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| Clinical Pharmaceutics and Compounding, Part XI |
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Alternate Dosage Form to Minimize Gastrointestinal Distress
A physician has called and described a patient with musculoskeletal pain affecting the elbow and forearm area and wants to prescribe a nonsteroidal anti-inflammatory drug (NSAID). The patient has a history of gastrointestinal ulcers, so the physician would like an alternative route of administration other than oral.
Options include the parenteral, rectal, and transdermal routes of administration; you recommend the transdermal route and explain good success has been obtained using a transdermal gel formulation of Ketoprofen 10% or a combination of Ibuprofen 20% with Piroxicam 1%. You explain that the transdermal gel vehicle consisting of a blend of a poloxamer, lecithin, and isopropyl palmitate has the ability to deliver the NSAIDs across the epidermal skin barrier for a prolonged effect. Also, with the flexibility of compounding, the prescriber has many options for different combinations or drugs and different strengths, to accommodate different patients. Compounded transdermal NSAIDs offer the practitioner a viable treatment option and alternative dosage form for NSAID therapy with decreased systemic side effects.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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Don't Be Left Out - Be Counted!
The International Journal of Pharmacy Compounding (IJPC), Rose Research, and inThought Research are conducting a benchmarking survey of pharmacists in the U.S. regarding current and future use of compounded medicines. If you are a U.S. pharmacist, we encourage you to participate in the online survey. The survey will be open from today until December 15. Responses are confidential. We expect to publish results in the International Journal of Pharmaceutical Compounding in early 2015. Thank you for your participation.
TAKE THE SURVEY TODAY
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News
International Academy of Compounding Pharmacists Action!
A broad cross-section of organizations representing varied healthcare providers and the pharmacy community, brought together by the International Academy of Compounding Pharmacists (IACP), sent a letter to U.S. Senate and House leaders. The letter expresses serious concerns with the federal government's implementation of the Drug Quality and Security Act (DQSA), enacted in November 2013, and is calling on Congress to fix the law.
Please click here for a copy of the letter sent to Congress, including the long list of healthcare organizations in support.
Please click here for a copy of IACP's press release.
All compounding pharmacists should be a member of, and actively support, IACP!
Avastin and Lucentis Equivalent
Lucentis, at $2,000 a dose, is similar to Avastin, at $50 a dose. In 2006, Genentech introduced Lucentis and found itself in an awkward position; persuading doctors to start using its new more expensive drug instead of a popular cheaper version that the company already sold. Use of Lucentis skyrocketed, and it became one of Medicare's most expensive treatments—costing the federal government about $1 billion a year—even though several studies have concluded Lucentis has no significant advantage over its cheaper alternative. Interestingly, a new federal database shows that many of the doctors who were the top prescribers of Lucentis were also among the highest-paid consultants for Genentech. Avastin is still the most popular choice of doctors even though Genentech has aggressively promoted Lucentis to doctors to encourage them to switch, including paying rebates to those who use large amounts of Lucentis.
Several studies have shown that the drugs are nearly equivalent, including a large government-sponsored clinical trial involving 1,200 patients. The clinical trial was completed in 2011. A recent review showed that in 3,665 patients, Avastin didn't increase the risk of death or serious side effects when compared with its pricier sister drug.
http://www.nytimes.com/2014/12/08/business/paid-to-promote-eye-drug-and-prescribing-it-widely-.html?_r=1
France, Germany, Belgium, Lux Suspend 25 Drug Approvals
Regulators in France, Germany, Belgium, and Luxembourg are suspending the marketing approval of 25 generic drugs due to concerns over the quality of data from clinical trials conducted by India's GVK Biosciences. The quality of Indian pharmaceutical companies has come under fire this year, with regulators in Europe and the U.S. citing problems ranging from data manipulation to sanitation and banning the import of certain products from several firms.
http://www.reuters.com/article/2014/12/06/india-pharmaceuticals-germany-idUSL6N0TP3HZ20141206
http://www.reuters.com/article/2014/12/09/india-pharmaceuticals-germany-idUSL6N0TT3QP20141209
DEA Rebuked in Florida Pharmacy Case
Last November, the West Chase Compounding Pharmacy in Tampa, Florida was unceremoniously closed after DEA agents seized its controlled substances and terminated its legal authorization to sell controlled substances. The pharmacy has recently resumed sales of controlled substances after a federal judge issued a temporary restraining order allowing it to resume operations until a full hearing can be held.
The U.S. District Judge Mary Scriven called the actions of the federal agents preposterous, criticizing the agency for violating rules and improperly caring for seized property. "Procedure wasn't followed," Judge Scriven reportedly said. "Even if they thought [the pharmacy owner] was a drug dealer, which there's no evidence on this record, they didn't follow the rules."
http://drugtopics.modernmedicine.com/drug-topics/news/judge-rebukes-dea-florida-pharmacy-case
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IJPC Now on Facebook and Youtube
Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding
Learn about the Journal's new multi-media features and view our growing collection of educational and training videos at www.ijpc.com/videos or by subscribing to our Youtube channel at https://www.youtube.com/user/IJPCompounding.
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Did You Know ...
�that Wednesday, December 17, is the first day of Hanukkah, also known as the Festival of Lights, Feast of Dedication? It is an eight-day Jewish holiday commemorating the rededication of the Holy Temple (the Second Temple) in Jerusalem at the time of the Maccabean Revolt against the Seleucid Empire of the 2nd century BC. Hanukkah is observed for eight nights and days. It is observed by the kindling of the lights of a unique candelabrum, the nine-branched menorah or hanukiah, one additional light on each night of the holiday, progressing to eight on the final night. Other Hanukkah festivities include playing dreidel and eating oil based foods such as doughnuts and latkes.
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Tip of the Week
It is important to learn about history and its influence on our current society and events.
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Looking Back
He always used
A steaming towel,
And mug and brush
And language foul,
"Til he tried
Burma Shave
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Accreditations |
ACHC is pleased to announce that the following pharmacies have achieved PCAB Accreditation:
Allcare Pharmacy, Lyons, Georgia; Brian Rickard, PharmD, rickard.brian@gmail.com. Initial Accreditation for Nonsterile Compounding
Nour Pharmacy, Clifton, New Jersey; Ahmed Ali. Initial PCAB Accreditation for Nonsterile Compounding
Pharmacy Creations, Randolph, New Jersey; Forrest Flodin. Initial PCAB Accreditation for Nonsterile and Sterile Compounding
Simfarose Pharmacy, Pembroke Pines, Florida; Scott Mozza. Initial PCAB Accreditation for Nonsterile and Sterile Compounding
Stroheckers Pharmacy, Portland, Oregon; Tyler Treharne. Initial PCAB Accreditation for Nonsterile and Sterile Compounding
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