Saturday, January 9, 2010

New Drugs in MOH Formulary

According to the pekeliling in Dec 2009 by Bahagian Perkhidmatan farmasi, there are some additions to the MOH Formulary.


[Drug name][Category][Indication]

Introduction of New Drug

Inj Cetrorelix 0.25 mg (A*)-Prevention of premature ovulation in pt undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive technique.


Inj Ganirelix 0.25 mg/0.5 mL (A*)- Prevention of premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction technique.


Inj Carbetoin 100 mcg/mL (A*)- Prevention of uterine atony and postpartum haemorrhage following elective caesarean section uner epidural or spinal anaesthesia.


Cap Dabigatran etexilate 75 mg (A*)- Prevention of venous thromboembolic events in patients who have undergone total knee replacement or total hip replacement surgery.


Cap Dabigatran etexilate 110 mg (A*)- Patients at risk for bleeding, recent bipsy or major trauma, spinal & epidural anaesthesia, lumbar puncture, pregnancy & lactation, children.


Cap Rifampicin 150 mg (B)- Initial phase (2 months) of tuberculosis


Tab Isoniazid 75 mg (B)- Initial phase (2 months) of tuberculosis


Tab Pyrazinamide 400 mg(B)- Initial phase (2 months) of tuberculosis


Tab Paliperidone 3 mg/6 mg/9 mg [extended release] (A)- Second or third line treatment of schizophrenia.


Human Papillomavirus (Types 6, 11, 16, 18) vaccine injection [Gardasil] (A)- For the prevention of cervical cancer due to papilloma virus. To be used as part of the public health programme only.


Human Papillomavirus (Types 16, 18) vaccine injection [Cervarix] (A)- For the prevention of cervical cancer due to papilloma virus. To be used as part of the public health programme only.


Tab Sodium dichloroisocyanurate 2.5 g/5 mg (C)-Low and medium level disinfectant


Addition of Formulation

Typhoid vaccine capsule (B)- Active immunisation against typhoid fever in adult and child 6 years of age or older.



Fentanyl 12 mcg/hr transdermal patch (A*)- As a second line drug in the management of chronic severe cancer pain not responding to non-narcotic analgesic. Not to be use in opioid naïve patients. The use is to be restricted to pain specialists, palliative medicine specialists and oncologists.



Menotrophin 75 IU injection (Follicle Stimulating Hormone 75 IU and Luteinizing Hormone 75 IU) (A*)

Menotrophin, Highly Purified 75 IU injection (Follicle Stimulating Hormone 75 IU and Luteinizing Hormone 75 IU) (A*)-

Treatment of infertility where clomifene has failed or stimulation of follicle growth as part of an assisted reproductive technology.



Addition of Indication

Salmeterol 50 mcg and fluticasone propionate 500 mcg inhalation [Seretide] (A)

Old indication- Regular treatment of reversible obstructive airways disease including asthma

New indication-

· Regular treatment of reversible obstructive airways disease including asthma

· COPD including chronic bronchitis and emphysema



Tab Leflunomide 10 mg/20 mg/100 mg (A*)

Old indication- Persistent active rheumatoid arthritis

New indication-

· Persistent active rheumatoid arthritis

· Active psoriatic arthritis


Dronedarone, a new anti-arrhythmic agent

DRONEDARONE HYDROCHLORIDE (MULTAQ(R), SR-33589)

- -Description: class III antiarrhythmic
- -Indication(s) Submitted for Approval: treatment of
atrial fibrillation
- -Drug Sponsor: Sanofi-Aventis
- -NDA Filed: 07-2008
- -User Fee Goal: 01-2009 (priority review)
- -NDA Status: pending; 03-18-2009, FDA Advisory

Study Summary/Authors conclusion :

1) Dronedarone is less effective than amiodarone for the maintenance of sinus rhythm, but has fewer adverse effects. For every 1,000 patients treated with dronedarone instead of amiodarone, we estimate approximately 228 more recurrences of AF in exchange for 9.6 fewer deaths and 62 fewer adverse events requiring discontinuation of drug.

Piccini JP, Hasselblad V, Peterson ED, et al. Comparative efficacy of dronedarone and amiodarone for the maintenance of sinus rhythms in patients with atrial fibrillation. J Am Coll Cardiol 2009; 54: 1089-95

2) "... antiarrhythmic drug trials that are available and demonstrated that mortality might be reduced by dronedarone, but might be adversely affected by amiodarone and sotalol. One the other hand, the advantageous affect on stroke seen with dronedarone, might also be paralleled by amiodarone and sotalol. ..." "......cardiovascular hospitalizations a great deal, specifically in relationship to the ATHENA trial where there was a dramatic effect of dronedarone on hospitalization of patients with AF and other CV risk factors. These hospitalizations were not trivial. They were not simply related to cardioversion. Many of them involved aggravation of heart failure. Many of them involved stays in the coronary care unit and the ITU [intensive treatment unit]. So, CV outcomes including hospitalization have now become a major endpoint.:"

John Camm A, Suart JC, Nick F. Pharmacologic Advances in Atrial Fibrillation: Achieving Optimal Antiarrhythmic and Cardiovascular Outcomes




Saturday, January 2, 2010

CPD Talk: 24/4: A Revolution in Oral Contraception

Date: 10th January 2010
Time: 7.30 pm- 9.30 pm
Venue: KL Hilton,Kuala Lumpur.


The CPD talk will witness the launch of Bayer's new oral contraceptive (OC), YAZ, the first 20 mcg ethinylestradiol ultra low dose OC with 3 mg drospirenone in a unique 24/4 days regimen.


Yax is the only OC to be approved in Malaysia with 3 indications:

  1. Oral contraception
  2. Treatment of symptoms of premenstrual disorder
  3. Treatment of moderate acne


Agenda:

Time Program
7.30 pm Arrival of Guest & Registration
7.50 pm Opening Speech by Dr Shunitra Devi, Medical Director, Bayer Schering Pharma
8.00 pm Welcome address by Puan Faridah Yusof
8.10 pm " Oral Contraception: Past, Present and Future' by Prof Jamiyah Hassan
8.30 pm "24/4: A Revolution in Oral Contraception" Prof Lee P. Shulman
9.00 pm Q & A
9.20 pm

Launch Ceremony

9.30 pm Dinner


For RSVP, Kindly Contact: Ms Roseline Heng 03-6209 3151, Ms Rosmah 03- 6209 3162, Mr Daniel Quek 012-288 7449, Mr Daryl Chooy 012-320 3906