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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
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Tips on maintaining health through perimenopause and beyond

If you’d like an overview of hormonal changes that happen for women at mid-life, check out this presentation by Lisa Brent, ND. Dr. Brent is a naturopathic physician who is a specialist in women’s health. We were delighted to host Dr. Brent this summer at Koshland Pharm and to hear her presentation, “Mind Over Menopause: Maintaining Health Through Perimenopause and Beyond,” and to share it here in its recorded version.

-Krista Shaffer, Outreach Director at Koshland Pharm and Peter Koshland, PharmD

 

 

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

New Compounding Law H.R. 3204: One Pharmacist’s Perspective

Sacramento state house

Sacramento state house

A little over a year ago, an outbreak of meningitis cases caused by injectable steroid medications made by a compounding pharmacy in Massachussetts cast a national spotlight on the compounding profession. As a result of this tragedy, new legislation was signed into law in November, 2013. This new legislation, called “H.R. 3204,”” strives to create legal distinctions between traditional compounding pharmacies and a newly designated category of pharmacy called an “outsourcing facility.”

A traditional compounding pharmacy is defined as one that mostly dispenses customized medications on a case-by-case, patient specific basis. Outsourcing facilities, on the other hand, will more closely resemble drug manufacturers in that they make large quantities of medications that are not patient-specific and that can be shipped regularly across state lines.

Although outsourcing facilities are now being encouraged to officially register with the Food and Drug Administration (FDA), traditional compounding pharmacies (such as Koshland Pharm) will continue to be regulated by their individual state boards of pharmacy. The FDA has always had and will continue to have the authority to inspect any facility or business that stores medications, which means that it can inspect a traditional compounding pharmacy at any time. However, H.R. 3204 puts the FDA’s greatest attention on outsourcing facilities, and it clarifies state boards’ of pharmacy responsibility to regulate traditional compounding pharmacies in their jurisdiction.

There are many aspects of the new legislation that will only become clear once it begins to be enforced in the coming year. One question that remains is how the FDA will carry out its power to create a “do not compound” list for both traditional compounding pharmacies and outsourcing facilities alike. In the past, the FDA has written statements expressing concerns about certain kinds of commonly compounded medications, such as the hormone estriol, but without citing specific research that led them to have these concerns (see my past blog post on the FDA and estriol for further information). Up until now, the FDA has not prohibited compounding pharmacies from making estriol, even though it has had the power to do so. Although the FDA has not taken this action in the past, it could potentially do so in the future at their discretion.

Stay tuned for on-going updates about this recent law and how it is impacting the field of customized medications. Feel free to post questions here for a dialogue about this important topic for the future of customized medications.

~Peter Koshland, PharmD

www.koshlandpharm.com

FDA approves Paxil for hot flashes? Come again?

Peter Koshland, Pharm.DOn June 28, 2013, the FDA approved the anti-depression drug paroxetine (Brisdelle, in a higher dosage form known as Paxil) as the first non-hormonal drug to treat hot flashes, which many women experience in menopause. This approval came despite the FDA’s own Advisory Committee’s 10 to 4 vote against approving paroxetine for this particular condition because its benefits did not outweigh its risks. (Paroxetine was only associated with on average one or two less hot flash/es per day than a placebo in two clinical studies, with the women in the studies starting out with an average of 10 hot flashes per day.) (“FDA Approves a Drug for Hot Flashes”, Andrew Pollack, The New York Times,  June 28, 2013)

As a pharmacist, I was shocked to see the FDA approve paroxetine—which the FDA’s own committee determined was only “minimally effective” for hot flashes—because it comes with many troublesome side effects. These include agitation, insomnia, sexual dysfunction and the life-threatening serotonin syndrome. Anti-depression medications can be very difficult to stop taking once on them as well; this is especially true for paroxetine. I’ve had several patients who have had severe withdrawal effects from this drug. Our pharmacy has had to make specially formulated 0.5mg doses so that these patients could titrate the dose very slowly and even then it was a rocky road.

Although the FDA did not explain in its announcement its reasons for going against its own committee’s recommendations, it seems as though there was pressure to approve a non-hormonal medication for hot flashes. The FDA stated in their June 28th press release: “There are a variety of FDA-approved treatments for hot flashes, but all contain either estrogen alone or estrogen plus a progestin.” This statement makes it sound as though estrogen and estrogen/progestin therapy are inherently bad.

This kind of statement is extremely frustrating to me as a pharmacist, because in fact, there is strong clinical evidence to support the use of bioidentical hormones to address menopausal symptoms both because of their efficacy and strong safety profile. (For a summary of some of the research on bioidentical hormones, see “The Bioidentical Hormone Debate” by Kent Holtorf.) In my experience as a pharmacist, I have also seen first-hand thousands of women benefit from these treatments.

A decision like this makes me believe there is still work to do when it comes to education around healthy aging for women in menopause and beyond. We can do better than giving women experiencing menopausal symptoms a drug that was designed for depression.

I welcome your thoughts and comments.

–Peter Koshland, PharmD

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

What a Doctor Learned from his Patients

KP_Newsletter_Spring_2013_Page_1Dr. Garrett Smith, MD, had a unique vision for an oncology practice here in San Francisco.  He explains, “The dream for our practice was to be more than just a doctor’s office where patients come to get their chemotherapy.  We also wanted to be a community center based on an integrative approach to healing, evolving over time to reflect what patients tell us they need.”  For example, he found Natalie Ledesma, a dietician, through one of his patients, who told him, “You’ve got to meet Natalie.  She saved my life.”  He also learned from patients that when they come in to talk about nutrition, they often bring a buddy or partner.  These lessons that he learned from patients informed his decision to set up a clinic that had enough space for complementary practitioners (including a nutritionist, a massage therapist, a psychotherapist, an exercise physiologist, and an acupuncturist) and for meeting spaces that allowed patients to bring friends and support to their appointments.

You can read more about Smith Integrative Oncology, including how Dr. Smith came to administer chemotherapy treatments himself and why Natalie believes nutrition counseling must be highly individualized, in the “Featured Practitioner” article of Koshland Pharm’s Spring 2013 Prescriptions for Health newsletter.  We were inspired by their approach to health and healing, and hope you are, too.

~Krista, Outreach Director at Koshland Pharm, and Peter

www.koshlandpharm.com


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