Online pharmacy
Online pharmacies, Internet pharmacies, or Mail Order Pharmacies are pharmacies that operate over the Internet and send the orders to customers. Online or internet pharmacies might include:
- Pharmacy benefit manager - A large administrator of corporate prescription drug plans
- Legitimate internet pharmacy in the same country as the person ordering.
- Legitimate internet pharmacy in a different country than the person ordering. This pharmacy usually is licensed by its home country and follows those regulations, not those of the international orders.
- Illegal or unethical internet pharmacy. The web page for an illegal pharmacy may contain lies about its home country, procedures, or certifications. The "pharmacy" may send outdated (expired shelf life ) or counterfeit medications and may not follow normal procedural safeguards.
Home delivery
Conventional stationary pharmacies usually have controlled distribution systems from the manufacturer. Validation (drug manufacture) and Good distribution practices are followed. Home delivery of pharmaceuticals can be a desirable convenience but sometimes there can be problems.
The shipment of drugs through the mail and parcel post is sometimes a concern for temperature-sensitive pharmaceuticals. Uncontrolled shipping conditions can include high and low temperatures outside of the listed storage conditions for a drug. For example, the US FDA found the temperature in a mail box in the sun could reach 136°F (58°C) while the ambient air temperature was 101°F (38°C)[1]
Shipment by express mail and couriers reduces transit time and often involves delivery to the door, rather than a mail box. The use of insulated shipping containers also helps control drug temperatures, reducing risks to drug safety and efficacy.
Risks and concerns
- Sometimes an online pharmacy may not be located in the country that is claimed. For example, one study of drug shipments claiming to be from Canada revealed many actually originated in several different countries and were often bogus medications[5]
- Other concerns include potential lack of confidentiality, improper packaging, inability to check for drug interactions, and several other issues.[6]
Discussion
Legitimate mail-order pharmacies are somewhat similar to community pharmacies; one primary difference is the method by which the medications are requested and received. Some customers consider this to be more convenient than traveling to a community drugstore, in the same way as ordering goods online rather than going to a shop.[7]
While many internet pharmacies sell prescription drugs only with a prescription, some do not require a pre-written prescription. In some countries, this is because prescriptions are not required. Some customers order drugs from such pharmacies to avoid the inconvenience of visiting a doctor or to obtain medications their doctors were unwilling to prescribe. People living in the United States and other countries where prescription medications are very expensive may turn to online pharmacies to save money. Many of the reputable websites employ their own in-house physicians to review the medication request and write a prescription accordingly. Some websites offer medications without a prescription or a doctor review. This practice has been criticized as potentially dangerous, especially by those who feel that only doctors can reliably assess contraindications, risk/benefit ratios, and the suitability of a medication for a specific individual.[8] Pharmacies offering medication without requiring a prescription and doctor review or supervision are sometimes fraudulent and may supply counterfeit—and ineffective and possibly dangerous—medicines.
International consumers
International consumers sometimes purchase drugs online from online pharmacies in their own countries, or those located in other counties. Some of these pharmacies require prescriptions, while others do not. Of those that do not require prescriptions, some ask the customer to fill in a health questionnaire with their order. Many drugs available online are produced by well-known manufacturers such as Pfizer, Wyeth, Roche, and generic drugmakers Cipla and Ranbaxy of India and Teva Pharmaceutical Industries of Israel.
