Posts Tagged 'compounding pharmacies'

Let’s Get This Straight – Greed is NOT Good.

greed stop signWhen greed gets involved, bad things happen. This seems to be a universal truth – whether we’re talking about the sub-prime loan fiasco in the financial industry, or the recent scandal in the world of compounding pharmacy where some pharmacies were overcharging insurance companies for customized medications for profit-driven motives.

From our experience as members of the compounding pharmacy community, the pharmacies that gamed the system were in a small minority. In fact, what has always inspired us about running a compounding pharmacy is the opportunity to help our patients achieve real health benefits from customized medications and to collaborate with colleagues who feel the same. In our own compounding pharmacy and in many others we know across the country, much care is taken to price compounds fairly.

We want to speak out as owners of one compounding pharmacy to say that greed, especially in our industry where people’s health is at stake, is never okay. The compounding industry has received a blow to its reputation due to the greed of a few. And the most unfortunate consequence is that patients are the ones who ultimately suffer. Many insurance plans now no longer cover certain compounded medications in response to the overcharging practices of a few pharmacies. Now if a patient is using a compounded topical cream with anti-inflammatory ingredients and ingredients that block nerve pain – a cream that precludes the use of oral opioids that we know can lead to addiction and other serious health problems – they probably need to pay four or five times what their previous co-pay was. And that’s a shame.

Compounding pharmacies now have to work to advocate for the reinstatement of insurance coverage for many customized medications. This is an important role for compounding pharmacies to play, for they see on a day-to-day basis how these medications can make a tangible, positive difference in people’s lives. Some of those real-life examples can be seen on  PCCA’s “Protect My Compounds” webpage.

We believe it is also important to be honest and forthcoming about the role greed played in the recent restriction in coverage of compounded medications, even though this truth is uncomfortable to talk about.

Ironically, the industry of compounding pharmacy was not so long ago on the other side of a story about greed, this time playing the role of the magnanimous alternative to a greedy pharmaceutical company. It was the case of a drug called 17 alpha-hydroxyprogesterone caproate, often prescribed to help lower the risk of pre-term births. Compounding pharmacies were able to make this medication for an affordable price of $20 per dose until KV Pharmaceutical got FDA approval for their own brand-name version of the drug, called Makena. Suddenly, the price of the same drug – 17 alpha-hydroxyprogesterone – went to $1,500. The reasoning behind the phenomenal increase in price from $20 to $1,500 was never convincingly argued by KV Pharmaceutical, and greed’s role in the controversy was easy to discern. (You can read a great recap of the Makena story in this blog article, “Pregnancy Woes: Why did the price of my progesterone skyrocket?”)

It’s easy to see greed in others. It’s harder to see in ourselves. It’s also hard to regulate greed. But if we’re more aware of its power to cloud judgment, we can be ready to recognize it and speak out against it when we first see it – especially in the very industries in which we work.

No one says it better than Sweet Honey in the Rock (click here to listen).

Krista Shaffer, Outreach Director, & Peter Koshland, PharmD

Koshland Pharm


OB/Gyn organization gets it wrong about compounding pharmacies

PCAB Accredited SealThe American College of Obstetricians and Gynecologists (ACOG), one of the leading organizations of OB/Gyn’s in the country, recently came out with a position statement telling their members not to use compounded medications for their patients.  Their statement includes factual inaccuracies about the quality and validity of compounded medications.

Compounded (or customized) medications are an important part of the host of therapeutic options available for an individual patient, and unfortunately, the ACOG position limits doctors’ ability to treat their patients’ conditions by suggesting that they solely rely on medications provided by the pharmaceutical industry.

One of ACOG’s key criticisms of bioidentical hormones from compounding pharmacies is the lack of quality control when it comes to purity and potency of the finished medications.  They mention an often cited FDA survey from 2001 (mistakenly referenced as being from 2009 in the ACOG paper, p. 4), that found a 34% potency failure rate from compounded prescriptions obtained over the internet.

Importantly, this FDA study (2001) about the potency of compounded products predates the founding of the Pharmacy Compounding Accreditation Board (PCAB), which created in 2006 “a system of standards by which each compounding pharmacy can test its quality processes.”  PCAB is a not-for-profit organization founded and directed by eight leading national pharmacy organizations:  The American College of Apothecaries, the National Community Pharmacists Association, the American Pharmacists Association, the National Alliance of State Pharmacy Associations, the International Academy of Compounding  Pharmacists, the National Home Infusion Association, the National Association of State Boards of Pharmacy, and the United States Pharmacopeia.

The ACOG paper states, “the purity, potency and quality of compounded preparations are a concern” (pg. 3).  They are clearly unaware of the rigorous quality control measures required in PCAB accredited compounding pharmacies, including the testing of multiple finished products as a way of ensuring quality and validating the processes used to make the compounded medications.

Compounded medications may not be right for all patients in all situations, but they are an important therapeutic tool for situations where a manufactured pharmaceutical does not meet a patient’s needs.  ACOG’s position perpetuates factual inaccuracies about these customized medications at the expense of a patient’s ability to obtain the best possible treatment for her/his specific condition.

For patients and doctors who want to ensure that they are working with a pharmacy whose compounded products have reliable potency and purity, they can check to see if the pharmacy is accredited by PCAB.  In addition, both patients and doctors can ask to see a pharmacy’s certificates of analysis of the products that they routinely test.

For 6 concise questions to ask a compounding pharmacy to evaluate the quality of its compounded medications, see Koshland Pharm’s “How to Evaluate a Compounding Pharmacy” hand-out.

I welcome your comments and feedback.

Peter Koshland, Pharm.D

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