Drug Shortages - We Can Help!

While drug shortages have always existed, the problem has escalated and more than 200 important medications are now unavailable. Current shortages are often the result of a drug company’s decision to halt production of older drugs that are less costly in favor of manufacturing newer, more profitable products. However, in many cases the medications that are pulled from production are life-sustaining, such as electrolyte solutions, chemotherapy, and drugs used during resuscitation. While the decisions made by pharmaceutical manufacturers may be in the best interest of their stockholders, patient care is suffering and many critical drugs are now indefinitely backordered. In many cases, we can help by compounding the needed medications. We have the resources to help practitioners and hospitals deal with these shortages, and we can also compound medications that have been discontinued for reasons such as declining usage, reduced profitability, short shelf life, or inability to source an ingredient used in the commercial product.

A list of drugs that are in short supply or completely unavailable can be found at http://www.ashp.org/shortages or http://www.fda.gov/Drugs/DrugSafety/DrugShortages .

Contact our compounding pharmacist if a medication that you need is not comercially available!

Diabetic Foot Ulcers

Complications of foot ulcers are a leading cause of hospitalization and amputation in people with diabetes. Diabetic foot ulcers result from neuropathy (loss of protective sensation) or ischemia (decreased blood flow and poor oxygenation that leads to tissue breakdown). Autonomic neuropathy causes dryness of the skin by decreased sweating and therefore vulnerability of the skin to break down. Necrotic (dying) tissue is laden with bacteria apt to grow in such an environment, so infections often complicate existing foot ulcers. Protective footwear and properly fitted diabetic shoes help to reduce the development of foot ulcers in people with diabetes. Every effort should be made to prevent diabetic foot ulceration and treat existing ulcers by multidisciplinary teams in order to decrease amputations. Relieving pressure on the ulcerated area is necessary to allow healing. Even when healed, diabetic foot ulcers should be regarded as a life-long condition and treated accordingly to prevent recurrence. Applying a cream containing the amino acid L-arginine to the feet has been reported to improve circulation in the feet of people with diabetes, which might be helpful in preventing foot ulcers.

Ask our compounding pharmacist for more information.

Chronic Sinus Congestion?

If unresponsive to treatment with decongestants and antibiotics, the cause of your chronic sinus congestion may be Allergic Fungal Sinusitis (AFS). Symptoms include blocked nasal passages, sinus pain, runny nose, and frequently pressure around the eyes. Systemic antifungal drugs have not been effective for treatment of AFS, primarily because the drugs are not secreted into the nasal secretion. Conventional treatment consists of sinus surgery, but AFS has a high rate of recurrence. At New York Presbyterian Hospital, a study showed that a compounded antifungal (fluconazole) nasal spray improved the disease and decreased swelling of the nasal passages, without significant side effects. A second study showed that treatment with topical fluconazole as either a nasal spray or an irrigation solution can significantly reduce the rate of recurrence of AFS after surgery. Ask our compounding pharmacist for more information.

For more information, and to research more about what you have read, you may check the following sources that contributed to this article:

Ear Nose Throat J. 2011 Aug;90(8):E1-7. http://www.ncbi.nlm.nih.gov/pubmed/21853425
Ear Nose Throat J. 2004 Oct;83(10):692, 694-5. http://www.ncbi.nlm.nih.gov/pubmed/15586870

Customized Medication for Warts, Plantar Warts, and Molluscum

Cantharidin is a medication that has been used by dermatologists as a treatment for molluscum contagiosum and warts since the 1950s. Following topical application, cantharidin is absorbed by the fat layers of the skin. Topical cantharidin treatment causes formation of blisters within 24 to 48 hours. Healing is complete in 4 to 7 days without scarring.

In a retrospective study at the Department of Dermatology, Henry Ford Hospital, Detroit, of 300 children with molluscum contagiosum treated with cantharidin, 90% of the patients experienced resolution of symptoms and an additional 8% noted some improvement. Warts are treated more intensively. “Warts are pared, followed by cantharidin application to the wart and a 1-mm rim of normal skin, and occluded with nonporous tape. Cantharidin is washed off in 4 hours. If necessary, paring and retreatment are done in 1 to 2 weeks, with contact time increased if needed.” A high cure rate has been achieved following treatment of plantar warts with a topical formulation consisting of 1% cantharidin, 5% podophyllotoxin and 30% salicylic acid (CPS). A study compared the efficacy of topical CPS and cryotherapy (freezing) and concluded that topical CPS is more effective than cryotherapy in the treatment of plantar warts.

