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Malaysian Transition Strategy for the Phase-out of CFC Use in Metered Dose Inhalers. National Pharmaceutical Control Bureau Ministry of Health Malaysia. Presentation Outline. Chronological Background Development of National Transition Strategy Proposed Action Plan Proposed Final Draft

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Malaysian transition strategy for the phase out of cfc use in metered dose inhalers

Malaysian Transition Strategy for the Phase-out of CFC Use in Metered Dose Inhalers

National Pharmaceutical Control Bureau

Ministry of Health Malaysia

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Presentation outline
Presentation Outline in Metered Dose Inhalers

  • Chronological Background

  • Development of National Transition Strategy

  • Proposed Action Plan

  • Proposed Final Draft

  • Consensus Agreement

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Chronological background
Chronological Background in Metered Dose Inhalers

  • 3 Jul 1998, 29th Meeting of National Steering Committee for Protection of Ozone Layers- Malaysia expressed no intention of supporting CFC MDIs phase-out proposal by 2005

  • 14 Jan 1999, Director of NPCB appointed as Chairman of Working Group for MDI Sector and member of National Steering Committee for Protection of Ozone Layers

  • 11 Jun 1999, 30th Meeting of National Steering Committee for Protection of Ozone Layers - Malaysia not ready to accept the phase-out because of several factors. Crucial need for public awareness.

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Chronological background1
Chronological Background in Metered Dose Inhalers

  • 4 Oct 1999 - Briefing by MDI expert

  • 9 Nov 1999, 31th Meeting of National Steering Committee for Protection of Ozone Layers – Position Paper for the 11th Meeting of the Party to the Montreal Protocol, Dec 1999, Beijing.

  • 8 Jul 2000 -32nd Meeting of National Steering Committee for Protection of Ozone Layers - Position Paper for the 20th Meeting of the Open Ended Working Group, July 2000, Geneva.

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Flashbacks dca directives
Flashbacks - DCA Directives in Metered Dose Inhalers

  • 10 Mar 1994 – Circular to Registration Holders on the Environmental Quality Act 1974 – Environmental Quality Order (Prohibition on the use of CFC and other gases as propellant and dispersing agent) 1993. Section 3(2) of the order reads as follows:

    “ The use of controlled substances as propellant in any manufacturing process, trade or aerosol industry in any pharmaceutical product which are:

    a) registered under Regulation 8 of the Control of Drugs and Cosmetics Regulations 1984; and

    b) used exclusively for medical treatment will be banned from 1 Jan 1999 “

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Flashbacks dca decisions
Flashbacks - DCA Decisions in Metered Dose Inhalers

  • DCA 89 – Highlighted the use of CFC in pharmaceuticals and relevant laws. Exemptions granted under Montreal Protocol Policy.

  • DCA News (1997) – Use of CFC as propellant and dispersing agent to be banned from 1.1.1999

  • DCA 94 (1998) – Agreed that registration of MDI containing CFC for asthma & COPD to continue for another 5 years until 2003 (essential use exemption under Montreal Protocol Policy). Those not used for asthma & COPD allowed until 1.1.99. New applications will not be accepted unless there is therapeutic advantage.

  • DCA 101 (1999) – Cancelled registration of products containing CFC that are not MDI for asthma & COPD

  • Grace period further extended to 2005 in accordance with developed countries.

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Working group meetings
WORKING GROUP MEETINGS in Metered Dose Inhalers

  • 18 May 1999

    - 1st Working Group Meeting

    - Director NPCB appointed Chairman

    - Malaysia committed towards phasing-out the use of CFC MDIs by 2010

    - Preliminary initiatives

  • 23 Oct 2002

    - Presentation by James Losey, International Consultant

    - Many countries adopting combination strategy

    - Malaysia first country under Article 5 countries to have a national strategy to phase-out the use of CFC-MDIs

    - TOR of WG proposed by DOE

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Working group meetings1
WORKING GROUP MEETINGS in Metered Dose Inhalers

  • 27 Mar 2003

    - To get industry feed-back on the initiatives taken

    - To formulate an Action Plan

    - To collect and compile statistics

  • 25 Apr 2003

    - Meeting with non-PhAMA and non-MOPI companies (importers and distributors)

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Working group meetings2
WORKING GROUP MEETINGS in Metered Dose Inhalers

  • 19 May 2003

    - Agreed on Plan of Action

    - Preparation of guidelines for national transition strategy

    - Adopt and adapt Canadian strategy

    - Industry to ensure no disruption in supplies

    - NPCB appointed consultant and coordinator for the strategy program

    - NPCB to be the signatory and trustee for the Multi Lateral Fund (MLF) for the program

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Working group meetings3
WORKING GROUP MEETINGS in Metered Dose Inhalers

  • 3 Mar 2004

    - Final target date to be discussed during Awareness Seminar on 9 May 2004.

    - To seek comments and consensus on the Guidelines prior to adoption as a national strategy.

  • Apr 2004

    - Finalize arrangements for seminar

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Draft national transition strategy
Draft National Transition Strategy in Metered Dose Inhalers

  • INTRODUCTION

    - Malaysia ratified the Vienna Convention for the Protection of Ozone Layer and the Montreal Protocol in Aug 1989. Operates under Article 5 of the Montreal Protocol, consumption per capita of ozone depleting substances (ODS) < 0.3kg ozone depleting potential (ODP) per year.

    - Obligation to reduce consumption, 50% in 2005, 85% in 2007 and 100% in 2010. Most ODS imported from India and China.

    - CFC MDIs are widely used in Malaysia. MDIs commonly used inhalation devices for treatment of asthma & COPD. Until 1995, all MDIs use CFC. 31 MDI containing CFC registered with DCA, 11 MDI CFC-free & 9 DPI.

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Draft national transition strategy1
Draft National Transition Strategy in Metered Dose Inhalers

- Common drugs in CFC MDIs : beta agonists (salbutamol, terbutaline, salmeterol) and corticosteroids.

- Alternatives to CFC MDIs : Hydrofluoroalkanes (HFA-134A & HFA-227) and dry powder inhalers (DPIs)

- Agreement by stakeholders

- Important to ensure smooth transition

- Outcome of consultations

- Review

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Draft national transition strategy2
Draft National Transition Strategy in Metered Dose Inhalers

  • BACKGROUND

    - Malaysia does not produce CFC MDIs. All imported. 4 major suppliers – GSK, AstraZenecca, 3M and Boehringer Ingelheim. 1999, 2 million imported – 32 tonnes of CFCs.

    - Implications to patients and prescribers.

    - 2003 status

    - Alternatives available – HFA, DPI, nebulised drugs, oral therapy

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Transition strategy principles
Transition Strategy Principles in Metered Dose Inhalers

  • Health of patients and access to supplies to be safeguarded.

  • Work together to ensure smooth and efficient transition towards CFC-free treatment of asthma & COPD.

  • Consultation with stakeholders prior to implementation.

  • Education and acceptance.

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


Transition strategy outline
Transition Strategy Outline in Metered Dose Inhalers

  • Objective : to support the target date for the phase-out by 2005

  • Action Plan 2003 – 2005 : Proposal, Work Description, Target and Responsible Parties

  • Approval of alternatives

  • Post-marketing surveillance : ADR monitoring, safety and effectiveness

  • Removal of CFC containing products : Timeframe, products with no alternatives

  • Education, information, awareness and acceptance

  • Pricing issues

  • Product labelling

  • Control on advertising

  • References

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


We seek your comments in Metered Dose Inhalers

and consensus.

Thank You

Awareness Seminar on CFC Free MDIs 9 May 2004, Sheraton Subang


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