Sunday, October 15, 2017

2018 Florida Legislative Proposal on Limiting Opioids

The Florida Legislature will at least debate drug abuse, overdose and addiction in 2018, the "Opioid Crisis." The news broke last week with the filing of House Bill 21 (HB 21). 

Anyone that has ever browsed this blog will know that I have been banging the Opioid gong for a while. We have seen some big gains this year in the war on drug abuse, dependency, and overdose. Last May, Governor Scott declared a public health emergency. The Center for Disease Control (CDC) published Opioid Guidelines. In August, President Trump declared the Opioid crisis a "national emergency." That coincided with the inaugural Hot Seat, and our awareness that we currently have 29 such national emergencies, dating back to President Carter (1977-1981). 

The scope of risk has been studied. There was a report last spring that concluded that "prescribing patterns for Opioids have long been thought to be linked to increased risks of continued use and addiction." Those risks "rise sharply in the first few days of use." Patients who use Opioids for three days have an increased risk of still using those drugs both one year later and three years later. And, the risk increases more after five days of use, see Addiction Risks Rise after Day Three of an Opioid Prescription. See also Opioid Dependence Can Start Within Just a Few Days.

Industry has begun to respond to these studies. In September, AOL and others reported that CVS Pharmacy would limit Opioid prescription dispensing for "certain conditions" to "a seven-day supply." CVS is reportedly the first national chain to impose limits. These limits will reportedly "apply to patients who are new to pain therapy."

Back in 2013, I noted that Dying to me don't sound like all that much fun. Then I chronicled the conclusion that there was "misuse and abuse" of medications. National attention was being drawn to Opioids, and Americans were dying. A persuasive point was the CDC statistics showing that overdose death was more prevalent than automobile accident death. The information was out there, but the market was slow to get it. We know Opioids are a problem. 

In 2015, I continued to highlight that drugs were killing Americans. In What can you do in 11.2 Minutes, I tried to illustrate the rate at which Americans were passing from drugs. We keep talking about it, until perhaps I sounded last spring Like a Broken (Drug Death) Record. They are killing people, depriving children of parents, depriving parents of children, and the fact is they are affecting us all. In 2016, more Americans died of drug overdose in one year than died in the entire span of the Vietnam conflict, see Hot Seat

There have been efforts. Florida has a robust Prescription Drug Monitoring Program, as do other states, see E-FORCSE and KASPER Cousins with a Cause. Florida started this effort in 2009. Florida requires physicians to report the prescribing of drugs, but has no requirement that they check this database before prescribing. In 2015, I questioned If it's Worth Having, Is it worth Checking? Other states have required physicians to check first. A year ago, I noted California joining this trend in If not, What is the Point? Early this year, I noted Maine Makes Opioid Changes, and last spring, I noted the success of Ohio in PDMP and Opioids in Ohio. Checking the data, it seems, works. 

Success was being made. And now, Florida seems poised to build on the success of restricting Opioid dispensing, and the closure of all those "pill mill" doctor offices/clinics (thank you Attorney General Pam Bondi). There will be debate and discussion in 2018. The impetus of that discussion lies with the Governor, the President, and now Representative Jim Boyd of Sarasota, the sponsor of HB 21. Reportedly, Senator Lizbeth Benacquisto will file a Senate bill to parallel Representative Boyd's bill in the Senate. 

There will be discussion. It is too early to say that there will be success or progress. But there will be discussion. Certainly, there may be good reasons for not checking the Florida PDMP before prescribing these drugs; there may be good reason for sending patients home with a thirty-day supply of these potentially addicting drugs; there may be good reason to not require physicians to be regularly educated about Opioids, standards, and addiction risk. I look forward to the discussion; I am ready to hear the reasons. 

What would HB 21 do?

HB 21 would require physicians to receive two hours of Opioid education every two years. They could enjoy this training in a "distance learning format," from the comfort of their own home or office. (Lines 108 - 115). Perhaps lawyers and judges could benefit from the same education. Perhaps everyone could. 

HB 21 defines "acute pain" and differentiates it from "chronic pain" and carefully avoids the troubling, but ever present "malignant pain." (Lines 155-160). The issue of malignant pain is a distraction  in this Opioid discussion and is best avoided. If someone is suffering from cancer or other life-ending condition, then there should be no limits on their access to pain medications. Malignant pain is not part of this discussion and not part of this bill. 

