« 2009年12月 | トップページ | 2010年2月 »

Look at myself objectively

As long as a person is a human, the person must have anything flawed somewhere.
If there is somebody perfect in this world, it should be the god. In this context, we don't need to be scared of not being perfect. We must admit there is something flawed in ourselves and look at the fact objectively. Once we could be aware of what disadvantage we have, we should sincerely admit the fact and think about what we should do to cover the disadvantage. In this way, we can minimize our inherent disadvantage and maximize our limited internal resource in ourselves.

| | コメント (0) | トラックバック (0)

Off-label use

In connection with drug lag problem (there is substantial delay in marketing approval of new drugs in Japan, comparing with FDA, EMEA), off-label use of already approved drugs has been raised as a problem in Japan. In order to solve this problem, it has been thought that concerned MAHs (marketing authorization holders) need to apply for label extension to PMDA (Japanese authority), after appropriate clinical trials could be conducted. But I think this is ineffective solution and practically impossible.
The said solution has originated from an unspoken assumption; all reimbursement of drug costs should be made based solely on what was written in package insert (approved indication). But it has been legally allowed to deviate from the written indication by a ministry ordinance called 'Showa 55 notification'. So even though it is legally allowed to deviate from the written indication, why can the off-label use problem exist in Japan? Firstly because many HCPs (healthcare providers) aren't aware of the 'Showa 55 notice'. Secondly because there is some uncertainty whether the drug cost can be surely reimbursed by the payer. In Japanese system, the eligibility of reimbursement is decided by a reviewer of health insurer, and their decision can differ by each prefecture. Eventually, the description in the package insert has been regarded as solely justification in the reimbursement. And the revision of the labeling (package insert) has been thought as the solution.
Separately, even though the labeling could be revised, its revision cannot catch up with medical advance. The actual dosage and usage of drugs may change in real medical practice, having a new knowledge in medical community. In very advanced field, this tendency of evolving change is significant.
Given above, my practical solution for this off-label use is to make the health insurer have their own formulary which should be the basis of reimbursement decision. The root problem is the 'package insert' has been considered as the sole document for indications.

| | コメント (2) | トラックバック (0)

元気出して行こう

新年明けましておめでとうございます.
横着して今年は年賀状も新年挨拶メールも出せていません.
いろんな方の御蔭で後悔無く毎日を送らせてもらっています.
末永く今年も宜しくお願いいたします.

2009年1月

p.s. こんなビデオを見かけました.何か壁にぶち当たった時に元気がでるかと期待しています.Nothing is impossibleと思って,小さな努力を重ねて行きたいと思います.
自閉症の高校生の話です.

| | コメント (2) | トラックバック (0)

« 2009年12月 | トップページ | 2010年2月 »