Here It Is Again: Patient Package Inserts

[Guest guest]

It was on the site here. I guess no one read it or cared to comment.

> > >

> > > Dear Christian,

> > > Well as you wrote the names of the classifications you NEVER

> > stated or I CAN NOT discern what you implied that should happen!

Is

> > it MANDATORY by law to give the patient insert or isit POLICY and

> > only Recommended for all drugs listed below EXCEPT Estrogen based

> > drugs as noted by the law previously????

> > >

> > > Is ther NOW a list fo DRUGS (provided by you and and

> > others) that are now required by Federal Law to be accompanied

with

> > literature EACH time it is dispensed?

> > >

> > >

> > > Pt information sheets are very different than the package

> > inserts. They are not as technical ot as scary. Further the

FEDERAL

> > law requires that EVERY drug on the shelf have a package insert

and

> > NOT be thrown away!!!! it is requiered by law that you KEEP the

> > package insert WITH the container of drug at all times, which is

why

> > some pharmacies keep a rubber band around the bottles to hold the

PKG

> > Insert in place. IF a patient asks for the package insert and

> > obvioulsy knows the difference between this and patient

information

> > sheet THEN you MUST give the pt this package insert. However a

good

> > techniican will inform the pharmacist to allow the pharmacist to

> > discern whether or not the pt really is asking for information or

> > the package insert AND to explain highly technical data to the pt

so

> > that the pt is not scared or unnecessarily alarmed and then does

not

> > adhere to the presecibed regime. So techs should never give a pt

any

> > information to the pt other than protocol without

> > > the RPh consent, because he or she may think it is necessary to

> > counsel or interpret technical data before the pt reads it.

> > >

> > > EACH pharmacy CAN do MORE than the Federal Law requires, Each

> > STATE can do more than the Federal Law requires, but they MUST do

the

> > minimum.

> > >

> > > Christian, please lead me to which drugs need the required

> > literature literally EVENi f I have misinterpreted or overlooked

any

> > blatent explanation that you have left. God save the Queen if I

have

> > read it and could not interpret it correctly.

> > >

> > > Respectfully,

> > >

> > > Jeanetta Mastron CPhT BS

> > > Founder/Owner

> > >

> > >

> > >

[Guest guest]

Dear ,

Thank you for this update. I am not sure how I missed the original

post. I am very happy about the requirement.

Respectfully,

Jeanetta Mastron CPhT BS

Pharm Tech Educator

> >

> > Hi Jeanetta,

> >

> > This information is the latest I have found. No answer as of yet

> from the FDA. I searched the CVS pharmacy data base and came up

> with the following information:

> >

> > --------------------------------------------------------------------

> --------------------------------

> >

> > The FDA has mandated that a Patient Medication Guide be added to

> the labeling of, and distributed with, all prescriptions filled for

> antidepressant drugs. The FDA has approved onde standard Medication

> Guide to be used for all antidepressants, irrespective of class (i.e.

> tricyclics, SSRI's, etc.) The guide highlights information regarding

> the increased risk of suicidal behavior in children and adolescents

> treated with these drugs. The guide must be distributed with each

> and every prescription - both new prescriptions and refills -

> dispensed for these drugs, irrespective of the patient's age. This

> includes brands and generics.

> > --------------------------------------------------------------------

> ---------------------------------

> >

> > This information is the first time I recall the Med Guides being

> required for a class of drugs. I believe they started sometime in

> 2005 late in the year. All the CVS pharmacies recieved initial

> supplies form a company call Hibbert Group but they have since been

> made available to us as an item we reorder from our warehouse. Since

> then they have come to include NSAIDS, coumadin/warfarin, amiodarone,

> advair and serevent and accutane and its generics. Upon further

> digging in the pharmacy " stuff " I've accumulated at my workstation I

> found this information on the Coumadin Med Guide. It's from Bristol-

> Myers Squibb and is dated October 17, 2006.

> >

> > --------------------------------------------------------------------

> ---------------------------------

>