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.

Esther Liu, PharmD

Recently, Abbott Laboratories took the initiative to introduce the newly formulated Vicodin, Vicodin ES and Vicodin HP tablets with a lower acetaminophen content of 300mg. This was changed to meet the recent FDA mandate to limit the amount of acetaminophen in prescription drug products to 325mg or less per tablet.  FDA’s efforts are aimed at reducing intake of acetaminophen and minimizing toxicity associated with high daily dosage.   The other impacted brand and generic manufacturers may follow Abbott’s step to start changing their formulations  in the future,  however, there are still quite a few active generic hydrocodone/acetaminophen combination products on the market with higher acetaminophen contents including 325mg, 500mg, 650mg, and 750mg. Due to the change of acetaminophen content for Vicodin brand, generic substitution by the pharmacy will be strictly limited to just a couple of generic options that actually match the new Vicodin formulation.   The combination products which contain 300mg of acetaminophen (both the new brand name Vicodin formulation and the few generics available) are more expensive compared to the older combination products that contain 325mg of acetaminophen.

To ensure the appropriate dosage and the most cost effective option is selected for your hospice patients, it is recommended to spell out the generic name for any acetaminophen combination products and specify the strength desired when writing an order.

Below is a list of the common hydrocodone/acetaminophen combination products:

Vicodin = hydrocodone/APAP 5mg/300mg
Vicodin ES = hydrocodone/APAP 7.5mg/300mg
Vicodin  HP= hydrocodone/APAP 10mg/300mg
Norco = hydrocodone/acetaminophen 5mg/325mg
Norco = hydrocodone/acetaminophen 7.5mg/325mg
Norco = hydrocodone/acetaminophen 10mg/325mg
Lortab = hydrocodone/acetaminophen 5mg/500mg
Lortab = hydrocodone/acetaminophen 7.5mg/500mg
Lortab = hydrocodone/acetaminophen 10mg/500mg
hydrocodone/acetaminophen 7.5mg/650mg
hydrocodone/acetaminophen 10mg/650mg
hydrocodone/acetaminophen 7.5mg/750mg
hydrocodone/acetaminophen 10mg/750mg

You may visit the following website for more information about the FDA mandate of acetaminophen limit: http://www.fda.gov/drugs/drugsafety/ucm239821.htm

The FDA has recommended against moving hydrocodone-containing combination products, such as hydrocodone/acetaminophen, from Schedule III to Schedule II. This rescheduling has been proposed as a way to reduce abuse and diversion, but according to the FDA, there's insufficient evidence to support the DEA’s finding that hydrocodone-containing products have a similar abuse potential as Schedule II drugs and should be regulated as such. According to Silvia Calderon, PhD, team leader for pharmacology on the FDA's controlled substance staff, “no objective threshold exists to correlate levels of abuse with the level of scheduling.”

The most recent effort to reschedule hydrocodone-containing combination products on the federal level came as an amendment to the Senate's FDA user fee reauthorization bill (see our previous blog post). However, that provision was stripped before the final bill was passed. As a compromise for its deletion, a two-day meeting of the Drug Safety and Risk Management Advisory Committee was held last week to discuss the proposed rescheduling. In addition, public comments are being accepted until tomorrow, November 6, 2012. To submit an electronic comment, go to http://www.regulations.gov.

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In an attempt to reduce hydrocodone diversion and abuse, legislation including an amendment that would reclassify all hydrocodone-containing products from Schedule III to Schedule II passed the US Senate on May 24. The proposed hydrocodone reclassification is under consideration for the final bill to be sent this summer to President Obama, who is expected to sign the bill into law.

Currently, hydrocodone-containing products such as the pain medications Vicodin, Lortab, Norco and the cough syrup Hycodan are classified as Schedule III controlled substances, along with codeine, another moderate potency opioid. If they are moved to schedule II, the classification of more potent opioids such as morphine, oxycodone and methadone, they will be subject to more stringent regulation and obtaining a prescription will become more difficult. Schedule II medications require a written prescription (no phone-ins and, in some states, no e-prescribing) and cannot be refilled; a new written prescription is required. They must be stored in locked cabinets in the pharmacy rather than on open pharmacy shelves, and take more time to fill due to additional steps, such as double-counting and more thorough documentation. In other words, a reclassification would put a strain on your hospice patients, prescribing doctors and local pharmacies alike.

In response to this pending legislation, letters to Congress were sent by pharmacy groups, including the American Pharmacists Association (APhA). They oppose the legislation, indicating that, while prescription drug abuse and diversion are concerning, “these concerns must be balanced with the impact on patients who legitimately need access to these products.” According to the letters, the Senate amendment is not needed because states can reclassify products as Schedule II without a change in federal law.

It’s easy to understand why this amendment was proposed. Hydrocodone-containing products are one of the most widely abused prescription medications in the country, and cause devastation to the patients addicted to such medications. However, they are also one of the most frequently prescribed for legitimate use by patients in pain. Lipitor is the #1 most commonly prescribed medication in the US, and hydrocodone/APAP is #2. So the number of patients who would be affected by this change, and the impact to pharmacies and prescribers, is astounding.

Tell us: Do you think a hydrocodone reclassification would do more good, or more harm?

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