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

1. INTRODUCTION AND SCOPE, Part B-Scope

   Each facility must have an Occupational Safety Plan and incorporate the standards in the chapter. The facilities health and safety management system must at least include:

   • Hazardous drugs list
   • Facility and engineering controls
   • Competent personnel
   • Safe work practices
   • Proper use of appropriate PPE (Personal Protective Equipment)
   • Policies for HD waste segregation and disposal.

   The chapter consists of 19 pages of which 6 pages are:

   • Glossary 1.5 pages
   • Appendices 2.5 pages
   • References 2 pages

   This leaves only 13 pages of standards.

   There are 18 "Sections" addressing the six items in the above list that are contained in the 13 pages, as follows (Note: Shading separates topics into general categories.):

   Section	Topic
   1.	Introduction and Scope
   2.	List of Hazardous Drugs
   3.	Types of Exposure
   4.	Responsibilities of Personnel Handling Hazardous Drugs
   5.	Facilities and Engineering Controls
   6.	Environmental Quality and Control
   7.	Personal Protective Equipment
   8.	Hazard Communication Program
   9.	Personnel Training
   10.	Receiving
   11.	Labeling, Packaging, Transport, and Disposal
   12.	Dispensing Final Dosage Forms
   13.	Compounding
   14.	Administering
   15.	Deactivating, Decontaminating, Cleaning, and Disinfecting
   16.	Spill Control
   17.	Documentation and Standard Operating Procedures
   18.	Medical Surveillance

   The following may aid in categorizing the above 18 sections:

   Sections	General Topic(s)
   1-3	Informational/Definitions, etc.
   4-7	Responsibilities and Protection Standards
   8-9	Communications and Training
   10-14	Processing Concerns
   15-16	Cleaning and Spills
   17-18	Documentation and Surveillance

QUESTIONS FROM PHARMACISTS:

• What is potentially covered in the phrase "not limited to"?
• Does "included personnel" also include drivers, custodians, inspectors, etc.?
• Is the patient bedside included in administration?
• Regarding transport, can HDs be transported in tubes, robots, patient carts, etc.?
• Is the nursing station where HDs may be stored included in "entities"?
• What is required of a nursing home for drug storage and administration?
• In a nursing home, are there requirements for the patient's room/apartment?
• What mechanism is to be used to gain compliance by all the non-pharmacy facilities?

There are potentially a lot of questions, and they will be raised (and hopefully answered) throughout this series for clarification to aid in compliance.

NEXT WEEK:
     2. List of Hazardous Drugs

DON'T FORGET TO OBTAIN:

• USP Chapter <800>: Available at:
  https://store.usp.org/OA_HTML/usp2_ibeCCtpSctDspRte.jsp?section=12487&minisite=10020
• NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014. [FREE] at: http://www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138.pdf
• A copy of a USP <800> Gap Analysis [FREE] at: http://www.CompoundingToday.com

News

State Pharmacy Oversight Varies
A study found large variations in how compounding pharmacies are regulated by states. Only about half of the states require compounding pharmacies making sterile preparations to fully comply with recognized quality standards. Also, 60% of the states do not require compounding pharmacies to report serious adverse events and reactions related to sterile compounding. Also, there are various definitions for compounded preparations between states.
http://www.statnews.com/pharmalot/2016/02/24/compounding-pharmacies-fda/

Banned Chinese Firm Allowed to Ship Chemotherapy to U.S.
The FDA will allow the import of a chemotherapy's active pharmaceutical ingredient (API) from China's Zhejiang Hisun Pharmaceutical Co. because of concerns of a shortage. The company is still under an import alert which means all other API products sent to the U.S. are banned entry.
http://www.raps.org/Regulatory-Focus/News/2016/02/18/24369/FDA-Allows-Banned-Chinese-Firm-to-Ship-Chemotherapy-to-US-as-Shortage-Threat-Looms/#

European Medicines Agency Cites Another China Plant for Manufacturing, Data Flaws
The European Medicines Agency (EMA) has cited Chengdu Okay Pharmaceutical in Qionglai, Sichuan Province. They found the plant was not meeting standards in manufacturing, quality control, and data integrity; they tallied 21 deficiencies, of which 5 rose to the critical mark and 10 others were classified as major. The plant was not properly calculating impurities; testing data had been overwritten; and the company had no protections to prevent unauthorized employees from getting into and changing test results in its computerized equipment. Some data of HVAC system qualification had also been falsified.
http://www.fiercepharmamanufacturing.com/story/ema-cites-another-china-plant-manufacturing-data-flaws/2016-02-23

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Did You Know ...

�that cognitive dissonance is inevitable in every pharmacist's life?

Tip of the Week

Cognitive dissonance is the mental stress or discomfort experienced by an individual who holds two or more contradictory beliefs at the same time. Read more at:
http://drugtopics.modernmedicine.com/drug-topics/news/pharmacists-and-cognitive-dissonance

Looking Back

The answer to
A Maiden's prayer,
Is not a chin
Of stubby hair!
     Burma Shave