Duragesic (Fentanyl Transdermal System) Changed About 6 Years Ago�Why?

The following is an interesting example of clinical pharmaceutics involving transdermal drug delivery and dosage form design, after reported deaths.

Read the following two descriptions:

PDR 1997—Proceeding from the outer surface toward the surface adhering to skin, these layers are:

1. a backing layer of polyester film
2. a drug reservoir of fentanyl and alcohol USP gelled with hydroxyethyl cellulose
3. an ethylene-vinyl acetate copolymer membrane that controls the rate of fentanyl delivery to the skin surface, and
4. a fentanyl containing silicone adhesive.
5. Before use, a protective liner covering the adhesive layer is removed and discarded.

PDR 2010—Proceeding from the outer surface toward the surface adhering to skin, these layers are:

1. a backing layer of polyester/ethyl vinyl acetate film;
2. a drug-in-adhesive layer.
3. Before use, a protective liner covering the adhesive layer is removed and discarded.

Why the change? In the original version, the drug in the silicone adhesive served to assist in rapidly producing a depot of fentanyl in the skin; in other words, it worked like a "loading dose." There were some deaths associated with obese patients where there was difficulty getting the "system" to stick to the skin and, in some cases, after a few hours the patch would loosen and the patient could not get it to stay on. So, they applied another patch, and then another, etc. This continually increased the quantity of drug being administered because each patch had a "loading dose" that kept building up in the skin and accumulating to a toxic level. The newer system eliminates the "loading dose" and still reaches a leveling off in the serum concentrations after 12 to 24 hours, the same as before. The advantage to the new system is less likelihood of accidental overdosing.

News

U.S. Settles False Claims Against Pharmacy for $8.4 Million
The U.S. has settled allegations that a Jacksonville-based compounding pharmacy, Blanding Health Mart Pharmacy, knowingly billed the government for improper and medically unnecessary compounded pain prescriptions. In this settlement, the parties resolved allegations that, from February 9, 2015, to April 13, 2015, Blanding Health Mart Pharmacy sought reimbursement for compounding pharmaceutical prescriptions that were not medically necessary and were written by physicians that had never actually seen the patients. The government agreed to accept $8,441,107 to resolve these allegations. U.S. Attorney A. Lee Bentley stated, "Since the beginning of the year, we have been focusing on pharmacies that have abused the TRICARE program and defrauded the government."
http://www.news4jax.com/news/us-settles-false-claims-against-pharmacy-for-8-million/34177214

FDA Issues Reminder on Withdrawn Prefilled Syringes
The FDA has issued a reminder to quarantine and discontinue distribution of all affected lots of Mylan's Calcium Chloride Intravenous Infusion 10% w/v. The company initially recalled 14 lots in April 2015 after customer complaints of difficulties in administration of the drug with an incompatibility between the syringe (10 mL) and certain needleless adaptors. This can possibly prohibit or delay the administration of the medication in emergency situations such as during the resuscitation procedure after a cardiac arrest and for the treatment of low calcium levels. It is also indicated for arrhythmias associated with hypocalcemia, hyperkalemia, or hypomagnesemia.
http://www.empr.com/safety-alerts-and-recalls/fda-reminder-calcium-chloride-intravenous-infusion/article/426479/

Emergency Epinephrine Syringes in Short Supply
The FDA is reporting shortages of pre-filled syringes of epinephrine, most commonly used to treat individuals who are in cardiac arrest. Both Amphastar Pharmaceuticals and Hospira are reporting shortages of the injections. The syringes are in intermittent supply, and it's not expected that will change anytime soon, said Stacey Winston, senior director of pharmacy contracting solutions at Amerinet, a group purchasing organization. Epinephrine vials are still available.
http://www.modernhealthcare.com/article/20150713/NEWS/150719985

FDA Bans Emcure India Plant
Last year's recall of drugs suggests that the Hinjawadi plant was caught manipulating test data; this adds Emcure to the significant list of Indian drugmakers with plants banned by the FDA. The problems that the FDA may have uncovered at the plant were alluded to when Teva had to recall nearly 40,000 drugs in May 2014 that had been manufactured for it by Emcure. The products were recalled for deviations in lab testing.
http://www.fiercepharmamanufacturing.com/story/emcure-india-plant-banned-fda/2015-07-14

FDA Warning Letter Lays Out Issues at Banned Two Wockhardt Plants
The FDA finds similar testing, data-security problems at the two plants, banning most of the products the company can ship to the U.S. A warning letter posted today shows that the plant was up to some of the same tricks that led the agency to its first ban earlier this year. The Wockhardt plant in Chikalthana was testing "trial samples" of some drugs, then linking results from those to official samples that had not met test requirements. Also, inspectors found that some results were not being kept on hard drives where they could confirm the results and the drugmaker does not limit computers to specific employees; there is the chance that test results that don't live up to standards could be deleted or changed. The FDA noted similar issues at Wockhardt's plant in Waluj, a facility the FDA issued a ban against in May.
http://www.fiercepharma.com/story/fda-warning-letter-lays-out-issues-banned-wockhardt-plants/2013-12-03

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Did You Know ...

�that "Globalization" may not be such a good idea?

Tip of the Week

Globalization results in a loss of cultural identity, loss of unique social values, loss of accountability, and loss of control. It also results in global government, big bucks, and privilege for a very few, while most people lose and become "one of the masses." If the move towards globalization continues, the world will be one melting pot of society with very few distinguishing characteristics. It reminds one of the events leading up to the Tower of Babel.

Looking Back

Candidate says,
Campaign confusing!
Babies kiss me,
Since I've been using,
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