News
Drugs and docs at a touch of your phone, e-consultations on the way
The introduction of e-consultation in Sri Lanka, a popular method enabling patients to access general practitioners (GPs) through their mobile phones is being studied by the National Medicinal Regulatory Authority (NMRA) to ensure the system is not hijacked by quacks.
The NMRA Chief Executive Officer Dr. Kamal Jayasinghe said that proper regulations need to be introduced soon to monitor the system and legitimise e-prescription and home-dispensing of medicinal drugs.
The Sunday Times learns that e-consultation is fast becoming popular among patients who find it easier to consult the GP over the mobile phone. This is a new concept where patients could consult a GP of their choice registered with a service providing company. An application is used on mobile phones and on a touch of the screen a GP can be accessed and consulted. There is no travelling, no waiting outside crowded corridors in hospitals and most importantly even at late nights and wee hours of the morning a doctor could be contacted in an emergency.
At the end of the consultation, within minutes an e-prescription will be sent to the patient through the mobile phone. In home dispensing, the medicinal drug is delivered to the door step. It can be from your nearest pharmacy, from Colombo if you are living in rural interiors or even from overseas via internet orders.
While welcoming the innovative technology, pharmacists and doctors alike said that the system needed to be regulated. Sri Lanka Medical Association (SLMA) President Dr. Ruvaiz Haniffa said the SLMA was not against new developments but insisted that the system needed to be monitored by an independent regulatory body. “We need to develop guidelines aimed at a fool proof method so that the patients confidentiality is protected,” he said. “Innovation is good but eventually the patient should benefit. There should be a fair playing field from the patients’ perspective,” he said.
Dr. Haniffa said the system should be fool proof enough to ward off quacks. “There are only around 25,000 qualified doctors registered with the SLMC but it is believed more than 40,000 quacks operate in the country and there is a possibility that these people can enter the system,” he said.
Chinta Abeywardena, the former president of the Pharmaceutical Society of Sri Lanka, said the NMRA Act was silent on e-prescription. Pointing out that dispensing medication without a proper prescription was illegal, she emphasised on the need to have guidelines to regulate the system.
A Wellawatte pharmacist said every month about five to ten people would walk in with phone prescriptions. He said he knew this was not correct, but he would still dispense the drugs to maintain his business. ‘In Wellawatte there are about 40 pharmacies. If we don’t sell the drugs, others will . We have invested millions of rupees into the business and therefore cannot afford to lose business,” he said.
He also said that maintaining records of medicinal drugs dispensed was necessary for the renewal of licences. “We are required to enter the patients’ age, sicknesses, addresses, the names of doctors and drugs in a record throughout the year,” he said.
Manjula Jayawardena, treasurer of the All Island Pharmacy Owners Association which has more than 3,000 members said that its members had no complaints on the issue. He said he saw no issue in dispensing the drugs as long as the e-prescription carried the doctor’s details – name, registration number and signature.
However, he did not rule out the possibility of the system being doctored by unscrupulous persons to suit their needs. ‘There is no way to identify whether the prescription had been tampered with,” he said.
Dr. Janaka Wickramasinghe, co-founder of ODoc Pvt Ltd., the pioneer company in launching the e-consultation for general practitioners, insisted that under the NMRA Act the electronic signature is valid. He said he saw no reason for pharmacists to complain about e-prescription when they had no qualms about dispensing medication without prescription.
‘The e-prescriptions are endorsed by SLMC registered doctors who are on our list. We cannot understand why the pharmacies cannot dispense the drugs,” he asked. Explaining what a prescription is, Dr. Janaka Wickramasinghe said it a document authorizing in writing to a Pharmacist from a person authorized by law to prescribe medicines or medical devices to dispense a specified medicine or medical device for use by a designated individual or for animal use;
Also under Section 52 of the Regulations of the Cosmetics, Devices and Drugs Act,persons authorised by law to prescribe medicines include “registered medical practitioners”. All SLMC registered doctors are “registered medical practitioners”. As to the legality of prescriptions, section4 of the Electronic Transactions Act says any instrument required by law to be “in writing” shall be deemed to satisfy that requirement if it is in the form of an electronic document.
Under section 3 of the same Act, by law, no electronic document be denied legal recognition, effect, validity or enforceability on the ground of it being in an electronic form.
Dr. Wickramasinghe said that all prescriptions issued on the oDoc Video Consultation Platform, are issued by SLMC registered doctors through a secure account unique to each doctor. These prescriptions clearly identify the doctor issuing the prescription, carrying the name, SLMC registration number, seal and signature of that doctor. The name of the patient is also clearly identified as the person who is to receive these medicines together with the patient’s gender and age. This prescription also carries in type written form, the specific medicines prescribed to the patient. Hence, he said the electronic form of the signature of a doctor on prescriptions issued on the oDoc Video Consultation Platform fulfils all requirements and should be recognised as a legal document under Section 7 of the Electronic Transactions Act, as amended by Act No. 25 of 2017
NMRA CEO Dr. Jayasinghe said that when the NMRA Act was drafted the e-consultation concept was not in operation. ‘This is a new concept and we need to add this to the Act under the pharmacy regulations,” he said.
The Sunday Times learns that the NMRA’s pharmacy regulation committee is drafting regulations. “We are discussing e- prescription and home dispensing of pharmaceutical drugs and how it could be regulated to protect the patient from any harm,” he said.
In terms of the present law, a prescription for medicinal drugs is an order by a registered qualified doctor for the dispensing of a medicinal product and should be dispensed by a professional — a pharmacist — who is legally authorised to dispense. The order, he said must be in writing in a legally prescribed format and signed by the doctor.
Dr. Jayasinghe said that under the Act the pharmacist has to literally come in contact with the prescription . However, in the e-prescription and home dispensing methods this does not happen. Either the prescription is read out over the phone or taken down by the delivery taker. “It is important that the pharmacists personally read the prescription and hand out the drugs to the patient or their proxy.”
Also certain drugs are required to be transported under optimum environmental conditions. In home dispensing this can be compromised, the NMRA CEO said.