Over-The-Counter Medication Safety: the Knowledge Gap

I love my job as a pharmacist and I have met some amazing people.  Whether my patient’s have a third grade education or a doctorate they all have their own expertise and their own knowledge gaps.  No one can know everything and I don’t expect my patients to be experts in pharmacology.  That’s my niche.  There is just one little problem:  Over-the-counter (OTC) medications.

Here is the problem with OTCs:

  1. There is a public misconception that OTCs are extremely safe for everyone because they don’t need a prescription and they don’t have to be signed for at the pharmacy.
  2. Advertising for OTCs is big business and they can be so incredibly confusing.
  3. The labeling required for OTC medications by the FDA is new, difficult to read, and some people don’t know it exists.
  4. Some pharmacies are located incredibly far away from the OTC section of their store so that patients can’t get the help they need to pick the correct medications.
  5. Some patients are not aware of the knowledge possessed by pharmacists.

So let’s get down to business.
Item 1:

There is a public misconception that OTCs are extremely safe for everyone because they don’t need a prescription and they don’t have to be signed for at the pharmacy.

This is a very understandable, but very dangerous assumption.  Some of these drugs have been determined to be “generally” safe, but some of these medications were grandfathered in when the FDA came into existence.  Acetaminophen, well known as Tylenol, is a great example of this.

Acetaminophen is very dangerous, partially because people are not aware that there is a very tight limit to the amount of acetaminophen they take every day.  In general, the limit is, at the most, 4000 mg.  This seems like a lot, except when you take into account that there is at least 500mg in each Tylenol tablet and the label instructs to take 2 tablets at a time.  That’s 1,000mg right there.  You only have 2 more doses left according to the package insert.  By the end of the day you will have taken, at the least, 3000mg .  That may not be a big deal, except that you may be on hydrocodone/APAP (Vicodin) or oxycodone/APAP (Percocet) for that dental appointment or surgery you had.  The APAP, by the way, stands for acetaminophen (that doesn’t make much sense does it?).  Those tablets can have 325mg, 500mg, or 750mg of acetaminophen per tablet.  You decide to take 2 tablets that contain 500mg each before bed to help with the pain.  If you haven’t had any other of these prescription pain killers during the day you are now at mg of acetaminophen.  But the pain is making it hard for you to sleep so you decide to have some Tylenol PM.  The box tells you to take 2 tablets.  Well that is another 1000mg of acetaminop hen.  You have now taken enough acetaminophen to send you into liver failure.  But what if you feel stuffed up and you also decide to take NyQuil.  You take 2 capsules and now you’ve taken another 650mg.  5650mg without even trying.

Okay that sounds scary.  But here is the other scary part:  You may not know you are in liver failure for another 2 days.  You may feel totally normal.  By then it is too late for the emergency room to administer the antidote.  That means you have two option:  See if your liver recovers or go in for a transplant.

This proves that not all over the counter medications are safe, but aren’t OTC medications, taken properly, safe for everyone?  No.  Sudafed PE contains phenylephrine.  Unless your physician says it is okay patients with heart disease, high blood pressure, thyroid disease, diabetes, or an enlarged prostate should not take these medications.  This is only one example of a medication.  Every medication has warnings like this at the bottom of the box.

Your confusion as a consumer is, however, understandable.  This leads to:

Item 2:

Advertising for OTCs is big business and they can be so incredibly confusing.

How many drug commercials do you see a day for medications?  Cold and sinus, PM, AM, Dayquil, Nyquil, 12 hour, 24 hour, Cold Multi-Symptom, Cold and Cough, etc., etc.  They even confuse me!  The major problem is many of these medications contain some of the same medications so you can get a lot of overlap.  Ibuprofen, anti-hystamines, anti-cough, acetaminophen… you can give yourself a double dose of a medication so easily it is not even funny.  The best strategy, as suggested by the FDA, is to only buy medications with one drug in them and then to combine as needed.  This does three things:  prevents you from over dosing, under treating, and over treating.  Why are you taking Mucinex DM is you don’t have a cough?  Because most people don’t have an idea for what to look for.  The advertisements are confusing and the OTC isle is just plain overwhelming.

