Report on Women’s and
Children’s Services Group
OB Clinical Work Group
Nashville, TN
March 17-18, 2011
Clinical Protocols
Blood Pressure Management of Severe
Intrapartum or Postpartum Hypertension
 VBAC HCA Policy
 Postpartum hemorrhage
 Management of Prolonged Second Stage
of Labor
 Magnesium for fetal neuroprotection
 Misoprostol labor induction
 Group B Strep Protocol

Blood Pressure Management of Severe
Intrapartum or Postpartnm Hypertension
systolic blood pressure is ≥ 160 mmHg OR
the diastolic blood pressure is ≥ 110 mmHg
 Labetalol or hydralazine option
 If either blood pressure criteria is exceeded
after 3 doses then MFM , anesthesia or
medicine consultation

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VBAC HCA Policy

Patients with more than 1 cesarean, an unknown
scar type, a baby with an estimated fetal weight >
4000 g or in whom labor induction is contemplated
require additional counseling regarding an
increased risk of rupture and a decreased chance
of success with a trial of labor. This counseling
should include: with > 1 prior cesarean, the risk of
rupture may be as high as 4%. With an unknown
scar type, the risk may be as high as 10% if the
scar is vertical. With a macrosomic infant, or with
oxytocin induction, the risk of rupture is increased
slightly.
Postpartum hemorrhage

If the estimated blood loss by any provider
(OB, Anesthesia or RN ) exceeds 1500 ml
OR whenever the systolic pressure is
below 90 mmHg OR the diastolic pressure
is below 50 mmHg in a bleeding patient 2
OB physicians are notified and required to
personally evaluate the patient and both
write notes in the chart.
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Management of Prolonged Second Stage
of Labor
Magnesium for fetal neuroprotection
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Misoprostol Labor Induction
P.o. option – 25mcg
Preterm Labor Assessment
Cervical Length
 Fetal Fibronectin
 Both

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Progesterone for Preterm Labor
Prophylaxis
Makena 1,500 dollars/dose
The Clinical Services Group (CSG) has received several questions and comments regarding the substantial price
Increase of hydroxyprogesterone caproate Makena®). The aforementioned product was granted approval to
Ther-Rx Corporation by the Food and Drug Administration (FDA) on February 4, 2011.
Hydroxyprogesterone caproate (Makena®) is an injectable product approved to reduce the risk of preterm birth in
women with a singleton pregnancy, who have a history of singleton spontaneous preterm birth1. In 2003, federally
funded research demonstrated both 17 alpha-hydroxyprogesterone caproate (17P) in oil, given as an
Intramuscular injection once weekly, and micronized vaginal progesterone suppositories (Endometrin®),
administered each night, were equally effective in preventing preterm births in the above-mentioned
population2,3,4. Prior to approval of hydroxyprogesterone caproate (Makena®), 17P has been widely available as
a prescription product at compounding pharmacies. Hydroxyprogesterone caproate (Makena®) is a manufactured
version of the identical compounded drug, 17P, with the same medical indications for use. If used, these
medications are typically initiated at a gestational age of 16 to 20 weeks. Therefore, use of the above product(s)
can approach 20 weeks’ duration. The primary reason for recent controversy revolves around the significant price
increase of the manufactured product (Makena’s® actual wholesale price (AWP) is $690/week; $13,800/course)
versus the compounded product (17P is approximately 15/week; $300/course). Ther-RX Corporation announced
on April 1, 2011 that the list price of Makena price would be reduced by 55% to $690 per injection.
CSG is aware of the “cease and desist” letters sent to many compounding pharmacies by Ther-Rx
Corporation,
threatening FDA enforcement action related to the compounded versions of hydroxyprogesterone
caproate. However, on March 30, 2011, the FDA released a statement indicating that the above
statement, made
by Ther-Rx Corporation, is incorrect. The FDA, according to the March 30 statement, will not exercise its
authority
to prevent pharmacies from Producing “compounded” versions of the drug unless evidence emerges that
patient
Safety was at risk.5 At this time, compounding pharmacies may continue to compound versions of
hydroxyprogesterone caproate, as long as the Food, Drug and Cosmetic Act (FD&C Act) is followed in
accordance
with the law. The FD&C Act, Application of Federal Law to Practice of Pharmacy Compounding, states
that
compounding may occur if the licensed pharmacist or licensed physician do not compound regularly or in
inordinate
amounts (manufacture) any drug products that are essentially copies of a commercially available
drug.6 Therefore,
Compounding pharmacies may choose to cease compounding hydroxyprogesterone caproate or they may
choose to create a different version of the product. The latter may involve alterations to the product,
including, but
not limited to, different vehicles, preservative-free preparation and/or single-use vials. The active
chemical,
hydroxyprogesterone caproate, will remain the same.
CSG, along with members of the Obstetric Clinical Workgroup, have worked together to create the
following guidance statements. It is our recommendation that facilities should:



Discuss hydroxyprogesterone caproate (Makena®) use with both the Pharmacy and Therapeutics (P
& T) Committee and the Obstetrics and Gynecology Committee.

Decide upon formulary versus non-formulary status.

Inform Obstetricians of the patient-assistance programs offered by Ther-Rx Corporation. This
information may be useful for the general outpatient population.

Inform Obstetricians of compounded versions of the product. These versions may be
purchased, on an outpatient basis, from specialized compounding pharmacies.

Decisions should be made by appropriate individuals regarding if compounded products,
purchased outside of the institution, are allowed. Factors to consider include, but are not
limited to, verification of the product and compounding pharmacy.
Discuss addition of micronized vaginal progesterone suppositories (Endometrin®) to the hospital
formulary as an acceptable alternative to the injection.

Micronized vaginal progesterone suppositories (Endometrin®) have an AWP of $7.50/day;
$1050/course, where a course of therapy is equal to 140 days (20 weeks) in duration.
Continue our attempts to optimize the management of preterm labor.
Progesterone for Preterm Labor
Prophylaxis
Alternate options
 1 Micronized vaginal suppositories 200 mg q hs
 2 Hydroxyprogesterone caproate in sesamie oil
Postpartum Readmission Rate
within 42 Days of Delivery
Phone call triage system 1 & 3 days
post discharge
AirStrip OB
Use it or lose it
 228$/mo per ob

Core Measures
No Elective Deliveries Prior TO 39 Weeks
 Cesarean Section – Nulliparous women
with a term, singleton baby in a vertex
position delivery by cesarean section
 Antenatal Steroids – full course 24-32
weeks
 Health Care-Associated Bloodstream
Infections in Newborns
 Exclusive Breast Milk Feeding

Draft of Proposed Score Card
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EMR is coming
Competency Maintenance Modules 2011
HCA Frequency of Adverse Outcomes
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