May 17, 2020

Heightened competition for pharmaceutical companies thanks to FDA

Admin
3 min
Heightened competition for pharmaceutical companies thanks to FDA .jpg
Written by Alyssa Clark How will pharmaceutical companies be impacted by the introduction of the harsher Schedule II regulations by the FDA? What will...

Written by Alyssa Clark

 

How will pharmaceutical companies be impacted by the introduction of the harsher Schedule II regulations by the FDA? What will the implications from introducing this new Zohydro drug against the FDA advisory committee’s opinion?

From 1999 to 2010, the number of deaths involving opioid analgesics more than quadrupled, to nearly seventeen thousand, according to the Centers for Disease Control and Prevention. The FDA recently made front-page news this past October when it announced its decision to move commonly prescribed pain medications to the all-powerful Schedule II class of drugs. Now, drugs like Vicodin, over-the-counter painkillers and hydrocodone are not going to be available in their traditional forms, hoping to combat what has come to be known as “the prescription drug epidemic”.

The FDA promoted the use and manufacturing of a new drug entitled Zohydro ER, against a negative review from the FDA advisory committee. Beginning extensive trials in March of 2010, Zogenix recently introduced Zohydro ER as an abuse-resistant type of drug which is set to decrease the numbers of addicted patients and control overall distribution. The New Yorker described the medication as, “…an extended-release painkiller developed by a California-based company called Zogenix, which is made of pure hydrocodone and uses a higher dosage scale than hydrocodone-combination drugs like Vicodin”. Unlike those drugs, Zohydro ER does not include acetaminophen or aspirin, which can cause liver damage if abused over a long period.

Companies who manufacture the outstanding painkillers will be drastically impacted by the new up-and-coming drug, which is set to outshine the already in place drugs due to its cost-effectiveness, efficiency and overall patient-results. Not only will the introduction of the most-recently approved painkiller be problematic for businesses, but the overall competition within the pharmaceutical market will be at an all-time-high. These impending, stricter regulations will catapult the amount of intensive drug-screenings, and maybe this crack-down on prescription drugs is exactly what our society needs in order to cut down the unfortunate numbers of people affected by long-term painkiller abuse.

Issues like better-labeling, more intensified screenings, drug-warnings and precautionary advertising are other measures which have attempted to, but failed in decreasing this ever-growing epidemic. But the question remains— how does an institution deem one prescription drug as hazardous, and others equally as hazardous, as safe for public use?

Andrew Kolodny, a physician who has fought for stronger restrictions on pain-pill prescriptions, attended the December meeting as a member of the public and spoke up during a period reserved for comments. “One has to wonder how many more pain patients have to be harmed, how many more people have to become addicted, how many more lives will have to be lost,” he said, “before the F.D.A. finally begins to exercise its authority and responsibility to prohibit drug companies from marketing opioids as if they have been proven safe and effective for long-term use.”

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Jun 13, 2021

How healthcare can safeguard itself against cyberthreats

#Cybersecurity
#cyberattacks
#digitaltransformation
#covid19
Jonathan Miles
6 min
Jonathan Miles, Head of Strategic Intelligence and Security Research at Mimecast, tells us how the healthcare sector can protect itself from attacks

One of the most fundamental lessons from the COVID crisis is that health should always be a priority.  In a similar fashion to the human body that frequently fights off viruses and foreign invaders that intend to cause it harm, the sector itself is now a prime target for another type of external threat: cyberattacks.

The figures speak for themselves: between December and January this year, hospitals in the UK were at 89% capacity, with 7,000 fewer available beds than there usually are. As the pandemic increased pressure on hospitals, clinics, and research facilities to create a treatment for patients globally, it has left the sector exposed to hackers who, like a virus, have been targeting it relentlessly and evolving their tactics. 

From patient records being held ransom, to fake emails claiming to originate from the UN WHO, the NHS, or vaccine centres, through to attacks on the cold supply chain to find out the secret formula of the COVID vaccine, the healthcare industry is facing constant cyberattacks and struggling to cope. This threat is unlikely to go away anytime soon – and as such, the industry needs to take a proactive, preventative stance to stay safe in a dynamic digital world. 

Going digital 

The responsive nature of healthcare – particularly of hospitals – means that efficiency is crucial to the industry’s standard operations. To support this, the sector has been embracing technological advancements that can improve the quality of work, enabling staff to meet pressing deadlines, and enhancing patient care. For example, the industry has been digitising records and improving its ways of working through digital means over the past few years. 

