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Narrow therapeutic, or NTI, drugs have a minimum effective concentration of less than a two-fold ratio. Now that’s something that we can kind of relate to, and then, okay, we can all think of what the toxic concentration might be for some drugs and the minimum effective concentration. But if I asked you to give me those numbers - how many of you can give me those numbers for the products that you prescribe and dispense? Probably not. These are not numbers. This is the pharmacokinetic stuff that the
The other component was, they said that in their official definition you had to meet one of these two criteria and you also had to have safe and effective use, requiring titration and careful patient monitoring. This is my definition of a critical dose drug. We have to titrate the dose, we have to monitor the patient even once they are on the drug and we think they are stable. Why? Because it’s critical. If we don’t monitor them
Based on your professional experience, can anybody tell me a drug you think is an NTI drug? Okay, Coumadin. There was kind of a little hint there with some of the sponsors around here. Dilantin. Digoxin. Lithium. Okay, usually if you stop and think about just from your clinical experience, as either a physician a nurse or a pharmacist, you can think of some drugs - probably a handful - that you would say meet this kind of
Critical dose drugs, though; very little difference here except for one thing. The one group of physicians that was the least concerned about critical dose drugs, was not anywhere near as low as the pharmacists group that was not concerned. Most all of the physicians were concerned to some degree and most of them to a fairly large degree,
When we go in and put labels on these groups, what we find is the first group is anti-substitution, neutral about the idea there are influences, and they are really concerned about critical dose drugs. That’s about 30% of the
Switching generic suppliers can often result in a lot of problems. We did a study a few years ago. We had 29 pharmacies around the United States. We asked them to send us 18 months worth of scrip data for a compliance project. When I went back into it, one of the things that we found when we went and looked at the carbamazepine patients and the furosemide patients, 52% of the carbamazepine substitutions and 76% of the furosemide substitutions were generic to generic, to generic to generic, to generic. One patient had five different manufacturers
Switching between generics can be a bigger problem than actually switching between the brand and the generic. All generics are tested against the brand, which means the brand is always in the middle of the distribution. So you
They also have the committee I mentioned that’s already recommending new bio-equivalence standards. That’s kind of awkward. We’ve got one committee that says there’s no problem and another one that is saying we need new
What’s the bottom-line, take-home message for everybody? This state does not have restrictions on substitution of NTI drugs or problematic therapies. Whether it needs to or not, that’s another issue. Regulations are nothing other than something that assure the minimum standard of care that’s practiced in a state, by physicians and pharmacists and nurses. That’s what those regulations assure us. That nobody can legally practice lower than that. They don’t say you can’t practice better than that. What I tell people is think of what you think of the NTI drugs that you are