Are prescriptions for Sudafed the answer?

Broken Arrow Family Drug blog

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  • 16 June 2011
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    Are prescriptions for Sudafed the answer?

    There’s been a lot of talk locally about the methamphetamine problems in Oklahoma, and the desire to further restrict pseudoephedrine (PSE) sales in an effort to decrease or eliminate the meth problem altogether. One gentleman has gone on a personal quest to restrict these sales, travelling from town to town attempting to convince city leaders to pass city ordinances requiring PSE be sold only by prescription. While I commend this gentleman in his efforts, there are some ‘unintended consequences’ that these restrictions will cause.

    As background, the current law requires that PSE only be sold through a pharmacy, only by a licensed technician or pharmacist. The pharmacist or tech must get the state-issued identification of the purchaser and input this information into a statewide database. The database tracks whether the person has purchased too much PSE. Purchases, as well as attempts to purchase, are immediately registered. State law restricts these purchases to 3 grams of PSE in a rolling 24-hour period (100 – 30mg tablets), or 9 grams of PSE in a rolling 30 day period (300 – 30mg tablets).

    People who purchase PSE for illegitimate reasons attempt to circumvent the aforementioned restrictions by going to pharmacies in groups, with each person purchasing their limit of PSE. It is not unusual to see reports of carloads of people going into a pharmacy and standing in line to purchase PSE, one after another. I have been told stories by law enforcement that these people will take the product to their car and begin the ‘shake and bake’ method of meth production immediately, and have the finished product by the time they get home. Those who don’t immediately manufacture it will take the tablets and sell them to the meth ‘cook’.

    The new restrictions being proposed involve moving the purchase of the tablet form of PSE to a prescription-only basis. I’d like to explore some of the consequences of making this change.

    1. Supporters of the proposal state that liquid-form PSE, including gel caps, will still be available for purchase without a prescription. This is true, but…..

    PSE is not available as a single-ingredient product in a liquid gel cap form. Liquid gel cap products containing PSE also contain other ingredients, such as ibuprofen or acetaminophen (note that every time a television station shows a liquid gel cap form of the product in their stories, it is an Advil product, containing ibuprofen). There are legitimate clinical reasons that a person may not be able to take a product containing ibuprofen or acetaminophen.

    PSE is available as a single-ingredient product as a liquid. I’m not sure that people will be happy having to carry around a 4 ounce bottle of syrup to treat their sinus headache, but it is an option.

    Some have argued that liquid versions of PSE are less effective or work for a shorter period of time than tablet versions. I know of no clinical basis to support these statements.

    2. Some have suggested reformulating the PSE tablets into something that cannot be crushed and used. They suggest modeling a product after Oxycontin – a narcotic pain medication that has been frequently abused by crushing. The Oxycontin tablet has been modified where it cannot be crushed as easily. Providing PSE in a hard-to-crush formulation may slow the abuse, but…

    Understand that the active ingredient of Oxycontin has been available generically for years, but Oxycontin itself is not available generically. The reason for this is because it is not the medication that has been patented, but the release mechanism (the tablet).

    Just for grins, I checked the cost of a regular release oxycodone tablet with the same strength Oxycontin tablet. The Oxycontin tablet is more expensive by a factor of 13 ½. While I can only speculate on what the eventual cost would be of PSE in an Oxycontin-type tablet, if you used these numbers, a $10 bottle of generic PSE now would cost $135.00 after modifying the tablet.

    This also assumes that at least one company will be willing to develop such a crush-proof tablet.

    3. Moving PSE to prescription-only status WILL make it more expensive for the end user. The patient will now have to take time away from work (sick time from the employer), have an appointment with a doctor (copay), and fill a prescription at the pharmacy (another copay). The actual cost of the product will also go up, as when a pharmacy fills a prescription, there is a set cost (overhead) involved that is not involved with the sale of an over-the-counter item. Prescription input, labeling, bottle, clinical evaluation against other medications, transmission of the claim to the patient’s insurer – all of these things take time and money. The pharmacy WILL charge you for these things, all of which are currently not required with the purchase of the over-the-counter version.

    What might have been a $5 purchase to self-treat a sinus headache becomes a half-day trip to the doctor and pharmacy, with much greater expenses. And this doesn’t even account for those who may be in rural areas with restricted access to healthcare providers as it is.

    I have mentioned to some that I am reluctantly supportive of the attempts to move PSE to prescription status. Most have been surprised about my support, knowing my conservative beliefs.

    As owner of a pharmacy, I am the ultimate authority as to whether I sell a product to a person. When a carload of PSE users comes in one after another to purchase product, I have the authority and discretion to deny questionable sales. Chain pharmacists may not have the ultimate authority to question or deny sales. It is much simpler for them to make the legal (but questionable) sale than rock the boat and perhaps get into trouble from their superiors.

    I suspect if you asked technicians and pharmacists who worked at chain stores, the general company policy for PSE sales would be “if the tracking database says they are able to purchase, then sell it to them”. Pharmacists don’t want to be put in the position of being the enforcer. Many times, I have been handed narcotic prescriptions that have CLEARLY been forged, but the prescription has markings on it that show it as previously being presented to another pharmacy. The pharmacy simply returned the prescription to the patient and told them it was “out of stock” – because the pharmacist didn’t want to mess with it or get involved.

    As it stands, the system works IF the pharmacist is allowed the ability to decline a sale even if the tracking database says that the sale is permissible. If the pharmacist is unwilling or unable to exercise that judgment, then unfortunately it is best that the judgment be removed from their hands.

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