There are some tools to help you choose the right medication.

Item 3:

The labeling required for OTC medications by the FDA is new, difficult to read, and some people don’t know it exists.

The new nutrition labels and drug labels can make life a little easier, but there are some problems with them.  Some people don’t know how important and informative the labels are.  The labels are wordy so it is hard to figure out what you need to read.  The labels are very small and difficult to read.  The hardest part is that the labels use medical language that can be very difficult to understand.  So let’s go over a label really quick.  Tylenol and the FDA also have some great overviews: http://www.tylenol.com/page.jhtml?id=tylenol/painex/subhowto.inc and http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143551.htm

Here is an example of a label from the back of a Chlor-Trimeton container:

These labels are required to be on the back of all OTC medications (not herbals) and so all the information you need is at your fingertips.  So let’s take a walk through the label:

 Active ingredient (in each tablet):  This is the quantity of medication per one tablet not one dose.  This is where you can find how many medications are in the product, the name of the medication, and what it is used for.  This can get a little confusing because antihistamine may mean something to you or it may not.  Same with the word analgesic.  Depending on your health literacy these words could totally throw you for a loop.

Uses:  These are the uses, in normal terms, that the medication(s) have been proven to treat.  If you have these signs or symptoms this may be the right medication for you.

Warnings:  This is a very important section.  This is where you may find a health problem you have where you need to talk to your physician before starting the medication.  This is also where you might find possible drug interactions that you should discuss with your physician or pharmacist.  Side effects are listed here.  This section will tell you what you should do if you are pregnant or breastfeeding, although most labels will tell you to speak to a healthcare professional (physicians, pharmacists, physicians assistance, nurse practitioners, etc.) .  All the labels will tell you to keep them out of the reach of children and if they take them to call poison control.

Directions:  This is where you will find patient ages and the quantity of medications you should take without healthcare professional guidance.

Other Information:  This area usually contains storage information.  This one says not to store in your hot car or in your fridge or freezer.  It also request to keep from excessive moisture.  DO NOT store this medication in a bucket of water.  Especially a frozen or boiling one.

Inactive Ingredients:  These are the other non-medication ingredients.  If you are severely allergic to lactose then some medications may not be good for you (this doesn’t mean lactose intollerance).  The same may go for people who are allergic to food coloring.  If you have allergies this a good place too look.

Items 4 and 5:

Some pharmacies are located incredibly far away from the OTC section of their store so that patients can’t get the help they need to pick the correct medications.

Some patients are not aware of the knowledge possessed by pharmacists.

So here is the deal.  I am not trying to tell you that your health care isn’t in your own hands, but professionals are available to help you make the best decisions.  I don’t care where the OTC section is in relation to the pharmacy in your store.  Please go over and bother your pharmacist.  I love being bothered!  It means I get to take a field trip away from my box.  It’s awesome.  Can you trust your pharmacist though?  I mean, didn’t they just take a test or go to trade school?   Oh hell no.  Trust me.   There are two sets of pharmacists out there.  RPh and PharmDs.  You can’t get your RPh degree anymore.  We HAVE to get our doctorates now.  But that doesn’t mean that PharmDs are better than RPhs.  RPhs have a degree, had to take the same test that PharmDs do and have had to attend the same continuing education classes.  The world just moved forward and required a higher degree, but there is no substitute for life experience.  The big sum up:  Talk to the pharmacist.  Make sure it is the pharmacist.  The pharmacy technician can’t tell you which medications to take.  They can lose their license.  So be patient and wait for the pharmacist.  It’s your health though.  You have time for your health right?

I hope this blog helps and I hope you can feel confident to ask questions and talk to your pharmacist and physicians.  No one is going to think you’re incompetent if you ask.  Actually I think very highly of people that ask questions.  No one knows it all right?  If any of you have any questions in regards to this blog or have questions you would like me to blog about please feel free to comment, ask on our facebook page (http://www.facebook.com/pages/Mixtures-Pharmacy/150842975339), or tweet us on twitter @mixturesrx.

 

 

 

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