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VIPPSCM Accreditation ProgramProgram Update and Frequently Asked
Questions

VIPPS
VIPPS

VIPPS Program Update
2009
Ryan Haight Online Pharmacy Consumer Protection Act of 2008

VIPPS Application, Requirements – Updates:
Pharmacies submitting new applications for accreditation after
 April 15, 2009, must provide proof that the business holds a
 modified Drug Enforcement Administration (DEA) registration
 authorizing it to dispense controlled substances by means of the
 Internet. Flexibility will be granted if there are delays in DEA
 processes that prevent pharmacies from complying with registration
 modification requirements.

At time of annual compliance review, each accredited pharmacy must
 provide proof that it has notified DEA and applicable state boards
 of pharmacy that the business operates as an existing online
 pharmacy dispensing controlled substances by way of the Internet.
The VIPPS Policies & Procedures (P&P) Guidance Worksheet includes
a checklist of the documentation needed when applying to and
continuing VIPPS accreditation, and represents a self-appraisal
tool to gauge readiness for accreditation.

As noted in the P&P Guidance Worksheet, policies and procedures
 will be re-evaluated against the checklist to ensure all
 accredited entities are in full compliance with VIPPS Criteria.
Proof of compliance:

1. Policies and procedures (P&Ps):
After April 15, 2009, applicant pharmacies must submit to
 NABP acceptable policies and procedures that demonstrate:

Processes that prohibit the delivery, distribution, or
 dispensing of controlled substances over the Internet
 without a valid prescription issued for a legitimate
 purpose by a practitioner who has conducted at least one
 in-person medical evaluation of the patient within the
 last 24 months
Suitable P&Ps will comply with current prescription
verification standards as identified in the program’s
interpretive guide, plus processes for verifying the
patient has received the in-person medical evaluation as
required by the Act. Although not all inclusive,
components of the P&P should address pharmacy staff
contacting the prescriber on all new controlled substance
prescription orders, signs of suspicious identity when
calling a physician’s office, and how staff verifies the
identity of a person setting up the account.

Processes for providing monthly reports to DEA of the
quantity of each controlled substance dispensed, unless
the total number of prescriptions involved is less than
100, or the total dosage units are less than 5,000 during
the month. For purposes of this section, and contingent on
DEA issuing clarifying information, only controlled
substances prescriptions will be considered when
determining the total number for reporting purposes.
Accredited pharmacies will receive the P&P Guidance
 Worksheet at time of annual compliance review and be
 expected to meet these standards at time of three-year
 reaccreditation.

2. Operational compliance:
In addition to demonstrating compliance with P&P standards as
 stated above, an on-site survey will verify operational
 compliance

At the initial survey of applicant pharmacies; or
At the three-year cycle during the reaccreditation survey of
 accredited pharmacies.

Methamphetamine Production Prevention Act of 2008
Frequently Asked Questions

1. What is the VIPPS Program?
The Verified Internet Pharmacy Practice Sites (VIPPS) program and its
accompanying VIPPS seal of approval identifies to the public those
online pharmacy practice sites that are appropriately licensed, are
legitimately operating via the Internet, and that have successfully
completed a rigorous criteria review and inspection.
2. How does NABP verify the sites?
Internet-based pharmacy practice sites wishing to become VIPPS
accredited submit a detailed application to NABP, which includes the
pharmacy’s policies and procedures addressing the VIPPS criteria.
Licensure information is verified with applicable state boards of
pharmacy. The VIPPS team reviews the application, policies, and
applicant’s Web site, and performs an on-site inspection of the
pharmacy’s facilities. Once the policies and procedures as well as the
operations of the pharmacy appear to meet the intent of the VIPPS
criteria, permission to display the VIPPS Seal is granted and the
verified information about the pharmacy is posted on the VIPPS Web
site. Clicking on the VIPPS Seal links the user to the VIPPS Web site
that then verifies that the Seal is indeed posted on a
VIPPS-accredited site. If so, the user is then shown pharmacy-specific
information, including licensure information.

3. Does NABP regulate online pharmacies?
NABP does not regulate online pharmacies. Regulation of pharmacy
practice, whether online or not, is primarily the jurisdiction of the
state boards of pharmacy with some federal oversight. The VIPPS
program is a voluntary accreditation program for which Internet
pharmacy practice sites may apply. The value of the program to the
patient and the Internet pharmacy is that it provides members of the
public with a means to assure themselves that the Internet pharmacy
they choose is a bona fide, fully licensed facility exercising
competent Internet/interstate pharmacy practices.
4. When was the VIPPS program developed?
In 1999, NABP became aware of the need for this program when consumers
contacted several state pharmacy boards to complain about illegal
Internet prescribing and dispensing sites posing as legitimate
pharmacies. The Association developed the VIPPS program in response to
public and regulatory agency concerns regarding safety of Internet
pharmacy practices in order to provide a means for the public to
distinguish between legitimate and illegitimate online pharmacy
practice sites.

