KING KHALID UNIVERSITY HOSPITAL PHARMACY TEAM

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1 KING KHALID UNIVERSITY HOSPITAL PHARMACY TEAM MINUTES OF THE MEETING Month: 29 th September Location: Director of Pharmacy office Date/Time : ( H) 12.30pm to 2.30pm Chairman of the Committee : Dr. Almajed Total # of Members : 8 Quorum Complete : 8 Present Members Dr. Ayed Al Shamrani Dr. Ahmed Hersi Dr. Anwar Jammah Dr. Zainab Habib Dr. Mohammad Moufleh Ph. Mohammad Blaihes Dr. Randa Jaroudi Apologized members ISSUE NO. TOPIC MATTERS ARISED (Discussion / Conclusion / Recommendation) RESPONSIBLE PERSON TIME FRAME STATUS Approval of Previous Minutes of the Meeting Done Dr. Almajed Unfinished Business New Business Drugs that were discussed for potential addition to KKUH formulary

2 Sertraline Hydrochloride Generic Name: Sertraline Hydrochloride (Lustral ) Brand Name: Lustral Dosage form & Strength: 25-50mg oral Tablets Requested by: Dr. Abdulqader Al-Jarad (Psychiatric Department) Requested Indication: Major depressive disorder, Anxiety disorder, Labeled Indications: MDD, OCD, PD, PTSD, Social Anxiety disorder. Approved organizations: USA, KSA, UK, Canada, Sweden Citalopram Escitalopram Fluoxetine Fluvoxamine Paroxetine Fluoxetine Conclusion of Efficacy & safety studies: Sertraline approved by FDA in 1996 for several indication. It is the shortest half life of the currently available SSRI in the markets and one of the most effective and safe antidepressant. One of the unique finding than other SSRI, the positive cardiac outcome in patients with HF. It is produced greater reductions in platelet/endothelial activation as compared with placebo and may offer further advantage for this patient population. In acute bipolar depression no significant difference between adjunctive bupropion, sertraline or venlafaxine was revealed among response or remission rates. Approved to be used in pediatric OCD. It has place in therapy for wide range of psychiatric illness. Advantages: The shortest half life of the currently available SSRI and safest in breast feeding. Cost/tablet: 3.6 SR Cost/pack: 30 tablet-108 SR PT committee refused to add Sertraline Hydrochloride (Lustral ) to the KKUH Formulary due to there are more than 6 SSRI drugs available in the formulary with the same MOA and side effect, plus there isn t any advantage of sertraline over the other to be add it. PT will discuss SSRI group with Dr Khalid bazaid in next meeting. Dr. Solafa Fatani

3 Paroxetine Hydrochloride (Seroxat CR ) Generic Name: Paroxetine CR Brand Name: Seroxat CR Dosage form & Strength: 12.5mg, 25mg oral tablet Requested by: Dr. Khalid Bazaid (Psychiatric department) Requested Indication: Approved Indications- Major depressive disorder, Panic disorder, Social anxiety disorder, Premenstrual dysphoric disorder. Approved organizations: *** Paroxetine IR Citalopram Escitalopram Fluoxetine Fluvoxamine Conclusion of Efficacy & safety studies: Paroxetine CR is a controlled-release formulation of the SSRI Paroxetine. It was introduced in 2002 as enteric film-coated tablet containing a degradable polymeric matrix using a technology called Geomatrix. The enteric coat on Paroxetine CR delays the drug release until the tablet has left the stomach. This effect may avoid the stimulation of gastric 5-HT receptors, which is associated with gastrointestinal side effects, in particular nausea. The polymeric matrix of paroxetine CR controls the dissolution rate; approximately 80% of the dose is absorbed over 4 5 h and the remaining 20% is retained in the tablet and does not enter the systemic circulation. Therefore, the equivalent dose of paroxetine CR needs to be 20 25% higher than that of Paroxetine (that to say 25 mg CR is equivalent to 20mg IR). The available tablet formulation of paroxetine CR is 12.5, 25 and 37.5 mg/day, while Paroxetine has 10, 20, 30 and 40 mg/day. Advantage: Paroxetine CR was effective as well as paroxetine IR in depression but was better tolerated and associated with low rates of earlyonset nausea and dropout rates due to adverse events comparable to those of placebo Cost/Pack : 12.5mg: 63 SR (30Tablet) 25mg: 84 SR (30Tablet) PT Committee decided not to be add Paroxetine CR to the KKUH formulary. There is not much advantage over IR. Dr. Solofa Fatani Rivaroxaban Generic Name: Rivaroxaban Dr. Sulaiman

