New Federal Plan Targets Prescription Drugs

Over the past two years, the AVMA has been closely monitoring a federal situation that has the potential to impact practitioner access to human-labeled drugs, particularly certain opioids. The federal government’s concern is regarding abuse of prescription drugs in people (especially youth). The federal plan is to increase education of healthcare providers, patients, parents, and youth about the dangers of prescription drug abuse; to increase drug tracking, monitoring, and enforcement; and to increase proper drug disposal. 

In February 2009, the Food and Drug Administration (FDA) proposed to implement a “Risk Evaluation and Mitigation Strategy” (REMS – strategies the FDA can implement to ensure a drug’s benefits outweigh the risks) for extended-release opioids. During the FDA’s first proposed REMS program for extended-release opioids, AVMA presented both verbal and written comments to FDA personnel, and to two of FDA’s advisory committees.  (View previous actions including the AVMA’s correspondence with FDA, AVMA’s verbal comments to two of FDA’s advisory committees, and our AVMA Advocate article on this topic.)  Our basic assertions were that veterinarians need continued access to extended-release opioids for relieving animal pain and suffering, and we believe veterinarians should be exempted from any opioid REMS, or, any REMS required for veterinarians should be tailored for veterinary needs so access is not barred. Two advisory committees voted against the FDA’s proposed REMS in July 2010. In short, the advisory committees felt this REMS did not go far enough to prevent misuse of opioids.

The federal government has reformulated its overall plan on opioid diversion, with the FDA’s REMS being just one component of the entire plan. The federal government’s new plan to curtail drug abuse is Epidemic: Responding to America’s Prescription Drug Abuse Crisis. There are many components to the plan, but the main components that are probably most pertinent to the profession are:
1) The Administration’s desire for Congress to pass legislation to require practitioners to take training on responsible opioid prescribing, use, storage, and disposal before being able to procure DEA registration, 2) plans for federal rulemaking on proper medication disposal, 3) requirement for opioid manufacturers to develop training for prescribers (FDA’s REMS), 4) plans to engage stakeholders on the publicizing of need for the public to use, store and dispose of opioids safely, 5) plans to work with states to implement prescription-monitoring programs in all states and to require prescriber training on program use, and 6) encouragement of federal agencies to increase “take-back” programs.

AVMA’s Governmental Relations Division and Scientific Activities staff continue working in coordination with our lead governance groups on this topic (Council on Biologic and Therapeutic Agents and Clinical Practitioners Advisory Committee), and we will continue to monitor the situation carefully.

5 thoughts on “New Federal Plan Targets Prescription Drugs

  1. Dear Debra,

    My sincere sympathies for the loss of your beloved dog Jack, and thank you for reaching out to us about your concerns. If you have not done so already, please reach out to your veterinarian to discuss your concerns and to talk about possibly reporting the situation to Novartis (manufacturer of Deramaxx). When problems with a medication occur, reporting them allows the government, manufacturers and veterinarians to investigate and determine if the product’s labeling or use should be changed. If your veterinarian has not reported it, you may want to consider reporting this situation to the manufacturer.

    Drugs go under scrutiny by the Food and Drug Administration before being approved. Filing adverse event reports provides the government, manufacturers and veterinarians with critical information about products on the market.

    We also have a website that shares additional information about “adverse event reporting” that you might find helpful:

    Again, my sincere sympathies for your loss.

