Compounding Pharmacy Comeback
After devasting news in 2012, compounding pharmacies have new regulations and are posied for growth.
In 2012, compounding pharmacies were reined in after The New England Compounding Center (NECC) in Massachusetts manufactured steroid shots contaminated with black mold were sent to medical centers that killed 64 people across the United States.
The tragedy placed all compounding pharmacies in the middle of a public relations nightmare, fairly or not.
“What happened in Massachusetts is an example of certain compounding pharmacies utilizing poor practices leading to medicines that are not in regulation of industry standards for purity, strength, sterility and quality,” said Michael A. Smith, MD, senior health scientist with Life Extension in Florida. “This catastrophic event has led to state legislatures examining whether accreditation should be mandatory and if compounding pharmacies should adhere to the same standards as drug manufacturers. The debate begins in regard to how much the FDA (U.S. Food and Drug Administration) has authority over compounding pharmacies.”
David G. Miller, Rph, executive vice president and CEO, of the Texas-based International Academy of Compounding Pharmacists (IACP), added that compounders have had to make decisions about whether to stay in the business in light of new regulatory scrutiny and tougher manufacturing standards that are being applied to the profession. “Those that have decided to stay in the business are ‘all in’ and are investing in new equipment and establishing tough new safety protocols. Many have spent hundreds of thousands of dollars on new equipment.”
Specialized Solutions
As for the state of the market for compounding pharmacy services since in the years following the NECC tragedy, “we have no definitive data that points to increased demand,” Miller said. “Though anecdotally it certainly seems as demand is up as more patients seek customized therapies and more commercially manufactured medications are back-ordered or otherwise unavailable, necessitating compounded alternatives.”
Dr. Smith noted that it did flatten with the FDA warning letters on compounding estriol and the negative media coverage in 2012. “However, the industry in making a comeback and they are reporting a rise in compounding prescriptions for 2014.”
As people search for anti-aging and preventative medicine solutions they find doctors who specialize in anti-aging and preventative care, said Holly Lucille ND, RN in California, and member of the Natural Practitioner advisory board. “This growing field of medicine turns to compounding pharmacies to get the job done.”
According to Miller, there are two types of pharmacy compounding: non-sterile and sterile. Non-sterile, which is governed by United States Pharmacopeia (USP) <795>, refers generally to liquid medications, capsules, gels, creams, etc. Sterile compounding refers to medications that are generally injected into the body or to things like sterile eye drops. Sterile is governed by USP <797> and is naturally higher risk because it bypasses key filters such as the liver and kidneys, but that risk is managed by following proper procedures for sterile compounding.
“Compounding pharmacies can customize any type of medication for a patient who: might have an allergy or sensitivity; needs a particular strength that is commercially unavailable; requires the drug in a special form,” Miller explained. “A classic, simple example is an amoxicillin suspension for a toddler with an ear infection. In this case a compounding pharmacist might take tablets and mill them, and put them into a liquid so that the toddler can take the medication more easily. A more complicated example might be an HIV patient who is on many drugs, and the pharmacist creates a compound so that the patient only needs [to] worry about taking one drug. In that case, all the drugs are present, but they are combined into a single form. Compounding pharmacists can create pain gels, which offer patients the benefit of a non-addictive opioid product. Sterile compounders can prepare an IV bag of sodium bicarbonate, which is a drug that has been around for decades, but is frequently unavailable from manufacturers because of drug shortages. Compounding was the only way to make a drug before the post-World War II mass production of pharmaceuticals and to this day compounders can make most anything.”
Dr. Lucille said compounding pharmacies often have varying areas of specialty, similar to physicians. “Most compounding pharmacies compound prescriptions for bio-identical hormone replacement therapy (BHRT), topical pain creams that target pain while being non-habit forming, allergen- free medications, dermatological preparations and anti-aging products such as IV vitamins,” she added. “A unique advantage the compounding pharmacies have is their ability to compound medications that are no longer available on the market. The compounding pharmacy I send my patients to, Great Earth Compounding Pharmacy in West Hollywood, CA, also provides consultation services, which other pharmacies typically charge for. They are also very resourceful in helping find solutions where commercially available medication options are not a viable solution. If I ever have a question on a particular medication, the pharmacist is very knowledgeable and resourceful in answering my questions. They also make formulations that are sugar-free, allergenfree, and preservative free to meet the needs of my patients.”
“Compounding pharmacies can personalize almost any prescription drug,” added Dr. Smith. “They can adjust the strength of a medication, remove or avoid unwanted ingredients, such as dyes, preservatives, lactose, gluten or sugar. They can add flavor to make the medication more palatable and prepare medications using unique delivery systems. For patients who find it difficult to swallow a capsule, a compounding pharmacist may prepare the drug as a flavored liquid suspension instead. Other medication forms include topical gels or creams that can be absorbed through the skin, suppositories, sublingual troches, or even lollipops, such as bioidentical hormones.”
Moving Forward
At the time of the NECC incident, critics complained that some compounding pharmacies had been run like pharmaceutical companies rather than dealing with personalized prescriptions. “That criticism is directly linked to the behavior of the NECC, a company which was responsible for compounding and shipping thousands of vials of sterile medications around the country in direct violation of state law,” Miller said.
