Why Compounded Medications Take Longer Than Regular Prescriptions

Making capsules with an individualized prescription is a time-consuming process.

Making capsules with an individualized prescription is a time-consuming process.

Patients sometimes ask us at our compounding pharmacy: “Why does my medication typically take a day to be ready and sometimes longer?”

There are several factors that can affect how quickly each medication is made at a compounding pharmacy. These factors include:

  1. The number of orders ahead of a patient’s prescription
    The number of prescriptions a compounding pharmacy receives on any given day is one factor we can’t always predict.. At Koshland Pharm, we do our best to catch up when we are especially busy by taking measures such as bringing our staff in on weekends to make medications.
  2. The dosage form of the medication ordered
    Capsules, for example, are one of the most time-consuming medications to make. Each capsule is hand-packed, and a random capsule weight check is performed on each finished batch to ensure each capsule holds the proper amount.
  3. The availability of specific ingredients
    At a compounding-only pharmacy like Koshland Pharm, we stock the active ingredients of the medications we most often make; sometimes, however, a customized medication is prescribed with an active ingredient that we need to order before making.
  4. Communication needed between the doctor, pharmacist, and patient
    Because each medication is formulated specifically for an individual patient, sometimes the prescribing doctor and pharmacist need to talk to clarify or adjust an order. This can make the process take a little bit longer. Also, because each prescription is made from scratch and by hand, we only begin the process after both receiving the prescription (or refill authorization) from the doctor and also verifying with the patient that we should go ahead with the order.

It always helps compounding pharmacies like ours to have as much advance notice as possible when filling a customized prescription. We greatly appreciate any advance planning that is possible, especially for refills. We also encourage patients to choose our expedited, trackable shipping option if they are going out of town and needing the medication on an exact date.

Much like the slow food movement, the “slow medicine” movement prioritizes processes that sometimes take longer but lead to successful health outcomes. Compounding pharmacies that make individualized prescriptions for specific patients with only the highest quality standards are a part of this “slow medicine” philosophy. While we want to make medications in a timely fashion, especially when it is an antibiotic or another medication that is immediately needed, we know we must always follow the best procedures that have been developed and tested within the industry to ensure quality.

Krista Shaffer, Outreach Director at Koshland Pharm

A three-dimensional approach to healing

Dr. Cantwell

Michael Cantwell, MD, MPH

One great aspect of working in a compounding pharmacy is getting to meet doctors from multiple disciplines with unique approaches to health and healing. We recently had the chance to interview Michael Cantwell, MD, of Rising Phoenix Integrative Medicine Center in San Francisco. He talked with us about how he takes the mind, body and spirit into account when working with his patients; his experience prescribing compounded medications; and current inspirations in his work.

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

Interview with Dr. Michael Cantwell

Practice Approach
I believe a doctor needs to be a three dimensional diagnostician – looking at the body, mind, and spirit. It’s important to be fluent in those three areas. A doctor might treat some of those areas himself or refer out for others.

When it comes to the body, I look at issues such as the liver’s detoxification system. Some of what alternative medicine does is to see beyond the normal ways of looking at the body. Detoxification is something that is studied in conventional medicine but is often forgotten. The body’s detoxification system determines whether a person gets toxin-mediated inflammation, which probably contributes to many cases of affective disorders like anxiety, depression, and bipolar disease, and even possibly to diseases such as autism, Parkinson’s and Alzheimer’s. So detoxification can be very helpful to look at.

When it comes to the mind, there are different psychological systems of how we progress and develop our personalities, and there are subconscious factors as well. I do a lot of subconscious work in my practice, such as hypnotherapy and guided imagery, because it’s often an area that is neglected. I also send people out for regular therapy.

Then there’s the spiritual part. I’ve written a book, Map of the Spirit, that discusses how transitions in spirituality affect health. It gives people a clear way of making that calculation. It includes all religions, including existentialism, and puts them on a level playing field. There’s a lot of spiritual disease in our society, and to not be able to treat that would mean I couldn’t really live with myself.

