Emerging Needs for Regulations for online Pharmacies, pharmaceutical sales and virtual Clinics

Changes in technology inevitably bring about changes in the legal rules governing technology. The explosion of e-commerce in the last several years has caused many to question whether the virtual realm ought to be more specifically regulated. Health care providers and consumers are among those contributing to the growth of e-commerce. Increasingly, consumers have been using the Internet to obtain medical information to complement their visits to clinical providers. Unfortunately, there has been a consistent rise of illegitimate online pharmacies, pharmaceutical sale, whose emergence and regulation are inadequately handled by the current patchwork of provincial and federal legislation Providers are responding to consumer demand for availability of products and services on the Internet, and consumers are responding to their increased online options by obtaining medical products and services online.

The ability of consumers to obtain prescription medications via the Internet has grown exponentially over the past decade, there are more than 180,000 “portal” Web sites that allow individuals to place medication orders through illegal pharmacies.

Online pharmacies and virtual clinics are continue to grow in number, and many sites operate illegally or inappropriately through distributing counterfeit or substandard medications, dispensing medications without a valid prescription, or filling prescriptions from “cyber doctors” who do not have a legitimate relationship with the patient. Although several laws exist to regulate online pharmacies, oversight and enforcement are poor.

The regulatory challenges and responses arising from online pharmacies. Consumers choose to utilize online pharmacies over traditional medical stores for a variety of reasons, including accessibility, time constraints, and potential cost savings.

Benefits of Online Pharmacies

• Online pharmacies offer elderly and disabled persons, as well as persons living in remote areas, an increased ability to access pharmaceutical services. Physicians and patients both may enjoy the efficiencies created by online pharmacies. Online pharmacies increase consumers’ ability to comparison shop for drug price and availability.
• The foremost advantage that online pharmacies provide is lower prices. The lower prices are facilitated through the absence of many operating costs associated with traditional medical stores. Online pharmacies also provide consumers the ability to comparison shop for drug price and availability.
• Online pharmacies are extremely convenient. Ordering on the web is also time-efficient in that consumers can save their medical and pharmacological profiles online.
• Lastly, using online pharmacies Buy growth hormone online in the online store Order growth hormone in Voronezh affords consumers with more privacy than the traditional doctor or pharmacy visit. By using an online pharmacy, medication could be shipped overnight to his front door, saving time and aggravation.
• Additionally, online pharmacies offer an opportunity for increased reporting of side effects and adverse drug reactions. The governments relies on reports of adverse effects and drug quality from consumers to monitor and enhance the safety of drugs already on the market.

B. Risks of Online Pharmacies

• The ultimate concern with online pharmacy operations is consumer protection. Patients who obtain their prescriptions through online pharmacies place themselves at risk of drug-related injury. The fault for these injuries lies with various parties: Patients may misrepresent their medical histories, physicians may not deliver bona fide medical consultations, or pharmacists may not require valid prescriptions.
• The ability to access prescription drugs without a confirmed face- to- face physician consultation creates a large risk of misdiagnosis which, in turn, results in the wrong prescription being dispensed.
• Online pharmacies also provide a relatively effortless way for drug abusers and addicts to acquire prescription drugs.
• The biggest risk that online pharmacies and virtual clinics pose is to the patient’s health. Many sites offer very limited consultations and require the patient to answer only a few questions before prescribing a medication.
• Another major issue with the increased use of online pharmacies is its simplicity of ordering prescription drugs thereby permitting children and drug abusers to acquire non- prescribed medication easily.

A Global approach is needed

The DRAP devotes comparatively little effort praising online pharmacies, virtual clinics and in relation to the effort spent warning consumers concerning the risks of purchasing medicine through an online pharmacy and checking health condition. The DRAP should describes these practices potential threat to the health and safety of peoples of Pakistan.

Enforcement of regulatory rules is mainly possible within a legal jurisdiction and businesses which operate outside the scope of that legal jurisdiction present difficult problems to regulators. The nature of the Internet means that people of one country are exposed to global online commerce, except where country-specific filtering software is used to block certain sites (from outside the jurisdiction). Internet filtering is not in widespread use for commercial Internet activity in Western countries (such as the UK and US) as seen in other jurisdictions like China and Singapore.

It is difficult or impossible for regulatory bodies to control advertising of prescription drugs from Internet sites beyond their legal jurisdiction. This therefore, will continue to create a challenge to regulators in jurisdictions where the advertising of prescription drugs (to the public) is prohibited.

The need for a national approach to address drug sales on the Internet (especially Internet Pharmacies engaging in illegal activity) is indeed as the use of a global approach to address matters which are of global significance has been successfully implemented in the past.

 It must be noted that the regulation of Internet Pharmacies is more complex and even some may argue that it is difficult or undesirable to regulate Internet-based entities (that transcend national boundaries). Nonetheless, Pakistan can begin to harmonize their laws, have cooperative agreements, and develop new institutions to collectively address the concerns that Internet Pharmacies bring. Technological solutions (where possible) and public education programs can also be implemented at national levels.  

Proposed Regulations to regularize the online Pharmacies and Virtual clinics:

1. Regulatory reforms:

The regulatory reforms should be sufficed to regularize the online pharmacies and pharmaceutical sales. Government should classified itself in two jurisdictions, one is a centralized control by a DRAP that sets policy and secondly, can regulate pharmacies, pharmacists and medical practice, have limited powers to regulate activities at Provincial level. This creates better to effectively control activities related to Internet Pharmacies and pharmaceutical sale at national level. The regulatory challenges that arise from the online practice of pharmacy and from the practice of medicine facilitated by the online pharmacies include professional practice standards and consumer protection concerns, as well as health care fraud and abuse issues. A brief introduction to these issues is presented below.