U.S. consumers
An attraction of online pharmacies is drug prices. Shoppers can sometimes obtain 50 to 80 percent or more savings on U.S. prices at foreign pharmacies.[9]
The Washington Post reported that "...millions of Americans have turned to Mexico and other countries in search of bargain drugs...U.S. Customs estimates 10 million U.S. citizens bring in medications at land borders each year. An additional 2 million packages of pharmaceuticals arrive annually by international mail from Thailand, India, South Africa and other points. Still more packages come from online pharmacies in Canada."[10]
Some people in the US, including some legislators, favor accessing foreign-made prescription drugs to lower Americans’ health costs. According to a Wall Street Journal/Harris Online poll in 2006, 80 percent of Americans favor importing drugs from Canada and other countries.[11] President Obama’s budget supports a plan to allow people to buy cheaper drugs from other countries.[12] A report in the journal Clinical Therapeutics found that U.S. consumers face a risk of getting counterfeit drugs because of the rising Internet sales of drugs, projected to reach $75 billion by 2010.[13]
In the United States, there are two verification programs for online pharmacies that are recognized by the National Association of Boards of Pharmacy (NABP). One is the Verified Internet Pharmacy Practice Sites Program (VIPPS), which is operated by the NABP and was created in 1999.[14] The Food and Drug Administration refers Internet users interested in using an online pharmacy to the VIPPS program.[15] The other is LegitScript, which as of September 2010 had approved over 340 Internet pharmacies as legitimate and identified over 47,000 "rogue" Internet pharmacies.[16]
Overseas online pharmacies and U.S. law
Legality and risks of purchasing drugs online depend on the specific kind and amount of drug being purchased.
- It is illegal to purchase controlled substances from an overseas pharmacy. A person purchasing a controlled substance from such a pharmacy may be violating two federal laws that carry stiff penalties. The act of importation of the drug from overseas violates 21 USC, Section 952 (up to 5 years in prison and $250,000 fine for importation of non-narcotic Schedule III, IV, or V drugs; possibly more for narcotics and Schedule I and II drugs). The act of simple possession of a controlled substance without a valid prescription violates 21 USC, Section 844 (up to 1 year in prison and $1,000 fine). FDA does not recognize online prescriptions; for a prescription to be valid there must be a face-to-face relationship between the patient and the health-care professional prescribing the drug. What exactly constitutes a "face-to-face" relationship is considered by many online pharmacies to be a subjective definition that would allow them to operate as an adjunct to the patient's own physician if the patient submits medical records documenting a condition for which the requested medication is deemed appropriate for treatment. Sections 956 and 1301 provide exemptions for travellers who bring small quantities of controlled substances in or out of the country in person, but not by mail.
- Importation of an unapproved prescription drug (not necessarily a controlled substance) violates 21 USC, Section 301(aa), even for personal use.[17] The Food, Drug, and Cosmetic Act does allow for the importation of drug products for unapproved new drugs for which there is no approved American version. However, this allowance does not allow for the importation of foreign-made versions of U.S. approved drugs.
- The law further specifies that enforcement should be focused on cases in which the importation by an individual poses a threat to public health, and discretion should be exercised to permit individuals to make such importations in circumstances in which the prescription drug or device imported does not appear to present an unreasonable risk to the individual.[18]
- It is also illegal to import non-approved drugs (21 USC sections 331(d) and 355(a)); however, FDA policies suggest that, under certain circumstances, patients may be allowed to keep these drugs.[19]
- Individual U.S. states may implement their own laws regulating importation, possession, and trafficking in prescription drugs and/or controlled substances.
- For several years, the states of Nevada, Minnesota, Illinois and Wisconsin have run official state programs to help their residents order lower-cost drugs from abroad to save money.
Enforcement
- Any package containing prescription drugs may be seized by US Customs and Border Protection. The package may be held and eventually returned to the sender if the addressee does not respond and provide proof that they are allowed to receive these drugs (e.g., a valid prescription).[20] In practice, the number of packages containing prescription drugs sent to United States on a daily basis far exceeds CBP's capabilities to inspect them.[21] In the past, packages often passed through customs even if they were not sent from Canada or otherwise didn't meet the requirements of section 804 of 21 USC. Until recently, about 5 percent of prescription drug packages sent from Canada were being seized.[22]
- DEA and FDA[23] generally do not target consumers unless drugs are imported in large quantities (suggesting intent to distribute) or represent a perceived danger to public health (opiates, amphetamines).
- Rarely, drug importation laws are enforced on the local level. For example, in June 2005 in Baton Rouge, Louisiana, a number of customers of online pharmacies were arrested by local law enforcement officers and charged with possession of a controlled substance without prescription.[24]
UK consumers
In the UK more than 2m people buy drugs regularly over the internet from online pharmacies; some are legitimate but others have "dangerous practices" that could endanger children.[25] In 2008, the RPSGB introduced a green cross logo to help identify accredited online pharmacies (from 2010 the internet pharmacy logo scheme is run by the GPhC).[26]
European registered pharmacists have reciprocal agreements allowing them to practice in the UK by simply getting registered with the General Pharmaceutical Council.