5. Isn’t the number of Internet sites far too large to monitor and
control?
No. NABP and the regulatory framework of state boards of pharmacy,
federal agencies, and the medical community have been working together
for several years now to achieve this goal.
Online Pharmacy Questions

6. How many online pharmacies are out there?
It is difficult, if not impossible, to answer this question
accurately, but it is probably fewer than you would think.
Illegitimate pharmacies (usually those that offer online prescribing)
open and close on a daily basis. One company posing as a legitimate
pharmacy may have many URLs or Web addresses, creating the impression
that there is a greater number of Internet pharmacies than actually
exists. In addition, pharmacies may only register with select search
engines. If these search engines are not utilized when performing a
search then all pharmacies may not be counted.
7. How many prescribing sites are out there?
The number of prescribing sites, using patient questionnaires and
fee-based cyberspace consultations, as well as sites that sell
prescription medications and controlled substances without requiring a
“consult,” is difficult to estimate. NABP research indicates, however,
that 96% of the over 5,000 Internet drug outlets NABP has assessed
appear to be out of compliance with pharmacy laws and practice
standards..

8. What’s wrong with using a prescribing site to get Viagra® and
Xenical®?
I don’t have to see a doctor and can obtain the medicine with
increased privacy and confidentiality; and it’s cheaper.
First, Food and Drug Administration (FDA) restricts the distribution
of certain drugs to a prescription-only basis because in certain
medical situations they can be dangerous if not taken with ongoing
medical consultation. Most regulatory authorities and professional
organizations regard online prescribing to be unprofessional, and in
some states it is illegal, unless it is done pursuant to a valid,
ongoing patient-prescriber relationship that has included an in-person
physical examination. Completing only an online questionnaire does not
establish a valid patient-prescriber relationship. Moreover, without a
physical examination you could receive inappropriate medication and
worsen an underlying, undiagnosed, serious medical condition.
As for increased privacy and confidentiality, evidence appears to
indicate that illegitimate prescribing sites frequently sell their
customer lists to other illegitimate online pharmacy operators and
owners of Internet scam and pornography sites. By buying drugs from an
illegitimate site you may be designating yourself as someone who is a
good target for rip-off schemes.

Frequently, deceived consumers notify us of non-receipt of medications
they ordered, and/or credit card charges that illegitimately operating
pharmacies refuse to remove. Many also complain that they are unable
to contact the pharmacies: phone lines are disconnected or no one
answers.
9. Can I get really cheap prices from pharmacies outside the US?
First, FDA generally prohibits the importation of foreign-made
versions of prescription medications that are commercially available
in the US. The safety and efficacy of these medications cannot be
guaranteed. Many countries’ drug research and control programs are not
as safety oriented as those in the US. Though some of the drugs
advertised by foreign sites may be manufactured by the same name brand
international drug manufacturer as you are used to, they usually are
not manufactured in FDA inspected facilities that have met FDA
standards. Further, sometimes the medications have been subjected to
storage conditions that compromised their potency or safety.

10. Can I get cheap prices from legitimate online pharmacies?
Yes, and more. One of the great benefits to shopping online to fill
your prescriptions is the ease with which you can comparison shop.
Many pharmacies offer price comparisons between their charge and that
of other legitimate pharmacies. This is one way to stretch your health
care dollar. Many online pharmacies accept prescription benefit
insurance coverage as well. In addition, legitimate online pharmacies
often offer valuable health care information in a searchable format.
VIPPS-accredited pharmacies are required to offer their customers free
phone consultation with a pharmacist, and many offer free
ask-a-pharmacist e-mail service as well.
11. What are the main advantages of ordering medications online?
Convenience is a major advantage that online pharmacies provide over
some of their pharmacy competitors. Consumers’ ability to order and
receive medications without leaving their home is a tremendous
time-saver. Often, drug information and price information may be
accessed via the pharmacy’s Web site, or this information may be
requested via e-mail so the consumer does not have to wait on the
phone for an answer or travel to the pharmacy to ask for this
information in person.

In addition, online pharmacies may provide more privacy than
traditional brick-and-mortar pharmacies. Consumers who are too
embarrassed to purchase certain medications or health care products
from the local pharmacy may find greater anonymity by ordering these
products from an e-pharmacy where staff may not be able to put a “face
to a name.”
Laws/Regulations

12. Who regulates online pharmacies?
The state boards of pharmacy have primary responsibility for
regulation of online pharmacies. Regulatory authority is mainly
exercised by the state board of pharmacy of the state in which the
pharmacy is physically located. In addition, most states protect their
citizens by licensing “out-of-state pharmacies” that ship medications
to patients in their jurisdictions. The same regulations that apply to
traditional brick-and-mortar and mail-order pharmacies typically apply
to online pharmacies. Federal agencies, such as FDA and Drug
Enforcement Administration (DEA), are also partners with the state
boards of pharmacy in this regulatory process. FDA, however, mainly
regulates foreign-based sites and practitioners.
13. How do I set-up an online pharmacy?
When pharmacists are thinking about setting up an online pharmacy, we
encourage them to do their homework and work in conjunction with the
state boards of pharmacy. The VIPPS criteria may serve as a solid
guideline when an organization plans to expand into
interstate/Internet pharmacy practice and seeks to address issues of
quality, verifiable relationships, regulatory compliance, and good
pharmacy practices.