Because of cantharidin's potential for toxicity, the FDA has proposed that cantharidin should be limited to "topical use in the professional office setting only." Severe blistering can result from improper use, and ingestion, especially by children, can be fatal. Treatment of mucous membranes is contraindicated and placement of cantharidin near the eyes and eyelids should be avoided to prevent scleral erosion. When cantharidin is used appropriately, complications are exceedingly rare. Mild to moderate pain, temporary erythema, a transient burning sensation, and pruritis may occur. There is no scarring with proper use.

Cantharidin lost FDA approval in 1962 because its manufacturers failed to submit data attesting to cantharidin's efficacy. Although not commercially available, cantharidin is approved for compounding on a customized basis for individual patients.

For more information, and to research more about what you have read, you may check the following sources that contributed to this article:

Arch Dermatol. 2001;137:1357-1360
J Am Acad Dermatol. 2000;43:503-507
J Eur Acad Dermatol Venereol. 2011 Jul 26.
J Am Podiatr Med Assoc. 2008 Nov-Dec;98(6):445-50
http://www.mayoclinic.com/health/plantar-warts/DS00509/DSECTION=treatments-and-drugs

Hormone Therapy for Wellness and Disease Prevention

Hormones are needed for all types of bodily functions. Our hormone levels change in response to our environment, thought processes, stress levels, food intake, and medications. We know that when hormone levels decline as part of the normal aging process, problems with health arise. Hormone therapy can relieve symptoms of menopause, improve quality of life, prevent chronic illnesses, and maintain wellness. Because each woman has unique biological needs which change as she ages, we compound hormone therapy in the most appropriate dose and dosage form to meet individual needs. We work together with each woman and her healthcare provider (physician, physician’s assistant, or nurse practitioner) to customize hormone therapy based on the results of laboratory testing. And we monitor each woman’s symptoms as well as follow-up lab results, to recommend changes when needed. The type of hormone therapy that is selected “is what makes the difference and must be carefully considered,” according to Erika T. Schwartz, MD, and Kent Holtorf, MD, leading experts in hormone therapy. We recommend bioidentical hormones, which are molecularly identical to hormones found in the human body.

The terminology used by both the scientific and lay communities has lead to confusion and controversy about the benefits and side effects of bioidentical hormones including estrogen, progesterone, testosterone and thyroid hormones. For example, the three components of human estrogen (estriol, estradiol, and estrone) are frequently referred to as simply “estrogen”; however, each one acts differently in the body. For these reasons, hormone therapy is frequently prescribed as a combination of estradiol and estriol, but estrone is typically not included.

The term progesterone is often used to describe the human hormone as well as synthetic derivatives (such as medroxyprogesterone acetate) which should more appropriately be called “progestins”. Progesterone is a precursor to most sex hormones, including estrogen, testosterone and other androgens, and adrenal hormones. Therefore, an adequate level of progesterone is needed by all women, not just to prevent endometrial hyperplasia (which can lead to uterine cancer) in women who are receiving estrogen. Progesterone also counteracts estrogen’s stimulation of cell growth in breast tissue (which can lead to breast cancer).

Testosterone is produced by the ovaries and adrenals in young women in low amounts, and has been nicknamed "The Hormone of Desire" after a book by Susan Rako, MD. But, testosterone and dehydroepiandrosterone (DHEA), which are classified as androgens, offer many benefits in addition to enhancing libido in aging women. "The addition of testosterone to conjugated estrogen results in an increase in fat-free body mass and mitigates central fat deposition associated with estrogen use. Further evaluation and research must be conducted as we address the possibility of usage of testosterone in the aging female to help improve muscle mass and decrease central [body fat]… A growing number of physicians involved with menopausal women’s wellness are using testosterone supplementation to provide improvement in libido and mood simply based on clinical findings and blood levels." Commercially available testosterone preparations which are FDA-approved for use in men should not be used in women as the dose is too high. Testosterone can be compounded in topical and sublingual dosage forms in doses that are appropriate for women.

For an excellent review of the medical literature and more information, we highly recommend the following article (from which we have used several quotations above):

Hormones in Wellness and Disease Prevention: Common Practices, Current State of the Evidence, and Questions for the Future

By: Erika T. Schwartz, MD, and Kent Holtorf, MD.

This article was published in the journal Primary Care [2008 Dec:35(4):669-705]

As of this writing (Aug. 24, 2011), the article can be found in its entirety at www.drerika.com/Files/ServicePageFiles/ 9ad83a4d-247f-47b4-8d99-96bf19f19b10.pdf

We compound customized preparations of bioidentical hormones for women and men in the most appropriate strength and dosage form to meet individual patient needs, based on a prescription from a licensed practitioner.

