If you missed yesterday’s blog, the winner of the Innovation Awards was Glycotope for its GlycoExpress platform technology, which optimised glycosylation of antibodies and other biotherapeutics. The award was received by a very proud and happy Jens Pohl, managing director on Oct. 25, 2011.

In other news, UBM Live announced its plans for ICSE USA, which will debut at the Pennsylvania Convention Centre in Philadelphia and run from May 22-23, 2012. Apparently, 60.2 % of ICSE Europe visitors indicated that North America is the main target for business development, and ICSE USA seeks to address this trend. “ICSE USA’s introduction, in conjunction with Pharmapack North America, EAST Pack and MD&M is a win-win across the board. The combined events offer a platform for US companies that are working to address the upcoming blockbuster drugs [patent] expirations to connect with global business contacts and partner with and vice versa,” said Haf Cennyd, brand director of ICSE in UBM’s Show Daily magazine.

RX-360 in 2012

In a press conference Oct. 25, Guy Villax, board member of the RX-360 Consortium and CEO of Hovione, Portugal, was pleased to discuss the recent activities of RX-360 and the positive feedback received from medicines agencies. RX-360 brings together industry and regulators to address the issues of counterfeits and other interruptions to the supply chain, ultimately to protect the safety of patients. Villas was keen to note that RX-360 is a transversal trade organisation that is open to everyone, referring to membership trends in waves, the first being pioneers, the second a flood of suppliers, and the suspected third wave a deluge of generics companies. With current membership at 70 organisations globally, RX-360 has been working closely with regulatory authorities, including the FDA, EMA and WHO, and seems to have won positive feedback from everyone with hopes to expand further afield; Brazil is a target for 2012.

Giving examples of potentially adulterated acetonitrile and the effects of the tsunami and subsequent radiation leaks in Japan earlier this year, one of RX-360’s aims is to provide early identification of issues followed by rapid response, disseminating information through the website and social media channels at virtually no cost.

RX-360 has recently concluded its Audit Pilot, which aims to improve efficiency in the system through two routes. Sharing of redacted supplier audits through a secure database is the first, with joint audits offering further opportunities; sponsor companies can plan ahead through RX-360 and request joint audits to be conducted by a vetted third party auditor. The audit campaign will be rolled in 2012, and is particularly relevant as the Falsified Medicines Directive (FMD) will make it mandatory to conduct audits of all API suppliers every three years.

EXCiPACT – International Pharmaceutical Excipients Certification

RX-360 also sets standards of quality and offers best practice examples, providing summaries of proposed, draft and enacted legislation. Notably, RX-360 has adopted the EXCiPACT standard for excipients, another NPO initiative whose representative, Folker Ruschatz, BASF Pharma presented at a press conference organised by the European Fine Chemicals Group (EFCG). Ruschatz, an EFCG board member, stressed that excipients need to be as closely monitored as APIs in the supply chain, and will also be impacted by the FMD. One of EXCiPACT main objectives is to make risk assessments easier, requesting an increase in periodical, physical audits whilst also reducing the economic burden. Ensuring that cGMP and cGDP standards are set for today and the future, the last year has seen EXCiPACT raising funds with plans to establish an advisory board and begin operations on Jan. 25, 2012. Once again, feedback has been very positive from regulatory bodies, and I hope to be able to report progress at PharmTech.com.

Finally, Guy Villax graced the stage for a second time on behalf of EFCG, this time to talk about the FDA’s proposed Generic Drug User Fee Act (GDUFA, seemingly pronounced ger-doo-fer), which seeks to raise funds of $299 million for FDA “to allow the FDA to do their job on a global scale.” This means, from the Vilax’ point of view, that FDA will be able to accelerate the approval process, promote faster access to lower-cost, higher-quality medicines, and level the playing field―all major steps forward for generics. Watch this space for news and upcoming information.

Thank you for reading, and see you in Madrid in 2012!

It’s a shame that so many communication platforms quickly become corrupted with spam. Of course, it’s not always pharmaceuticals that are being advertised – I’ve had emails about jewellery, fake inheritances and lottery funds, among other things. In the study, however, the authors cite Symantec, which claims that pharmaceutical spam accounts for 65% of all traditional spam email sent.

