Summary.
House Bill-1 passed in 2012 was a landmark legialstive effort to deal with Kentucky’s exploding epidemic of substance abuse. It clearly was effective in acheiving some of its goals, but it seems to have had less effect in some parts of the state and may have done as much as it can. We have improved our ability to collect data about prescription of controlled substances, but we have lagged in taking advaitage of what we have learned. We need to keep trying to do other things. Not all will work as well as hoped for either, but doing nothing is a non-starter.
Press conference(s).
In July, Governor Steve Beshear, Attorney General Jack Conway, Senate President Robert Stivers and House Speaker Greg Stumbo presided over a press conference to provide an update on House Bill 1, the comprehensive prescription drug abuse legislation passed in 2012. Details presented included that the number of overdose deaths were down, the numbers of prescriptions for commonly abused drugs had dropped, and that 20 pain clinics had been shut down since HB-1 took effect. Recall that prescriptions for controlled drugs dispensed in Kentucky must be reported to the Kentucky All Schedule Prescription Electronic Reporting (KASPER) database. The number of prescribers enrolled in the KASPER program increased from 75,45 to more than 24,000 with a tripling of queries to the KASPER database for reports on their patients from 811,000 to 2.7 million. Over a ten-month period, the number of doses of hydrocodone dispensed dropped 9.5% from 198 million to 179 million doses. The number of doses of oxycodone dropped 10.5% from 72 million to 64 million does. Some of the other improvements were not so impressive. Overdose fatalities over the previous year dropped, but only from 1023 to 1004. The number of physicians disciplined for prescribing violations by the the Kentucky Board of Medical Licensure rose from 53 to only 64. Some bad news was that the number of overdose deaths attributed to heroin rose from 22 to 143, a forerunner of worse to come.
There is no doubt that HB-1, enacted in July 2012, has had an impact in the right directions, but some of the observed effects were relatively modest and some of the major impacts were probably one-time benefits. Most of the immediate impact of the bill was either predictable or the result of picking the low-hanging fruit. The 20 or so “pain clinics” that were shut down were obvious pseudo-medical pill-mills in disguise. Enrollment in KASPER by prescribers became mandatory with the new law which also required prescribers to make at least some inquiries about their patients before prescribing selected high-risk drugs. A stunning number of out-of-state licensed prescribers all of a sudden discovered it was too risky to use Kentucky as the drugstore of choice for their prescriptions to abusing co-conspirators. These changes to the prescriber population alone would be expected to decrease the overall volume of controlled substances entering the system. The distressing observation remained that use and diversion of controlled prescription drugs remains huge and pervasive.
Oops— Start over!
Even though I had heard last week’s press conference live, I was a few paragraphs into the document summarized above before I realized I was erroneously reading a press release from July 25, 2013 that I had just downloaded from the Internet! The players from last week’s press conference were the same, but the occasion was the release of a study commissioned by the Cabinet for Health and Family Services and prepared by a unit of the University of Kentucky’s College of Pharmacy. The report compared two year’s prescribing of controlled substances before HB-1 to that of the following full year ending July 2013. The July 27, 2015 press conference therefore had a longer follow-up to draw upon but the results were not all that different and not always better than those of two years before.
A great deal of data was sliced and diced for the UK report. There is much to be pleased about. KASPER queries were up to 5 million in 2014. “Doctor shopping” by individual patients was said to have dropped by 54%, but since multiple prescriptions presented by the same patient to different pharmacies is probably the easiest thing to detect in the KASPER program, this is not unexpected. (The KASPER database says little or nothing about whether a prescription was appropriate in the first place.) The provider community was either forced or shamed into addressing more aggressively the problem of prescription drug abuse. Attorney General Conway noted that the number of referrals to his office from the Medical Licensure Board office for prescribing issues rose from zero during his first term in office, to 211 after HB-1. Disciplinary actions actions of some kind against physicians related to prescribing since HB-1’s passage in July 2012 through March 2015 rose to a total of 142 physicians. Complaints against prescribers are now shared among selected medical, government, and law enforcement agencies. Efforts have been made to increase treatment for drug-addicted individuals. The participants in the press conference recognized that the changes were modest. They were by no means declaring victory, but acknowledged a palpable new beginning to solving a recalcitrant problem. A bipartisan and continuing promise of full engagement was made. I think they all meant it. The current study presents a challenge that demands further action.
