2017– 2018 has been a period marked by significant ups and downs in the pharma and healthcare industries. From marking the end of the Hepatitis-C treatment era, which was a significant contributor to the industry’s growth rate from 2014– 2016, to the greater impact of expiring patents and the introduction of Biosimilars, the year has been quite phenomenal. While the industry is still trying to come to terms with these new developments, the market that was once pegged at a growth rate of 9% annually in 2014-2016, owing to the increase in cancer and Hepatitis-C related treatments, has now dropped to just 6% with the hope of eventual recovery by 2022. On the other side of things, where the maintenance of standards, manufacturing conditions, and equipment quality is concerned, pharma and medical devices manufacturers have a whole new ball game to contemplate. The 2018 GMP (good manufacturing practices) regulations are geared to take big steps towards many companies falling behind on maintaining standards as dictated by the US Food and Drug Administration, and more companies stand the chance of being included in this list as audits commence for the year 2018-2019.
Meanwhile, the Regulatory Affairs Body for the pharma and medical devices industry, which focuses on maintaining standards of distribution, marketing, promotions, and assesses the quality of training provided to medical staff (doctors, nurses, physicians), is also playing a major role in governing the ethical promotions and marketing activities of what companies claim their products can and cannot do. The focus, however, is more on ensuring that drugs and medical devices are not misrepresented, especially when it comes to side effects involved with using them.
Through all of these disruptions, there has been a certain window which has opened up for the industry, allowing companies to utilize eLearning and it various auxiliary arms as gripping mechanisms, which hold on to the guard rails of compliance, safety, training, and development to safely make it through this topsy-turvy ride of new innovations, sluggish markets, regulatory bodies and their demands.
This article looks at a few disruptions that occurred in the period of 2014-2018 whose effects organizations are increasingly dampening using various eLearning approaches.
Increasing costs and its effects on traditional training: A study conducted by a renowned university concluded that if a drug gains an FDA approval, the combined direct and indirect costs are enormous. The actual cost of bringing a new drug to the current market is $2.56 billion. This is directly impacting the activities of allocating budgets for training, especially when it comes to compliance training being provided to employees, who are in-charge of maintaining standards. This is quite evident given that the FDA has identified an increase in organizations who are not adhering to the set standards.
Increasing costs of introducing a drug into the market can never be a reason for manufacturers to take a back seat on compliance and standards training. More so, international pharmaceuticals who are major exporters to the US pharma market, which alone accounts for 45% of the global market share, are increasingly getting caught up in the crosshairs of the FDA. Major organizations which were quick in adapting to eLearning technologies around 2013-2014 are facing fewer disruptions with their training and compliance activities since the investment into eLearning has resulted in them spending considerably less on training and compliance, when compared to traditional training activities. This has also resulted in FDA providing more of these companies with a clean sheet
With the increasing costs and reduced expenditure on medicines projected till 2022, the only way to ensure economic employee training activities is by adapting to eLearning and its auxiliary branches.
Compliance and GMP: With the FDA’s standard audits commencing for the year of 2018, it has become imperative for organizations to maintain ethical practices and standards. The GMP is aimed to regulate standards at all levels of manufacturing, from the sourcing of raw materials to the finished products. Generally, companies that rely on vendors for semi-finished products need to take greater care, ensuring enough training is being provided to vendors on good manufacturing practices. The EU-GMP and the US-FDA standards are already perceived as much stricter when compared to the WHO-GMP standards, which is why European and US-based organizations sourcing semi-finished products from countries like India and China are focusing on increased training programs being provided to these vendors. Since the costs of traditional training on a global scale are steep, and ensuring vendor compliance is even tougher, an increasing number of organizations are relying on remote eLearning as a method of effective training and assessing compliance. Training delivered through custom compliance, manufacturing standards, and product safety eLearning courses, have time and time again proved themselves to be a cost-effective method of reaching out to geographically dispersed vendors and keeping track of their compliance activities. Learning management systems (LMS) managed by a centralized training and compliance department, play prominent roles.
Standards of advertising and promotions (Regulatory Affairs): The regulatory affairs body for pharma and medical devices industry is one of the more recent authoritative figures on the scene; however, it is quickly setting the expectations straight when it comes to companies following ethical advertising and promotions activities of their products. This mostly pertains to advertising the actual benefits of using a drug, the side effects associated with it and ensuring that it is promoted accurately via distributors and pharmacies at the bottom of the chain.
eLearning has become a standard for manufacturers training their distributors, doctors, and marketers to accurately and effectively promote a drug. Healthcare systems have implemented eLearning courses as a primary method for medical staff to get trained on a range of drugs and services, which change regularly. Furthermore, these courses are also used as guidelines when treating patients using a specific drug or setting up alternate therapeutic approaches to particular ailments using these drugs.
The reason eLearning is a better approach to training on products, its uses, benefits, and side effects is due to the ease of accessing information. With thousands of products and devices being introduced every year, it is essential for the distributors and users to understand them adequately. eLearning has also found favor with companies using them as a medium to train direct customers.
Shortage of staff and trainers in the healthcare system: On a micro level, healthcare providers feel the direct impact of frequently launching new products by pharma companies. Healthcare systems are sending their medical staff for extended periods of training to understand these new products and its usages. The expenses borne by these companies range from the cost of employees traveling to the costs incurred as a result of lack of staff available when training.
The training being provided here is imperative, and healthcare companies cannot afford missing out on the training being presented, but enormous costs and the shortage of staff are definite deterrents. The advantage of including eLearning into the mix has to do more with reducing costs and time spent by medical staff away on traveling and training. Some healthcare companies were regularly sending their medical staff on three-week long training initiatives, with massive costs of facilitating the traveling staff. These three-week long training activities are now reduced to 1.5 weeks of eLearning courses from the comfort of their homes, and the remaining 1.5 weeks traveling. Such is the power of eLearning; in an industry where the strong presence of trained staff is a mandatory requirement, eLearning is currently playing a pivotal role.
We are in a time where pharma and medical devices are increasingly dependent on technology to meet its growing needs. The reality is quite astonishing; there are hundreds of drugs and medical devices released each year. There are even more regulations falling into place. The pressure on this industry is spread evenly on doctors, nurses, and physicians to the actual manufacturers and drug developers themselves. eLearning and its supporting arms are providing a damping cushion to organizations accepting it. At least this holds true when it comes to training on compliance, standards, distribution, and marketing. It is best recommended for an organization to include some form of eLearning into their current mix, gradually turning the entire process of cost-intensive traditional training activities into a cost-effective eLearning program.
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