Scary article on FDA regulations

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Scary article on FDA regulations

Post  sailingmuffin on Tue Mar 15, 2016 2:55 pm

Hi All,

Here is the link to an article about new guidelines for treating pain. It is really kind of scary.Article on Pain guidelines

Pain free days

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Re: Scary article on FDA regulations

Post  Migrainegirl on Wed Mar 16, 2016 6:06 pm

This is going to have serious ramifications for all the people who live with very real pain every day. Although supposedly "voluntary", compliance will very quickly get pushed into insurance requirements and many physicians are already afraid to write pain prescriptions for their patients. It's going to get very very difficult for people with chronic pain to get treated and there goes what little quality of life they have. I predict suicides will go up along with countless needed pain and suffering.

Just more red tape and more costs. I will very happily submit to a drug test as often as they like. But who pays for that? The patient at about $300 a pop. What about people who can barely afford their meds as it is?

I generally don't wish ill health on anyone, but it really makes me wish these people would live for just a few months with chronic pain, and then they can decide what these rules should be.

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Re: Scary article on FDA regulations

Post  tortoisegirl on Wed Mar 16, 2016 9:06 pm

I'm hopeful this won't have any significant impact for managing chronic pain with opioids. It appears that this is geared towards primary care physicians treating chronic pain, and a lot of this should be common sense.

Although I am all for treatment of pain with whatever it takes, including opioids: I have heard of people being prescribed 30 days of a strong opioid for injuries that would typically only require 3 days worth. Or, being prescribed high dose Oxycontin (a long acting med for chronic pain) to take for a week after a surgery. Or, opioids being used as a first line therapy instead of NSAIDs, pt, ice, etc, and before a diagnosis is made. Or, combining opioids, benzos, and sleeping pills.

I think these guidelines are meant to discourage prescribing more like that than saying don't use opioids for chronic pain. I agree with the articles associated with the guidelines that there is a real problem out there. However, some guidelines previous to this were much more restrictive (such as the one in my state of WA which quotes an actual upper recommended daily dose limit for chronic pain!), These new guidelines (and they are only guidelines) don't actually scare me.

I'd be curious on the stats for addiction and overdoses and the like which stemmed from starting to take opioids for legitimate pain based on whether the patient was prescribed in a way which met common sense guidelines or not...it seems like many issues stem from prescribing opioids too long for acute pain, prescribing a medication which is inappropriate, med combinations, starting with too high of a dose, not evaluating whether the patient is a high risk (ex. addiction tendencies), etc.

Or, in the case of overdose, whether some are suicides, especially in chronic pain patients. I'd think its more likely the majority of issues aren't from prescribing for severe chronic pain. Pharmacists can also flag some of these issues, but I've also heard of them going much too far.

For patients with documented chronic pain who have trialed other treatment methods which receive their pain meds from a pain management specialist (like me), I'd hope this doesn't have an impact. I think most patients are much better off seeing a pain management specialist by the time they are thinking about a long acting opioid for their chronic pain (or ideally, well before then); they have the training and experience that primary physicians don't.

Although I'm very glad my primary doctor started me on Methadone years ago as its been the only thing to significantly and consistently treat my pain, and I agree it was time to try a long acting pain med as we were out of reasonable options, he didn't have the experience he should have to prescribe it, and made some mistakes that could have been dangerous.

Plus he rather quickly escalated the dose when it wasn't helping enough, which has caused me some problems long term as it gets to a point that no one will prescribe for your tolerance level, even if you are getting less pain relief than someone on a fraction of the dose because they have a low tolerance. My dose was reduced down to lower than I first tapered up to. Best wishes.

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Re: Scary article on FDA regulations

Post  Sara79 on Mon Mar 21, 2016 6:54 am

I'm hoping this is more for those that MD's are beginning pain regiments with a pt, because if my doc were to try this with me, after years of pt history (primary's office has been my doc since leaving my pediatrician-back in the early 90's) he knows he'll have me revolt and plan some truly nasty form of revenge. Ide mentioned that I knew the DEA/Med associations were getting tougher about primaries managing chronic pain, and my doc told he he had no worries about prescribing for me...that I've never made any actions that have made him thing abuser and that basically 'we're kewl' to use a smidgen of web speak. I opened the subject, mentioning that if he ever needed to give urine screenings or the like, to just tell me, I'm fine with helping out on something to keep him legally safe prescribing to me.

