Virginia: Jodi Ettare and Vince Ettare: Rustburg Family Pharmacy and Valley Compounding Pharmacy

State board sets hearing for pharmacist

By: CRAIG DAVISON | The News & Advance 
Published: February 09, 2012

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A Rustburg pharmacist faces an informal hearing before the state Board of Pharmacy next week for possible administrative violations related to the operation of the pharmacy.

Jodi Ettare operates Rustburg Family Pharmacy with her husband, Vince Ettare. The husband-and-wife team of pharmacists also operated Valley Compounding Pharmacy on Timberlake Road in Campbell County, but it closed last fall after Vince Ettare’s license was suspended for a year by the state for violations similar to the allegations Jodi Ettare now faces.

The state Board of Pharmacy found that he left technicians and interns at the pharmacy while he left for other business and that he maintained prescription records saying he was there at the time. The board also found he allowed staff to use the alarm and keys to enter the drug storage area without a pharmacist present, according to the Board of Pharmacy’s order.

A pharmacist is required on the premises at all times and technicians are allowed access to the alarm only under “exceptional” circumstances, said Caroline Juran, executive director of the Board of Pharmacy.

Ettare said it happened because he pushed himself past his limits trying to meet the needs of running a small business. He testified to the board his absence during the periods in question was due to his confidence in his senior pharmacy technician, according to the board’s order.

Losing his license left Jodi Ettare with the responsibility of running the pharmacy.

“Jodi has had to bear the brunt of the burden,” Vince Ettare said.

Jodi Ettare is accused of improperly verifying prescriptions she was not present for and allowing an unlicensed individual to use the alarm code and keys to enter the prescription area, according to the notice for her informal hearing. According to that document, the incidents are alleged to have happened in May and June 2011; Vince Ettare’s license was suspended in August 2011.

The committee at the informal hearing next week can take several actions: dismissal of the charges, probation, a fine, a reprimand or a referral to a formal hearing.

In 2010, the board reprimanded Jodi Ettare for making and dispensing generic Viagra. She signed a consent order that did not admit or deny the accusation.

Valley Compounding opened in January 2008 and Rustburg Family Pharmacy opened about a year later, filling a void in the town after Allied Community Pharmacy closed.

The Ettares' work specializes in compounding medicines, a niche field in pharmacy where chain stores readily dispense premanufactured drugs.

Compounding medications can help make a medication work better for a patient. For example, a person too sick to take pills orally can have the medication compounded into a cream to be rubbed on his or her skin. The couple’s pharmacy also compounds drugs for veterinarians.

Vince Ettare said the stress of keeping two pharmacies open led them to consider consolidating the pharmacies before his suspension. He said it allows them to spend more time with their three children.

“It was something we had considered for a long time,” he said.

Article found here.

Compounding Drugs for Horses

From Equus Magazine

Who Makes the Drugs Your Horse Takes?

By Joseph Rettone, DVM

Where do the drugs that you give your horse come from? Unless you've asked your veterinarian or you've carefully scrutinized the label affixed to the bottle or box, you're probably not aware of the name and location of the firm that manufactured the product. After all, as long as the preparation produces the desired effect to support your horse's health and well-being, it hardly seems essential for you to know much more than how often the drug should be administered and in what amount. Nevertheless, learning just how a pharmaceutical is made and by whom can save you from giving your horse ineffective or even dangerous medications.Compounding drug pharmacies provide a valuable service to the equine community, but it's wise to become familiar with their credentials and procedures.

Brand-name and generic drugs approved by the Food and Drug Administration (FDA) are supplied to veterinarians by the manufacturers, who must comply with strict regulations regarding product safety, efficacy and the manufacturing process. As a result, consumers who use pharmaceuticals that are FDA approved generally are confident of the products' drug content and quality.

In some cases, however, there is no FDA-approved preparation readily available or conveniently formulated to treat a horse--and that's where the services of a compounding pharmacy come in. For example, if a veterinarian wants to administer a particular drug intravenously but only the tablet version has been approved by the FDA, he may ask a compounding pharmacy to produce the medication in intravenous form. In other instances, a compounding pharmacy can make a drug that is not FDA approved in any form. For example, a veterinarian may want to use an antibiotic that is reported to work on a particular infection in laboratory studies but which is not FDA approved for that particular purpose. The compounding pharmacy can use bulk raw chemicals and produce the preparation at the veterinarian's request.

In the absence of stringent government oversight, the use of compounded medications is bounded ethically by several stipulations that include, but are not limited to, the observance of the restrictions that govern the dispensing of prescription drugs, the need for the compounded preparation in the treatment of disease or to improve the welfare of the animal, and the lack of an FDA-approved product in a suitable dosage form to treat the condition.Compounding pharmacies provide an invaluable service because there are not enough FDA-approved drugs to treat all equine diseases. However, the pharmacies that produce compounded drugs are not held to the same standards that the manufacturers of FDA-approved drugs must meet.

Yet, even when these stipulations are satisfied, there is no guarantee that the formulation created by a compounding pharmacy is safe and effective. There are, however, some specific questions your veterinarian can ask to assure that a compounding pharmacy is doing its best for you and your horse.

