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Osphena (Ospemifene) Approved for Reducing Painful Sex After Menopause

Wednesday February 27, 2013
Postmenopausal women who experience pain during intercourse -- a condition called dyspareunia -- have a new treatment option with Shionogi Inc.'s Osphena (ospemifene).

The U.S. Food and Drug Administration approved the once-daily pill on February 26, 2013. The drug acts like estrogen without replacing the hormone, which has been the treatment of choice for reducing incidences of painful sex following menopause.

Even though Osphena is neither estrogen nor a hormone-replacement therapy, it has many of the same potential side effects and adverse events as the older treatments. Labeling for Osphena emphasizes that women should take the medication for the shortest period necessary to produce benefits like thickening and strengthening vaginal and vulvar tissues. The label also includes black box warnings about risks for deep-vein thrombosis, strokes and endometrial cancer.

Osphena can damage a developing fetus, so it should never be used during pregnancy. The medication should also not be prescribed or dispensed to women with estrogen-sensitive cancers, undiagnosed genital bleeding or blood clots.

Full prescribing information for Osphena is available online.

Editorial Note: This will be the last blog post for a while. I have been offered another professional opportunity that is too pass up and which will make writing and editing this blog and website impossible. About.com should begin looking for a new pharmacy guide soon. Thanks for reading.

SlimXtreme Diet Pills Seized for Containing Dangerous Prescription Drug

Sunday February 17, 2013
Any pharmacy or health and wellness store stocking SlimXtreme, SlimPlus, SlimLee, GetSlim, SlimDrops or Colonew should stop selling the weight loss aids immediately.

SlimXtreme and all other weight loss supplements from Globe All Wellness have been seized.The U.S. Food and Drug Administration announced on Feb. 14, 2013, that U.S. marshals had seized all unshipped packages of the products from Globe All Wellness. Analyses and inspections by FDA officials found that the company had used the prescription-only drug sibutramine when formulating its products. It also failed to follow current good manufacturing practices required for dietary supplements.

Sibutramine was the active pharmaceutical ingredient in Abbott Laboratories' diet drug Meridia. Abott withdrew Meridia from the market in 2010 after evidence emerged that patients taking the medication had significantly increased risks for suffering debilitating and fatal heart attacks and strokes.

FDA considers the seized weight loss supplements from Globe All to be both unapproved and counterfeit drugs under federal law. The products were sold primarily through the company's website, which has been taken down, and through online pharmacies.

A warning letter sent to Globe All in early 2012 alerted company executives that they would face administrative and legal penalties if they did not resolve identified production, drug approval and product safety issues. The enforcement actions taken last week indicate that necessary improvement were not made.

This incident is just the latest example that should remind patients that dietary supplements can be as risky as prescription and OTC drugs. In addition to ridding their pharmacies of all Globe All products, pharmacists and pharmacy technicians should consider taking this opportunity to offer counseling on supplement use.

Product package image courtesy of FDA

Gilead Recalls One Lot of Vistide (Cidofovir Injection)

Sunday February 17, 2013
Gilead Sciences is recalling one lot of Vistide (cidofovir) because of particulates in some vials.The detection of particulates in some vials from a single lot of Vistide (cidofovir injection) has led Gilead Sciences, the medication's manufacturer, to recall the potentially contaminated products.

Vials from the affected lot bear the production code B120217A and a May 2015 expiration date. Gilead informed the U.S. Food and Drug Administration that the recalled products had been delivered to community pharmacies, drug wholesalers and hospitals in the United States, Europe and Canada.

Generic versions of cidofovir injection and other lots of Vistide can remain in stock. However, any injectable medication should be visually inspected before administration. If any unusual cloudiness or discoloration is detected, the drug in question should not be given to a patient. Preliminary reports on the tainted steroid injections prepared by the New England Compounding Center indicate that the vials should not have passed a "looks" test.

CMV retinitis is a viral infection of the retina at the back of the eye. It most often becomes symptomatic in people with weakened immune system. Untreated or mistreated, the disease can cause blindness. Adding to potential problems, particles in injected medication can lead to other infections and life-threatening blood clots.

Pharmacies and other health care facilities that have recalled Vistide can contact Stericycle at (888) 965-5791 to get information on returns and refunds.

Gilead is also accepting questions from pharmacists, doctors, nurses and patients at (800) GILEAD-5, which is also (800) 445-3235.

Any serious or unexpected side effects or adverse events from any medication should be reported to FDA's MedWatch.

