Pharmacovigilance Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. Background: WHO established its Program for International Drug Monitoring in response to the thalidomide disaster detected in 1961 (Many children in the 1960’s were born with Phocomelia as a side effect of the drug thalidomide, resulting in the shortening or absence of limbs). At the end of 2010, 134 countries were part of the WHO PV Program. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health program by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines. COVID-19 Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It was first identified in December 2019. The outbreak came to light when China informed the World Health Organization of a cluster of cases of pneumonia of an unknown cause in Wuhan City in Hubei Province. Subsequently the disease spread to more Provinces in China, and to the rest of the world. The WHO has now declared it a pandemic. As per WHO: As of 19 May 2020, more than 4.8 million cases have been reported across 188 countries and territories, resulting in more than 318,000 deaths. More than 1.78 million people have recovered. Challenges faced by PV during this pandemic: The main challenges are with:
  • Data collection,
  • Data Analysis and
  • Safety reporting.
Challenges for Data collection: Many people are unable to reach out to their doctors because of the lockdown throughout globally. Also some patients who reports through couriers are facing issues in logistics which is significantly effecting the data collection from people. However, some patients are reporting through telephones and E-Mails, but the HCPs are busy in serving the COVID-19 patients hence the other patients are less attended, creating a void in the data collection. Challenges for Data Analysis: As we know data analysis have many steps involved like Book-in of data, Triage, Data Entry, Quality Review, Finalization etc. it involves more people. But many organizations around the globe are shut down due to local government measures to handle the pandemic and travel restrictions. This resulted in scarcity of people involved in data analysis. Also as discussed above, there is shortage in data collection all these factors became challenges for data Analysis. Challenges for safety reporting: There are many safety reporting techniques across the globe. Many countries have adopted electronic reporting, such as the portal entry, Email and E2B gateway to the Authorities. But many countries still use traditional methods of courier or hand delivery to the Authorities or reporting through data devices like compact disc. Electronic reporting is not directly impacted due to COVID-19. But, the Coordination becomes difficult among the pharmacovigilance teams, local legal representatives and teams distributed across different parts of the globe. As some portion of safety reports are still submitted using courier or hand delivery to national Competent Authorities, these reports include expedited like SADR, SUSAR and SAE and periodic like PUSR, DSUR, etc. In the early stage of this pandemic, there was disruption to courier and hand delivery services from the sender or receiver due to travel restrictions and logistic obstacles. There were delayed or failed deliveries Challenges Faced by Life Sciences Companies: Main hurdle Life Sciences companies have is “Protecting the current Business and trying to be a part of the solution”. There are many challenges being faced because of this pandemic, not to dig deep I want to focus on the below main issues. Drug Manufacturing: China and India established themselves as main players in the global Pharmaceutical industry. Many countries either import finished drugs or APIs from China and India. Due to COVID-19 pandemic there is disruption in the production in China and India. It is known that any disruption in supply chain of raw materials or APIs can effect drug manufacturing. Even India being one of the biggest exporter of Pharmaceutical products, imports more than 50% of its APIs from China due to cost effectiveness. Hence Drug manufacturing is in deceleration due to un availability of raw materials and Man power. Also the Manufactured drugs are facing logistics issues to reach the destinations. Other Health Care Equipment: Due do this ongoing pandemic there is a huge surge in the demand for critical products like masks, gloves, sanitizing products, ventilators etc. Most of the companies again depend on China to procure them. Hence procuring these essentials became a burden for many countries. The companies that can supply this critical equipment are best positioned to withstand the impacts of COVID-19. Demand for existing drug: Many people are unable to reach out to their doctors because of the lockdown, so prescription generation has almost come to a standstill. Many pharmaceutical companies could face weaker drug sales due to fewer doctor visits and less prescriptions. Health Care companies that can supply critical medicines for high-burden disease such as cardiovascular diseases, diabetes, tuberculosis etc. and medicines used to treat COVID-19 are facing huge demand. Launch of new drug: Drug companies need fresh prescriptions for their new introductions, which are not consumed by general public and only made available at medical stores near the clinics of Doctors/HCPs who will prescribe them. Reduced visits to the clinics and lockdowns has made the launch of new drugs a challenge. As a result, new launches have fallen sharply. Research and Development: All Pharmaceutical companies will suffer from a slowdown in research and development. Patient recruitment, travel constraints, quarantines and raw material shortages could delay clinical trials, product launches and manufacturing of new products. Patients are not coming forward for clinical trials of new drugs because of this ongoing pandemic. People are likely to participate in a virtual or hybrid trial, in which travel and in-person interaction would be limited or eliminated How Life sciences companies can be better prepared to face the Pandemic: Here comes the main part of the story! there is no place in the world to hide from COVID-19, only we can do is to be better prepared to face it. We must develop significant efforts to Diagnose, Treat and Prevent the ongoing pandemic. It need an extensive collaborating between the Life sciences companies, Government and Health care systems. There is a need for increase in the COVID-19 testing capabilities. Vaccine is not expected to be available for at least a year but that drugs to treat active cases may be discovered on a faster timeline. Key Stages for vaccine in simple terms:
  • Development,
  • Manufacture and
  • Delivery of vaccine,
we are still in first stage. It requires rapid screening of vast Global library of medicines to identify potential treatments, and have numerous clinical trials to develop the Vaccine. Within the Life sciences there is greater need for unity, teamwork and collaboration to tackle this challenge. There is a need for sharing of deep scientific knowledge gained from decades of experience and research with similar viruses to combat the COVID-19. Companies must explore new ways to use existing technologies to provide the ability to ramp up production once the vaccine is found.Better preparation for Future: The current challenges posed by the COVID-19 pandemic have prompted for the importance of below things:
  • Importance of electronic reporting
  • Need for robust Business Continuity Plan (BCP)
  • Avoiding too much dependency on a single nation for critical products.
  • Update with latest trends like Online Consultation, Telemedicine, Digital Health, etc.
  • Use of webinars for training Health care professionals and launching of new products.
The challenges posed by the COVID-19 pandemic have prompted regulatory agencies to reconsider their requirements and have emphasized the importance of electronic reporting to ensure data exchange for patient safety. It highlighted the importance of having a robust business continuity plan (BCP). Cost effective important for survival but in times of pandemic situations like this, Companies must have a strong BCP. For example, if a country depends on China for a critical drug, they should have a backup if China fails to deliver. In the worst case they should have a domestic facility which can operate in times like this. COVID-19 revealed that too much dependency on a single nation for the critical products is not safe anymore. I want to explain with an example. China is the largest supplier of Ibuprofen, with a production market share nearly 48% and India is the second largest supplier of Ibuprofen having production market share nearly 31% (2016 statistics). So nearly world’s 80% of this drug is exported only from these 2 countries. It explains how much dependent the other nations are. webinars have become more important during this pandemic, as the field work is no more easy. Let me example with an Example, Mumbai-based JB Chemicals and Pharmaceuticals launched a cardiac (hypertension) product in March through a webinar. They first trained medical representatives through webinars. Then launched the product through webinars with doctors. Conclusion: The impact of COVID-19 would be limited to the short-term, we must strive to perform better in long-term. Health care systems are struggling to respond effectively. Decisions/Developments that used to be taken in months and years are being accelerated. As a blessing in disguise COVID-19 exposed all the loop holes in the Health care industry. On a positive note the demand for antibiotics, and even astrointestinal medicines etc. is slowing down, with people staying indoors, eating home-cooked food and taking care of their health.