APC Bulletin Oct 09 by HC120325134438


									              Doncaster & Bassetlaw Area Prescribing Committee
                         (APC) Update October 2009
                Welcome to the October feedback from the Area Prescribing Committee
            This bulletin aims to keep you informed of items discussed at the APC as well as
                          updates and reviews of the Traffic Light System (TLS)

                                        Shared Care Update

Management of Inflammatory Arthritis & Connective Tissue Disease for Adult services, over

  Documents have been updated to include information regarding twice weekly dosing from the

 Updated versions of the Shared Care Protocol are now available on the Medicines Management

                                   Traffic Light System update

 In light of a review of current Shared Care Protocols the following re-classifications were agreed:

              Somatropin – Growth Hormone for adults – was reclassified from Amber 1, 2 to
                   Red 1 and Doncaster and Bassetlaw Shared Care will be developed.

              Triptorelin for Precocious puberty was reclassified from Amber 1, 2, 3 to Red 1
                 As there is no evidence to support that Shared Care is in use.

        Guidance for Clopidogrel and Prasugrel use in Primary and Secondary care

          Sheffield APC and Doncaster and Bassetlaw APC have adopted this guidance

The full guidance is available now on the Medicines Management webpage on the following route:


                      Guidelines >> Local >> Clopidogrel and Prasugrel Use
                                     Drugs for Consideration -
                                    New entries added to the TLS
       Drug            Brand name(s) Indication                                                    Category &
Dronedarone           Multaq               Atrial fibrillation (AF)                           Red 7
Human hepatitis B     Zutectra             Prevention of hepatitis B virus re-infection in    Red 7
immunoglobin                               HBV-DNA negative patients  6 months after
                                           liver transplantation for hepatitis B-induced
                                           liver failure
Indacaterol maleate   Onbrez,              Maintenance bronchodilator treatment of            Red 7
                      Hirobriz, Oslif      airflow obstruction in adult patients with
                      Breezhaler           COPD
Plerixafor            Mozobil              Mobilisation of haematopoietic stem cells          Red 1, 2
Sunitinib             Sutent               Gastrointestinal stromal tumours                   Red 1,2,3,8
Trabedersen           *                    Pancreatic carcinoma, High-grade gliomas           Red 7

               Indacaterol maleate has been referred to the Formulary Liaison Group (FLG) for
                                     consideration of place in therapy.

              For further details of the information the APC used to make these recommendations go to
              The National electronic Library for Medicines and insert the drug name in the search box

                                                 TLS Update

              Following NPSA Rapid Response January 2008, Anti cancer medications have been
                          reviewed and the amendments to the TLS are as follows:

Capecitabine (Xeloda) for Advanced metastatic breast cancer and metastatic colorectal cancers
has had NICE TA 61 added to the TLS entry.
For full details of the guidance follow the link below:


Carmustine (Gliadel) for Multiple myeloma, non-Hodgkin’s lymphomas, and brain tumours has
had NICE TA 121 added to the TLS entry.
For full details of the guidance follow the link below:


For full details of the NPSA guidance follow the link below:


20 drugs added to TLS – Gaps identified – Listed in table below
                                             Anti-Cancer -
                                     New entries added to the TLS
       Drug            Brand name(s) Indication                                                  Category &
Bexarotene             Targetin           Skin manifestations of advanced stage cutaneous    Red 1,2
                                          T-cell lymphoma (CTCL) patients
Carmustine             Gliadel            Multiple myeloma, non-Hodgkin’s lymphomas, and     Red 1,2,3,8
                                          brain tumours
Cladribine             Leustat, Litak     Hairy cell leukaemia                               Red 1,2,3
Crisantaspase          Erwinase           Acute lymphoblastic leukaemia                      Red 1,2,3
Cytaribine             *                  All licensed indications                           Red 1,2,3
Dacarbazine            *                  Metastatic melanoma and, in combination therapy,   Red 1,2,3
                                          soft tissue sarcomas and Hodgkin’s disease
Estramustine           Estracyt           Prostate cancer                                    Red 1,2
Hydroxycarbamide       Hydrea             Chronic myeloid leukaemia                          Red 1,2,3
                                          (CML.Thrombocythemia or polycythemia vera
Lapatinib              Tyverb             Advanced or metastatic breast cancer whose         Red 1,2,3
                                          tumours overexpress ErbB2 (HER2) in
                                          combination with Capecitabine
Lomustine              Medac              Hodgkin’s disease resistant to conventional        Red 1,2
                                          therapy, malignant melanoma and certain solid
Melphalan              Alkeran            Multiple myeloma, advanced ovarian                 Red 1,2,3
                                          adenocarcinoma, advanced breast carcinoma,
                                          polycythaemia vera
Methotrexate Oral      Methotrexate       Malignant disease, Chronic bowel disorders,        Red 1,2,3
                                          Inflammatory bowel disease, Eczema & Psoriasis
Pentostatin            Nipent             Hairy cell leukaemia                               Red 1,2,3
Porfimer sodium        Photofrin          Non-small cell lung cancer: oesophageal cancer     Red 1,2,3
Procarbazine           *                  Hodgkin’s disease, other advanced lymphomata       Red 1,2
                                          and solid tumours
Tegafur/Uracil         Uftoral            Metastatic colorectal cancer                       Red 1,2,3
Thiotepa               *                  Malignant effusions, Bladder and Breast cancer     Red 1,2,3
Tioguanine             Lanvis             Acute leukaemias and chronic myeloid leukaemia     Red 1,2,3
Treosulfan             *                  Ovarian cancer                                     Red 1,2
Tretinoin              *                  Acute promyelocytic leukaemia                      Red 1,2,3

