PROVIDENCE – There were no headlines in the newspapers or breaking news alerts on TV or Twitter. But the number of overdose deaths in Rhode Island has climbed past 300 for 2016, reaching 302 this month, and still counting, because the official number of deaths for the last three months is still being confirmed.

Despite the best efforts of the Governor’s Overdose Prevention and Intervention Task Force, with its goal to save the lives of Rhode Islanders, the flood of fentanyl into the illicit drug market has driven the death toll up by more than 16 percent from 2015.

Overdose deaths remain one of the top public health challenges facing Rhode Island.

“Like many other states, Rhode Island’s overdose crisis began with prescription drugs,” explained the R.I. Department of Health page on its website tracking the numbers of overdose deaths. “Since 2009 deaths caused by prescription drugs have leveled; deaths from illicit drugs are on the rise.” Still, the website continued: “Overdose deaths caused by a combination of illicit drugs and prescription medication are up nearly a third since 2011.”

One of the strategies being pursued is to bolster prevention efforts by expanding the reach of the Prescription Drug Monitoring Program, a statewide database coordinated by the R.I. Department of Health by Dr. James V. McDonald, the chief administrative officer of the R.I. Board of Medical Licensure and Discipline.

The PCMP database is shared with both prescribers and pharmacists, alerting them to possible prescriber/pharmacy shoppers, tracking prescriptions of Schedule 2, 3, 4 and 5 controlled substances. In addition, a new program of sending out clinical alerts has begun, including alerts for when patients have been prescribed both opioids and benzodiazepines, commonly known as anti-anxiety drugs, whose combination can prove deadly.

The overarching goal of the program, McDonald told ConvergenceRI, it to reinforce good clinical practices by prescribers to encourage them to check with the PDMP database before writing a prescription for opioids for their patients.

“Ideally, a physician or a prescriber is looking at the PDMP before they prescribe,” McDonald said. “You’re hoping a pharmacist looks at the PDMP before they dispense. So, you have two roadblocks that will stop prescriptions that shouldn’t be written from being dispensed and actually given to a patient.”

The amount of opioids being prescribed in Rhode Island, measured by one pill equals one dose, is large: on average, about 2.7 to 3 million doses of opioids are being prescribed per month in Rhode Island, according to McDonald. While that represents a decrease compared to previous years, and despite new regulations about the number of doses that can be prescribed, McDonald admitted that the “utilization of the PDMP was not where we want it to be.”

As a result, the R.I. Department of Health, working with a grant for the Centers for Disease Control and Prevention, is looking to create an interconnect between the PDMP and electronic health records, so that there is a seamless interface between a patient’s electronic health record and the PDMP.

A more fundamental problem in addressing prescription painkillers is the way that they have often been misused – to treat chronic pain, without addressing the root causes, which results in dependency, according to McDonald.

“Opioids don’t treat the underlying cause of pain,” he said. “They mask pain. It’s a very important point. Because if the underlying problem is a short-term problem like a broken bone, your body will fix that problem.”

McDonald continued: “If your underlying problem is a chronic problem, like arthritis, it isn’t going to fix that problem.”

And, he explained further, “When you take an opioid for a long period of time, for whatever reason, even for 30 days, you may not become addicted to it, but you will develop a physiological dependence. It’s a pharmacological dependence, and it’s going to happen with almost everybody. When I say dependence, it means that if you stop taking it, you’re going to have to withdraw. If you are not removed from the medicine gradually, you are going to go through an uncomfortable experience called withdrawal.”

Here is the ConvergenceRI interview with Dr. James V. McDonald, the Chief Administrative Officer for the Board of Medical Licensure and Discipline at the R.I. Department of Health, discussing prevention strategies to improve the way that prescription painkillers are prescribed and dispensed in Rhode Island.

ConvergenceRI: Can you provide some history and background to how the Prescription Monitoring Database Program was developed?
McDONALD: The history traces back to 1998, to something called the EDT, or Electronic Data Transfer. That’s when we stopped using what were called triplicate prescriptions. Doctors from yesteryear will remember those.

The EDT gradually went away; in 2012, it really went away. In September of 2012, the EDT became the Prescription Drug Monitoring Program.

The difference between the EDP and PDMP is that the EDP was inward facing to the Department of Health, as data from Schedule 2 medications.

