The tremendous increase in accessibility to internet in recent years has changed the global scenario of many fields by technological advancements. One of such development in e-pharmacy service is now being replaced the traditional way of prescribing and dispensing of medicines through online ordering and mail delivery via internet on electronic prescription network. In 1997 the WHO called on its member states to tighten controls on the sale of medical products through internet and intact concerned that this may bypass national drug authorities there by liberating medical products onto the market which are unsafe, unapproved, fraudulent or in-effective.
In India, e-pharmacy came under the purview of the drugs and cosmetics act 1940 and the information technology act 2000 doesn’t distinguish between online and offline pharmacies. So specific amendments are required to this act to bring e-pharmacies within the scope of drug and cosmetics act. The current study is to analyse the advantages and drawbacks of E-pharmacy services. The laws governing pharmacies and their regulations and the future perspective of the trend of online pharmacy services in modern India.
The 21st century has witnessed the drastic changes in globalization with continuous process of development with advancements in science and technology. In context of developments in cyber technology, the massive growth rate can be seen in online business and services in the market termed as e-commerce.
e-commerce is a business model where in the goods and services are done through transmission of data and funds from consumer to producer or the service provider over an electronic network through internet. This made easy for the consumers to directly place an order of their choice on website and avail the products on their doorstep from the producers. Globally a modern trend has been raised, termed as e-pharmacy/ online pharmacy which enables the patients to buy the medicines/drugs of his choice online in his fingertips. This trend is similar to the online shopping of other materials such as clothes, grocery and electronics etc. This is mainly because the % of population using internet have been increased dramatically since2010. Reports suggest that recently in India, the reliance jio scheme added more number of smart phone users. This advancements in technology made easy access to the drugs through internet even for a very common man. The popularity of e-pharmacies is because of 24*7 access, transparency, convenience, time saving & money saving and there are few challenging factors like cost, quality, availability, services, legality, low e-tailing penetration & high pharmacies/ drug store penetration etc will decide the success of e-pharmacies.
Types of online pharmacies
The online pharmacies basically can be classified as two:
- Legitimate internet pharmacy; the websites providing high quality pharmacy services after verification of standards.
- Illegitimate internet pharmacy; these are not verified and may not comply with national international professional standards and regulations.
Role of prescription
Online pharmacies will promote drug abuse, misuse, self-medication etc. The self-medication practice is encouraged by the online sale of drugs. It is dangerous and even potentially life-threatening when any medication is taken without medical supervision, certain categories such as Schedule X and Schedule H should be sold only on prescription. So, the prescription plays an important role in purchasing drugs online. The prescription copy should be retained by the licensed pharmacist for 2years after dispensing the drug.
The necessary elements in improving patients care according to early visionaries of EHR (electronic health records) inclusion are note documentation, direct order entry and decision support capability. Computerised physician order entry (COPE) system including electronic-prescribing (e-prescribing) are an integral part of EHR. COPE has the major impact on work-flow of physicians & nurses compared to paper- based methods, the e-prescribing system got high adaptation rates and acceptance due to its positive impact on reduction of medication errors & ADE’s, and thus the e-prescription is being implemented in online pharmacy sector for its ease of use of medications. The approved e-prescription is uploaded online to the supplier who verify and supplies the right medicine to the patient’s door steps. This methodology is now being incorporated at most in e-pharmacy services as a part and made easy for patient, prescriber and supplier too.
LOCAL PHARMACIES VS ONLINE PHARMACIES
The price is a major factor in which the cost of medicines in online pharmacies is less compared to local conventional pharmacies since there is no particular production unit and physical store for medications storage and dispensing and the sites will have a large network of retailers to draw medicines from.
Its more convenient for consumers when the online pharmacies work on basis of submission of prescription in a convenient business hour and dispense medicines to the doorsteps than the local pharmacies where there is a need to rush to pharmacies during working hours.
The online pharmacies are large chains works 24*7, and have an access to wide range of medication supplies where in local pharmacies are small independent business plans which may be restricted in quality of drugs they procure.
The responsibility of pharmacist is to dispense the right medicine and counsel the patient about side effects and dosage. This can be achieved in local pharmacies but not in online pharmacies since there is no possibility of an interaction between patient and pharmacist. The benefits of using online pharmacy over local pharmacy reflects the advantages found in online pharmacy. They include convenience, access to medical information, cost efficacy, wide range of availability, ability to avail medicines in a same day. The disadvantages include lack of physical interaction between pharmacists and patient and medication misuse by patients as well as illegal websites.
- ·Drugs and cosmetics act,1940: As per section 18 (c) of drugs and cosmetics (D&C) act only a licensed retailer is allowed for the sales of drugs on the basis of prescription of a doctor. Section 27 of D&C act has provisions for penalty in the form of imprisonment and monetary fine for manufacture & sale without license. Section 10 prohibits import of drug that is substandard, misbranded, adulterated or spurious requires a license for import. D&C act,1940 and D&C rules,1945, recommends specific guidelines for the sale of schedule H and schedule X can be sold only on prescription by registered medical practitioner (RMP). The prescription should be a duplicate copy which is to be retained by pharmacist for 2years.
- The pharmacy act,1948: Section 42 and Sub-section 1 of Indian pharmacy act,1948, quotes “no person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of RMP” and who ever contravenes the provisions shall be punishable. Drugs and magic remedies act,1954: This act mentions a list of ailments for which no advertising is permitted. The act prohibits false and misleading advertisements that may end up making wrong claims. In India it is been increasingly exposed to advertise for prescription drugs despite legal prohibitions.
