Online Pharmacy

An online pharmacy, Internet pharmacy, or mail-order pharmacy is a pharmacy that operate over the Internet and sends the orders to customers through the mail or shipping companies.

Online 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 The "pharmacy" may send outdated (expired shelf life) or counterfeit medications and may not follow normal procedural safeguards.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 and good distribution practices are followed. Home delivery of pharmaceuticals can be a desirable convenience but sometimes there can be problems with uncontrolled distribution.

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

  • Illegal or unethical pharmacies sometimes send outdated, substituted, or counterfeit medications[2][3][4]
  • 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]
  • Minors or children can order controlled substances without adult supervision.
  • Other concerns include potential lack of confidentiality, improper packaging, inability to check for drug interactions, and several other issues.[6]

Discussion

Canisters containing pharmaceuticals are loaded into an automatic dispensing machine at a mail order pharmacy.

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 cost and 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 countries. 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 at legitimate online pharmacies 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. However, it remains difficult for a patient to ascertain whether an online pharmacy is legitimate. Medicines obtained from rogue online pharmacies come with no guarantees with regard to their identity, history and source. A study in three cities in the Netherlands found that over 60% of the consumed sildenafil was obtained from illegal sources.[9]

U.S. consumers

An attraction of online pharmacies is drug prices.[10] Shoppers can sometimes obtain 50 to 80 percent or more savings on U.S. prices at foreign pharmacies.[] 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."[11] According to a Wall Street Journal/Harris Online poll in 2006, 80 percent of Americans favor importing drugs from Canada and other countries.[12] Factors independently associated with importation by U.S. residents are age greater than 45 years, south or west region of residence, Hispanic ethnicity, college education, poor or near poor poverty status, lack of U.S. citizenship, travel to developing countries, lack of health insurance, high family out-of-pocket medical costs, trouble finding a healthcare provider, fair or poor self-reported health status, filling a prescription on the Internet, and using online chat groups to learn about health.[13] President Obama's budget supports a plan to allow people to buy cheaper drugs from other countries.[14] A 2016 study suggested that providing health insurance coverage may significantly reduce personal prescription drug importation and the subsequent risk of exposure to counterfeit, adulterated, and substandard medications.[10] Further, health insurance coverage is likely to be particularly effective at reducing importation among persons who were Hispanic; born in Latin America, Russia, or Europe; and traveled to developing countries.[10] 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, with worldwide counterfeit drug sales, offline and online, projected to reach $75 billion by 2010.[15]

Independent research published by the National Bureau of Economic Research demonstrates that online pharmacies, U.S. and foreign, verified by certain credentialing entities, sell genuine medication and require a prescription.[16] In that study, all tested prescription drug orders were found to be authentic when ordered from online pharmacies, international and U.S.-only, approved by PharmacyChecker.com, as well as U.S. online pharmacies approved by the National Association of Boards of Pharmacy (NABP) Verified Internet Pharmacy Practice Sites (VIPPS) program or LegitScript, and Canadian-based online pharmacies approved by the Canadian International Pharmacy Association. Nine percent of tested products ordered from non-credentialed online pharmacies were counterfeit.[16]

There are two verification programs for online pharmacies that are recognized by the National Association of Boards of Pharmacy (NABP). One is VIPPS, which is operated by the NABP and was created in 1999.[17] The Food and Drug Administration refers Internet users interested in using an online pharmacy to the VIPPS program.[18] 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.[19] Canadian and all non-U.S. online pharmacies that sell prescription medication to Americans, regardless of credentials, are not eligible for approval in the VIPPS and LegitScript programs.[20]

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.

The FDA believes that many selling illegal pharmaceutical products without prescriptions are controlled by organised criminal networks.[21] In 2014, The U.S. FDA, in partnership with other federal and international agencies and technology companies like Google, took action against websites, some based in India, that were selling drugs to U.S. consumers.[22] Mail Order pharmacies are regulated by the federal laws of the US [23] and hundreds of them operate legally in the US. ICANN and U.S. regulatory authorities are also engaged in hot debate about blocking and seizing of illegal online pharmacies websites that ICANN is not very much interested in doing these days. [24]

Enforcement

It is illegal to purchase controlled substances from an overseas pharmacy. A person purchasing a controlled substance from such a pharmacy may be violating several federal laws that carry stiff penalties.

