My doctor DAWs a generic and my pharmacist will order it in if he doesn’t have it. They were mortified by how things went down with Dilantin.

It’s not necessarily the pharmacist who don’t understand the need to maintain on whatever generic you’re on. They get their generics from their wholesaler who may be shipping whatever one they could get the best deal on that month.

Salmon

As many of us know, generic drug manufacturing is being outsourced to foreign countries, including countries that are documented to have much higher rates of product tampering, counterfeits and/or substandard medications.

Last but not least, it would be great if all conflicts were disclosed…for example, do any of the authors consult for brand name pharma, pharmacy chains, PBMs or health insurers or receive grants that may involve increasing prescription access?

I agree to some extent on the NTI issue. if I were on coumadin or an anti-epileptic I would want to stay on the brand name. When I was at Boots, we tried to sell the NTI story as part of a marketing strategy to keep patients from switching to lower cost T4 preparations (in addition to suppressing for seven years the results of a BE study showing equivalence of these products). With major financial support to the societies, we enlisted the American Thyroid Association and the American Association of Clinical Endocrinologists to toe this party line of non-switchability. We said that the cost of generic switching would increase health care costa. The reality was that the cost of switching (MD visits plus lab tests) was less than one year’s cost of Synthroid, and remember this is a lifetime drug. My only suggestion is that if you switch to a generic NTI drug, you should stay with that generic, since generic-to-generic NTI switching can cause repeated need for retitration. Unfortunately some pharmacists don’t understand this.

However, there are a very few instances when I would hesitate–primarily in drug classes with very narrow therapeutic indexes (anti-epileptics, anticoagulants, etc.). The issue is not that the generics in these classes are bad; in both of the instances I mention, a patient can be titrated to the proper dose of a particularly generic manufacturer’s product. Unfortunately, it’s the potential of being switch from one generic to another at the whim of a purchasing agent for a drug store chain that causes concern. That inconsistency would cause me concern in those few drug classes. Personally, I would opt to stay with the brand in these few cases.

Atlex

you are partially right.. but you are missing a key component when a drug goes off patent there is a public standard that the US pharmacopeia makes that the FDA enforces for both branded and generic so the molecule is truly bioequivalent.

The larger swing isn’t just based on the looser criteria- the larger swing is in the brand.. when a generic reverse engineers a drug they buy several lots and their formulation is geared within the swing variance of the brand..

The only way any of this will change is for the FDA to require complete characterization of a molecule (small or large) and to make drug companies invest in manufacturing so they aren’t using 20 year old technology that is actually let them manufacture in Bangladesh, Sri Lanka and all these areas where regulation is even farther behind.

It makes no sense to toss the complete testing that gained the approval under a new drug application- but it is what it is. Branded drugs can strive to be of equal quality to a generic. No one seems to be able to explain what that means for comparisons to the reference product when the reference product is changed.
This study is probably more accurate than you want to believe. Not because generic drugs are just as good- but because branded drugs are allowed to be equally loose upon reformulation.

The problem that arrises is with a larger swing between lot numbers based on the looser FDA criteria- in either instance. Some drugs require more precise dosing to be safe and effective.