ACT NOW to Protect your Access to Compounded Medications.
Our compounding pharmacists work directly with practitioners including physicians, nurse practitioners, dentists and veterinarians to create customized medication solutions for patients and animals whose healthcare needs cannot be met by manufactured medications.
Compounding helps people and pets in our community with problems such as:
• chronic pain related to injuries or illness such as cancer, or neuropathic pain (associated with diabetes, or following chemotherapy or shingles).
• Autism Spectrum Disorder.
• hormone imbalances.
• dermatologic problems including rosacea, psoriasis and pigmentation disorders.
• slow-healing wounds.
• oral problems including chronic canker sores (aphthous ulcers) or cold sores.
We can compound medications that are:
• unavailable due to current drug shortages or lack of manufacturer profitability.
• free of additives such as dyes, gluten, alcohol, lactose and sugar that are present in manufactured medications.
• in dosage forms such as topical or transdermal gels that are not commercially available.
• suitable for cats, dogs and other animals with Infections, skin disorders, chronic pain, or thyroid disease.
S.959 would unduly restrict access to custom compounded medications. The bill is a reaction to the tragedy of the New England Compounding Center (NECC) that produced contaminated injectable medications and shipped thousands of doses around the country, resulting in patient deaths from fungal meningitis. In its current form, S.959 would give the FDA broad new authorities with little to no additional accountability to prevent a repeat of the mistakes and ineffectiveness of state and federal regulatory authorities that resulted in a failure to inspect and shut down NECC.
Safety is of the utmost importance and we support actions to improve safety and protect patients everywhere. However, S.959 has unintended consequences that will deny patient access to important medications prepared by reputable professional compounding pharmacies. You may not be using compounded medications now but S.959 will limit your future options and your physician’s/dentist’s/veterinarian’s ability to prescribe the best solution for you, your family or your pet.
Please contact your Senators and Representatives TODAY and
SPEAK OUT TO OPPOSE BILL S.959.
You can find your Senators’ contact info at
and www.help.senate.gov/about/contact lists the members of the
Senate HELP Committee that introduced S.959. We believe that the most effective method of contact is via a personal phone call to voice your concerns to a staff member.
If S.959 passes in the Senate, it will go to the House of Representatives for consideration, and further action will be required before the bill becomes law. Other legislation is being worked on concurrently by Congressman Griffith. You can find updates and more information at www.iacprx.org and www.ProtectMyCompounds.com.
ACT NOW TO PROTECT YOUR ACCESS TO CUSTOMIZED MEDICATIONS
and as always, bring us your medication problems!
Please let us know if you have any questions.
Infertility affects one in every 7 couples and usually multiple issues are involved. Treatments for infertility are often provided by physicians trained in subspecialties, including artificial insemination, ovulation induction, and hormonal support of the menstrual cycle. The increasing shift of treatment toward Assisted Reproductive Technologies (ART), including in vitro fertilization (IVF) and intracytoplasmic sperm injection, has further removed infertility treatment from the realm of the OB/GYN and family physician. ART is expensive, invasive, and involves some risk to women. There are also concerns about short- and long-term outcomes for the children. The most prominent concerns relate to the incidence of multiple pregnancies with ART treatment and the subsequent perinatal complications, including low birth weight and prematurity.
Natural Procreative Technology (NaProTechnology, NPT) is a systematic medical approach for optimizing physiologic conditions for natural conception. When utilized by an OB/GYN or a trained general physician such as a family practitioner, NPT has produced live birth rates comparable those associated with more invasive treatments, including ART. However, NPT is less expensive than ART and has minimal risk of multiple births. The availability and use of NPT may improve access to care for couples dealing with infertility, with low risk to women and offspring.
