Enduring & Improving
In light of the NECC tragedy, quality compounding pharmacies continue to provide personalized service. They’re easy to find for those who ask the right questions.
You have probably heard illinformed parties rant about the dangers of supplements for years.”They’re unregulated!” “It’s a business run by charlatans!” You’ve ignored them a hundred times. After all, you know the real story.
The same anguished cries, to a lesser extent, can now be heard in regard to compounding pharmacies, thanks to the New England Compounding Center (NECC), which last year manufactured steroid shots contaminated with black mold that were sent to medical facilities in at least 23 states.
At press time, more than 60 people had died as a result of NECC’s tragic mistake; there have been 750 cases of illness. The incident has placed all compounding pharmacies in the middle of a public relations nightmare-one they do not deserve to navigate.
Think of it this way: Were a major drugstore chain accused of endangering the lives of hundreds, would you also blame the family pharmacy around the corner?
Personalized Service, Not Bulk
NECC, explained Michael Smith, MD, senior health scientist at Florida-based Life Extension, was a “drug manufacturing factory acting like a pharmacy.” With legitimate compounding pharmacies, “there is no conveyor belt involved,” only “one dose for one person.”
“Many medications may be available in one or two strengths,” said Holly Lucille, ND, RN, a naturopathic physician based in West Hollywood, CA and a member of Natural Practitioner’s advisory board. “However, compounding pharmacies can prepare a dosage strength that contains exactly what the doctor ordered.”
“A practitioner should use a compounding pharmacy when he or she wants to make very personalized choices for their patients,” said Carol Petersen, Rph, CNP, marketing liaison for Women’s International Pharmacy in Wisconsin. “It can be to control the quantity, the mode of administration, avoiding additives, colors, etc.”
The media have run with the idea of NECC as a traditional compounding pharmacy, said Dr. Smith. “It seems as if everyone- the Food and Drug Administration (FDA), state agencies, your local newspaper’s science editor-is in a tizzy for the wrong reasons. Especially when NECC had long been on the FDA’s radar,” he explained.House Republicans reported that FDA hadn’t acted “on years of complaints about problematic drugs and practices,” according to the Associated Press and CBS News.
FDA and Massachusetts state officials have said they lacked the proper powers to stop NECC from making and distributing drugs on such a large scale. NECC, meanwhile, filed for Chapter 11 bankruptcy protection last December.
“NECC is a very large outlier, which has placed attention on the industry,” said Joe Cabaleiro, a registered pharmacist and executive director of the Pharmacy Compounding Accreditation Board (PCAB), a Washington, D.C.-based organization that provides voluntary quality accreditation designation for the compounding industry.
What hasn’t been brought up in reports, he added, are the “thousands of patients” who have safely received compounding medication.
Further, all pharmacies perform some amount of compounding, Cabaleiro said, so it’s not as if this is some kind of black art. In Dr. Smith’s opinion, an idea has sprouted that compounding pharmacists are “wild chemists” when they’re “really biochemists at heart,” who are licensed and supervised. Dr. Lucille concurred, noting that the State Board of Pharmacy in every state rigorously regulates compounding pharmacies.
Added JR Lynn, account director for Wellness Pharmacy in Alabama, “We do a great many things that go above the standards.”
To go along with the unwanted attention, compounding pharmacists have to deal with proposed legislation that many feel will do far more harm than good.
CPs to U.S. Senate: “Really?”
The talk amongst the supporters of compounding pharmacy is Senate Bill 959, or the Pharmaceutical Quality, Security, and Accountability Act. The bill contains two titles. The first is the Pharmaceutical Compounding Quality and Accountability Act, described as follows:
“[It] establishes a clear boundary between traditional compounders and compounding manufacturers, which make sterile products without or in advance of a prescription and sell those products across state lines. It clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation.”
The second title, the Drug Supply Chain Security Act, “provides a uniform, national drug tracing framework to track prescription drugs from the manufacturer to the pharmacy and raises the standards for prescription drug wholesalers across the U.S.”
Beyond the fancy summaries, few are happy. “The FDA will be able to regulate interstate and intrastate,” Lynn explained. “It restricts access for patients and takes away their right to choose a preferred pharmacy. A compounding pharmacy will be regulated like a large-scale commercial retail pharmacy.”
In September, National Community Pharmacists Association (NCPA) CEO B. Douglas Hoey, Rph, wrote a letter to House Energy and Commerce Committee chairman Fred Upton (R-MI) and ranking member Harvey Waxman (D-CA) to express concerns over S. 959.
