Complaint filed against Santa Clara Drug "The Compounding Shop"

The California Board of Pharmacy filed a complaint against Lionel Francis Jara and Santa Clara Drug “The Compounding Shop”, Administrative Case AC 3990, in March 2012.  The case is still pending.  To read the complaint, click here.

Report on Current Investigative Findings in Case Against Franck's : 33 cases in 7 states: Clinicians warned to avoid use of compounded products labeled as sterile from Franck's

Notes from the Field: Multistate Outbreak of Postprocedural Fungal Endophthalmitis Associated with a Single Compounding Pharmacy — United States, March–April 2012

Morbidity and Mortality Weekly Report (MMWR)

May 4, 2012 / 61(17);310-311
On March 5, 2012, the California Department of Public Health was notified of nine cases of clinically diagnosed fungal endophthalmitis at a single California ambulatory surgical center. The initial investigation, led by the Los Angeles County Department of Public Health, determined that in all cases patients had undergone vitrectomy with epiretinal membrane peeling using a dye called Brilliant Blue-G (BBG) from Franck's Compounding Lab, Ocala, Florida. This investigation has since expanded to involve intravitreal injection of triamcinolone-containing products from Franck's, an overall total of 33 cases in seven states, and collaboration between state and local health departments, CDC, and the Food and Drug Administration (FDA). This report describes the current investigative findings. Clinicians should be aware of the ongoing investigation and should avoid use of compounded products labeled as sterile from Franck's during this ongoing investigation.
A probable case is defined as ophthalmologist-diagnosed fungal endophthalmitis occurring in a patient who underwent an invasive ophthalmic procedure, including but not limited to vitrectomy, corneal surgery, or intravitreal injections on or after August 23, 2011, the production date of the contaminated BBG lot. Confirmed cases meet criteria for probable infection and also have fungi identified from the affected eye by culture, genetic sequencing, or histopathology. Active case-finding in this investigation has included calls for cases through Epi-X postings, FDA MedWatch alerts, ClinMicroNet microbiology laboratories, e-mails sent to all members of two professional ophthalmology societies, and state and local health alerts.
As of April 30, a total of 33 confirmed and probable cases have been identified, with earliest onset of symptoms in November 2011. Of these, 20 cases (13 probable and seven confirmed) are associated with BBG dye use, and 13 (two probable and 11 confirmed) are associated with triamcinolone use. All BBG or triamcinolone products administered to patients reportedly were purchased from Franck's. All available isolates from the seven confirmed cases associated with BBG dye use were identified by culture or genetic sequencing as the mold Fusarium incarnatum-equiseti species complex. All available isolates from the 11 confirmed cases that occurred following intravitreal injection of triamcinolone-containing products have been identified as the mold Bipolaris hawaiiensis. Both Fusarium and Bipolaris are ubiquitous molds present in air, soil, and water. Among the 30 patients for whom data are available, 23 (77%) have suffered some degree of vision loss, ranging from partial to severe, or worsened vision because of infection; 24 (80%) have required repeat ophthalmic surgery.
Culture of unopened bottles and intact (unused, pharmacy-prepared) syringes of BBG dye collected by FDA yielded multiple bacterial and fungal species, including F. incarnatum-equiseti species complex, Rhodotorula, Bullera, Pseudomonas, and Enterobacter species. Microbiologic testing of triamcinolone-containing products from Franck's is ongoing. On March 9, Franck's recalled all BBG dye lots; on March 31, a single lot of triamcinolone was recalled. The investigation to identify the root cause of product contamination is ongoing. The pharmacy has not recalled or halted production of other sterile compounded products, which, in addition to ophthalmic preparations, include chemotherapy and numerous other medications administered by injection (including intrathecal and epidural), inhalation, and intranasal routes.
Postprocedural endophthalmitis is uncommon, complicating 0.04% of either intravitreal injections or pars plana vitrectomies (1,2). The majority of these infections are bacterial; fungal infection is rare and often is diagnosed only after a patient has failed empiric antibacterial therapy. Clinicians are encouraged to be vigilant for postprocedure adverse events, particularly among patients who have received a product labeled as sterile from Franck's, and should consider methods to confirm and treat possible fungal infection.
Compounding pharmacies, which combine or alter medications from standard preparations, provide needed formulations that often are not available from pharmaceutical companies. Compounded sterile preparations must be prepared according to aseptic practices recommended by organizations such as the United States Pharmacopeia, as stated in United States Pharmacopeia-National Formulary (3). However, contamination of compounded sterile preparations has caused outbreaks. Since 1990, FDA has learned of approximately 200 adverse events associated with 71 compounded products (4). A recent outbreak of bacterial endophthalmitis following intravitreal injection of contaminated bevacizumab occurred after breaches in aseptic technique at a different compounding pharmacy (5).
Because of the seriousness of endophthalmitis and because the full extent of the outbreak and root cause of contamination remain unknown, CDC recommends that, at this time, clinicians avoid use of compounded products labeled as sterile from Franck's. Health-care providers should maintain a heightened suspicion for infections among patients who received compounded products labeled as sterile from Franck's and should report suspected infections to their local and state health departments for further investigation. Patients also should avoid use of compounded products labeled as sterile from Franck's and report adverse events or suspected infections promptly to their physician.

