Monday, November 15, 2010

OTCs and OB/GYNs

Fifteen years ago, my wife and I were preparing for the birth of our first child. As part of her obstetrical care, the OB/GYN provided my wife with a list of over-the-counter medications that were deemed to be safe to use.

That list was handy. When I was working at a busier pharmacy, my wife wasn't always able to contact me to check on the safety of a medication. She would look at the list and know if the medication was safe or not.

Let's fast forward to today. A few weeks ago, I had a young mom-to-be stop by the pharmacy because she was not able to locate a particular over-the-counter medication. She had a sheet of paper that had a list of acceptable products.

The list was almost identical to the list my wife had fifteen years ago.

And even better, the list wasn't printed from a Microsoft Word document. It was a photocopy of a typewritten list that was probably made in the early 90s.

Maybe it's just me, but I would hope that an obstetrician would update the handouts that they provide to expectant mothers. Seems like good patient care.

Several items on the list were brand name products. Of items that have been either discontinued or reformulated over the years. So it falls on me, the pharmacist, to determine what is safe for the patient. Which is part of the job, and is fine with me. But have you ever paid attention to the looks that you get when you say that the doctor is providing the patient with outdated information?

A lot of it is based on brand recognition. The manufacturers have sold the physicians and public on the idea that ABC Sinus tablets are far superior to the store brand. But this presents a problem when ABC manufacturer changes the formula of the medication. What used to be safe for use in pregnancy may now have a couple pregnancy category C ingredients, but it's still on the OB/GYN's list.

As pharmacists, we need to educate the public about the active ingredients that are in a product. General terms on a brand-name product label like congestion, sinus, and allergy mean different things to different people. I can't tell you how many people buy the store-brand syrup for cough and congestion when they really need something for cough and sinus congestion.

Personally, I would rather take several single ingredient medications than a three-in-one product. I want to treat the specific symptoms that I have. No need to try to kill a fly with a sledgehammer and suffer unnecessary side effects from unneeded medications.

In my cabinet at home, you will find the following OTC medications:
  • diphenhydramine solution and capsules
  • chlorpheniramine tablets
  • ibuprofen tablets and suspension
  • acetaminophen tablets and suspension
  • pseudoephedrine tablets
  • cetirizine tablets and syrup
The only combination products you will find are Mucinex-DM and generic Codimal-DM (the only product that works for my asthmatic son's non-asthma coughs).

But back to the OB/GYN list. Just give the women a list of active ingredients that are safe for use in pregnancy. Tell the women that if the product they are selecting has anything other than what is specifically mentioned on the list, it is not safe. Stop with the brand-name references.


PAS said...

This post encompasses quite a few issues.

Brand name recognition in medical practice has a certain amount of use. Many brand names are far easier to recognize and remember than many generic names. Particularly when referring to combination products, where you've got a soup of generic names, salts and strengths. On the other hand, it also creates adherence to particular brand names - which ultimately increases costs, and can certainly contribute to errors when formulations and strengths are changed.

I'm profoundly mistrustful of combination products. They certainly have their place: when a patient is taking two separate products at a particular strength, regularly, and there exists a combination product with the same ingredients, in the same strength, then it can improve adherence, outcomes and potentially reduce costs. However, what I've seen far more often is the sledgehammer approach, frequently as a result of brand name recognition.

For instance, the published guidelines by relevant societies, medical compendia and reviews are pretty clear on the treatment of asthma in children - with respect to inhaled medications: short acting bronchodialator (eg, Albuterol MDI). If that is insufficient and excessively used, then escalate to an inhaled corticosteroid maintenance with some caution. If that fails, add a long acting beta agonist (eg, Formeterol).

Presently, Advair Diskus is a pretty well recognized brand name drug. It's a combination of an ICS and a LABA. What we very often see is an escalation from even mild asthma (eg, consumption of 1 albuterol MDI) straight up to twice daily Advair without any rational at all.

On the subject of reuse of dated resources - well, that just doesn't work in pharmacy. Everything changes, and changes daily, from pricing, to drug availability to indications and treatment guidelines. Brand names shift, swap manufacturers, swap formulations. Absolutely nothing is static, yet we regularly receive Prior Auths faxed in on forms from 15 years prior.

Some of these have been photocopied to death. In particular, one physician is using a form from approximately five years prior that they filled out once. When they need a PA, they photocopy the sheet with the MD's info and signature on it and fill out a patient/drug. This would be fine, except their contact info wasn't legible when they originally filled it out - and they've been using it for five years.

Anonymous said...

One of the main concerns expressed in this post PAS is that 'brand-names' of OTCs often CHANGE in formulation from year to year.

What one expects as the active ingredient (never mind inactive ingredients!) in the pink stuff called 'Pepto-Bismol' one year is changed willy-nilly to something else the next, and can be legally called by the very same name (and, incidentally used for the same upset tummy).

This is something to do with the fact that proprietary OTC drugs are regulated in the gray area of interstate commerce e.g. State Boards of Health and such, and allowed for sale only having to meet sanitary standards and good manufacturing practices instead of following stringent FDA regulatory guidelines and policies such as in the labeling of 'drugs' because OTCs are not considered drug-type drugs but drug-'type' products. For example, this is why Fat-Buster could be sold in gas stations without a prescription even though it contained the stimulant phenylpropanoloamine that caused strokes and death in woman who were also taking birth control hormones.

This is why the 'natural foods' industry can get away with putting in a smidgeon or dumping a boatload of valerian root in capsules and selling it next to the eyeshades in the airport because it's called a 'food', and only required to adhere to regulations dealing with handling of 'herbal drugs' such as ensuring rat poo-poo doesnt' go into the bottle before the customer pays good money for it!

There are jillions of OTC products in this category. One thing one year and another the next. The only reliable reference WOULD be the pharmacist in these instances, since they have access to incipients and active agents in pharmaceutical products, not some photo-copied list from two decades ago...let's see that could possibly mean the NP advice was from 20 formulations ago?

Let's just look at some problematic re-formulations, shall we?