Government Regulations on Accutane Completely Out of Control

I'm too tired to even rant. Need some exercise? Want to jump through hoops? Then Accutane is the acne drug for you.

 

Accutane is the wonder drugs of acne cures. However, like all wonder anythings, it isn't entirely safe. If you get pregnant while taking it your child will almost certainly have extremely serious birth defects. (So don't get pregnant.) And a senator's son committed suicide while on it, so they've made it extremely difficult to get and issue all kinds of warnings about depression. Depression, such as you will certainly come down with while trying to fill your prescription and hitting obstacle after obstacle after obstacle.

I took Accutane when I was 30, which was back when people had sense. Not many, but more than now. My doctor made me take pregnancy tests and did blood work every month. He was being responsible and I was 30, not 13. The drug worked beautifully and my skin cleared up and stayed mostly clear. In fact, I grew beautiful new skin all over. That was fun. (New skin is now old, however.)

So, now that Lily has taken increasingly stronger acne drugs, treatments, potions, washes, pills and even many visits to a professional zit-picker who also did a good job of picking my pocket since the insurance didn't cover it -- not to mention all the clothing and towels that are now bleached out and spotted from the strong medicines and washes -- it's time for Accutane. The acne medicine of last resort.

She's only 13. This is a strong drug and I really don't like letting the doctor put her on it. But after exhaustive, almost OCD research on my part, I've decided that it is a good choice and our best option. And she won't be on it but for a few months.

How things have changed since I was on it! Now the government is involved. There's a new way to spell "bureaucracy, " and it is iPledge.

You'd think you could just follow the rules and all would be well. But of course the world is not set up to make following any rules other than gravity easy.

Here's how it works. (This is from memory so I may have left out a step or ten.) Your dermatologist has to give your 13-year-old a talk about how any baby your daughter conceives while on Accutane will have birth defects. Then you have to discuss birth control. All of you together.

Your child has to be on birth control. TWO forms of birth control. I explained to the doctor that she is on two forms of birth control, an active mother and father who will kill her if she gets pregnant. Good enough for the doctor, but not the government. So we decide that for the purposes of the Accutane iPledge program, she is on "abstinence" and "condoms" in that order. When I go on-line to pledge all kinds of hooey I have to key in "abstinence" and "condoms" in that order, or my daughter will not be allowed to receive her acne medicine.

There's more. Pregnancy tests. Blood tests. A book we all have to read about birth defects, depression, birth control and way TMI for even a sophisticated, biologically knowledgeable 13-year-old. And all kinds of things to sign. All kinds of pledges, the main one of which was, "I pledge to jump through hoops because I love my daughter and the stupid U.S. government is not going to keep her from getting a drug that will improve her quality of life."

Then there are the timing issues. The dermatologist has a certain window in which she can prescribe Accutane following the pregnancy tests and blood work. First she has to enter some kind of magic words online at iPledge, probably, "The government is good so that means big government is even better. iPledge allegiance to even bigger, more intrusive government." The dermatologist's staffer was a few days late doing this, so when we went in to get Lily's prescription, the dermatologist couldn't write it that day but had to wait a few days. Okey dokey. Few days here, few days there. We're still moving forward.

So I got a call on Saturday from the dermatologist's office that the appropriate time had elapsed and the prescription had been faxed to the pharmacy. I was told to go back online and do the iPledge patient part. The questions I had to answer on the iPledge website were difficult (yes, they were!) but I'm proud to report that I got 100 percent. We have until Friday to get the prescription filled. The prescription will expire on Friday and we will have to start the process over if we don't get it filled by then. And we're going to have to do this same blankety-blank thing every month that Lily is on the blankety-blank drug.

Sounds easy, right? Just go get the blankety-blank stuff at the pharmacy. But wait! The pharmacy we use has let their iPledge status expire. When I went to pick up the Accutane on Saturday, my pharmacist couldn't give it to me. My pharmacist is going to have to go home and read a book so that she can answer the pharmacist questions online and be allowed to fill the prescription. (Even though the dermatologist has done her part and so have Lily and I.)