In 2012, with PDMP, it became outward facing toward prescribers who registered with us, for Schedule 2 and 3 medications.

We didn’t get Schedule 4 [controlled substances] until July of 2013. I don’t know why they were not originally put in [the database]. That’s important because they include benzodiazepines.

ConvergenceRI: Anti-anxiety drugs?
McDONALD: That’s what they are mostly marketed and used for, to treat anxiety.

In the last legislative session, we got the Schedule 5 [drugs], so now the PDMP has all the controlled substances, Schedule 2, 3, 4 and 5 are there now.

There have been multiple changes to make the PDMP easier to use, and easier to register for, as well.

When we first started with the PDMP, in order to register, you had to send us a copy of your driver’s license and a notarized application. We realized that we know who the people are, they already have a license with us; so the registration [process] has been made simpler. In the last legislative session, the change occurred that allows us, once we register you for a license, we could also register you for the PDMP.

It is common sense to register them before they start prescribing, so that when they come into the state and they are working and prescribing, they can hit the ground running.

ConvergenceRI: And this database covers all doctors, physician assistants, nurse practitioners…
McDONALD: There are eight different groups who can prescribe controlled substances. They include: physicians, APRNs, or advanced practice nurse practitioners, physician assistants, midwives, optometrists, dentists and veterinarians.

In terms of veterinarians, diversion doesn’t seem obvious between Fido and Spot, but diversion can occur between Fido and the owner. That’s something that is an issue as well.

ConvergenceRI: How does the PDMP connect with the database used by pharmacists?
McDONALD: That’s a great question. Prescribers and pharmacists look at the database. Ideally, a physician or prescriber is looking at the PDMP before they prescribe. You’re hoping that the pharmacist looks at the PDMP before they dispense.

So, you have two roadblocks that will stop the prescription that shouldn’t be written from being dispensed and actually given to a patient.

The regulations are in place for prescribers to use the PDMP. I am not aware of any requirements for pharmacists to check the PDMP.

ConvergenceRI: Is it voluntary then for pharmacists?
McDONALD: I think voluntary is one way of looking at it. There is professional responsibility to do something.

In March of 2015, it became mandatory for physicians and prescribers to look at the PDMP, before they write a prescription for an opioid.

Even before then, there was a professional obligation to prevent diversion.

I can’t say that any particular physician was ever sanctioned solely for not checking the PDMP prior to the mandatory requirement in the regulation. However, checking the PDMP is considered an affirmative defense when you’re dealing with the medical licensing board.

ConvergenceRI: Getting back to the pharmacies, it seems, in many ways, that the regulations put the risk, if that’s the right word, on the physicians and prescribers? Is that correct?
McDONALD: Responsibility is definitely the right word. Laws and regulations are not effective unless someone enforces them. The bottom line is: these are enforceable laws and regulations.

ConvergenceRI: How does that carry over to the pharmacist?
McDONALD: It’s unclear. There’s no requirement for them, so it’s really a professional standard.

What I’m seeing is that the pharmacies are cooperating; I’m seeing great utilization among the pharmacy reports. They actually exceed the prescriber reports.

We have roughly 2,00 pharmacists in the state, and roughly 8,000 prescribers.

The pharmacies are very invested in [using the PDMP], even if they are not required. I’m not seeing them as the problem.

ConvergenceRI: Weren’t the dentists and oral surgeons up in arms about changes in the regulations two years ago?
McDONALD: I believe what you are referring to are the control regulations, which we completed in March of 2015.

You’re right, there was a fair amount of pushback on several proposed regulations that went through public hearings.

By the way, those regulations are going to be before a public hearing again on Jan. 31, at 1 p.m., at the Department of Health. I don’t know if anyone is coming to testify, but you are welcome to attend.

ConvergenceRI: Getting back to the dentists…
McDONALD: There were several groups that were upset about the first proposed set of regulations, including the Rhode Island Medical Society.

With anything new and different, I’m not saying that the control regulations were disruptive, but they were new and different. So, when you think about big changes like that, there were a lot of people involved in the conversation.

At the first public hearing, it was amazing how many people came out. At the second public hearing, there was a fair amount of objections from the dentists, specifically about one issue: a prohibition on prescribing opioids to oneself or to the immediate family.

In the final version of the controlled substance regulations, we did not include that prohibition, because there were strong objections from the dental community. Dr. [Michael] Fine, [then the director at the agency] said: Quite frankly, this isn’t why people are dying, so why don’t we get through what we can get through.

