• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Download full size image

Loophole Allows Pharmacies To Switch Drugs Without Consent

Posted on: Wednesday, 3 June 2009, 06:42 CDT

When filling a prescription, most of us expect to receive the medication the doctor ordered.  However, because of a loophole in rules governing how drugs are dispensed, this is not always the case.

The practice, known as “therapeutic substitution,” can have disastrous consequences.

Prevention magazine reported the story of Amy Detrick, a 40-year-old social worker in Grove City, Ohio, who had been diagnosed with epilepsy.  Detrick’s physician customized a precise cocktail of drugs that would keep her from having seizures. 

The doctor carefully calibrated and adjusted doses, then meticulously tracked Detrick’s responses.  Once her condition was finally under control, she filled a prescription for Tegretol, one of two drugs she took, but suffered a seizure shortly thereafter while riding her bicycle.  The fall resulted in a broken leg and a hairline fracture in her left eye socket. 

While treating her injuries, doctors noticed Detrick’s blood level of her medication had declined.  She later learned her pharmacist had exchanged the Tegretol for a generic drug that worked slightly different.

"Just imagine what could have happened had I been behind the wheel of a car," she told Prevention.

Although Detrick's story may sound like a medical mistake, it wasn't. Rather, she experienced a potentially lethal consequence of therapeutic substitution, in which her pharmacist legally switched a drug prescribed by her doctor without notifying either Detrick or her physician.

Pharmacists often replace a brand-name drug with a generic formulation of the same medication.  But therapeutic substitution carries a key distinction in that the substituted drug is not precisely the same medication, despite being in the same class and used to treat the same condition.

Statins provide a good illustration of the nuance involved in the practice.  The statins constitute a single class of drugs because they all serve to lower cholesterol by reducing its production in the liver.  However, not every statin lowers cholesterol by the same amount or with the same ratio of LDL to HDL.

Therefore, if a doctor prescribes a brand name statin but the pharmacist exchanges it for a lower-cost version of a different statin, the patient may not receive the benefits the doctor intended.  In fact, they may even suffer from unexpected side effects.

While these substitutions may result in smaller co-payments for patients, nearly two-thirds of those who reported having their drugs switched said they were not told of the substitutions, according to a National Consumers League survey.  Of those who had their drugs switched, four in ten said the new drug was not effective, while one in three reported suffering more side effects from the new drug.

"It's not okay for your insurance company or pharmacist to change your drugs without your knowledge," NCL Executive Director Sally Greenberg told Prevention.

Although the rules allowing therapeutic substitution are not likely to change anytime soon, there are steps patients can take to reduce their chances of being harmed.

For one, make sure you get the right drug.  If your doctor believes the drug prescribed should not be switched for another, ask him to write “medically necessary," "may not substitute," or "DAW" — for "dispense as written" — on the prescription. That requires the pharmacist to check with the patient and the doctor before making any changes.

If a pharmacy says state law requires the substitution, find out which ones your state allow and challenge the exchange if the pharmacy is in error.  This information can be found on the Web sites of most state’s Boards of Pharmacy.  Visit www.nabp.net and select the Boards of Pharmacy option to display a contact list for every state office.

Patients can often avoid problems by selecting a pharmacy they like, and then sticking with it.  Having the pharmacist put a blanket statement in a patient’s record requesting that no medications be switched without prior approval from both the patient and the doctor can also help. 

Insurance plan formularies are at the heart of most substitution disputes.

"The insurance company will tell me that the drug I prescribed for a patient is not approved or is at the higher co-pay, so I need to submit documentation justifying why insurance should cover it instead of making a substitution," Lori Heim, MD, president-elect of the American Academy of Family Physicians, told Prevention.

If a doctor can convince the insurance company that a particular drug is medically necessary, the insurer may ultimately cover it.  However, the process can be exhausting.   And the follow-ups, appeals and oceans of paperwork often cause patients to suffer.

"I've had patients who did not have control of their allergy symptoms — sneezing and feeling miserable — while I jumped through hoops showing that these other drugs didn't work for them," said Heim.

Patients should ask their doctor, before filling a prescription, which generics, if any, are acceptable substitutes. If an unacceptable switch has been made, patients should contact their doctor immediately to begin documenting an appeal. 

"Busy doctors sign papers quickly, so it's easy for a substitution to sneak through," Robert Reneker, MD, an urgent care doctor at Spectrum Health in Grand Rapids, MI, told Prevention.  

Finally, patients should be aware that pharmacies are not always paragons of ethical behavior.

"They're not always aboveboard," said Reneker, adding that  pharmacies sometimes exchange drugs because profit margins are higher on lower-cost substitutes.

"Pharmacies are directly reimbursed by insurance companies and make more money from generics even though the sticker price for brand-name drugs is higher," Reneker said.

"I've had pharmacies tell me a drug isn't on the formulary when I've already checked with the insurance company and know that it is. The switch to a cheaper substitute is motivated purely by profit."

Patients can sometimes avoid such problems by shopping for prescriptions at stores that have reduced prices on generics — a move that lessens profit margins and reduces the temptation for pharmacies to make switches.

Large retailers such as Target and Wal-Mart have led the way on price reductions on drugs, pressuring smaller pharmacies to follow suit.

"Drugs have become a way to attract people to stores so they'll spend money on other items," said Reneker.

Source: redOrbit Staff & Wire Reports

More News in this Category