Effective Treatment for Chronic and Cancer Pain – Dispelling the Myths

Pain is among the most common reasons Americans use the health care system and the leading cause of disability. Chronic pain (pain that lasts more than six months) can be caused by a variety of injuries and diseases, including nerve damage and cancer, and most commonly affects the lower back and legs. Chronic pain may be intermittent or continuous, and it prevents many people from working, eating properly, participating in physical activity or enjoying life. Left untreated or under treated, chronic pain may cause significant physical and emotional disability. Cancer is a major cause of both acute and chronic pain. Most people with cancer will experience pain at some point during their course of treatment, and some will continue to have pain after the treatment ends. The vast majority of people with cancer are treated for pain by practitioners who are not pain specialists. As a result, they are at high risk of under-treatment for pain. The World Health Organization (WHO) has developed guidelines for the treatment of cancer pain with opioid medications (previously referred to as “narcotics”), which are considered the mainstay approach for all people with cancer who have moderate to severe pain. However, non-opioid medications, psychosocial interventions, rehabilitative techniques and other pain treatment options should be part of the treatment plan. Application of the WHO approach suggests that satisfactory control of pain is possible in 75 percent to 90 percent of cases.

Satisfactory pain control is possible but barriers exist… with health care professionals:

Inadequate knowledge of pain management

Poor assessment of pain

Concern about regulation of controlled substances

Fear of patient addiction

Concern about side effects of analgesics

Concern about patients becoming tolerant to analgesics

with patients:

Reluctance to report pain
Concern about distracting physicians from treatment of underlying disease
Fear that pain means disease is worse
Concern about not being a "good" patient
Reluctance to take pain medication
Fear of addiciton or perception of being an addict

with the health care system:

Low priority given to treatment of cancer pain
Most appropriate treatment not reimbursed or too costly for patients and families
Restrictive regulation of controlled substances
Problems of availability of treatment or access to it

Fears and misunderstandings about addiction, tolerance and physical dependence greatly hinder use of opioid therapy. On their website, www.painfoundation.org, the American Pain Foundation seeks to clarify these issues: Addiction may occur when people use legal or illegal substances repeatedly in a way that causes them to feel high or euphoric, or, sometimes, to escape psychological pain. This use may trigger a brain change that may cause the person to crave the substance, lose control over its use and continue to use the drug despite physical or psychological harm.

Physical dependence does NOT mean that the person has developed an addiction. It does mean that the person’s body will go through withdrawal if the drug is stopped abruptly. Physical dependence on an opioid is an expected response to daily use for more than a few days. If the opioid is no longer necessary, withdrawal symptoms can be avoided if the dosage is lowered gradually over several days.

Tolerance to an opioid is a physical response that may occur as the body adapts to the medication over time, making the original dose less effective. An increase in pain may be caused by a new or increasing physical problem or by tolerance. To manage this pain, the doctor may increase the dose or may change the prescription to a different medication. People may also develop a tolerance to some of the side effects of opioids, such as drowsiness.

The behavior of an “addict” is the opposite of someone whose pain is effectively managed.

“The key to successful pain management is to manage the pain to improve the function and quality of the life of the person living with pain.” Our compounding pharmacist works together with patients and their physicians (or PA or RN) to customize medications that meet the specific needs of each individual. Often, the need for or dose of opioids can be reduced when used in combination with other medications with different mechanisms of action. Ask our pharmacist for more information on how we can help to solve your medication problems.

Copyright 2011, Storey Marketing. All rights reserved. Questions regarding this article should be directed to the compounding professionals at Rice's Pharmacy.

Men's Health: Restoring Vitality

Beginning at approximately 40 years of age, a man’s testosterone levels slowly decline. Approximately 30% of men aged 60-70 years and 70% of men aged 70-80 have low levels of testosterone, a condition often called “andropause” because testosterone is in a class of hormones known as androgens. Androgen 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). Androgens may provide a protective effect against the development and/or progression of atherosclerosis in men, and emerging evidence indicates that appropriate therapy can relieve or partially reverse the progression of these problems in testosterone-deficient men.

Hypogonadism is the clinical term for low levels of serum testosterone in association with specific signs and symptoms including:

diminished sex drive and sense of vitality

erectile dysfunction

depression

anemia

heart disease or worsening lipid profile

reduced muscle mass and bone density

increased fat mass

frailty

osteoporosis

Testosterone levels can be measured by saliva or blood tests. Hormone therapy is recommended for men with symptoms of hypogonadism and low total testosterone levels or high estrogen levels.

Depressed men have been found to have significantly lower bioavailable (free; able to be used by the body) testosterone levels, perhaps because an associated decrease in sexual function results in depression, irritability, and mood swings. Testosterone therapy may improve depressed mood in older men who have low levels of bioavailable testosterone.