Product package image courtesy of DailyMed

Drug and Dietary Supplement Maker Titan Medical Ordered to Shut Down

Monday February 11, 2013
Any pharmacies stocking Rad Block KI potassium iodide dietary supplements or 600 mg enteric-coated guaifenesin tablets produced by Titan Medical Enterprises should remove the products from their shelves immediately.

A federal court ordered Titan Medical Enterprises to stop making all drugs and dietary supplements.The U.S. Food and Drug and Drug Administration on Feb. 4, 2013, won a federal cease-and-desist order against Titan Medical after nearly a decade's worth of inspection showed that the drugmaker persistently failed to comply with current good manufacturing practices for its supplements and medications. The agency also determined that the company had failed to receive approval for its version of guaifenesin.

The only FDA-approved guaifenesin products are a generic made by Perrigo and the brand name nonprescription cough and cold medicine Mucines from Reckitt Benckiser.

The full text of the five-page summary judgment against Titan Medical is available online. The company could potentially return to producing and marketing supplements and drugs if FDA certifies that Titan Medical has resolved all identified problems, particularly in regards to certifying the purity and regulatory status of the active pharmaceutical ingredients and supplement ingredients it uses.

According to Acting Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, her agency "continues to take strong enforcement actions against companies that fail to comply with federal drug and dietary supplement manufacturing regulations. The actions we are taking are necessary to make sure that the drugs and dietary supplements consumers purchase have been manufactured in compliance with cGMP."

When pharmacists and pharmacy technicians learn of such enforcement actions, they owe it to patients to stop selling and dispensing affected products.

Illustration courtesy of DTR

Study: MTM Improved Outcomes for Diabetes Patients

Sunday February 10, 2013
Pharmacist counseling as part of medication therapy management services improved diabetes outcomes.In news that should not surprise members of the pharmacy profession but needs to reach as many patients and health care payers and policymakers as possible, patients in Minneapolis who received pharmacist-provided medication therapy management services for at least 12 months did significantly better at controlling their diabetes than did patients who declined MTM services.

Results from the study conducted during 2007 appear in the Feb. 2013 Population Health Management.

Led by Fairview Health Services MTM Team Manager Amanda Brummel, PharmD, researchers found that "the percentage of diabetes patients optimally managed was significantly higher for MTM patients compared to 2006 values." Perhaps more importantly, patients' HbA1c, low-density lipoprotein cholesterol and blood pressure measures tended to rise after they stopped meeting with pharmacists' each moth for face-to-face counseling, assessments and drug reviews.

Tobacco use also increased for patients no longer receiving MTM services, and daily aspirin use declined. Goals for diabetes care and management are summarized in these 2012 guidelines from the American Diabetes Association.

As Obamacare programs aimed at preventing disease, better controlling chronic conditions and containing costs incurred due to health crises brought on by poor self-care take effect, evidence of the efficacy of MTM services should catch the attention of insurers and politicians. Reimbursing pharmacists for individual interventions and supporting MTM with regulations can benefit patients and the public at large.

As National Association of Chain Drug Stores President and CEO Steven C. Anderson, IOM, CAE, said in a press release highlighting the study findings, "This study really showcases the positive impact of pharmacist-provided MTM services for patients suffering from chronic diseases. The face-to-face medical intervention by a pharmacist is irreplaceable."

Photo courtesy of CDC/Amanda Mills

Celgene's Pomalyst (Pomalidomide) Approved for Relapsed/Refractory Multiple Myeloma

Saturday February 9, 2013
The U.S. Food and Drug Administration on Feb. 8, 2013, announced its approval of Celgene's Pomalyst (pomalidomide) for treating the blood cancer multiple myeloma.

Celgene's Pomalyst (pomalidomide) is a cousin to its other blood cancer drug Thalomid (thalidomide).The new medication comes in tablet form, and it can be used alone or in conjunction with low doses of dexamethasone. Only patients who have already undergone at least two courses of chemotherapy with different drugs, including Revlimid (lenalidomide from Celgene) and Velcade (bortezomib from Millennium Pharmaceuticals), but have had their cancer relapse or continue to spread within 60 days of completing the last round of treatment should be prescribed Pomalyst.

Because Pomalyst is chemically very similar to Thalomid (thalomid), it carries many of the same risks and warnings regarding birth defects, miscarriages, blood clots and opportunistic infections as that other blood cancer drug.