  • 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).[25] 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.[26] 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 844 of 21 USC. Until recently, about 5 percent of prescription drug packages sent from Canada were being seized.[27]
  • DEA and FDA[28] 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.[29]
  • The act of importation of the controlled substance 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 travelers 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.[28] 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.[30]
  • 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.[31]
  • 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,[32]Minnesota, Illinois and Wisconsin have run official state programs to help their residents order lower-cost drugs from abroad to save money.

Mail fraud

All online pharmacies sell through the internet but must ship the product usually via the mail. The selling of many class (schedule)[33] drugs without a valid prescription (also called Rx-only drugs or legend drugs) is illegal and companies shipping them by mail can be prosecuted for mail fraud (Postal Inspection Service) as well as investigations and Federal charges by the DEA, IRS, Homeland Security, Food and Drug Administration's Office of Criminal Investigations, Department of Justice, INTERPOL,[34] and the U.S. Immigration and Customs Enforcement (ICE),[35] and it is common practice for many agencies to jointly investigate alleged crimes.[36]

Bulgarian consumers

All Bulgarian online pharmacies must be registered with the Bulgarian drug agency (BDA). BDA controls the trade with medicines and makes analysis when doubting the quality and safety of drugs. A special BDA logo and a certificate for registration of pharmacy proves the accreditation and the legitimacy of the store. When clicking on the logo, the consumer will be taken to the official page of the Bulgarian drug agency. The web page must deliver information about the pharmacy's name, address, registration number and its manager.

Canadian online pharmacies selling to United States customers

Buying prescription drugs from even the most well respected internet pharmacies in Canada often results in a prescription filled from drugs sourced not from Canada but rather Caribbean nations or from eastern Europe. The Canadian online pharmacy that sells the drugs offers a Canadian price but buys at a still cheaper rate from third parties overseas. This has led to problems with prescriptions being filled with counterfeit drugs, which sometimes have no activity whatsoever. Some pharmacists have exited this business because of the ethical problems involved, and some less-established Internet sites may be knowingly selling fake drugs. In 2014, the largest online Canada drug retailer was forbidden by Health Canada from selling wholesale drug. Of the three primary entrepreneurs of online Canadian drugs sold to the United States, one is in jail, one exited the industry entirely, and the third is under investigation for criminal wrongdoing.[37][38][39]

Indian consumers

Online pharmacies in India have significantly increased due to growing E-commerce in India and little regulation of the industry.[40]

There is "no regulatory control over drug advertisements on television or the Internet".[40]

Technology can help in meeting the healthcare objective of India.[41][42][43] Indian government is planning to spend Rs 500 crore on computer literacy project for 50 lakh people over a period of 3 years. This would help Indian citizens to access government services in the fields of e-education, e-health and e-governance. [44] Healthcare providers in India are also expected to spend $1.1 billion on IT products and services in 2014. [45]

Legal status in India

There is no specific law to deal with online pharmacies in India but multiple laws govern online pharmacies in an indirect manner. The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have guidelines on the sale of Schedule H and Schedule X drugs. These can be sold only on prescription and there are specific rules, including for labelling and bar coding.[46]

It appears that electronic prescriptions should be valid especially in the light of the Pharmacy Practise Regulations of 2015 declared by Pharmacy Council of India in January 2015. In these regulations, "Prescription" is defined by regulation 2 (j)[3] 'means a written or electronic direction from a Registered Medical Practitioner.......'[47] On basis of existing regulations it appears that a scanned copy of prescription will be perfectly considered as a valid prescription. However, whether such electronic prescriptions can be used to buy medicine from online pharmacies has been questioned.[48]

The Maharashtra Food and Drugs Administration (FDA) raided 27 online pharmacies located in Mumbai, Thane and Pune and seized drugs worth Rs. 2 Crore.[49]

Pakistani consumers

in 2015, the Drug Regulatory Authority of Pakistan Act passed[50] for the registration of homeopathic, herbal, unani, allopathic, and nutraceutical products. This has also implied that only registered retail pharmacies can sell such items, along with OTC and Prescription medication, to the public.[51][52]

The sale of all drugs in Pakistan is subject to the Drugs Act of 1976.[53]

UK consumers

In the UK more than 2 million people buy drugs regularly over the Internet from online pharmacies; some are legitimate but others have "dangerous practices" that could endanger children.[54] 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).[55]

European registered pharmacists have reciprocal agreements allowing them to practice in the UK by getting registered with the General Pharmaceutical Council.

