Archive for the 'Answering the Critics' Category

Recent Forbes Article About Women’s Use of Compounded Hormones

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Running creams through an ointment mill is one important quality assurance procedure that a compounding pharmacy should follow

A recent article came out in Forbes’ online magazine entitled “Women Fooled By Untested Hormones From Compounding Pharmacies” (February 20,2015).

As a co-owner of a compounding pharmacy that values patient care and therefore quality as its primary mission, I’d like to respond to the critique that this article makes of compounded medications.
The topic of the Forbes article is a recent study that was published in the online journal Menopause, The Journal of the North American Menopause Society, about women’s use of hormone replacement therapy. Even though the source of funding for this study is not mentioned in the Forbes article, this piece of information is important. The study was funded by TherapeuticsMD, which is a pharmaceutical company working to bring hormone products to market. This company certainly has the right to fund a study of hormone usage among women  – but to not mention its involvement leaves out an important contextual backdrop for the study’s design.
In addition to providing the funding, TherapeuticsMD also put together the questionnaire that was used in the study, which helps explain why certain questions were asked, and why other questions might not have been asked. One of the survey’s findings is that 76% of the 800 women surveyed didn’t know if compounded hormones are FDA-approved or not. The results are written up in a way that suggest this finding is surprising and alarming.
But did the women surveyed believe that FDA approval was the most important element in assessing the quality of the medications they were taking? We don’t know because this follow-up question was not asked. How would the women surveyed have responded if they had been asked, “How do you evaluate the quality of the hormone products you are taking?”
Compounding pharmacies do not claim (and should not claim) that their medications are FDA-approved, for the FDA is not the regulatory body entrusted with monitoring their conduct– that regulatory role is played by state boards of pharmacy. Did the women surveyed know that compounding pharmacies are regulated by state boards of pharmacy, and were they aware of the quality assurance measures taken by the compounding pharmacy they use? This is important information to know.
The assumption of this Forbes article is that non-FDA-approved means “dangerous.” The FDA is put in the role as the solution to a problem.

Quality matters in compounded medications – but this can happen without expanding the role of the FDA in the field of compounding pharmacy. As the recent outbreak of a superbug in LA’s Ronald Reagan Hospital illustrates, the FDA already has a big job – such as regulating the use of medical instruments in hospitals which can prove dangerous when not cleaned properly. The compounding industry has always argued that the FDA should not take on the additional role of policing compounding pharmacies. The primary role of regulation should stay with state boards of pharmacy, which understand the industry better than the FDA does, for the FDA’s area of focus is mass-manufacturing and hospital settings.

The Forbes article ends with a caution against compounding pharmacies, stating, “Fewer than 50 compounding pharmacies have volunteered to subject themselves to the agency’s [the FDA’s]  stricter oversight.” This statement represents a lack of understanding of the new federal legislation written about compounding pharmacies (the Drug Quality and Security Act of 2013), for it does not distinguish between outsourcing facilities and traditional compounding pharmacies. Outsourcing facilities, as defined by the new law, make sterile medications in large quantities without patient-specific prescriptions and ship across state lines, while traditional compounding pharmacies make patient-specific prescriptions and work within their own state. Only outsourcing facilities have been asked to voluntarily register with the FDA, since traditional compounding pharmacies are still regulated by state boards of pharmacy. To make it sound as though “fewer than 50 compounding pharmacies” have high quality standards because they have not registered as outsourcing facilities is simply wrong.
Pharmacies with good policies and procedures, top-of-the-line equipment and continual quality control can make compounded medications that rival mass-produced pharmaceuticals in both their potency and purity. However, variation does exist in individual pharmacies’ quality assurance procedures. It is important for both doctors and patients to critically evaluate the compounding pharmacies that they are using for customized medications. Here are six key questions to ask of a compounding pharmacy to evaluate its quality assurance program.
Are women fooled by hormones from compounding pharmacies, as the Forbes article states, or are they critically evaluating their options for hormone replacement therapy?
What is your experience? Do quality considerations play a role when you choose a mass-manufactured or compounded medication? How do you assess quality in customized medications made by a compounding pharmacy?
Krista Shaffer, Outreach Director at Koshland Pharm

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

An Open Letter to Our Senators Opposing Proposed Compounding Legislation

Koshland PharmThe regulation of compounding pharmacies is currently being debated in the Senate due to the understandable concern that followed the meningitis outbreak tied to a compounding facility in Massachusetts in October of 2012.  As the founders of a compounding pharmacy in San Francisco, we are supportive of efforts to tighten the regulation standards and practices of State Boards of Pharmacy to ensure the safety and protection of patient health.

