Mylan hires Adele Gulfo to head global collaboration, strategic operations
PITTSBURGH — Generic drug maker Mylan has hired a former Pfizer executive to its executive leadership team.
The company announced Wednesday the appointment of Adele Gulf as EVP global collaboration and strategic operations. Before working for Mylan, Gulfo served as regional president of Latin America for Pfizer’s Emerging Markets Business Unit, overseeing more than 4,000 employees in 23 countries and achieving more than $3 billion in sales in Latin America in 2012.
"Adele’s rich and diverse experience in the pharmaceutical industry will bring significant strategic value and leadership to Mylan in numerous areas," Mylan CEO Heather Bresch said. "For instance, we believe Adele’s expertise will support many of our key growth drivers, including our expansion in Latin America, the development and expansion of our global specialty franchise and the development of global commercial strategies to maximize our key upcoming launches of increasingly complex generic products, such as in the biologics and respiratory areas."
Vitals predicts consumer healthcare trends for 2014
LYNDHURST, N.J. — It is no secret that the healthcare industry is undergoing great change, fueled by the implementation of the Patient Protection and Affordable Care Act and the advent of the empowered online healthcare consumer. And given the changing landscape, Vitals, a provider of online health tools, has outlined five key predictions for the coming year.
According to Vitals CEO Mitch Rothschild, five key changes that healthcare consumers will see in the coming year are —
- Wait Times Will Go Up. More than a million new people enrolled in the healthcare system in 2013, and many millions more are estimated to begin participating in 2014. Yet, medical resources are already stretched to capacity in this country. While Baby Boomers age and place greater demands on the healthcare system, medical schools have continued to graduate only a finite number of doctors each year. In fact, in the last half-century only one new medical school has opened in this country. Add to that a physician population that is aging rapidly. The American Medical Association found that by 2009, 45% of physicians were ages 55 years and older. The demand for even more primary care services will inevitably cause a major disruption to the system. For the unchanging supply of doctors, it will mean less time to spend with patients in examination rooms and with follow-up care. For patients, it will mean appointments will become harder to schedule and wait times longer. Consider this: When Massachusetts implemented their healthcare reform, the average wait to get an appointment with a primary care doctor jumped from 39 days to 48 days. The Vitals Index, which tracks wait time data, also saw the average time a patient waits in the office creep up from 19 minutes, 48 seconds in 2010 to 20 minutes, 15 seconds in 2013.
- Patients Will Continue to Love Their Doctors. While it may seem counterintuitive that patients will continue to love their physicians even as they make them wait longer, healthcare consumers are becoming more savvy about choosing a doctor with whom they can build a lasting relationship. Today, more people go online first to research doctors to find that physician who is a better fit for them. In a recent Vitals Index survey, 56% of respondents said that they spend several days researching the right physician. And their work is paying off. Forty-five percent described their doctor as “the one.” That’s double the number of people who chose the same response in a similar survey last year.
- Urgent Care and Alternate Care Center Use Will Continue To Grow. In 2014, consumers have more options to choose from than just their primary care physician when they want or need to receive care. Urgent care centers are able to provide quick, walk in medical care for everything from skin irritations to the flu. Currently more than 9,000 urgent care facilities are operating today, with another 700 to 800 slated to open this coming year. At the same time, retailers like CVS and Walgreens have been opening more of their own clinics for access to low-cost care, Vitals stated. According to the Vitals Index, 41% of respondents indicated they have used urgent care centers for their health needs. Expect these figures to grow as consumers bear more of the brunt of medical costs and look for lower cost options, Vitals noted. “Alternative care centers are growing because they are convenient and provide easy, more affordable access to medical care and services,” Rothschild stated. “Healthcare reform will fuel this further as patients become more aware that they can save up to 80% by avoiding an emergency room.” A major driver for this sector of the medical care market is young adults. In a recent Vitals Index report, those between the ages of 18 years and 29 years were twice as likely to use alternative medical care facilities compared to adults older than 50 years. Yet, they’re also less likely to have a primary care physician. Only 1-out-of-3 said they have a primary care doctor to rely on in the case of an emergency.
- More Online Appointments. In 2005, only 6% of family doctors offered online appointment scheduling. Fast forward to 2013 and about 20% of practices allow online appointment requests either through patient portals or online scheduling services. The Vitals Index report indicates that today, 80% of healthcare consumers still prefer to make appointments “the old-fashioned way” — over the phone. Changing demographics and the availability of technology to enable online scheduling will be key in changing consumer behavior. “Just as the travel industry made a shift towards online reservations, doctor practices will follow suit,” Rothschild added. “It’s not only a less manual process for the office staff, it also allows patients to schedule office visits when convenient and without waiting on hold.”
- Increase in the Power of Online Patient Reviews. In 2014, more will turn to online reviews for comparing doctors, just like we do for other purchase decisions. Doctor reviews are finally coming into their own in 2014, thanks to a critical mass that has been building. When it comes to online reviews, most people believe that five to six reviews provide an accurate indicator of quality, according to a recent Vitals Index report. And the reviews are having an impact. Almost 47% of the people who looked up a physician online felt differently about that doctor after viewing their profile. About 40% said they felt reassured or more comfortable with their choice after reading the review, while 7% said they felt the need to find a different doctor. In fact, as an indicator of quality, patient reviews were considered just as important as a doctor’s years of experience when it came to determining a doctor’s qualifications — both were selected by 76% of all respondents.
Ensuring access to chronic pain medications
NEW YORK — News stories about doctor shopping and prescription pad pilfering in pursuit of a pain-pill induced high have become commonplace, prompting many legislators and regulators to consider further restrictions on pain medicines like hydrocodone compounds.