Since Twitter is a relatively new platform, spam hasn’t reached the same level of annoyance that it now occupies in email inboxes. However, the situation is getting worse as spammers learn how to exploit certain Twitter features.

For those of you who aren’t familiar with twitter, it’s possible to ‘mention’ another user by placing @username in a post. Twitter collects all of these mentions and feeds them back to the user so they know what is being discussed. It’s a really useful feature and I monitor mentions of our Twitter feed PharmTechGroup. Increasingly though, a lot of these mentions contain spam messages. Scammers have realised that using the @username is an effective (and irritating) way to get their spam message noticed.

Spammers also have many other tricks up their sleeve, such as embedding buzz words within the tweet that may be picked up by user searches. It’s frustrating that a platform with so much potential is being corrupted in this way. By the time pharma companies do get a firmer grip on Twitter, any posts to do with medicines may already have a bad reputation. In addition, the proliferation of spam pharmaceutical messages will also make it difficult for users to find official medicines information.

The Akron research is an insightful read (available here) if you’re interested in social media and goes on to describe how to classify and identify pharmaceutical spam. Hopefully, research such as this will eventually help to subdue the spam storm that is building around Twitter, as well as other social media platforms. Most of us just consider spam an annoyance, but a small number of people do follow the links from spam emails to purchase medicines online. There are a number of reasons why people choose to do this, including embarrassment (particularly for impotence drugs) and price.

In the next issue of Pharmaceutical Technology Europe, we will be looking at the danger of counterfeit pharmaceuticals in a special feature on packaging security. We’ll also look at why consumers buy medicines online and what procedures the industry is putting in place to safeguard its products and reputation. The issue is almost ready for print so keep an eye on our website!

Related articles

Is Facebook the place for FDA?

Novartis gets Warning Letter for Facebook widgit

Pharma and social media: ready to make nice?

ABPI releases social media guidance

However, more recently it has been the advertising of such online pharmacies on Google that caused the stir. Along with the supply of counterfeit products, illegal online pharmacies often flaunt the law in terms of prescription requirement; clearly concerned, the United States Department of Justice launched an inquiry in May.

$500 million in settlement money later (which is perhaps, in Google dollars, a slap on the wrist), and a change in Google’s Adwords policy, and we have another victory for regulators…

However, looking at the issue on a higher level, the ever-shifting nature of the Internet coupled with the never-ending enthusiasm of counterfeiters does seem like the recipe for a recurring regulatory nightmare. How exactly do you shut down a virtual company, or stop that same company reopening with a new name or web address the next day? Whose responsibility is it? Should Google censor our search results to preclude illegal pharmacies? “Censorship online? Absolutely not!” shout the masses. In my opinion, inquiries focused on Google, or any other Internet behemoth, is perhaps not the answer; those resources could be better spent elsewhere…

For me, increasing public awareness is the only way forward. Do people know the real risks of buying medicines online or are they merely cavalier in attitude? My personal mail provider (coincidentally, also Google) does a great deal to protect me from the hundreds of emails offering “V1AGRA ONLINE WITHOUT PRESCRIPTION” and the likes, and this is welcome if only to save inbox space and not my health.

But shielding people from the risk is rudimentary. Government programmes highlighting dangers in more consumer friendly ways could be a lot more successful than trying to regulate the million places where illegal pharmacies pervade our increasingly online selves.

Further reading:

Report from Europe: the Falsified Medicines Directive (PharmTech July 2011 issue)

Bringing Online Pharmacies Into Line

Illegitimate Online Pharmacies Drive Counterfeiting, Says Report

In India, Delhi Chief Minister Sheila Dikshit promised earlier this week to fight the public health threat of counterfeit drugs. Speaking at a seminar on combating counterfeit drugs, she urged a policy of zero tolerance toward them, according to an article from The Times of India.

Dikshit’s action plan calls for improved testing of suspected counterfeit drugs and increased vigilance against fakes among pharmacists and regulatory agencies. It also recommended that the State Drug Control Department be strengthened and should focus on halting the spread of counterfeit medicines.

“It is also the need of the hour to have an adequate testing laboratory to ensure that the suspected samples are tested expeditiously,” she said. Dikshit urged pharmacists to ensure that their sources of pharmaceuticals are safe. Establishing a toll-free helpline to receive complaints of suspected counterfeit drugs was also proposed.

