Posts Tagged 'compounding pharmacy'

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

Recent Forbes Article About Women’s Use of Compounded Hormones

web_working_koshland-36

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

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

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

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

Remembering 21 Horses

polo-horseI was shocked and saddened when I learned about the mysterious deaths of 21 Venezuean polo horses last week. I was even more saddened when it was revealed that the deaths were due to an error from a compounding pharmacy in Florida.

Granted, Franck’s Pharmacy did the right thing by being the first to break the news that they were responsible for the deaths, but that still doesn’t bring the horses back.  This incident is a wake-up call to all pharmacies who dispense compounded medications to step-up their quality control measures and aggressively pursue accreditation. 

Compounded pharmacies across the country dispense thousands of quality, life-improving medications every day.  But incidents like this must be prevented and it is up to those of us engaged in compounding to make sure it is.

I don’t know the specifics of Franck’s Pharmacy’s operations, but I do know that there are many ways to set up procedures to catch errors, understanding that even the most skilled pharmacist or technician can make a mistake.  I think it’s reasonable to ask any compounding pharmacy what quality control measures they take to prevent errors and to ensure the potency of their products.  For more information on how to evaluate a compounding pharmacy, see my blog post How to Evaluate a Compounding Pharmacy.

My heart goes out to the owners of the horses and to horse lovers everywhere. 

Please post any questions or thoughts on the matter.


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