Archive for the 'Bioidentical Hormones' 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

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

 

 

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

Bioidentical Hormone Therapy Team: Patient, Doctor and Pharmacist

APatel photoWe are pleased to have a guest post this week on our blog. We welcome your comments and feedback.

~ Krista Shaffer, Outreach Director at Koshland Pharm

Many people want to know the process involved for bioidentical hormone replacement before starting treatment. There are Whos, Whats, Whens, and Whys involved before starting any therapy and being informed helps each person feel more confident of the care they are receiving. Bioidentical hormone therapy is typically a team approach including the patient, the doctor, and the compounding pharmacist. Let’s start at the beginning.

When you book an appointment with your doctor, he or she will ask you a full health history and questions that are specific to the symptoms you’re experiencing. They often seek to explore how the symptoms are connected, what makes the symptoms feel better or worse, and which underlying hormones may be deficient, excessive, or out of balance in the body. Hormones work best when they are in concert with one another at healthy levels and ratios. For example, the body needs enough progesterone hormone to balance estrogen levels.  (To see an example of a symptom checklist, click here.)

Once the doctor has collected important information about your symptoms, health history, and lifestyle, he or she may decide to order salivary or blood hormone testing for confirmation. Patients sometimes worry that the results from one single hormone test may be skewed if it’s a bad day. Don’t worry, your doctor should put your comprehensive health intake and lab results side by side to make sure there is a correlation before writing a prescription. In addition, many providers re-test hormone levels at 3 or 6 months to monitor treatment.

After your doctor detects patterns in hormone imbalances, and if she determines an individualized prescription would work best for you, she will contact a compounding pharmacy. The pharmacist speaks to the doctor and can help advise on dosing, route of administration (cream or pill, for example), and other important prescription considerations. The pharmacy staff knows that hormone prescriptions need to be tailored to the individual, and they are there to help make that happen.

Once the compounding pharmacy has your prescription, they’ll give you a call to arrange pick-up or shipping and to answer any questions you may have. Don’t be shy—ask any questions that come to mind about how to use your bioidentical hormones. I recommend working with accredited and quality compounding pharmacies, which can be found nation-wide through the website of the Pharmacy Compounding Accreditation Board.

After you get your bioidentical hormone prescription and start using it, try to pay attention to how your body adapts to the medicine for the first couple of months. A quick update to your doctor can let them know that the dose you’re on is working for you, or it can alert them that you may need an adjustment. Your body knows best, so your detective skills can help you, the doctor, and the compounding pharmacist arrive at the best dose for your symptoms and overall health. If needed, during the first few months your doctor may work with the compounding pharmacy to tweak the prescription until it fits just right.

Good communication among the patient, the doctor, and the compounding pharmacist helps maximize the benefits that bioidentical hormone replacement can provide to your health and your life. You have a team at your disposal on the road to better hormone balance, increased energy and vitality, and improved health!

~ Aarti Patel, ND, Guest Author
Inner Balance Natural Health
Connecting the dots in health
www.Innerbalancenaturalhealth.com

Getting to the Root Cause of Symptoms

tree-rootsWe are fortunate through our work to get to meet physicians across the Bay Area who are committed to the health and well-being of their patients. We recently had the opportunity to interview one of these doctors, Dr. Todd Maderis, for our Prescriptions for Health newsletter. Dr. Maderis talked with us about his passion for getting to the root cause of symptoms:

Practice Approach

In my practice at Marin Natural Medicine, I’m keen on communicating two concepts with my patients. The first is education. I find that if patients are aware of the reasons behind their condition, they have a better chance of getting better.

The second concept, and the premise of my practice, is getting to the root cause of a patient’s symptoms.  Sleep is a great example of this. If a patient comes in complaining of insomnia, she might say, “I’m taking all of these wonderful supplements like melatonin and kava, and I’m still not sleeping.” In response, I might say, “Melatonin and kava are nice, and I like them…but let’s figure out what’s going on with you. What has changed in your life that might cause the insomnia?” We look at age, and the way hormones might have shifted, to see if there is a connection. The patient may not necessarily have a melatonin deficiency; she may have a hormonal imbalance.