The first internet pharmacy in the UK was Pharmacy2U, which started operating in 1999.[56] The UK is a frontline leader in internet pharmacy since a change to NHS pharmacy regulations in 2005 that made it legal for pharmacies to fill NHS prescriptions over the internet.[57] 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 flat price or nothing for prescribed medicine (except for medicine classed as lifestyle medicine, e.g. anti-malarials for travel), and medical equipment.[] Since July 2015 the Medicines and Products Regulatory Agency (MHRA) has required online sellers of medicines to adopt an EU wide logo and maintain an entry in the MHRA medicines sellers registry.[58]

In the UK, online pharmacies often link up with online clinic doctors. Doctors carry out online consultations and issue prescriptions.[59] 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.

As of April 2016, there are 46 registered online pharmacies in England. In April 2017 the Care Quality Commission suspended the registration of Doctor Matt Ltd - trading as theonlinesurgery.co.uk because of inadequate medical assessment of prescription requests. Six have been warned after inspections.[60]

See also

References

  1. ^ Black, J. C.; Layoff, T. "Summer of 1995 - Mailbox Temperature Excurions of St Louis" (PDF). US FDA Division of Drug Analysis. Retrieved 2011. 
  2. ^ Counterfeit medical products, WHO; Report by the Secretariat, A61/16, 7 April 2008.
  3. ^ Mark Davison, "Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs", Wiley, 2011, 426pp
  4. ^ "FDA Alerts Consumers to Unsafe, Misrepresented Drugs Purchased Over the Internet". US FDA. February 2007. Retrieved 2011. 
  5. ^ "FDA Operation Reveals Many Drugs Promoted as "Canadian" Products Really Originate From Other Countries". US FDA. December 2005. Retrieved 2011. 
  6. ^ Griffin, R. M. (October 2010). "Beyond the Pharmacy, Oneline and mail-order prescription drugs". Web MD. Retrieved 2011. 
  7. ^ "BBC NEWS - Health - Internet pharmacies get go-ahead". bbc.co.uk. Retrieved 2015. 
  8. ^ "BBC News - HEALTH - Online pharmacy warning". bbc.co.uk. Retrieved 2015. 
  9. ^ Venhuis, BJ; de Voogt, P; Emke, E; Causanilles, A; Keizers, PHJ (2014). "Success of rogue online pharmacies: sewage study of sildenafil in the Netherlands". BMJ. 349: g4317. doi:10.1136/bmj.g4317. PMID 24989165. 
  10. ^ a b c Zullo, AR; Howe, CJ; Galárraga, O (2 February 2016). "Estimating the Effect of Health Insurance on Personal Prescription Drug Importation". Medical care research and review : MCRR. doi:10.1177/1077558716629039. PMID 26837427. 
  11. ^ Millions of Americans Look Outside U.S. For Drugs, Washington Post, Oct. 23, 2003
  12. ^ http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=1092 Harris Interactive, Sept 16 2006
  13. ^ Zullo, Andrew R.; Dore, David D.; Galárraga, Omar (2015). "Development and validation of an index to predict personal prescription drug importation by adults in the United States". Journal of Pharmaceutical Health Services Research. doi:10.1111/jphs.12088. 
  14. ^ https://www.reuters.com/article/domesticNews/idUSTRE51P53920090226 Reuters, Obama's budget supports drug import plana, Feb 26 2009
  15. ^ Risks in Ordering Drugs by Internet on the Rise Newswise, Retrieved on July 20, 2008.
  16. ^ a b "In Whom We Trust: The Role of Certification Agencies in Online Drug Markets." Bate, Roger and Ginger Zhe Jin and Amarna Mathur. National Bureau of Economic Research. NBER Working Paper No. 17955. Issued in March 2012.
  17. ^ "redirect VIPPS". vipps.info. Retrieved 2015. 
  18. ^ "Buying Prescription Medicine Online: A Consumer Safety Guide". fda.gov. Retrieved 2015. 
  19. ^ "Online Pharmacy Reviews & Verification - LegitScript". legitscript.com. Retrieved 2015. 
  20. ^ For VIPPS U.S. only standard see [1]. For LegitScript's standards see [2].