These measures launched by China and India will be good steps toward eliminating the spread of illegal fake goods and pharmaceuticals. Because of the growing problem of counterfeits, more efforts will be needed to make strides in eliminating them to protect the health of consumers and the business interests of pharmaceutical companies.

Ghana
Regulators in Ghana last week found that substandard and counterfeit versions of 13 antimalarial drugs were in use in sites across the nation. The discovery of the fake medicines was made possible by the Medicines Quality Monitoring surveillance program, which is a collaboration between the Ghana Food and Drugs Board (FDB), the US Pharmacopeial Convention (USP), and the US Agency for International Development (USAID). The program was established in 2008 and is implemented by USP’s Promoting the Quality of Medicines (PQM) initiative, which aims to improve the drug quality in developing countries.

A recall of the antimalarial drugs was initiated, and the names of the outlets where the drugs were uncovered were publicized. According to a USP press statement, the release of those locations was “intended as a strong deterrent, making pharmacy and hospital procurement personnel more vigilant about their suppliers.”

Patrick Lukulay, director of the PQM program, said, “It’s important to keep in mind that all these fake and substandard medicines were found just in one round of postmarket surveillance, just of antimalarials. The existence of many more substandard and counterfeit medications for other types of medicines and in other locations and facilities must be assumed. Public education and official collaborations between public and private sectors are both essential to protecting public health here in Ghana and in many other developing nations.”

Liberia
Liberia established a new regulatory authority to oversee the country’s medicines by signing into law the Liberia Medicines and Health Products Regulatory Authority (LMHRA) Act earlier this month. The legislation addresses the growing problem of substandard and counterfeit drugs in the nation’s market, according to a USP press release. USP’s PQM found that postmarketing sampling and testing that the organization conducted in March 2010 revealed a failure rate of 44% when 104 of 234 samples tested failed either simple disintegration, thin-layer chromatography, or both.

“We celebrate this important milestone in the history of the pharmaceutical sector of our country,” Reverend Tijli Tarty Tyee, Sr., chief pharmacist of the Republic of Liberia, said in the press release. “We believe that the implementation [of this Act] will be the most important aspect of the law that can ensure the protection of the citizens within our borders.”

Zambia
A pharmacist in Zambia called on the government last week to empower regulators to help fight the spread of counterfeit drugs. According to an article in the Zambia Post, Christopher Sakala said in a presentation during the Stop Stockout Campaign anticounterfeiting seminar in Lusaka that the country’s Pharmaceutical Regulatory Authority needs more inspectors, saying that five for the entire country conducting inspections at two entry points is simply not enough.

“The Pharmaceutical Regulatory Agency needs to be equipped properly. It is a professional body that works very hard to check on the quality of medicines the Zambian patients consume. This is a body that is serious with issues of public health, but they work under difficult conditions,” Sakala said.

He also advised health institutions to employ licensed pharmacists to distinguish between legitimate and counterfeit drugs.

See related PharmTech articles:

USP and USAID Launch New Program to Improve Drug Quality

Sproxil’s Mobile-Phone Technology Tracks Medical and Food Donations, Prevents Diversion

An International Web May Trap Pharma Counterfeiters, but It Won’t Keep Them for Long

When Substandard Drugs and Developing Nations Collide

Systech International is a provider of packaging execution systems, and Marchesini Group USA focuses on labeling technology. The two companies showcased their integrated platform designed for global serialization requirements for the pharmaceutical industry. The demonstration featured Systech’s Serialized Product Tracking (SPT) solution integrated with Marchesini’s labeler and casepacker to show a complete packaging environment for serialization in real-time production mode. Joe Ringwood, COO at Systech, and Roger Toll, executive vice-president at Marchesini, shared their thoughts about the show.

PharmTech: What were some of the hot topics at this year’s Pack Expo? What were people buzzing about?

Ringwood: At this year’s show, some of the hot topics that we saw and heard were an emphasis on overall equipment effectiveness (OEE) and line efficiency. This information was prevalent at exhibitors’ booths, speaking sessions hosted by the event, and in the discussions we had with attendees.

Toll: Robotics and line efficiency.

PharmTech: What were the top concerns of clients and people visiting your booth?