Reported by

Suber Huang, MD, Pravin Dugel, MD, American Society of Retina Specialists, Chicago, Illinois. George Williams, MD, American Academy of Ophthalmology. Moon Kim, MD, Kelsey Oyong, MPH, Clara Tyson, MSN, Laurene Mascola, MD, Los Angeles County Dept of Public Health. Kavita K. Trivedi, MD, California Dept of Public Health. Julie Duran, MPH, Colorado Dept of Public Health and Environment. Shannon Millay, MPH, Indiana State Dept of Health. Stephanie Black, MD, Chicago Dept of Public Health; Judith Conway, Illinois Dept of Public Health. Susanne Straif-Bourgeois, PhD, Louisiana Office of Public Health. Rick Sowadsky, MSPH, Nevada State Health Div. Ellen H. Lee, MD, New York City Dept of Health and Mental Hygiene. Tom Török, MD, Benjamin Sun, DVM, Career Epidemiology Field Officer Program, Office of Public Health Preparedness and Response; Shawn Lockhart, PhD, Julie Harris, PhD, Benjamin J. Park, MD, Div of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging and Zoonotic Infectious Diseases; Rachel Smith, MD, Christina Mikosz, MD, Raymund Dantes, MD, Yoran Grant, PhD, EIS officers, CDC. Corresponding contributors: Christina Mikosz, dex0@cdc.gov, 213-240-7941; Rachel Smith, vih9@cdc.gov, 404-639-7738.

References

1. Chen E, Lin MY, Cox J, Brown DM. Endophthalmitis after intravitreal injection: the importance of viridans streptococci. Retina 2011;31:1525–33.
2. Eifrig CWG, Scott IU, Flynn HW, Smiddy WE, Newton J. Endophthalmitis after pars plana vitrectomy: incidence, causative organisms, and visual acuity outcomes. Am J Ophthalmol 2004;138:799–802.
3. Kastango ES, Bradshaw BD. USP chapter 797: establishing a practice standard for compounding sterile preparations in pharmacy. Am J Health Syst Pharm 2004;6:1928–38.
4. Food and Drug Administration. The special risks of pharmacy compounding. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2007. Available at http://www.fda.gov/forconsumers/consumerupdates/ucm107836.htm. Accessed April 30, 2012.
5. Goldberg RA, Flynn HW, Isom RF, Miller D, Gonzalez S. An outbreak of streptococcus endophthalmitis after intravitreal injection of bevacizumab. Am J Ophthalmol 2012;153:204–8.e1.

U.S. Senators Seek Investigation of State Medical Boards

U.S. Senators Seek Investigation of State Medical Boards

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Three U.S. 

Senators have teamed up to request an evaluation of state medical boards. This bipartisan effort was initiated at the end of February 2012 when Senators Charles Grassley R-Iowa , Orrin Hatch R-Utah and Max Baucus D-Mont. sent a letter to the director of the Office of the Inspector General OIG for the Department of Health and Human Services HHS.  Click here to read more.

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.