Among the issues, according to NCPA, were community pharmacies having “to report directly to the FDA when they are compounding medications to alleviate a drug shortage” and that S. 959 would limit patient’s access to important medications via the FDA maintaining a “do not compound” list. The association believes this “could potentially be used by the agency to prevent compounding in response to a doctor’s prescription for medications such as hormone medications [a major reason behind practitioners directing patients to compounding pharmacies], thyroid preparations, promethazine gels and medications to treat autism.”
If the bill passes, it “will increase the national drug shortage,” said Lynn, which, ironically, compounding pharmacies help alleviate.
NCPA, however, does support The Compounding Clarity Act, (H.R. 3089), sponsored by U.S. Representatives Morgan Griffith (R-VA), Gene Green (D-TX) and Diana DeGette (D-CO). The bill, introduced on September 12, “would better enable regulators to protect the public from any entities like the NECC without harming patients or saddling independent community pharmacists with new red tape,” NCPA said in a statement.
LifeGuard Integrative Pharmacies, which does business as Health First! Pharmacy in California, has circulated a letter for others to send to high-profile senators-including Representatives Tom Harkin (D-IA) and Elizabeth Warren (D-MA)-urging them to vote “no” on S. 959.
“The language of the bill is so broad it may transform all compounded medications into new drugs (according to the FDA) and new drug applications cost millions of dollars and years to decades to submit, test and fulfill,” the company explained in a prelude to its petition, found on change.org. “Compounding is an ages-old pharmacy practice where a pharmacist receives a prescription from a prescriber and fills that prescription for one patient. The FDA was developed to monitor and regulate manufacturers.”
“We want to be regulated,” Lynn said, “but we need to be regulated at the right level, and that’s with the states.” His reason?The FDA can only spread itself so far. “There are thousands of compounding pharmacies in the U.S. that are doing this the right way and the wrong way. They’d have to figure out what’s going on.”
Women’s International Pharmacy’s Petersen is, to put it mildly, upset over the proposed changes. “We have to ask a few more questions,” she said. “I understand that more people have died with the FDAapproved betamethasone product from infections and more are left with lifelong issues than has been discussed. Why are these very dangerous and often not very useful medical procedures being done? If a product is supposed to be injected into the cerebral spinal fluid, wouldn’t you expect a health practitioner to examine the product before they use it? If there was contamination visible, as the FDA has put out, where were all the people who handled it and why weren’t they also looking?
“These are real problems that are not going to be solved by this Senate bill,” she continued. “The FDA has demonstrated that it is not capable of keeping treatments ‘safe and effective’ as it was charged. Since it is funded by the drug companies, those entities are the real customers of the FDA. This Senate bill is a power grab for the FDA and ultimately for PhRMA (the Pharmaceutical Research and Manufacturers of America) to control any threat to business as usual.” PCAB’s Cabaleiro took an optimistic approach to the swirl of legislation, noting that compounding pharmacies have “existed in a legal grey zone” because they have to abide by state and federal laws.
“Depending on which circuit region the pharmacy was located in, the FDA interpreted the rules differently,” he said. “There’s been a lack of clarity in that regard on a federal level, and there’s been a lack of clarity in some state laws regarding what compounding pharmacies can and cannot do. And sometimes those state laws [contradict] the federal laws.” So, Cabaleiro added, if “fair and clear legislation is passed to define what compounding pharmacies can and can’t do,” the initial inconvenience will diminish when “well-compounded drugs” are available to the public.
“The industry is probably mature,” Cabaleiro said. “It’s just that the laws [are] not quite clear or caught up. The laws were written to address compounding a long time ago, but the industry has changed.” For the time being, there are benefits to the increased awareness and visits from the State Board of Pharmacy. “We’ve gotten better because of it,” said Stephen Bernardi, MS, Rph, co-owner of Johnson Compounding & Wellness Center in Massachusetts. “We’ve tightened up everything we could … I think it’s never been a safer time for a consumer to get a compounding medication from us.”
Life Extension’s Dr. Smith said many inspectors will leave compounding pharmacies with the same discovery: “They’re going to find out they’re awesome.”
Finding the Phenomenal
According to Texas-based International Academy of Compounding Pharmacists, 7,500 pharmacies in the U.S. specialize in compounding. Also, about 8,200 pharmacies “associated with hospitals and other health institutions” engage “in compounding on a daily basis to meet their inpatient and outpatient care.”