Does the compounding pharmacy have a licensed pharmacist on staff? Some compounders do not have a pharmacist on staff, or they maintain only a loose association with a pharmacist. Pharmacists have the training, as well as the legal and ethical responsibility, to follow good compounding practices as prescribed by the practice of pharmacy and as outlined by state pharmacy boards. Through their training, pharmacists understand the issues of drug quality, strength, purity and stability, which are essential to the rational use of drugs. Your veterinarian can verify a pharmacist's name and license number with the appropriate state agency.

Are high-quality raw materials used? Obviously, the individual ingredients that go into a drug formulation must be of high quality for the resultant compounded product to be of high quality. When drugs are not FDA approved, there is no assurance that the raw materials are of acceptable quality. Raw materials used by reputable compounding pharmacies are accompanied by a valid certificate of analysis. A reputable compounding pharmacy will not hesitate to provide that information to veterinarians. At the least, a veterinarian can--and should--ask the compounder if the wholesaler of the raw materials is licensed or registered with the state pharmacy board.

What type of quality testing is performed? Ideally, each individual drug preparation would be quality tested before it was shipped to a veterinarian. However, this is impractical in many situations. At a minimum, a compounding pharmacy can test batches of any formulation that is produced regularly. Such analysis will detect any loss of quality of calculation errors.

How stable is the compounded drug? The nature of equine practice leads me to stress the importance of the stability of compounded products. Equine practitioners tend to work outdoors, so the medications that we administer to horses often are kept in uncontrolled climates, which can lead to the breakdown of unstable compounds. The compounding pharmacy should provide some storage instructions with the medication.

To read the rest of the article click here.

Mistakes by Franck's Pharmacy put spotlight on FDA's limited oversight of compounding

Story appears at Ocala.com:

Mistakes by Franck's Pharmacy put spotlight on FDA's limited oversight of compounding

By Carlos E. Medina
Correspondent

Published: Saturday, June 2, 2012 at 7:16 p.m.

Last Modified: Saturday, June 2, 2012 at 7:16 p.m.

The recent recalls of sterile products made by Franck's Pharmacy in Ocala, as well as its position as a high-volume drug maker, are aspects of the compounding pharmacy business that has troubled federal regulators for years.

The Federal Drug Administration, which is tasked with ensuring the safety of drugs in the nation, has limited oversight over compounding pharmacies like Franck's because of a 74-year-old law that allows pharmacists to “compound,” or create unique variations of existing drugs for patients.

But that law, and the FDA's lack of authority over the practice of compounding, may draw new scrutiny in the wake of a well-publicized mistake at Franck's that killed two dozen prized polo ponies in 2009 and the production of contaminated solutions that reportedly damaged the vision of 33 eye surgery patients in recent months.

Compounding pharmacies make medications and other medical preparations from scratch. They cannot make straight copies of commercially available medications and can only make medications when they are ordered by a doctor.

These pharmacies fine tune drugs to a patient's need, whether that means creating a specific dosage not offered by a manufacturer or a liquid form of a drug only available in pill form.

Historically, compounding was the way most people got their prescription medicines. As recently as the 1960s pharmacists routinely ground and mixed compounds in their stores to make the medicines prescribed by local doctors.

The age of mass-produced drugs is a phenomenon of the last fifty years. The availability of those mass-produced drugs eventually led most pharmacies only to dispense ready-made medicines.

To read the rest of the story, click here.

Recent Report Projects that Compounding Pharmacies Will Experience Growth

IBISWorld Inc recently issued the following report:

The Compounding Pharmacies industry is expected to experience annualized revenue growth of 5.5% to $1.8 billion in the five years to 2012. During that time, the industry has benefited from increased awareness of pharmaceutical options among consumers and a growing number of senior citizens. The industry has also gotten a boost from an increasing number of mass manufactured drugs that are in short supply. However, the industry was not entirely unaffected by the recession. Revenue growth slowed during the recession due to a sharp increase in the unemployment rate, which reduced the number of people with private health insurance. Furthermore, the recession hurt per capita disposable income. According to industry analyst Kevin Culbert, “this factor slowed growth because a larger proportion of industry products are paid for out of pocket by consumers compared with traditional pharmaceuticals.”
Luckily for the Compounding Pharmacies industry, there has been no shortage of demand in recent years. In 2012, revenue is expected to grow 7.9%, largely due to a steadily aging US population and an increase in physician visits. In the five years to 2012, the number of adults aged 65 and older is expected to grow 2.4% annually to about 42.7 million people. People aged 65 and older are a major market for this industry because they tend to require more prescription medication than the rest of the population. Consequently, growth in the market has boosted industry demand during the past five years. According to Culbert, “drug shortages can also cause doctors and patients to use compounding pharmacies because operators purchase chemicals in bulk and make medicines on-site.” During the past five years, the number of prescription drug shortages has increased, rising from 61 in 2005 to more than 280 in 2012.
In the five years to 2017, IBISWorld estimates that revenue will increase. During that time, a growing number of doctors and patients will likely turn to compounding pharmacies to prepare medications with alternate doses and strengths. Rising demand will ultimately bring more operators into the industry. IBISWorld projects that the number of firms operating in this industry will increase at an average of 2.3% annually to 178 in the five years to 2017.
For more information visit IBISWorld’s Compounding Pharmacies in the US industry page
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This industry includes stores that make and sell compounded medications. Compounded medications are prescriptions that are written by physicians and prepared by pharmacists for individual patients. These medications are not commercially available; rather, they are prescribed by physicians and prepared by pharmacists to meet unique needs.
IBISWorld industry Report Key Topics