There's been a lot said recently about generic drug pricing and sticker shock, but the following probably takes the cake. If doctors aren't careful with prescriptions, patients and insurers can wind up paying exorbitant amounts - unnecessarily.

As most readers are aware, a pain medication called Vicodin has been one of the most widely abused prescription opioid products on the US market. The drug is actually a combination of the opioid hydrocodone along with acetaminophen, a nonprescription analgesic. It generally is at the top of the charts as the first or second most widely sold medicine.

Forget about the drug abusers for a minute because there are also millions of patients who suffer from chronic pain that receive legitimate prescriptions from their doctor. They need to be aware of a bizarre situation that's developed due to recent changes that involve these products.

The acetaminophen component in this product is associated with liver toxicity when doses exceed more than 4 grams a day - even less in patients who also drink a lot of alcohol. Some of the generic formulations for this medicine had as much as 500 or even 750 mg of the drug in each pill. Some were taking several tablets a day and even mixing in over-the-counter acetaminophen products, far exceeding the 4 gram limit. So in 2012, in the name of liver safety, FDA asked companies to change their formulation, cutting back on the amount of acetaminophen in Vicodin-like products to 325 mg or less per tablet. A boxed warning about severe liver toxicity was also added.

At the time, Vicodin was still on the market (that brand has since been discontinued). There were also generic products with 325 mg and they continue to be available at low cost. But guess what happened?  The Vicodin manufacturer had an idea. Why not create a generic with only 300 mg of acetaminophen, unlike the generics? That would allow them to sell it as if it were a new drug - the only one with 300 mg. Patients would need to get their product if doctors prescribed a 300 mg combination. Any prescriptions that stated "Vicodin" could not be legally filled with the old formula. The Vicodin product manufacturer notified the healthcare community out about this formulation change, mentioning that all strengths of hydrocodone will now be combined with 300 mg of acetaminophen.  Doctors everywhere began reprogramming their computers to list the 300 mg acetaminophen dose but they didn't necessarily also list products with the 325 mg dose. To this day, prescriptions are often for the 300 mg strength. Many doctors aren't even aware there is a 325 mg generic product. Other manufacturers have jumped on the bandwagon since then so the 300 mg product is now generic.

Something else happened. Because the drug was so widely abused, the Drug Enforcement Agency (DEA) and FDA issued a new rule effective last October. They reclassified the drug from Schedule III to a Schedule II controlled substance, the same as straight morphine. Whereas doctors and pharmacists had looser rules for Schedule III, for example allowing refills, Schedule II prohibits refills and generally makes prescriptions it much more difficult to handle for doctors and pharmacists. Patients must obtain an original prescription from their doctor each time they need a new supply. Prescriptions can't be faxed or emailed to the pharmacy and there can be no telephone orders. Pharmacists can't just strike out information on the prescription or make changes on their own, such as changing the prescription to hydrocodone with acetaminophen 325 mg.

The price of the less expensive 325 mg product and the 300 mg product is dramatically different. Prescription prices run about $9 to $12 for 30 tablets of the older 325 mg product. But, for the same exact medicine with 25 mg less acetaminophen, prices are between $30 to $45 for 30 tablets or about $125 to $150 for 100 tablets. Again, pharmacists can't just change to the 325 mg combination. To pay less, the patient literally has to go back to their doctor to get a new prescription.

A 300 mg combination doesn't cost manufacturers any more to make. So we can conclude how much drug companies are profiting from this travesty.  Chronic pain patients beware, ask for generic hydrocodone/acetaminophen combinations that have 325 mg of acetaminophen, not 300 mg. Otherwise, the cost will just add to your suffering.

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