Osteoporosis-related fractures occur in 12% of all men over 50 years of age. Twenty-five percent of all hip fractures occur in men, and 33% of these patients die within one year of fracture. Gradual loss of testosterone is one of the major causes of osteoporosis in elderly men. Studies have reported beneficial effects of testosterone therapy in older men, showing an increase in bone mineral density (BMD) and slowing of bone degeneration.

Testosterone replacement therapy (TRT) has relieved symptoms and improved the quality of life for many men. TRT is well tolerated. Laboratory values and clinical response should be monitored frequently so that any necessary adjustments can be made. A recent study found that TRT was associated with beneficial effects on insulin resistance, cardiovascular risk factors (total and LDL-cholesterol, Lipoprotein-a), and symptoms in hypogonadal men with type 2 diabetes and/or metabolic syndrome.

By administering testosterone transdermally (through the skin) in a cream or gel, adequate amounts of testosterone can be absorbed 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 specific dose of homone(s) needed by each man can be compounded as a dosage form that is most appropriate for that individual
there is no need to shave the scrotum to apply a patch and there is no skin irritation from the patch adhesive

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, and appropriate use of supplements.

The presence of prostate or breast cancer is an absolute contraindication for androgen replacement therapy. Guidelines recommend that TRT 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.

Unavailable, Discontinued or Hard-to-Find Medications

WE CAN HELP!!

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

(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.)

Our professional pharmacists can help during a medication shortage or when a medication is discontinued 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.

Current Shortages (as of March 1, 2011):

Acetaminophen Suppositories
Alprostadil (Caverject®)
Armour Thyroid®
Disulfuram (Antabuse®) Tablets
Metformin HCl 100 mg/ml Oral Solution
Metronidazole Tablets
Mexiliene Capsules
Oxsoralen®
Sinemet® (carbidopa-levodopa) 25 mg/100 mg Tablets
Tamiflu® Suspension

Examples of Discontinued Medications:

Cafergot®
Cromolyn
Dilantin® Suspension
Midrin®
Minocycline Suspension
Mycelex-G® Vaginal Tablets
Negatan®
Nystatin Suspension
Robaxisal®
Whitfield’s Ointment

In addition to the above, there are countless products and “remedies” that are no longer commercially available, but that physicians and patients report are very useful in treating a specific problem. Ask our compounding pharmacist about therapeutic options.

Copyright 2011, Storey Marketing. All rights reserved. Questions regarding this article should be directed to the compounding professionals at Rice's Pharmacy.

Drugs Used to Improve Bone Density

May Actually Increase Risk of Fractures

Bisphosphonates are a class of drugs commonly used to treat osteoporosis, and include alendronate, etidronate, risedronate, and zoledronic acid. Bisphosphonates are designed to slow or stop the bone loss that occurs during the body’s natural process that involves removal and replacement of bone tissue. In March 2010, at the annual meeting of the American Academy of Orthopaedic Surgeons, reports suggested that if bisphosphonates are used for four or more years, they may actually impair bone quality and increase the risk of certain bone fractures. Two separate studies by researchers from the Hospital for Special Surgery (HSS) and Columbia University Medical Center revealed data suggesting that long-term suppression of bone remodeling with bisphosphonates may alter the material properties of bone, potentially resulting in brittle bone and contributing to the risk of atypical fractures.

http://www3.aaos.org/education/anmeet/anmt2010/podium/podium.cfm?Pevent=339

Accessed March 22, 2010

Bisphosphonates have also been associated with osteonecrosis of the jaw (ONJ), an uncommon but potentially serious condition that can cause severe destruction of the jaw. Initially, it was thought that the greatest risk was in patients with cancer who received treatment with intravenous bisphosphonates. However, a recent study at the University of Southern California found that ONJ caused by oral aledronate was more common than previously suggested. The jaw problem was found in 9 of 208 patients receiving oral alendronate, or approximately 4% of the population. The findings from this study indicated that even short-term oral use of alendronate led to ONJ in a subset of patients after certain dental procedures were performed.

J Am Dent Assoc. 2009 Jan; 140(1):61-6.

Concerns about bisphosphonates have prompted many people to search for other forms of therapy to improve bone density and prevent osteoporosis.

Declining estrogen levels after menopause result in bone loss and increased fracture risk. Estrogen levels can be increased with transdermal estradiol, which is well tolerated and similarly effective to raloxifene (a drug approved for the prevention and treatment of postmenopausal osteoporosis) in preventing bone loss.

Menopause. 2009 May-Jun; 16(3):559-65.

