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

I. INTRODUCTION AND SCOPE, Part A—Introduction

• Purpose:
  • To promote-
    • Patient safety
    • Worker safety
    • Environmental protection
• Handling Hazardous Drugs (HDs) includes but is not limited to:
  • Receipt
  • Storage
  • Compounding
  • Dispensing
  • Administration, and
  • Disposal of sterile and nonsterile products and preparations
• Applies to:
  • All healthcare personnel handling HDs
  • All entities that store, prepare, transport or administer HDs
• Included personnel that may be exposed to HDs are:
  • Pharmacists
  • Pharmacy technicians
  • Nurses
  • Physicians
  • Physician assistants
  • Home healthcare workers
  • Veterinarians
  • Veterinary technicians

QUESTIONS FROM A PHARMACIST:

• 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:
     I. INTRODUCTION AND SCOPE, Part B—Scope

DON'T FORGET:
See last week's Newsletter for information on obtaining the following:

1. USP Chapter <800>
2. "NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014" [FREE]
3. A copy of a USP <800> Gap Analysis [FREE]

News

Superpotent Morphine Recalled by Compounder
Pharmakon Pharmaceuticals is recalling syringes of morphine after discovering they were superpotent and tied to adverse reactions in three babies who were injected with the drug. The voluntary recall involved morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride, 1-mL syringe. The preparations were manufactured by Noblesville, IN-based Pharmakon on February 3 and have an expiration date of March 19, 2016.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor
HumanMedicalProducts/ucm486431.htm

Issues Found with Walgreens' Option One Infusion Services
Option One recalls 33 products after two inspections find issues. The FDA has been making its way through inspections of the country's largest compounders and has found issues with Option One (formed last year when Walgreens sold its infusion care services to a private equity group). Two inspections by the FDA of its Option One compounding operations in Texas were found to be short on sterility precautions. The recall includes products ranging from saline and dextrose, to heparin, insulin, vancomycin, milrinone, and compounded Remicade.
http://www.fiercepharmamanufacturing.com/story/fda-finds-issues-walgreens-infusion-compounding-services/2016-01-13

AmerisourceBergen Buys Sterile Compounder PharMEDium for $2.5B
AmerisourceBergen said it would pay $2.575 billion for PharMEDium Healthcare Holdings, which it is buying from Clayton, Dubilier & Rice. Founded in 2003, PharMEDium has compounding centers in Tennessee, Mississippi, Texas, and New Jersey, all registered with the FDA, from which it ships to more than 3,000 hospitals. The deal is its second major acquisition announced this year by AmerisourceBergen, as it has completed a $2.5 billion acquisition of the international animal health distribution company, MWI Veterinary Supply.
http://www.fiercepharmamanufacturing.com/story/amerisourcebergen-lays-out-25b-sterile-compounder-pharmedium/2015-10-06

Testosterone Gel Treatment Found Effective in Older Men (NEJM)
Serum testosterone concentrations decrease as men age; however, benefits of raising testosterone levels in older men have not been firmly established. This study involved 790 men 65 years of age or older with a serum testosterone concentration of less than 275 ng per deciliter and symptoms suggesting hypoandrogenism who received either testosterone gel or placebo gel for 1 year. In symptomatic men 65 years of age or older, raising testosterone concentrations for 1 year from moderately low to the mid-normal range had a moderate benefit with respect to sexual function, some benefit with respect to mood and depressive symptoms, but no benefit with respect to vitality or walking distance.
http://www.nejm.org/doi/full/10.1056/NEJMoa1506119?query=featured_home

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Did You Know ...

�that it's funny but it's sad when people are asked questions and they know very little about America? One college student, when asked who Judge Judy was, said she was a Supreme Court Justice!

Tip of the Week

Ignorance is something for which we all pay the price! Education is critical and involves "learning" and "not just studying to pass an exam"! Computer games and social media will NOT prepare you for life!

Looking Back

To kiss a mug,
That's like a cactus,
Takes more nerve,
Than it does practice
     Burma Shave