I am so grateful that my doc has this level of trust in me...it makes my life much easier. I go in and he'll write three scripts at at time, first, fill now. Second, do not fill before date 30 days out. Third, same, but 60 days out. That was I only have to pay to see him for these every 3 months. And if I go in for something else close to the 90 day date, he's gone ahead and given me the next three, written just like I'd mentioned previously.

My only fear is that I do have to be educated about my meds...my last migraine, he was ready to give me the old combo of migraine eradication (torodol and phengrine IM injections-old, given last November) however, I've had multiple clots and been put on warfarin in December, and torodol is an NSAID, so I can't have it while on warfarin. I had to remind my MD of this, while battling a migraine. If it wasn't for the fact that letting him do so could turn a paper cut into something requiring super glue stitches, I'd almost let him do it, stupid migraine pain!!!

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Re: Scary article on FDA regulations

Post  Brenda L. on Sat Apr 02, 2016 8:31 pm

I agree---the new FDA guidelines are downright scary for those of us in chronic pain. It all seems to be hitting us at once.

My longtime pain doctor said that the new FDA guidelines are going to affect the way that he prescribes medications. My pain doc is being forced to change the treatment plans of several patients who were on stable higher doses of opioids--all because of new regulations. It doesn't matter that I've been a model pain patient---the regulations trump everything.

I even consulted with a second pain doctor to get his take on the new regulations. That pain doc said, "The new FDA (or CDC) regulations are not good. I'm being forced to limit opioid doses at very low levels." It doesn't matter anymore if the individual patient needs a 'higher' dose; the government is making their own rules in regard to pain medicine. They don't want patients to be taking opioids, and they are going to make things as impossible as they can. (My new pain doc said that the drug addicts will figure out how to get pain meds no matter WHAT the DEA does). He treats some addicts with Suboxone, so he's heard a lot of stories from 'the street'.

Doctors now don't want to prescribe opioids. Pharmacists don't want to carry them, dispense them, order them, or fill them. (I just had a pharmacist tell me the DEA watches everything that he orders. He could not special order my prescription).

And worst of all: Health insurers are now refusing to COVER opioids! My new pain doc told me that my plan (a major insurance company) is suddenly not allowing him to write any scripts for pain meds. He can write them, but they refuse to PAY for pain meds. Suddenly, my insurance is refusing to cover my pain meds. There's been no problem for years, but SUDDENLY, things have changed drastically!

My old pain doc and my new pain doc both agree that the new FDA guidelines are horrible and are having a drastic effect on their ability to practice pain medicine. Some of these pain meds are very expensive---most people could never afford them without insurance covering them!

I agree that there will be suicides among chronic pain patients. People are going to get so desperate they won't know what to do. I wonder how many people will be forced to turn to street drugs? I'm guessing that heroin sales will increase. How demeaning---legitimate chronic pain patients having to go to a backstreet drug dealer? Some people will seek out the black market.

I also wish that those who make the regulations would have to LIVE in this severe pain for a few months. Then they might get a clue as to why CP patients need their opiate pain meds. In Florida, the attorney general is blaming the DEA, the DEA is denying culpability, the pharmacists are publically stating fear of the DEA, etc. The 'blame game' goes in a circle.

The officials all keep saying that the new laws will NOT affect legit chronic pain patients--yeah, right! They've already received thousands of letters and emails of complaint from people who can't get their pain meds. There MAY be an exception for terminal cancer pain (even that is questionable), but it's becoming impossible to get opiates for non-cancer chronic pain. Making people SUFFER is NOT the answer.

I do wonder how the drug companies that manufacture opioids are even going to stay in business. Soon, we may be hearing that many opioids are no longer being manufactured. There already are shortages from the distributors. I fear that the drug companies may halt production altogether of some of the opiate medicines in the near future.

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Re: Scary article on FDA regulations

Post  Migrainegirl on Sat Apr 02, 2016 10:32 pm

Unfortunately this is the reality we were afraid of. It's truly criminal.
Sadly addicts are more important than helping people in severe pain.

If there were any real alternative that helped us, I am sure we would all jump at it.
When they have real solutions, then they can take away pain meds, but this is just
Truly unjust.

So, in the mean time, the best we can do is to use the solutions that are out there.
Many have had luck with Botox or Cefaly. Have you tried those?

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Hi

Post  Jeff2014 on Sun Apr 03, 2016 4:53 pm

Hi,

I didn't see the link to the article. Where can I find the article on the new FDA regulations?

Jeff

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Re: Scary article on FDA regulations

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