You are hereINTERNET PHARMACY REGULATIONS ON MARKETING DRUGS DIRECTLY TO CUSTOMER

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.

Sl no

Portal address

Location

Deals with pres-cription drugs?

Approved or not?

1

walgreen.com

Walgreen Co.200 Wilmot Road
Deerfield, IL 60015, US

yes

Approved by VIPPS and Legitscript.

2

beardrugs.com

5200 N Croatan Hwy, Suite 10 & 11, Kitty Hawk, US

yes

Approved by Legitscript.

3

stjohn.org

St. John Providence Health Corporate Services Building
28000 Dequindre Warren,  MI 48092,US

yes

Approved by Legitscript.

4

CanadaDrugs.com

24 Terracon Place
Winnipeg, Manitoba, Canada

yes

Approved by  CIPA and  Pharmacychecker

5

bioplusrx.com

376 S Northlake Blvd, Ste 1008
Altamonte Springs, FL 32701

yes

Approved by VIPP

NOW YOU CAN ALSO PUBLISH YOUR ARTICLE ONLINE.

SUBMIT YOUR ARTICLE/PROJECT AT articles@pharmatutor.org

Subscribe to Pharmatutor Alerts by Email

FIND OUT MORE ARTICLES AT OUR DATABASE


FIND MORE ARTICLES

Subscribe to RSS headline updates from:
Powered by FeedBurner