Regulating e-pharmacies: Whose job is it anyway?

Sir,

An e-pharmacy is an online pharmacy (OP) or internet pharmacy, which takes orders over the internet and sends the orders to customers through the mail or shipping companies.[1] During the COVID-19 pandemic, there has been a surge in sales of e-pharmacies.[2] There is a potential hazard of use of medications for nonbonafide use, which is more with psychotropics due to their abuse potential. The paucity of stringent laws and laxity in their application increases this risk of unregulated sale and harmful use of medications. In India, “Self-regulation Code of Conduct” for the e-pharmacy sector was released in November 2016 by the Indian Internet Pharmacy Association.[3]

Orizio et al. reported that some e-pharmacies sold drugs without a prescription and that an online questionnaire was a frequent tool to replace prescription.[4] Parikh et al. noted that of the 32 OPs from India at least 20 did not comply with primary regulatory criteria. India was grouped under the list of countries with no local regulatory body.[5]

We had a patient (18-year-old boy) of polysubstance abuse who used marijuana, modafinil, and lomotil along with other psychoactive substances such as alcohol and nicotine. The patient reported using around 8–10 tablets of modafinil (100 mg each) and 50–70 tablets of lomotil a day, which he apparently procured through multiple e-pharmacies. He apparently uploaded the same prescription on different websites/apps and forging prescriptions by editing them online. Diphenoxylate is under Section 1 of List of Narcotic Drugs under International Control.[6] The case was managed by gradual tapering off of medication under supervision. He was followed on weekly basis with urine drug screen and was taken up for motivational enhancement and group therapy. He was not given any physical prescriptions. His parents were encouraged to scan the prescription and generate a jpeg/pdf which was uploaded for placing orders of his medication when in the outpatient department itself.

This case highlights a key problem of online dispensaries. The government has formed a group of ministers to look into the regulation of e-pharmacies.[7] However, concrete measures are being awaited.

The COVID pandemic has resulted in significant increase in online consultations, especially after formalization of telemedicine guidelines by the MCI-Board of Governors. As a result, e-prescriptions and sales of e-pharmacies are bound to increase. This warrants a stringent approach regulating e-pharmacies. Possible suggestions are enumerated as follows:

1. Constitution of a dedicated body to regulate licensing of online dispensaries. Like in US, OPs have to adhere to certain standards to obtain the verified internet pharmacy practice sites seal of the National Association of Boards of Pharmacy[8]

2. The WHO has also recognized this challenge and recommended “e-prescriptions” for prescription-only medications,[9] but this would entail its own technical and public health challenges. A stringent check on prescriptions and a ceiling on the number of drugs dispensed based on the schedule of the drug may be enforced

3. Psychotropics should be governed by specific guidelines as per the Drugs and Cosmetics Act, 1940

4. Restrict online sales or refilling a particular prescription to maximum 2 weeks after the date of prescribing

5. Uploading of prescription by a caregiver and avoiding physical prescriptions are other options to be considered

6. Password locked e-prescriptions can be shared with patient. The password to be given by doctor or their staff only to one e-pharmacy and not to the patient

7. In addition, periodic quality controls and updating of rules in the wake of emerging challenges will be required. IEC activities involving schools, colleges, parents, and media are also recommended.

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Conflicts of interest

There are no conflicts of interest.