HB 21 requires Florida to 
adopt rules establishing guidelines for prescribing controlled substances for acute pain, including evaluation of the patient, creation of a treatment plan, obtaining informed consent and agreement for treatment, periodic review of the treatment plan, consultation, medical record review, and compliance with controlled substance laws and regulations. (Lines 300-306)
HB 21 limits most Opioid prescriptions to a "3-day supply." There is an exception that allows physicians to exceed this, and allows up to a "7-day supply." But that exception requires the physician to document the condition and the "lack of alternative treatment options that justify deviation." In other words, prescribe 7 days worth of medication if you need to, but explain why you need to. (Lines 309-325).

HB 21 requires pharmacists to verify the identity of patients receiving such prescriptions. Those patients must present photo identification issued by "a state or the Federal Government," or the pharmacist must "verify the validity of the prescription and the identity of the patient with the prescriber. (Lines 601-605; 627-630).

HB 21 substantially rewords Section 893.055, Fla. Stat. regarding the Florida PDMP (E-FORCSE). (Line 1044). And, the law would place a new requirement on the physician 
A prescriber or dispenser or a designee of a prescriber or dispenser must consult the system to review a patient's controlled substance dispensing history before prescribing or dispensing a controlled substance.
If the PDMP is not available ("not operational"), then the prescriber would have to document the reason for not checking the PDMP and "shall not prescribe or dispense greater than a 3-day supply of a controlled substance to the patient." So, with the PDMP not operational, the "7-day" option is not available. Failure to "consult the system" would result in the issuance of a "nondisciplinary citation to any prescriber or physician who fails to consult." (Lines 1255-1273).

HB 21 requires annual reporting to Florida's elected leaders regarding the success of education programs, progress in decreasing medication obtained by fraud, improved patient care, reduced "drug diversion," and "increased coordination among partners participating in the" PDMP.

HB 21 is 114 pages long. It addresses a great many details and would make many changes. The foregoing is but a summary of a few. In this time of Opioid crisis, there are a few things that seem clear to those who have been following, chronicling and discussing Opioids:

1. Pain is real
2. Pain is a complex, multifaceted issue
3. People are dying and being damaged by Opioid use
4. Those Opioids are both prescription and "street" drugs
5. Prescription drugs have in some instances been seen as a "gateway" to street drug use
6. Addiction is real
7. Addiction is likewise a complex, multifaceted issue

There is no physician that wants to see a patient in pain, and no patient wants pain. But, medicine has to strive to approach pain relief in a responsible manner. There is evidence supporting that Opioids can be a danger to patients. There is ample evidence that PDMP programs have been effective in decreasing inappropriate distribution of these drugs. What HB 21 will not do is magically and instantly correct all risks and issues with Opioids. That panacea either does not exist, or has not been discovered. But, the fact that all issues cannot be completely solved does not excuse failure to try. 

There will likely be critics of these proposed legislative efforts. There will be those who will raise addiction as the primary issue, and they may ask why more is not done for those already in the grip of addiction. Certainly, there are many in that situation and in need of intervention or assistance. They are the victims perhaps of prior prescriptions and Opioid availability. But, if this legislative effort can prevent or even delay new patients from dependence on Opioids, then it is an admirable start. Drugs are killing people. Preventing dependence is important. And, that does not mean there is not a need for further efforts assisting those already dependent. 

Finally, medicine must address pain. The history of Opioid medication is troubling. The death toll is staggering, with predictions that the next decade could bring 500,000 Opioid deaths. But that does not change the fact that people experience pain. Following injury or surgery, people need to understand that pain and they will naturally look to medicine to assist them. Medicine needs to respond with treatment and care that addresses that pain in a manner that does not lead to addiction, dependency, and death. It may be that there is, in a given situation, a "lack of alternative treatment options" (Lines 309-325), but that does not mean medicine cannot seek them.

I wish this were a simple problem with some simple solution. It is not. Pain is real, Opioids have been our collective solution, and pain drugs can damage and kill people. That is an inherent conflict that confounds us. There has to be a way to solve that dilemma. And, frankly, the time has come for that national discussion. How do we deal with pain without merely substituting a different problem like debilitation, addiction or death?

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