The version [of the regulations] we came out with is something that is much better than what most states have.

ConvergenceRI: Isn’t there an effort to combat the mixing of prescriptions for opioids and the anti-anxiety drugs, the benzodiazepines? Including a new series of warning labels? How is that working?
McDONALD: Benzodiazepines are all Schedule 4 drugs.

ConvergenceRI: How many are prescribed per year in Rhode Island?
McDONALD: The rough number is about 5 million doses a year. The last time I looked, Rhode Island was number four in the country in the per capita use of benzodiazepines.

I want to give you some background on these medications. Opioids are Schedule 2s; benzodiazepines are Schedule 4s. They are classified in different schedules because of their abuse potential; opioids are more abusable.

These two drugs have something in common. Opioids don’t treat the underlying cause of pain; they mask the pain. It’s a very important point. Because, if the underlying [causes of pain] is short term, [such as] a broken bone, your body will fix that problem.

If your underlying cause [of pain] is a chronic problem, like arthritis, it is not going to fix that problem

Benzodiazepines were originally approved for two weeks’ use, four weeks at the most, for anxiety. That’s still what it says on their package inserts.

They don’t remove whatever is causing the anxiety; they just mask the feeling of anxiety.

There is a commonality here that is important. When you take an opioid for a long period of time, for whatever reason, if you are on it for 30 days, you may not become addicted to it, but you will develop a physiological dependence to it. It’s going to happen with almost everybody.

When I say dependence, it means that if you stop taking it, you are going to have to withdraw. If you’re not removed from the medicine gradually, you are going to go through an uncomfortable experience called withdrawal.

When I say dependence, it means that if you stop taking it, you’re going to have to withdraw.

For benzodiazepines, if you take them for a long period of time, there is a lesser chance that you will become dependent, but when you stop taking [the medications], the use has to be tapered down.

I’m giving you this background because I think it’s important to understand why this is such a difficult problem to solve.

It’s hard to change something in your life that you’ve become physically dependent on.

When you talk about quitting opioids and getting into recovery, even if you’re not addicted, you’re talking about a very difficult thing for people to do.

The reason why I’m saying that is because, as I recall, you once said to me something about the horse being out of the barn [in talking about opioids[, and I think I responded by saying that herds are well out into the mountains.

ConvergenceRI: How much of that is the responsibility of the drug companies that are pushing the use of opioids?
McDONALD: I think your question is poignant and complex. Pharmaceutical companies have incentives to market products for return on their investments for shareholders.

I think that there are other issues in our culture that are more complex, that for whatever reason, people are living in a culture where they are not content with their lives, and so the discontent needs to be addressed.

Looking for an answer for discontentment and unhappiness may not be done best with pharmacological substances.

However, psychotherapy is hard, counseling is hard. Changing life circumstances isn’t always possible for individuals.

Since 4,000 B.C., when the poppy was first discovered, we know that people have been escaping reality with opium.

There are many substances that people use to escape or alter their reality, not the least of which is pharmaceutical agents. Alcohol is another.

I’m giving you an honest answer to your question.

ConvergenceRI: Given all the efforts to prevent the substance use epidemic from growing, what is the information that the public needs to know about its own health?
McDONALD: I love the question. If someone has chronic pain, the treatment you need to seek is one that treats the underlying cause of your pain.

The treatment that you don’t need is something that masks your pain and doesn’t address get the underlying cause resolved.

Opioids need to be a treatment of last resort. If you take an opioid for 30 days, you’re becoming dependent on it.

We’re talking about a lifestyle change for people.

If you look at our regulations, it is a requirement for patient education, where there needs to be a discussion about dependence, the risk of addiction,.

The end point [of prescribing opioids] for chronic pain doesn’t make sense for the first rule of medicine, which is first, do no harm.

We know that Tylenol, and ibuprofen products like Motrin and Advil, are effective for treating chronic pain, with less morbidity.

We live in a culture where people want to be pain free, and that is a deep seated emotional issue. Humans can’t be pain free, that’s the way life is.

I think we need to say to people: if you’re looking for a treatment for chronic pain, the treatment you choose must be something that treats the underlying cause.

It may not be a pill, it might be a physical therapist, it might be an acupuncturist, it might be a massage therapist.