Compounding Success Story
I prescribe glutathione for many of my patients in various forms – oral forms that are mass-manufactured, and creams, suppositories, injections, and IV drips that are compounded. As more toxins are put in the environment (such as organophosphates and parabens), more optimal function of the body’s detoxification system is required. This increase in environmental toxins can unmask places genetically where we might have weaknesses.

Through both blood tests and genetic tests, you can get a really good idea if there are deficits in the liver’s detoxification system. In the first stage of detoxification, the liver is trying to put hydroxyl groups on everything it needs to get rid of. It then needs to substitute another group for the hydroxyl group in order to put it through the bile. The two main groups that can be substituted for the hydroxyl group are a methyl group and a glutathione group. The liver’s ability to make methyl and glutathione groups are the main variables in whether a person gets toxin-mediated inflammation.

I’ve had many successes prescribing glutathione when patients have defects of glutathione synthesis. I had one patient with poor immune function who had symptoms including rashes, nerve pain, herpes, and low energy level–symptoms which would come and go. With glutathione 500mg suppositories from Koshland Pharm, my patient’s symptoms went away and his quality of life greatly improved.

Current Inspirations
I found that working within the insurance system as a holistic doctor is very difficult. Insurance really wants to reimburse doctors to treat bodies. In the insurance system, if you’re not treating a body, it’s not reimbursable. If you’re a psychiatrist, you can bill as a psychiatrist, but you’re still treating the body as a biochemical mechanism and giving medication.

Also, there is no Medicare billing for more than forty minutes. That’s the most you’re ever supposed to spend with people. I was finding forty minutes to be way too cramped. I was losing the part that really mattered to me, which was the spiritual connection.

At Rising Phoenix Integrative Medicine Center, we set up a place that was off insurance. I keep my overhead down and pass that saving on to patients, so I can charge a reasonable hourly rate. They can then submit the bills directly to their insurance and get half of it back.

I enjoy my work at Rising Phoenix because patients really come first. It’s an old school place where pretty much if it needs to get done for a patient, we’ll find a way to do it. In a corporate environment, many times it’s easier to say “no,”
but here there’s no one to say that.

Now I think I’m ready for my next book. It’s about the four things you need to have a joyful life. The first is to know the limits of your control – know what’s under your control, what’s out of your control, and what’s mixed. The second is to have a theory of why that control exists, which relates to my book, Map of the Spirit. The third is to have a purpose, and the fourth is to carry out that purpose. Nobody ever tells you it’s that simple, but that’s it. That’s really all you need to know.

To read more about Dr. Cantwell and
Rising Phoenix Integrative Medicine
Center, see:
risingphoenixmedicine.com

To read a synopsis of
Map of the Spirit, see:
koshlandpharm.com/books

Peter Koshland’s upcoming audio interview about hormone replacement

CalvadosPeter Koshland, PharmD, will be interviewed next Wednesday, March 25th by Dr. Amy Day as a part of her Women’s Wellness Wednesday series. The topic of the interview is hormones – which ones to use, when to use them, and how to do so safely. You can tune in by signing up (which is free) here: http://womenswellnesswednesdays.com/. While the interview is broadcast Wednesday at 12:00 pm, it is accessible for 72 hours afterward as well.

 

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

Healing Thyroid Imbalance Presentation with Dr. Shiroko Sokitch

What is thyroid disfunction? What are the symptoms? How is it tested? How can it be treated on an individual basis?

Dr. Shiroko Sokitch of Santa Rosa, CA addressed these questions, and shared her unique approach to healing using both Western and Eastern medicine, in a presentation at Koshland Pharm last fall. We are pleased to share that presentation here in its recorded form.

For more about Dr. Shiroko Sokitch, see her website at http://www.hthmc.com/.

We welcome your comments, questions and feedback. All our best,

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

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


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