RX Package Insert — Just Read It!

I was trying to remember when prescription drugs were allowed to advertise on television (called “Direct To Consumer Advertising, or DTCA”).  Fortunately, I didn’t have to bust my memory cells – I just had to “Google it.”

1995. The year all HHHHell broke loose.  At least if you were a doctor.

Suddenly, patients could make their own diagnoses and prescriptions and just phone the order in to their doctor.  At least, that’s how most patients thought it should work.  And – hoo boy! – were they upset when it wasn’t quite that easy.

Comedian Dennis Miller has a hilarious line: “I divide medical practitioners into two camps. Those who will give me a scrip for Vicodin over the phone, and those who won’t.”

Hilarious if you aren’t a doctor, that is.

Yes, DTCA has certainly changed the way consumers react with their medical specialists. And that’s because DTCA radically changed the way consumers got their medical information.

If you have ever read any of my writing, you might get the impression that I consider pharmaceutical companies a little bit biased.  They seem to think everyone needs a drug for every little thing going on in their lives.

Notice I didn’t say “everything going wrong.”

Sometimes, you just don’t need a drug.  Or perhaps you need some kind of help that can be obtained by avoiding certain foods you eat, or by adding certain things like vitamins and probiotics.

But diagnosing and prescribing are pretty complicated things.  Spending an hour — or a half or even an quarter hour — with your doctor will probably get you more information (and more accurate information) than a 30 or 60 second commercial on TV.

The 411 (as the “hip” people say today when spreading information) about drugs is required by law to be presented by the drug companies.  For example, in your prescription, you will probably have an information sheet, or your pharmacist may give you some printed instructions.  There is a book called the Physician’s Desk Reference (PDR) that is available in libraries and – to a limited extent – online.

The information in the PDR comes directly from what we call “the package insert.”  You know – that piece of paper that is so long that it is folded more times than a map of the Great Wall Of China and printed in type so small you have to be an insect to read it.

That’s the package insert.

When your doctor gives you free samples of a medicine, an official hard copy of the package insert is usually available in the free sample box.  If it isn’t, maybe the doctor can be coerced into giving you one.

The print-out you get from a pharmacy is “nice” and may have added value but it is not an official FDA package.  It probably comes from a third-party, maybe even a print-out of an internet web page. Obviously I’m stressing this package insert because you want one, believe me, and they are not that hard to come by. Beware if you go to the public library and photocopy the appropriate page from the PDR.  If the drug has not been out long enough, it may be available through some sort of attempt to update same.  If it has been out for a while, there may be updates not included in the library’s volume.  Things like warnings of dangerous side-effects and other cautions. Now me, personally, unless it is a life and death emergency, if we are dealing with the day to day chronic conditions that plague most of us, I would want to read the package insert before taking the drug. Starting on the first day of my third year in medical school (when I finally got to see live patients), I started reading — and remembering big hunks — of package inserts.  I learned an awful lot of practical medicine. You probably thought, when you first heard of the PDR — upon hearing its full official name — that it had useful information like standard laboratory results so that doctors did not have to worry their heads with such things. No way. 

The PDR contains nothing but commercial proprietary information provided by the manufacturing drug companies.  How could that be wrong or dangerous?

In my experience, the PDR seems to have just  enough information so that when someone takes a drug and runs into problems, as much of the liability as possible is redirected from the drug company to the doctor. Isn’t that nice of them?

A package insert is determined in the final analysis by the FDA.  But the system we have in these United States is neither complete nor accurate, largely for commercial and political reasons.

If a drug company believes it is inappropriate for something to be on the package label, because it should not be “called attention to” (read — should not be taken as serious enough to limit sales of the drug) it just might get lost in cyberspace.  So if anything actually makes it there, it is really important to know. The official “package insert” is generally available on line.  Sometimes, however, they call it “prescribing information,” and says you have to get a doctor or a pharmacist to print it out for you.  Personally, I think it is lovely to ask someone else and make them feel important. Once you get that important document in your hands, here’s what to look for: At the outset it ought to have both the original manufacturer’s brand name and all generic names that are authorized for sale in these United States.

There is a lot of technical stuff that’s more for a doctor to read and understand, like how the stuff gets metabolized.  That’s not so important for you to worry about. You do want to look at the “Indications” section.  This ought to be a list of the diseases and symptoms the medication will help. 

Do not hit the ceiling if your illness is not on the list.  Plenty of drugs have been used by plenty of people for “off-label indications.”  There are lots of these in the literature (published journals) that are valid and good.  So do not belt your doctor in the mouth just yet.  A polite phone call (or email) will do.  “Counterindications” are the reasons for which a drug ought not to be used.

“Warnings” and “Precautions” are highly relevant for everybody and should be read as if they were Holy Writ. The strongest warnings are in a “black box;” at the top of the insert, not quite as strong as the “Counterindications” but believe me, this is stuff you want to know. Even though the addition of a black box is usually widely publicized with letters direct to doctors, NEVER assume that your doctor actually knows about them.  Sometimes, a lot of times, the letters from the drug company can be mistaken for junk mail.  Do you know the contents of your junk mail?  I have seen studies showing that a doctor needs to be sent something in the mail at least three times before it gets read.  Doctors are only human.  I rest my case. General Precautions and Information for Patients usually look and sound a lot alike.  One for patient, one for doctor.  Generally, like all else here, read by neither. Laboratory tests are recommended.  Few doctors actually follow through on these as recommended, maybe feeling in their invincibility that they will “know” if something is wrong. But usually because your insurance won’t pay for them. If lab tests recommended on the package insert have not been performed, make sure you ask the doctor WHY.  There may be a decent reason, such as recent tests done for something else. Sections like labor, delivery pediatric use, are self-explanatory. If the drug has been prescribed to a pregnant woman, you pay special attention to the pregnancy category.  It tells you what is known about the effect on the unborn when the mother is using this drug:
A.) has been clinically tested during first trimester (the most susceptible period, as organs are being formed) and has failed to cause birth defects in animals or humans.
B.) has no risk in human tests, may have some in animals but it is not possible to infer directly.
C.) either no animal or human testing has been done or some animal testing and no human testing.
D.) has been shown to have human fetal risk based on case reports but may still be useful in a human when advantages and risks are reviewed.
“Adverse Reactions” might be a scary section; it lists everything that has happened – no matter how rarely — starting with testing before the drug’s approval.  If these things are happening, an official report to FDA is warranted. Read the “Dosage and Administration” section particularly closely.  I have personally cleaned up messes from doctors who prescribed a tiny dose, thinking to avert a side effect, (nothing got better; time and money were wasted) and those who overprescribed, making a patient quite ill. I heartily recommend that you check for a package insert equivalent online, as getting hold of your doctor or a trip to a pharmacy or public library may not fit your schedule – especially when time is critical and you want to find out if your medicine is responsible for some odd reactions you are having:

RXList.com

Drugs.com

I really don’t lose any sleep if Dennis Miller doesn’t think I’m a good doctor.  I’d never phone in a prescription for Vicodin for somebody I’d never met who just called me on the phone.

However, there are some “good doctors” out there, fitting Mr. Miller’s description.

That is what makes me lose sleep.

But that is another essay.