I often talk with patients about correcting menopausal symptoms such as insomnia with hormonal balancing. The goal is to mimic nature in how we administer hormones. When we get patients back to their normal physiological range of hormone production, they often feel better and move through the world with greater ease. Ultimately, if we can identify and treat the root cause of their symptoms, the results are more sustainable over time.

Compounding Success Story

There was a woman who had had open heart surgery a few years before coming to see me, and she had been feeling very fatigued ever since. She had a low-grade depression, and wasn’t doing the activities she liked to do, such as playing the piano or reading. It took everything she had to get up and out of the house each day. Because she was clinically presenting with low estrogen and progesterone, I prescribed a topical bi-est (80%estriol/20%estradiol) cream and progesterone capsules from Koshland Pharm. Two or three months into her prescription, she felt a bit better. I had her do a follow-up urine test, and it turned out that her testosterone was also very low. Once testosterone was added to her prescription, she went from feeling 70 percent better to feeling 100 percent better. She started playing the piano and reading again; she got her life back.

Current Inspirations

It is the stories of patients improving the quality of their lives that keeps me inspired. I am also inspired by learning from experts in different fields, and then bringing that knowledge back to my patients in Marin County.

For example, last year I did a physician training with Ray Stricker, M.D. and the International Lyme and Associated Disease Society. I became interested in Lyme because there was always a subset of patients I treated with symptoms of chronic fatigue syndrome who did not respond to typical therapies.

I find that the American health care system is being burdened today not by acute illnesses but by chronic, debilitating conditions such as chronic fatigue, chronic pain and depression. Oftentimes, people are put on multiple drugs to address their different symptoms, but the cause is never approached.

Most patients with chronic conditions didn’t get sick overnight, and they are definitely not going to get better in one day. It’s a process.  I recall a saying I heard from a mentor of mine: “In the same way we do not light a room by removing darkness, we do not achieve health by removing disease.” If I can help at least one patient every day to move further away from disease, and closer to good health, then I’m doing my job. That’s my passion.

For more information about Dr. Maderis and Marin Natural Medicine Clinic, see Marin Natural Medicine Clinic’s webpage.

As always, we welcome your comments and feedback.

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

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

Thyroid Health

Thyroid Health - CopyI get a lot of questions as a  pharmacist about thyroid medications.  This is not surprising, considering that an estimated 11 million people worldwide are affected by hypothyroidism.  Common symptoms include low energy, fatigue, cold in the extremities, and constipation.  Hypothyroidism means that the body’s thyroid gland is producing too little thyroid hormone.

The body’s thyroid gland produces two types of peptide hormones.  Liothyronine (T3) is the active thyroid molecule, the form that exerts its effects on the body’s cells. The body also produces levothyroxine (T4) and converts it to T3 in the blood vessels.

The conventional treatment of hypothyroidism starts a patient off on T4 alone (i.e. Synthroid, Levoxyl). For many patients, this is an effective treatment, but it assumes that they efficiently convert T4 to T3.  For patients who do not respond well to T4, desiccated porcine thyroid (i.e. Armour Thyroid, Nature-throid), which contains T3 and T4 in roughly physiological doses, can be a viable option.

Another option is a compounded, or customized, thyroid capsule that has T3 and T4 in a sustained-release form. This product is similar to the off-the-shelf products like Synthroid (T4) and Cytomel (T3) with two distinct advantages. First, T3 and T4 can be combined into a single dose and customized to a strength that perfectly suites a patient’s profile. Secondly, by making these capsules sustained-release, it prolongs the activity of the T3, which has a short half-life.  This allows the T3/T4 capsule to be taken once daily for most patients.

For patients taking any thyroid medication, it is important to know that this type of medication interacts with most foods, drugs, and supplements.  Therefore, it is important to take the capsule one hour before any food or drug, and four hours before any supplement containing minerals like iron, calcium, or zinc.

To see a thyroid symptom rating form that helps to screen for thyroid imbalance, see Koshland Pharm’s new webpage about thyroid treatments.  The webpage also addresses quality considerations for compounded thyroid medications.

~Peter

www.koshlandpharm.com


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