  21. ^ "Websites selling illegal drugs are controlled by underworld". India Today. 22 May 2014. Retrieved 2014. 
  22. ^ "FDA targets illegal online pharmacies in globally coordinated action". U.S. Food and Drug Administration. 22 May 2014. Retrieved 2014. 
  23. ^ "NH State Laws/Rules Regarding Non-Resident / Mail-Order / Internet Pharmacies" (PDF). New Hampshire Government Website. 11 February 2009. Retrieved 2014. 
  24. ^ "Icann or I Can't? Internet Agency Clashes with FDA Over Online Sites". The Wall Street Journal. 28 October 2014. Retrieved 2014. 
  25. ^ See Regulatory Procedures Manual March 2010 page 9-83 for sample package detention notification letter
  26. ^ Prescription drugs: Preliminary Observations on Efforts to Enforce the Prohibitions on Personal Importation
  27. ^ " Seized drugs being released", Los Angeles Times, March 1, 2006
  28. ^ a b "Importations of Drugs". fda.gov. Retrieved 2015. 
  29. ^ "So is buying prescription drugs online illegal?", WAFB, June 3, 2005
  30. ^ "Federal Food, Drug, and Cosmetic Act (FD&C Act)". fda.gov. Retrieved 2015. 
  31. ^ "Import Program". fda.gov. Retrieved 2015. 
  32. ^ Nevada online pharmacy approval-Retrieved 2012-12-29
  33. ^ Drug schedules- Retrieved 2012-12-29
  34. ^ NJ.com-Retrieved 2012-12-29
  35. ^ [3]- Retrieved 2012-12-29
  36. ^ [4]- Retrieved 2012-12-29
  37. ^ "Generation Rx: Waking the giants". winnipegfreepress.com. Retrieved 2015. 
  38. ^ "Health Canada suspends Winnipeg-based online pharmacy's licence". winnipegfreepress.com. Retrieved 2015. 
  39. ^ "Bitter Pill: The rise and fall of Manitoba's Internet pharmacy pioneers". winnipegfreepress.com. Retrieved 2015. 
  40. ^ a b "Lax regulation sees India becoming a haven for illegal online pharmacies". Live Mint. 14 September 2008. Retrieved 2014. 
  41. ^ "Healthcare not yet reaching rural India". The Hindu BusinessLine. 14 November 2014. Retrieved 2014. 
  42. ^ "How smart technology can fight disease in India". World Economic Forum Blog. 3 November 2014. Retrieved 2014. 
  43. ^ "Bridging the gap between urban and rural communities". Enterprise Innovation. 14 November 2014. Retrieved 2014. 
  44. ^ "Centre plans Rs 500 crore computer literacy project for 50 lakh people over 3 years". The Economic Times. 13 November 2014. Retrieved 2014. 
  45. ^ "Healthcare Providers To Spend $1.1 Billion On IT In 2014". CRN. 13 November 2014. Retrieved 2014. 
  46. ^ "State to crack down on online pharmacies". The Hindu. 20 June 2013. Retrieved 2014. 
  47. ^ "Pharmacy Practice Regulations, 2015" (PDF). Pharmacy Council of India. Government of India. Retrieved 2015.  |first1= missing |last1= in Authors list (help)
  48. ^ Malvai, Ekalavya. "Legality Of Selling Medicines Online In India". iPleaders Blog. iPleaders. Retrieved 2015. 
  49. ^ "NDTV.com". 
  50. ^ "DRAP Act" (PDF). 
  51. ^ "Joint Meeting of Allopathic, Herbal, Unani, Homeopathic, and Nutraceutical Manufacturing Association against DRAP". 
  52. ^ "DRAP asks alternative medicine dealers to register drugs". 
  53. ^ "Drugs Act 1976 (Pakistan)". 
  54. ^ "eBay medicines 'a risk to child health': Study warns of danger from drugs bought on net", The Observer, June 21, 2009
  55. ^ "Internet pharmacy". pharmacyregulation.org. Retrieved 2015. 
  56. ^ "UK's first online pharmacy opens". BBC. November 27, 1999. Retrieved 2013. 
  57. ^ http://www.psnc.org.uk/pages/internet_pharmacy_faqs.html
  58. ^ "New mandatory logo for selling medicines online". Gov.uk. Retrieved 2015. 
  59. ^ "British patients click online to see doctor". The Washingtion Times. Retrieved 2015. 
  60. ^ "Regulator takes action against four online pharmacies over patient safety fears". Pharmaceutical Journal. 6 April 2017. Retrieved 2017. 

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