Update on What the News Reports Are Missing in the New England Compounding Center Meningitis Outbreak Case; And Why We Need And Must Have Compounded Drugs Reposted

This new article, 47 patients linked to meningitis infections, from CNN notes that nearly 10% of drugs administered in the United States come from compound pharmacies, according to a 2003 Government Accountability Office report.  However, there are a number of things that the reporters fail to point out.    Some articles cite the tragic Franck's case involving the 21 dead horses.  The Food and Drug Administration attempted to stop Franck in that case but a district court judge in Florida said it did not have any jurisdiction over veterinary compounding.  The FDA appeal to the 11th Circuit Federal Court of Appeal.  The case will be argued next month.  In the mean time Franck was at it again, causing eye infections from human drug compounds.  No one can fault the FDA in that case because the FDA had tried to stop Franck.  The state board of pharmacy imposed a fine for the dead horses.  The insurance companies are now suing Franck to get back their money.

Other articles fail to cite the end result of the Apothecure and Gary D. Osborn case, where human compounded drugs resulted in deaths.  In that case the federal government prosecuted Apothecure and Gary D. Osborn after all the civil lawsuits.  Apothecure and Gary D. Osborn pled guilty but were recently sentenced to no jail time and a $100,000 fine was imposed on both-- not much for the harm caused.  But again the FDA and the United States Attorney's Office in the Northern District of Texas did take action.  They did try to stop the bad compounders.

But as my previous post noted, we must have compounded drugs. No one seems to be pointing out that a lot higher percentage of compounded drugs are used on animals. That is so evident in the veterinary world where most of the drugs used for animals are either human drugs or most likely compounded drugs made special for a specific animal.    What must continue to be stressed is that there is a place for compounded drugs and that there are good compounding pharmacies and pharmacists out there who do everything within their powers to follow all the rules and regulations, who have compliant sterile rooms, who spend the money to test to make sure the compound is what it is suppose to be.  Tragic as the New England Compounding Center meningitis outbreak is hopefully the world of compounded drugs for both humans and animals will become a better, safer environment, not one that no longer exists.

Update:  News articles are now reporting on the Apothecure and Gary D. Osborn case.  Still not much coverage on why we must have compounded drugs in the United States.  See previous post for a list of reasons compounded medications for animals and humans are essential.  Here is a repost of that blog entry:

This is a previous post that has been updated.  It is now more important than ever not to lose sight of the fact that compounded medications are essential to both pets and humans.  Do changes in regulations, laws,and enforcement need to be made.  Yes, that is clear.  However, do compounded drugs need to be a thing of the past. No, absolutely not. This post  will hopefully help to explain some of the reasons: Why We Need and Must Have Compounded Medications.

In the wake of the tragic deaths in the New England Compounding Center case, 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.