A standardized NPT investigation (involving a patient exam and lab work ) usually results in the diagnosis of one or more abnormalities associated with infertility, including decreased production of cervical mucus, irregular menstrual bleeding or spotting, short or variable luteal phases, and suboptimal levels of the ovarian hormones estrogen and progesterone. The physician trained in NPT then determines a course of treatment that aims to correct the underlying abnormality, with the goal of optimizing physiologic conditions for conception. Common interventions include induction or stimulation of ovulation and medications to enhance cervical mucus production, including vitamin B6 and guaifenesin. Vitamin B6 also increases the utilization of estrogen at the level of the cervix and improves cervical fluid production. Guaifenesin is used to loosen the cervical fluid around the time of ovulation. Luteal phase support can be provided by human chorionic gonadotropin (HCG), compounded progesterone vaginal suppositories, or compounded progesterone in oil for intramuscular injection.
A study evaluated outcomes in couples receiving treatment for infertility from two NPT-trained family physicians. A total of 1,239 couples had an initial consult for NPT, of which 1072 had been trying for at least a year to conceive and initiated NPT. The average female age was 35.8 years, the average duration of attempting to conceive was 5.6 years, 24% had a prior birth, and 33% had previously attempted treatment with assisted reproductive technology (ART). All couples were taught to identify the fertile days of the menstrual cycle with the Creighton Model Fertility Care System, and most received additional medical treatment, including the drug clomiphene (75%). Younger couples and couples without previous ART attempts had higher rates of live birth. Among live births, there were 4.6% twin births. The 364 couples who ultimately conceived with NPT treatment were slightly younger (average 34.8 years); had not been attempting conception as long (mean duration, 4.8 years); were likely to have had a previous birth (30%); and less likely to have attempted ART (21%). Adjusting for withdrawals from treatment and continuing treatment at the end of study follow-up, the cumulative proportion of first live births was 27.1% for those who used NPT for up to 12 months, and 52.8% for those who used NPT for up to 24 months.
Ask our compounding pharmacist for more information about infertility, as well as customized treatments for hormone-related problems.
J Am Board Fam Med. 2008;21(5):375-384.
Int’l Journal of Pharmaceutical Compounding Vol. 5 No. 2 March/April 2001:136-9
The Medical & Surgical Practice of NaProTechnology, by Thomas W. Hilgers, MD
Medication problems include:
• Trouble swallowing capsules or tablets
• Bad tasting medicine
• Nausea that prevents individuals from taking oral medications
• Side effects such as stomach upset or drowsiness that aren’t tolerable or interfere with daily activities.
All of the above problems can be helped with topical and transdermal medications that can be compounded by our pharmacist.
Many medications can be absorbed through the skin instead of being taken orally or by injection. Prior to the availability of compounded dosage forms, patients who couldn’t take oral medications frequently had to receive intravenous therapy. Injectable therapy is invasive, usually requires a properly trained caregiver and is usually significantly more expensive. But, often we can compound the needed medications into a gel or cream that can be applied to the skin, and avoid the need for injections or IVs.
When medication is applied topically to the site of the problem – such as an anti-inflammatory medication to a joint – less active ingredient is needed because the medication doesn’t need to be absorbed through the gut and circulate to the site. And, additionally, there are typically fewer side effects and drug interactions, because blood levels of the drug are lower, although the tissue levels at the site of application are higher.
Pet owners no longer have to risk an infection from scratches or bites inflicted by an angry pet who is tired of having medication forced down his throat! Transdermal delivery is particularly useful in pets that receive daily “maintenance” medications and should not be stressed due to heart problems or high blood pressure. It is important that the person who is applying the medication wears a finger cot to protect him/herself from absorbing the animal’s medication.
Additionally, if a patient has fluctuating or declining liver function, transdermal administration may be advantageous because transdermal meds do not need to pass through the liver before being absorbed, like oral medications do.
Topical and transdermal therapies can be compounded to treat the following problems:
• Pain and inflammation
• Hormone imbalance
• Fungal infections of the skin and nails
• Wounds and scars
• Conditions associated with autism
• Thyroid or heart disease in pets
Proper preparation of topical and transdermal medications requires the use of chemicals and specialized equipment that are not available in most pharmacies.