But there may be a story that’s not being told — that the patients who suffer from chronic pain and need that hydrocodone to reclaim their lives are being stigmatized. The prevalence of pain pill abuse has left in its wake as many as 116 million legitimate pain sufferers who are finding it more difficult to access their therapies.
It’s a stigmatized population, but not unfamiliar. The disease states in which patients may need chronic pain relief include such well-known conditions as fibromyalgia, diabetes neuropathy, post-surgical, osteoarthritis and lupus. Cancer patients going through chemotherapy are also chronic pain sufferers.
The reality is there is a significant population suffering from chronic pain. The perception is that anyone seeking relief from that chronic pain likely is an addict.
“A pain patient is not the same as an abuser — they’re two different people,” Paul Gileno, president of the U.S. Pain Foundation, told DSN. “A person with pain is not the person that’s robbing the pharmacies in search of pain meds. They’re two different people, but they seem to be lumped in together.”
“People feel so stigmatized when they’re a person with [chronic] pain,” Gileno, said. “They feel like they’re doing something wrong because they need pain meds. [And] the doctors are getting so nervous about prescribing [the controlled substances] that they underprescribe.”
According to a study of physicians’ attitudes about pain drugs published in 2013 in The Journal of Pain, negative physician attitudes about opioid medications are closely associated with lower rates of prescribing, and more favorable attitudes are linked with higher prescribing levels.
And while that stigma represents its own barrier to appropriate access, both regulators and legislators are seeking to further restrict access to these medicines in an effort to crack down on the problem of controlled substance abusers.
The Food and Drug Administration currently is pushing to reclassify hydrocodone compounds by a more restrictive schedule — moving these medicines from Schedule III, where they are now, to Schedule II.
“Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs,” stated Sen. Charles Schumer, R-N.Y. “I’m very pleased that the FDA … will tighten up control of one of the most highly prescribed — and abused — drugs on the market.” Schumer has lobbied hard for the rescheduling of hydrocodone compounds. His home state of New York has already moved in that direction by reclassifying these pain relievers to Schedule II in February 2013.
For patients, reclassifying hydrocodone compounds as a Schedule II substance would require them to make a doctor’s visit every time they need a prescription. Refills of Schedule II drugs are not permissible; and the prescriptions have to be original copies. That represents a significant cost barrier that for many pain sufferers may further restrict access to much-needed medicines.
“We see it as an access issue,” Gileno said. “It means more doctor visits for patients, more travel, more co-pays. It means more cost to a person with pain,” he said. “These are people who are on a regimen of medicine that has been working for them. … It raises costs for the patient. People who are already struggling to work now have the additional co-pays and time [commitments].”
The rescheduling of hydrocodone compounds will have repercussions up and down the supply chain, in large part because of the sheer volume of prescriptions that would be reclassified. In 2012, pain was the No. 2 most-prescribed therapeutic class of medicines, with 472 million prescriptions written, according to IMS Health. The most-prescribed medicine for the year was hydrocodone/acetaminophen, with 135.3 million prescriptions written for the pain-relieving compound.
Proponents of rescheduling point to the large volume of pain pill prescriptions written each year and suggest that that’s the problem — doctors are writing too many prescriptions for products like hydrocodone/acetaminophen. Pain patient advocates can identify with that volume of prescriptions as well, because behind the majority of those prescriptions is a pain sufferer. Restricting access doesn’t help them.
At the wholesale level, Schedule II substances have to be stored in a locked vault vs. being restricted to a caged area, meaning drug distributors would need to make wholesale capital investments in expanding their vault space to accommodate that additional 135.3 million in hydrocodone/acetaminophen prescriptions alone.
And retailers would likewise need to invest in larger, security storage units in an effort to be compliant with the new restrictions. That is, if they want to stock enough supply to meet demand.
That increase in investment could force many pharmacy operators, especially smaller community pharmacies serving rural patients, to reconsider carrying hydrocodone compounds at all.
On the state level, many legislators are debating how to best regulate controlled substances like hydrocodone compounds. But in place of rescheduling, some states are imposing restrictions on refills of Schedule III medicines. For example, New Mexico recently placed limitations on the time period within which a prescription for hydrocodone and APAP, for example, can be filled. The restriction encourages prescribers to see patients more frequently vs. just calling in refills.
In Alabama, Gov. Robert Bentley in August signed three bills in an effort to curb prescription drug abuse and diversion. One beefed up the state’s prescription drug monitoring program; another increased regulation of pain management clinics, a regulatory trend that stretches from Ohio down to Florida; and a third made “doctor shopping” a criminal offense. None of these measures restrict access of pain medicines from legitimate patients, necessarily.
“There are many good physicians treating patients who have legitimate issues with pain, and we want to encourage the continued treatment of those patients,” stated Buddy Smith, chairman of the Medical Association of the State of Alabama Board of Censors. “Some states that have tried to combat prescription drug abuse have passed legislation that had disastrous effects on patient care and placed tremendous burdens on physicians. This package presents a workable solution. It comprehensively tackles this growing problem in our state.”
Presently, 49 states and the District of Columbia have prescription monitoring programs in place that help reduce the ability to doctor shop — only Missouri doesn’t have a monitoring program in place. When seeing a patient, a doctor can access the program and make sure their patient hasn’t recently filled a pain medicine prescription. And many of the states are sharing that information with bordering states to prevent someone from doctor shopping across state lines.
“It makes a lot of sense because it protects legitimate patients who have been going to the same pharmacy, getting their prescriptions filled,” Gileno said. “We don’t want people scared of appropriate therapies. We want them to be aware of it and educated. There are millions of people with positive stories who are taking these medicines legitimately.”