Amneal generic Accutane
PHARMACY

Amneal intros generic Accutane

BY David Salazar

Amneal Pharmaceuticals has introduced its generic Accutane (isotretinoin) capsules. The drug is indicated to treat severe recalcitrant nodular acne.

Amneal’s generic Accutane was approved under a Risk Evaluation and Mitigation Strategy known as the iPledge Program.

The product had U.S. sales of roughly $250 million for the 12 months ended December 2017, according to IQVIA data. Amneal’s generic Accutane will be available in 10-, 20-, 30- and 40-mg dosage strengths in cartons that contain three blister packs with 10 capsules each.

Ameal said it would begin shipping the product immediately.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
opioids
PHARMACY

Turning the tide: Retail pharmacy grapples with the opioid epidemic

BY David Salazar

The opioid crisis is one staggering statistic after another. Opioid-related deaths — including those due to prescription opioids, heroin and fentanyl — have more than quadrupled since 1999, with the Centers for Disease Control and Prevention logging 42,000 opioid-related fatalities in 2016. That year, 40% of all opioid overdose deaths — about 17,000 — involved prescription opioids.

That the crisis is something to be reckoned with is not news to the healthcare industry, which is arguably the one closest to it, particularly when it comes to community pharmacies. What is changing is that the industry is more aggressively looking to offer solutions — from overdose prevention to safe disposal and educational programs — as it waits for legislative solutions that codify preventive measures against opioid abuse and misuse. At the same time, it still wants to ensure that patients with chronic pain can retain access to necessary treatment.

Industry leaders agree that offering access to resources is a key way to help stem the tide of the epidemic. They also agree that it cannot be done by one actor alone, and that the way out of the crisis is through collaboration between retailers, distributors and third parties, including various state and federal government agencies, around solutions that can be carried out in-store and in the communities they serve.

Stopping overdose in its tracks
Narcan Nasal Spray opioid overdose reversalOverdose prevention is high on the call-to-action list. Naloxone was not a household name before the opioid crisis. Now, it and its brand name Narcan have become well-known among patients for its ability to reverse an opioid overdose. Its ubiquity also is due in part to retail and distributor efforts to make naloxone — both as an injectable and a nasal spray — available to patients without requiring a prescription.

At Walgreens — which stocks Adapt Pharma’s Narcan Nasal Spray chainwide through a collaboration with AmerisourceBergen — 8,100 stores across 46 states are able to dispense the overdose reversal drug without a prescription. Rick Gates, the retailer’s group president of pharmacy, said that the chain’s naloxone efforts have expanded to the point where patients leaving the pharmacy with a prescription that contains more than the equivalent of 50 morphine milligrams receive pharmacist counseling about naloxone availability and its use.

“When patients most at risk with higher doses are leaving our stores, we’re having relevant conversations with them to really ensure that they understand the risk and they have the ability to get the antidote, if possible, before they leave,” he said.

Similarly, CVS Health has rolled out prescription-free naloxone to 43 states, and Rite Aid has made it available without a script in 25 states, training more than 11,000 pharmacists on dispensing. Even less pharmacy-centered retailers have begun offering naloxone, with supermarket company Albertsons rolling out access to Narcan Nasal Spray at several of its banners across 13 states early last year. It has trained 3,000 pharmacists on how to dispense the drug.

Naloxone access beyond the pharmacy is another area that the industry has been keen to engage in, with Cardinal Health’s recently-announced Opioid Action Plan, which includes the donation of roughly 80,000 doses to law enforcement and first responders in Ohio, Kentucky, Tennessee and West Virginia.

Throwing away risk
Alongside efforts to make sure potential overdoses can be reversed, the industry has come together around a way to hopefully prevent the possibility of overdoses by offering a way for patients to easily get rid of unwanted medications.

“Disposal is a big issue that I don’t think people understand,” Cardinal Health senior vice president of independent sales Steve Lawrence said. “About 54% of the people that misuse prescription painkillers get them from a friend or family member. If those friends or family members had a better way to dispose of medication, I don’t think so many of those pills would be out there for someone to get their hands on and potentially abuse and become addicted to.”

Stericycle medication disposal

Stericycle Envrionmental Solutions’ disposal kiosk

Industry players have begun to see the value in providing a safe place for patients to dispose of their medications as part of a response to the opioid crisis. Stericycle Environmental Solutions, which includes among its offerings both drug disposal kiosks and prepaid seal-and-send envelopes, has seen an uptick in interest nationwide since it began its drug take-back efforts several years ago. A San Luis Obispo County, Calif., ordinance that required retailers to have a consumer medication take back outlet spurred the move.

