(This is a preview of the next upcoming issue of The Safety Report, a publication dedicated to educating professionals about safety, liability and consumer items)
Inventory management is an art in itself: to know how much to ship, when, time to destinations, the right cost at the right time. Add risky products or pharmaceutical products to this process and you have a lethal combination of responsibility, but hopefully financial rewards for offering something unique. However, what about when something goes wrong? Or worse, what if the users or consumers arenâ€™t aware of all the effects?
This year, more than 300 recall instances of pharmaceutical-related items will occur, accounting for more than 50mm units of life-saving drugs, sometimes hospital administered, other times over the counter.
Pharmaceutical production is up nearly 30% over the past few years. In fact, according to Pharmaceutical Research and Manufacturers of Americaâ€™s 2013 Biopharmaceutical Research Profile, research and development (R&D) in the consumer medicines space was estimated at $48.5 billion in 2012; in 1980, while it was estimated at $2 billion. At more than 5,400 medicines now in clinical development, there are no signs of the pace slowing down.
For an industry that has and will continue to see massive growth, safety becomes an even more important issue. For many pharmaceutical companies, issues with factories or conditions can lead to large recalls on non-prescription or OTC (over the counter) drugs in which the volume of units affected are spread across the globe and within hundreds of retailers and retail locations.
Often â€œcompoundersâ€â€”or locations that act like high-scale pharmaciesâ€”have also been overlooked by federal regulators, such as the FDA, in lieu of state regulators that can be ill-equipped or not understanding of compliance needed to ensure safety. This means that when issues hit a compounder, it can affect multiple brands and companies as was the case in August 2013 when more than 56 compounders were investigated, triggering all lots of 45+ different products, according to a FiercePharma report.
In some cases, the products can be household aspirin; in other cases, it could be more complex medicines such as Nimodine, which recalled more than 46,000 cartons of the brain hemorrhage treatment due to crystallization. Just imagine how many medicines are in the average consumerâ€™s medicine cabinet?
â€œCommunication is critical in OTC recalls to ensure that the product is removed from the marketplace in rapid and accurate fashion.â€ says Mike Rozembajgier, vice president of recalls for ExpertRECALL. â€œThis needs to occur through multiple channels to accommodate all affected parties and limit confusion within the crisis.â€
According to the FDA, more than 48% of the American population is on one or more prescription medication and 1 in 5 Americans are believed to be on three or more prescription medications. Add a few medicines for the common cold or headache and there are a lot of potentially lethal or harmful items loaded in the medicine cabinets of every consumer home.
The problem isnâ€™t quality per se; there are several large hurdles to deal with especially in regards to volume. While recalls are initiated faster than ever, some doctors believe recalls can be activated too soon, that clinical trials are limited and often a drug should be prescribed more diligently. For example, certain drugs not prescribed to those who are pregnant or have other known risk factors for particular side effects. But, with lives on the line, reaction is often pushed more than prevention.
For some doctors, this is seen as a disservice to well-made drugs, explains Kenneth Andrews, M.D., of NYU Medical Center.Â “What you donâ€™t want is for a drug that is effective in one population being removed from the market because it may adversely affect a particular segment of the population,â€ he says. â€œA classic example would be thalidomide, an anti-nausea medication that resulted in tragic birth defects for thousands of children born in the 50s and 60s. This medication was subsequently removed from the U.S. market, but is still a very good anti-nausea medication that could be used to greatly benefit nonpregnant cancer patients.
â€œAs all medications have side effects, the goal should be to determine for which populations the benefits outweigh the risks from a given medication,â€ he adds, â€œthus allowing doctors to make the most judicious use of the drugs available.â€
Supposing recalls are simply an exchange for fast development and getting life-saving drugs in the hands of consumers faster, it also leads to criticism of advertising and social media practices.
Most sales departments have full-time marketers to approve and distribute content related to brands. But for medicines and highly regulated pharmaceutical items, the approval process can take much longer to meet industry standards, putting companies at an disadvantage competing with fast moving social media channels, such as Twitter or Facebook.
A consumer complaint could go viral in the hundreds of thousands before legal even approves of a recall notice, let alone what could be communicated to others online or publicly. The issues with a particular drug could even be unknown to a manufacturer while trending online with consumers.
How do you ensure accurate information is disseminated with companies that are regulated, but consumers are not? Said one unnamed executive of an international pharmaceutical company, â€œItâ€™s unfair. You try to do the right thing, but in a regulated space you often need approvals from so many areas it makes it impossible to play on the offensive.â€
Consumers, on the other hand, are seemingly oblivious to understanding medication side effects or doses, with 70% of patients actually taking their prescriptions as prescribed. Take three different prescriptions, taken at 70% accuracy, and now we have high odds of something going wrong and public health being put at risk, instead of treated.
While social media growth shows no signs of slowing down, apps for safety and information are nearly nonexistent. In a world in which a recall can be one click away, how are pharmaceutical companies expected to keep up?
â€œSocial media creates significant opportunities to manage the message in the marketplace and ensure it is accurate,â€ says Rozembajgier, whose company has been handling many of the increased pharma-related recalls. â€œ[However,] it must be managed carefully as the speed of social media can result in greater damage if bad information percolates for a period of time.â€