HB-1 Impact Evaluation.
The 88 page study from the UK College of Pharmacy and its 157-page supplement provide additional insights. I suggest you read at least the 6-page executive summary. The major take-away message for me was how ineffective Kentucky’s measures to prevent controlled substance abuse and diversion were before HB-1. Much more can be said, but I offer the following initial comments based on my reading of the report.
Chilling effect of HB-1?
The report addresses often the question of whether HB-1 would have “unintended consequences,” or a “chilling effect” on prescribers such that legitimate use of controlled substances would be suppressed. These labels are standard code phrases used by the lobbying and advocacy communities when arguing against legislation they don’t like. It is fair, indeed important to objectively measure the effects of legislation or policy changes. We need to do more of that. However, not all unintended consequences are bad, and I would ague that some degree of a chilling effect on controlled drug prescribing was, or should have been the intent of the legislation! Whether a prescription for a controlled substance is “legitimate” is in the eye of the beholder, or the mouth of the user. I suspect there is still significant push-back from the medical and pharmaceutical industry against state initiatives to reduce the use of prescription narcotics. After all, professional independence and incomes are being threatened. The authors may have been trying to lend ammunition to Frankfort in this regard.
The report could not demonstrate that much, if any, cold water had been thrown on the legitimate use of controlled substances. While the prescription of abuser-preferred drugs such as oxycodone and hydrocodone had gone down modestly (see below), the use of other prescription drugs such as stimulants had gone up. Surveys turned up a small number of providers who claimed that they were no longer prescribing controlled substances, but these are probably the same providers who swear they will no longer see patients when faced with other regulations they don’t like. It cannot yet be said that such comments were in the way of protest rather than actual prescribing behavior. Other circumstantial evidence did not support an overt chilling effect, but lets fact it— the intent of HB-1 was and should have been to decrease the overall prescribing of narcotics and other controlled substances by healthcare providers.
Who uses Kasper?
Although the KASPER program has been around since 1998, as a result largely of objection from the user communities, enrollment and queries were completely voluntary. Before HB-1, as few as 28% of providers otherwise licensed to prescribe controlled substances were registered with KASPER. Although the report encountered difficulties cross-tabulating and compiling the data, by July 2013 some 95% of eligible prescribers of controlled substances were enrolled in KASPER. Curiously, only some 83% of licensed pharmacists were registered with KASPER. Apparently Kentucky pharmacists working in licensed pharmacies are not required to report their relevant activities to the Board of Pharmacy! Since it is through the doors of drug stores that the bulk of controlled substances pass, I would hope that the Board of Pharmacy would step up to the community plate and change their regulations.
HB-1 requires prescribers to query KASPER before prescribing Schedule II or Schedule III drugs containing hydrocodone. (I am not aware that there are any Schedule III substances containing this drug.) For this and other reasons, the number of queries by prescribers to see what other drugs their patients might be taking or who else is prescribing for them soared into the several millions. The number of queries per inhabitant varied among the counties from fewer than one query per 100 inhabitants as in Jefferson County, to as many as one for every 10 people living in some of the counties in eastern and western Kentucky. Pharmacists are not required to query KASPER. [Why not?] As a result, queries by pharmacists for controlled substances budged little during the study period. Queries from law enforcement did not change significantly at all. So much for fears that HB-1 would be abused by law enforcement. I think it should be used more! Much obvious malfeasance still exists that is not going to go away voluntarily or through education.
Number of prescriptions by Schedule.