We have barely started and I am already over this iPledge program. Why can't the pharmacist just put the *&$*($)&# pills in a bottle and let me pay for them? Lily has been to the dermatologist, read an inappropriate book showing her how to put a condom on her partner's parts, had pregnancy and blood tests and stopped all her other medications. I have been online to prove that I can still take stupid tests, remember more than I ever needed to know about birth control and even the stupid rules of the stupid iPledge program. Heaven knows what the dermatologist and her staff have had to do. So why can't the pharmacist, who only needs to know how to read a pill bottle label and count said pills into a bottle with Lily's name on it (no, I'm not discounting the pharmacist's need to know about drugs, but this is just so over the top), just dispense the stupid pills?

Because the government is looking out for our health. Oh, what a great use of resources. An obstacle course that an over-educated, reasonably intelligent mom can barely get through. Lots of trips to lots of places. Extra stuff for the doctor and pharmacist to do. And a time limit. Tick tick tick. The clock is running on getting this prescription filled and my pharmacist is home reading a book and taking tests online. If we don't get it filled by Friday, we start over.

So my pharmacist, who has become my friend, calls me after hours on Saturday to tell me that she has found another pharmacy that can help me, but because of the iPledge program, she can't just transfer the blankety-blank prescription over there. She has talked at length with the other pharmacist and has given him my insurance info., etc. However, I need to call the dermatologist Monday morning (since the pharmacist is off and thinks it gets too complicated if she leaves notes to the Monday pharmacist) to get the prescription faxed to this other pharmacy. So I do and the prescription eventually gets faxed to the other pharmacy.

Sounds like I'm almost in business, right? Not so fast. Once the pharmacy receives the faxed prescription, I'll need to bring them Lily's iPledge card and they'll have to go online to get authorized to fill her prescription.

So I went to the pharmacy and waited. A long time. Yes, they had the prescription, but they only had half as many Accutane pills as are prescribed, even though their pharmacist, knowing that we were coming in today, had ordered what we needed. They will order again and "hope" that the pills come in.

?!?!?!?!?!??!

"Why can't I get half the pills today so Lily can get started and pick up the rest when they arrive?" I ask.

"Can't do a 'partial' on Accutane," they say. Too expensive.

"I have to have this prescription filled by Friday or we have to do it all over again," I insist.

"Maybe the pills will come in tomorrow. Call us in the morning," they say.

In the meantime, they take Lily's iPledge card and call The Government to start the authorization process (or possibly to really booger it up for me if the pills don't come in -- again). The assistant pharmacist is on the phone with the iPledge people answering endless questions. At some point she has to put in a fingerprint. It goes on and on.

When she hangs up, she announces to the rest of the pharmacists, "Can you believe we've got to go through all this again every month for a refill?" (I guess that's why they stuck the young assistant pharmacist with the job.)

So, we don't have Accutane. If the pharmacy doesn't get it in in the morning, I'll have to find someone who has it, and somehow unhook the current pharmacy from our iPledge registration.

No wonder none of the pharmacies are prepared for this. It can't be worth their trouble.

And to think we get to do this every month.

Comments

[jae]

And just think, all you have to do to vote is show a driver's license (IF you're lucky)!

[Anwyn]

I am saying many bad words on your behalf inside my head.

[Zephra]

Crap! I have a son who might be getting this stuff soon. Thanks for the heads up. I wonder if it is like that for boys? It is worse than getting a script for Concerta.

[groovyoldlady]

Mercy!

But you know she could get bc pills WITHOUT YOUR KNOWLEDGE OR PERMISSION from her school nurse even though they involve hormones and could cause her heart problems or cancer problems down the road.

It. Makes. No. Sense.

Ditto what Anwyn said!

[Sister Sassy]

interesting. You'd think they'd let you just do it once and not have to every month.

when I was in h.S. (so, like 12 years ago) my friend was on that drug (pretty sure that is it). She had to go on BC pills while on it but she developed serious depression and couldn't even get herself out of bed. It freaked her out and I think they finally realized it could be that, took her off it, and she was fine again.

It was weird. I kind of P'shawed her about it (in my head) because it seemed weird to me that a skin pill could do that. But that was before my Behavioral Neuroscience courses.

Anyway, sorry for the hoops. I wish once was enough for your sake.

[Angry]

I can't believe the rigmarole you have to go through... which means there is a business opportunity waiting to be developed.

As soon as demand picks up and customer dissatisfaction at how much ‘red tape’ there is becomes a common cry, you'll be able to pick up your Accutane from your local drug pusher... and for a lot cheaper too.

