PILs and pillsPILS and pillsPILs and pills PILs and pills

The patient who uses pills and other medicines gets most of the information on the medicine from the patient information leaflet (PIL).  During my three decades as a clinician and medical translator I have been able to follow the changes in the softer side of the information provided to the patient.

Softer?  Well, treating sick people is part science, much art.  The PILs, on the other hand, are part science and much legalese.  Just look at the technical name of the document: product information leaflet.  A medicine is much more the “product”.  It may be the lifeline for a very sick person or the only solution for relieving aches and pains.

Of course the PIL must contain what the patient needs to know on administration, effects and side effects.  Actually, the section creating most consternation is the one on adverse effects (or”undesirable effects” as these are called in the summary of products characteristics or”adverse events” as they are called in clinical trials).  I realize that the company responsible for the medicine being on the market needs to inform the ”consumer”, i.e., the patient, of what the medicine is all about.  But where to draw the line between rare and dangerous side effects and common and not so dangerous side effects?  To cover all risks, it’s easiest to include all dangerous side effects, be it that they have occurred only a few times globally.  This is honest, but may deter innumerable patients from using the medicine and getting the treatment they need.  There is no good solution to this problem, which is a growing one.

The patient who uses pills and other medicines gets most of the information on the medicine from the patient information leaflet (PIL).  During my three decades as a clinician and medical translator I have been able to follow the changes in the softer side of the information provided to the patient.

Softer?  Well, treating sick people is part science, much art.  The PILs, on the other hand, are part science and much legalese.  Just look at the technical name of the document: product information leaflet.  A medicine is much more the “product”.  It may be the lifeline for a very sick person or the only solution for relieving aches and pains.

Of course the PIL must contain what the patient needs to know on administration, effects and side effects.  Actually, the section creating most consternation is the one on adverse effects (or”undesirable effects” as these are called in the summary of products characteristics or”adverse events” as they are called in clinical trials).  I realize that the company responsible for the medicine being on the market needs to inform the ”consumer”, i.e., the patient, of what the medicine is all about.  But where to draw the line between rare and dangerous side effects and common and not so dangerous side effects?  To cover all risks, it’s easiest to include all dangerous side effects, be it that they have occurred only a few times globally.  This is honest, but may deter innumerable patients from using the medicine and getting the treatment they need.  There is no good solution to this problem, which is a growing one.

The patient who uses pills and other medicines gets most of the information on the medicine from the patient information leaflet (PIL).  During my three decades as a clinician and medical translator I have been able to follow the changes in the softer side of the information provided to the patient.

Softer?  Well, treating sick people is part science, much art.  The PILs, on the other hand, are part science and much legalese.  Just look at the technical name of the document: product information leaflet.  A medicine is much more the “product”.  It may be the lifeline for a very sick person or the only solution for relieving aches and pains.

Of course the PIL must contain what the patient needs to know on administration, effects and side effects.  Actually, the section creating most consternation is the one on adverse effects (or”undesirable effects” as these are called in the summary of products characteristics or”adverse events” as they are called in clinical trials).  I realize that the company responsible for the medicine being on the market needs to inform the ”consumer”, i.e., the patient, of what the medicine is all about.  But where to draw the line between rare and dangerous side effects and common and not so dangerous side effects?  To cover all risks, it’s easiest to include all dangerous side effects, be it that they have occurred only a few times globally.  This is honest, but may deter innumerable patients from using the medicine and getting the treatment they need.  There is no good solution to this problem, which is a growing one.

The patient who uses pills and other medicines gets most of the information on the medicine from the patient information leaflet (PIL).  During my three decades as a clinician and medical translator I have been able to follow the changes in the softer side of the information provided to the patient.

Softer?  Well, treating sick people is part science, much art.  The PILs, on the other hand, are part science and much legalese.  Just look at the technical name of the document: product information leaflet.  A medicine is much more the “product”.  It may be the lifeline for a very sick person or the only solution for relieving aches and pains.

Of course the PIL must contain what the patient needs to know on administration, effects and side effects.  Actually, the section creating most consternation is the one on adverse effects (or”undesirable effects” as these are called in the summary of products characteristics or”adverse events” as they are called in clinical trials).  I realize that the company responsible for the medicine being on the market needs to inform the ”consumer”, i.e., the patient, of what the medicine is all about.  But where to draw the line between rare and dangerous side effects and common and not so dangerous side effects?  To cover all risks, it’s easiest to include all dangerous side effects, be it that they have occurred only a few times globally.  This is honest, but may deter innumerable patients from using the medicine and getting the treatment they need.  There is no good solution to this problem, which is a growing one.

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