No drug is absolutely safe; all drugs have side effects. "Safe" here means that the benefits of the drug appear to outweigh the risks. Drugs may contribute to 5-10 per cent of all hospital admissions; around 10-20 per cent of all inpatients may suffer a serious adverse drug reaction (ADR) in hospital. Some ADRs lead to death, and also may contribute 5-10 per cent of hospital costs. So the monitoring of the adverse effects of drugs becomes crucial for good medical practice. Therefore, the pharmaceutical industry has entered a new era of pharmacovigilance (PV).
Pharmacovigilance is relevant for everyone whose life is touched in any way by medical interventions. Pharmacovigilance provides comprehensive, risk-based, flexible solutions for the management of product safety, risk, and patient health during the entire life cycle of a medicinal product.
A series of high profile safety concerns, like withdrawal of certain drugs and the link between antidepressants and suicidal thoughts in children over the last three years, has made drug safety a major issue for governments, regulatory bodies and pharmaceutical companies. Hence, pharmaceutical companies are highly emphasizing pharmacovigilance in the wake of product recalls, “black box” warnings, and litigation.
An inventory of legislative requirements has been enforced during the last few years in the ICH regions. By now, pharmacovigilance planning has become a substantive issue for the long term success of any drug on the market, as malfunction of pharmacovigilance systems and communication channels may lead to license retraction. Recent instant communication channels rightly position manufacturers and marketers of medicinal drugs to report adverse drug reactions immediately to their competent authorities.
Present-day statute demands from the liable manufacturer to inform concerned authorities rapidly about serious adverse drug reactions (ADR) and other drug safety related events that are occurring during the developmental and marketing periods of a drug, such as Suspected Unexpected Serious Adverse Reaction (SUSAR) in clinical development or other immediately reporting events in later stages of a drug's life-cycle.
Non-compliance with these requirements could make the difference between keeping your drug on the market and being forced to withdraw it. Therefore, early planning of your pharmacovigilance strategy is essential to the success of pharmaceutical products.
This may indicate areas of concern which may require closer attention by a potential sponsor.
The pharmaceutical companies in Europe and US usually outsource a part or sometimes much of its pharmacovigilance system due to lack of experience and resource, especially with commercial pressures to get the product to market. Sometimes, all the necessary parts of the system cannot be implemented in time by a company as first-time marketing authorization holder. However, additional factors may drive outsourcing in India, such as neither a physical presence nor a cultural experience as well as reduced costs, so that even call centres acting for Western Europe may be placed in India. As regards development in general, it is hoped that the Indian research environment may help to solve enrolment challenges on large multinational phase III studies or indeed be a source of treatment-naive patients for phase II or III. A robust pharmacovigilance is critical to ensure quality and to protect the interests of patients whether this applies to investigational and marketed products. However, both the observational and interventional clinical researches, are governed by the internationally applicable Declaration of Helsinki. Similarly, if the results from Indian trials are to be used for regulatory submission in the West, then good clinical practices (GCP) compliance is essential.
Difficulty in operating PV in-house in cos
In fact, pharmacovigilance is an activity that has international significance. Pharmacovigilance involves proficient individuals, from registered nurses to specialist doctors who are performing relatively clerical functions, such as sifting through data and probing case reports; but despite the clerical nature of the work, it requires such a high level of competency that a company must pay lavishly for it if the work is done domestically.
The requirements, and the stakes, of this kind of work continue to rise. Every new drug is put under dissection, wound up by negative media coverage. The volume of events to be reviewed and addressed is going up at an astounding rate, and so is the cost.
Cos reducing the cost of PV
The era of outsourcing has enabled pharmaceutical companies to hire third party vendors to perform non-core processes at lower cost and higher quality. Outsourcing of the pharmacovigilance process provides a cost effective solution, especially for small and medium sized pharmaceutical companies. This would avoid the high upfront investments and fixed over-head costs connected with setting up an in-house drug safety system. Along with meeting the regulatory requirements, outsourcing would allow immediate participation in the efficiencies provided through the looming implementation of electronic SAE (Serous Adverse Event) reporting. Even if a pharmaceutical company decides to develop their own drug safety group in-house over time, often there is need for external advice and possibly provisional coverage until the team gets up to speed.
Benefits of outsourcing PV system
The use of an offsite pharmacovigilance system may be less expensive than in-house system. The most important benefits for an outsourcing solution are the ease of managing certain peaks and new demands, and the reduced cost for database infrastructure and license cost for software programmes. These key benefits allow a firm to keep the internal headcount low, as negligible corporate infrastructure is required. Outsourcing can provide an immediate, multi-location pharmacovigilance network with minimal IT investment.
