India Opening up Power of PV – I
No drug is absolutely safe; all drugs have side effects. “Safe” here means that the benefits of the drug appear to outweigh the risks. Drug 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, life 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-naïve 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 researchers, are government 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 natural of the work, it requires such a high level of competency that a company that a company must pay lavishly for it is 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 medical sized pharmaceutical companies. This would avoid the high upfront investments and fixed over-head cost 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 Even) 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 with 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.
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