As the number of compounding pharmacies increases – there are now more than 3,000 worldwide – many are calling for greater regulation to ensure quality control and pharmacist education.
“Pharmacists advertise precise and individual dosing, [but] studies show the opposite is true, ” says U.S. FDA expert Sarah Sellers. Sellers, a pharmacist, is strongly opposed to most compounding, particularly for non-essential uses such as reflavouring and kosher formulations.
Sellers concedes that “in rare cases, a pediatric patient may require a compounded product,” but warns that because dosages may not always be precise, there’s more “potential for poisonings and sub-therapeutic dosing.
Compounded medicines are custom-prepared by pharmacies in nonstandard doses. They do not receive the same safety testing that other pharmaceuticals require before they can be sold. "YOU ARE DEPENDING ON THE QUALITY CONTROL OF ONE PERSON WHEN HE/SHE MIXES THE COMPOUNDED DRUG. IF THEY HAD A BAD DAY OR ARE DISTRACTED BY A PHONE CALL...............WHAT EXACTLY ARE YOU GETTING!!!! Mnay court cases are due to improperly compounded medications."
“We have seven people including a supervisor who are trained investigators,” Work said. “We haven’t the resources to do sufficient oversight”.
The absence of regulation presents some risks to patients, FDA consultant Sellers said. “The industry is making untested, unvalidated, unapproved drugs that are not manufactured under federal standards,” she said. “These drugs are experimental, and patients need to understand that”.
“They basically told me I had to use it,” said Maureen MacNeill of Raleigh.
“It should be disclosed to patients they’re getting a compounded product,” Sellers said. “It’s really about informing consumers about the risks".
One product, purportedly a 10 mg hormone treatment, had no detectable active ingredient, while a drug used to prevent organ rejection had only 52% of the labeled drug present. Other products had too much ingredient, up to 135% of the labeled amount.
The results showed an 18% failure rate, which is demonstrative that the products are unreliable and the purported benefits of compounded drugs may not, in fact, outweigh their risk.
It is an unacceptable failure rate.
Excerpt from: Glod M. Prescription deaths bring call for checks; critics seek pharmacy oversight. The Washington Post July 3, 2000:
Mike McClave is a foreman for the CSX railroad in Virgina. If one of his workers is injured, he has to tell the federal government. If a train slips off the tracks, he files a report. And when an engineer has worked for 12 hours, he stops and rests. So when McClave’s 8-year old Daughter, Megan, died six years ago after a Hampton Roads pharmacy gave her the wrong medicine, McClave was shocked that pharmacists in most states don’t have to report their mistakes to anyone.
**Registered manufacturers are required to monitor and report adverse events associated with products they make. This enables drug companies and the FDA to calculate reporting rates and detect signals for serious adverse events.
Excerpts from: Keehn M. Doctor suspended over drug prescriptions. The Legal Intelligencer July 19, 2000:
A local psychiatrist who is no stranger to allegations of misconduct had his medical license temporarily suspended July 5 by the Pennsylvania State Board of Medicine amid accusations he treated patients with a drug currently unapproved by the Food and Drug Administration.
**Prescribers may be liable for injuries associated with compounded drugs, and they also may face professional discipline. In extreme cases they may face criminal violations of the federal Food Drug and Cosmetics Act.
Excerpts from: Liddane L. Custom-made medications enjoying a renaissance. Florida Times-Union January 9, 2001:
But compounding is enjoying newfound renaissance because some patients are finding that tailor-made medicine works best for them, said Dennis Saadeh, pharmacist at Park Pharmacy in Irvine CA. In 5 years since he first offered compounding, he has seen the number of compounded prescriptions at his pharmacy rise from 5 a day to 45 a day.
Excerpts from: Frierson J. Compounding controversy. Chattanooga Times Free Press. March 3, 2001:
The large drug companies of the PhRMA are, interestingly, of two minds. They offer support to the Compounders on speech and advertising issues, but express doubts about the quality control, safety and effectiveness of customized mixtures.
**Historically, pharmaceutical manufacturers have shown little interest in this issue, generally supporting traditional, medically necessary compounding. However, the unapproved manufacturing of certain drugs has reached such large proportions that it is increasingly reaching their radar screens for both competitive and drug safety reasons.
Excerpts from: Teegardin C. State drug agents looking for link between
thyroid capsules, ailments. The Atlanta Journal-Constitution March 29, 2001:
The Georgia Drugs and Narcotics Agency opened an investigation and seized the specially formulated medications after at least three patients this month experienced severe adverse reactions to a thyroid medication known as T3.
Patients should be told a product is compounded, said Marjorie Powell, assistant general counsel to PhRMA. And they should know that compounded drugs have not gone through clinical trialsto measure safety and effectiveness, she said. “They really are working with what would be the equivalent of an experimental drug”.
**The Consumer Health Alliance for Safe Medications One product, purportedly a 10 mg hormone treatment, had no detectable active ingredient, while a drug used to prevent organ rejection had only 52% of the labeled drug present. Other products had too much ingredient, up to 135% of the labeled amount.
The results showed an 18% failure rate, which is demonstrative that the products are unreliable and the purported benefits of compounded drugs may not, in fact, outweigh their risk.
It is an unacceptable failure rate.