4 (Xarelto ) Brand Name: Xarelto Dosage form & Strength: 20mg oral tablet Requested by: F. Alhussain, A. Kareem Almomen Requested Indication: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, Treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults. Approved organizations: USA, UK, Canada Enoxaparin Warfarin Efficacy & safety studies: The annual rate of the primary safety outcome was not significantly different between the rivaroxaban and warfarin groups. Each of the annual rates of critical, fatal and intracranial bleeding was significantly lower with rivaroxaban compared with warfarin. The primary outcome was confirmed in 2.1% of patients in the rivaroxaban group and 3.0% of patients in the enoxaparin/vka group, favoring rivaroxaban, and demonstrating the noninferiority versus combined parenteral enoxaparin/oral VKA regimen in the initial treatment of DVT and prevention of recurrent VTE. The incidence of treatment-emergent adverse events, excluding bleeding and recurrent VTE, was comparable between the rivaroxaban and placebo treatment groups and, overall, was lower than in the EINSTEIN-DVT study. Cost/Pack:: 15mg,20mg = 12 SR Cost/month: 15mg,2omg SR PT Committee approved for new indication of rivaroxaban which are treatment of DVT, prevention of recurrent DVT, and to be restricted to hematology department only. For prevent stroke indication, PT committee will send letter to cardiology for their opinion. Aprepitant/Fosaprepitant (Emend/ IV Emend ) Generic Name: Aprepitant/Fosaprepitant Brand Name: Emend/ IV Emend Dosage form & Strength: Aprepitant -Oral Capsules: 40mg, 80mg, 125mg Fosaprepitant- IV, 115mg, 150mg Requested by: Dr. Ahmed Al-Sagheir (Hematology/Oncology Department) Al-Homaidah Dr. Haya Al- Salloum

5 Eltrombopag (Revolade ) Requested Indication: Chemotherapy induced nausea and vomiting, Due to highly emetogenic chemotherapy, including high-dose cisplatin, Prophylaxis Chemotherapy induced nausea and vomiting, Due to moderate emetogenic chemotherapy, Prophylaxis Post operative nausea and vomiting, Prophylaxis Approved organizations: USA, UK Metoclopramide Granisteron Dexamethasone Efficacy & safety studies: According to many evidences & studies, addition of aprepitant is more effective in controlling acute & delayed nausea & vomiting induced by highly & moderately chemotherapy than standard regimen including 5-HT3 antagonists & corticosteroids. Oral aprepitant is indicated in combination with other antiemetic agents for the prevention of nausea and vomiting associated with moderately- and highly-emetogenic cancer chemotherapy Aprepitant-containing anti-emetic regimen (in combination with dexamethasone and ondansetron) has been shown to be superior to the standard therapy Fosaprepitant dimeglumine is rapidly converted to aprepitant. 500 SR / 3days Cost-effectiveness of aprepitant regimen against standard regimen showed that, aprepitant regimen is more cost-effective than conventional regimens. PT Committee agreed to be added Fosaprepitant IV (IV Emend ) to the KKUH formulary. Generic Name: Eltrombopag Brand Name: Revolade Dosage form & Strength: 25mg, 50mg oral tablets. Requested by: Dr. A. Almomen (Oncology/Hematology Department). Requested Indication: Refractory ITP (FDA approved) Approved organizations: USA, UK, KAS, Canada Romiplostim Efficacy & safety studies: There is no published study comparing efficacy and safety of Romiplastim and eltrombopag, but each drug showed comparable efficacy and safety in the literature. Dr. Haya Al- Salloum

6 Dr. Abdullah Mobeirek letter: Crestor Dr. F. Al- Hussan request for Crestor Dr. Hersi letter: Pulmonary Hypertension medication Dr Hazem Al Mandel letter: Postin Next Meeting There is no head to head comparison between romiplostim and eltrombopag in the literature Eltrombopag should be used in patients with ITP only and are at risk of bleeding Cost/Pack: 25mg = 5024 SR 50mg = SR Cost/month: 25mg = SR 50mg = SR PT Committee not agreed to add Eltrombopag (Revolade )to KKUH Formulary, due to PT committee approved Romiplastin has similar class few months ago and restricted to hematology. Non formulary Drugs None Letter The letter shows the advantage of crestor and objected about PT C decision for refusing to add crestor to hospital formulary. Crestor refused to be added to KKUH formulary few months ago by PT C and the policy for any drug rejected need one year to be reevaluate it again and discus it by PT C. crestor request for stroke prevention: clinical review by clinical pharmacist need for this indication. Dr Hersi need to increase number of PHT patients on sildegril and cloprost up to 50 patients per year for cardiology patients PT C decision: Need clinical review of PHT guideline and the best treatment. Need to change dosage form of prostin vaginal sup. to propess form. PTC decision: need to discuss and approve letter from gynecology department. Prepared by: Dr.Randa Jaroudi Noted by: Dr. Almajed

7 Secretary of PT Committee Department Head / Team Leader

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