Food Allergies and the Pharmacy


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Pharmacy Basics: DAW codes

DAW icon

I am finishing up a week of vacation but I didn’t want to miss a week on the blog. Plus, a little alone time was much needed.

We have established that the Orange Book is a fun read, but you can bypass it by using DAW codes. DAW or Dispense as Written codes are codes that specify that a particular brand or manufacturer must be dispensed without substitutions.

There are two DAW codes that I believe are most important for our food allergy discussions/issues: DAW 1 and DAW 2.

DAW 1

DAW 1 means that the prescriber has specified that the BRAND medication only (not the “A” rated, therapeutically equivalent, generic) must be dispensed. Laws vary from state to state but, in general, the prescriber must write DAW or Dispense as Written or Brand Medically Necessary or Brand Necessary on the prescription. At this point the pharmacy is ONLY allowed to dispense that particular product, no substitutions permitted.

This can be good and bad.

The bad:

If the brand product or a specific manufacturer is not covered on your insurance, the pharmacist cannot legally switch to the generic. The pharmacist must call the prescriber and get permission to give the generic product. This will take time. The pharmacy staff may have to leave a message and, depending on how busy the prescriber’s office is, may not receive a return call for several hours to several days.

The specific medication desired may require a Prior Authorization. A Prior Authorization is when the prescriber must call the insurance company, explain why the patient must have a certain medication, and often give diagnoses.This usually happens due to cost issues. Sometimes, the insurance company wants a patient to have tried several cheaper options before allowing a more expensive medication to be covered.

For example: Brand Singulair may require a Prior Authorization since a less expensive, “A”rated generic called montelukast is available.

The good:

Some insurances will assign different copays based on DAW 1 vs DAW 2; DAW 1 being cheaper. Additionally, in instances such as with epinephrine auto-injectors, a “B” rated auto-injector cannot be substituted as with the special circumstances discussed at the end of The Orange Book post.

Example: Adrenaclick written as Brand Medically Necessary CANNOT be substituted with Lineage’s epinephrine auto-injector under any circumstance of which I am aware without the prescriber removing the DAW 1 indication.

Another way that DAW 1 can be awesome in the food allergy world is by specifying a particular manufacturer.

As we have discussed in Pharmacy Basics: NDC numbers and Package Inserts, inactive ingredients often contain food items. If you have found a manufacturer that makes a product without your particular food allergens, stick with it.

medically necessary

As always, review the package insert before purchasing the medication.  Inactive ingredients change just like the recipes for the food we eat. We must review the inactive ingredients each time the medication is picked up.

DAW 2

DAW 2 is simply the patient, patient’s guardian, or patient’s representative requesting a specific brand or manufacturer of medication.

This still may require a Prior Authorization, it may not be covered at all depending on your insurance formulary, and it will not be a less expensive copay but it may be the same copay as prescriptions specified as  DAW 1.

However, with DAW 2, if one of those problems arise, you can decide that it’s not worth the copay price or the wait that may be required for a Prior Authorization to be processed.You can say “Never mind, give me the generic.” No need to call the prescriber.

At that point, you can have the pharmacist help you find another compatible manufacturer, if one exists. This will take time, please be patient. If the pharmacist cannot find a suitable alternative, she may need to call the prescriber to see if a medication change is appropriate.

Plus, you may request the brand medication or a particular manufacturer at any time, even if it’s the third refill.

Once the pharmacy staff processes the medication, they should be able to tell you how much it costs, if it requires a “Prior Auth” (as we call it), or if it is just simply not covered.

For more information on DAW codes go here:  http://www.pharmacy-tech-resources.com/Dispense-As-Written-Codes.html

In the next few weeks, I will be posting an epinephrine auto-injector comparison chart and Pharmacy Basics: Vocabulary. Please comment below on any particular phrases or vocabulary you would like explained.

Don’t worry, there won’t be a quiz at the end.


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Pharmacy Basics: The Orange Book

No, this is not the next book on your toddler’s reading list. It’s something much more fun. And by fun, I mean completely boring, but really useful in the pharmacy world.

What is the Orange Book?

The Orange Book is a list of the drug products the FDA has approved as being equivalent to one another. The Orange Book approvals are based on safety, effectiveness, and “therapeutic equivalence”.

The FDA has added an online Orange Book search to its data base which can be accessed at:http://www.accessdata.fda.gov/scripts/cder/ob/

 Why am I telling you about this?

Recently I’ve seen several comments on social media sites with anecdotes about pharmacies substituting an Epi Pen for other epinephrine injectors. However, these items are not considered therapeutic equivalents. The Orange Book is the pharmacists guide to therapeutic equivalence, but it is also available to you as another tool in being proactive about your health, or the health of the person you are caring for.

