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Compounded Bioidentical Hormones

Hormones are chemical mes­sengers that circulate in the bloodstream and orchestrate continuous activity in the cells and organs. The human body’s endocrine system produces many unique hormones that direct the functions of our bodies, from regulating breathing and heartbeat to controlling blood pressure and metabolism. Some of the better-known hormones are the “sex hormones,” such as es­trogens, progesterone, and testosterone, which play important roles in controlling sex drive, regulating the menstrual cycle, and allowing for pregnancy and birth, but are also potent “neurosteroids” involved in nervous system function.

Maintaining the endocrine system’s delicate balance is critical because excesses or deficiencies in hormone levels may have a significant impact on overall health. When it comes to knowing how to maintain endocrine health, however, some of the information available is inconsistent, and at times misleading—especially with re­spect to hormone therapy. Different types of hormone therapy are pre­scribed to relieve symptoms associated with hormonal imbalances, yet the differ­ences between such therapies are not always clear.

What Are “Bioidentical” Hormones?

Although they are generally created in a laboratory, bioidentical hormones are chemically identical to the hormones naturally produced by the human body. In deciding which hormone therapy to prescribe to their patients, a practitioner evaluates each individu­al’s hormone levels and takes into consideration the inter­actions among the different hormones, as well as other po­tential effects of each hormone throughout the body.

Dr. Kent Holtorf asserts when making choices about hormone therapies, “current evidence demonstrates that bioidentical hormones are associated with lower risks than their non-bioidentical counterparts.”

Bioidentical hormones are available from pharmaceutical manufacturers or compound­ing pharmacies. Manufactured bioidentical hormones are only available in limited dosing strengths and formulations. On the other hand, compound­ed bioidentical hormones may be prepared in indi­vidualized dosages or strengths, and several different formulations.

Terminology

Common terms used when referring to bioidentical hor­mones include:

  • Natural
  • Bioidentical
  • Human-identical
  • Plant-based hormones

Acronyms

Hormone therapies may be referred to by a variety of acronyms, such as:

  • HRT – Hormone Replacement Therapy – The general acronym that may be used to refer to any supplementation of hormones of any kind (whether synthetic or bioidentical)
  • BHT – Bioidentical Hormone Therapy
  • BHRT – Bioidentical Hormone Replacement Therapy
  • cBHRT – Compounded Bioidentical Hormone Replacement Therapy

Why Compound?

Pharmacy compounding is a precise and careful process in which medications are prepared for an individual patient based on a practitioner’s prescription. Ingredients are combined to produce the exact strength and dosage form required to meet a patient’s specific needs. Practitioners have more options in treating their patients when prescribing compounded medications, especially when it comes to the individual needs of premature infants, babies, children, and the elderly.

Dr. David Brownstein is an advocate of compound­ed prescriptions, pointing out in a special report in Integrative Medicine that patients need individual­ized doses of hormones. “Pharmaceutical compa­nies want us to believe that everybody needs the same dose of all medications,” he writes. “In truth, everyone has a unique biochemical thumbprint; we don’t all need the same dose of phar­maceuticals, vitamins, or even the same amounts of nutrients in foods.”

Benefits of Working with a Compounding Pharmacy

  • Practitioners can prescribe medication specific to their patient’s individual needs, decreasing the likelihood of the patient experiencing side effects.
  • Prescriptions are more flexible: they’re not limited to the commercially available dosages, strengths, and forms. Practitioners can fine-tune or modify the prescription as the patient’s individual needs change. Dosage forms may be tailored to accommodate individual preferences and absorption abilities.
  • Compounded prescriptions may be customized to different formulations that may be more efficient or easier to administer. (For example, if a patient has difficulty swallowing pills, the pharmacist may be able to formulate the medication as a cream or gel instead.)
  • Multiple prescriptions may be combined into a single dosage form for convenience and to better ensure ease of use. In cBHRT, this includes combining multiple hormones into one dosage form.
  • Preservative-free or allergen-free prescriptions can be compounded for patients with chemical sensitivities.
  • Flavoring may be added to make drops and lozenges more palatable.

The Many Uses of Compounded Medications

Compounded medications are essential to the well-being of many individuals and are used in many facets of healthcare, such as pediatrics, geriatrics, internal medicine, obstetrics and gynecology, and endocrinology. Compounding is also helpful to the veterinary profession, as many more species and sizes of animals may be treated with individually tailored medications (learn more at www.pethealthrx.net). In each of these specialties, practitioners can address specific needs with individualized dosage forms, dosage strengths, flavors, routes of administration, or combinations of medications.

Thanks to compounding, hormone therapies may be prescribed to suit a patient’s individual hormone needs. Compounding pharmacists compound medications, as prescribed by a medical practitioner, into specific dos­age forms such as:

  • Capsules
  • Creams
  • Gels
  • Lozenges
  • Tab­lets
  • Suppositories

Compounding for Every Life Stage

Infants born prematurely and weighing only a few pounds rely on compounded smaller dosages of many lifesaving and life-sustaining drugs, while geriatric patients who are sometimes unable to swallow pills may need their medications compounded in different dosage forms.

End-of-life therapy in hospice or through palliative care also often involves compounding different dosage forms to allow patients to spend the rest of their lives free of pain and discomfort. Compounded medications may be vital for patients who can’t swallow medications or don’t have the muscle mass required to endure daily multiple injections. Many cancer-fighting medications and lifesaving intravenous drugs used in hospitals are compounded.

