So everyone's on board. How do we minimize the risk?
Of course we wanna minimize the risk of babies developing birth defects
but pregnant patients should avoid unnecessary drug use.
Now, this is a very awkward subject but it's a problem in America.
Pregnant women still use alcohol, cocaine, elicit drugs,
so that's one of the things we're talking about when we speak of placental drug transfer.
Those substances also make it across the placenta.
We even have babies that are born drug-addicted through no fault of their own.
But see, it's not about fault.
As nurses, our job is to help everyone become healthier
including moms that are making choices that we do not agree with
but we still owe them respect as humans,
they're people of value, and to try to help them see the benefit
to their own life in making some choices that are healthier for them.
Now, we talk about prescription drugs.
That's gonna involve significant consultation with your physician.
Over the counter meds, also.
You wanna consult with the health care provider who has prescriptive authority
before you take prescriptions and/or over the counter medications.
The problem is, if a patient is of child-bearing age,
you always wanna consider any prescription or over the counter med
a possibility that you could be pregnant if you're of child-bearing age and sexually active.
So keep that in mind, even if you're taking birth control
and you don't want to be pregnant,
you do need to think about the effect of that prescription
or that over the counter medication on an unborn child.
Now, this is old school.
This is FDA pregnancy risk categories.
Now you can see they go from A, B, C, D and then we drop right to X.
So if you've seen FDA pregnancy risk category X, that means don't take it.
It's gonna cause fetal harm or fetal death. But the rest of this got kinda complicated.
Look, A is safest, B is more dangerous than A
but C is more dangerous than A and B, and D is more dangerous than A, B, and C.
Okay, can you see why people were confused?
It really wasn't that helpful which is why these have gone away.
The original A, B, C, D, and X pregnancy risk categories have been replaced.
Now there's 3 narrative sections with multiple subsections.
So A, B, C, D, and X, that's no longer cool. That is old school.
The original A, B, C, D, and X have been replaced with 3 narrative sections
that have multiple subsections.
So the pregnancy and lactation labeling final rule, PLLR,
that's what's replaced the A, B, C, D, and X.
Now, it went into effect on June 30th 2015 but the timelines for implementation
and new information on drug labels packaging kinda varies
but know that it went into effect 2015.
So we are well beyond 2015.
Now, prescription drugs that were submitted for FDA approval
after 2015 have to use the new PLLR format.
So anything that was submitted for FDA approval after June 30th in 2015,
they have to use the PLLR label.
Now, prescription drugs approved on or after June 30th 2001
are being kind of phased in gradually.
So if you're after the 2015 date, you have to do it no choice.
The others that were before that, they're gonna be phased in gradually.
Okay, lots of dates in here. I know you're feeling like we're in history class but just stick with me.
Medications approved before June 29, 2001 aren't subject to the PLLR rule.
However, the pregnancy letter category A, B, C, D, and X
had to be removed by June 29th 2018. So those all have to go away.
So over the counter drug products aren't affected by the new FDA pregnancy labeling
so you won't see the PLLR.
These are the 2 major categories of exceptions to PLLR.
Now let's talk about the new stuff, right?
Let's talk about what these 3 sections are and their subsections.
First, pregnancy which now includes labor and delivery.
So from the time that you know you're pregnant all the way through the delivery of the baby.
The next is lactation. That includes nursing mothers.
And finally, here is kind of a new one. Females and males of reproductive potential.
Remember, we talked about if you're of child-bearing years
and you wanna make sure that you think of yourself as you have a reproductive potential,
what impact will this medication, prescription,
or over the counter have on developing fetus.
So let's look at the subsections. I love how that pops up. Ain't that cool?
Okay, so in pregnancy, labor and delivery, we're talking about pregnancy exposure registry,
got a risk summary, clinical considerations, and data.
These are the subsections of the PLLR. No need to memorize these.
I want you to be familiar with what the 3 major categories are
but these let you know what the subsections are underneath.
With lactation, we've got risk summary, clinical considerations, and data.
Finally with the last category, got pregnancy testing, contraception, and infertility.
So these are the major categories and their subsections that are covered in the PLLR.
That means if I'm looking up information on a drug,
the data and information about this drug is organized in one of the 3 major categories
and additionally in the subsections.