In addition, we recommend that both men and women utilize a broad-spectrum bone support program beyond the basic calcium/magnesium/vitamin D in order to optimize bone density and quality and to reduce the risk of osteoporosis.

Your questions are welcome.

Clearing Up Fungal Nail

The first sign of a fungal nail infection is discoloration - yellow or white opacity - of the nail, most commonly on the big (great) toe. If left untreated, toenails can become thick, causing pressure and irritation, and thus act as a trigger for more severe complications. This can be particularly problematic in elderly patients and patients with diabetes, because fungal nail (clinically known as onychomycosis) is among the most significant predictors of foot ulcer, which can ultimately lead to severe infection and even amputation. As the severity of onychomycosis may be associated with the length of time the individual has had the infection, early intervention is advisable.

Conventional therapy involves taking oral antifungal drugs for several months. When these medications are taken orally, the patient must have baseline and regular lab work to monitor liver function, as these medications can be harmful to the liver. The reason that topical antifungals typically are not used to treat fungal nail is that most commercially available topical creams are unable to penetrate the nail to reach the site of infection. Our compounding pharmacy can solve this problem by preparing customized formulations containing a penetration enhancer to increase the extent of absorption through the nail. When selecting the best form of treatment, the practitioner needs to consider the cause of the infection, other medications that the patient is taking in order to avoid drug interactions, and the potential for adverse events associated with antifungal therapy. Topical treatment of onychomycosis offers a distinct advantage to oral therapy. Because topical preparations can be applied directly to the affected area and therefore result in lower drug levels in the blood, the potential for serious problems associated with oral antifungal therapy, such as drug interactions and liver problems, is decreased. Ask our compounding pharmacist for more information on customized therapies for fungal nail.

Am J Clin Dermatol. 2009;10(4):211-20.

J Dermatolog Treat. 2005 Feb;16(1):52-5

J Cutan Med Surg. 2004 Jan-Feb;8(1):25-30.

Prescrire Int. 2009 Feb;18(99):26-30.

Pure Sesame Oil for Treatment of Dry Nasal Mucosa

Many people experience problems with dryness of the tissue lining the inside of the nose, which is worse during the winter, in warm and dry inland climates or deserts, and after nasal irradiation. Complaints of nasal dryness may occur in situations involving low humidity including long journeys by airplane and air-conditioned environments. Normal saline (Isotonic sodium chloride solution; ISCS) has long been the most commonly used therapy for nasal dryness. But, it has been shown that normal saline produces little change and pure pharmaceutical grade sesame oil has been shown to be significantly more effective than normal saline for treatment of nasal dryness.

Our compounding pharmacy can place pure pharmaceutical grade sesame oil in a nasal spray. The recommended dose is 1 to 3 sprays in each nostril 3 times daily.

In studies, a few patients reported allergies to sesame seed. However, when they received oral 1-ml doses of pharmaceutical quality pure sesame oil, no allergic reactions were observed. Pharmaceutical grade pure sesame oil does not contain the proteins that typically cause allergic reactions.

Sesame oil contains a high concentration of tocopherols (vitamin E) that might neutralize oxidants and prevent tissue damage and inflammation that would otherwise occur.

Rhinology 2000 Dec;38(4):200-3

Arch Otolaryngol Head Neck Surg 2001 Nov;127:1353-1356

Medication Changes Needed after Gastric Bypass

Bariatric surgery is done to help patients lose weight, control diabetes, and improve cardiovascular risk. Roux-en-Y gastric bypass reduces the stomach size and bypasses part of the small intestine to limit absorption, and therefore medication form and doses may need to be adjusted after surgery. For example, patients should use liquid or non-oral meds (such as a transdermal gel) for weeks to months after bypass surgery to allow healing. It is important to avoid medications that contain sugar, sucrose, corn syrup, maltose, fructose, lactose, honey, mannitol, and sorbitol to reduce symptoms of dumping syndrome (nausea, pain, diarrhea, sweating, rapid heart rate, or fainting). We can compound medications that are free of these problem-causing additives.

After bypass surgery, absorption is unpredictable due to the shortened intestine, and medications should be switched to “immediate release” versus extended-release or enteric-coated forms. Our compounding pharmacist will work together with patients and their physicians to customize medication doses to meet each patient’s specific needs.

When people lose weight, medications for problems such as diabetes and hypertension may no longer be necessary. Birth control may need to be changed.

Due to decreased absorption of nutrients, patients who have had a Roux-en-Y procedure may need to increase their consumption of calcium, fat-soluble vitamins (especially vitamin D), folic acid, iron, thiamine, and vitamin B12. Ask our professional staff to recommend quality supplements.