Labeling Medications

Alright, let's talk about what needs to be on a label. There's the easy stuff: pharmacy name and all of that, but that's mostly the job of the pharmacist (or whoever is ordering the labels) since most of the time that is all preprinted. Don't worry... I'll cover that stuff, too. But my biggest concern right now is the part that you're in charge of. So really... What do you actually NEED to put on the label?

There are eight items required by federal law to appear on all prescription labels....Any guesses on what?

1. Name and address of dispensing pharmacy
2. Serial number of the prescription
3. Date of the prescription - this is the fill date, not the date the prescription was originally written
4. Name of the doctor who wrote the prescription
5. Name of the patient
6. Name and strength of the medication in the bottle
7. Directions for use, including any precautions
8. "Federal Law prohibits the transfer of this drug to any other person other than for whom it was prescribed" on all controlled medications

It is important to note that state law may make these requirements more strict, but this is the bare minimum that must be on the label. Other common things you may see on a label include: 

1. Manufacturer of medication
2. Description of tablets/capsules
3. Pharmacy phone number
4. Patient address or date of birth
5. Number of refills remaining

But like I said above, most of that information is handled by either being pre-printed onto the labels, or is automatically printed by the software onto the label. 

The silliest mistake I ever see is typing tablet when the medication is a capsule or vice versa. While this sort of mistake will rarely make it past a pharmacist, if it does it may confuse the patient and cause you more trouble in the end trying to assure them that they received the right medication. Always double check your dosage form before printing your label. 

The quantity and the frequency are important for obvious reasons. Be careful not to confuse q.d. (daily) and q.i.d. (four times a day) and remember that q.s. means "quantity sufficient". Yes, this means that you might have to do a little math to figure out how many tablets or capsules the patient is to receive. 

Always include the route that the medication is to be used on the label. Even though the physicians orders may not specify by mouth, you should. There are vaginal and rectal suppositories and oral, sublingual and buccal tablets. Never assume that the patient knows where or how they're supposed to use their medication.

Remember that eye drops can be used as ear drops, but ear drops cannot be used as eye drops. Nasal sprays should specify if they are to be used in one or both nostrils. If the doctor specifies the "affected area" for a topical medication, that should appear on the label as well. Some transdermal patches have to be put on specific areas of the body (Lidoderm and Flector, for example should be applied to the painful area). There are special vaginal formulations of certain creams (especially anti-fungals for yeast infections) that are designed to be used intra-vaginally, while topical formulations are not. 

Some horror stories in this department include patients putting ear drops in their eyes and ending up with painful inflammation. Some sublingual tablets (like nitroglycerin) are used sublingually because that minimized the drug's first-pass metabolism in the liver. If swallowed whole, they are destroyed by the liver before ever reaching circulation. I've even heard a story of a patient attempting to swallow a promethazine suppository because they thought the doctor was giving them tablets and that they just "looked funny". I wish I was kidding about that...

When dispensing transdermal patches, you should specify the length of time the patch is supposed to stay on (usually 72 hours for fentanyl, 1 week for clonidine, 12 hours for Lidoderm, etc.). As silly as this sounds, you should always specify to "remove old patch before applying new". 

I know. "Who in the world would be that stupid?" I've seen a patient come in with multiple nicotine patches on because he didn't know he was supposed to remove the old one... he thought they would fall off then they were out of medication. 

If the doctor specifies a duration of therapy (as is common with antibiotics), you should include that on the label as well. Some doctors will specify a maximum quantity of tablets per day, as is common with pain medications taken on an as needed basis and this should be put on the label as well.

Remember that every 12 hours and twice daily are not necessarily the same thing (same with every 6 hours and four times daily, etc.) and you should never take it upon yourself to use the two interchangeably. Four times a day usually indicates that the patient should space them evenly through their waking hours, while every 6 hours indicates that they should likely wake themselves up to take the medication to ensure appropriate blood levels.

Finally, some of the auxiliary labels can be just as important as the directions that you type on the label itself. They can warn of side effects, instruct patients on which foods or drugs can interact with their medication, tell them how to store their medication or simply remind them of what their medication is for (which can be especially useful in older patients).

Auxiliary labels indicating route of administration (rectal, nasal, external) can reinforce what is written in the directions. It is important to remember that auxiliary labels are to reinforce proper use and using the auxiliary label is no reason not to indicate the route of administration in the directions as discussed above.

Labels such as take with food, water or do not take with dairy products help a patient to take their medication properly, which increases the likelihood that the medication will actually help them. When a patient feels that the medication is helping them, it increases patient compliance and overall health.

Warnings about drowsiness or impaired ability to operate machinery are required in some states. Many states enforce the same DUI rules with prescription medication that they would enforce with alcohol and it is important that your patients be aware that their medication may hinder their ability to perform certain tasks.

Other sorts of side effect labels (such as a note that a medication may discolor urine or feces) can warn patients of frightening, but harmless side effects.

Labels reminding a patient to shake well, store in the refrigerator or discard after certain dates ensure that the patient receives the right dose and that the medication is not compromised by inadequate storage conditions.

Remember to always err on the side of over-cautious. Yes, you know that the sleep aid may cause drowsiness, but never assume that the patient does. 

Sorry there was no FDA Update on Sunday. There was nothing of big interest to note. 

Happy labeling,

C. Samuels 

References

"Auxiliary Labels." The Pharmaceutics and Compounding Laboratory. Web. 16 May 2011. <http://pharmlabs.unc.edu/labs/prescriptions/auxiliary.htm>.

"May Cause Discoloration of Urine/Feces Pharm Instr Label." pharmcy labels,labels,instructional labels-Pocket Nurse. Web. 16 May 2011. <http://www.pocketnurse.com/May-Cause-Discoloration-of-Urine_Feces-Pharm-Instr-Label/productinfo/06%2D31%2DP09/>.