An interview with Dr. David Bear, former Professor of Psychiatry, inventor, and founder of brand protection specialist Covectra, on the topic of how serialisation can play an important role in prescription medication adherence.
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Dr. Bear, what are some of the steps that a physician typically takes to increase medication adherence?
The first step is for the physician to be clear about why he is prescribing a particular medicine while letting the patient know in what time period the medicine should become effective. I think psychiatrists in particular should be careful to explain side effects of medication, because if the patient can anticipate side effects in advance that are annoying, but worth putting up with, to reverse major depression or psychosis, you build trust and therapeutic alliance. If you don't mention such side effects, patients often stop taking the medicine.After the patient starts taking the medication, how do you sustain adherence?
We patiently wait for improvement in the psychiatric symptoms. A thoughtful doctor knows that for antidepressants to work it might require three or four weeks. In the case of antipsychotics, a sustained improvement can take 10 days or two weeks. You are prepared for an answer such as, "Doctor, I don't see a big change yet." So I think it's important to say, "That's understandable, in fact, as expected. Don't be discouraged." It is important to add information about side effects that are embarrassing to patients and may not be brought up. Sexual side effects of antidepressants are common. Movement symptoms like tremor are embarrassing. But by asking about a range of symptoms, I think you build alliance with the patient. And we stress that side effects are worth putting up with, considering how devastating a depression has been, or how much chaos was caused by hypomania or psychosis.What would you do if you discovered that the patient was not adhering to the regimen that was laid out?
That's a very important question because adherence is critical. We often ask a patient, "Have you been able to remember to take your medicines?" There is a lot of evidence that most patients will say "of course," but that answer is not trustworthy. Many patients who say they have taken their medicines have not. My favourite story is from a neuro-ophthalmologist who asked about drops for the eyes that were critical for maintaining vision, and the patient said "Oh, yes, I take them, Doctor." The specialist had actually seen his patient just outside his office pour the medication into a ditch, to make it look as though he had been taking the eye drops.
It's important to ask the question in several ways—"Do you ever forget the medicine, or are there things that might make you more likely forget to take your medicines?" With some medicines we actually get blood tests periodically, and the serum level is the best objective evidence to see if someone is adherent. If they're not adherent, it's important to take some steps to get them to resume the medication, because it's been shown in the literature in psychiatry that premature jumping from one medicine to another is a waste of time. It makes more sense to work on adherence with the first medicine and find out for certain if it is effective.What do you think is most missing in the doctor-patient relationship these days?
I have a feeling that if you took a poll among patients or doctors and asked that question, the answer would be time. Healthcare costs and constraints, and insurance requirements lead to the fact that doctors of all sorts have to work quickly, and have less time to see their patients. That includes psychiatrists who used to be notorious for taking a therapeutic hour. Few psychiatrists have the luxury of doing this, especially if they are primarily focused on psychopharmacology. Primary care doctors often work on a schedule in which they literally have eight minutes per patient. This leads to a perceived lack of concern on the part of the doctor with his patient's problem. There are ways to be attentive even in a short appointment, looking at the patient and listening carefully to each question or answer. In terms of medication, because adherence is so important, I think going over the reasons for non-adherence, including side effects, is extremely important.Talk to us about cost, from the point of view of the physician, the patient, the hospitals, the insurance companies, and even the manufacturers.
Let's start with something that sounds simplistic. It is simple, but I would not say it is simplistic, and that is to say that every one of our medicines only works if it is taken as directed. We could have the best medicine in the world, and if it is not taken regularly on time, it won't work. Pretty soon a large percentage of the public will conclude the medicine has no value, and the pharmaceutical company will observe falling sales. They will report that the "net lifetime benefit" of the drug has dropped, and a good medication could be discontinued. If we look at expensive diseases, chronic illnesses that are busting our health care budget - congestive heart failure, diabetes, depression - when drugs which are a reasonable cost are not taken and fail, the result is hospitalization, which is very costly. The result is also irreversible deterioration in illness. That is, if someone has gotten depressed and gone off his medicines and become depressed again, that depression is now harder to treat than the initial illness. A patient with congestive heart failure who might have been in balance at home with a diuretic and anti-coagulant drug - which are inexpensive - if that person is not adherent and gets sick and goes into the hospital, he is not the same patient. He is a sicker patient. For example, he may suffer further myocardial infarction. Now the patient is unhappier, families are unhappier, and, in terms of cost, there is a more costly problem to deal with. So anything that builds adherence and successful use of medicines is going to be cost-saving and, more generally, happiness promoting. And that is what we all want: to be on the side of the angels.