Ringwood: One of the major concerns attendees had with implementing serialization was the impact of IT touching the packaging line and ultimately impacting OEE. Whether we discussed authentication or track and trace, employing these initiatives on the packaging line and through the supply chain requires a very high quality of serialized data. We discussed that in order to ensure that bi-directional communication can occur between IT and packaging when executing serialization, manufacturers need a packaging execution system (PES) infrastructure. By managing data between the packaging line and the enterprise, a PES will need to protect data integrity at the enterprise level while ensuring packaging line throughput. Implementing productized, configurable, and expandable serialization solutions that leverage a PES infrastructure, manufacturers can protect data integrity while also quickly and cost-effectively meeting new demands and maintaining operational efficiency.

Toll: Projects seem to be starting to come back on line after restrictions were in place for a couple of years now. People were also concerned about mergers and the effect that they are having on us all.

PharmTech: How did this year’s show compare with previous years, particularly in terms of today’s economic climate?

Ringwood: We observed several differences between this show and Pack Expo 2008. First, we saw an increase in the amount of foot traffic starting on Sunday through Tuesday. Second, from our perspective, there were more quality leads that we were able to capture than two years ago. Third, the number of vendors exhibiting serialization/track-and-trace solutions were down from two years ago. However, the customers and attendees that we spoke to were interested in serialization and sought information about track-and-trace solutions. Last, attendees had actual projects that they were working on and we think that may have affected the amount of foot traffic and types of conversations we were having with them in their search for vendors.

Toll: This show did not have the same volume of customers in our opinion; however, we did get a higher quality of meetings and project discussions than ever before.

PharmTech: What are your overall impressions of the show?

Ringwood: It was a great show and very beneficial for us. It provided us with an opportunity to meet with customers, prospects, potential partners, and current partners. Additionally, show attendees were able to view a Systech–Pester Pac solution that a major pharmaceutical manufacturer will deploy at their packaging facility. Attendees also had the opportunity to see Marchesini showing a functional configuration of a casepacker and a labeler running our vision inspection, line management, and serialization solution with post-lot rework and manual pallet-building stations. Overall, the show provided us with a great way to unveil some our new products, work with our partners to showcase integrated serialization solutions, and speak with show attendees about what their needs and challenges are.

Toll: It was better than previous years.

Systech also partnered with Pester Pac Automation, a supplier of end-of-line packaging systems, at Pack Expo to showcase a serialization solution the companies created that is designed to support track-and-trace and authentication initiatives. In the solution, Systech’s SPT handles serialization, delivers data to enterprise IT systems, and integrates with Pester’s end-of-line equipment, which includes a top-loading casepacker, a two-station palletizer with a 6-axis KUKA robot, and an interlayer slip-sheet magazine. The booth exhibit showed the same system that will be deployed by a major pharmaceutical manufacturer, according to a company press release.

Look for more on the pharmaceutical industry at next year’s show—Pack Expo’s organizer, PMMI, announced earlier this week that due to industry requests, it will add a Pharmaceutical Pavilion at Pack Expo Las Vegas 2011.

Internet pharmacies were seen as a major source of counterfeit drugs and a significant driver of the worldwide problem. The authors of the report analyzed more than 100 websites and found the following:

• 95.6% of online pharmacies researched are operating illegally
• 90.3% of websites do not require sight of a prescription
• 86% of online “pharmacy approval” stamps are fake
• 78.8% of websites are violating brand intellectual property
• 50% of medicines supplied by online pharmacies which conceal their physical address are fake.

“Although there has been some debate around the size of the worldwide counterfeit medicine market that has been estimated at $75 billion and upward, one cannot dispute that the unregulated growth of Internet pharmacies will only contribute to this problem,” Rainuka Gupta, Group Manager of Medical Technologies at Cambridge Consultants, said in a company statement. “Our research concluded that this presents both a dual threat to consumers and the industry alike. Easier access to cheaper drugs has exposed consumers to dangerous mixes of fake drugs and placebos. Meanwhile, pharmaceutical companies risk losing credibility and regulatory bodies risk losing control with the spread of these counterfeit medicines. As an industry, we need to better educate consumers on the threats associated with fake drugs, but we also must work together to coordinate and implement technologies that can detect and deter counterfeiters.”