Over the two fiscal years prior to HB-1, the number of prescriptions for Schedule II drugs (largely the opioid narcotics and stimulants) increased by 8.3% and 6.6% respectively. In the year after HB-1, the number of prescriptions for Schedule II drugs decreased by 4.2%. While this is desirable, the total number of prescriptions (2,295,782) was still more than in either of the two previous years. For Schedule III drugs (Tylenol #3 variants, barbiturates, and anabolic steroids), prescriptions were increasing annually at 4.8% and 4.7% before HB-1 and decreased by 5.7% the year after. While the numbers and charts counting prescriptions for these most-abused drugs were moving in the right direction, they cannot be used to demonstrate a definitive, and certainly not a continuing trend downward. [Editorially speaking, I disapprove of graphing the numbers on an axis that does not include zero. This emphasizes small differences.] These state-wide numbers are promising. However, when graphed by county, the number of prescriptions for these two and other schedules of controlled substances are still rising in some eastern Kentucky counties. An unfortunate number of counties had more than one and two prescriptions written per person for Schedule II and III controlled substances respectively. Clearly the controlled-substance express is still racing in some parts of Kentucky. [An extensive list of controlled substances by Schedule is available here.]
Prescriptions by class of drugs.
Much of the analysis in the report lumped all controlled substances together. However, most of the public’s attention has been drawn to the narcotic opioids. According to the report, opioids are the most commonly prescribed class of controlled substances in Kentucky comprising over 50% of all controlled substances. Prescriptions for opioids, benzodiazepines [Valium-like drugs], and stimulants [diet, study, and AHDS pills] were all on the rise before HB-1. In the following year, prescriptions for opioids and benzodiazepines decreased by 8.7% and 7.7% respectively, while stimulants continued to increase by 8.6%. (The rise in stimulants was used by the investigators to argue against an overall chilling effect.)
Breakdown by specific drug.
Looking at individual drugs is where the money and the insight is to be found. Hydrocodone, the most frequently prescribed schedule II drug, decreased 13.0% to 3.25 million prescriptions; oxycodone 11.8% to 0.97 million; and tramadol 12.4% to 0.59 million prescriptions. These decreases in number of prescriptions appear meaningful, but they do not count the actual number of pills dispensed or account for non-prescribed drugs. Prescriptions for morphine including MS-Contin actually increased 2.4% to 0.14 Million. It will be interesting to know whether this reflects the use of morphine in cancer or hospice care, or is rising as other powerful narcotics come under scrutiny. The largest increases in narcotic prescriptions are for buprenorphine, a schedule III narcotic that is used, like methadone, in drug-assisted treatment for narcotic addiction. However it is also subject to abuse. Prescriptions for methadone are falling but those for buprenorphine and its combination with with the opioid inhibitor naloxone have been rising in double digits of over 40% more each totaling a combined 0.92 million yearly prescriptions at the end of the study period in 2013. Treatment of narcotic addiction, to the extent that it is supported by insurance payers, will be the next big growth industry in medicine. In my opinion, based on Medicare provider payment files, addiction treatment is already being abused by some providers.
Problem getting worse in many counties.
Despite the aggregate statewide improvements, inspection of the county maps provided in the report is disturbing. For example, oxycodone prescriptions in several counties in eastern and western Kentucky continue to rise in a dramatic fashion. Clearly, for some parts of Kentucky that need the help the most, our current solutions are inadequate. Kentucky is still awash in controlled substances. There were 10.9 million prescriptions for controlled substances for the year ending June 2013. This is 2.5 prescriptions for every man, women and child living in the state. Every unique patient who appears in the KASPER database because they received at least one controlled substance has an average of 7 such prescriptions. This number is still going up.
Some bad actors out there.
The vast bulk of prescriptions for controlled substances are written by a very small minority of providers. The report tells us that 90% of all controlled substances are prescribed by the top 10% of prescribers. In fact, the numbers are heavily skewed to an even smaller number of prescribers. For example, in the year following HB-1, 10 individual providers wrote 311,626 prescriptions for controlled substances– fully 2.4% of all such prescriptions! When broken down by specific drug, the concentration of prescriptions among providers is even more striking. For example, the top 10 individual prescribers of oxycodone wrote 8.9% of all oxycodone prescriptions in 2013! The report noted that the top prescriber of opioids “issued 34,349 prescriptions and would need to write 14 opioid prescriptions per hour to issue this number over the course of a year.” [Surely this prescriber needs to be investigated, despite any chilling effect that might have on us colleagues! If he or she has not been looked at already, abandon all hope ye who hope for progress against this plague.] Blessedly, “consistent efforts to identify and investigate top prescribers for possible inappropriate prescribing” are being made by the Cabinet and its enforcement partners. Surely such observations should be an embarrassment to the medical community, its licensing authorities, and the regulatory and legal systems charged with protecting the public.
