INTERNET PHARMACY REGULATIONS ON MARKETING DRUGS DIRECTLY TO CUSTOMER

About Authors:
Jomy Joy, Dr. Anantha Nagappa
Manipal College of Pharmaceutical Sciences,
Manipal University,
Karnataka, India

ABSTRACT
In the age of information, the applications of business have become not only simple but also of high impact. The impact of internet on society can be felt by popularity of social media like Facebook, twitter, orkut etc. The application of internet to access drugs and diagnostics which begin early in advent of infoage has matured into portals or virtual drugs stores popularly known as internet pharmacy. The advent of internet pharmacy and access of drugs and diagnostics is gaining popularity due to cost effectiveness, high speed delivery to door step of patients. The patient can order medicines from their own home in privacy.

Reference ID: PHARMATUTOR-ART-1211

INTERNET OR ONLINE PHARMACY
Ryan Haight Online Pharmacy Consumer Protection Act of 2008’’ Sec 3; The term ‘online pharmacy’—means a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet.’ “Rogue internet pharmacies continue to pose a serious threat to the health and safety. They provide pharmaceuticals – including powerful narcotics and anti-depressants – to patients without an in-person examination, based solely on an online questionnaire. The longer we wait to take action, the more people will be killed or seriously injured as a result of this unethical behavior.”¹-The seriousness of this issue was encapsulated in a 2005 speech to the 108th Congress given by US Senator Dianne Feinstein.Online pharmacies fall into different categories based on their prescription requirements:Traditional Online Pharmacies; Most legitimate online pharmacies requires one to provide original prescription - the one obtained from an in-person examination with your doctor. Most pharmacies with a traditional prescription requirement carry the full stock of prescription drugs one would find near one’sneighborhood pharmacy. Remote Consultation Online Pharmacies; Some consumers wish to purchase prescription drugs without having to visit their physicians to obtain a prescription. There are online pharmacies, generally known as online consultation pharmacies, remote consulting pharmacies, or prescribing pharmacies, that work with physicians who review a patient’s self-reported medical history and then write a prescription if deemed appropriate. No-Prescription Required Mail-order and Online Pharmacies; some rogue websites will sell prescription medication without requiring any prescription at all, which can be extremely dangerous. Other websites that offer to sell you drugs without a prescription pose as online pharmacies for the purpose of stealing your credit card information.

BENEFITS
The widespread use of the Internet for commercial activities (electronic commerce) has resulted in the global access to drugs and medical services at the click of a button. There are many benefits as well as concerns related to the operation and use of Internet Pharmacies.Easeconvenience & increased choice; Online services allow 24-7 access, and easy comparison of products. This is especially relevant to consumers who live in sparsely populated areas where there are no pharmaceutical services, and for disabled people.Increased consumer information and information exchange; through online searches,consumers can investigate issues such as the effectiveness of different drugs, side/adverse effects of medications, and new/alternative treatments among others.Privacyand anonymity; Consumers buying online can ask questions regarding medicationsand treatments which they may otherwise be embarrassed to ask in a public place.Availability of alternative treatments; the licensing of drugs can a very slow process, but the Internet can facilitate access to effective non-licensed drugs that patients with terminal illness (e.g. Cancer, AIDS) may be willing to use on an experimental basis. This however, may not always be a benefit since there are many fraudulent treatments and drugs available online.

CONCERNS
Online prescriptions without prior physical examination by a doctor; Some Internet pharmacies use online consultations (questionnaires) to issue prescriptions to dispensedrugs. There are many risks associated with this practice such as: the potential for misdiagnosis or drug interaction (among other problems) due to the lack of a physical examinationthe possibility of prescribing medications on false information.Purity and quality of drugs; some online drugs can be either: past their expiry date, counterfeit; sub-potent; or above potency. Further, drugs may be contaminated in storage or during shipping. It is also difficult to ascertain the origin of drugs bought online.Foreign labels and different drug names; A drug may have different names in different countries and different classifications. Countries also have different labeling requirements and dosage instructions. This can lead to market confusion and consumers obtaining wrong drugs.Availability of unapproved or illegal substances & fraudulent products; Many unapprovedsubstances are marketed on Internet. These includes narcotic and psychotropic drugs, also ‘miracle cures’ and fraudulent treatments which can causeharm and can be costly.

