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| Standardization of Some Compounded Dosage Forms, Part 3 |
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Parenteral medications, including IV administration, account for twice as many errors as other methods of administration. Stakeholders from:
- ASHP;
- Infusion Nurses Society;
- Joint Commission;
- National Patient Safety Foundation;
- Institute for Safe Medication Practices; and
- USP
have met and called for standardization in IV compounding, especially with infusion concentrations and dosage units. (Note: This was to have been completed by 2012 but has yet to be accomplished.)
Various healthcare settings use different concentrations of IV medications, and this can encourage errors because pharmacists and other healthcare practitioners must recalculate and compound medications for individual patients. As a result, the above-mentioned group has requested that pharmaceutical manufacturers and the FDA create products available in "ready-to-use" (RTU) form which does not require manipulation (compounding). Furthermore, the group recommended that medications which cannot be provided in RTU-dosage forms be compounded exclusively in the pharmacy whenever possible.
More next week.
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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News
FDA Commissioner on Product Quality at Foreign Drug Manufacturing Sites
The shift to overseas production of U.S. goods, including some drugs and their components, predominantly occurred in the early 2000s and has added new complexities to the U.S. drug-supply chain. Consequently, the FDA has taken different steps to address the issue.
To add greater transparency, the FDA is publishing their internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections. The policy explains how a facility's compliance history, recall trends, time since last inspection, inherent risk of the drug being manufactured, processing complexity, and other factors are all weighed and considered.
The FDA prioritizes inspections of sites regardless of their location. For manufacturing facilities in other countries, inspections may be conducted by staff in foreign offices, those on temporary duty assignments, or staff who travels internationally to conduct the inspection. In addition, to maximize resources and efficiency, the FDA has also pursued opportunities to collaborate with other countries. With the announcement last year concerning the Mutual Recognition Agreement with the EU, they have ensured that the FDA can recognize the drug inspections conducted by foreign regulatory authorities that meet U.S. requirements. In doing so, the FDA is able to dedicate more of their investigators' time to those sites that pose the greatest risk.
https://www.pharmoutsourcing.com/1315-News/353295-Statement-from-FDA-Commissioner-on-Product-Quality-at-Foreign-Drug-Manufacturing-Facilities/
Hospitals Fed Up with Drug Companies are Starting Their Own
A group of major American hospitals, battered by price spikes on old drugs and long-lasting shortages of critical medicines, has launched a mission-driven, not-for-profit generic drug company, Civica Rx, to take some control over the drug supply.
This effort is backed by seven large health systems and three philanthropic groups and will be led by an industry insider. The company will focus initially on establishing price transparency and stable supplies for 14 generic drugs used in hospitals, without pressure from shareholders to issue dividends or push a stock price higher.
https://www.washingtonpost.com/national/health-science/hospitals-are-fed-up-with-drug-companies-so-theyre-starting-their-own/2018/09/05/61c27ec4-b111-11e8-9a6a-565d92a3585d_story.html?noredirect=on&utm_term=.41ce7351abfa
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Did You Know ...
�that I saw a billboard last week referring to "xyz�in a post-truth era"? Are we really in a "post-truth era"?
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Tip of the Week
What has happened to our concern for the truth in what we are exposed to every day and in our communications? Are we really in a "post-truth era"? We know that:
- A significant amount of what is on the Internet is not true,
- Many television shows project situations that are not true,
- Many news stories contain a lot of "opinion" and "little news," which is a misrepresentation,
- Politicians state things that are not true during their campaigns and even after they are elected,
- Advertisements on radio, television, and other media make statements that are not true...
�and yet we don't seem too concerned about it for some reason.
Even though there are situations where individuals are confronted and pay the penalties when caught lying, but this does not occur in all cases.
The penalties for lying are inconsistent and even nonexistent in many cases.
Why is it we can see television scenarios where lying occurs, but we just accept it as being okay?
What is this teaching our kids?
Why do we accept "ignorant" individuals lying and promoting an agenda as just being excited about their cause as if that makes it okay and we should all accept it?
How can we expect individuals to tell the truth when they are being confronted with lies all day long?
What happened to character, reputation, honesty, dependability, etc.? Are we also in a post-character, post-reputation, post-honesty, post-dependability era?
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Looking Back
Highways are,
No place to sleep!
Stop your car,
To count your sheep!
Burma Shave
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