It is important to separate out NECC from the rest of the profession, Miller stressed. “There is no doubt, based on the reports of federal and state investigators, that NECC was a drug manufacturer operating with a pharmacy license,” he said. “NECC aside, there is strong demand for compounded medications (as noted above) from hospitals and physicians who are unable to get certain manufactured medications, and that has led to many compounding pharmacies working with those health facilities to fulfill that demand.”
On November 27, 2013, the Compounding Quality Act was signed into law. “With our new federal law there is now a mechanism for compounding pharmacies that want to evolve into a supplier of sterile drugs for hospitals, clinics and physician offices and they can make that decision to take their business in a new direction and voluntarily register with the FDA and be subject to FDA oversight,” Miller explained. “We are seeing many pharmacies consider this step and we hope that the trend continues because compounders provide a critical safety net for the U.S. drug supply system in times of shortages and backorders. There is also, and will always be, a need for pharmacies and compounding pharmacists that focus solely on providing individual patient prescriptions in partnership with prescribers.”
Dr. Smith added that the Drug Quality and Security Act was written in direct response to the NECC meningitis outbreak. “The bill grants the FDA more authority to regulate and monitor compounded drugs. The bill’s writers believe it will make it easier for the FDA to trace drugs throughout the U.S. supply chain. It accomplishes this by requiring all compounding pharmacies to register annually and meet compounding standards. The one unknown in the bill has to do with “difficult to compound” drugs. A committee is being established that would create a list of these drugs. Whether or not the drugs on this list could be compounded is not clear. Not surprisingly, this part of the bill has some compounding pharmacists concerned.
Choosing a Compounding Pharmacist
Dr. Lucille stated that the laws in compounding pharmacies are correctly under review to ensure that the incident that occurred in Massachusetts does not reoccur. “Compounding pharmacies need to have stringent standards to ensure the quality and integrity of the medications that they compound. For example, Great Earth Pharmacy, independently tests each batch of medication to ensure that the medication they are dispensing is both potent and sterile.”
She listed several questions for practitioners to consider when choosing a compounding pharmacy:
1. Is every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and verified by a licensed pharmacist?
2. Are your pharmacists, technical and customer care staff dedicated to compounding?
3. Are you active members of the Professional Compounding Center of America (PCCA)?
4. Is the pharmacy licensed and in good standing with their state board of pharmacy?
5. Does the pharmacy have a license to practice in your state?
6. Does the pharmacy tests its preparations for sterility and potency?
7. Does the pharmacy have written SOPs and do they document Certificate of Analyses on their ingredients?
8. Does the pharmacist have extensive experience with compounding?
9. Can the staff help solve your problems?
Are they knowledgeable in your areas of practice?
10. Does the staff participate in ongoing continuing education courses related to compounding?
“It is critical that compounding pharmacies not only have competent staff and internal measures for quality assurance but also independently test their products for potency, sterility and endotoxins,” Dr. Lucille added. “My compounding pharmacy has a folder containing regular potency testing results to ensure that my patients get quality medications.”
“Make sure they are truly a compounding pharmacy, designing formulations caseby- case,” noted Dr. Smith. “Ask if a certified, licensed compounding pharmacist will be assigned to formulate your prescription.”
The IACP has a tool right on its website for this exact purpose. Visit www.iacprx.org to view the Compounding Pharmacy Assessment Questionnaire (CPAQ).
“To make patients feel safe, the compounded medications must be safe,” said Miller. “To do this, compounding pharmacies follow national standards for compounding, and some go one step further and get an accreditation, such as from the Pharmacy Compounding Accreditation Board (PCAB). Compounding pharmacies test sterile products to ensure their sterility and potency as an added step to build public confidence and assure public safety.”
Is the future of compounding pharmacies bright?
“We think it is,” Miller added. “It is a changed landscape that is more complex than it once was, but we are bullish on the compounding pharmacy profession and we see increasing numbers of students choosing this career.”
“Absolutely! The ability to produce individualized therapy versus one-size fits all is crucial for my patients,” said Dr. Lucille. “A practitioner is able to formulate a unique combination of medications and rely on a compounding pharmacy to make it.”
Dr. Smith agreed. “Yes! The trend in health care is toward individualization of drug therapy. In the future, pharmacogenomics will allow the development of tailored drugs to treat a wide range of health problems. Pharmacotherapy will be more specific and physicians working collaboratively with compounding pharmacists to develop effective, safe medications and doses that will be tailored to a person’s genetic makeup.“
. The controversy surrounding the NECC tragedy has led to state legislatures examining whether accreditation should be mandatory and if compounding phar macies should adhere to the same standards as drug manufacturers.
. NECC aside, there is strong demand for compounded medications (as noted above) from hospitals and physicians who are unable to get certain manufactured medications, and that has led to many compounding pharmacies working with those health facilities to fulfill that demand.
. Finding a compounding pharmacy requires research from the practitioner. Find out if the pharmacy can provide the ser vices needed and dig into its business practices and resume. Bottom line: practitioners must feel comfortable with a compounding pharmacy before involving one in their practice.
. Practitioners can visit www.iacprx.org to view the Compounding Pharmacy Assessment Questionnaire.
FOR MORE INFORMATION:
. Dr. Holly Lucille, www.drhollylucille.com
. U.S. Food and Drug Administration, (888) 463-6332, www.fda.gov
. International Association of Compounding Pharmacists, (281) 933-8400, www.iacprx.org
. 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
