(Learning about USP Chapter <800> in 10 minutes a week.)

3. Types of Exposure

Table 1 in this section of Chapter <800> lists "Examples of Potential Opportunities of Exposure Based on Activity." The types of activity include the following and the actual table should be reviewed for how exposure may occur:

• Receipt
• Dispensing
• Compounding and other manipulations
• Administration
• Patient-care activities
• Spills
• Transport
• Waste

NEXT WEEK:
    4. Responsibilities of Personnel Handling Hazardous Drugs

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. Also, a new 14.003 Hazardous Drugs List is now available.

2. A copy of a USP <800> Gap Analysis [FREE to all] available for downloading.

Both available at: http://www.CompoundingToday.com

4. COMING!!! A LOT more Standard Operating Procedures for USP <800>.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

Announcement

USP is presenting a course on General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings on March 24, 2016. You can receive a discount of 20% if you register online and use the promotion code: PE800Member2016

News

FDA-PCAC Meeting Results
The FDA-PCAC met this week and voted on the following drugs to be recommended to the FDA for addition to the "Positive List." THIS IS NOT EFFECTIVE YET. Only the majority result of votes is listed:

Voting on "demonstrably difficult to compound": A "YES" vote places the dosage form on the demonstrably difficult to compound list so it cannot be compounded.

Editor's Note: This is the same as has been in effect since the FDAMA 97 PCAC, and these are not compounded. See the "Did You Know" section below.

Most Intravenous-medical Errors Linked to Clinical Practice/Administration
A recent study suggests that mistakes that occur during the administration of intravenous (IV) medications occur mostly due to clinical errors. IV-med errors have long been one of the most common types of errors in hospitals and many have believed that the use of so-called smart pumps were the key to solving that problem. A new study, however, suggests that eliminating administration errors is far more complex and involves sound clinical practices and an adherence to those practices. A recent survey conducted by the American Society of Health-System Pharmacists in 2012 reported that 77% of hospitals in the U.S. use smart-pump technology. Results from the study showed 60% of infusions contained one or more errors; violations of IV labeling and tubing change policies accounted for approximately 65% of the observed mistakes.
http://www.infectioncontroltoday.com/news/2016/03/majority-of-iv-medication-errors-linked-to-clinical-practice-not-technology.aspx

Higher Spending in Retail Health Clinics
Even though receiving minor medical care at retail clinics is cheaper, the frequency of use may offset savings. A new study published in Health Affairs, a policy journal, casts fresh doubt on whether these popular retail clinics will save money. Researchers concluded that the clinics led to slightly higher spending because people used them for minor medical conditions they would typically have treated on their own. They report that the higher use outweighed the savings that resulted when people went to a cheaper retail clinic instead of to the doctor or emergency room.
http://www.nytimes.com/2016/03/08/business/retail-health-clinics-result-in-higher-spending-survey-finds.html?_r=0

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Did You Know ...

�that one wonders why it is okay for people to purchase many of the drugs recommended for the "positive list" over-the-counter at health food/nutrition stores and even in pharmacies but �pharmacists may not be able to compound with them and be integrally involved with patients in their proper use?

Tip of the Week

Seems like the FDA doesn't care if healthcare practitioners are involved in patient care with the physician-pharmacist-patient relationship with some of these drugs recommended for the positive list�the patients will just have to buy them and use them on their own! Why can they be safe enough for unrestricted OTC use but unsafe for restricted-use compounding?

Looking Back

Toughest whiskers,
In the town,
We hold 'em up,
You mow 'em down!
     Burma Shave