  2. To All Concerned Pet Owners:
    My name is Debra Lane and I have worked and taught in the human health field for 28 years. I am currently teaching adjunct professor courses on health and fitness at a local community college here in Michigan. I also personal train and teach fitness classes to the elderly including those with Alzheimer’s and Parkinson’s disease at a local senior center. I have seen the positive benefits of properly prescribed medications in improving the quality of life in humans and on occasion I have seen the negative impact of interactions of prescription medications and understand the disastrous consequences that can arise from misinformed or in this case totally uninformed individuals.
    I am a dog lover and a dog owner and am shocked and dismayed at the relatively poor quality of the information given to myself and other pet owners in regards to prescription medication for animals. I recently lost my sweet two year old black Labrador Captain Jack Sparrow Lane to the side effects of Deramaxx, a drug developed for the regulation of pain in dogs with osteoarthritis. Jack had to have ACL repair and has been placed on Deramaxx prior to the surgery and afterwards. Four days after his surgery we rushed him back to the emergency clinic and he was diagnosed with a stomach perforation. Emergency surgery was performed; Jack had two liters of fluid in his abdomen but he never showed us he was in pain. Our entire family rallied around him and we took him home.
    Little did we know that the rollercoaster ride was just beginning; Jack was back at the vet’s office in two weeks unable to pass stool. His intestines had telescoped due to the effects of his stomach contents creating scar tissue and another surgery was performed trying to save Jack. Afterwards, Jack didn’t want to eat and he barely drank. Three days later he was again leaking internally, another surgery was required. In a desperate attempt to save him the vet left him slightly open to drain; three days later he was closed up with two external drains in place. A few days later a barium test was run to make sure he wasn’t leaking and the barium showed up in the drains. On July 12th after spending nearly ten thousand dollars trying to save his life Jack was euthanized because he was again leaking and nothing more could be done to spare him the pain of these numerous surgeries and complications. The attending veterinarians and surgeons were absolutely clear that they believed Jack was a victim of Deramaxx. Our entire family rode the rollercoaster for weeks loving, encouraging and supporting Jack and we are still grieving the senseless loss of this gentle soul.
    This was a senseless loss because after his death I researched on the internet and was overcome by the postings and stories of the numerous dogs that have suffered similar fates from being prescribed this drug or similar types of this medication. I am sure Novartis – the company that created Deramaxx – will downplay my claim that Jack suffered and died as a result of their medication but I recommend that other animals lovers, veterinarians and vet techs do their research on the internet because the fact is that a portion of the animals given Deramaxx are dying senseless deaths.
    Just as it is important for the FDA to regulate the design, development, testing and prescribing of drugs in humans, it is critical that stronger measures be instituted in the drugs used on animals. One thing I have been asked numerous times is whether or not the veterinarian who prescribed Deramaxx for Jack gave us any verbal or written warnings about the drug and I can emphatically state an absolute “NO”. Unlike the brochures that I receive each and every time I obtain a human prescription describing the potential side effects, we received nothing. For animal medications there is no mandate to require that information be given to pet owners. In the case of Jack, the consequences were fatal.
    There must be something done! I clearly realize that a dog is an animal and not a human. I do believe as a human being I have a responsibility and sacred trust to care for the animals that are a part of my family. There needs to be a serious review and updates for animal drug regulations including mandatory written warnings and cautions on any and all medications prescribed by veterinarians. Pet owners would be able to make an informed decision by weighing the risk versus the benefits of their pet’s prescriptions.
    For Jack, it is too late. There must be better mandatory controls and communication of drugs being prescribed to our pets to help prevent senseless deaths.

    Thank you
    Debra Lane
    Justice for Jack

    • Justice for Jack became Time for Tag!
      My name is Tammy Cropp and my dog’s name is Tag. We would like to tell you our story with awareness being our top priority! Tag is a 10 ½ year old mixed breed that captures the hearts of all who come in contact with him. He is a large breed of 120 lbs of pure love. Tag has traveled everywhere with us and never knows when we grab the keys if he will be going to the grocery store or Nova Scotia. Considering his large size and his age, you may already have guessed he started showing signs of arthritis. This broke my heart and I wanted to help him continue to go for walks, which he absolutely loves, and basically just keep moving as much as possible. I am not one to take meds myself, but was talked into putting him on Deramaxx from the Vet who blew off any of my concerns. I mentioned on facebook that I was thinking about trying this, although it was against my better judgment. Many people commented that they had used this with their pets and I got no bad feedback which convinced me to give it a try. Tag started taking Deramaxx around the beginning of June, 2012. I noticed he was willing to move around more, following me around like he used to, although he still was unable to go in town for walks…too much for him. I did take him swimming every morning, which is his all-time-favorite thing to do. Swimming was good for his arthritis and being on Deramaxx he was able to last longer than before. This made me feel good about my decision and we enjoyed our early mornings at the marina most of the summer! Tag slowly began to eat less and slowly started losing weight, still not thinking anything but the fact that he was exercising more. The middle of August Tag had a visit to the Vet. Tag’s Deramaxx was running out and we were leaving for vacation, but Deramaxx was unavailable. Novartis – The company that created Deramaxx – had shut themselves down for an unknown length of time. When asking about the shutdown, they made the company look good by telling me they were fixing a small issue they had between human and animal medications. With this being unavailable, the Vet wanted to prescribe another med called Previcox. Again, I was uncomfortable with this, but convinced it would be fine. I was told to take Tag off Deramaxx for 2 or 3 days before starting the Previcox, all this would be while on vacation. Tag had already showed a weight loss of 6 lbs from starting Deramaxx, but no signs of concern from the Vet (he was now 113 lbs). Labor Day Tag decided he was done eating and pretty much drinking for the most part. Wednesday morning I got him to the Vet when even gourmet dog foods had to be coaxed down. Tag now weighed 106 lbs. The clinic did blood work and took x-rays of his abdomen and everything looked normal. On this visit, the Vet was able to get his hands on more Deramaxx and he sold me what he had. He told me to take him off the Previcox for 2 or 3 days and put him back on Deramaxx, never mentioning to me about the issues dogs were having with Deramaxx and Previcox. He was thinking Tag was just not tolerating the Previcox. He did prescribe Fonebade (doggy pepsid) to be taken before eating both morning and night. I took Tag home and went to Oakland Community College for my first class of the fall semester. Obviously, my mind was not in class and I asked the professor after class for a copy of the power point. In conversation she mentioned she had to put her dog down the week prior – at that point I couldn’t hold back my own tears and began to briefly explain where I had been all morning before class. Her radar went up when she heard that Tag stopped eating and drinking along with having arthritis. She asked if by any chance he was on Deramaxx…my heart sank! She told me a short version of her ordeal and said that Fonebane should be prescribed with Deramaxx to help protect their stomach…hopefully it wasn’t too late for Tag just receiving that prescription that morning. By Thursday evening Tag started having diarrhea, you can imagine our fear. Friday morning I called the Vet to try to get him in before another class. I was shocked and angered when all they would tell me was to take him to emergency for an ultra sound! They wouldn’t even see him or let me talk to anyone. I called a friend to see if she would come sit with Tag (a person he loves and can get him to do things he won’t do for us) while I went to my class. We both thought maybe she would be able to get him to eat or drink something…nothing. Out of despair, I called another Vet who I had recently met and respected. He agreed to see Tag within 2 hours of my plea! After seeing results of the blood work & x-rays from 2 days prior, and hearing my story; he decided that right now Tag needed “supportive help” (now at 104 lbs). He explained how dogs were having issues with both medications and that we would start by treating him for an ulcer from the meds (which he had been off now for 2 days). He kept him on fonebane (which he’ll be on for the rest of his life, but only in the mornings), gave him IV’s, low dose of steroids (mainly for appetite enhancer), along with putting him on a home-cooked meal diet (boiled chicken/burger/and white rice). It has been 2 ½ months since Tag received “supportive help” and is back on a dog food diet (holistic). Tag is still having arthritis issues, although he is as close to being back to himself (before the meds) as we could hope for. Now that his only issue is arthritis, I know what we will not be doing for him!! My new vet tells us we will start looking into “other” ways of treating his arthritis! I totally agree with Debra Lane; “There needs to be a serious review and updates for animal drug regulations including mandatory written warnings and cautions on any and all medications prescribed by veterinarians. Pet owners would be able to make an informed decision by weighing the risk versus the benefits of their pet’s prescriptions”.
      Thank You Jack!

