Louisiana Pharmacy Board Disciplines Petmed Express

Informal conferences were conducted by the Violations Committee of the Louisiana Board of Pharmacy (Board) on November 28, 2001, and again on March 6, 2002 at the Board office in Baton Rouge, Louisiana, with Alison Bergis, attorney for Petmed Express, Inc.  The conferences were called related to Complaint No. 01-0058 “regarding dispensing of a veterinary medication to Jamie Sulton for her dog ‘Belle’ in April of 2001” and Complaint No. 01-0127 “regarding dispensing of a veterinary medication to Janis Bland for her dog ‘Brandy’ in August of 2001.”

Petmed Express entered a plea of no lo contendere to the cited violations, in exchange for which the Board agreed to dismiss any and all other complaints received by the Board against Petmed Express as of March 6, 2002.  A Consent Agreement was signed, agreed to and entered on March 28, 2002, in which Petmed Express agreed to the following:

1. The permit of Petmed Express (Permit No. 4338) is placed on probation for five (5) years, beginning May 10, 2002, and ending May 9, 2007, subject to the following special conditions of probation:  Petmed Express is not to violate any federal, state or local laws or regulations relating to the practice of pharmacy;
2. Petmed Express further agrees that should it be found guilty, after notice and opportunity to be heard as provided by law, of violating any condition of probation, said violation occurring during the probationary period, its permit in the State of Louisiana will be suspended;
3. In Report No. 01-0058, Petmed Express agrees to pay a fine of $5,000 and to reimburse the Board administrative costs of $500.00 and investigative costs of $297.50, for total payment due the Board of $5,797.50, to be paid simultaneously with the execution of the Consent Agreement by Petmed Express;
4. In Report No. 01-0127, Petmed Express agrees to pay a fine of $5,000 and to reimburse the Board administrative costs of $500.00 and investigative costs of $540.48, for total payment due the Board of $6,040.48, to be paid simultaneously with the execution of the Consent Agreement by Petmed Express.

The Consent Agreement was approved by a formal meeting of the Board on May 9, 2002.

Florida Board Disciplines Well-Known Internet Pharmacies

On Tuesday April 16, 2002, the Florida Board of Pharmacy disciplined Pet Med Express, Inc. and Savemax, Inc. of Pompano Beach, Florida. Company pharmacists Gordon Gyor, Gary Koesten, Richard Schwartz, and Martin Wiederkehr were also disciplined.

The reasons for the discipline included the contracting of veterinarians to write prescriptions without examining the animal and dispensing drugs not approved by the US Food and Drug Administration.

AVMA representatives (observers), Florida Veterinary Medical Association representatives, and a Journal of the AVMA news reporter were in attendance.

In all, sixty-two cases were investigated. The Board's counsel expressed that prosecution-related charges would substantially increase if the cases were handled singularly, so stipulation agreements were developed for each company and pharmacist. Key stipulation content follows:

Pet Med Express, Inc. (license # PH 14144)

• Shall not purchase, dispense, or distribute any drugs that are not approved by the United States Food and Drug Administration.
• Shall not knowingly fill, dispense, or distribute medication for prescriptions written by veterinary physicians who have not physically examined the animal for whom the prescription is written.
• Shall immediately terminate its alternate veterinarian program, to the extent Pet Med Express employs or contracts with veterinarians to write prescriptions for medication when the veterinarian has not physically examined the animal for whom the prescription is written.
• Shall pay an administrative fine of $40,000 to the Florida Department of Health within 90 days.
• Shall reimburse the Department for investigation and prosecution costs totaling $27,799 within 1 year.
• Shall be placed on a 3-year probationary period. During this period:
• Pet Med Express shall have its pharmacy inspected quarterly by a representative of the Board of Pharmacy. Inspections shall be random and unannounced, and paid for by Pet Med Express.
• Prescription Department Manager, Richard Schwartz, shall successfully complete 12 hours of CE on the laws and rules governing the practice of pharmacy in Florida within 1 year. CEO Menderes Akdag must also complete 12 hours of laws and rules training.
• Pet Med Express shall perform 200 hours of community service in the form of providing free pharmaceutical services to the public within 3 years. Pet Med Express' plan must be pre-approved by the Board chair, or its designee.
• Shall not violate Chapter 456, 465, 499, and/or 893, Florida Statutes, the rules promulgated pursuant thereto, or any other state or federal law, rule, or regulation relating to the practice or to the ability to practice pharmacy.
• Violation of the terms of the stipulation is grounds for disciplinary action.
• All pending, related cases where the complaint arises from alleged actions or complaints that occurred prior to this stipulation shall be dismissed.

Savemax, Inc. (license #PH 16899)

It was made clear that Savemax had been set up in the same building as Pet Med Express for reasons of economy, and to allow continued operation in case Pet Med Express' pharmacy license was revoked.

• Within 3 months Savemax shall no longer operate at its current location.
• Shall not fill, dispense, or distribute drugs that are not approved by the United States Food and Drug Administration.
• Shall not knowingly fill, dispense, or distribute medication for prescriptions written by veterinary physicians who have not physically examined the patient for whom the prescription is written.
• The administrative fine is $5,000.
• The investigation and prosecution costs to be paid are $4,358.
• Random, unannounced inspections will be conducted quarterly for 1 year.
• 12 hours of CE are required of the prescription department manager.
• Savemax shall perform 100 hours of community service in the form of providing free pharmaceutical services to be pre-approved by the Board Chair or designee.

