes.of.planning.specific.interventions,.data.must. be.obtained.on.a.country-by-country.basis.in.order.to.develop.context-appropriate. strategies.for.expanding.magnesium.sulfate.availability.and.utilization.The.types.of. local.information.that.are.needed.include:.maternal.morbidity.and.mortality.resulting. from.pre-eclampsia/eclampsia,.legal.status.of.magnesium.sulfate.and.presence.on. essential.drug.list,.potential.for.political.support.for.health.policy.change,.and.current. practices.in.management.of.pre-eclampsia.and.eclampsia.The.desire.for.a.complete. data.set.for.each.country.must.be.weighed.against.the.costs,.length.of.time.needed,. and.reliability.of.the.data.collection. . The.opportunities.for.reducing.maternal.and.perinatal.morbidity.and.mortality.from. pre-eclampsia.and.eclampsia.are.extraordinary.Magnesium.sulfate.is.a.solution.with. proven.effectiveness.and.safety,.and.yet.it.still.eludes.thousands.of.women.who.die. needlessly.each.year.Although.the.use.of.magnesium.sulfate.has.lagged.in.many. developing.countries,.resources.to.expand.its.availability.and.use.also.exist:.Actions. by.international.organizations,.championing.by.highly.regarded.local.clinicians,.and. the.support.of.local.policy.makers.can.all.help.make.magnesium.sulfate.the.leading. treatment.to.save.women’s.lives. “When you’re dealing with a condition that rarely results in death in countries like the united States but persists as the number one killer of pregnant women in other countries, including mexico, then the problem is not the limit of modern medicine, but one of lack of access, clinicians’ training, and political will.” – dr. ana langer, engenderhealth mainStreaming the uSe of magneSium Sulfate in mexico Dr.Ricardo.David.Muñoz.Soto,.from.the. Ministry.of.Health,.and.Dr.Sandra.García,. from.the.Population.Council,.Mexico,. shared.the.situation.of.magnesium.sulfate. in.Mexico.Pre-eclampsia.and.eclampsia. is.the.leading.cause.of.maternal.death.in. Mexico,.with.magnesium.sulfate.officially. listed.as.the.recommended.standard. of.care.for.this.problem.The.drug.is. inexpensive,.costing.less.than.$5.per. patient,.and.it.is.widely.available,.with. very.few.reported.side.effects.Despite. these.factors,.magnesium.sulfate.is.not. widely.used.in.the.country.Key.barriers. include:.insufficient.medical.curricula.about. pre-eclampsia.and.eclampsia;.difficult. packaging.of.magnesium.sulfate.(i.e.,. magnesium.sulfate.coming.in.1,000.and. 500.ml.packs,.when.the.needed.amount. is.250ml);.less-effective.drugs,.such.as. phenytoin,.coming.prepackaged.and.thus. being.easier.to.administer;.and.insufficient. medical.training,.with.providers.failing.to. detect.the.symptoms.of.mild.pre-eclampsia. and.lacking.confidence.to.administer. magnesium.sulfate. In.response,.the.Ministry.of.Health.has. pledged.its.commitment.to.making. magnesium.sulfate.more.widely.utilized. for.the.treatment.of.pre-eclampsia.and. eclampsia.In.2005,.intensive.emergency. obstetric.care.workshops.held.in.12.states. included.pre-eclampsia.and.eclampsia.and. its.management.with.magnesium.sulfate. The.Ministry.of.Health.and.the.Population. Council.are.partnering.to.address.the. barriers.to.use.of.magnesium.sulfate.and. to.test.interventions.aimed.at.increasing. utilization. 14. References Aaserud,.M.,.Lewin,.S.,.Innvaer,.S.,.et.al.2005.Translating.research.into.policy.and.practice. in.developing.countries:.a.case.study.of.magnesium.sulphate.for.pre-eclampsia.BMC.Health. Services.Research.5:68. Altman,.D.,.Carroli,.G.,.Duley,.L.,.et.al.2002.Do.women.with.pre-eclampsia,.and.their.babies,. benefit.from.magnesium.sulfate?.The.Magpie.Trial:.a.randomized.placebo-controlled.trial. Lancet.359(9321):1877–1890. 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