What is pharmacovigilance?
Pharmacovigilance also known as drug safety, refers to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problem. Here ‘adverse effects’ refer to any untoward medical occurrence which happens to either a patient or a subject in a clinical investigation when a pharmaceutical product has been given to them. This includes any signs which are unfavorable and unexpected for the patient or subject, including any abnormal laboratory findings. Information received via pharmacovigilance agreements (PVAs) from patients and healthcare providers, as well as other sources such as the medical literature, plays a critical role in providing the necessary information for undertaking pharmacovigilance. In fact, in order to market or to test a pharmaceutical product, most countries have mandated the requirement for adverse event data received by the license holder (usually a pharmaceutical company). This data is required to be submitted to the local drug regulatory authority. Let’s examine some of the key importance of pharmacovigilance in healthcare:
Importance of pharmacovigilance
Clinical trial regulation
One of the importance of pharmacovigilance is that it facilitates clinical trial regulation. The recent years have witnessed a skyrocketing increase in clinical trials in the United States alone. Furthermore, the increase in the complexity of clinical trials is leaving regulators with several challenges to face. Clinical trials are mostly contracted to clinical research organizations and patient recruitment agencies. These agencies act as intermediaries between the sponsors of the study, the investigators, and the patients. The importance of pharmacovigilance can also be established from the fact that it enables improved and more rapid changes in labeling or even withdrawal of a new drug from the market. Furthermore, a standardized reporting system for safety concerns arising during clinical trials can be established. Pharmacovigilance also plays a vital role in ensuring patient safety and strict compliance with prescribed regulatory requirements that would substantially improve standards of clinical trials.
Monitoring post-marketing safety
A part of the process of evaluating drug safety should ideally take place in the post-marketing phase. Safety monitoring is not only limited to the cases of new drugs or significant therapeutic advances. The importance of pharmacovigilance is notable in the introduction of generic medicines, and in the review of the safety profile of older medicines already available, where new safety issues may have arisen. Spontaneous reporting is a cornerstone of pharmacovigilance in the regulatory environment is indispensable for signal detection. The need for more active surveillance has also become increasingly clear in recent years. Without reliable and authentic information on utilization and the extent of consumption, spontaneous reports do not make it possible to determine the frequency of an ADR related to a product or its safety.
There has been an increased spending in direct to consumer advertising by pharmaceutical manufacturers. This results in national regulations on advertising to become ineffective. Several websites now enable buying and selling of prescription drugs such as benzodiazepines without controls. These developments in communication have a significant impact on the safety of medicine. Such issues suggest the need for more thorough monitoring of drug safety and scrutiny of advertising. This highlights the importance of pharmacovigilance.
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The past few years have witnessed a myriad of changes in FDA-regulated sectors such as the medical device industry. Accountable care and value-based reimbursement models are causing a groundbreaking shift in the medical device industry. This means that now focusing on data and the value of the medical device is not enough to boost the ROI. Companies in the medical device industry need to begin their quest for new avenues of revenue and profitability. The radical shift towards value-based care demands solutions that can deliver actionable insights for use in existing electronic medical record systems. Here are some critical challenges that are pressuring the medical device industry:
Medical Device Industry Challenges
The competition in the medical device industry is soaring to a whole new level, prompting players in this space to manufacture more complex and integrated products to stay ahead of their peers in the market. Consequently, this results in a rise in the cost of field service and repair processes. Moreover, this has also doubled the cost of training field service specialists and engineers. Quantzig’ s cost analytics solutions help medical devices companies identify and set the optimum price for their products and yield maximum ROI.
Meeting customer expectations
The advent of technology has given customers around the world access to the internet and smartphones. They now have numerous choices at their disposal and demand more from companies in the medical device industry, especially in terms of implementing more aggressive SLAs. The end-users of medical devices are demanding more incentives from their reduces capital. Quantzig’ s customer analytics solutions are designed to help healthcare device manufacturers gain glean customer insights to drive sales and improve revenues through acquisition, growth, and retention.
Shift towards home-based care
The popularity of home healthcare services and POC tests are skyrocketing, this means that players in the medical device industry need to follow suit and migrate towards the production of home-based health kits. This would pose as a threat in reducing the spend on capital programs for the development of new lab equipment.
Manufacturers in the medical device industry are gradually losing their ability to fund capital for their new devices primarily due to the implementation of new schemes to reduce reimbursements for medical assays by insurers. To add on, heightening competition from other emerging companies in the market will contribute to eroding customer loyalty and thereby reducing the profit margins of top medical device companies.
Healthcare professionals constantly encounter a seemingly impossible number of obstacles in their mission to deliver quality care at affordable prices to the patients. From rapidly skyrocketing pharmaceutical prices to needing to jump through hoops for treatment reimbursement, the tasks have been becoming more complex with time. Quantzig’ s analytics solutions for the healthcare industry help companies including pharma, medical devices, diagnostics, and healthcare delivery companies to address key challenges, reduce costs, increase margins, and gain a competitive market advantage.