However, we have substantial concerns with the current June 27th Senate bill (S. 959) that is scheduled to be voted on next week.  We do not believe that it effectively protects patient safety while preserving patients’ and practitioners’ access to compounded medications.  These medications can be vital to individuals’ health and well-being. We believe that revision of this current Senate bill is important not only in our particular lives as the founders of a compounding pharmacy, but also in the lives of thousands of patients we have worked with and witnessed benefiting from compounded medications.

To read more about Senate bill 959, we recommend the website of the International Academy of Compounding Pharmacists. We are also including below the letter that we sent to our senators on this topic:

Dear Senators Feinstein and Boxer:

We are writing to bring to your attention concerns that we have with the recently reported version of S. 959, “The Pharmaceutical Compounding Quality and Accountability Act,” which we understand the Senate may consider the week of July 15.

We are a husband and wife who opened a compounding pharmacy in San Francisco in 2009.  Our pharmacy is committed to making high quality, customized medications (as demonstrated by our accreditation by the Pharmacy Compounding Accreditation Board) and to building relationships with both patients and their doctors to ensure the best possible treatment outcomes. It was Peter’s desire to work in a pharmacy setting where he had the time to talk one-on-one with patients that led him into the compounding profession, and it is this ability to focus on patient care that continues to inspire us, as well as our staff of eleven others, in our collective work of supporting patients in their health and well-being.  One patient recently wrote to us, “The medications Peter and his group made for me have made such a difference in my life. I have never had a pharmacy call to see how I am doing on any medicine. Thank you!”

We are aware that the U.S. Senate’s Committee on Health, Education, Labor and Pensions has worked diligently and cooperatively for several months with the various stakeholders in the pharmacy and practitioner communities to draft legislation to address the tragic patient deaths and illnesses associated with the New England Compounding Center (NECC). In reviewing the Committee’s most recent version of S. 959, we wanted to make you aware of several provisions we have concerns about.  We ask you to take these concerns in consideration as the Senate debates this legislation.

Our primary concern is that the current draft of the bill would interfere with the regulation of traditional compounding pharmacies by State Boards of Pharmacy – the regulatory board that we believe is most appropriate and best able to oversee traditional compounding pharmacies.  The state of California currently has some of the strictest laws in the nation to regulate compounding pharmacies, and we believe that our State Board  – not the FDA –is best able to balance the dually important needs of ensuring the safety of compounded medications while preserving patient and practitioner access to vital compounded medications. Our understanding of S.959 is that it:

• contradicts existing and evolving state laws allowing for “office-use” and “anticipatory compounding”

• inappropriately gives the FDA (instead of State Boards of Pharmacy) authority to determine if a pharmacy is acting within the scope of its permit

• gives the FDA arbitrary authority to restrict the compounding of specific products based on ambiguous standards , permitting the FDA to create a “do not compound” list based on unclear definitions about “complex” or “difficult” to compound issues rather than true patient safety issues

• places the FDA in the role of determining whether a compounding pharmacist’s preparation and dispensing of a variation of a marketed drug is “clinically significant”

Of greatest concern to us is the fact that one of the fundamental documented problems in the NECC scenario was inaction by the Massachusetts Board of Pharmacy and the Federal Food and Drug Administration (FDA) in a situation where they had made numerous visits to the facility and had knowledge of significant problems. Despite that, they did not shut NECC down. This bill does not provide for any reporting system for the FDA, nor does it hold the agency accountable in any way. This is a significant flaw that needs to be addressed in the legislation.

We hope you will take our concerns into consideration before final consideration of S. 959. Should these provisions not be addressed before the bill goes to the Senate floor for a final vote, we urge your opposition to this well-intended but flawed legislation.

Sincerely,

Peter Koshland, PharmD and Krista Shaffer

Recent Trial (KEEPS) Shows Benefits of Hormone Therapy in Newly Menopausal Women

The researchers who conducted the KEEPS trial (Kronos Early Estrogen Prevention Study) presented initial findings to the North American Menopause Society on October 3, 2012, summarized in the statement:

“Estrogen/progesterone treatment started soon after menopause appears safe and relieves many of the symptoms menopausal women face as well as improving mood and markers of cardiovascular risk.”  (KEEPS press release, “Hormone Therapy Has Many Favorable Effects in Newly Menopausal Women,”10-3-12)

This four year, randomized, double-blinded, placebo-controlled clinical trial (the gold standard in clinical trials) compared oral vs. transdermal estrogen in conjunction with cyclic progesterone.  The participants were healthy women aged 42-58 who started therapy within three years of the onset of menopause.  The oral estrogen used was conjugated equine estrogen (Premarin), and the transdermal estrogen was a bioidentical, estradiol patch (Climara).