Compounding and Quality

The science of pharmacy originated in the practice of compounding. In the twentieth century, however, mass-produced drugs began to take precedence because these medications could be manufactured more efficiently and their contents more easily regulated. However, mass-produced drugs are sometimes unable to address patients’ needs on an individual basis, as many are available in limited dosage forms and strengths.

During the 1980s and 1990s, the importance of personalized medicine gained renewed recognition. As a result, the number of compounded prescriptions began increasing and instigated a renaissance in compounding pharmacy. Today, the demand for compounded medications makes compounding a rapidly-growing component of phar­macy practice as a whole.

In the pharmacy industry, compounding pharmacists are regulated by their state boards of pharmacy. Standards are set by the U.S. Pharmacopeia (USP) and National Formulary for qual­ity assurance. The Food and Drug Administration (FDA) also has jurisdiction over ensuring the quality of the ingredients involved in compounding.

Women’s International Pharmacy is Accredited!

Pharmacies and pharmacists are regulated by the Boards of Pharmacy for each state. An additional, voluntary step to evaluate compounding practices is by requesting PCAB Accreditation. This is our industry’s most rigorous review and inspection and illustrates a pharmacy’s ability to deliver quality, compounded medications to consumers.

The Pharmacy Compounding Accreditation Board (PCAB®) is a service of the Accreditation Commission for Health Care (ACHC) and is a third-party organization that has developed the highest national standards. PCAB performs extensive on-site inspections by industry experts who audit specific areas of performance. Continued accreditation with PCAB requires annual validation to ensure continued compliance with all applicable standards.

Women’s International Pharmacy is proudly accredited with PCAB for compliance with their stringent quality standards. Achieving accreditation is a strong statement of our pharmacy’s commitment to providing high-quality, consistent, compounded medications. By choosing a compounding pharmacy that has achieved PCAB Accreditation, you can take comfort in knowing that our pharmacy meets the highest national quality standards.

The “Essential Triad”

Awareness, education, and communication are key to optimizing hormone balance. With compounded hormone prescriptions, it’s vital that the patient, practitioner, and pharmacist maintain an open line of communication and sharing information. All three individuals play a critical role in obtaining and maintaining the patient’s optimal hormone balance.

The Patient

To achieve hormone balance, the patient needs to pay careful attention to symptoms and com­municate this information to the practitioner. Using this informa­tion, the practitioner can direct the pharmacist in developing an effective hormone therapy. It is important that patients feel comfortable asking questions and requesting information from their practitioner and pharmacist concerning their hormone therapy.

The Practitioner

The practitioner examines, evaluates, tests, diagnoses, and prescribes treatment. Once the practitioner prescribes hormone therapy, they will monitor its effects. Compounded bioidentical hormones may be adjusted in their dosing as well as their formulation, under the practitioner’s guidance, to achieve the goal of optimal hormone bal­ance for each of their patients.

The Pharmacist

The pharmacist provides quality assurance for every prescription com­pounded. The compounding pharmacist is available to provide information and resources about hormone strengths, dosages, formula­tions, and effects. If either the practitioner or patient has questions or concerns, the pharmacist is available for peer-to-peer or personal consultations.

A Note from the Staff at Women’s International Pharmacy

Compounding pharmacists are valuable resources to both practitioners and their patients. Prior to obtaining a prescription for compounded bioidentical hormones, be confident that your prescription comes from a highly qualified pharmacy that specializes in compounding. Work with pharmacists who can offer you reliable information about hormone therapies, answer your questions, and provide accurately compounded prescriptions.

The pharmacists at Women’s International Pharmacy understand the uniqueness of each person, taking the time and effort to meet the specific needs of practitioners and their patients.

Conclusion

Compounded bioidenti­cal hormone therapy has the potential to improve the lives of many people who suffer from symptoms related to a hor­mone imbalance. However, all hormone therapies —whether bioidentical or not—may have risks associat­ed with them, and these risks may be different depend­ing on the kind of hormone therapy. You and your practitioner should discuss the advan­tages and disadvantages of various hormone therapies, and weigh the risks of ther­apy against the risks of the potential health issues and discomfort associated with leaving your hormone imbal­ance untreated.

Connections is a publication of Women’s International Pharmacy, which is dedicated to the education and management of PMS, menopause, infertility, postpartum depression, and other hormone-related conditions and therapies.

Information Use and Disclaimer: This information is not specific medical advice. It should not be used to decide whether or not to prescribe any medication. Only the healthcare provider has the knowledge and training to decide which treatments are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition, and does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. Patients interested in any medications compounded by Women’s International Pharmacy are encouraged to speak to a medical professional.

Publisher: Women’s International Pharmacy
Editors: Laura Strommen; Samantha Lebsock, PharmD
Writers: Carol Petersen, RPh, CNP; Michelle Violi, PharmD

Copyright © Women’s International Pharmacy. This newsletter may be printed and photocopied for educational purposes, provided that your copy (or copies) include full copyright and contact information.

For more information, please visit womensinternational.com or call 800.279.5708.

Women’s International Pharmacy | Madison, WI 53718 | Youngtown, AZ 85363

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