Breckenridge gets FDA approval for generic Daliresp for COPD
Breckenridge Pharmaceutical has received the FDA nod for roflumilast tablets, 500 mcg.
The product is the generic of AstraZeneca’s Daliresp tablets.
Roflumilast tablets are a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Daliresp had a market value of $211 million for the year ended Aug. 31, 2018, according to industry sales data.
Roflumilast tablets were developed by Ferrer Internacional, S.A.
Walgreens survey finds 70% of Americans planning to get flu shot
A new survey conducted by Walgreens found patients preparing themselves for a flu season that many expect to be on par with last year’s. The survey found 40% saying they expected the flu season’s severity to be the same as last year, and 12% who expected it to be worse. In anticipation, 54% said they planned to get a flu vaccine earlier this year, with 70% saying they expected to get a flu shot at some point this year.
However, the survey found that there is ground to gain in terms of getting patients immunized, as 32% of those surveyed said they hadn’t received a flu vaccine in the past three years. That’s despite roughly 80% saying that either they or a family member had suffered from the flu in the same time period. Of those who didn’t get a vaccine, 39% said they had avoided doing so because they believed the vaccine to be ineffective.
The survey also found that despite the severity of last year’s flu season — one of the worst in recent years — some 37% of respondents said they had gone to work while suffering from the flu. Additionally, 2-in-5 of those surveyed said they stay home to protect themselves from the flu.
Walgreens noted that since 2010, it has administered more than 60 million flu vaccines to patients.
Proactive steps can keep pharmacists safe
Retail pharmacists face a number of occupational hazards, and the key to mitigating risks that could compromise pharmacist safety is assessing risk with an eye toward compliance. Preventable accidents — those due to employee negligence or improper training, for instance — are far too common and can even lead to the endangerment of pharmacy customers.
Here are three ways retail pharmacies may inadvertently be compromising worker safety and health, and tips to help correct behaviors potentially leading to worker harm and noncompliance:
1. Improper device handling, leading to needlestick injuries and infection:
According to the Occupational Safety and Health Administration, an estimated 800,000 needlesticks occur each year in the United States, and retail pharmacists are not exempt from injury. Flu shots are increasingly administered in nonmedical settings, including pharmacies. Since 2010, all U.S. pharmacists are authorized to administer influenza vaccines, making drug store and supermarket pharmacies one of the most popular spots for adults to receive their annual flu shot, representing nearly 25% of all flu vaccinations. With that, however, comes an increased risk of injury.
Preventive step: Schedule staff-wide training sessions on sharps management
Pharmacies have an indisputable responsibility to protect workers from needlestick injuries, which is why they need to make training a top priority. One strategy to educate new hires and increase the skill level of existing staff includes holding a facility-wide training week — aka “Sharp Week” — that provides staff members the flexibility to attend a session that is convenient for their schedules.
2. The lack of take-back solutions:
Drug take-back programs are one of the most effective solutions when it comes to preventing the diversion, misuse and abuse of prescription drugs. Offering secure and convenient disposal options for unneeded or unused medications can be pivotal in helping pharmacists educate customers about smart disposal options. However, less than 3% of pharmacies and other entities authorized by the DEA to collect unused prescription drugs for disposal have volunteered to do so.
Preventive step: Work with government officials to grant access to medical waste disposal bins
Putting medical waste collection kiosks in close proximity to where pharmacists need to dispose of waste can help mitigate the risk of improper drug or device disposal. This is especially critical with more pharmacists administering vaccines within their facilities than ever before, and also can be a solid preventive step against sharps theft.
3. The accessibility of drugs within health care can contribute to diversion and abuse:
The prevalence of opioids within all healthcare facilities, not just pharmacies, makes institutional diversion easy to do and difficult to detect. In an effort to deter diversion within pharmacies and healthcare facilities, states are implementing prescription drug monitoring programs to facilitate the reporting of information on the prescribing, dispensing and use of prescription drugs within a state. Currently, 49 states and the District of Columbia have PDMP legislation in place.
Preventive step: Host frequent drug take-back events to create a culture of compliance
While the implementation of such programs as PDMPs is critical to maintaining compliance and preventing diversion, take-back programs are just as important when it comes to fostering a culture of compassion. The stigma associated with drug diversion and addiction among healthcare professionals — along with feelings of guilt and shame, and the fear of losing one’s job and license — often prevents workers from coming forward or seeking help. Pharmacies that host or participate in drug take-back days can help foster a sense of community and enable staff to anonymously dispose of any improperly obtained drugs.
The bottom line is that making staff and overall compliance a priority will lead to a safer, more healthful healthcare environment.
Richard Best is the director of OSHA compliance at Stericycle.