The report gives further statistics on the spread of counterfeit drugs, stating that in Africa and Southeast Asia, the World Health Organization has estimated that about 50% of medicines could be fake. Worldwide, WHO estimated that 15% of all drugs are counterfeits. In the United States, the Customs and Border Protection Agency stated in 2008 that the value of seizures of counterfeit pharmaceuticals had increased to $11.1M in 2007, which is a 500% increase on 2006, says the report.

Regarding regulations, the authors acknowledge the complexities facing governments when drafting policies for counterfeiting and diversion. Regulations should be flexible, for example, so manufacturers can use new technologies to keep ahead of criminals, given the time needed to shape new regulations and enforce them. This is why many feel that regulations should focus on standards and not on specific technologies required to combat counterfeiting, according to the report.

The issue of punishing counterfeiters was also discussed by interviewees involved in the report, who believe that stricter laws and penalties are required. According to the report, “Currently, in some countries, counterfeit drugs are not illegal; or are a violation of trademark laws; and in many countries the punishment associated with counterfeiting is a fine, which is small in comparison to the revenues generated by the sale of counterfeit products, and not reflecting the potential harm of counterfeit drugs.”

Cambridge Consultants held a panel on counterfeiting during the 2010 BIO International Convention earlier this year, which featured representatives from Amgen, Genzyme, and BIO.  The panelists discussed three different types of technologies that can be deployed (anti-tamper packaging, serialization, and authentication) to fight against counterfeit pharmaceuticals. Given the global nature of counterfeiting and diversion carried out by organized criminals, the panel and research participants agreed that collaboration among various stakeholders, including manufacturers, supply chain partners, and law-enforcement entities, is critical to address the problem.

See related PharmTech articles:

Authentication and Pharmaceutical Protection: An Industry Roundtable (Pharmaceutical Technology magazine)

New Report Addresses Pharma Execs’ Top Supply-Chain Concerns (blog post)

Report: Online Drug Brand Abuse on the Rise (blog post)

New Report Focuses on Yahoo’s Rogue Pharmacy Advertisers (blog post)

Reports Point to Increased Counterfeit Drug Activity (blog post)

Half of the respondents said the biggest area of risk is raw materials sourced outside of the US. Sixty-one percent said contaminated or nonconforming raw materials was the top threat in the next five years.

Drug counterfeiting and diversion were seen by executives as major threats to their global supply chains in the next five years, with 44% and 35% of respondents, respectively, citing them as risks. Forty percent of all respondents that produce life science products reported that their company’s products have been counterfeited or illegally diverted. The report says that these threats were “virtually non-existent” as little as 10 years ago, which underscores the rapid growth of the problem of counterfeit drugs.

The growth of globalization presents challenges to industry that the report grouped into three broad categories: on-demand visibility, control over the supply network, and the need for collaboration.

In terms of visibility of their supply chains, 77% of executives said that their primary means of gaining visibility into suppliers’ practices is a periodic audit, 25% said they share common practices and 3% have access to real-time data. The report states that the lack of on-demand visibility is due to the slow speed of gathering information about a company’s supply chain. Regarding the ability to merge data from multiple locations to provide a global view of the supply chain, 66% said they could do it, but they must manually aggregate the data; 15% said that it was not possible; and only 19% said they could do it in real time.

When asked about track-and-trace and serialization technologies, which can help industry gain control over the supply chain, survey respondents said the hurdles to implementing such technology are cost; difficulty of implementation; lack of industry standards; and lack of regulatory requirements and guidance. In terms of specific technologies in use or planned by the executives, 79% said their company uses barcodes, 57% use 2D barcodes, 34% use RFID, 17% use GPS tags, and 8% use none of these measures. Most executives said they could track manufacturing location (84%) and genealogy such as raw material, ingredient, etc., (73%), but 50% or less were able to track elements such as transaction history, chain of custody, record of ownership, environmental storage conditions, and ePedigree.

Industry executives identified the need for collaboration, and said their preferred method for creating best practices around standards is through industry consortium such as the Pharmaceutical Supply Chain Initiative, the Experimental Physics and Industrial Control System, and the Rx-360 consortium.