This shift is critical to offer high quality patient care; yet, it also means the sector has become more dependent on IT, which can come with a risk if cybersecurity processes employed are deemed as inadequate. 

Without the correct security measures in place, the desired efficiency gains realised, can be easily lost in a heartbeat. Simply put, an elementary glitch in the system can have a tremendous ripple effect on many areas, from accessing patient records and conducting scans, to maintaining physical security and protecting the intellectual property of experimental treatment development.

To prevent this, healthcare organisations need to ensure they’re considering cybersecurity as part of their overall digital transformation strategy – and setting the right foundations to create a culture where safety goes hand in hand with patient care. 

Strengthening defences

Before implementing cybersecurity process, healthcare organisations need to assess the potential risks they face. Depending on how much confidential data the trust has, where it is stored, who has access to it and via which means, the cybersecurity strategy and associated solutions will change. 

It’s fair to say that a medical device start-up where all employees have a corporate-sanctioned laptop and access data via a VPN will have radically different needs to a large hospital with hundreds of frontline workers connecting to the hospital’s Wi-Fi using their personal device. 

These requirements will pale by comparison to a global pharmaceutical giant with offices in multiple locations, a large R&D department researching new treatments for complex diseases and a fully integrated supply chain. Considering the existing setup and what the organisations is looking to achieve with its digital transformation strategy will therefore have an immediate impact on the cybersecurity strategy.

Despite this, there are fundamentals that any organisation should implement: 
Review and test your back-up policy to ensure it is thorough and sufficient – By checking that the organisation’s back-up is running smoothly, IT teams can limit any risks of disruption in the midst of an incident and of losing data permanently.

In our recent State of Email Security report, we found that six out of ten organisations have been victims of ransomware in 2020. As a result, afflicted organisations have lost an average of six days to downtime. One third of organisations even admitted that they failed to get their data back, despite paying the ransom. In the healthcare industry, this could mean losing valuable patient records or data related to new treatments – two areas the sector cannot afford to be cavalier about.

Conduct due diligence across the organisation’s supply chain – Healthcare organisations should review their ways of working with partners, providers and regulatory institutions they work with in order to prevent any weak link in their cybersecurity chain. Without this due diligence, organisations leave themselves exposed to the risks of third party-led incidents. 

Roll out mandatory cybersecurity awareness training - Healthcare organisations shouldn’t neglect the training and awareness of their entire staff – including frontline workers who may not access the corporate network on a regular basis. According to our State of Email Security report, only one fifth of organisations carry out ongoing cyber awareness training.

This suggests it is not widely considered as a fundamental part of most organisations cyber-resilience strategy, despite the fact many employees rely on their organisation’s corporate network to work. By providing systematic training, healthcare organisations can help workers at all levels better understand the current cyberthreats they face, how they could impact their organisation, the role they play in defending the networks, and develop consistent, good cybersecurity hygiene habits to limit the risks of incidents. 
Consider a degree of separation – Information and Operational Technology (IT and OT) networks should be separated.

Although mutually supported and reliance on each other, employees shouldn’t be accessing one via the other. This should be complemented by a considered tried and tested contingency and resiliency plan that allows crucial services to function unabated should there be a compromise. Similarly, admin terminals should not have internet access to afford a degree of hardening and protection for these critical accounts.

As the sector becomes a common target for fraudulent and malicious activity, putting cybersecurity at the core of the organisation’s operations is critical. It will help limit the risks of disruption due to cyberattacks, reduce time spent by the cybersecurity team to resolve easily avoidable errors, and ensure that institutions can deliver patient care, safe in the knowledge that their networks are safe.  

Fighting future threats

With technology continuing to change the face of healthcare, the surface area and vectors available for attacks by malicious actors is constantly increasing. With the introduction of apps, networked monitoring devices, and a need for communication, the attack vector is ever expanding, a trend that needs to be monitored and secured against.

To prevent any damage to patients, staff, or the organisation they are responsible for, healthcare leaders must put security front and centre of their digital transformation strategy. Only then can the sector harness the full benefits of technology. Doing this should include implementing cybersecurity awareness training to challenge misconceptions around security, encourage conversation, and to ensure employee knowledge of the security basics and threats faced. 

This ultimately allows healthcare organisations to do what they do best: provide the highest standard of patient care, safe in the knowledge that their operations, patients, and data are safe.

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