The barrage of stories about the compounding pharmacy scandal and the meningitis outbreak, which has claimed 20
The survey, which is ongoing, tracked 398 active digital health consumers, who were defined as people using the Internet and social media to search online for health content during a six-month period just prior to the news of the outbreak. They were given stories and news summaries to review about the unfolding drama between October 9 and October 15.
A total of 14 percent, or 55 people, encountered content about the outbreak. Of that group, there were 202 responses to a single question about the impact of the content on their safety perceptions - were they more likely to be concerned about safety? And 63 percent of the 202 responses indicated safety concerns. Their responses, by the way, were recorded immediately.
While this is a small sample, the results offer a window into consumer reactions, if only because the stories - seen on Yahoo, Facebook, Twitter and via e-mail - underscored confusion and uncertainty about the ability of the FDA to regulate compounding pharmacies. The agency claims its enforcement powers were greatly limited by a US Supreme Court ruling a decade ago.
Enspektos, a health marketing consulting firm, is still conducting the survey, but says the preliminary findings suggest that negative online content about a health crisis can influence consumer perceptions immediately after it is read, and highlights the role of e-mail and traditional online news outlets on the spread and consumption of important health information.
And there is a lesson here not only for regulators and policymakers, but also the pharmaceutical industry, because Enspektos founder and president Fard Johnmar notes that, even though the medication is different from a regular prescription drug, the overall story is similar to other safety scandals that have received widespread attention over the past decade.
"This research represents the first time we've been able to understand - in real time - how health content consumed on online news sites, e-mail and other channels is influencing perceptions of an ongoing health crisis," he writes us. "We're not relying on assumptions about the impact of content tonality on opinion. We're also not conducting surveys where we ask people to recall the impact of news content on their current mindset.
"Instead, we're capturing data on how specific news stories, with specific messages published in specific media is influencing perceptions of the meningitis outbreak. This information can be used for a range of purposes, including efforts to keep the public better informed about this serious issue" (you can read more here).
Separately, shortly after the meningitis outbreak became a widely known story, more people online were turning to the US Centers for Disease & Control Prevention than the FDA for information. In fact, the ratio was 4.5-to-1 on October 8, just four days after the agencies began issuing notices about the outbreak, according to a different analysis.
"I believe it's because the CDC is respected for its work in infectious disease, even though this was due to a contaminated drug that was not causing an infectious outbreak," says D’vorah Graeser, ceo of iMedSocial, a social media consultancy in public health and life sciences. "Also I think the FDA was not perceived as part of the solution, and maybe part of the problem."
[UPDATE: This afternoon, the CDC and FDA confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate - 80mg/ml - from one of the three implicated lots from NECC. The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections. Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues (here is the statement)].
shock pic thx to ogimogi on flickr
3 Comments
Congress, bribed by Pharma, has rolled over and played dead on this issue long enough, as has the Administration - which receives its own share of campaign cash.
It is estimated that 200,000 Americans every single year die from the lethal side effects of allegedly "safe" prescription drugs. When will enough be enough?
In addition to the American Society of Health System Pharmacists, doctors and patients might want to check to see if a compounding pharmacy follows and is accredited by the Pharmacy Compounding Accreditation Board (PCAB) Ref: http://www.pcab.org/about
While there are calls for more FDA oversight of compounding, were existing regulations properly enforced?
Would new oversight and jurisdiction of compounders be based on FDA jurisdiction and enforcement capacity over U.S. manufacturers, or would it based on federal authorities more limited capacity and jurisdiction over foreign manufacturers?
If FDA gains oversight of compounding pharmacies, given that their jurisdiction and capacity limits their oversight of some foreign manufacturers, would and could this create a double standard, and also, would it precipitate a new round of pharmaceutical company outsourcing? Many U.S. compounding pharmacies are independently owned small businesses. Could they or would they be able to adhere to and compete with global pharmaceutical manufacturers who can and do outsource to foreign countries where there is a lower level of FDA jurisdiction and oversight?
As reported commercially approved versions of the contaminated steroid contain a preservative that may cause serious side effects in some patients. In addition, the medicine in question has been on shortage and may have been discontinued in-part because of FDA manufacturing issues. The drug shortage, potential shortfalls in FDA's ability to oversee and enforce current pharmaceutical manufacturing quality standards, and the stated potential for complications indicates that it is medically necessary for some patients to use compounded drugs because the commercially approved drugs are contraindicated.
What happened at NECC is tragic, and the company and the executives deserve what is happening and about to happen to them.
That being said, it would seem to me that the decision of whether or not to risk the use of either a compounded drug or the commercially manufactured drug lies between the patient in consultation with their doctor and pharmacist, and that it should not be influenced or decided by FDA or CMS officials (who may revoke payment and leave the patient responsible for the bill).
As for quality concerns with compounded drugs, most members of the public - including a lot of physicians- fail to realize that prescription drug recall authority is voluntary and lies with manufacturers and distributors.
The FDA website indicates that most of the time, even after they issue a FDA Warning Letter deeming drugs adulterated due to manufacturing issues, it is safe for patients to continue to take them. http://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm
"If a manufacturer is not following cGMPs, are drug products safe for use?
If a company is not complying with cGMP regulations, any drug it makes is considered “adulterated” under the law. This kind of adulteration means that the drug was not manufactured under conditions that comply with cGMP. It does not mean that there is necessarily something wrong with the drug. For consumers currently taking medicines from a company that was not following cGMPs, FDA usually advises these consumers not to interrupt their drug therapy, which could have serious implications for their health. Consumers should seek advice from their health care professionals before stopping or changing medications."
Many doctors and pharmacists are not aware of FDA actions, including 483 inspection reports, FDA Warning Letters deeming drug adulterated and/or FDA Import Alerts and bans of adulterated drugs from foreign countries. They are also not aware that the FDA does not have recall prescription drug recall authority, and that FDA jurisdiction and oversight over drug distribution is limited.
So, how can doctors and pharmacists possibly provide their patients with the information that they need to make an informed decision and, in turn, how can the patient give informed consent?