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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 pharmacys 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 applicants Web site, and performs an on-site inspection of the pharmacys 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. Isnt 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. Whats wrong with using a prescribing site to get Viagra® and Xenical®? I dont have to see a doctor and can obtain the medicine with increased privacy and confidentiality; and its 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 pharmacys 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 patients 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
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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 Top of Page
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your munchies where my whomThe information appearing on this Web site is intended to provide information about the activities, programs, and services of the National Association of Boards of Pharmacy. This information is advisory only and the visitor to this Web site assumes sole responsibility for any decisions made based upon its content. NABP disclaims all warranties regarding such information, whether expressed or implied, including, but not limited to, any warranty as to the quality, accuracy, or suitability of this information for any particular purpose. This web page was last updated 04/03/2010 19:01:48
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