- Indian medical council act,1956: Regulation 5.3 of medical council of India (MCI) stipulates that both pharmacists and doctors should work together. But, because of e-pharmacies this relationship is lost. Regulation 7.14 of MCI, does not allow RMP to disclose the patient information in the exercise of his/her profession. According to regulation 6.4 of MCI, giving or receiving rebates or commissions are prohibited. But, e-pharmacies may provide rebates and commissions to doctors to provide prescriptions on basis of online information filled by patient.
- Narcotic drugs and psychotropic substances act,1985: This act provides a strict guideline for un-monitored and un-controlled sale of narcotic drugs listed under the act. This is enforced with due regard of minimising the misuse of habit forming drugs.
- Information technology act,2000: This act governs few legal issues pertaining to online dealings but it is silent on the aspect of e-pharmacy. This act deals with data protection or privacy in India under Section 43A of IT act, 2000 and IT rules,2011. In 2013 the privacy bill is proposed which focuses on protection of sensitive personal data of persons. There is an ambiguity in Indian law whether a pharmacy is allowed to take money prior to delivery of medicines but, medicines certain provisions mandate the money to b collected only after physical handover to the customer.
- Pharmacy practice regulations,2015: The regulation declared by pharmacy council of India in January 2015, states that electronic prescription must be valid for dispensing medicines. This also defines the prescription as a written or electronic direction from a registered medical practitioner or other licensed dentist, veterinarian, etc. to a pharmacist to compound and dispense a specific type of drug to a patient. Based on the regulations the scanned copy of prescription can be considered as valid prescription, but for the purchase of medicines from e-pharmacies has still been questioned.
BENEFITS OF e-PHARMACIES
- Privacy/Anonymity: it is convenient to order medicines from online drug stores privately as well as to get free delivery. Consumer feels comfortable purchasing online or over the phone rather than in person. In order to prevent the use of consumer’s personal information for any unauthorised purposes, make sure the pharmacy has appropriate privacy policies.
- Convenience: the online pharmacies provides greater convenience as they are one stop shops for ample of products. The access to product information at these sites is way easier than conventional walk-in pharmacies. They provide the convenient service and supply to the consumer when he/ she find it physically difficult to make it to the pharmacy, have a busy schedule live in remote rural area etc. Hence, it is easy to submit prescription and avail the medicines at their convenient time schedule.
- Medical information: few online pharmacies provide the essential information regarding medications and diseases as well as links to medical resources.
- Lower cost: several studies conducted by research institutes have shown that shopping drugs online helps consumer to save as much as one-third cost.
- Avails greater cost: the online stores provides the drugs ample enough to cater to the consumers living far from the pharmacy and this provides an option to compare the prices before placing an order.
- Drug approval: most of the legal online pharmacies have the process of drug approval. They require a prescription to supply medications. They offer a drug only after filling up a questionnaire and this questionnaire is reviewed by a doctor before dispatching.
- Patient safety: an estimated 1.5million ADE’s occur annually in US. The avoidable errors such as selection of incorrect or unavailable drug, dosage form / dose; duplication of therapy, omission of information and misinterpretation of the order due to illegible handwriting. These all problems can be overcome by e-prescribing pattern which is equipped with point of care decision support that notifies provider of potential prescription errors.
DRAWBACKS OF e-PHARMACIES
- Unauthorised or un-licensed pharmacies: purchasing drugs from these drug stores can increase chances of buying counterfeit, substandard or adulterated products. Few international pharmacies are licensed particularly to import and export medications in a free trade zone area but may not be within the domestic jurisdiction. They require proper inspection over safe dispensing practices and the licensed pharmacists.
- Lack of physical evaluation: the meaningful interaction with physician, pharmacist and the patient is minimised because of online pharmacies not having any processes of medical supervision or physical evaluation. The lack of licensed health professional may lead to unauthorised decision-making process.
- Inadequate safeguard of health: online pharmacies fails to require a prescription and you could take the medication inappropriate for you. This can disturb your health conditions. Some illegal online stores deal in counterfeit, substandard or contaminated drugs that can lead to dangerous drug interactions.
- Illegal websites: it is important for any pharmacy website to publish their contact information to enquire about the medication information or other issues. It is important to have proper contact details and helps consumers to raise the question, complaint or the concern about drugs and their cost.
- Selling of potent drugs: a very few sites have the pattern of obtaining an order by an online questionnaire to those medications which should be dispensed under prescription. Some times other restricted drugs such as Accutane, Thalomidare which are not controlled substances but dangerous if taken without medical supervision.
- Sudden change in price: few sites post low-ball prices to attract the customers and raise them more abruptly. This may confuse the consumer and it is necessary to make sure the prices listed in sites are up to date and accurate.
MEASURES TO OVERCOME PROBLEMS
The responsibility of governing bodies across the country is to improve the safer use of online pharmacy websites to achieve proper usage, few of the key factors should be considered:
- Designing a website or a body to check the legality of e-pharmacy
- Make specific guidelines for both consumers and sellers for safer use of sites.
- Bring some essential policies for legal operation of e-pharmacies and blacklist the illegal sites providing services.
- The role of central and state government should be well defined for the drug regulation.
- All the sites selling medications online, should be licensed and registered from a regulating body.
- Watch should be kept on dispensing of potent, banned drugs which don’t come under specific categories under jurisdiction.
- A strict adherence to laws is required to ensure efficient and smooth running of e-pharmacies with greater compliance.
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