We welcome your questions and medication problems!
nternational Men’s Health Week is June 9-15, 2014. “Recognizing and preventing men’s health problems is not just a man’s issue. Because of its impact on wives, mothers, daughters, and sisters, men’s health is truly a family issue,” said U.S. Congressman Bill Richardson. Knowing that on average, men smoke more, drink more, see doctors less, and die five years sooner than women, we want to encourage men to take care of their health. Many of the major health problems that men face, such as colon cancer and heart disease, have better outcomes with early diagnosis and treatment. We encourage all men (and women!) to schedule regular wellness checkups and know your cholesterol, blood pressure, and glucose levels.
Another important value that is not always measured is testosterone (“free” testosterone indicates the bioactive form). “Low T” or testosterone deficiency is strongly associated with common medical conditions including metabolic syndrome, obesity, diabetes, hypertension and atherosclerosis; as well as elevations in triglycerides (TGs), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C). Other signs and symptoms include:
• Diminished sex drive and sense of vitality
• Erectile dysfunction
• Reduced muscle mass and bone density
• Increased fat mass
Evidence indicates that appropriate therapy can relieve or partially reverse the progression of these problems in testosterone-deficient men. Transdermal therapy facilitates adequate absorption of testosterone to mimic the normal daily production. Testosterone can also be administered as a sublingual drop or a lozenge that dissolves in the mouth. Compounded preparations can be very advantageous because customized therapies increase compliance.
The presence of prostate or breast cancer is an absolute contraindication for testosterone replacement therapy, or use of other hormones in this class, known as androgens. Guidelines recommend that testosterone therapy should not be started in older men with PSA serum levels above the normal range. Testosterone should be used with caution in men with severe heart, kidney or liver disease, increased red blood cell counts, and sleep apnea.
A healthy lifestyle is associated with higher hormone levels, and higher hormone levels seem to induce a more active, healthier lifestyle. For optimal results, it is vital that hormone replacement therapy be combined with adequate exercise, proper nutrition, weight management and treatment of other health problems.
Talk to our compounding pharmacist to learn how we can help in your journey to live well.
J Endocrinol. 2014 Jan 27;220(3):R37-55.
When talking about a woman’s hormones, the term “estrogen” is frequently used. Estrogens are steroid hormones present in both men and women, but at significantly higher levels in women of reproductive age. But, do you know that there are three types of estrogens found in the human body? Estriol (E3), Estradiol (E2) and Estrone (E1) each have unique biological effects, benefits and side effects. Also, the different forms of estrogen have different affinities for certain body tissues (such as the brain, breast and vagina) and therefore it is important to select the most appropriate estrogen for optimal treatment or prevention of a specific problem.
Estriol, coined the “weaker” of the three estrogens naturally made by the human body, has signiﬁcant therapeutic benefits, and is commonly used to treat hot ﬂashes, insomnia, and vaginal atrophy; to reduce the frequency of urinary tract infections; and for skin enhancement. Recently, estriol has shown the potential to treat individuals with autoimmune illnesses, including multiple sclerosis and rheumatoid arthritis.
After menopause, as estrogen levels fall, many women experience thinning, drying and inflammation of the vaginal walls, clinically known as vaginal atrophy. Multiple studies have demonstrated the benefits of a vaginal tablet containing an ultra-low-dose of estriol (E3) in combination with the probiotic Lactobacillus acidophilus for the treatment of vaginal atrophy.
The FDA “respects a healthcare provider’s decision that his or her patient should receive estriol.” E3 has a USP monograph that therefore can be compounded by prescription. E3 has been commercially available in Europe and Asia for many years and its use is well supported in the medical literature.
Our compounding pharmacist will work together with you and your doctor to customize medications that are not commercially available, to meet your specific needs. Your questions are welcome.