                                                Drugs Reviewed
The following drugs were reviewed and reclassified from Red 7 following availability of prescribing information:

Everolimus (Afinitor) for advanced renal cell carcinoma was reclassified to Red 1, 2, 3 with a review date of
October 2014

Histrelin acetate (Vantas) for prostate cancer was reclassified to Red 1 with a review date of September 2014

Naloxone/Oxycodone Prolonged release (Targinact) for severe pain was reclassified to Green-G with the
following guidance:
For palliative care and chronic pain, reserved as second-line to formulary opioids (i.e. morphine) and laxatives
with a review date of September 2014

Ranolazine (Ranexa) for severe chronic stable angina was reclassified to Grey with a review date of September

Lubiprostone (Amitiza) was removed from the TLS due to withdrawal of the license application
                                            Officers Actions

Amantadine, oseltamivir and zanamivir for the treatment of Influenza has had NICE TA168
February 2009 added to the TLS entries.
For full details of the guidance follow the link below:


Erlotinib (Tarceva) for Non-small-cell lung cancer has had NICE TA 162 November 2008
added to the TLS entry.
For full details of the guidance follow the link below:


Pemetrexed (Alimta) for Non-small-cell lung cancer has had NICE TA 181 September 2009
added to the TLS entry.
For full details of the guidance follow the link below:


Pimecrolimus (Elidel) for Acute treatment of mild to moderate atopic eczema (including
flares) and Tacrolimus (Protopic) for Moderate to severe atopic dermatitis has had NICE TA
82 August 2004 added to the TLS entry.
For full details of the guidance follow the link below:


Sunitinib Malate (Sutent) for Advanced/Metastatic renal cell carcinoma has had NICE TA
169 March 2009 and NICE TA 178 (second line) August 2009 added to the TLS entry.
For full details of the guidance follow the link below:


Cyproterone Acetate (Androcur) – Anti-androgen used in the treatment of severe
hypersexuallity and sexual deviation in the male has had MHRA Drug safety update guidance
added to the entry on the TLS.

Advice for healthcare professionals:
• Patients with existing meningioma or a history of meningioma must not be prescribed cyproterone acetate at
doses of 25 mg per day or higher (ie, should not receive Cyprostat-50, Cyprostat-100, or Androcur-50)
• This advice does not apply to medicines that contain low-dose cyproterone acetate such as co-cyprindiol

The full guidance can be viewed using the link below:
                                          NPSA Oxygen safety

           Current guidance for the prescribing of oxygen by General Practitioners is:

• Oxygen therapy can be initiated for palliation of dyspnoea in pulmonary malignancy and other
  causes of disabling dyspnoea due to terminal disease. Oxygen should be initiated at 28% 2
                         litres per minute via a mask or nasal canulae.

   • Holiday oxygen maybe ordered for patients already receiving oxygen therapy. Refer to
           current Home Oxygen Order Form (HOOF) for details of the prescription.

   • All other patients, for whom oxygen therapy is thought to be a consideration, should be
         referred as an outpatient to a Respiratory Physician for an oxygen assessment.

   • If the patient has been under the care of a Respiratory Physician within the last 3 years
   advice maybe sought from the community based Respiratory Nurse Specialist telephone
                                         01302 796219

              New NPSA guidance on oxygen safety can be found at the link below:


  If you have any comments, questions or have identified any discrepancies, omissions or additions required to
               the current TLS please contact a member of the Medicines Assurance Team below


                                                 With Thanks

                                To view the updated TLS use the below link


   An up to date TLS should always available on the Medicines Management Website. If you have any
   difficulties in accessing the TLS or if your version is not up to date please contact a member of the
                            Medicines Management Team on the below address

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