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Thank you for entrusting in the compounding services at MD Custom Rx to help meet the unique medication needs of your patients. We are excited to share with you our monthly newsletter and look forward to continuing to be your medication problem solvers. Please don't ever hesitate to let us know how we can be of further assistance to you and your practice.
Sincerely,
John, Dan and Monica |
In February 2015, the Pharmacy Compounding Advisory Committee (PCAC) of the US Food and Drug Administration (FDA) voted to add the following to the list of medications that can be compounded.
- Cantharidin
- Diphenylcyclopropenone (DPCP)
- Squaric acid dibutyl ester (SADE)
- Thymol Iodide
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Drug Shortages
Medications may be commercially unavailable for a variety of reasons, the most common being:
- Back-ordered due to a manufacturing problem
- Discontinued due to decreased usage or declining manufacturer profits, which may be related to the introduction of a newer drug
Sometimes only certain doses and dosage forms of a particular drug, or specific combinations are discontinued. Our professional pharmacists can help by obtaining the Active Pharmaceutical Ingredient (API) and compounding the needed drug in the most appropriate dose, dosage form, and flavor for each patient. We can also compound medications that are free of problem-causing additives such as sugar, alcohol, preservatives, dyes, and gluten. We utilize the finest FDA approved chemicals, follow current USP guidelines, and are licensed and regulated by our State Board of Pharmacy. Note: Drugs are also withdrawn from the market due to health risks, and we do not compound medications that were discontinued due to safety concerns. As of March 2015, the following medications are not commercially available. - Acyclovir Suspension
- Buprenorphine Sublingual Tablets
- Calcium Citrate Oral Solution
- Cortisone capsules
- Dichloralphenazone/Isometheptene/Acetaminophen capsules
- Doxycycline Capsules and Tablets
- Memantine HCl 14 and 21 mg capsules
- Reserpine Tablets
- Nystatin 100,000 U Suppository
Please contact our compounding pharmacist to prescribe these or other customized medications that can be customized to meet specific patient needs when manufactured products have not worked.
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Menopausal Hormone Therapy and Mortality
A new systematic review and meta-analysis of 43 randomized clinical trials concluded there were no significant associations between use of menopausal hormone-replacement therapy and all-cause mortality. No significant associations were found between hormone use and mortality due to myocardial infarction, breast cancer, or stroke. When analyzed separately, there were also no associations with risks for death from cancers of the lung, ovary, or colon/rectum. Results were similar for estrogen-only therapy and for combined estrogen-progesterone therapy.
The paper was presented March 6 in San Diego at the Endocrine Society's annual meeting by Khalid Benkhadra, MD, a postdoctoral research fellow in the Evidence-Based Practice Research Program-Knowledge and Evaluation Research Unit, Mayo Clinic, in Rochester, MN. He said "Women shouldn't be fearful of long-term events, but each case is an individual....Clinicians should engage postmenopausal women and share decision-making so they can reach an agreement."
Dr. Benkhadra and colleagues identified the 43 randomized controlled trials (which included landmark Women's Health Initiative) using online databases and studies through August 2013. All compared menopausal hormone therapy with either placebo or no treatment. The study population totaled more than 52,000 women with a mean age of 62 years and an average 5 years of follow-up.
However, Dr Benkhadra cautioned that the certainty of these results is "low to moderate" and that the length of follow-up was limited to 5 years. Most recently, hormone-replacement therapy was reported to be significantly associated with a small but increased risk for ovarian cancer in postmenopausal women in an article published in the Lancet.
Cynthia A Stuenkel, MD, clinical professor of medicine at the University of California, San Diego, School of Medicine, noted that the estrogen-alone data from the Women's Health Initiative and other studies had suggested a decrease in mortality with menopausal hormone replacement, and one problem with the current meta-analysis is that there was no stratification by age at initiation of treatment. It is thought that there is a timing factor, or critical window of opportunity, for hormone therapy. "I think we're very clear that hormone-replacement therapy is a very reasonable option for treating the symptoms of menopause. But we dance around the question related to prevention....If a healthy 50-year-old woman going through menopause starts hormone therapy, might her outcome be different from a 70-year-old woman, who ...might have greater risk for cardiovascular disease? It's a tricky question." However, she noted, most symptomatic women do not wait that long to seek treatment.
References:
The Endocrine Society Annual Meeting. Abstract FRI-125, presented March 6, 2015.
(a Medscape account is needed to view this article)
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Testosterone Replacement in Men with
Opioid-Induced Androgen Deficiency
Symptomatic androgen deficiency is common in patients taking opioid analgesics, as opioids potently suppress the hypothalamic-pituitary-gonadal axis. However, the efficacy of testosterone replacement in this setting has been unclear. The objective of research by a team from Brigham and Women's Hospital, Harvard Medical School, Boston University School of Public Health, Boston University School of Medicine, and University of Pittsburgh School of Medicine was to evaluate the efficacy of testosterone replacement on pain perception and other androgen-dependent outcomes in men with opioid-induced androgen deficiency. A randomized, double-blind, parallel placebo-controlled trial at an outpatient academic research center included men aged 18 to 64 years taking opioid analgesics for chronic non-cancer pain, who had total testosterone levels less than 350 ng/dL. Participants were randomly assigned to 14 weeks of daily transdermal gel that contained testosterone or placebo. Primary outcomes were changes in self-reported clinical pain and objectively assessed pain sensitivity. Sexual function, quality of life, and body composition were also assessed. The mean age was 49 years. The median total and free testosterone levels at baseline were 243 ng/dL and 47 pg/mL and 251 ng/dL and 43 pg/mL in the testosterone and placebo arm, respectively. Of the 84 randomized participants, 65 had follow-up data on efficacy outcomes. Compared with men assigned to the placebo arm, those assigned to testosterone replacement experienced greater improvements in pressure and mechanical hyperalgesia, sexual desire, and role limitation due to emotional problems. Testosterone administration was also associated with an improvement in body composition. There were no between-group differences in changes in self-reported pain. In conclusion, in men with opioid-induced androgen deficiency, testosterone administration improved pain sensitivity, sexual desire, body composition, and aspects of quality of life. We customize hormones and other medications in the best strength and dosage form to meet unique needs and solve problems. Your questions are welcome.
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