Patients, prescribers and pharmacists must participate in the Pomalyst REMS in order to use the medication. Key to that risk evaluation and mitigation strategy are signed agreements between doctors and both men and women to use contraceptives or abstain from heterosexual sex while taking Pomalyst. Full details of the REMS, as well as information on how pharmacists and pharmacies can certify as Pomalyst dispensers, will appear soon on the Celgene website.

Full prescribing information for Pomalyst was not posted online at the time this blog post was written. Highlights from the FDA-approved drug label, including the black box warning regarding fetal harm and details about significant side effects like anemia and low white blood cell counts, are included in this Celegene press release.

In late summer 2012, FDA also approved Onyx Pharmaceuticals' Kyprolis (carfilzomib) to treat advanced multiple myeloma.

Product image courtesy of Business Wire/Celgene

Most Mass. Compounding Pharmacies Fail Unannounced Inspections

Friday February 8, 2013
Pharmacy compounding has drawn new attention from state and federal regulators.Initial reports from unannounced inspections of 40 compounding pharmacies in Massachusetts are in, and the news is not good.

On Feb. 5, 2013, the state health department announced that 32 of the 40 facilities inspected in the wake of the 2012 outbreak of fatal fungal meningitis linked to contaminated steroid injections prepared at the New England Compounding Center failed to meet all relevant standards. Problems ranged from failing to keep proper documentation on all active pharmaceutical ingredients to not having the proper equipment and clean rooms needed to ensure sterility.

Eleven of the pharmacies have been ordered to stop nonsterile or sterile compounding until major improvements are made. The list of those pharmacies -- along with summaries of the violations of USP 795, USP 797, state and federal standards and regulations -- appear in this press release.

Massachusetts, being home to NECC, has been the most aggressive in reviewing, updating and enforcing its regulations regarding the preparation, dispensing and sale of custom-made dosage forms. Other states will no doubt follow suit, and the U.S. Congress is considering legislation to expand the authority of the U.S. Food and Drug Administration to directly regulate the practice of pharmacists and pharmacy technicians.

As state pharmacy officials take new looks at drug compounding, they would be well advised to follow recommendations the International Academy of Compounding Pharmacists issued in December 2012. In a nutshell, the IACP suggests that boards of pharmacy should have fully staffed and well-funded teams of expert pharmacist inspectors tasked with conducting annual inspections of all health care facilities where dosages are prepared for individual patients, including veterinary clinics. A legislative package introduced in Massachusetts contains such provisions.

For pharmacists and pharmacy technicians, the best way to ensure and demonstrate full compliance with best compounding practices is probably to earn and maintain accreditation through the Pharmacy Compounding Accreditation Board.

Photo courtesy of National Library of Medicine

FDA: Stop Dispensing, Report All Altuzan (Bevacizumab)

Thursday February 7, 2013
Feb. 5, 2013, headlines about a counterfeit Avastin warning missed the mark by a wide margin.

What the U.S. Food and Drug Administration was trying to bring to pharmacists', pharmacy technicians', doctors' and patients' immediate attention was the possible widespread distribution of an unapproved and potentially useless Avastin copy bearing the brand name Altuzan. One lot of product labeled as Altuzan contains no medication.

Any pharmacy, clinic or hospital with Altuzan in stock should stop using the product immediately and contact FDA's Office of Criminal Investigations. The companies that sold the product, which appears to be made by Roche and legal only in Turkey, broke federal laws prohibiting importation of unapproved drug products.

Purchasers should not fear prosecution, but FDA and Department of Justice officials may take action against personnel affiliated with drug wholesalers operating under the names Medical Device King, Pharmalogical, Taranis Medical, Richards Pharma, Richards Services, Warwick Healthcare Solutions and Ban Dune Marketing Inc. (BDMI).

Altuzan has apparently been marketed and delivered to U.S. health care facilities as an equivalent of Genentech's Avastin, which contains the chemotherapy drug bevacizumab. Avastin is the only version of bevacizumab approved as safe and effective by the FDA. It is indicated for use with other chemo drugs for treating metastatic and treatment-resistant colon, rectal and lung cancer.

FDA has issued at least two earlier warning about Altuzan and counterfeit Avastin:
  • Feb. 14, 2012 -- accompanied by letters to 19 facilities known to have received Altuzan
  • July 10, 2012 -- updates on the status of Altuzan distribution and use, as well as product images for Altuzan
None of the products identified in the alerts should be administered to patients. All should be brought to FDA's attention and removed from pharmacy stock.