      • Dear Tammy,

        Thank you for reaching out to us. I am glad to hear that Tag is closer to being his regular self these days. It sounds like you have a good working relationship with your veterinarian, which is key, especially as you and your veterinarian work to help Tag with his arthritis. As you already know, we think there is real value with reporting any problems associated with a medication to the manufacturer, which is something you might want to consider. In addition, to assist veterinarians and clients, the AVMA also has a policy called “Guidelines for Veterinary Prescription Drugs” which underscores the value of labeling dispensed prescription drugs to reflect adequate directions for proper use, any cautionary type statements, and other helpful information. Thanks again for your comment, and all the best to you and Tag –

  3. I would like to protest the new prescription drug law targeting people who have prescriptions for controlled drugs to have to have their license, passport, SS #, etc. on file at one’s pharmacy and have to show their ID every time they pick up that prescription. I understand that there is an issue with people selling their prescription medications. However, this new law targets a particular population and is discriminatory. It is an invasion of personal privacy. There is no privacy when you have to flash your ID so all other customers know you are taking a “controlled substance”. If you do not drive and depend on someone to pick up your prescription, you are out of luck with this new law. The police can even access your presciption data. What if you are a retired woman who has never had a traffic accident and you are involved in an accident? The police can get your medication records now in a database. Even though you may have taken this same medication for many years, even though you have demonstrated that you have a perfect driving record, you could be charged with driving under the influence of a controlled substance, You could 1. lose your license 2. be imprisoned 3. sued by the other driver and lose your home. I have a friend who was driving in a snowstorm when he skidded and killed the driver of another car. This individual was overwhelmed by guilt. Law enforcement said it wasn’t his fault. He was not speeding. The road should have been treated. Several months later, his license was revoked. It took 8 months for the state to admit it had been a mistake and return his license. There are many medications which can cause drowsiness that are not in the “controlled” category that are much stronger than some low dose “controlled” prescriptions such as anti-depressants. Why target one group and not the other? “Big Brother” has way too much power. I feel like I am being treated like someone on the “sex offender list”. They DO need to be monitored carefully. I have done nothing wrong but feel like I am being treated like a criminal. There were tears running down my cheeks when I had to submit to this indignity for the first time. I could not find another site where I could air my views so that is why you are receiving this e-mail. I hope that you can tell me to whom I should address my outrage. Thank you