Journal of Restorative Medicine 2013; 2: page 45-52.
Climacteric. 2013 Jun;16(3):347-55.
Breast Cancer Res Treat. 2014 Jun;145(2):371-9.
More than half of all people with thyroid disease are unaware of their condition. Individuals with low levels of thyroid hormones (hypothyroidism) may have some or all of the following symptoms, but may not be diagnosed for years.
• PMS, Irregular menstrual periods
• Lack of exercise tolerance
• Weight gain (especially in the stomach)
• Hypoglycemia (low blood sugar)
• Irritability - low self esteem
• Low sexual desire Infertility
• Dry skin, eyes and/or hair
• Yellowed skin
• Loss of eyebrows
• Headaches, migraines
• Depression, apathy and anxiety
• Memory and concentration impairment
• Fluid retention - face, legs, eyelids and abdomen
• Slowed metabolism and slowed heart rate
• Cold and heat intolerance – cold hands and feet
• Enlarged tongue, deep voice and swollen neck
If you have some of these symptoms, ask your health care provider about thyroid testing.
What makes women more vulnerable to thyroid imbalances?
• Environmental toxins
• Suboptimal nutrition
• Hormonal changes (puberty, birth control pills, pregnancy, menopause, HRT)
Hormone replacement therapy often is focused on other hormones such as estrogens, progesterone, DHEA and testosterone, but optimal hormone balance cannot be achieved without correcting thyroid hormone imbalances. Many symptoms of hypothyroidism and menopause overlap. It is especially important for menopausal women who decide to use hormone replacement therapy (HRT) to have their thyroid function tested, because oral estrogens can lower the amount of bioavailable thyroid hormone. This means that if a woman is already on thyroid treatment, and begins oral estrogens, her thyroid dose may need to be increased.
Our compounding professionals work together with patients and their health care providers to customize medications in the specific strength and dosage form that is most appropriate to meet each patient’s specific needs and solve medication problems.
We welcome your questions about testing and thyroid hormone therapy.
Although sexuality remains an important part of emotional and physical intimacy that most women desire to experience throughout their lives, the prevalence of sexual dysfunction among all women is estimated to be between 25% and 63%; and the problem is even more common in postmenopausal women with rates between 68% and 86.5%. Increasing recognition of this problem and future research in this field may change perceptions about sexuality, dismiss taboo and incorrect thoughts on sexual dysfunction, and lead to more women receiving helpful treatment.
Postmenopausal women experience significant declines in sexual responsiveness, frequency of sexual activities and libido, with significant increases in dyspareunia (painful intercourse). Sexual dysfunction significantly impacts a woman’s self-esteem and causes emotional distress, often leading to relationship problems.
Female Sexual Dysfunction (FSD) is a multicausal and multidimensional problem. Lack of sexual interest can be affected by medications, family situations, work-related issues, and psychologic factors. FSD is also related to a partner’s function: when erectile failure of a male partner is improved, a woman’s desire and satisfaction improve. More than 70% of patients with FSD are depressed, and the FSD may worsen when these patients are treated with medications such as selective serotonin reuptake inhibitors (SSRIs). Selection of medications should take into account sexual side effects. Common disorders related to sexual dysfunction and increasing age include cardiovascular disease, diabetes, lower urinary tract symptoms, and depression; and breast cancer, hysterectomy, oophorectomy (removal of ovaries), obesity, bariatric surgery, osteoarthritis, clinical depression, and smoking are all linked to female sexual dysfunction. Treating those disorders or modifying lifestyle-related risk factors (e.g., obesity) may help reduce sexual dysfunction.
The biologic processes involved in sexual response center around estrogen and testosterone. Low estrogen levels lead to vaginal dryness and chronic estrogen deprivation causes the labia to become less responsive to touch, ultimately leading to discomfort during intercourse and loss of sexual interest. The bladder often becomes thin and atrophies with diminished estrogen, potentially leading to urinary incontinence, urinary frequency, painful urination, and cystitis after intercourse. Libido changes in menopause also may be attributed more to falling testosterone levels.