Cabaleiro compares choosing a compounding pharmacy to choosing a specialist.”You don’t send a chiropractic patient to an orthopedist,” he said.
His checklist is relatively simple: reputation, a good history and knowledge in addressing your patient’s needs; compounding pharmacies have different strengths, which may not align with what a practitioner needs. Women’s International Pharmacy, Petersen said, offers mainly compounded operations of bioidentical hormones. Others, like Johnson Compounding & Wellness Center, don’t claim a specialty, though Bernardi “look[s] for opportunities that haven’t been met.”
Compounding pharmacies need to have their limits. “If someone says they’re better than someone else, I always run fast,” Bernardi said.
Ultimately, practitioners have to do their work. Make sure the pharmacy in question is licensed, Dr. Smith said-“I know that sounds like a given”-and ask for its statistics.
In Dr. Smith’s opinion, “a well-experienced compounding pharmacist” should be handling 10 to 20 prescriptions a week.
Look for accreditations from organizations such as PCAB, Lynn advised. He also suggested exploring the pharmacy’s social media outreach and its website. “Really dig in and see what the company is about. Read their vision, read their mission.”
“Talk to the pharmacist personally,” Dr. Lucille said. “Do you feel confident in them?
Visit the pharmacy and check for cleanliness.
Ask to see potency and sterility testing’s.”
That’s just the beginning for Dr. Lucille, who suggested practitioners and patients ask the following questions:
• Do you have systems in place for handling complaints and investigating sterility failures and adverse events?
• Is every step of the compounding process-from prescribing to compounding and labeling through dispensing-reviewed and verified by a licensed pharmacist?
• Are your pharmacists, technical and customer care staff dedicated to compounding?
• Are you active members of the Professional Compounding Centers of America (PCCA)?
• Is the pharmacy licensed and in good standing with its state Board of Pharmacy?
• Does the pharmacy have a license to practice in your state? [Cabaleiro also said to check with the pharmacy regarding formulations for in-office use. Requirements differ from state to state.]
• Does the pharmacy tests its preparations and do they share the test results?
• Does the pharmacy have written standard operating procedures and do they document Certificate of Analyses on their ingredients?
• How much experience does the pharmacy have with compounding?
• Does the staff participate in ongoing continuing education courses related to compounding?
Patients trust the recommendations of their practitioners. The compounding pharmacy is an extension of that trust, so “make sure whomever you deal with, you’re comfortable with,” Bernardi cautioned. “Ask the important questions and see if they want to hide the answers or give the answers.”
Healthy Take Always
■ The controversy surrounding the NECC tragedy should not obscure the fact that reputable compounding pharmacies deal with personalized prescriptions for patients. That is a primary reason why practitioners have such faith in them.
■ Compounding pharmacies are regulated on a state level, specifically, its Board of Pharmacy.
■ Proposed legislation in the U.S. Senate (S.959) is considered a major threat to compounding pharmacies. Many feel it could severely limit the services offered, thanks to the increased role of the FDA, and worsen the national drug shortage. Many in the compounding pharmacy industry are actively petitioning against the bill.
■ Finding a compounding pharmacy requires extensive research from the practitioner. He or she must find out if the pharmacy can provide the services they need and dig into its business practices and resume. Bottom line: practitioners must feel comfortable with a compounding pharmacy before involving one in their practice.
FOR MORE INFORMATION:
■ International Association of Compounding Pharmacists, (281) 933-8400, www.iacprx.org
■ FDA, (888) 463-6332, www.fda.gov
■ Health First! Pharmacy, (707) 837-7948, www.healthfirstpharmacy.net
■ Johnson Compounding & Wellness Center,(888) 335-5577, www.naturalcompounder.com
■ Life Extension, (954) 766-8433, www.lef.org
■ National Community Pharmacists Association,(703) 683-8200, www.ncpanet.org
■ Pharmaceutical Research and Manufacturers of America, (202) 835-3400, www.phrma.org
■ Pharmacy Compounding Association Board,(866) 377-5104, www.pcab.org
■ Professional Compounding Centers of America, (800) 331-2498, www.pccarx.com
■ Wellness Pharmacy, (800) 227-2627, www.wellnesspharmacy.com
■ Women’s International Pharmacy,(800) 279-5708, www.womensinternational.com
