Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

Want to know what the future of pharma science looks like? AAPS knows. They recently awarded several graduate students for their work in research and development, pharma analysis, drug delivery, bio- and nano-technology, and more. PharmTech had the chance to talk with some of the winners and their stories appear in the December issue of PharmTech. You can get a sneak preview of the students’ winning research via a video podcast on PharmTech.com and the 

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Want to know what the future of pharma science looks like? AAPS knows.

Grad Student Innovation

The editorial offices of PharmTech are based in New Jersey, so when Hurricane Sandy hit last month, we were all affected. Flooding and high winds destroyed many coastline homes along with well-known destinations across Atlantic City, the Jersey Shore, and the neighboring Manhattan boroughs. Suburban communities and businesses (including many US biopharma manufacturing headquarters) across the state were without power for days and schools were shutdown for a week or more in several counties. President Obama declared the state, along with New York, a major disaster area. The entire ordeal was quite surreal, and our team considers ourselves to be lucky that we made it through unscathed. Our thoughts go out to those who are still recovering from the storm and trying to get back to normal.

		Many common questions arose during the hurricane and its aftermath, including how long food products could be considered safe to eat without refrigeration and where the closest open gas station was to refill generators. Pertaining to our industry were questions about medications that required refrigeration (primarily injectables and liquids), prescriptions that needed refilling (many doctors’ offices and drugstores were closed due to flooding and power outages), and drug products that had gotten wet or been lost in the storm.
		Fortunately, FDA has a consumer 

 devoted to drug safety after a natural disaster, whether it be exposure to fire, unsafe water (key for drugs that have to be reconstituted), or lack of refrigeration. Certain life-saving drugs (e.g., insulin) can be used even if not cold as long as they are not past their expiration date, says the agency webpage.

		There are also some rules of thumb to follow in any emergency-preparedness plan. Many patient advocates recommend having on hand a 30-day supply of regularly used medicines (both prescription and over the counter), as well as extra quantities of devices needed to administer medications. But as a consumer, it seems there should be even more information available for those unfortunate times when something out of human control affects the medications we need.

		Drug labels are already quite lengthy, but it may be worthwhile to add a few more details. For instance, language may focus on how long a cold-chain medicine can go without refrigeration, or how long a drug exposed to excessive heat can be considered safe, or the reasons behind drug-product expiration dates. Some of these details may be provided in medication guides that come with drug products, but even those of us in the pharma industry know that the majority of end users do not read those packets in full or keep them. This is probably an area where FDA and pharmacists can do a better job educating consumers about the importance of guides.

		Another piece of information worth including on labels may be where to find information during emergency situations. As so many discovered during Hurricane Sandy, we rely heavily on technology to get our information. Smart phones, in particular, became indisposable in the aftermath of the storm when power outages held hostage traditional television, phone, and Internet access. Pharma companies could consider, for example, having active Twitter feeds during emergencies so that people can still access crucial information.

		Various disasters and crises are bound to affect the global community in the future. Now is the time to think more about the crucial information we will need to have on hand–and attached to our medications–when that next time strikes.

The editorial offices of PharmTech are based in New Jersey, so when Hurricane Sandy hit last month, we were all affected.

When Disaster Strikes at Home

		Laboratory best practices for meeting regulatory and compendial requirements are changing. FDA’s emerging expectations on data integrity, operational qualification report generation, along with the ISPE GAMP Good Practice Guide for Validation of Computerized Systems have provided the industry with new ways to approach laboratory compliance. In addition, the status of USP Informational Chapter <1058> on analytical instrument qualification is being discussed across the industry and the pharmacopeial body. A stimulus paper is being written on this chapter, offering some revision proposals.

		Paul Smith, EMEA and India Compliance Program Manager at Agilent, spoke about these issues and offered some best practices for moving forward in an educational webcast. You can watch the webcast for free on demand 

Laboratory best practices for meeting regulatory and compendial requirements are changing. FDA’s emerging expectations on data integrity.

Changing Trends in Laboratory Compliance

On Oct. 3, 2012, NPR's Richard Knox reported on a growing trend in identifying infectious diseases and new viruses. The World Health Organization (WHO) issued an alert in September about a new SARS-related coronavirus that affected a Qatari man who had recently visited Saudi Arabia. Another Saudi Arabian man died in July from the same virus. In the US, the Centers for Disease Control and Prevention (CDC) identified a new tick-borne virus, being called the Heartland virus, in Missouri in late August. And recently in the Democratic Republic of Congo, researchers identified a new Rhabdovirus associated with hemorrhagic fever, based on an outbreak that started in 2009.  