The researchers are still analyzing the data, but have so far concluded that “The results provide reassurance for women who are recently menopausal and taking HT for short-term treatment of menopausal symptoms.  KEEPS also highlights the need for individualized decision making about hormone therapy, given that oral conjugated equine estrogen and transdermal estradiol  have different profiles of effects and different women have different symptom profiles and priorities for treatment”  (KEEPS press release, “Hormone Therapy Has Many Favorable Effects in Newly Menopausal Women,” 10-3-12).  The different profiles of effects include an association with the use of oral conjugated equine estrogen with an increase in HDL (“good”) cholesterol, a decrease in LDL (“bad”) cholesterol, and an increase in triglyceride levels (a lipid fraction that is of uncertain significance), and an association between the use of bioidentical transdermal estradiol with with improved insulin sensitivity (lower insulin resistance).  For more information, see: http://www.koshlandpharm.com/KEEPS.

These initial findings support our understanding of existing studies that estrogen therapy, started close towards the beginning of menopause, can be an effective treatment of menopausal symptoms without  posing a risk to cardiovascular health.

~Peter

www.koshlandpharm.com 

Ensuring Quality and Safety in Compounded Medications

As a compounding pharmacist, I have been saddened by recent unfolding news about a meningitis outbreak in southern and eastern states tied to injectable medications made at a compounding pharmacy in Massachusetts. As this news is shining a national spotlight on compounding, I would like to highlight two key issues this situation raises:

1) Accreditation by the Pharmacy Compounding Accreditation Board (PCAB) is essential in the compounding profession. Although new facts continue to be uncovered in the investigation of the pharmacy in question in Massachusetts, it has been established that it was not PCAB accredited. There are currently 165 compounding pharmacies nation-wide (and  21 in the state of California) that are PCAB accredited.

Although every compounding pharmacy is regulated by its state board of pharmacy, variation does exist state to state in practice requirements. Being PCAB accredited ensures that a pharmacy has passed the highest standards for safety and quality in the profession. The Pharmacy Compounding Accreditation Board was founded and is governed by eight leading national pharmacy organizations, including the United States Pharmacopeia (USP), and it requires pharmacies to adhere to strict policies and procedures that include rigorous and consistent testing of their finished products.

2) Sterile and non-sterile compounding are two different kinds of compounding a pharmacy can specialize in. Of the approximate 7,500 pharmacies nation-wide that specialize in compounding, 3,000 provide sterile compounding.  Sterile compounding requires additional equipment and procedures to ensure the sterility of the finished products that are injected directly into the body.  The medications that are under current investigation from the Massachusetts compounding pharmacy were sterile injections.

I, along with thousands of my compounding pharmacist colleagues, am dedicated to providing patients with the valuable option of using high-quality, customized medications when standard treatments are not working for their particular situation.  To read six key questions for a patient to keep in mind when evaluating a compounding pharmacy (particularly one that makes non-sterile products), see  Koshland Pharm’s “Understanding Compounding” webpage.  To read extensive questions a doctor can ask of a compounding pharmacy (particularly one that makes sterile products), see this questionairre created by the International Academy of Compounding Pharmacists. To read another recent blog about how the Massachusetts compounding pharmacy in question appears to differ from traditional pharmacy compounding, see the National Community Pharmacists Association blog.

Your comments and questions on this important topic are welcome.

~Peter

www.koshlandpharm.com

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

Recent Article Comparing Conventional and Bioidentical Hormones

I often get requests from doctors and patients for links to recent studies about bioidentical hormone replacement therapy.

This recent article in the latest issue of the International Journal of Pharmaceutical Compounding is a nice summary of the research to date on this topic.  The study summarizes and compares randomized, controlled trials in human females (published between 1995 and 2010) looking at conventional and bioidentical hormone replacement therapy and their impact on cardiovascular and breast cancer risks.

The authors conclude that conventional hormone replacement therapy (the use of conjugated estrogens and medroxyprogesterone) is detrimental to cardiovascular and breast health, while the use of bioidentical estrogen improves some markers of cardiovascular health but may induce breast epithelial proliferation if administered without progesterone.  For a link to the ten page article, click here.

It’s important to keep key questions in mind when reading an article such as this one about hormone replacement therapy, such as: What hormones are being studied? and, What disease end points are being looked at?

For a full list of questions to ask when reading articles and studies about this topic, see Koshland Pharm’s website that gives an overview of bioidentical hormones.  Also remember that when making decisions about your own health, it is always important to talk with a knowledgeable practitioner about the research and its implications for your treatment approach.  Thanks for reading,

Peter


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