Usually the pharmacovigilance provider lacks the specific product knowledge, and so an effective transfer of drug information data is necessary. This can be facilitated when liaising with a structurally competent partner who is able to assimilate the necessary product knowledge easily; for example, with a comprehensive training programme and regular interactions with the core product team of the pharmaceutical firm.
Moreover, this field opens to unfamiliar grounds of difficult legal ramifications requiring high levels of inter disciplinary know-how. As legislation and regulatory bodies are increasingly demanding more and more functions and tools to detect and to respond to safety concerns with any drug, the benefits of pharmacovigilance outsourcing become more evident.
The first significant pharmacovigilance outsourcing deal in the industry was the Bristol-Myers Squibb agreement with Accenture, in which the work is being done in India.
As pharmacovigilance is a relatively new function in terms of outsourcing, there are not a large number of providers presently able to do the work. In essence, there are two classes of providers capable of moving tactically:
Contract research organizations (CROs)
These companies are focused on drug development and managing trials through their various steps and processes, and so are well suited to step up and address pharmacovigilance. These cover Quintiles, Covance, and MDS Pharma Services.
Business process outsourcing (BPO)
These include those organizations particularly based entirely in India. Examples are Cap Gemini, Tata Consultancy Services, Infosys, Cognizant, Icon and Keane.
India - a hub for offshore outsourcing of PV
India is well known for delivering high quality IT and IT-related services, and now India is becoming the most obvious choice for offshore outsourcing of pharmacovigilance activities and responsibilities.
India-based operations have tremendous language skills, superb education, and a large number of doctors who are looking for higher-dollar work in a related field. Here’s one more instance in which what is considered in India to be expensive, high-dollar work is, by US standards, inexpensive.
Swot analysis of India as an outsourcing destination for PV
To select a service provider
While making a selection of a service provider, more prominence must be placed on the levels of training each provides to its people, scalability, and the comparative rates of turnover. For these reasons, pharmaceutical companies are making much more use of outside resources as they draft agreements with service providers, build their governance organizations, and manage the agreement over time. Outside advisors with proficiency in the market, the nature of the work, and the legal aspects of the relationships are being used extensively both by pharmaceutical organizations and service providers.
Some companies first achieve a comfort level in outsourcing and then deal directly with their existing providers or additional providers to expand agreements. However, pharmaceutical companies, even those who outsource heavily in other areas, still feel they are walking on new ground when it comes to pharmacovigilance outsourcing.
Fear in hiring servicing providers or outsourcing PV
This is due to fear of the legal implications if the outsourcing partner 'gets it wrong', and a hesitancy to be the first to adopt the outsourcing model. It was also a reflection of the limited choice of both service providers and scope of services available at the time.
But today's marketplace offers a wide range of pharmacovigilance services provided by both large and small companies. These may form part of a suite of services offered by CROs, be the core business of specialist companies, or form part of the expertise available through the growing network of freelance individuals, many of whom are former pharmaceutical company employees.
This growth in the services available for pharmacovigilance outsourcing has been driven by the annual increase in the volume of data generated both in terms of number of individual adverse event case reports and contributing organizations. This has prompted both the regulatory bodies and the pharmaceutical industry to seek more efficient methods of processing product adverse event data with the goal of both improving public safety and reducing the cost overhead for marketing and support of pharmaceutical products wide-reaching.
India primed to become terminus of choice for outsourcing PV
Outsourcing allows pharmaceutical companies to focus attention where it is needed most i.e. a proactive, not reactive approach that ensures drug performance and overall safety. They gain access to specific expertise and place responsibility upon the supplier to meet the cost of items such as coding dictionaries.
Regulatory authorities are becoming more sophisticated by including electronic reporting, MedDRA coding and reporting and 21 CFR Part 11 compliance. These pressures are felt more keenly in pharma companies with low case volumes who are unable to justify a full time pharmacovigilance specialist.
All said and done, let the outsourced provider bear the cost of the initial license, software upgrades, system management, and the management of whole of the product safety reporting requirements.
Currently, India is poised to become the destination of choice for the outsourcing activities along the entire value chain of drug safety. The outsourcing of pharmacovigilance is a trend that is clearly gaining impetus, as pharmaceutical companies reach deeper into their business processes to reduce costs and enhance performance. As business process outsourcing (BPO) organizations make every effort in these types of deals, and CROs endeavour to compete with BPOs on equal footing, both types of provider organizations will enhance their operations with the right people.
-(The author is Team Lead - Drug Safety, Tata Consultancy Services)