Putting serial numbers on medicines, as simple as it is, can be a very big step toward adherence. It's a way of guaranteeing that the right medicine - good, not counterfeit, well protected, that travelled along through sanitary warehouses, on temperature controlled trucks and got to the patient - and secondly through a variety of personalized adherence programs - reminder systems, reinforcement of sustained adherence, in some cases medication adherence devices that help organization - these insure that medicines are taken appropriately.So continuing with a look at the total benefits, not only from the physician's point of view but also all of the other stakeholders in the system, what else could be a positive cost savings or even profit enhancing use of serial numbers in the health industry?
Serialisation creates a personal link between the maker of a medicine, the physician who prescribed the medicine, and the patient. Its most powerful effect is to create greater adherence. Serialisation can link external awards to adherence. Even conditioned reinforcement after taking the medicine is powerful. Adherence is a major lever in terms of both healthcare quality and cost. It maximizes the chance that any medicine will work and therefore once someone has paid for that medicine, such as an insurer, the most important thing is to facilitate taking medication as directed.
That's appropriately what the pharmaceutical company wants because it means their product will be used. There will be appropriate refills. It is what the doctor wants because he wishes to see his patient taking the medicines and staying outside hospitals. It is what the patient wants. What the healthcare system does not want is someone getting sicker and going into a hospital, exposed to resistant organisms, running up huge costs. Even hospitals systems now understand this. The old saying, "Just keep the beds filled," is now an egregious error! What the hospitals are looking at are strong penalties from private insurers, Medicare, and Medicaid. If they haven't instructed patients about taking medicines correctly, and are not conscientiously keeping people outside the hospital, they will be called on it. Serialisation is a tool for building adherence; of having patients become involved in the medicine they are prescribed. Serialisation is, therefore, both good for health and for cost control.The research shows that text messaging to encourage adherence may not work. So what kind of new technology, using smartphones, for example, could you see as having that serial number connect the patient and the physician with a comprehensive support system at a reasonable cost?
Well, let me be a bit heterodox. I think technology is overvalued whether it is a phone, or whether it's any method of transmitting electromagnetic waves get from point A to B. And that is why I think text messaging is a false start and disappointing. Human behavioural engineering or understanding psychology is more important. There are loads of ways to communicate.. But I think that B.F. Skinner's insights are key when he found that rapid reinforcement of an emitted event-operant reinforcement was powerful. So you've taken your medicine - taking it for a week, taking it for a month or whatever - let's grant a reward to that person rapidly AFTER dosing and link continued adherence to other rewards. We then have created a conditioned reinforce when the system announces successful dosing, because reinforcers work best when they are delivered very close to the time of the response. Simple as it sounds this is much more powerful than the gimmick of a cartoon figure jumping up and down on a screen in a phone app, or a jangling alarm, which is, by definition, "alarming" and unpleasant.
A large study in the New England Journal of Medicine
found that protocoled telephone reminders were ineffective. Patients found them unpleasant and many abandoned the system. So I think what is delivered, and when, is more important than the way in which it is delivered. Of course one can use an Android or iPhone platform. I have designed a medication adherence device that looks at the medicine through digital imaging technology and tracks both accuracy of selection and adherence. We know if the right pills are loaded and if any were not taken. But the most important thing may be finding ways to reward the person when they get it right. Just buzzing and penalizing - that is annoying whatever the technology. Related to this, intelligent patients invested in their own health are precious! They research medicines. They find a medicine that they believe will work. At that point, having a serial number, creating a relationship between the company that made the medicine and doing everything possible to get to get that medicine to work right - it all fits and makes sense. Dr. Danny Sands of Cisco delivered a beautiful lecture with one of his patients, a university professor, who researched so deeply into his illness that he came to Dr. Sands and said, "You know, I have discovered some things you may not know about what medicine works, and what program can work." He listened to his patient and learned from him. As doctors and nurses we absolutely have to be open to that.To summarise, in terms of how this patient and physician relationship can become stronger - and how that serial number would be a key to unlocking and then maintaining that program - would it be a call centre, and would there be a variety of different services offered through that serial number? Could serial numbers be used case by case depending on the goal set of patients and physicians?
