More News Articles about Franck's and its link to Eye Infections: Is Florida Department of Health Investigating?

The Florida Department of Health (FDOH) has stated that it cannot divulge if Franck’s is being investigated at this time. If an investigation is being done and the pharmacy is believed to pose an immediate threat to patient safety, FDOH could issue an emergency suspension order (ESO) to immediately suspend the pharmacy’s license.  FDOH can't confirm whether they are investigating Franck's or any pharmacy until 10 days after the alleged investigation and only if probable cause is found. 
 
To read more about Franck's current issues with its compounding pharmacy, see the following:


Associated Press. “CDC Links Eye Infections to Troubled Florida Pharmacy.” Fox News.com. (May 04, 2012), click here.

CBS News Staff. “Rare Fungal Eye Infections Tied to Fla. Pharmacy, CDC Warns.” CBS News. (May 04, 2012), click here.

Medina, Carlos E. “Eye Infections Linked to Ocala’s Franck’s Compounding Lab.” The Gainesville Sun. (May 03, 2012), click here.

WFTV. “Ocala Pharmacy Blamed for Dozens of People Suffering Vision Loss.” WFTV.com. (May 04, 2012), click here.

Why We Need and Must Have Compounded Medications

In the wake of the tragic deaths in Franck's (Florida), Apothecure (Texas) and Meds IV (Alabama), it is important to not lose sight of the fact that we need and must have compounded medications.    If these medications were not available, some patients  (both humans and animals) would suffer and some could die. This was explained by Loyd V. Allen, Jr., Ph.D., R.Ph., Editor-in-Chief, International Journal of Pharmaceutical Compounding, when he testified on April 19, 2007, before the U.S. Senate Special Committee on Aging in Washington, DC.  During his testimony he explained:

Millions of Americans have unique health needs that off-the-shelf prescription medicines cannot meet. For many of them a customized, compounded medication prescribed by licensed physicians or veterinarians and mixed by trained, licensed compounding pharmacists are the only way to better health. If customized medicines were not available, some of our most at-risk patients would needlessly suffer and some would die.

Allen also gave excellent examples of those who rely on compounded medications:

• Infants and children: Compounding pharmacists can transform medicines from
hard-to-swallow pills intended for adults into syrups, elixirs, suspensions, and
emulsions for children, at the request of physicians. Flavors offered by
compounding pharmacists can make drugs more palatable to children. In
addition, premature infants often rely on lifesaving and life-sustaining drugs made
only in compounding pharmacies.
• Hospital patients: Many, if not most, of the lifesaving intravenous drugs given in
hospitals and clinics are compounded. Because hospital patients are often on
multiple medications, compounding them into one treatment saves the hospital
personnel time and the patient multiple injections or administrations.
• Cancer patients: Cancer treatment often involves special mixtures of cancer drugs
that are compounded pursuant to a doctor’s prescription. Pharmacists can
combine multiple drugs into one treatment, leading to shorter administration times
for cancer patients.
• Senior citizens: Elderly patients often have difficulty with traditional dosage
forms, such as pills taken orally. Compounding pharmacists create alternate
methods of delivery, like transdermal gels, to make it easier for the elderly to take
their medicine.
• Pets: Animals come in all shapes and sizes, so one-size-fits-all pharmaceuticals do
not always meet their needs. In many cases, a compounded medication may be
necessary for a non-food animal to be satisfactorily treated.
• Patients with allergies: Patients who are allergic to a preservative, dye, flavor or
other ingredient in commercial products can have their doctor write a prescription
for a compounding pharmacist to customize the same medication without the
offending ingredient.
• Menopausal women: Many women experience significant pain and discomfort as
their bodies’ progress through menopause. Doctors prescribe bioidentical
hormones for patients for whom synthetic hormone treatments may be ineffective
or produce undesired side effects. Several bioidentical hormone products are
available in FDA-approved, one-size-fits-all formulations from pharmaceutical
companies. However, physicians may determine that their patients have unique
needs that warrant prescribing a different compounded hormone treatment. This
often allows patients to take the smallest amount of a given hormone preparation
to treat their symptoms, in conjunction with the recommendation provided by the
Women’s Health Initiative study.
• Patients who require non-traditional dosage forms: Many patients are unable to
take medications orally or as injections – the traditional dosage forms for
manufactured drugs. Compounding pharmacists can create alternate methods of
delivery, like ointments, solutions or suppositories, to fit these patients’ unique
health needs. The pharmaceutical industry supplies only limited strengths of
drugs, which some patients cannot tolerate. It is often necessary for a doctor to
request a different strength of a drug for a patient through compounding.
• Patients who rely on discontinued drugs: Pharmaceutical manufacturers have
discontinued thousands of drug products over the years, due to low profitability.
For certain groups of patients, these were very effective, important, and
sometimes life-saving medications. Such medications are now only available if a
doctor prescribes them to be compounded.
• Hospice patients: End-of-life therapy involves the compounding of many different
and unique dosage forms to allow patients to live out their lives free of pain and
discomfort. Many combinations of drugs are prescribed by doctors and used for
these patients who cannot swallow medications and who don’t have the muscle
mass that is required to receive multiple injections each day. Compounding
pharmacists can provide alternate delivery methods such as oral inhalation, nasal
administration, topical, transdermal or rectal use.