“We’re seeing quite a bit of traction, and it’s grown exponentially over I would say the last two years,“ Stericycle Environmental Solutionsvice president of sales and marketing operations Maricha Ellis said. “Having convenient outlets for that disposal is so important, so that these drugs don’t get diverted and fall into the wrong hands. If we can take any of those unused medications off the street, it’s a huge benefit to helping with diversion possibilities.”

In an October 2017 letter to President Donald Trump, members of the administration and the President’s Commission on Combating Drug Addiction and the Opioid Crisis, the National Association of Chain Drug Stores included safe disposal as a key policy that could be enacted to curb opioid abuse and misuse. And retailers have been keen to get ahead of policy and make safe disposal a cornerstone of their response efforts.

Walgreens medication disposal

Walgreens disposal kiosk

Walgreens introduced its medication disposal program in February 2016, and Rick Gates, the chain’s group vice president of pharmacy, said that, based on the most recent data, the disposal kiosks have collected 115 metric tons of unwanted medication from patients. The company currently has 600 kiosks throughout its store base, with plans to add 900 more through partnerships with wholesaler AmerisourceBergen, the Blue Cross Blue Shield Association, Pfizer and Prime Therapeutics.

“It’s been highly successful, but that’s just a start — and we need to continue to look at making it even easier for patients to get rid of unwanted or unused medication,” Gates said. “AmerisourceBergen is helping us expand the actual kiosks, they’re funding into it. It’s not free, but we do believe it’s necessary and something that we need to do to step up and help in communities across America.”

Disposal also is an area where independent pharmacists, many of whom are located in some of the areas hardest hit by the opioid epidemic, can help play a role, too — albeit with an assist from pharmaceutical manufacturers. Inmar, an intelligent commerce company, launched its consumer drug take back effort in October, with nine North Carolina pharmacies debuting a disposal kiosk. Through its disposal program, Inmar is offering pharmaceutical manufacturers some sponsorship opportunities, with the ability for a kiosk to bear a sponsorship message. The company has said that it hopes to offer kiosks in roughly one-third of counties nationwide early this year.

Kiosks and mail-in bags have been the most typically adopted ways companies offer disposal, but in mid-January, Walmart unveiled its own disposal method, bridging the gap between allowing patients to dispose of medication safely from home and offering in-store resources.

Walmart rolled out its opioid disposal program to all 4,700 of its company pharmacies, as well as those at Sam’s Club locations. Walmart’s DisposeRx gives patients a packet that can be combined with unused medication and warm water in a pill bottle to create a biodegradable gel that patients can dispose of at home. DisposeRx is given to every patient filling a new Class II opioid prescription, alongside an opioid safety brochure, with patients who fill chronic opioid prescriptions receiving DisposeRx packets every six months. Any patient can request one from the pharmacy at any time, the company said.

“While this issue requires many resources to solve, we are confident this unique, easy-to-use disposal solution, DisposeRx, will make a meaningful impact on the lives of many,” said Marybeth Hays, Walmart’s executive vice president of consumables and health and wellness.

Education from all angles
A problem as persistent as the opioid crisis requires solutions beyond offering medication disposal and overdose reversal access — it also necessitates outreach to inform patients about the dangers, an undertaking that industry players have made central to their efforts to combat opioid abuse.

One of the longest-running educational efforts in the industry has been Cardinal Health’s Generation Rx program, which the company’s foundation developed in 2009 through a partnership with The Ohio State University College of Pharmacy. The curriculum, which initially focused on school-age children in elementary, middle and high schools, has since expanded to include seven presentations that span different age groups and settings, including a resource for healthcare professionals counseling a patient.

Cardinal Health’s Lawrence said that the company’s independent pharmacy customers have played an integral role in Generation Rx’s expansion, including going into community classrooms to give presentations to different students. The program also has gained traction with chains. Cardinal Health has worked with Kroger to train 250 pharmacists to go into community classrooms to talk about prescription drug abuse in Ohio. The company’s Opioid Action Program includes grants for schools — K-12 and higher education — and healthcare institutions for prescriber education. But beyond healthcare professionals, Lawrence credits the accessibility of program, which is now available in 40 states.

“The reason I think it’s grown is because anybody who cares and wants to be involved can go to GenerationRx.org, download the presentation and take it to a school, civic organization or meeting of people and talk to them about the issue,” he said.

CVS Pharmacists Teach

CVS Health pharmacists in the classroom

Like Cardinal Health, CVS Health has recognized the difference that a presentation to students can make, which is why it launched its Pharmacists Teach program in fall 2015. Through the initiative, which features a 30-minute presentation called “One Choice Changes Everything,” CVS Health pharmacists had given more than 4,200 presentations by the end of 2016.

