Perrigo gets tentative FDA approval for Picato Gel generic
SILVER SPRING, Md. — The Food and Drug Administration has granted tentative approval to Perrigo for its generic of actinic keratosis treatment Picato Gel (ingenol mebutate, 0.015%). The company said that its submission date made it the first to file for a generic of this product.
"This tentative approval illustrates the hard work and dedication of our R&D and regulatory teams as they continue to advance our new product pipeline,” Perrigo EVP and president Rx pharmaceuticals John Wesolowski said. “The Rx team remains committed to delivering savings for patients and families.”
The drug had U.S. sales of roughly $51 million for the 12 months ended August 2017, according to QuintilesIMS data.
NACDS letter offers Administration, Congress 4 policy solutions to curb opioid abuse
ARLINGTON, Va. — With President Donald Trump set to declare a national opioid emergency this week, the National Association of Chain Drug Stores has suggested four public policy initiatives to the Administration and members of Congress. The suggestions, outlined in a letter sent Tuesday, are aimed at building on current collaborative efforts to stem opioid abuse while maintaining high-quality patient care, NACDS said.
“These four integrated public policy strategies would further reduce the volume of unneeded and unused opioid medications entering the public domain, and reduce the chances that they fall into the wrong hands – while taking into account the needs of those most severely affected by chronic pain as a result of cancer and other serious illnesses,” NACDS president and CEO Steve Anderson said. “The fact that these public policy proposals are gaining traction among those in the healthcare and enforcement communities reflects that much-needed consensus may be starting to build for additional and sound approaches to this epidemic.”
Among the suggestions is a seven-day supply limit for initial opioid prescriptions issued for acute pain — a limit that is in-line with the Centers for Disease Control and Prevention’s Guideline for Prescribing Opioids for Chronic Pain. The letter notes that 20 states have already taken action on this issue, calling for federal legislation to ensure consistent care.
NACDS’ letter also calls for federal legislation mandating electronic prescribing for controlled substances — something that currently only happens for 14% of controlled substance prescriptions. Earlier this year, NACDS voiced its support for the Every Prescription Conveyed Securely Act, which was introduced in August.
The e-prescribing mandate would be one way to enhance security while curbing fraud, waste and abuse. It also would provide a foundation for improving security through a national prescription drug monitoring program that would harmonize varying state requirements for reporting and accessing PDMP data, creating a single system. A national PDMP would use e-prescribing to offer providers and dispensers real-time guidance for patients, NACDS said.
The organization also suggested the use of manufacturer-funded envelopes that patients could use to mail back unused opioids. The envelopes would be available at pharmacies upon request, and their use could be reinforced by a state-legislated mail-back program, NACDS said.
The letter also notes the need to regulate synthetic opioids, the importance of advancing prescriber education tools through the Food and Drug Administration’s Risk Evaluation and Mitigation Strategies for opioids and the need for enhanced treatment for patients with opioid abuse disorders, among other approaches.
“As public health authorities have indicated, face-to-face interactions between pharmacists and patients have made pharmacists keenly aware of the extreme challenges and complexities associated with this epidemic,” Anderson wrote in the letter. “Based on this first-hand experience and our commitment to the patients and communities we serve, NACDS remains steadfast in our efforts to partner with law enforcement agencies, policymakers, and others to work on viable strategies to prevent prescription drug diversion and abuse, including prescription opioids. Chain pharmacies engage daily in activities with the goal of preventing drug diversion and abuse.”
Walgreens to keep Narcan in stock chainwide
DEERFIELD, Ill. — As part of its comprehensive national plan to combat drug abuse, Walgreens is now stocking Narcan, an FDA-approved nasal form of naloxone, in all of its more than 8,000 pharmacies nationwide.
“By stocking Narcan in all our pharmacies, we are making it easier for families and caregivers to help their loved ones by having it on hand in case it is needed,” stated Rick Gates, Walgreens group VP pharmacy. “As a pharmacy we are committed to making Narcan more accessible in the communities we serve.”
In addition, Walgreens is adopting Centers for Disease Control and Prevention recommendations by educating patients about Narcan when they are dispensed a controlled substance greater than 50 morphine milligram equivalents and may be at risk of accidental overdose.
"This action is an important milestone and we applaud Walgreens initiatives to improve access to Narcan Nasal Spray in communities across the U.S.,” said Seamus Mulligan, CEO Adapt Pharma. “This effort, combined with the opportunity for patients and caregivers to obtain Narcan Nasal Spray without an individual prescription in 45 states, is critical in combating this crisis.”
In an effort to educate the public on use of naloxone, pharmaceutical wholesaler AmerisourceBergen has distributed Narcan demo devices at no cost to Walgreens pharmacists for use in instructing patients on how to administer the medication. Additional instructions include calling 911, as Narcan is not a substitute for medical care. Anyone who is administered the medication should seek immediate medical attention.
“At AmerisourceBergen, we strive to provide our customers the highest quality care and support so they can ultimately enhance the lives of patients in their communities,” said Robert Mauch, EVP and group president, Pharmaceutical Distribution & Strategic Global Sourcing for AmerisourceBergen. “We recognize the important role we play in addressing the opioid epidemic, and our collaboration with Walgreens is another key milestone to supply our customers with access to lifesaving initiatives and emergency medications that can help keep individuals safe across the country.”
Last year Walgreens announced an effort to make naloxone available without requiring a prescription in states where regulations allow. The company now offers naloxone without requiring a prescription in 45 states and is eager and willing to work with the remaining states to make naloxone easier to obtain.
Walgreens has also collected more than 155 tons of unwanted medications through its safe medication disposal kiosks in 600 pharmacies across 45 states and Washington D.C. The kiosks allow individuals to safely and conveniently dispose of unwanted prescriptions, including controlled substances and over-the-counter medications, year-round at no cost.