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| Implementing United States Pharmacopeia <800>, Part 4: Hazardous Drugs-Handling in Healthcare Settings |
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2. LIST OF HAZARDOUS DRUGS
Each entity must maintain a LIST of HDs.
- Any drug on the NIOSH LIST the entity uses must be on the LIST.
- The LIST must be reviewed at least annually.
- When using a new agent, it must be compared to the LIST.
- New agents must be compared to the NIOSH criteria for HDs.
- The drugs that must follow the requirements of this chapter include:
- Any HD API
- Any antineoplastic drug requiring HD manipulation.
Exemptions if an "assessment of risk" is performed and implemented include:
- Final dosage forms of HD preparations (compounded and manufactured) including antineoplastic dosage forms requiring no further manipulation other than counting or repackaging unless such manipulation is required by the manufacturer.
For dosage forms NOT on the NIOSH LIST, the entity may perform a "risk assessment" to determine alternative containment strategies and/or work practices. If not performed, the dosage form must be handled according to the chapter. The published NIOSH List�contains information on evaluating drugs to determine if they are hazardous.
The "risk assessment" must at least consider each of the following, be documented, and reviewed at least annually:
- Type of HD
- Dosage form
- Risk of exposure
- Packaging
- Manipulation
Please note that the NIOSH LIST will be continually updated! Also, it contains a section on "How to Generate Your Own List of Hazardous Drugs" and states that "compliance requires practice-specific assessments for drugs used at any one time by a facility."
See below for SOPs containing the NIOSH LIST of Hazardous Drugs in Microsoft Word format for ease of implementing.
NEXT WEEK:
3. Types of Exposure
DON'T FORGET TO OBTAIN:
1. NEW!!! [FREE to Subscribers] New SOPs containing each of the 3 NIOSH LISTs as well as a composite LIST in Microsoft Word form are available for downloading. SOPs 14.004, 14.005, 14.006, and 14.008. New SOP 14.007 contains NIOSH LIST Table 5 "Personal Protective Equipment and Engineering Controls for Working With Hazardous Drugs in Healthcare Settings," also in Microsoft Word.
2. A copy of a USP <800> Gap Analysis [FREE to all] available for downloading.
Both available at: http://www.CompoundingToday.com
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
Cancer Drug Waste Costs $3 Billion a Year
Medicare and private health insurers waste nearly $3 billion every year buying cancer drugs that are thrown out because drug companies distribute the drugs only in vials that hold too much for most patients. The expensive drugs are injected by nurses who measure the amount needed for a particular patient and then, because of safety concerns, discard the rest. Manufacturers should distribute the drugs in vials containing smaller quantities. In Europe, some of these medicines are distributed in smaller vial sizes where governments play a more active role than the U.S. in drug pricing and distribution.
http://www.nytimes.com/2016/03/01/health/waste-in-cancer-drugs-costs-3-billion-a-year-a-study-says.html
Short Supplies and Rising Prices—Symptoms of America's Broken Drug System
Skyrocketing prices of some drugs are just a part of the problem. Hundreds of common drugs we depend on aren't available because of production problems, shortages of raw materials, or a myriad of other issues that have no easy solution. Most shortages are caused by manufacturing and quality problems, according to the FDA. Over the past decade, there's been a consolidation among U.S. drug companies and now there's often only one or two companies producing a particular medication. So what happens? Rationing!
http://www.ohio.com/news/break-news/america-s-broken-drug-system-short-supplies-randomly-rising-prices-and-no-solution-in-sight-1.665132
French Regulators Uncover Potentially Tainted Heparin from China
A recent report filed by the European Medicines Agency (EMA) regarding an inspection of Dongying Tiandong Pharmaceutical in Dongying City, Shandong Province, by French regulators uncovered data suggesting the drugmaker has manipulated tests of crude heparin supplies that had showed the presence of ruminant DNA. It said that there was no evidence that the samples used to do retesting came from the same batches that showed the ruminant. Regulators said that issues resulted in 7 batches of crude heparin received in 2014 and 2015 being used for making finished APIs without ever being investigated for out-of-specification potency. The inspectors, in fact, found a host of problems with the drug company's testing procedures.
http://www.fiercepharmamanufacturing.com/story/potentially-tainted-heparin-china-uncovered-french-regulators/2016-02-29
Very Few Doctors Can Write for Buprenorphine to Treat Addiction
About a million U.S. physicians can write a prescription for an opioid analgesic like Vicodin and OxyContin but, because of regulatory hurdles and other factors, fewer than 32,000 doctors are permitted to prescribe buprenorphine, a medication to treat the addiction.
http://www.nytimes.com/2016/03/03/upshot/fighting-drug-addiction-with-drugs-works-but-only-if-doctors-sign-on.html?_r=0
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Did You Know ...
�that Henry Kissinger once stated that ninety percent of the politicians give the other ten percent a bad reputation?
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Tip of the Week
It has been said, "If it's true you can't take it with you, then maybe it's about what you leave behind!"
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Looking Back
We don't know how,
To split an atom,
But as to whiskers,
Let us at 'em!
Burma Shave
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