With over half of Americans on prescription drugs and many on significant polypharmacy, not a lot is known about the decisions to take a medication or the associated informed consent issues. There is always a question about whether a productivity based, low quality medical environment will result in more prescriptions or less. There is the ever present marketing issue and regulatory decisions by the FDA that often seem to be market based. The CDC came out with recent data on this phenomenon today including some excellent information on potential overprescribing - see the antidepressant and antibiotic slides (click to enlarge any graphic).
I thought I would look at how medication information seems to be used by patients. I try to condense this issue down to a graphic to capture what I think are the essential elements to consider in terms of the information requirements that people need to make decisions about medications. There is a full spectrum of considerations from people who don't want to know anything about a medication to those who want as close to a medical level of knowledge as possible. The one area of this table that I know for certain is that we all start out in a common place and that is not wanting to take a medication at all. As I have pointed out here several times, searching for a medication that will work for a problem is often fueled by desperation. Medication side effects and a lack of efficacy of medications is common. The graphic is based on my direct observations about medications and how people decide that they will use them. I eliminated the scenarios that involve addiction for the purpose of a more simplified scenario, but could develop that if anyone is interested. (click to enlarge)
In 30 years of practice I have encountered all of the scenarios listed in the above table at one point or another. As an intern on the Internal Medicine service, I recall a young man who I had just admitted to the ICU for acute asthma. We gave him the usual glucocorticoids, theophylline, and albuterol nebulizers. Within and hour he wanted to leave. His respiratory status was slightly improved at the time but my resident, attending, and I did not think it was a good idea. He signed out AMA with the complaint that is was just too boring to stay in a hospital despite his flare up of asthma and continuou wheezing.
I have also had plenty of experience at the other end of the spectrum. They are generally complicated situations involving treating physicians or other professionals or the relatives of professionals, people with severe complicated problems that have not responded to any of the usual therapies, people taking highly interactive or toxic medications, or people with personality structures (innate or acquired) that require a lot of information or the idea that better decisions are predicated on the maximum amount of information. Many of these folks also have ideas about physicians and expectations of how much time they are able to spend with physicians.
If I had to guess about the distribution of people I have talked with most of them would probably lie in column 5 (from the left). The distribution of people on both ends of the table is low. I think that the most important aspect of this spectrum for a physician is recognizing the approach that the patient is taking and trying to complement that. That involves being more available to people who don't want a lot of information up front in the event that they have experiences with the medication that they might want to ask about. Even in the case of refusal of medication, people change their mind especially when dealing with illnesses that are clearly disruptive and potentially life-threatening. Some people may come back and demand to know why nobody forced them to take a medication in the first place even when they refused it initially.
Television ads for new medications seem to take a high pressure approach to column 6 with a very rapid speech about severe and potentially life threatening complications. The ads obviously lack depth for the person described in this column, but they have a degree of transparency about severe effects. I would wonder if a person speaking more slowly about the side effects would have more impact.
The other lesson that is often lost is that there is no correct way to consider information for an informed consent decision about medication. Physicians consider rational thinkers to look at the probabilities of the risks versus the benefits and make a decisions. That is what much of the medication information educational material is based on. In fact, medication decisions are very personalized. The response of the population in general does not dictate the response of the individual. The affected person may have no interest at all in a new medication that is offered but they may recall detailed information about their response or the response of their family members to medications. They may also have had very adverse experiences with medications, physicians, and other medical personnel. People develop medical comorbidities at different rates and that will also be an important aspect of the decision making process. The only decision-maker who is really problematic in this table is a person who takes an empirical approach and then does not report any side effects thinking that they will "get used to" the medication. I think a lot of those ideas may originate with physicians who have inflexible approaches because in my experience people rarely get used to side effects and some side effects are harbingers of potentially severe problems.
There are also important questions about the overprescribing issue. In at least some of those cases, physicians are often dealing with patients who may be receiving information like: "You don't have signs of a bacterial infection" but processing it as: "I believe in antibiotics and need to take antibiotics to get better".
I think this is all an important aspect of the informed consent process. The informational aspects of informed consent need to include how much information a person is willing to consider is the first step. The analysis of that data follows.
George Dawson, MD, DFAPA
