REMS stands for Risk Evaluation and Mitigation Strategy (REMS)
It is to make sure use of the drugs have benefits that outweigh the risks. To make sure that drugs are prescribed and taken correctly.


An example of Mifeprex prescribing ( part of REMS program): prescriber must be certified with pharmaceutical company to prescribe. Once certified, prescriber must follow the medication guide, patient package insert, a communication plan (when to call doctor, when to go 911), etc. (2)


An example of REMS is iPledge program for severe cystic acne Zenatade medication that can cause terotrogenicity birth defects. Therefore, patients, prescribers, pharmacists, and the drug company must all work with this program. Pt with pregnancy potential has to go thru monthly testing. (1)



List of REMS programs: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm


References:
(1): https://en.wikipedia.org/wiki/IPLEDGE
(2): http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_REMS_full.pdf

GTPAL 
G = gravida - pregnancy
P = Parity (pregnancy delivered @ >20weeks)meaning labors (Para is the number of times the uterus is emptied) broken down into the following:
          T = term deliveries (#) (the number of term pregnancies – twins count as 1 pregnancy! @ > 37 weeks)  
          P = preterm deliveries (@ <37weeks)
          A = abortions or miscarriages (spontaneous + therapeutic/elective)
          L = live births

Ex: G6, P3023 means 6 pregnancies, 3 term deliveries, 0 preterm deliveries, 2 abortions/miscarriages (including early term losses), 3 living children

Ex: "a woman who has 2 living children born as preterm twins in her first pregnancy would be designated as: TPAL 0-1-0-2 - 0 term births, 1 delivery prior to 37 weeks gestation (preterm), 0 pregnancies ending in spontaneous or induced abortions, and 2 living children" (3)

New ACOG guidelines for term pregnancies (1):
 The following represent the four new definitions of ‘term’ deliveries:

• Early Term:  Between 37 weeks 0 days and 38 weeks 6 days

• Full Term:    Between 39 weeks 0 days and 40 weeks 6 days

• Late Term:   Between 41 weeks 0 days and 41 weeks 6 days

• Postterm:     Between 42 weeks 0 days and beyond

Confusing terms (2):
Gravida
A woman who currently is pregnant or has been in the past, irrespective of the pregnancy outcome. 
Gravidity: The number of pregnancies, current and past, regardless of the pregnancy outcome.

ISSUES 
• What counts as evidence of pregnancy? 
Do chemical pregnancies count? 
Do physicians have to have evidence of pregnancy?

RATIONALE 
• If a woman says she was pregnant and there was any evidence, should count. 
• Includes chemical pregnancies



Parity 
The number of pregnancies delivered at 20 weeks, 0 days or beyond, regardless of the number of fetuses, alive or dead.

ISSUES
• Fetal death certificate versus certificate of live birth
• Address confusion over multiple gestation.
• Question of viability at 20 weeks
• Include abortions after 20 weeks

RATIONALE 
• Would, by definition, include abortions 
• 20 weeks was decided by fetal death certificate; do not want to debate viability




~Wonder Me!

Citations:
(1) http://www.acog.org/About-ACOG/News-Room/News-Releases/2013/Ob-Gyns-Redefine-Meaning-of-Term-Pregnancy


(2) http://www.acog.org/About_ACOG/ACOG_Departments/Patient_Safety_and_Quality_Improvement/~/media/Departments/Patient%20Safety%20and%20Quality%20Improvement/201213IssuesandRationale-HistoricalDiagnoses.pdf
https://www.acog.org/-/media/Departments/Patient-Safety-and-Quality-Improvement/2014reVITALizeObstetricDataDefinitionsV10.pdf