These are important examples of why we need and must have compounded medications in the United States.  The problems in the tragic cases do not suggested that the practice of compounded medications must be stopped; instead, the tragedies shows that the rules and regulations relating to compounding need to be complied with by pharmacies, doctors, veterinarians and enforced by state boards of pharmacy, state boards of medicine, state veterinary boards and the United States Food and Drug Administration.   To read the entire transcript of Dr. Allen's testimony, click here.

Franck's had to Answer Why It had Not Paid Penalties

A recent article entitled Trouble ahead for Franck's, Second Drug Controversy in Three Years could Spell Problems for Ocala Compounding Law, written by Carlos E. Medina and published on May 4, 2012, points out that Franck's has not satisfied state penalties handed down in the settlement after the 2009 incident that killed the 21 horses and Franck's recently had to appear before the Florida State Board of Pharmacy to answer why it had not paid the penalties.  The articles states: 

But even as the company deals with the latest investigation, it still has not satisfied state penalties handed down in a settlement after the 2009 incident that killed the 21 horses.The Florida State Board of Pharmacy recently brought Franck's before them to answer for not paying the penalties.
On May 1, the board ordered the lab to pay more than $14,387.21 in original penalties, plus another $2,000 fine and $1,000 in administrative costs for not abiding by the first settlement. The company has 90 days to pay the fines.

In the 2009 case, Franck's was cited by the state Department of Health for numerous violations of Florida law covering pharmacies. 

To read the entire article, click here.

Settlement Agreement Between Franck's and Florida State Department of Health

A draft of the Florida State Department of Health board meeting minutes for April shows more trouble for Paul Franck and Franck Pharmacy.  To read the entire draft of the minutes, click here.  Here are the disciplinary actions against Franck.

TAB 3 DISCIPLINARY CASES – John Truitt, Assistant General Counsel
A. SETTLEMENT AGREEMENT– APPEARANCE REQUIRED CASES
A-1  Paul Wayne Franck, PS 17342, Ocala, FL
  Case No. 2008-17152 – PCP Powers/Jones
Respondent violated:
Count One:  Section 465.016(1)(e), F.S., by violating Sections 499.01(1) and 499.005(22), F.S., by failing to obtain a prescription drug wholesaler’s permit or a retail pharmacy drug wholesaler’s permit prior to engaging in wholesale distribution of prescription drugs.
Count Two:  Section 465.016(1)(e), F.S., by violation of section 499.005(22)m by failing to obtain a permit prior to operation as a prescription drug repackager as required by section 499.01(1)(b).
Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $427.17. Respondent shall complete a 12 hour Laws and Rules CE course.
Respondent was present and sworn in by the court reporter. Respondent was represented by William Furlow.
Motion: by Weizer, seconded by Fallon, to accept the Settlement Agreement. Motion carried.
A-2  Francks Lab, Inc, PH 19761, Ocala, FL
Case No. 2008-16979, 2010-16555 – PCP Powers/Jones, Garcia/Weizer
(2008-16979) Respondent violated:
Count One:  Section 465.016(1)(e), F.S., by violating Sections 499.01(1) and 499.005(22), F.S., by failing to obtain a prescription drug wholesaler’s permit or a retail pharmacy drug wholesaler’s permit prior to engaging in wholesale distribution of prescription drugs.
Count Two:  Section 465.016(1)(e), F.S., by violation of section 499.005(22)m by failing to obtain a permit prior to operation as a prescription drug repackager as required by section 499.01(1)(b).
(2008-16979) Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $750.97.

Respondent was present and sworn in by the court reporter. Respondent was represented by William Furlow.
For the first Settlement Agreement:
Motion: by Ms. Mullins, seconded by Dr. Fallon, to dismiss the case. Motion carried with Dr. Griffin opposed.
(2010-16555) Respondent violated Section 456.072(1)(k), F.S., by failing to perform any statutory or legal obligation placed upon a licensee.
(2010-16555) Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $80.67.
For the second Settlement Agreement:
Motion: by Dr. Fallon, seconded by Ms. Glass, to accept the Settlement Agreement. Motion carried.