Substance abuse treatment admissions.
If anything, they are going down, but this certainly reflects a deficiency of resources and not the need. Deaths from narcotic overdose, including from heroin, are rising. Our leadership realizes that we can’t convict our way out of this mess by putting addicts in jail. It hasn’t worked so far and we can’t afford it anyway. There are not enough treatment and detox facilities, and those who have the greatest need are the least able to afford them. The “social engineering” that needs to be done to improve the lives of people enough to mitigate against substance abuse or to improve the chances for sobriety once addicted is as yet untested and likely to be difficult to agree upon. Perhaps now that the stereotype of the narcotic addict is changing from poor, under-educated, inner-city dweller who is often a minority (not that the stereotype was ever valid); to young, white, high-school or college educated person from an affluent suburban family; the social and legislative dynamic will change and funding will magically become available. We have to do something in any event because of the increasing cost to society in terms of derivative crime, disease, dollars, and general misery. We are paying already, just for the wrong things.
How good is the underlying data?
As with all such studies, the conclusions are only as good as the accuracy of the data. This was not a perfect data set. According to the authors: “We found large increases and decreases in some monthly statistics, which may be indicative of data quality problems. We worked with CHFS to correct one major reporting error. Further review of the data needs to be done to test whether the changes that we observe are true changes in the data or data anomalies due to the processing of the data. Fiscal year 2011 appears to be most problematic.” Hmm. Not a robust endorsement.
Did HB-1 work?
Yes, HB-1 worked largely as hoped for. Despite all or any the problems, it would appear the HB-1 achieved or at least has begun to achieve at least some of its intended goals. Closing the most obvious pill mills and scaring away abusing out-of-state providers occurred concurrently with a modest decline in the number of prescriptions of controlled substances dispensed by Kentucky pharmacies and providers. Doctor shopping was stepped on hard. The decrease in number of prescriptions for the the most commonly abused drugs decreased a meaningful 12-13%. However, I fear HB-1 has already done most of what it could on its own. The decreases in prescribing have not occurred in the places where it is needed most. Indeed, the evidence is that things are getting worse in some counties. Drugs can be obtained in other ways than through legal prescription. The community of drug-abusers and those providing for them has shown impressive flexibility in adopting to obstacles. Our community of providers, policymakers, and their enforcement partners need to be equally nimble and flexible in addressing this terrible public health and social problem. Evaluating the effect of HB-1 is fine, but in my opinion it is already outdated. We are good at collecting data, but are lagging in what we do with it. We need to bite the bullet and begin to aggressively look at and intervene with with the highest volume prescribers, patients, and pharmacies. We need to investigate the hot-spot communities that show up on maps of the counties. We need to eliminate as many existing exemptions to reporting and prescribing laws and regulation as is possible and to hand out fewer in the future. The process of dealing with prescription drug abuse and addiction needs to be a continuous one. Given the political difficulties in passing even the modest reforms we have not does not make me very optimistic about our ability to get ahead of our problem.
Recommendations.
The contract with the Cabinet asked for recommendations but few if any were offered in the report. It was recommended that the Cabinet continue to identify and investigate top prescribers. It was also suggested that, “Continued analyses of prescribing behavior, patient behavior and outcomes in the post-HB1 period are warranted to determine if the impacts observed in the first year following implementation of HB1 are sustained.” While this latter recommendation might produce another contract, I don’t think we should wait for the results. What do my readers think we should do next?
Peter Hasselbacher, MD
President, KHPI.
Emeritus Professor of Medicine, UofL
August 3, 2015
House Bill 1 is contained in its entirety in the supplement to the UK report. 10.1 MB