Medical and financial privacy concerns; Many Internet Pharmacies do not adhere to their assurances on privacy and confidentiality, and some have no privacy policy. Direct to consumer advertising of prescription drugs; while this practice is illegal in UK it is legal in US. Such advertising may have effect of stimulating the use of prescription drugs.Risks of buying drugs online; the possibility of non-delivery of drugs or confiscation of drugs during shipment.Drug resistance; indiscriminate use of antibiotics can lead to bacteria developing resistance/immunity to such drugs resulting in new and deadlier strains of bacteria.

REGULATORY ENVIRONMENTS
US SCENARIO
•    FDCA,19382; Policing online pharmacies primarily falls on the FDA. Under the Food, Drug, and Cosmetic Act ("FDCA"), the FDA can take action against the importation, sale, or distribution of an adulterated, misbranded, or unapproved drug.Furthermore, the FDA can take action against illegal promotion of a drug, the sale or dispensing of prescription drugs without a valid prescription, and counterfeit drugs. Prescription drugs include any drug that is habit-forming or has a toxicity or method of use that is potentially harmful.All drugs delivered should be FDA approved and every transportation and storage details documented.
•    NABP,19043 ;Founded in 1904, the National Association of Boards of Pharmacy (NABP) is the impartial professional organization that supports the state boards of pharmacy in protecting public health. NABP aims to ensure the public’s health and safety through its pharmacist license transfer and pharmacist competence assessment programs, as well as through its VIPPS, Vet-VIPPS, VAWD and e-Advertiser accreditation program.
•    VIPPS3;The Verified Internet Pharmacy Practice Sites program.Online pharmacy has to pass certain criteria to get the VIPPS sealof approval.Qualifying VIPPS Pharmacy must;
1.    Provide NABP with the information necessary to verify that the VIPPS pharmacy is licensed or registered.
2.    Enforce a comprehensive policy and procedure that documents how the pharmacy's policies and procedures are organized.
3.    Comply with all applicable statutes and regulations governing the practice of pharmacy and comply with the more stringent law or regulation as determined by conflicts of law rules.
4.    Maintain and enforce policies and procedures that assure the integrity, legitimacy, and authenticity of the Prescription Drug Order.
5.    Enforce policies and procedures to assure patient confidentiality and the protection of patient identity and patient-specific information.
6.    Ship controlled substances to patients via a secure means and Assure that medications and devices are maintained within appropriate temperature, light, and humidity standards, as established by the United States Pharmacopeia (USP).
7.    Notify NABP within thirty (30) days of any change of information provided as part of the verification process, including change in pharmacist-in-charge, or involving data displayed on the VIPPS Web site. VIPPS pharmacies shall notify NABP in writing within ten (10) days of ceasing operations.
•    DRUG ENFORCEMENT ADMINISTRATION4; Bureau of Narcotics and Dangerous Drugs (BNDD), the Office of Drug Abuse Law Enforcement (ODALE), merged together to form DEA in 1973.The mission is to enforce the controlled substanceslaws and regulations of the United States under Controlled Substances Act, 1970.
•    FEDERAL TRADE COMMISSION; The Federal Trade Commission (FTC) enforces consumer protection laws that prohibit unfair or deceptive acts in the marketplace. Applying this power to online pharmacies, the FTC can take action if a website operator makes false or misleading claims about the products or services it provides, including medical consultation in connection with prescribing and dispensing a drug.
•    US CUSTOMS AND BORDER PROTECTION.; The Federal Food, Drug, and Cosmetic Act (the Act) prohibits persons from importing into the United States any prescription drug that has not been approved for sale by the United States Food and Drug Administration (FDA), or which is adulterated or misbranded within the meaning of the Act.
•    ACTS;In October 2000, Rep. Tom Bliley introduced the Internet Prescription Drug Consumer Protection Act of 2000. Requiring an online pharmacy to post visibly its street address, authorized state of operation,certain prescriber information and a statement that it will dispense prescription drugs only upon a valid prescription, but it never passed. In July 2001, Sen. Paul Wellstone introduced The Personal Prescription Drug Import Fairness Act.Allowing the importation of prescription drugs by individuals, subject to the use of an Import Form.Coverage of Personal Importations5 allowed imports when; (1) Treatment may not be available domestically.(2) There is no known commercialization or promotion. (3) Doesn’t represent an unreasonable risk. (4) The individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible.Ryan Haight Act, 20086 requires (1) Display on its Internet homepage a statement that it complies with the requirements of this Act.(2) Comply with state laws for the licensure of pharmacies in each state in which it operates or sells controlled substances.(3) Post on its Internet homepage specified information, including the name, address, and telephone number of the pharmacy, the qualifications of its pharmacist-in-charge, and a certification of its registration under this Act.(4) Should prescribe and dispense controlled substance only after one prior in-person examination.(5) Notify the Attorney General and applicable state boards of pharmacy at least 30 days prior to offering to sell, deliver, distribute, or dispense controlled substances over the Internet.
•    INDEPENDENT AGENCIESLegitscript7; LegitScript's Internet pharmacy verification program is the largest in the world. Their program is identified by the National Association of Boards of Pharmacy as the only Internet pharmacy verification service, other than the NABP's own program, that adheres to its standards. These standards are designed to protect patients, and are based on legality, safety and transparency. ClassifiesInternet pharmacies into four categories; (1)Legitimate. (2) Unverified. (3) Unapproved. (4) Rogue.
Table 1. Some approved online pharmacies.

