[Federal Register Volume 72, Number 192 (Thursday, October 4, 2007)]
[Notices]
[Pages 56769-56770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19329]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0356]
Behind the Counter Availability of Certain Drugs; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to obtain comments regarding behind-the-counter (BTC)
availability of drugs. Currently, drugs are available as prescription
and non-prescription. Generally, non-prescription products are
available in an ``over-the-counter'' (OTC) manner. The FDA is
interested in obtaining public comment as it explores the public health
benefit of certain drugs being available without a prescription but
only after intervention by a pharmacist. The purpose of the meeting is
to solicit information and views from interested persons on specific
issues associated with BTC availability, including the impact on
patient access to safe and effective drug products.
Dates and Times: The public meeting will be held on November 14,
2007, from 8 a.m. to 5 p.m.
Location: The public meeting will be held at the National
Transportation Safety Board Conference Center, 429 L'Enfant Plaza SW.,
Washington, DC 20594.
ADDRESSES: Submit written registration and written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
registration to http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm.
Submit electronic comments to http://www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm. Transcripts of the meeting will
be available for review at the Division of Dockets Management and on
the Internet at http://www.fda.gov/ohrms/dockets approximately 30 days
after the meeting.
For Registration to Attend and/or Participate in the Meeting:
Seating at the meeting is limited. People interested in attending
should submit written or electronic registration to the Division of
Docket Management (see ADDRESSES) by close of business on November 5,
2007. Registration is free and will be on a first-come, first-serve
basis. Written or electronic comments will be accepted until November
28, 2007.
If you wish to make an oral presentation at the meeting, you must
state your intention on your registration submission (see ADDRESSES).
To speak, submit your name, title, business affiliation, address,
telephone number, fax number, and e-mail address. FDA has included
questions for comment in this notice. You should also identify by
number each question you wish to address in your presentation. FDA will
do its best to accommodate requests to speak. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and to request time for a joint
presentation. FDA will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is
scheduled to begin.
If you need special accommodations due to a disability, please
inform Erik Mettler (see For Information on the Meeting Contact).
For Information on the Meeting Contact: Erik Mettler, Office of
Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, rm.
14-101, Rockville, MD 20857, 301-827-3360, FAX: 301-594-6777, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is committed to ensuring the safety and efficacy of all drug
products it regulates. FDA is exploring the public health benefit of
certain drugs being available BTC that were previously prescription
medications. BTC could be comprised of certain medications available
behind the counter at the pharmacy without a prescription and require
the intervention of a pharmacist before dispensing.
Some groups have asserted that pharmacist interaction with the
consumer could ensure safe and effective use of a drug product that
otherwise might require a prescription. Because pharmacists have the
training and knowledge to provide certain interventions, they may be
able to ensure that patients meet the conditions for use and educate
patients on appropriate use of the drug product. These groups have
suggested, moreover, that the availability of certain drugs BTC could
increase patient access to medications that may be underutilized,
particularly by patients without health insurance because these
medications otherwise would be available only with a prescription.
Variations of a BTC status are already in effect in other
countries, including Australia, Canada, France, New Zealand, United
Kingdom (UK), Denmark, Germany, Italy, Netherlands, Sweden, and
Switzerland. In the UK, there is a ``pharmacist-only'' class of drugs,
while the other countries have more than three classes. In general,
foreign countries have used the following criteria for switching a drug
from prescription to intermediate class: (1) Indications suitable for
self-medication, including self-diagnosis, with the intervention of a
pharmacist and (2) the medicine has a low potential for side effects or
overdose, and intervention by a pharmacist could minimize these risks.
Other considerations include: Abuse potential, patient choice and
accessibility, and public health issues. With the pharmacy-only
classification, typically the pharmacist is required to ensure the
patient meets certain criteria prior to dispensing, as well as to
provide education on proper use and monitoring.