[Deanna]

Actually, I agree with you. I'm a 27-year-old female attorney who takes Accutane. I do not think the government or any public health program has the right to be this involved in my reproductive health, which is my business and is protected by the right to privacy interpreted in the U.S. Constitution and Roe v. Wade. Women were becoming pregnant while on Accutane and having children with birth defects? Not my fault. Not your fault. This is an example of where the policies in the U.S. are determined by the lowest common denominator of intelligence, i.e. just because some people do stupid things, we all must suffer. The better plan is to have everyone sign informed consent forms, and when there are lawsuits, don't allow them to recover a single cent. Are people so naive to think that many of these women who became pregnant did not do so PURPOSEFULLY knowing they would be able to sue for a significant amount for these birth defects? Ask anyone who is familiar with personal injury pharma practice - they will tell you these people exist, trolling for drugs which may cause "jackpot" side-effects. Also, a certain number of people, while not malicious like this, are just going to be irresponsible no matter what - whether iPLEDGE exists or not. Still others may be raped or otherwise misled into having sex. iPLEDGE does not fix these problems. It just causes more for the rest of us. I am sorry you are having to deal with this for your daughter. I have similar issues, but my real problems with the iPLEDGE program are its condenscension towards women, invasion of privacy, and setting of a standard that American consumers are idiots and need handholding by the government in order to make proper decisions. I urge you all to make your opinions known, to your elected officials, the FDA, and anyone else who will listen. Today's Accutane regulation may lead to the regulation of something you need tomorrow.

Also to the person who is talking about picking up Accutane from other "illegitimate" sources - it's already here. Just Google it. You can buy it anywhere - Mexico, Canada, & those are just our neighbors. You can get it for pennies per pill if you want to import from India. Only those of us who pride ourselves on following the law (no matter how stupid) would not take this path of least resistance. Maybe we're the stupid ones.

[Xpress]

My son's dermatologist referred patients to another doctor for 2 years because he couldn't afford to dedicate one member of his staff to deal with Accutane's IPledge hoops. He said it was much worse for Females, then Males. But he couldn't discriminate.

When we went in to request Accutane he was just getting back on the IPledge program. My son had to initial about 10 spots on a warning form. I read it and said, it doesn't give you ANY idea of what the likely rate of occurence is for the side-effects. The one guaranteed side-effect: Dry lips, was listed last. So, hypothetically, there is nothing that says 10% of patients reported hair loss, 5% reported night vision problems...

You would think that every person taking this drug gets depressed and commits suicide after- of course - having unprotected sex.

The box containing the pills is almost impossible to open without a sharp instrument. They ought to add the warning that "opening your accutane with a steak knife may result in accidental death when the knife slips and you stab yourself in the chest."

Each pill is separately wrapped and the opening has a symbol of a pregnant woman with a line through it. I tell my teenage son to view it as a daily reminder not to have sex and get anyone pregnant! (Not that his use of accutane would cause any deformities in a child, but I am too young to be a grandmother!)

When the next President is looking to cut programs to save money - I hope Accutane's IPledge program of big brother monitoring is TOP on the list.

Then they can do something about HIPAA - what a waste of trees and an obstacle to helping your elderly parents with their medical insurance or even talking to their doctor!

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[Peter Jackson]

I've experienced accutane many years ago and now I'm on my second term about 6 years later. When I first took it, it got a little worse before it got better, but around the 2nd and 3rd month I completely cleared up from head to toe. It was an amazing transformation.

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[Dakota]

Been trying to get my 18 yr old script filled lab work came back fine,,got the ipledge thing done- as a parent just reading that green book both times two years ago when he was prescribed it the book sacred me crazey -- and I was an accutane kid took it for six months in the early eighties and it was my miracle never a pimple since I am now 41 and my eighteen yr old son has been fighting the acne curse for three years nows you know every antoboitic out there taken daily for a year to two every derm cream made for acne and me searching like crazey for all cures known to man- well we got our script two days ago and I have been to like four phamcies and they do not want to work with my insurace or discount cards they all try to scam me for 700.1,000 for a 30 day one month refill thinking Ill pay it due to the timeline, Im calling my derm tomorrow to get it cleared cause now I have to wait a week till my insurance will kick in this is insane I have spent wasted hours talking visiting pharmacies dealing with myinsuracne all for nothing they really make it too hard so we cannot get the drug for our kid not to meniton my child is depresssed due to acne for years now...and I am tooo ... what a mess what a headache any answers is their help for us moms.