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| Considerations in a Global Pharmaceutical System (June 4, 2010) |
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Note: With the current situation regarding the global supply of pharmaceuticals, we have been asked to reprint the Editorial of this Newsletter from almost ten years go.
As we (the U.S.) are dependent upon other countries for active pharmaceutical ingredients (APIs), we need to be aware of some inherent problems, a few of which are discussed in this newsletter, that are associated with this situation.
First, if there is a political disagreement between the countries of the provider and the purchaser, the provider may not be able to "sell" to the "purchaser" for political reasons. This would leave the country purchasing the APIs without the needed medication.
Second, there may be a situation when sanctions are placed upon a provider country and the purchaser cannot order and receive the APIs to produce their medications.
Third, since many people in some countries receive their health care, including pharmaceuticals, from their government, when the government has severe budget problems and drops the prices they are willing to pay for pharmaceuticals to help balance the budget, the company simply stops selling to the buyer country. This is the case in Greece, where it was reported this past week that the government was not willing to pay the price for insulin that was required by patients with diabetes. It isn't that the company necessarily wants to stop selling to Greece; it is that the lower price the government is willing to pay because of the economic conditions is lower than the price at which the seller is willing to sell for. Consequently, they choose to not sell their product rather than sell at a loss. This may put patients with diabetes that live in Greece in a very dangerous situation.
Fourth, quality issues may surface and quality standards may not be met. For example, many providers sell different quality levels of drug substances to different purchasers/countries and the price difference may be such that the seller prefers to sell the lower-quality drug substance at lower prices and may not wish to do the additional work required to produce higher-quality APIs.
Fifth, one may not always know the "actual owners" of a company, or they may not always know the actual company that does the synthesis of the APIs since there may be numerous "middle-men" or brokerage firms involved.
Sixth, many companies stopped synthesizing APIs here in the U.S. because of the increased OSHA and EPA standards and the fact that it can be done less expensively in other countries with less personnel costs and issues. However, what happens when these countries start increasing their prices and we no longer can source the API from other providers?
The U.S. has about 70% to 80% of their APIs synthesized in other countries (primarily China and India), which is potentially a dangerous situation. Maybe it's time that U.S. companies started looking at what it would take to bring this industry back home so that the U.S. manufactures its APIs instead of importing them.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition
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News
FDA Releases COVID-19 Compounding Policy
The FDA has released the final "Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency" Guidance for Industry.
It is avaailable for download at https://www.fda.gov/media/137031/download
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Hydroxychloroquine Study Available
With the drug "hydroxychloroquine" becoming a familiar word in the COVID-19 battle, please refer to our website to view a stability study titled "Stability of Extemporaneously Prepared Hydroxychloroquine Sulfate 25-mg/mL Suspensions in Plastic Bottles and Syringes." It can be found at: https://ijpc.com/Abstracts/Abstract.cfm?ABS=4322
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Q&A on an Upcoming Article in IJPC
"Compounding Pearls - Wound Care: Diabetic Foot Ulcers, Part 1," by Mike Riepl, (May/June 2020 issue of IJPC)
Are diabetic foot ulcers classified by type? Which factors cause those ulcers, and why are those lesions so difficult to treat?
Diabetic foot ulcers (DFUs) are among the most common types of chronic wounds. DFUs can be classified as neuropathic (ulcers that are caused by an impairment in sensory, motor, or autonomic input and/or function that in turn renders the skin more vulnerable to injury, reduces the sensation of pain, and delays awareness of wound development), ischemic (ulcers that result from peripheral arterial disease), or neuroischemic (ulcers caused by a combination of ischemia and neuropathy that can damage intrinsic foot muscles and lead to an imbalance in the flexion and extension of the foot). Causes of DFUs include trauma, arterial or peripheral neuropathy, poor glycemic control, a disruption in the immune response to infection, and high foot-plantar pressure. Those wounds can be challenging to treat because in people with diabetes and certain biochemical abnormalities the wounds can lead to the development of neuropathy and vascular changes in the feet.
Which drugs are effective in healing DFUs?
Among the drugs that enable DFU healing are misoprostol, phenytoin, doxycycline, insulin, naltrexone, melatonin, and nifedipine. To treat underlying pathologic conditions and promote the healing of DFUs, a compound (unlike a manufactured medication) can be formulated to include combinations of those agents in varying strengths in a healing base, such as those listed below:
- Poloxamer 407, NF, 30% gel
- An oil-in-water cream base
- Ointment base no. 198 (bulk) (Alpawash; Medisca Pharmaceutique, Inc., Montreal, Quebec City, Canada)
- Gel base no. 197 (bulk) (CopaSil; Medisca Pharmaceutique, Inc., Montreal, Quebec, Canada)
- Gel base no. 151 (bulk) (Lavare; Humco, Austin, Texas)
- Clovagel base (Fagron, Rotterdam, Netherlands)
- Gel base no. 86 (bulk) (Spira-Wash gel; Professional Compounding Centers of America, Houston, Texas)
For an in-depth discussion, effective formulations, and additional information about compounding for the treatment of these DFUs, please see the upcoming May/June 2020 issue of IJPC.
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Did You Know ...
...that Will Rogers said the following?
"All I know is just what I read in the papers, and that's an alibi for my ignorance."
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Tip of the Week
We could add all the media (television, radio, social media, etc.) to the newspapers in the above quote. It seems that the media is not as much interested in the "What, When, How, and Where" as they are in the "Why" and the "Gotcha!". And if they don't get the answers they want, they often misrepresent what was said, give their own opinions or only report portions of statements, etc. It also seems that they are now saying their comments have been "Fact-Checked"; however, WHO is checking the "Fact-Checkers?" Even though there are many great, truthful, serious, and honorable journalists, I really don't think journalists will ever be voted as the "most honorable profession" in our lifetimes!
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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 - https://www.facebook.com/IJPCompounding
View our growing collection of educational and training videos at www.ijpc.com/video or by subscribing to our Youtube channel at https://www.youtube.com/IJPCompounding.
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Looking Back
Tho living costs,
Are upward bound,
Four bits still buys,
Half a pound!
Burma-Shave
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