Accordingly, FDA is interested in exploring the public health
implications of BTC dispensing of certain drug products, including
(among other things) the implications for patient access and
utilization, including drug prices, the continued safety and
effectiveness of drugs, and patient compliance with drug therapy.
II. Scope of Meeting
FDA is interested in obtaining public comment on BTC availability
of certain drugs, the appropriate regulatory
[[Page 56770]]
framework for such drugs, and criteria for BTC availability.
Specifically, we are seeking input on the following issues related
to BTC:
General
1. Should there be BTC availability of certain drug products? If so
why? If not why?
2. What might the impact of BTC be on patient access?
3. What might the impact of BTC be on patient compliance with drug
therapy?
4. What should the criteria or standards be for a drug to be
treated as BTC?
5. Please comment on the following criteria for what roles a
pharmacist or other health professional might play, which are included
below for discussion purposes. For example, a pharmacist or other
practitioner licensed by law to dispense prescription drugs prior to
sale might:
(A) Review or conduct an initial screening for clinical laboratory
test results, contraindications, or drug interactions;
(B) Counsel the patient on safe use;
(C) Monitor for continued safe or effective use.
6. Should BTC availability be used as a temporary or transitional
status for drugs that move from prescription status to OTC versus a
permanent status?
7. Should there be criteria or standards for a drug to transition
out of BTC status to OTC status? If so, what should these criteria or
standards be?
8. If safety concerns arise, should there be criteria or standards
for a drug to transition out of BTC status to prescription status? Or
from OTC status to BTC status? If so what should these criteria or
standards be for each scenario?
9. What effect would BTC availability have on patient access to
medications in this category?
10. How could we evaluate whether BTC improves patient access to
medications?
11. Would BTC availability be cost-effective to patients? Please
explain.
12. What effect would BTC availability have on patient safety?
13. What measures would be necessary to ensure patient safety?
14. In general, what are the benefits and costs to the healthcare
system as a whole related to BTC availability?
Logistics
1. Discuss logistical challenges for pharmacy storage and
dispensing of BTC drugs. How might these challenges be addressed?
2. What dispensing procedures should be associated with BTC
medications?
3. What types of records should be kept in association with BTC
dispensing? If such records were to include patient laboratory values,
how would the pharmacist gain access to this information as well as
other information in the patient's medical records?
4. How would patient privacy be protected in a retail pharmacy
setting? Please discuss any privacy concerns that would need to be
addressed.
5. Should reimbursement be available to pharmacists for providing
services associated with BTC dispensing? What type? What type of
billing procedures could be utilized and how would third party
companies facilitate such reimbursements?
6. Who would oversee a BTC program? What impact would it have on
States and what might be the role for the State boards of pharmacy?
7. Would special training be needed for pharmacists to participate
in dispensing BTC medications? If any, what type of training would this
entail?
8. Would special training be needed for other pharmacy staff to aid
in managing the work flow (storage, record keeping, distribution) and
additional BTC responsibilities of the pharmacist(s) and the pharmacy?
If so, what type of training or measures should be put in place?
9. Could qualified healthcare professionals/providers other than
pharmacists be responsible for dispensing of BTC drugs? If so, what
types of healthcare professionals/providers? And in what type of
settings could this situation be accommodated?
10. What impact would BTC availability of drugs have on the
practice of pharmacy?
11. What impact would BTC availability of drugs have on the
practice of medicine?
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic notices of participation and
comments for consideration. To permit time for all interested persons
to submit data, information, or views on this subject, the docket for
the meeting will open 14 days prior to the meeting and remain open for
30 days following the meeting. Persons who wish to provide additional
materials for consideration should file these materials with the
Division of Dockets Management. You should annotate and organize your
comments to identify the specific questions identified by the number
and subject to which they refer in the previous text in this document.
Please identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday. Transcripts of the meeting also will be available for
review at the Division of Dockets Management.
Dated: September 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-19329 Filed 10-3-07; 8:45 am]
BILLING CODE 4160-01-S