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CANADIAN SCENARIO
Google has agreed to pay a $500 million fine for the way it allowed Canadian pharmacies to use its Adwords system to market pharmaceuticals to American consumers was the news posted on Forbes on8/25/20119
•    NAPRA10NAPRA is the National Association of Pharmacy Regulatory Authorities.  They are a voluntary association of provincial and territorial pharmacy regulatory bodies as well as the Canadian Forces Pharmacy Services.  Their members regulate the practice of pharmacy and operation of pharmacies in their respective jurisdictions in Canada.The National Association of Pharmacy Regulatory Authorities (NAPRA) was founded in February 1995 by 14 pharmacy regulatory bodies.NAPRA is incorporated under the Canada Corporations Act as a voluntary, not-for-profit association.NAPRA approved pharmacies are provided with the VIPPS seal since their collaboration with NABP.
•    Controlled Drugs and Substances Act, 1996.
•    TPDC Therapeutic Products Division of Canada; all drugs sold in Canada has to be approved by this agency.
•    CIPA11Canadian International Pharmacy Association founded in 2002.Each CIPA pharmacy member is licensed and regulated by the government for safety. Each pharmacy that satisfies their criteria gets a CIPA seal. Microsoft and Yahoo! joined Google in recognition of CIPA standards recently. E.g.; canadameds.com

UK SCENARIO
Regulations in UK aredone by following Agencies;
>MHRAThe medicines and health care products regulatory agency was set up in 2003. This government agency is responsible for ensuring that medicines and medical devices work are acceptably safe.
>The Royal Pharmaceutical Societywhich is abody for pharmacists and pharmacies in England, Scotland and Wales also has a regulatory role.
>European Medicines Agency (EMA).The European Medicines agency is a decentralized agency of the European Union, located in London. This agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in European Union.
>General pharmaceutical council (GPhC).This body is responsible for the independent regulation of the pharmacy profession, pharmacy technicians and pharmacy premises within England, Scotland and wales. It provides a green cross with an identification number which is required as a sign of verification.>Care Quality Commission (CQC)is an independent regulator of all health and social services in England. For giving E-prescription, doctor has to be registered in CQC.>Health and Social Care Act 2008 and National Health Service Act 2005are the acts which regulate most health concerns in England.

INDIAN SCENARIO
Presence of many national and multinational pharma companies in India, availability of huge and diverse patient pool and moreover the cost of medicine in the Indian market, should have lured online pharmacies.
Even after the presence of all such required ingredients, online pharmacies are present in small patches in India. In India, access to doctors, specifically general practioners (GP's) is relatively economic and internet is still not the viable option for all. Online pharmacies have not picked up in the Indian market due to many reasons. Low e-tailing penetration, high market penetration of drugstores/ pharmacies, lower cost of drugs in India compared to western countries, branded drug prescription and lack of regulation to govern online pharmacy are some of those.
In India a limited numbers of online pharmacies are operational through different channels. Giving examples, Apollo Pharmacy has installed fax machines in clinics of doctors, from where prescriptions are faxed to Apollo stores, which then deliver the medicines to customers at the desired location. Lifeken (Religare Wellness) has a feature to post the requirement of drugs on the website, based on which medicines are dispensed at the desired location. Typical online pharmacies such as in.keegy.com, realpharma.com, chennaiclassic.com are also functioning.
As far as regulation is concerned,Drugs and Cosmetics Act, 1940 which does not separately recognize online pharmacy as a retail channel and hence no specific provisions to address this channel exists currently.

