Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments
2019-208 CDER Notice Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain Request for Comments OPEN
2021-01-08 2021-01-06 2019-06-28 2019-06-10 2019-06-10 2019-06-10 2019-06-10 2019-06-10 2019-06-10 2019-06-10
FDA-2019-N-1845-0152 FDA-2019-N-1845-0149 FDA-2019-N-1845-0073 FDA-2019-N-1845-0031 FDA-2019-N-1845-0016 FDA-2019-N-1845-0003 FDA-2019-N-1845-0009 FDA-2019-N-1845-0026 FDA-2019-N-1845-0028 FDA-2019-N-1845-0013
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https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0152 https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0149 https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0073 https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0031 https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0016 https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0003 https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0009 https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0026 https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0028 https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0013
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January 07, 2021Stephen Hahn, MDCommissionerFood and Drug AdministrationC/O Dockets Management Staff (HFA-305)5630 Fishers Lane, Rm. 1061Rockville, MD 20852RE: Docket No. FDA-2019-N-1845, Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for CommentsDear Commissioner Hahn:On behalf of Adam and Marybeth Gillan, and their daughter, Maisie Lucienne Gillan, we urge you to take action in packaging safety and technology advancements to mandate blister packaging for any medication lethal to an infant or child. These medications, known as one pill kills, are over-prescribed in high quantities. The packaging is intended as safe, but the functional use of the prescription and its traditional pill bottle container creates untold opportunities for mishandling, miscounting, and access to children.The Gillans daughter, at a neighbors home, came across a methadone pill no one even knew was missing. Hours later she was dead, and it took an autopsy to understand why. From the criminal justice system to the current regulatory environment around opioids and patient safety, Maisie was failed at every turn, cast off as an unforeseeable tragedy.Between 1999 and 2017, more than 9,000 children and teenagers died from opioid poisoning in the United States, including 650 children under 5 years old, according to the Centers for Disease Control and Prevention. These are tragedies that left 9,000 parents to bury their children.We can do better and we must do better. Layers of protection are available to protect patients from harming themselves or others. Blister packaging alone may not have saved Maisies life, but that layer of protection would have clearly identified a pill as missing, or it may never have been lost in the first place. Lives are at stake, and too many, including Maisies, have already been lost.Sincerely,A concerned parent Opioids should be in blister packs. These one kill pills have taken babies from too many families simply from poor packaging. Please consider the safety of the youngest members of our society.  Your request says active pain but if you launch this it will be done across the board and those of us that have chronic pain will then be negatively impacted again! There is no need for this and please stop trying to force new rules to an already convoluted process. We dont need any more rules or changes or additions added to the reason why we wont be able to get our pain medication. We are responsible adults and we are not the problem! Its illegal drugs, please focus on that.  I am a registered recovery room nurse from MA and I welcomed the idea of unit-dose blister packs for distribution. Currently, surgeons always order 30 plus tabs of opioid analgesics for procedures that might just need a days supply. Patients go home all of this extra medication which might lead to misuse. I welcome the idea of the blister packs but most importantly I like the discussion on how to dispose of these medications. Either education on the back of the packaging on how to dispose of these medications properly or mail pouches for easy return are both good options. Blister packages are difficult to open for seniors and others with compromised dexterity. They are not child proof and may expose children to a higher risk of ingestion. I applaud efforts to address opioid misuse and accidental exposure. The proposed blister packaging requirement is costly with limited to no benefit. Prescribing smaller quantities and allowing partial fills of CII medications will better address opioid concerns.  I feel that as a retail pharmacist the economics as well as storage space for unit dose packaging would be hard on the average store. It would be okay if pharmacies bought 100 packs of unit/dose (like hospitals have) and then dispensed 10 or 15 tabs,eg, in a container. However if manufacturers started making specific 10 or 15 packs that pharmacies had to buy and store it would create a security problems in the pharmacy to find storage room for all the different sizes made. Right now we just have bottles of 100 tabs which take up much less room and easily be kept in small secure lockers.Thank You Blister packs could be a good option for acute pain patients following surgery, but increasing cost and making access of the medication more difficult for chronic pain patients would be adding to the disastrous policies that have severely affected chronic pain patients.  