How has the pandemic made implementing LMS necessary for drug manufacturers?
The pandemic has made it necessary for pharma companies to deal with clients on a special basis. The pharma industry has indeed faced a lot of pressure due to the pandemic over the years.
Because of the coronavirus, the role of the medical sales staff became quite challenging because the drugs requested by a doctor have to be delivered by courier. In fact. Once the delivery was done, it had to be confirmed through the doctor’s credentials like his name, signature, and address. The doctor also had to submit a written request for getting a drug.
Challenges before the pharma industry
The pandemic exposed the pharma industry to face unanticipated challenges like never before. There were restrictions on medical trials to ensure that the researchers were not exposed to the Virus.
But apart from that, the salespeople also had to follow regulations like they could not sell medicines by meeting doctors in person.
Hence, there was a shortage of people willing to work in this industry, due to which companies had to ensure that the existing labor was retained.
Due to this, there was a large-scale use of pharma LMS to ensure that the labor employed in sales and manufacturing departments was made abreast of the new laws and regulations.
The companies have to ensure that an LMS is implemented to upload any updates made in the compliance laws immediately. If such content is not provided to healthcare workers by pharma companies, they can face heavy penalties caused to violation of such laws.
LMS helps in RIE
For example, during the Covid-19 problem, pharma companies could not cut down on their output because the authorities were not available for in-person drug approval as they could not visit the drug manufacturing sites in person. Hence they approved drugs through the process of remote interactive evaluations. Hence the employees have to be trained on how to ensure that the drug is approved in an RIE. The LMS can be used to train employees with the requisite knowledge for this purpose.
FDA grants drug approval before it is manufactured and marketed. The FDA conducts PAIs(Pre Approval Inspections) to ensure that the manufacturing of a specific drug is approved. But due to Covid-19, such in-person site inspections were not possible. Such critical inspection ensures that the drug can be manufactured at the concerned site as per CGMP practices or whether the drug is safe for human consumption through clinical trials.
But during the pandemic, such inspections are conducted in remote interactive evaluations(RIE) because travel restrictions have been imposed due to this virus. The authorities at the site must know how to ensure complete cooperation with the FDA staff during such inspections. The FDA also uses its own technical equipment for conducting such RIE, including the FDA Microsoft teams, FDA adobe Connect, and FDA Zoom for Government. The FDA requires a lot of evidence about the safety of manufacturing practices, including showing proper records to them. Apart from that, the staff must ensure that the FDA gets an idea about the site’s manufacturing and testing facilities.
How does an RIE happen?
The drug manufacturing site has to consent to its capability to participate in such an evaluation and must be willing to share documents through a teleconference or screen-sharing facility. The site will indicate its consent for such an evaluation in response to a request filed by the FDA.
FDA conducted the PAIs through RIEs, and once the sites were found to be eligible for this process, the site operators are notified through emails. A site cannot request an RIE and it’s at the discretion of the FDA to request the procedure. The FDA uses the registration file of the site to establish any correspondence with it.
What happens during an RIE?
The employees of such a facility can show a live video of their facilities during working hours, including how the types of equipment are cleaned and how the samples of a drug are taken and tested, the setting up of medical equipment, and the sanitization practices, etc.
Hence before the remote interactive evaluation, the staff at such facilities should ensure that there are no connection issues, and the FDA should be able to watch the working practices at the facility with ease. Once the FDA has assessed the manufacturing processes, it will approve the drug.
The staff of such facilities must take such inspections quite seriously. Its because such inspections determine the fate of a drug. During a Remote interactive evaluation, the FDA can ask for documents via email it has requested before. The pharma company must share such documents via email during an RIE or share them through a screen-sharing tool. Such documents are protected by password as they are confidential and should be disclosed to authorities for their review. If a pharma company can’t provide any requested document in English during RIE, it should provide a translator to aid the FDA officers in understanding the document.
How does an LMS help in an RIE?
An LMS can be a source of communication for the site officers to communicate about the impending RIE and ensure that it goes as per procedure and that there are no lapses. An RIE is not a substitute for on-site inspection because if any problems are detected during the former, the latter can still happen.
However, when a warning letter is issued to the pharma company after any faulty manufacturing methods are discovered during an RIE, they can be uploaded on an LMS for immediate action. The warning letters could be issued to drug manufacturers when they refuse to comply with records requests during an RIE. i. e if they fail to show any requested document.
An LMS keeps the medical employees of a pharma company updated about the consequences of an RIE because it includes an RIE report that includes all the FDA authorities’ observations during it. This report can be shared with the pharma company employees when it has been taken from the FDA through a disclosure request filed by the company.
Pharma companies have to use an LMS because the FDA is not facing any pandemic-related travel restrictions but has to use RIE to deal with the extraordinary application backlog created because of the Virus.