Healthcare companies are in possession of more patient data than ever before, all thanks to advanced technologies and record keeping mechanisms. Healthcare providers can use various data analytics tools to extract useful information and examine patterns among the data available to them. A proper data analysis would also provide healthcare researchers and practitioners with a comprehensive clinical, financial, fraud, HR and supply chain analysis. The magnitude of this data and the different sources from which it’s derived often makes it cumbersome and difficult to manage. Hence these best practices outline the most effective ways toapproach healthcare data analytics:
Focus on data quality rather than quantity
It is vital for healthcare providers to focus on the relevance and quality of information rather than the quantity of data aggregated in the system. Organizations must lay in-depth focus on what information the data translates into and the possible trends in healthcare and outcomes. The presence of a large amount of irrelevant data can hide insightful and useful information. By recognizing data characteristics organizations can build a meaningful data quality management framework and deploy the most appropriate data cleaning workflows.
Keep an eye on the competitive landscape
While using healthcare data to formulate strategic decisions, organizations must take into account the competition and evolving strategic environment. This also means formulating strategies based on long-term goals in mind rather than giving excessive importance to short-term wins. Organizations should also ensure that healthcare analytics frameworks help in the creation of data sets that would be useful in the future.
Data warehouse and access to the testing environment
It is ideal for healthcare organizations to establish an enterprise data warehouse also known as EDW instead of handling data manually. The EDW acts as a central location for analysts to access all data across the entire healthcare system. After an enterprise data warehouse is established, it is important to give analysts full access to this data. With the help of various data analytics tools, analysts can organize the data, rebuild sets, and improve on it in order to further advance their work.
Healthcare analytics systems must revolve around the idea of sustainability by focusing on skill sets. A roadmap is then developed, helping healthcare organizations to gradually build on the required skill set. This greatly helps in minimizing the risk and dependency on outside resources. It is essential for healthcare enterprises to plan future resource needs in order to sustain future organization needs and growth.
Build for scalability
It is advisable for healthcare companies to not build complex systems right off the bat. Information produced from a healthcare analytics platform might be successful in identifying a problem, but an established operational framework is needed to solve the problem. Organizations should start with a structured proof of concept that builds the framework and aims at cashing in on quick wins and low hanging fruits. It is critical to realize that analytics roadmap is not a one-time implementation.
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Several industry trends, industry innovations, technological evolution, and policy changes are fueling changes in both physician and patient behavior in the healthcare industry. This makes it essential for healthcare marketing professionals to approach audience engagement from a whole new perspective. As the priorities of both healthcare professionals and patients are evolving, the need for brands to engage with their audiences in a meaningful way is becoming critical. Here are four upcoming healthcare marketing trends that providers should be aware of:
When patients search for healthcare professionals, they are most likely to add search queries that include ‘near me” or a search string that specifies their location. This is because patients are most likely to look for physicians who are at their closest proximity. Your healthcare marketing strategy must revolve around local SEO. To keep in line with the changing healthcare marketing trends, players in this sector must try to rank well for local searches, popping up in the much-coveted location preview on Google. For this, location-based keywords need to be optimized which will be extremely useful in garnering customers using voice searches.
Healthcare marketing on social media
Social media is gradually becoming an essential element of healthcare marketing strategy for agile players in the healthcare sector. Though providers must be extremely careful not to divulge any vital patient data or incidents on social media, this powerful tool can be used to build trust and relationships with the patients. Social media is one of the noted healthcare marketing trends, which is a great way to take word of mouth healthcare marketing and amplify it in a public setting. Patients can also provide testimonies of their experience on the company’s social media profile, which improves their reputation.
Mobile optimized sites
The use of mobile has only skyrocketed over the past few years, which means that having a mobile-optimized site will soon be an integral element of any healthcare marketing strategy. The mobile-optimized sites must-have features such as easy-to-use drop-down menus that quickly display the information patients are looking for and a click-to-call mobile numbers on your page for easy access.
Personalization and customization
Smart players in the healthcare space have come to terms with the fact that customization and personalization in their healthcare marketing strategy is the way to stay ahead in the game. Personalization of content is known to generate greater interest and response. Also, blogs on the provider’s website is another key healthcare marketing trends that have been garnering immense attention from the audience. These blogs not only talk about a particular health condition that a user might have searched for but also has the contact details of the physician who can be consulted to cure that particular ailment.
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Are you looking for ways to provide the best care to each patient at your healthcare organization at lower costs? Reducing healthcare costs can often be a tough and challenging task for healthcare providers. But it is achievable! Today, there are some new tools and strategies that are being employed to help bring down the healthcare costs. And analytics is one of those tools. The advent of big data and AI has enabled healthcare professionals to capture and analyze heaps of digitized healthcare data to unveil new insights. Analytics is also ushering in a new era of premium quality healthcare that is available at lower costs.