"The most striking thing about all three new viruses is that they were found on the basis of just two or three human cases," said Knox in his NPR report. "That's a long way from where the world was 10 years ago, when another new virus popped up in Asia [SARS] and quickly went global."  

In fact, the 2003 SARS virus affected 8000 people in 26 countries before it was brought under control, according to the WHO website. One key difference with the original SARS is that Chinese authorities did not immediately notify the public of the outbreak, which started in 2002 in the country's Guangdong Province, leading to something of a wild goose chase for global health workers. Another difference is that the way the world communicated was very different, even just 10 years ago.  

"Today, we would have seen that information bubbling up in many different places," John Brownstein, PhD, of Boston's Children's Hospital (BCH) told Knox in the NPR report. Brownstein helped to create a real-time website called 

 and a related mobile app called Outbreaks Near Me. Both technologies collect and post information on global disease outbreaks 24 hours a day, 365 days a year, with the goal of facilitating early detection of global public health threats.  

Digital disease-detection programs like Healthmap are on the rise and are having a big effect on how fast virus news can spread. Google has a population-tracking website for influenza epidemics that monitors trends worldwide. A similar tracker, Influenzanet, has been monitoring flu-like viruses across Europe since 2003. Canada's Global Public Health Intelligence Network is an Internet-based early-warning system that gathers public health reports in real time from global media sources in six languages. And the US CDC's BioSense 2.0 program, which launched in 2011, tracks evolving health problems across the country to get word out to healthcare authorities and patients quickly. Taking this a step further, President Obama enacted the first US National Strategy for Biosurveillance over the summer. The strategy, based on the government's counterterrorism efforts, enables the Department of Defense to track and analyze disease-related activity with an eye towards early warning and detection.  

Another catalyst for the move towards rapid global disease identification and response has to do with new global regulations. WHO enacted new binding International Health Regulations in 2005 (they hadn't been updated since 1969 and, until 2005, only included cholera, yellow fever, and dengue) that require countries to report certain disease outbreaks and public-health events.  

And let's not forget the power of social-media platforms. At the BCH's 2012 international conference on digital-disease detection, an entire session was devoted to Twitter, in which John Dredze of Johns Hopkins University, among others, spoke about using the social media to mine public health information. Using algorithms, Dredze's team identified 1.6 million health-related tweets between Apr. 2009 and Oct. 2012, and categorized them into 15 fields, such as common cold, cancer, and depression. Courtney Corley and his team at the Pacific Northwest National Laboratory presented research into how social media conversations can be used to identify emerging concerns about vaccine safety.  

In general, social media and the Internet have opened a world in which scientists, healthcare professionals, academics, regulators, and patients can work together to bring light to new or growing diseases before they spread in mass numbers, thereby strengthening global public protection in ways we never thought possible. As new viruses and infectious diseases emerge—and they will—it's good to know we have such information technologies at our disposal. As they say, knowledge is power.  

Global tactics that incorporate online technologies and social media are reshaping disease response.

Knowledge is Power

Just before Hurricane Sandy hit the East Coast, on Friday, Oct. 26, 2012, FDA was in full swing. The agency released a copy of a Form 483 issued to the New England Compounding Center (NECC), which has been under investigation for violating the Federal Food, Drug, and Cosmetic Act. For back story, see the video on 

 regarding the compounding center and its connection to the recent fungal meningitis outbreak. 

 “FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Massachusetts facility,” states the FDA press release. Specifically, investigators observed problems with the center’s cleanroom maintenance and monitoring program, as well as concerns with sterility of raw materials used in its products.  

 “The inspection report for NECC has not been completed and is not being shared at this time,” says the release. FDA is still working with the US Centers for Disease Control and Prevention and Massachusetts partners regarding fungal meningitis outbreak and those patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid, according to the release. 

New England Compounding Center gets 483 after linked fungal meningitis outbreak.

FDA Issues 483 to New England Compounding Center

	The East Coast, including PharmTech’s offices, is largely boarding up and shutting down in preparation for Hurricane Sandy.  But the FDA is still keeping vigilant. Just before the weekend, on Friday, Oct. 26, 2012, FDA released a copy of a Form 483 issued to the New England Compounding Center (NECC), which has been under investigation for violating the Federal Food, Drug, and Cosmetic Act.

	“The inspection report for NECC has not been completed and is not being shared at this time,” says the release. FDA is still working with the US Centers for Disease Control and Prevention and Massachusetts partners regarding fungal meningitis outbreak and those patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid, according to the release.

 regarding the compounding center and its connection to the recent fungal meningitis outbreak.

The East Coast, including PharmTech’s offices, is largely boarding up and shutting down in preparation for Hurricane Sandy.