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Pfizer boosts Champix warnings

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FRIDAY 4 SEPTEMBER, 2009                EDITOR: SIMONE.ROBERTS@REEDBUSINESS.COM.AU I ADVERTISING: VICTORIA.SEYMOUR@REEDBUSINESS.COM.AU
                                                                                                  JOHN.GRIFFITH@REEDBUSINESS.COM.AU         1


Pfizer boosts Champix warnings
Mark Gertskis                            the manufacturers to include a        also highlight “potentially fatal
                                         boxed warning about their drugs’      cutaneous reactions”, including
THE maker of a popular smoking           impact on mental health after         Stevens-Johnson Syndrome and
cessation drug has heightened            reviewing reports of adverse          erythema multiforme, and advise
warnings of adverse psychiatric          psychiatric effects.                  patients to stop using the drug
and dermatological effects from            However, a spokeswoman for          at the first sign of a rash or skin
the medication.                          Zyban maker GSK said the TGA did      reaction.
   Pfizer has announced that             not find that any changes to the         The changes come nine months
product information for the drug         drug’s product information were       after Champix-related side effects
Champix (varenicline) would now          necessary and would not update        were highlighted in the Australian
carry added precautions and              any of its labels.                    Adverse Drug Reactions Bulletin,
recommendations about serious              In addition to warnings             with almost three quarters of
side effects.                            about depression, agitation,          complaints about the drug
   The change is in line with a          hallucinations and suicidal           describing psychiatric symptoms.
commitment by the Therapeutic            thoughts, Champix product                “Pfizer takes drug safety very            Advertisement
Goods Administration (TGA) in            information will now carry            seriously,” a statement from the               removed
July to strengthen the warning           precautions about changes in          manufacturer said.
requirements for Champix and             thinking, anxiety, psychosis and         “Pfizer believes that the
another smoking cessation drug           mood swings, and will recommend       benefits of Champix outweigh its
Zyban (bupropion) following a            for health professionals to follow    risks, given the immediate and
similar move in the United States.       up patients with neuropsychiatric     significant health benefits of giving
   The US Food and Drug                  symptoms until symptoms resolve.      up cigarettes.”
Administration (FDA) compelled             The new warnings will now              To comment click here.



Britain imposes strict codeine rules
ADDICTION to drugs containing            more than three days.                 Committee to upschedule OTC
codeine has taken centre stage              The authorities have also          codeine products from Schedule 2
in new warning requirements              ruled that any drugs containing       to Schedule 3 and limit treatment
imposed on over-the-counter              codeine cannot be indicated for       duration to five days.
preparations of the medications in       the treatment of colds, flu, coughs      The MHRA also upscheduled all
the United Kingdom.                      and sore throats, but only be used    effervescent codeine packs of more
   The peak UK drugs regulator,          in the short term treatment of        than 32 tablets to a prescription-
the Medicines and Healthcare             acute, moderate pain which is not     only medication class.
products Regulatory Agency               relieved by paracetamol, ibuprofen       “These products can be addictive      Not a subscriber?
(MHRA), has announced new
stringent guidelines for packaging,
                                         or aspirin alone.
                                            The new requirements in the
                                                                               and we are taking action to tackle
                                                                               this risk,” MHRA director of vigilance
                                                                                                                          CLICK HERE
consumer information leaflets and        UK go much further than a recent      and risk management of medicines
                                                                                                                        to register for your
advertising that underline the risk      decision by Australia’s National      Dr June Raine said.                       FREE daily news
of addiction to the drug if taken for    Drugs and Poisons Schedule               To comment click here.                      update.




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FRIDAY 4 SEPTEMBER, 2009                   EDITOR: SIMONE.ROBERTS@REEDBUSINESS.COM.AU I ADVERTISING: VICTORIA.SEYMOUR@REEDBUSINESS.COM.AU
                                                                                                     JOHN.GRIFFITH@REEDBUSINESS.COM.AU                       2

 FROM THE GUILD PRESIDENT - KOS SCLAVOS                                                                                 TO HAVE YOUR SAY CLICK HERE


 Government reform agenda mirrors Guild’s priorities
                                             information about the issues that      to assist in health solutions,          led to the development of the
                                             emerged during the consultation        the infrastructure strengths of         MedsIndex medicines compliance
                                             process that accompanied               community pharmacy and the              score as an identifier and overlaid
                                             the development of the draft           Guild’s leadership in e-health          the systemisation and e-health
                                             strategy; sets out the broader         initiatives. Our fiscally responsible   enablement of Mirixa and eRx.
                                             context in which primary health        approach is also an element that        These e-health systems allow
                                             care in Australia operates and has     places the Guild above other            greater accountability and
                                             developed; and describes many          groups.                                 performance measurement of
                                             of the challenges which the draft         In addition the report               pharmacist interventions.
                                             strategy aims to address.              highlights four key priority areas:        The preventative health
                                                It is interesting to note the way   ● Improving access and                  role of pharmacists continues
                                             the report is structured. To build     reducing inequity                       through various agreement and
                                             such a modern primary health           ● Better management of                  Government programs. Just
                                             care system, it is proposed that       chronic conditions                      last week we had major general
 THE Guild welcomes the release              there are five key building blocks:    ● Increasing the focus on               media coverage of our Standard
 of Australia’s first National Primary       ● Regional integration                 prevention                              Alcoholic Drink education
 Health Care Strategy - Building             ● Information and technology,          ● Improving quality, safety,            campaign.
 a 21st Century Primary Health               including e-health                     performance and accountability             The Guild will continue to
 Care System. I was also delighted           ● Skilled workforce                       The Guild is pleased that the        work cooperatively with the
 that the media release by the               ● Infrastructure                       action plan it put in place in late     Federal Government to ensure
 Prime Minister, Kevin Rudd, and             ● Financing and system                 2005 covers these key points.           vision is turned into reality for
 Minister for Health, Nicola Roxon,          performance                            Through that strategic process          the good of all Australians. While
 specifically mentions pharmacists              The approach is almost              the Guild ensured there was             other health groups talk about
 in their response to the report             identical to the seven key             continued equitable access to the       changes in health, the Guild is
 regarding what the Government               building blocks the Guild uses,        PBS. The PBS is now one of the          actually getting on with the job of
 can do to improve the frontline             as outlined in my National             few elements of the health system       building a new improved health
 health care that Australians                Press Club presentation in July.       where there is equitable access.        system.
 depend on.                                  This approach highlights the           The Guild’s focus on chronic               To comment click here.
    Th e     re p o r t    p rov i d e s     current capacity of pharmacists        disease and the pharmacist’s role




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