Embracing change is one of the buzzwords that healthcare insurance providers swear by when it comes to sustaining themselves in the competitive marketplace. The industry, for a while now, has been going through rapid transformations. And with the implementation of new healthcare reforms and cost structures, health insurance companies are facing the daunting task of staying a step ahead of the competition, meeting the rising demand for insurance coverage, and keeping their costs low. Therefore, in a bid to reduce costs and streamline processes, many providers have started using strategic tools such as health insurance analytics. The biggest advantage of health insurance analytics lies in its ability to help companies position themselves competitively in the insurance marketplace.
The constantly rising healthcare costs accompanied by the struggle to provide quality healthcare is driving the need for health insurance analytics.
In this blog, we at Quantzig, have listed a few ways in which health insurance analytics is transforming the insurance marketplace and is providing a better opportunity for insurance companies to grow.
The US healthcare industry is endeavoring to find a balance between value-based care and fee-for-service. But this smart step is not going to come easy for companies because of the ever-changing policies, processes, capabilities, and complexities impacting the US healthcare industry. Moreover, factors such as increasing revenue pressure, consistently deteriorating margins, demand for the latest equipment and technology, and limited financial resources have put healthcare providers in a difficult and challenging position.
US Healthcare Industry Overview
Current estimates put US healthcare industry’s spending at approximately 15% of the total GDP, which is considered to be the highest in the world. The US spends the highest on health care costs for pharmaceuticals in the world. In this region, approximately 85% of the citizens have the privilege of health insurance, availed through their employer or purchased individually. The federal government in the United States does not guarantee universal health care to all of its citizens. The healthcare programs that are publicly funded help provide for some of the disabled, the elderly, and the poor. Federal laws in the US ensure public access to emergency services regardless of their ability to pay. Those who don’t have health insurance coverage are expected to pay for medical services privately, which is costly. The most common reason for personal bankruptcy in the US is the expensive health insurance and medical bills. But the emerging trends in the US healthcare industry are going to bring about significant changes to the market landscape.
Continue reading to know more about the US healthcare industry trends
What the Client Wanted
Leverage data mining techniques to predict future outcomes by identifying incongruities, data correlations, and patterns within huge sets of data in the traditional Chinese medicine segment.
A leading traditional Chinese medicine (TCM) manufacturing firm, wanted to help their patients achieve and maintain health by developing precise remedies to tackle their health issues. The staggering amount of unstructured data related to lifestyle disorders and other chronic diseases posed major challenges that hampered their R&D process.
To unearth insights using the right data mining techniques, the traditional Chinese medicine manufacturing firm approached Quantzig to leverage its expertise and devise appropriate solutions to help their customers.
Traditional Chinese Medicine Market Overview
Traditional Chinese medicine is an ancient field of medicine based on the principles of Daoism, which states that everything in the universe is interrelated. Thousands of years of observation and practice resulted in the development of traditional Chinese medicine, which follows a unique strategy to understand the functions of internal organs and physiological processes. Traditional Chinese medicine is a very complex and complicated field of the medical system that aims at promoting health through diet and exercise. It also focuses on treating illnesses using herbs, acupuncture, and Qigong.
Challenges facing the Traditional Chinese Medicine Market
- Authentication issues: Traditional Chinese Medicine (TCM) is winning supporters across the world, which makes it necessary for players in this filed to validate the safety and quality of their medicinal products. A proper authentication process along with the use of data mining techniques can help ensure that the products are safe from contaminants. However, the recently formed Chinese Medicine Association of Suppliers (CMAS) in the UK plays a key role in authentication.
- Difficulty in creating an appropriate placebo: A major challenge for traditional Chinese medicine practitioners revolves around the difficulty in developing appropriate placebos for multiple-herb based decoctions. This is because it is technically challenging to produce an indistinguishable placebo in the form of decoction for a multiple-herb formulation.
About the Client
One of the largest manufacturers of premium traditional Chinese medicine. The client is a global leader in scientific research and production of Chinese Granule Herbs, with their sales network spread across 30 countries globally.
Owing to the challenges they faced in drug discovery, the client wanted to implement efficient data mining techniques to discover data patterns that help improve the quality of drug discovery and drug delivery methods. The traditional Chinese medicine firm wanted to sift through the repetitive noise in their data to gain an understanding and make use of relevant factors and assess likely outcomes.
Data Mining Engagement Summary
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Implementation of data mining techniques helped the traditional Chinese medicine manufacturer to build a successful predictive model to predict future outcomes of their medicinal formulations. It also helped them find answers to essential analytical questions such as – Which formulations are likely to be retained? How to ensure effectiveness and efficiency with optimal resource allocation? What factors after the drug discovery process?
Insights on data mining techniques
Organizations today have access to huge volumes of information that is gathered from all kinds of sources across the industry. However, the unanswered question here is – How can you use this data to generate insights that are required to drive business value? This is where ‘Data Mining Techniques’ contribute in a big way. Data mining techniques play a key role in helping organizations predict future trends and act accordingly to carve out a niche for themselves in the market.
Did this case study help you gain detailed insights on how data mining techniques can help drive your business’ profit margins and keep abreast of the new industry trends? To know more