I’ve just returned from Riyadh, Saudi Arabia where both the Saudi FDA and the Ministry of Health are embroiled in the current MERS (coronavirus ) crisis.
It’s already cost the Minister of Health his job and many citizens are questioning the ability of the government to protect their wellbeing. It’s also an international news story that does not reflect well on the Kingdom.
Another reason to reexamine the state of overall health preparedness – and not only in Saudi Arabia.
A good place to start is with a serious conversation on 21st century pharmacovigilance. Let’s start with definitions.
According to the WHO, “Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
Okay as far as it goes. But this is a very 20th century perspective. Perhaps a more progressive view comes from our regulatory cousins at the MHRA, “Assessing the risks and benefits of medicines in order to determine what action, if any, is necessary to improve their safe use.”
The significant difference is that most regulatory officials still view PV through the lens of adverse events. The MHRA definition, however, broadens the conversation to include safe use. That’s 21st century pharmacovigilance.
What does this have to do with the coronavirus?
It speaks to the need of public health officials to be both the guardians of the public health as well as the watchmen. And that takes more than vigilance – it takes resources. It also takes a village – a public health village – comprised not just of public officials, but physicians, nurses, pharmacists, hospitalists, patients, and caregivers.
And it’s got to be more than MedWatch.
How much sooner could the coronavirus been identified and dealt with if the Saudi Ministry of Health had a more robust mechanism for post-market surveillance that went beyond adverse events?
But it’s not just the Saudis.
The FDA is establishing an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic and over-the-counter drugs, CDER Director, Dr. Janet Woodcock said at the Bloomberg health-care summit. The FDA is talking with the industry to develop data that may signal which manufacturing plants are straying from standards and need inspection, she said.
The agency now collects such information only during inspections. The thrust of the effort would be to head off potential concerns before the agency wields penalties such as banning products from troubled factories. “We want to use leading indicators. These people aren’t in trouble yet but they could be.”
Forewarned is Forearmed.