Gordon Gyor, RPh (license #PS 11402)

Mr. Gyor's discipline centered on dispensing prescription drugs without valid veterinarian authorizations.

• Shall not knowingly fill, dispense, or distribute medications for prescriptions written by veterinary physicians who have not physically examined the patient for whom the prescription was written.
• The administrative fine is $10,000.
• The investigation and prosecution costs to be paid are $10,117.
• 12 hours of CE, and 50 hours of community service are required.

Gary Koesten, RPh (license # PS 23697)

Mr. Koesten's discipline centered on dispensing prescription drugs without valid veterinarian authorizations, and dispensing drugs not approved by the US Food and Drug Administration. Mr. Koesten will be the pharmacy manager at Savemax.

• Shall not fill, dispense, or distribute drugs that are not approved by the United States Food and Drug Administration.
• Shall not knowingly fill, dispense, or distribute medication for prescriptions written by veterinary physicians who have not physically examined the patient for whom the prescription is written.
• The administrative fine is $5,000.
• The investigation and prosecution costs to be paid are $2,349.
• 12 hours of CE, and 50 hours of community service are required.
• Random, unannounced inspections will be conducted quarterly for 1 year.

Richard Schwartz, RPh (license # PS 25616)

Mr. Schwartz's discipline centered on dispensing prescription drugs without valid veterinarian authorizations, and dispensing drugs not approved by the US Food and Drug Administration.

• Shall not fill, dispense, or distribute drugs that are not approved by the United States Food and Drug Administration.
• Shall not knowingly fill, dispense, or distribute medication for prescriptions written by veterinary physicians who have not physically examined the patient for whom the prescription is written.
• The administrative fine is $2,500.
• The investigation and prosecution costs to be paid are $1,621.
• 12 hours of CE, and 50 hours of community service are required.
• Random, unannounced inspections will be conducted quarterly for 1 year.

Martin Wiederkehr, RPh (license # PS 7924)

Mr. Wiederkehr's discipline centered on dispensing prescription drugs without valid veterinarian authorizations. Mr. Wiederkehr was the interim pharmacy manager at Pet Med Express. He will be a Pet Med Express staff pharmacist.

• Shall not knowingly fill, dispense, or distribute medications for prescriptions written by veterinary physicians who have not physically examined the patient for whom the prescription was written.
• The administrative fine is $1,500.
• The investigation and prosecution costs to be paid are $1,031.
• 12 hours of CE, and 50 hours of community service are required.
• Random, unannounced inspections will be conducted quarterly for 1 year.
• The stipulations for both pharmacies and all four pharmacists include these provisions:
• Shall not violate Chapter 456, 465, 499, and/or 893, Florida Statutes, the rules promulgated pursuant thereto, or any other state or federal law, rule, or regulation relating to the practice or to the ability to practice pharmacy.
• Violation of the terms of the stipulation is grounds for disciplinary action.
• All pending, related cases where the complaint arises from alleged actions or complaints that occurred prior to this stipulation shall be dismissed.

For additional information on Internet pharmacies, including guidance and the Pharmacy Complaint Form, please visit the AVMA Web site at www.avma.org.

Novartis Animal Health Files Suit Against Petmeds

March 19, 2002

From a press release

GREENSBORO, N.C.-- Citing numerous violations, including trademark infringement and false advertising, Novartis Animal Health US, Inc. has filed a lawsuit against PetMed Express Inc., Drs. Fosters & Smith, Inc., and Savemax, Inc., online retailers of pet-care products. The suit challenges those retailers' unlawful sale of foreign versions of pet medicines sold under the SENTINEL ® (lufenuron/milbemycin oxime) FLAVOR TABS ® and INTERCEPTOR ® (milbemycin oxime) FLAVOR TABS ® brands.

"We felt compelled to take legal action in order to protect the integrity of our products," said Jim Guidone, CEO of Novartis Animal Health US. "The unlawful actions of PetMed Express, Savemax, and Drs. Fosters & Smith undermine the expertise and authority of veterinarians. They are also likely to confuse our customers and may cause them to give their pets incorrect doses of these important medicines," Guidone pointed out.

According to the complaint, which was filed on March 19, 2002 with the United States District Court for the Southern District of Florida, Novartis Animal Health US alleges that PetMed Express and the other defendants are illegally selling pet medications in the United States that were made specifically for the Australian and other foreign markets. These foreign medicines are not approved by the U.S Food and Drug Administration (FDA) for sale in the United States. In fact they are materially different from Novartis Animal Health US products in a number of ways, including in the formulation of the products and in their instructions for use. The sale of these foreign medicines in the United States is an express violation of United States drug laws.

Novartis Animal Health US, which dispenses its products only where there is a valid veterinarian-client relationship, believes that pet owners are confusing the foreign medications sold by PetMed Express and the other defendants with the FDA-approved products sold by Novartis Animal Health US and its authorized distributors in the United States.

Furthermore, although the products have similar packaging, the foreign medicines do not indicate that they must be prescribed by a veterinarian, do not have valid poison control numbers, and lack information on how consumers can contact Novartis Animal Health US with questions. They are also missing many of the statements required by FDA rules and regulations for pet medicines sold in the United States.

"We believe that this lawsuit against PetMed Express is in the best interest of both veterinarians and pet owners across America, as well as the companion animals we strive to protect," Guidone stressed. "We are looking forward to a swift and fair resolution to this matter," he added.