14. How does NABP work with government agencies that regulate online
pharmacies?
NABP has strong working relationships with the state boards of
pharmacy and the federal agencies. Inspector training programs and the
VIPPS “Report a Suspicious Site” programs are examples of ways in
which NABP helps regulatory agencies monitor and investigate
illegitimate pharmacy Web sites.
15. How are international online sites regulated?
As mentioned earlier, online sites located outside the United States
pose the greatest challenges for state and federal regulators.
Cooperation with other nations and their regulatory agencies has been
and continues to be the key to regulating online international
pharmacy sites. NABP is working with a number of international
regulatory agencies to establish VIPPS programs for their online
pharmacies.

16. What organization can I contact regarding regulations and online
pharmacies?
Your first contact should be the local state board of pharmacy. You
may also subscribe to NABPLAW®, the NABP state pharmacy law and rules
database, which allows users to research subjects one state at a time
or across all 50 states. For more information e-mail NABP at
custserv@nabp.net.
17. What if I believe an online pharmacy has dispensed the wrong
medication or labeled the medication incorrectly?
Please report these incidents to your local state board of pharmacy as
well as the board of pharmacy in the state where the pharmacy is
located. You should also contact the pharmacy that mistakenly
dispensed the medication. VIPPS pharmacies are required to document,
track, and analyze these types of incidents to determine what went
wrong and to prevent recurrences.

18. What are the signs of a suspiciously operating pharmacy?
First, e-pharmacies are suspect if they dispense prescription
medications without requiring the consumer to mail in a prescription,
and if they dispense prescription medications and do not contact the
patient’s prescriber to obtain a valid verbal prescription. Further,
online pharmacies are suspect if they dispense prescription
medications solely based upon the consumer completing an online
questionnaire without the consumer having a pre-existing relationship
with a prescriber and the benefit of an in-person physical
examination. State boards of pharmacy, boards of medicine, FDA, as
well as the AMA, condemn this practice and consider it to be
unprofessional.
Second, online pharmacies should have a toll-free phone number as well
as a street address posted on their site. If the pharmacy merely has
an e-mail feature, so that the sole means of communication between the
consumer and the pharmacy is via e-mail, this is a suspect site.

Third, legitimate sites allow consumers to contact pharmacists if they
have questions about their medications. If a site does not advertise
the availability of pharmacists for medication consultation, it should
be avoided.
Many suspiciously operating e-pharmacies have limited numbers of
medications that they sell, particularly “lifestyle” medications that
treat such conditions and diseases as impotence, obesity, herpes,
pain, and acne. Although pharmacies may not sell every medication
available in the US, those online pharmacies solely selling lifestyle
medications may not be operating legitimately.

19. What if I believe that an online pharmacy may be operating
suspiciously?
Please report suspiciously operating pharmacies to NABP by using the “Report-a-Site”
feature in the VIPPS section of our Web site. You may do so
anonymously. We also encourage you to report such sites to your local
state board of pharmacy, especially if you or a loved one has been
harmed. NABP forwards information regarding suspiciously operating
sites to the most appropriate regulatory authorities.
20. What organization covers the security of patient information for
online pharmacies?
Security, confidentiality, and privacy are among the chief concerns of
patients and health care professionals regarding online pharmacy
services. State and federal laws such as the Health Insurance
Portability and Accountability Act (HIPAA) protect patient
identifiable information. VIPPS and other voluntary certification
programs require participating organizations to adhere to and post
their privacy policies. In addition, NABP has published guidelines
regarding the confidentiality of patient health care information,
which can be found in Appendix E of the Model State Pharmacy Act and
Model Rules of the National Association of Boards of Pharmacy. The
Model Act is available as free download on the NABP Web site.

Prescriptions/Prescribers
21. Can a prescription be faxed to the online pharmacy, or does the
pharmacy need the original prescription? Does the online pharmacy
verify the prescription with the prescriber?
Generally state laws require faxed prescriptions to be received
directly from the prescriber (not the patient) to be valid. Online
sites that do not protect the integrity of the original prescription,
or that do not verify the authenticity of suspect prescriptions may be
in violation of the law. In addition, VIPPS-accredited pharmacies must
have policies and procedures in place that address these issues.
Before you entrust your health to anyone online, look for the VIPPS
Seal, and click to verify.

Disclaimer
Program Updates & FAQ

Application
Buying Medicine Online

Search for a Pharmacy
List of VIPPS Pharmacies

Criteria
Definitions

Report a Site
Accreditation Process

Instructions
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E-mail VIPPS Staff
Information Kit

 
National Association of Boards of Pharmacy®
1600 Feehanville Drive • Mount Prospect, IL 60056 Tel: 847/391-4406
Fax: 847/391-4502
Carmen A. Catizone, MS, RPh, DPh, Executive Director/Secretary

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This web page was last updated 04/03/2010 19:01:48
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