• Advertising of Prescription drugs to the public

The advertising of prescription drugs to the general public is illegal in the Pakistan under the Drugs Act, 1976. However, the display of sign boards for a clinic, a dispensary or a hospital or such other institution offering treatment are allowed.

The legality of any advertising regulation is subject to the advertising on internet, online pharmacies, social media and it has been difficult for the Federal Government to regulate the advertising of prescription drugs to the same extent that it has regulated the prescription drugs in current circumstances. In an effort to tighten advertising requirements, the DRAP should new draft guideline proposals for direct-to consumer drug advertising which encourages greater disclosing of risk information to consumers.

• Protection of Personal Information Database

Internet Pharmacies based in the Pakistan are more likely to violate privacy protection requirements compared to those working in stringent regulatory authorities’ countries. .In order to regularize internet sale, DRAP should also stipulates regulatory requirements to ensure that personal data collected on consumers are safeguarded from abuse and remain confidential. It plays a role in regulating Internet pharmacies, in terms of stipulating controls for the processing, storage and transfer of personal data collected during online transactions because in Pakistan, there is no strong culture of privacy and data protection legislation.

• Online Consultations and Prescribing 

 Seeing the emerging trends of online clinics and consultations by the doctors and pharmaceutical companies in Pakistan, DRAP should have to issue new guidelines to address the prescribing via the Internet This practice is not seen as consistent with good medical care and is not encouraged in globally.

The guidelines insists that a practitioner must have a qualifying medical relationship with the patient at the time of issuing a prescription. Such a relationship entails conducting a face-to-face physical examination of the patient and having knowledge of the patient’s medical history to prevent public from obtaining drugs without a prescription

• Policy for Import of Medicine for personal use

Regulatory provisions regarding the importation of drugs for personal use have available and guidelines issued by DRAP under Drug (Import and Export) Rules, 1976. The DRAP allows individuals to import medicinal products for personal or family use without needing authorization or a license. However, the conditions would be verify before issuing the NOC:

The patient must have a serious condition for which an effective treatment is not available in the Pakistan.

The drug must not present an unreasonable risk and to verify the business interest in issuing of the NOC and who is importing on behalf of patient and institutions.

The patient must give the name and address of the doctor responsible for treatment with the unapproved drug or show evidence that the unapproved drug is used to continue a treatment started in a foreign country.

• Standards for Professional

An obvious regulatory concern is ensuring that online pharmacies and virtual clinics do not provide an unfettered avenue for medical. Physicians must have undertaken certain courses of study and passed examinations to be licensed. Physicians also are subject to scrutiny of moral character and must conform to professional conduct codes.

Pharmacists must comply with Pakistan Pharmacy Council requirements that they be of good moral character and fit to practice pharmacy. Pharmacists also are required to get a license given by the provincial pharmacy council. Pharmacies must comply with requirements as to the size and sanitation of their physical space. They also must maintain specific records and equip the pharmacy with the requisite supplies. A separate license may be required for each physically distinct site of a pharmacy.

• Patient Protection

Identifying which entities are operating or affiliated with online pharmacies is not an easy task. Registration and disclosure of pharmacy ownership and staff, therefore, will be necessary for effective regulation of online pharmacy operations for betterment of consumer protection.

•  Business Practices

Another challenge of online pharmacies is the potential for health care fraud and abuse presented by affiliations among health care providers. Physicians through virtual clinics and online pharmacies are affiliating with each other in order to enhance their respective issuing and dispensing of prescriptions; this can be accomplished through dual operations at one site or through links to another site offering the corollary service.

Conclusion:

The rapid growth of E-commerce continues to present challenges for federal and provincial governments. Thus far the existing federal and provincial drug laws have experienced limited Success in curbing the sale of prescription drugs on the Internet.  For both legislators and the public at large, it is becoming harder and harder to ignore the influence of the internet. The internet is fast becoming ubiquitous as its presence seems to increase daily. As the percentage of the population that may be exposed to potentially dangerous online pharmacies grows, the demand for effective regulation will become harder to ignore. Improvements for future legislation must address aspects of online pharmacies unique to the internet sale.  The federal government Continues to lag in passing specific legislation aimed at the online pharmacy and virtual clinics industry. Provincial governments lack the capabilities to effectively handle the increasing number of illegitimate pharmacies and online pharmaceutical sale.

Federal governments allocates prosecution powers to the provincial an integral role in combating illegitimate online pharmacies and healthcare commissions of respective province must play role in regulating the virtual clinics.

This will be more effective because the provincial governments will be better equipped to investigate and prosecute. The objective of eliminating illegitimate pharmacies will require active Cooperation between the federal government and the provincial governments. Legislation must be carefully crafted to regulate the Internet prescription sales, thereby reducing the harm to consumers while still allowing them to take advantage of the benefits of online pharmacies

There is a pressing need for Pakistan to develop a national approach/strategy to collectively address the issue of online drugs and medical services. This national approach/strategy should entail enforcement and the harmonization of national policy and legislation, to reflect internationally agreed standards. Failure to address this problem may result in serious consequences (in the future) for the health and well-being of the whole community.