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Drug shortage raises risks of Lyme time

SoVaNow.com / May 16, 2013
A nationwide shortage of the drug Doxycycline — used to treat many tick borne diseases in both humans and pets — has caused prices for the drug to skyrocket and left some local physicians and veterinarians worried for their patients who might contract Lyme disease or Rocky Mountain Spotted Fever this summer.

It is the “antibiotic of choice for treating” these tick borne illness, according to local physician Dr. Susan Hundley with the Piedmont Access To Health Services (PATHS) medical clinic in Boydton.

Clarksville veterinarian Al Dahl agreed: “There is no substitute that is as effective. It is the best treatment for pets with tick borne illnesses, including Erlichia, as well as an important part of the protocol for treating heart worms.”

The American Heartworm Society lists Southside Virginia as the area with the highest incident of the disease in the country, according to Dahl.

Hundley said the drug, which previously cost $4 at the local pharmacy now runs as high as $500 before insurance. “I’ve already seen one case of Lyme disease this year,” said Hundley, “and that person, who had insurance, still had to pay $100.”

Sophia Decker, a licensed vet tech with Animal Medical Clinic of South Boston said luckily her pet owners probably have not experienced the same price increases, but that is not uncommon. Even though doxycycline is used to treat both humans and pets, there is often a price difference.

“We [the veterinarian practice] are usually not charged as much as the human market.”

Dahl is seeing what he calls a trend in medicine shortages — very inexpensive antibiotic, such as doxycycline, which have been readily available for 18 years suddenly leave the market, but then comes back at a higher cost, often without explanation.

According to reports from manufacturers to the Food and Drug Administration (FDA), the latest shortage can be blamed, in part, on Hurricane Sandy and the damage it caused to manufacturing plants such as one owned by West-Ward Pharmaceuticals. After the storm, company officials initially told the Center for Disease Control (CDC) and the FDA that the plant’s production schedule would not return to normal until “Mid-February 2013.” As of April 3, West-Ward Pharmaceuticals claimed it did not know when the drug would again become available.

Other companies offer a variety of different reasons for the shortage. Mutual Pharmaceutical Company, which was also in the path of Hurricane Sandy, blamed the shortage on a lack of raw materials needed to manufacture doxycycline, not the hurricane. But that contradicts the view of Decker, who said the clinic where she works has had no problem getting doxycycline because of the clinic’s ability to purchase the drug from a “compounding pharmacy” — a pharmacy that purchases raw materials to mix the drug.

Three manufacturers, Heritage, Mylan and Watson (now known as Actavis) Pharmaceuticals, blame the drug shortage on increased demand. However, Dahl and Clarksville Pharmacist Kevin Allgood have not seen any increase in the demand for the drug, which has been readily available for over 18 years.

“It is and always has been a broad spectrum antibiotic,” Allgood said. In addition to tick borne diseases, the drug is often used to treat severe acne, many sexually transmitted diseases and malaria.

Two other manufacturers, Major and Teva Pharmaceuticals ceased production of the drug earlier this year, without offering an explanation.

Some in the medical field speculate that one never reported reason for the shortage of popular generic drugs like doxycycline is lack of profitability. There is not enough profit in manufacturing older generic drugs, so companies cease production.

Over at Clarksville Family Pharmacy, Allgood said he’s had no official notice about a doxycycline shortage, but agrees there is “a little bit of a shortage.” He adds that it is not unusual for him to receive no notice from the FDA or CDC about a shortage. “I usually only hear if there is a recall.”

For now, Allgood is still able to get doxycycline from his suppliers. Unfortunately, the price for the drug has increased nearly 4,000 percent. Those with insurance will “most likely not feel the impact of the price increase,” said Allgood, but he worries about those patients who have no insurance. He is attempting to address the problem by “shopping around,” trying to find the lowest prices. Often, this requires him to come in early or stay late at the pharmacy to find the medicines his customers need at the lowest prices.

Hundley did not speculate as to the cause of the shortage, instead choosing to focus on the consequence to her patients. She says, “There are alternatives to doxycycline,” but they each come with their own set of limitations. For example, one alternative to prescribing doxycycline is amoxicillin. “Anyone allergic to penicillin is most like allergic to amoxicillin,” Hundley says.

For humans another alternative drug is tetracycline, but that drug is also on the FDA shortage list and not available. Still others drugs are not recommended for children as they cause discoloration to their teeth or other areas of the mouth and throat.

Dahl said no other antibiotic has the efficacy of doxycycline when it comes to treating erlichia or heart worms. “After two doses of the drug, the animals show improvement. Without doxycycline, I am really handicapped when it comes to treating my patients.”

The problem is not limited to tetracycline or doxycycline. Currently the FDA lists more than 130 medications on its shortage list.

Two years ago, President Barack Obama attempted to address the ever-growing drug shortage problem by asking pharmaceutical companies to notify the FDA if they foresee a shortage. This was followed by legislation adopted and signed into law in July 2012, that included the early notification system requiring drug manufacturers to notify the FDA of production problems or if a product will be discontinued. The bill also gave the FDA authority to expedite the review of products and new drug applications; created a generic user fee program; and allowed for repackaging of medications in short supply to be used within the same health system.

Yet, shortages continue to plague doctors, veterinarians and pharmacists, and notices of shortages are not passed down to those in need, the medical professionals.

So, what’s a doctor to do, when the drug used to treat a specific disease is unavailable? The only alternative is to turn to other more costly medications, which often are not as effective. Even this is not a realistic alternative for many people living in Southside Virginia who are without health insurance. Sadly, these patients may refuse treatment. Lyme disease left untreated can affect a person’s joints, heart and nervous system. In pets, Dahl adds that the disease if left untreated can led to death.

For some, the only insurance against tick borne illnesses is the simple advice Allgood offers, “I tell my kids, check yourself after being outside.”

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