The first internet pharmacy in the UK was Pharmacy2U, which started operating in November 1999.[27] The UK is a frontline leader in internet pharmacy since the law change in 2005 that made it legal for pharmacies to sell over the Internet.Drugs supplied in this way tend to be medicines which doctors refuse to prescribe for patients, or would charge a private prescription fee, as all patients treated under the National Health Service pay either a low flat price or nothing for prescribed medicine (except for medicine classed as lifestyle medicine, eg: anti-malarials for travel), and medical equipment.
In the UK, online pharmacies often link up with online clinic doctors. Doctors carry out online consultations and issue prescriptions.[28] The company employing the doctors must be registered with the Care Quality Commission. Online clinics only prescribe a limited number of medicines and do not replace regular doctors working from surgeries. There are various ways the doctors carry out the online consultations; sometimes it is done almost entirely by questionnaire. Customers usually pay one fee which includes the price of the consultation, prescription and the price of the medicine.
Related topics
References
- ^ Black, J. C.; Layoff, T. "Summer of 1995 – Mailbox Temperature Excurions of St Louis". US FDA Division of Drug Analysis. http://www.layloff.net/articles/1995%20Mailbox%20Temp%20in%20STL.pdf. Retrieved 12 July, 2011.
- ^ Counterfeit medical products, WHO; Report by the Secretariat, A61/16, 7 April 2008.
- ^ Mark Davison, "Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs", Wiley, 2011, 426pp
- ^ "FDA Alerts Consumers to Unsafe, Misrepresented Drugs Purchased Over the Internet". US FDA. February 2007. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108846.htm. Retrieved 14 July 2011.
- ^ "FDA Operation Reveals Many Drugs Promoted as "Canadian" Products Really Originate From Other Countries". US FDA. December, 2005. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108534.htm. Retrieved 14 July 2011.
- ^ Griffin, R. M. (October, 2010). "Beyond the Pharmacy, Oneline and mail-order prescription drugs". Web MD. http://www.webmd.com/a-to-z-guides/features/beyond-the-pharmacy-online-and-mail-order-prescription-drugs. Retrieved 14 July 2011.
- ^ Internet pharmacies get go-ahead
- ^ Online pharmacy warning
- ^ With Record Number of Uninsured, Americans Turn to Foreign Pharmacies, Yahoo News, June 11, 2008
- ^ Millions of Americans Look Outside U.S. For Drugs, Washington Post, Oct. 23, 2003
- ^ http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=1092 Harris Interactive, Sept 16 2006
- ^ http://www.reuters.com/article/domesticNews/idUSTRE51P53920090226 Reuters, Obama’s budget supports drug import plana, Feb 26 2009
- ^ Risks in Ordering Drugs by Internet on the Rise Newswise, Retrieved on July 20, 2008.
- ^ http://www.vipps.info
- ^ http://www.fda.gov/drugs/resourcesforyou/ucm080588.htm
- ^ http://www.legitscript.com
- ^ FDA's policy on importation on drugs
- ^ Federal Food, Drug and Cosmetic Act, Chapter VIII — Imports And Exports
- ^ FDA Traveler Alert — Importation of Prescription Medicines/Drugs
- ^ See Regulatory Procedures Manual March 2010 page 9–83 for sample package detention notification letter
- ^ Prescription drugs: Preliminary Observations on Efforts to Enforce the Prohibitions on Personal Importation
- ^ " Seized drugs being released", Los Angeles Times, March 1, 2006
- ^ FDA guidance — Coverage of Personal Importations
- ^ "So is buying prescription drugs online illegal?", WAFB, June 3, 2005
- ^ "eBay medicines 'a risk to child health': Study warns of danger from drugs bought on net" "The Observer", June 21, 2009
- ^ "Internet pharmacy logo"GPhC
- ^ UK's First Online Pharmacy Opens, BBC November 27, 1999
- ^ http://www.washingtontimes.com/news/2010/aug/6/british-patients-click-online-to-see-doctor/
External links