Estrogen preparations are currently the only FDA-approved medication for the treatment of sexual dysfunction. Small doses of estrogen vaginal cream can adequately improve lubrication and decrease pain with intercourse; however, response to estrogen is quite individual. Therefore, we customize hormone therapy in the best dose and dosage form for each patient. Drug efficacy may be affected by the route of estrogen administration. Transdermal and intravaginal routes of estrogen administration for patients with sexual dysfunction have become the most common and successful treatments for these patients. Testosterone therapy has also been shown to improve sexual dysfunction. Other hormones, such as progesterone, can be used alone or combined with estrogen repalacement therapy to enhance the positive effects or to diminish the negative effects when dealing with FSD.
We work together with patients and practitioners to customize hormone therapy and other medications to meet each individual’s unique needs.
We welcome your questions and your medication problems.
Obstet Gynecol. 2012; 5(1): 16–27.
A large team of scientists have determined that natural progesterone has the potential to slow the growth of many breast cancer tumors or even shrink them, unlike synthetic progestins which increase breast cancer risks, .
It has long been known that tumors with estrogen receptors (ER) and progesterone receptors (PR) – termed ER/PR double positive - have the best clinical outcome. A study conducted by researchers from prestigious institutions including the Cancer Research UK Cambridge Institute; University of Adelaide, Australia; University of Texas, Southwestern Medical Center at Dallas; and University of North Carolina at Chapel Hill explain why double positive breast cancer patients have the best chance of survival. The finding could benefit up to half of all breast cancer patients.
Scientists know that when activated by most forms of estrogen - especially estradiol and its metabolites - estrogen receptors turn on genes within cancerous cells that program those cells to multiply rapidly and stay alive rather than die off as normal, healthy cells do. When activated by progesterone, progesterone receptors attach themselves to estrogen receptors. Once this happens, estrogen receptors stop turning on genes that promote the growth of the cancer cells. Instead, they turn on genes that promote the death of cancer cells (apoptosis) and stimulate the growth of healthy, normal cells.
The researchers pointed out that only natural, customized progesterone slows the growth of breast cancer. Conversely, synthetic progestins (molecularly altered forms of progesterone including medroxyprogesterone acetate and other progesterone derivatives found in birth control pills) have been shown to increase rather than decrease breast cancer risks.
This is exciting news for women who are diagnosed with ER/PR positive breast cancers. If such women have healthy progesterone levels, or when progesterone levels are increased through natural progesterone supplementation, treatment outcomes may improve significantly.
Hormonal imbalances have reached epidemic proportions in most developed countries over the last several decades. Due to poor diets, lack of exercise, a rise in obesity levels, the widespread use of hormone-altering chemicals, and other factors, many women suffer from chronically higher than normal estrogen levels and much lower than normal progesterone levels.
In their book What Your Doctor May Not Tell You About Breast Cancer, John R. Lee, M.D. and David Zava, Ph.D. noted that women with progesterone levels that are low relative to estrogen levels are more likely to get breast cancer and have poorer treatment outcomes. They concluded that estrogen dominance causes estrogen receptors to activate genes such as BCL-2 that are known to promote the rapid growth of cancer cells. They theorized that chronic states of estrogen dominance contribute to high rates of breast cancer, and their theory has been validated with this latest research. Ask our compounding pharmacist for more information about the benefits of balancing hormones using natural progesterone. We will work together with you and your health care provider to customize medications in the proper dosage to meet your unique needs.
Nature 2015; 523; 313-317.
Pharmaceutical Journal, 17 Jul 2015.
John R. Lee, M.D.; David Zava, Ph.D.; and Virginia Hopkins. “What Your Doctor May Not Tell You About Breast Cancer.” 2002