With 2012 near, generics still face challenges
In February, Drug Store News discussed three issues concerning generic drugs that would figure prominently throughout the year: drug safety, user fees and patent settlements.
None of those issues have gone away. Fears recently surfaced that Ranbaxy might not get to launch its generic version of Pfizer’s cholesterol medication Lipitor (atorvastatin) this month due to concerns about safety at two of its plants in India, but it appears the scheduled launch is back on track. The Food and Drug Administration’s Office of Generic Drugs needs increased funding to address its massive backlog of generic drug approval applications, something that user fees would address, but the Generic Pharmaceutical Association has been pushing Congress to maintain funding for the OGD. Meanwhile, the Federal Trade Commission and such members of Congress as Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, continue their push to ban patent litigation settlements that involve any type of payment from branded drug companies in exchange for generics companies holding off product launches, even when those product launches happen months or years before the branded drug’s patents expire.
But IMS Health VP industry relations Doug Long recently told Drug Store News of another major issue emerging. “What’s really come to the forefront is this drug-shortage stuff,” Long said. According to the GPhA, the reasons for drug shortages are numerous and complex: insufficient supplies of raw materials; inadequate and delayed communications about shortages; changes in clinical practices that have altered volume production; and stockpiling of drugs within the gray market.
In September, the GPhA called for a broad effort by various stakeholders — ranging from branded and generics drug makers to component suppliers, from healthcare providers to regulators — to combat the problem.
Whatever the issues for 2012 turn out to be, it’s the trends in various disease-state markets that will continue to drive prescribing, dispensing and marketing of generic and branded drugs alike. Click here to see the highlights.
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Seniors tend to ‘get the point’
I know this older guy at my gym — I call him “The Professor,” mostly because he used to teach journalism, but also because it’s more fun to say and easier to remember than his actual name. He’s 85 now, and he says if he doesn’t get to the club to swim laps and sit in the steam room at least three times a week, he feels like he’s doing something wrong. He says he feels the same way about flu shots and all vaccinations for that matter.
I like The Professor a lot. We’re both journalists, both gym rats. We also both grew up in the city, and our mothers — despite the 43-year gap in our ages — both saved their money to send us away to summer camp to keep off us out of trouble.
But that’s where our experiences begin to differ. I remember the summer we had the big lice outbreak, and we had to shave a bunch of kids’ heads and shampoo the others with Quell. He remembers the year a polio outbreak shut down his camp and sent all of the kids home early.
The Professor is a living, breathing example of something Raymond Fabius, chief medical officer at Thomson Reuters healthcare business unit, commented upon in the context of his company’s recent survey regarding consumers’ opinions about vaccines. “Ironically, these surveys are a testament to the effectiveness of vaccines — older people remember what illnesses like polio did to cripple and kill patients, but the younger generation has never seen someone with polio.”
It’s frightening what people actually think vaccines will do to them. According to the Thomson Reuters survey, 24% of people say their opinions of vaccines have changed in the past five years, and among them, 59% said their views on vaccines have become less favorable. More than 26% expressed apprehensiveness over vaccine safety, with the highest level of worry among parents with children under 18 years old (30.8%), and those ages 65 years and older with the least concern (18.5%).
According to the research in which more than 100,000 households were polled between Aug. 1 and 16:
- 47% worry that vaccines could impact long-term health;
- 46% worry about side effects;
- 21% believe vaccines can cause autism;
- 9% believe vaccines can be linked to cancer;
- 7% believe vaccines can be linked to diabetes, and;
- 6% believe vaccines can be linked to heart disease.
Another survey, conducted by the University of Michigan, found that 1-in-10 parents use a different vaccination schedule for their children from the one recommended by the Centers for Disease Control and Prevention. The most commonly delayed vaccine among this group: meales-mumps-rubella (45%).
So it can’t be too hard to imagine that cases of the measles in the United States are at their highest levels in 15 years, with some 212 cases in 2011, according to research presented in late October at the Annual Meeting of the Infectious Diseases Society of America. In 13% of these cases, the infected was younger than 1 year old. Since that’s too young for a baby to get their first MMR — recommended between 12 months and 18 months, according to the CDC — it means those infants were exposed to someone else that wasn’t up to date on their vaccinations.
Retail pharmacy has done a strong job of improving immunization rates in this country; so have retail clinics. Last year, more than 18% of adults got their flu shot in a retail setting, according to the CDC. That’s up from about 7% five years ago. That’s an important contribution to our nation’s public health. Clearly, you’re making a dent here.
Studies like this give you an idea where to focus your messaging efforts — and to which segments of your customers. People like The Professor tend to get it.
Rob Eder is the editor in chief of The Drug Store News Group, publishers of Drug Store News, DSN Pharmacy Practice, PharmacyTech News, Specialty Pharmacy and Retail Clinician magazines. You can contact him at [email protected].
Just a comment...this is a pharmacy magazine and yet, the trade name for lindane shampoo was spelled incorrectly. The trade name was spelled Kwell, not Quell. But then, like The Professor I am an old-timer and remember how it was.
CCA roundtable focuses on role of retail clinics in changing health care
PHILADELPHIA — No matter the shape healthcare reform takes in the United States, the retail clinic industry will be a crucial cog. Today, healthcare reform means 33 million additional Americans with coverage, most likely split between Medicaid and low-cost providers. That will create a significant demand for cost-efficient solutions like retail clinics.
The fact that retail clinics will serve on healthcare’s front line was one of the key points made at a special roundtable of retail clinic leaders gathered by the Convenient Care Association earlier this month in celebration of its fifth anniversary at the historic Union League here. According to Ken Berndt, director of business development at Bellin Fast Care, retail clinics can expect to convert as many as one-third of patients without medical homes into the health system fold.
Another trend discussed by the panel: Healthcare payers are increasingly realizing cost-saving synergies by encouraging clinic operators to expand their scope of service from acute care to chronic care management offerings. “Payers certainly see the value,” noted Paulette Thabault, MinuteClinic chief nurse practitioner officer.
The roundtable also addressed the potential benefit realized through increased collaboration between pharmacists and practitioners. “It’s like capturing lightning in a bottle,” remarked Rob Eder, editor-in-chief of The Drug Store News Group, who served as a guest moderator for the group. “The potential for collaboration is immense,” agreed Web Golinkin, CCA board president and CEO of RediClinic and Interfit Health. “It makes a lot of sense.”
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