The medicine, the illness, the patient - all of these coming together requires some ingenuity. So to let me speak generally about a program we are involved with. I want to speak generally and not identify the individuals and the companies. As a psychiatrist, I see many people with addiction issues. There are medicines that treat addiction to opioids, alcohol, and so forth. Those medicines need to be taken infallibly to work, to cure the addiction. Through a process of serializing the addictive treatment medicine, a patient now is taking another step. He comes to a doctor and says, "I really want to get away from overuse of opioids." "I want to get away from drinking too heavily." The doctor would say, "Okay. I, Dr. X, can help you. But I need your commitment. Would you, for example, take 30 days of a product of Company X? And Company X will help us both, the doctor and the patient. If you call in with a serial number on their box, that will set the stage for this company working with you to help you take each and every dose, and we will have a record together that you used the medicine appropriately. I then have confidence that the medicine is used as directed."
Often, by the way, the medicines we use to treat addiction are also sold on the street. They are diverted. These programs, in which the patients are voluntarily registered through a serial number, can prove that the medicine is taken by the right person, and it cuts down on diversion. The serial number can help build the alliance between the doctor and patient so the program is effective and promotes treatment. That's a case where a call centre and a simple interaction based on the serial number can be so helpful.
Not all doctors are eager to treat patients with addiction. For many years in psychiatry, many of us, and I will include myself, said, "That's the kind of patient, the addictive patient, I know the kinds of problems those people have. Give me the nice depressed patient instead. I don't want them." Using serialisation can encourage more physicians to go into an area like addiction that is critical today. A serialisation-based program that provides unmistakable evidence of a patient using the medicine well - that's very reassuring. It lets a doctor rest easy. ‘I really am helping people. I am not going to be called in middle of the night by my licensing board, saying, "You know your patient X was out selling your medicines. Dr. Bear, I think you are careless, and I think we're going to call you up for discipline."' That is one of the most terrifying things to physicians and will drive them out of a whole area of prescribing. So the serialisation program can create a security that lets doctors treat patients who are right now being undertreated.And finally, in terms of government regulations, the FDA, from what I've been reading, is bombarded by some of these very issues that you've been talking about. Addiction problems, counterfeit medications coming in from all over the world, diversion on the streets - all of these issues. The government is hearing about this and they claim, from a lot of the panels I've been listening to, that it's not really their job in some ways, and that they can only do so much, in other words. But don't you think, if government and the health care industry started working together in this way through a simple use of serial numbers, that it would solve a multitude of problems even from a regulations point of view?
I really do. There is a long history of what the FDA's mandate has been, which is to keep medicines safe, and what their companion agency, the Drug Enforcement Administration, the DEA is required to do, which is to look at the criminal abuse of medicines. I'll say what every doctor knows, as it true of everyone who has looked at the problem. There has been a very wasteful antagonism between these two organizations in government, each underfunded. I think there is now a realization - and the FDA has always had the larger budget - that the FDA does have a responsibility, certainly regarding drugs that can be abused, to be doing everything possible to make sure drugs are used correctly. It's as if the treasury issued U.S. savings bonds and said, "We won't put numbers on them. Just let them be randomly counterfeited and sold on the street." That would be ridiculous. The FBI would then have every right to say, "You have handcuffed us. How can we possibly enforce this?"
The FDA is falling under many pressures to do more at a time when budgetary requirements are clamping down in every agency. So it is a very difficult problem. Serial numbers on medicines are one of the simplest and most powerful ways that the FDA can build safety, and give the DEA tools when necessary, to solve a problem. The FDA has introduced requirements that go by the acronym REMS, or Risk Evaluation Mitigation Strategy, particularly for abusable drugs. Every company that wants to bring out a drug has to explain what the risk of abuse is going to be, how they are evaluating it, and how they are mitigating it. It's never zero, but it can be minimized, and they need a strategy. Serialisation in my view should definitely be one of each of these strategies. It's a great way for a pharmaceutical company to come to the FDA with a powerful REMS plan.This has been fascinating, thank you so much. I hope we can continue on this important topic again soon.