“I’m trying to bring awareness to the schools, the students, the parents and teachers, because I feel that awareness is a form of prevention,” CVS Health pharmacist Monica Vera-Schubert — whose son faced an opioid abuse issue when he was in high school — said in May. “I’ve been given such a great platform to help people understand what abusing prescription medication can do, and help them make the right choices.”

Education is something that manufacturer trade organizations also are getting in on. The Association for Accessible Medicines, a group that promotes generic drugs, recently partnered with EverFi, a leading provider of education around alcohol abuse and sexual assault for campuses, to create a virtual prescription drug abuse prevention course for incoming first-year college students. The course launched last fall with a cohort of 30,000 students at various institutions.

The pharmacy industry’s education initiatives don’t only target the general public. The National Association of Chain Drug Stores, in a letter to President Trump and other administration agencies, noted that it has developed online training programs that are aimed at helping pharmacist and other personnel combat misuse and abuse of controlled substances. It also has been proactive in encouraging pharmacists to participate in Drug Enforcement Administration education sessions that are targeted at educating pharmacists about prescription drug abuse.

Acknowledging that pharmacists only dispense prescribed medication, Cardinal Health’s response plan includes funding for prescriber education, as well as a partnership with Brown University’s Warren Alpert School of Medicine to implement a curriculum focusing on safe opioid prescribing and alternatives to treating pain with opioids.

“There are a lot of drugs for pain and opioids have taken over, but I think a lot of people in the prescriber world are starting to say, ‘There are other ways we can deal with this like step therapy and other products,” Lawrence said. “We’re just trying to get that word out to as many people as we can, so we can hopefully slow down the tide of more and more prescriptions for opioids.

If the industry response shows anything, it’s that there is no magic bullet to fix the opioid crisis. Executives agree that it will require sustained, collaborative efforts — including legislative ones — to reach a solution that focuses on the most at-risk communities. “I think the future is a multiprong approach,” Stericycle Environmental Solutions’ Ellis said. “Retailers will be part of that solution, disposal folks like us will be part of that solution and the pharmaceutical companies will, too.”

Disposal efforts — including sponsorship opportunities like Inmar’s and such distributor-retailer partnerships as the one between Walgreens and AmerisourceBergen — are a prime example of the collaborative approach. Like Ellis, Walgreens’ Gates sees collaboration as a key part of potential next steps.

“If you look at the platform we’re sitting on, there are lots of areas where we should be actively participating,” Gates said. “I think you’re going to see us partner in the industry much more effectively to really bring relevant change whether that’s legislatively or in practice.”

Cardinal Health’s Lawrence also touted the importance of bringing relevant change through partnership, while also acknowledging that there is only so much that retailers and distributors can do, even with education and disposal efforts. The company’s Opioid Action Program is looking to go beyond the limitations by providing resources to frontline community organizations. The program includes grants of $75,000 to $100,000 that will go to five Ohio community collaboratives that do work around addiction, overdoses and opioid-related deaths.

Going forward, Lawrence said, these organizations will be doing work that could complement the impact of the industry’s efforts — they just need the funding.

“Trying to solve community problems across the country with one blanket solution doesn’t really work with this kind of problem,” Lawrence said. “Giving more resources to the people that are actually in the community and need the funding is something we’ve seen have the biggest impact. We’ll turn the tide in these communities.”

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

Mylan first to launch generic Sustiva

BY David Salazar

Mylan has launched its generic of Bristol-Myers Squibb’s Sustiva (efavirenz) tablets. Mylan’s generic Sustiva is the first copycat of the drug, which is indicated to treat HIV-1 alongside other antiretroviral agents in adults and children at least 3 months old weighing at least 3.5 kg.

“With the launch of efavirenz, Mylan marks an important achievement in bringing more affordable treatment options to the HIV patient community,” Mylan CEO Heather Bresch said. “Our global commitment to improving access to antiretroviral medicines for this important patient population spans more than a decade, and the U.S. launch bolsters our leadership in producing high-quality ARVs and positions us to continue to lead this important category in the future.”

The Food and Drug Administration noted in its approval of Mylan’s generic Sustiva that it is eligible for 180 days of market exclusivity, as it was one of the first substantially complete generics submissions for the product.

Mylan’s generic will be available in 600-mg dosage strength tablets. The product had U.S. sales of roughly $113 million for the 12 months ended Dec. 31, 2017, according to IQVIA data. Roughly 1.1 million patients in America live with HIV.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?