Software Hardline

By Ukens, Carol | Drug Topics, November 4, 1996 | Go to article overview

Software Hardline


Ukens, Carol, Drug Topics


The Food & Drug Administration's revived plans to bring some stand-alone medical software under its regulatory umbrella poses some interesting questions for pharmacists.

The FDA is in the midst of discussions in-house and with the healthcare software industry and health-care professionals to arrive at some consensus about whether some software should be regulated as medical devices, said spokeswoman Sharon Snider. While software used in conjunction with medical devices is already regulated, the agency is now taking a hard look at stand-alone software. Possible pharmacy-related targets for regulation include software for prescription ordering, drug interactions, and automated dosing calculations.

"The reason is that technology has advanced a lot since we first started looking at software," said FDA's Snider. "We are looking at the whole world of [health-care] stand-alone software. We're trying to decide what needs to be regulated and what doesn't."

Pharmacists will feel the impact if FDA regulates software, said Carmen Catizone, executive director, National Association of Boards of Pharmacy. In the first place, the necessity for agency approval could slow down development of software, which has a short shelf life. In addition, it raises other questions, such as whether pharmacists could deviate from the information provided by the software.

"Drug interaction software would fall in the new regulatory area, which has tremendous implications for pharmacists," said Catizone. "What if, for example, the information is outdated or is for an off-label use? If the pharmacist dispenses the drug, what happens then?"

State pharmacy boards don't want the FDA poaching on their turf because the software proposal would give the agency authority over regulation of pharmacy practice, said Catizone, who feels the FDA is serious about the proposal. "That is a function of state boards, not the FDA," he added.

The National Association of Chain Drug Stores voiced its opposition at an FDA workshop held in September, said Roy Bussewitz, managed care/telecommunications v. …

The rest of this article is only available to active members of Questia

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Note: primary sources have slightly different requirements for citation. Please see these guidelines for more information.

Cited article

Software Hardline
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen
Items saved from this article
  • Highlights & Notes
  • Citations
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Search by... Author
    Show... All Results Primary Sources Peer-reviewed

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.