“It is sad to realize that we live in a world in which some criminals are willing to maximize profits by placing poisons in products like infant formula, toothpaste and medically necessary drugs. But it is a reality we must face. And, more importantly, it is a reality that we must become more proactive in dealing with,” Hamburg said.

Hamburg gave several examples of high-profile cases of the harm that fake and adulterated drugs can cause, including the deaths of children in Haiti, Panama, and Nigeria, due to cough syrup and teething medication poisoned with diethylene glycol; the injury and deaths caused by adulterated heparin in 2008; and adverse reports of ineffective insulin, which is believed to have lost its potency after it had been stolen months before and most likely had not been handled properly.

FDA used lessons learned from the heparin crisis to develop a risk-based approach for identifying drugs and active pharmaceutical ingredients that could be targeted for adulteration. Hamburg explained:

“To date, the FDA has systematically ranked more than 1000 active pharmaceutical ingredients in order of their respective risk of economically-motivated adulteration, based on a multifactorial risk-based model that we developed. A subset of these high-risk ingredients is targeted for additional sampling and testing at the border. In addition, FDA is working to reduce the risk that counterfeit or adulterated drug products reach consumers in the US market by developing standards for track-and-trace systems that enable the identification of these products and facilitate efforts to recall them.”

Hamburg said that in addition to new anticounterfeiting technologies such as track-and-trace and authentication systems, more regulatory authority is needed by the agency to help keep counterfeit drugs out of the supply chain. “It is clear that FDA needs new regulatory tools that provide the authority we need to meet the challenges we face in today’s increasing globalized marketplace,” she said. “And we look forward to working with Congress on legislation that will give FDA the ability to protect Americans from harmful drugs and medical products—and fulfill our fundamental public health mission.”

More than a hundred governmental and industry stakeholders attended PSM’s inaugural event to discuss solutions to fight counterfeit and adulterated medicines. The Generic Pharmaceutical Association recently became a member of PSM, joining organizations such as the Biotechnology Industry Organization, European Federation of Pharmaceutical Industries and Associations, National Association of Boards of Pharmacy, Pharmaceutical Research and Manufacturers of America, and World Health Organization in the global effort to eradicate unsafe drugs.

Hamburg’s remarks can be viewed on C-SPAN’s video library.

For further reading, see PharmTech’s recent special report on anticounterfeiting technology, “Authentication and Pharmaceutical Protection: An Industry Roundtable.”

The company plans to aid donor organizations in preventing the diversion of drugs, medical supplies, and food and confirming the receipt of these goods by people in need. The anti-diversion program will be implemented in countries that receive large amounts of donated goods such as India, Nigeria, and South Africa.

“Beginning in 2011 Sproxil will leverage its mobile phone technology to empower patients and beneficiaries to verify that they obtained genuine medication and give donors better tools for remote monitoring and evaluation,” said Dr. Ashifi Gogo, CEO of Sproxil, in a press release. “Our goal is to have products like Long Lasting Insecticidal Nets (LLINs) bear simple tags that end-users can use to confirm receipt of a donation with a basic cell phone, providing donors with a record that their relief efforts are bringing benefits to the right groups, not being funneled into accounts controlled by corrupt elements or criminals.”

Sproxil’s donation-tracking program is based on its expertise in what the company calls “participatory product tracking” in which consumers use cell phones to verify the legitimacy of products. Using LLINs as an example product, the program would work as follows. The LLIN bears a scratch off code. When a beneficiary receives the LLIN from the donor organization, he or she scratches to reveal the code on the product. That code is sent via text message and the person receives confirmation that the donated product is legitimate. At the same time, the donor organization confirms that someone has received the LLIN.

Under Sproxil’s anti-diversion program, donor organizations will have the ability to monitor and evaluate the status of the donated goods. “Sproxil will provide donors with analytic tools to track information in real-time and analyze historic trends,” Alden Zecha, CFO and strategist of Sproxil, told Pharmaceutical Technology. Sproxil is working with analytic software tool providers such as IBM to develop the analytical solutions, according to Zecha.

Sproxil has successfully implemented a similar mobile-phone-based system for anticounterfeiting in Nigeria, as discussed in Pharmaceutical Technology’s recent special report on anticounterfeiting technology.

The program will be presented today at the Technology Plenary session of the CGI. A webcast of the session is available on the CGI website.