Religious Institutions Offered Work-Around on Contraception Coverage

Wednesday February 6, 2013
Work with women to help them understand their contraceptive options. Update Feb. 10, 2013: The U.S. Conference of Catholic Bishops has reaffirmed its opposition to any federal requirement that employer-subsidized health insurance plans include coverage of birth control without co-payments. The bishops published a statement directed to the U.S. Department of Health and Human Services on Feb. 7 that reads, in part, "In obedience to our Judeo-Christian heritage, we have consistently taught our people to live their lives during the week to reflect the same beliefs that they proclaim on the Sabbath.We cannot now abandon them to be forced to violate their morally well-informed consciences."

My Reaction: Taken at face value, the bishops are demanding that federal regulators compel Catholics to make health care decisions based on church doctrine. That should raise legitimate concerns from all involved about the separation of church and state.

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A major sticking point in implementation of the Patient Protection and Affordable Care Act may have been overcome. That is, if nonprofit religious institutions like Catholic universities and Baptist hospitals go along with a proposed rule regarding offering women zero co-pay contraceptive coverage issued by the Obama administration on Feb. 1, 2013.

As originally enacted, the Obamacare law included all forms of hormonal birth control on a long list of preventive services health insurance policies had to cover at no additional costs beyond premiums to beneficiaries. When that provision took effect in early 2012, religious leaders, led by the U.S. Conference of Catholic Bishops, objected to institutions under their control paying for contraceptives. They argued that their faith leads them to believe the medications end human lives.

The bishops and their counterparts particularly objected to financially supporting any use of the so-called "morning-after pill" Plan B (levonorgestrel from Teva Women's Health). Some pharmacists and pharmacy technicians have also taken this position of ethical and moral objection and refused to stock or dispense that medication.

The U.S. Department of Health and Human Services believes it has found an accommodation for the religious groups' concerns. The proposed rule -- published online and open for public comment until April 8, 2013 -- would allow nonprofit organizations that self-identify as religious institutions to notify insurance companies and plan administrators that women seeking contraceptive coverage must be offered plans that are not fully subsidized by their employer.

The details of how premiums for benficiaries and costs to insurers will be adjusted remain to worked out, but the upshot would be that payments for birth control pills would not be borne directly by the employer. The Catholic bishops have promised to study and respond to the regulatory proposal.

Controversies over contraceptive coverage will continue regardless.

The new rule would only apply to nonprofits like schools, charities and health care facilities. Lawsuits and refusals and refusals to comply by for-profit companies whose owners voice religious objections persist. The most high-profile of these cases involves the parent corporation for Hobby Lobby discount stores, and a federal appeals court in Virginia has been ordered to rehear a broad case brought by Liberty University against the entirety of the health insurance mandate.

Stay tuned.

Photo courtesy of CDC/Jim Gathany

Generic Doxorubcin Liposomal Injection May Ease Chemo Drug Shortage

Tuesday February 5, 2013
FDA's approval of a generic equivalent may ease the shortage of Doxil liposomal injection.A persistent shortage of a critical chemotherapy medication may soon be resolved.

The U.S. Food and Drug Administration on Feb. 4, 2013, announced its approval of Sun Pharma Global's generic version of doxorubicin liposomal injection. Available since 1995 from Janssen under the brand name Doxil, the drug is a common second or third chemo choice for patients with advanced ovarian cancer, multiple myeloma or AIDS-related Kaposi's sarcoma.

Insufficient supplies of medications can lead to cancer patents receiving suboptimal care, experiencing relapses and progressing to the point where no medications can help them.

Capt. Valerie Jensen, RPh, who serves as director of FDA's drug shortage staff in the Center for Drug Evaluation and Research, said in a press release that the "agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them. For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted."

FDA lists the status of every known drug shortage affecting U.S. patients and pharmacies on its website.

A decision to allow limited importation of non-FDA approved version of doxorubicin called Lipodex through Caraco Pharmaceuticals remains in effect until significant supplies of the generic medication become available.

Nonbranded doxorubicin has all the same indications, warnings, potential side effects and dosing restrictions as Doxil. The most important thing to keep in mind remains the distinction between the lioposomal injection, which remains encased in a fat cell-like vesicle after being infused, and the regular injectable formulation, which enters the bloodstream following administration. The two products must never be mixed up.

The full prescribing information for Doxil, which is identical for generic doxorubicin is available online.

Product packaging image courtesy of DailyMed

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