Table 2.Legislations

•    A global approach is needed for better regulation and can include;
(a)UN led programs (b) develop international agreements. (c) Harmonize national legislations to common policies.(d) Norms on online medical consultations.

•    Recently Pfizer Inc. and the National Association of Boards of Pharmacy (NABP) are planning to launch a new effort to draw attention to the risks associated with counterfeit prescription medicines and help patients learn how to safely buy medicines online. Prescription medicines are among the most counterfeited consumer goods. Worldwide sales of counterfeit medicines were estimated to exceed $75 billion last year 2010- an increase of 90 percent since 2005.
Online Pharmacy Opportunities.An online pharmacy business opportunity is one of the previous fast rising careers.  It is one of the previous profitable ways to make some easy money over internet. However, with the recent scams that are making life hard on the World Wide Web, one need to be careful about not only buying the products and medicines but about setting up the business as well.  To get to start this kind of job, oneneeds to understand first about what it is.  Technically, it is a drugstore that is operated via the Internet and is quite similar to operations to the traditional brick and mortar stores.  Perhaps the most noted difference between the two is the method by which the drugs and medications are delivered to the buyer.  The creations of such online pharmacies are to alleviate the time consuming task of going to the doctor to get a prescription.However, with the rising number of the online pharmacy business opportunity, one needs to be careful about setting it up.New regulations that require prescriptions have been installed in the web market as a sign of properly monitoring the issuance of prescription drugs in some countries.  Another rule of law that one must remember when one set up the business is that you must have an online and on-site pharmacist. If one is a licensed pharmacist or medical professional, then one have a head start when it comes to setting up the online drugstore.  If you are interested in setting up these Internet stores, then it would be wise to consult with a business lawyer. If one is planning to expand the business abroad, it would be wise to check the legality of the trade in those countries

Conclusion
Although many doctors and pharmacies that use the Internet to prescribe and dispense drugs in a safe and legal fashion, others have exploited gaps in the current system to prescribe and dispense potentially dangerous quantities of highly addictive prescription drugs.Even though the Internet continues to bring many benefits to the global community, the widespread availability of drugs and medical services via the Internet has the potential to result in problems of a global nature.

References
1.    Hertfordshire Law Journal; Internet Pharmacies: Global threat requires a global approach to regulation.2008 Oct 27 [cited 2011 Oct 20] Available at; herts.ac.uk/fms/documents/schools/law/HLJ_V4I1_George.pdf
2.     POLICING ONLINE PHARMACIES. 2001 Nov 11 [cited 2011 Oct 19] Available at; law.duke.edu/journals/dltr/articles/2001dltr0041.html
3.    National Association of Board of pharmacy. [cited 2011 Oct 19] Available at; nabp.net
4.    Drug Enforcement Administration. [cited 2011 Oct 19] Available at; searchjustice.usdoj.gov/search?q=online+pharmacy+regulation
5.    Coverage of Personal Importations. [cited 2011 Oct 19] fda.gov/Drugs/ResourcesForYou/Consumers/ucm143561.htm
6.     Ryan Haight Act,2008 2008 Sep 23 [cited 2011 Oct 19] ncpanet.org/pdf/leg/leg_ryanheightsummary.pdf  
7.    Legitscript, [cited 2011 Oct 28] available at legitscript.com
8.    Rouge pharmacies, [cited 2011 Oct 19]  available  at pharmacychecker.com
9.    forbes.com/sites/.../08/.../googles-500-million-pharma-ad-fine [cited 2011 Aug 25]
10.     NAPRA, [cited 2011 Oct 19]. Available at napra.ca/pages/home/default.aspx
11.     CIPA, [cited 2011 Oct 19] available at cipa.com

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