What is therapeutic equivalence?

Therapeutic equivalence is another way of saying that the medications contain the same active ingredient; they are the same strength, the same dosage form (tablet, capsule, etc.), and that they are administered the same way (by mouth, injection, etc.)

Medications that are considered “therapeutic equivalent” can vary in color, shape, markings, and inactive ingredients (preservatives, sweeteners, dyes, flavor additives, fillers, and so on).

The inactive ingredients are of extreme importance with regards to food allergies.

What is a TE code in the Orange Book?  

These are the codes that tell you if a product is therapeutically equivalent (TE).

An “A” code (codes beginning with the letter “A”)  such as AB, AT, AO, AN are considered therapeutically equivalent.

A “B” code (codes beginning with the letter “B”) such as BX, BN, BC are, at this time, NOT considered to be therapeutically equivalent.

Why does this matter?

Pharmacists should not substitute products (without physician approval) that are not “A” rated.

A quick search of epinephrine in the Orange Book lists several products including EpiPen, Auvi-Q, and Adrenaclick. The TE code reveals a BX rating. That means that there are no approved drug products equivalent to those specific medications.

An EpiPen prescription cannot be filled with Auvi-Q and vice versa.

The Orange Book can be confusing because there is a TON of information in it to digest. You probably won’t use this often but it’s a super handy tool to have.

Now I suggest you read something a little more fun and a lot more racy: the phone book.

 

 

Note: Some states allow a pharmacist to substitute products despite a BX rating provided that certain criteria are met. Make sure, before you leave the pharmacy counter, that you have the medication you have discussed with your physician.  Ask if it is an “A” rated substitution.

 

 

 

 

 

 


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Pharmacy Basics: NDC numbers and Package Inserts

Pharmacy Basics will be a reoccurring segment about, what else, Pharmacy Basics. This post is very long but very important, please read it all. You may get bored. Feel free to pause in the middle to watch your favorite sitcom or look at pictures of cute kittens, but come back because the information is worth it.

First up, what your pharmacist needs to know.

Tell the pharmacist and pharmacy techs about any food allergies. It has been my experience that people automatically assume medication allergies but rarely divulge food allergies when asked about allergies.

Even if the pharmacy staff doesn’t specifically ask you about food allergies, you tell them. Also tell them that you are aware that certain medications contain food allergens and they are NOT usually caught by the interaction system.  We’ll talk about that in an upcoming post.

What’s an NDC number?

An NDC is the 11 digit number found on each bottle of prescription (and some over-the-counter OTC medications) that specifies the exact medication you have received.

Why does it matter?

Each manufacturer may have different inactive ingredients (which may include food allergens) as compared to other manufacturers of the same medication. For example, Drisdol, a brand name Vitamin D Supplement, contains soybean oil, while certain manufacturers of it’s generic do not.

How does an NDC number work?

An NDC is broken into three sections. The first 5 numbers represent the actual manufacturer. The middle four numbers represent the medication name and strength. The final two numbers represent the package size.

levothyroxine bottle

How do you know which NDC you have received?

Ask the pharmacist! The number may not be listed on the label provided by the pharmacy. However, the NDC dispensed is kept on record in the pharmacy’s computer system.

How will this help me?

Now that you know the NDC number, ask for the package insert. Make sure that the pharmacist understands that the package insert must be for the same NDC that you received–the actual medication that is in your bottle. NO SUBSTITUTIONS.

The package insert is the information packet that comes with the medication. It contains prescribing information, adverse reactions (aka side effects) and lots of other data about the medication.

How do I use the Package Insert?

There are two sections in the package insert that I believe are important for food allergies:

1. Warnings/Contraindications

2. Inactive ingredients (possibly found under “Description”)

levo package insert

The warnings/contraindications sections will sometimes specifically state avoidance if the patient is allergic to a particular food. BUT NOT ALWAYS! Read the inactive ingredients. Highly refined soybean oil, for example, is exempt from the FALCPA, The Food Allergen Labeling & Consumer Protection Act. Soy is one example of a food allergen that is commonly found in gel capsules.

Keep in mind that if the pharmacy needs to “partial fill” or “owe” you medication because they did not have enough in stock, this process should be repeated.

Just like food recipes change, ingredient lists change. Get in the habit of checking the package inserts, better yet ask the pharmacy staff to add a note to your profile requesting that a package insert be included with each fill (if available). If not available then the pharmacist can usually look this information up in one of his/her on-line sources.  This will take time. BE PATIENT! Third option is to call the manufacturer; the pharmacist can provide this number.

The pharmacy staff will be more than happy to help keep you and/or your child safe. That’s what we do! TRUST ME: Pharmacists and techs will go out their way to help a customer that is patient and friendly.