Department of Labor
www.osha.gov

This newsletter is the second in a series on the topic of OSHA. As mentioned last week, OSHA is committed to protecting workers from toxic chemicals and deadly safety hazards at work, ensuring that vulnerable workers in high-risk jobs have access to critical information and education about job hazards, and providing employers with vigorous compliance assistance to promote best practices that can save lives.

This week, we will look at the inspection priorities in more detail as we summarize the hundreds of pages of documents of which pharmacy is a very small part.

Once a complaint has been received, it is prioritized based on its severity. There are two types of inspections used by OSHA:

• Phone/Fax Investigations
• On-Site Inspections

Phone/Fax Investigations

1. For lower-priority hazards and with the permission of the complainant, OSHA may telephone the employer to describe safety and health concerns, following up with a fax providing details on the alleged safety and health hazards.
2. The employer must then respond in writing within five working days, identifying any problems found and noting any corrective actions taken or planned.
3. If the response is adequate and the complainant is satisfied with the response, OSHA generally will not conduct an on-site investigation.

On-Site Inspections

1. Preparation: Before conducting an inspection, OSHA will research the inspection history of the worksite and review the operations and processes in use and the standards most likely to apply.
2. The on-site inspection begins with a presentation of credentials by the compliance officer(s).
3. Opening Conference: An "Opening Conference" is held to explain why OSHA selected the workplace for inspection and will describe the scope of the inspection, walkaround procedures, employee representation, and employee interviews.
4. Walkaround: For the "Walkaround," the employer will select a representative to accompany the compliance officer during the inspection.
   • The compliance officer will consult privately with a reasonable number of employees during the inspection.
   • The officer will also inspect for hazards, review worksite injury and illness records, and the posting of the official OSHA poster.
   • The officer will point out any apparent violations that need to be corrected.
   • The officer(s) will try to minimize work interruptions during the inspection and will keep confidential any trade secrets observed.
5. Closing Conference: After the Walkaround, there is a closing conference with the employer and the employee representatives to discuss the findings. Possible courses of action are discussed and can include an informal conference with OSHA or contesting citations and proposed penalties; the officer also discusses consultation services and employee rights.

Next week, we will look at what happens next, the appeals process, and worker's rights.

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

News

Stents Often Unwarranted, Study Shows
New research indicates that heart disease patients with blocked coronary arteries who received only drug therapy did not have more heart attacks or die more frequently than individuals who also received bypass surgery or stents. The findings, presented at the annual meeting of the American Heart Association last week, held true for individuals with several severely blocked coronary arteries. Stenting and bypass procedures were helpful for some patients with angina, however. "You would think that if you fix the blockage the patient will feel better or do better," said Alice Jacobs, MD, director of Cath Lab and Interventional Cardiology at Boston University. The study, she added, "certainly will challenge our clinical thinking." The more than 5,100 participants were followed for a median of 3.5 years. There were 145 deaths in the group that was randomized to receive stents or bypass in addition to medical therapy, compared with 144 among those who received medication alone. Additionally, there were 276 heart attacks in the stent and bypass group, vs. 314 in the medication group, a difference that was not considered significant.
https://www.nytimes.com/2019/11/16/health/heart-disease-stents-bypass.html

Statins Not Linked with Memory Loss in Seniors
A large new study finds no link between memory loss and the statin drugs. The six-year-long study of more than 1,000 patients found the drugs appeared to protect cognition in patients with heart disease, researchers reported in the Journal of the American College of Cardiology. "We could find no detrimental effect of statin medications on memory or global cognition over six years in older people, where memory had been comprehensively measured using five different kinds of memory tests," said study leader Katherine Samaras of the Garvan Institute of Medical Research in Sydney.
https://www.reuters.com/article/us-health-brain-statins/statins-not-linked-with-memory-loss-in-seniors-study-finds-idUSKBN1XS2EV

Did You Know ...

...that an anonymous person said the following?

"When you say it's hard, you actually mean you can't find the calculator or work out 112-56 in your head"! (Anonymous)

Tip of the Week

It's interesting that one of the most valuable and critical courses in pharmacy education is Pharmacy Calculations. However, some faculty don't enjoy teaching it, and some may not know how to teach it. Incorrect calculations in pharmacy compounding, whether its IV admixtures, TPNs, other sterile preparations, or nonsterile preparations, can result in serious harm and even death to patients. It should not be a "self-taught" course but a presentation with real-life examples and numerous comprehensive exams throughout the semester to enable the student to demonstrate mastery of pharmacy calculations. Appropriate calculation examples should also be added in other courses throughout the entire curriculum sequence. After all, their patients' lives will depend on it!

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Looking Back

"Best reference,
Public preference"!
     Burma-Shave

Don't Forget
Alternatives to USP Chapters for State Boards of Pharmacy is Available Online

At the CompoundingToday.com website "Homepage," there is an option to access "Alternatives to USP <795>, <797>, and <800>" documents. These documents are easily modifiable, bullet-point versions in Microsoft Word for use by State Boards of Pharmacy (SBOP) to prepare their own regulations.

It is easier and more convenient for SBOPs to "customize" the chapters and make them more appropriate and specific for their individual states and to ensure patient access to medications, both manufactured and compounded.

Once these have been modified and approved, they can be incorporated into the regulations of the state and can be easily updated as needed by the SBOP. They will be controlled by the SBOP and not by a national entity.