These patients, who responsibly use and manage their medication, often use different doses depending on their pain at the time (i.e., they may need 8 mg in the a.m. and 4 mg later in the day).  Furthermore, there are many conditions, which make blister packs difficult to impossible to use for chronic pain patients. Those with conditions such as rheumatoid arthritis or Ehlers Danlos often experience difficulty using and pain in their hands. The greatest issue impacting the opioid crisis is illegally obtained drugs such as heroin and carfentanil. For those chronic pain patients who have a proven history of responsibly using their medication, we need to be making life easier for those who are suffering unimaginable pain and treat them humanely and compassionately vs. like addicts.   The pack is fine for those who can absorp pill form.  Roux EnY Gastric by paas patients have malabsorption problems. Our vitamins have to be in Liquid, Chewable, Crushable in order to get absorptions. Plus the cost is the key of affordable. $8.00 or $10.00 co payment is reasonable co paymrent.Anything above this price is not affordable. . I cant afford $40.00 a prescription. If I cant get the pain medication that  I should be on because of the Roux En Y gastric by pass  cost I guess I just have to suck it up with an Nsaid. Which could cause more harm to my pouch  lower intestines. I guess Medicare wont mind if they have to pay for unesscessary expenditures at the Er or energency surgeries. I like the idea of having set blister quantities. It makes following the MME limits easier for prescribers and helps take some of the pressure off pharmacists. Often, pharmacists feel like they are playing a police officer role with opioids. However, I have two concerns. Firstly, will there be a push to have prescribers use just this blister pack amounts? What will stop them from continuing to write differently than the recommended amounts? Secondly, will this negatively impact drug diversion? Will this create a demand for these packaged drugs because it shows they havent been tapered with and easily identifies the drug name since the name would be printed on the back of the blister package?  This regulation may be good for short term use after minor surgery to control pain. Many people who get these meds for knees surgeries and such end up  seeking more and more meds and some doctors fail to properly monitor or the patients get meds outside of proper channels.  This leads to addiction and abuse.  But the numbers of those who become addicted to opioids by legal scripts is very small and those who get addicted usually are because of dependency and use of illicit or illegally obtained drugs.Right now it is hard to find a doctor willing to provide ANY opioids for any patient due to the oversight by State agencies, the FBI and DEA.  I had surgery and I was sent home to heal with no pain medication due to the recent attack on pain doctors who were properly treating pain patients but could not treat with laws written for rehab of addicts.Where I live, I can go two blocks and find any illicit drug any pain suffer would want and more.  So those who are weak have a way to get these drugs outside of bubble pack distribution.  Now I am not negative about the process for some patients but this failed to address chronic pain patients which includes millions around the countryBefore becoming disabled by pain, I worked for a primary contractor at a special one of a kind DOE facility in the Southwest.  I was a Nationally Certified Environmental Trainer who was responsible for compliance training, research and program construction.  I even wrote programs included in the first two permits required for operations by the EPA and the State EPA.I have read almost every regulations and guideline included the FDA and CDC and found that each fail to address patients especially chronic pain that if lifelong.  Many like me require lifelong treatment and monitoring by a pain specialist.  But this industry is being halted by these current regulations.Right now it is impossible with most of the other regulations.  I have researched most using the Federal Code of Regulations, the Federal Registry, State Regulations, CDC and FDA Guidelines.  Each may only have a brief statement on chronic pain but then apply conditions for abuse and addicts on these patients with no room for individual care for each condition being unique.While this change might help, many doctors may still refuse to supply medications to patient for fear of reprisal from government.  Along with this issue, at least two major drug stores have decided not to provide opioids to any patients.  That being Walmart and Walgreens.  I visited both while having scripts and was told that their corporate offices had stopped allowing any of their branches to provide such medication even with legal scripts.  So these were refusing medical treatment because of fear of legal action buy the government.So this might help with minor pain over a short period of time, there is a much larger looming need for real legislation for chronic pain that allows for treatment and not punishment.