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| ![](media/image1.png) | **American Association of Occupational       |
|                       | Health Nurses, Inc.**                        |
|                       |                                              |
|                       | Suite 100 • 2920 Brandywine Road             |
|                       |                                              |
|                       | Atlanta, Georgia 30341                       |
|                       |                                              |
|                       | \(770\) 455-7757 • fax (770) 455-7271 •      |
|                       | www.aaohn.org                                |
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Food and Drug Administration

Dockets Management Branch (HFA-305)

5630 Fishers Lane, Room 1061

Rockville, MD 20852

[e-mail:]{.underline} <FDADockets@oc.fda.gov>

c.c.: Chris Bechtel, [bechtelc@cder.fda.gov]{.underline}

RE: The American Association of Occupational Health Nurses' (AAOHN)
comments on the risk management of prescription drugs.

June 20, 2002

# Dear Dr. Smith:

In response to your April 15 letter requesting public comments about the
risk management of prescription drugs, the American Association of
Occupational Health Nurses (AAOHN) is pleased to give input.
Occupational health nurses are the largest group of health professionals
serving the workplace. These nurses frequently provide information about
medications to workers, as well as administer health care to workers who
adversely react to a medication or are injured on the job as a result of
a medication.

Below you'll find AAOHN's comments, which speak to this issue largely
from the consumer's perspective.

If you would like clarification or additional information, please feel
free to contact AAOHN's external affairs department at 770-455-7757,
x105.

[Questions and AAOHN Response:]{.underline}

[Risk Management:]{.underline}

What improvements are needed to enhance communication about safety
issues for drugs?

-   There is a need for improved communication among the
    physician/health care professional (HCP) who prescribes the
    medication, the pharmacist who dispenses the medication, the HCP who
    administers the medication, and the consumer who is taking the
    medication to provide clarity about safety issues and emergency
    follow up.

-more-

AAOHN Comments/2-2-2

-   Overall, communication needs to be tailored to a vast number of lay
    audiences. The FDA should take into consideration the changing
    demographics of American society, such as an aging population, and a
    society that is more culturally diverse. Suggestions include the use
    of labeling that is in a legible font size, and use of language that
    is easily understood. For example, the FDA could include a consumer
    insert to accompany the drug written for the lay person. In
    addition, the physician and/or pharmacist should communicate
    information about the efficacy of a drug to the consumer, including
    information about interactions with other medications, vitamins or
    dietary supplements.

How can communication with health care practitioners become more
effective?

-   Communication with health care practitioners needs to be simpler or
    more user-friendly. Fact sheets or Frequently Asked Questions (FAQ)s
    would be a good way to distribute information. In addition,
    newsletters or electronically-based communications such as a "news
    e-mail" or postings on a Web site would be helpful.

-   Also, when it comes to updates regarding efficacy or problems with
    medications, it is critical to identify ways to quickly transmit
    this kind of information. Suggestions include a Web site devoted to
    this area, or Web-based learning/training.

## Tools for Risk Management

What methods should FDA be using to manage risk?

-   Methods could be Web-based or e-based, voluntary, and have
    incentives for the health professional. In the case of an e-based
    tool, specific software can be downloaded to palm pilots or
    computers. Ideally, whichever method is used, the health care
    provider would have the capability to enter the name of the
    medication and gain the latest information about that medication,
    including details about adverse reactions.

What risk interventions can FDA initiate for pharmacists, physicians,
patients and drug manufacturers?

-   There needs to be a way to give pharmacists, physicians, consumers
    and drug manufacturers faster access to information. For example, it
    would be helpful if health care providers could use their computer
    to download information about a medication for review prior to
    filling a prescription, or to print out that information to pass on
    the consumer once the prescription is filled. Because it is very
    difficult for physicians and pharmacists to keep current on all
    medications that they prescribe, this would relieve some of the
    pressure on pharmacists, doctors, etc. If a computerized approach is
    not possible, a compromise might be to have a composite of
    frequently prescribed medications on file that could be
    tracked/monitored over time.

-more-

AAOHN/3-3-3

-   We encourage the FDA to think about other health care professionals,
    such as occupational health nurses, who provide health care. We
    would like to see a risk intervention developed that would encourage
    communication between pharmacists and the health professionals who
    treat employees on the job. For example, when a worker signs for
    medication at the pharmacy pick-up window, it would be nice to give
    him/her an option to allow the pharmacist to notify his/her
    occupational health nurse about the medication dispensed and its
    potential side effects.

## 

## Evaluation of Risk Management Strategies and Interventions

What criteria should be used to judge if a risk management intervention
is effective?

All drugs should be evaluated prior to intervention. An evaluation
system should address process and outcome and have some form of
measurement attached to it that will evaluate the various steps in the
process, along with the outcomes. (e.g. satisfaction surveys, etc.)

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