The Hospice Clinician Blog

Dr. Julia Harder, PharmD, CGP

At Outcome Resources, we have noticed many costly claims for brand name Vicodin (hydrocodone/acetaminophen). Typically, when a prescriber writes a prescription for a brand-name medication for which a generic equivalent is available, the dispensing pharmacy will substitute the generic version, unless the prescriber specifically indicates on the prescription that no generic substitution is allowed. When the prescription is for a combination product like Vicodin, the strengths of all ingredients must be equal in order for generic substitution to be allowed -- so if a prescriber writes for Vicodin 5/500, only generic hydrocodone/APAP in the specific combination of 5 mg of hydrocodone + 500 mg of acetaminophen can be dispensed.

In order to avoid adverse events associated with acetaminophen toxicity, most importantly liver failure, the FDA has recently limited the acetaminophen content of acetaminophen-containing prescription products. These products, such as Vicodin, can now contain no more than 325 mg of acetaminophen per tablet. Vicodin brand products, which previously contained 500 mg of acetaminophen per tablet, have been reformulated to contain only 300 mg of acetaminophen per tablet. Available strengths now include:

• Vicodin -- 5 mg hydrocodone/300 mg acetaminophen
• Vicodin ES -- 7.5 mg hydrocodone/300 mg acetaminophen
• Vicodin HP -- 10 mg hydrocodone/300 mg acetaminophen

Now, when a prescriber writes a prescription for Vicodin, pharmacies may only dispense a generic substitute that contains 300 mg acetaminophen per tablet -- and there is only one generic manufacturer currently making hydrocodone/APAP combination products containing 300 mg of acetaminophen. This single-source generic version of Vicodin is just as expensive as the brand name product. So whether the pharmacies dispense brand-name Vicodin or the single-source generic version, the cost to the hospice is high.

To avoid this increased cost, hospice prescribers need to write for generic hydrocodone/APAP, and specify an acetaminophen content of 325 mg (e.g., hydrocodone/APAP 5/325 1 tablet orally every 4 hours as needed). There are many generic hydrocodone/APAP products that contain 325 mg of acetaminophen, and the cost of these products is substantially lower. The slightly increased amount of acetaminophen contained in these products (325 mg versus 300 mg) will not be clinically significant.

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Our clinical pharmacists analyze our hospice partners medication utilization every month and help alert them to situations such as these to reduce costs. Does your hospice have a proactive pharmacy partner? Find out More Information.

Starting this fall, the labeling of some OTC Tylenol products will indicate a lower maximum dose. Extra-strength Tylenol labels will recommend not to take more than six 500 mg tabs (3000 mg) per day, instead of eight tabs (4000 mg) per day. Next year, the labeling for regular-strength Tylenol products will be revised to indicate a maximum daily dose of ten 325 mg tablets (3250 mg). However, extended-release Tylenol dosing won’t change from the current recommendation of six 650 mg tablets, or 3900 mg, per day.

This measure is part of a continued effort by the FDA and manufacturers of Tylenol and acetaminophen-containing products to reduce the risk of severe liver injury from acetaminophen overdose, and it is, some would argue, a change that is long overdue. However, the inconsistency among labels is bound to create some confusion for patients, caregivers, and healthcare providers (what exactly IS the maximum daily dose of acetaminophen?). Especially for the hospice population, who tend to be older, suffer from multiple disease states, and have an increased likelihood of impaired liver function, it would be wise to limit acetaminophen intake to 3000 mg per day. Make sure to account for the acetaminophen contained in opioid combination products (like hydrocodone/APAP and oxycodone/APAP) as well as over-the-counter medications for cough/cold/flu, sleep, and pain. Also, counsel patients who are taking prescription acetaminophen-containing products to check OTC labels (tell them that acetaminophen is sometimes abbreviated as “APAP”) and to avoid alcohol.

See our blog posts “Pediatric Palliative Care: Pediatric Acetaminophen Concentration & Dosing” and “Hospice Medication Update: New Limits on Acetaminophen Content in Opioid/APAP Combination Products” for more information regarding recent changes affecting acetaminophen-containing products.

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