Ensuring Best Practice in the Notification of Prescription Medical Product Discontinuations

Transcription

1 Ensuring Best Practice in the Notification of Prescription Medical Product Discontinuations TGA and Medicines Australia Conjoint Best Practice Guidelines October

2 Ensuring Best Practice in the Notification of Prescription Medical Product Discontinuations TGA and Medicines Australia Conjoint Best Practice Guidelines October 2007 Discontinuing a medicine is a decision that most pharmaceutical companies will take at some point. The Therapeutic Goods Administration (TGA) and Medicines Australia want to ensure that the impact of such a decision on patients is minimised. Therefore we have developed these best practice guidelines, which are an adaptation of the equivalent guidelines adopted by the Association of the British Pharmaceutical Industry (ABPI) and the UK Department of Health. The guidelines are designed to ensure best practice in managing the phase out of products, especially the timing and recipients of notifications of the deletion. They make recommendations about who to tell, when and what information will be needed. The emphasis is very much on early timing and information exchange and dissemination. To help companies and health professionals further, a central contact point has been established within the TGA; the details are on the proforma in these guidelines. 2

3 These guidelines have been adopted jointly by the Therapeutic Goods Administration and Medicines Australia. We believe they will establish good practice across the industry and the wider health community, and allow discontinuations to be managed with as little inconvenience and worry as possible for patients. We very much hope that you will adopt them within your company. The usefulness of these guidelines will be reviewed in 12 months time. If you have any comments on this document, please contact either Medicines Australia or the TGA (contact details are at the end of the document). Introduction Every product has a limited medical or economic life cycle and the decision to delete a product can be made for a variety of reasons including: Change in medical practice and availability of newer and better drugs Change in marketing strategy Commercial decisions Parent company decisions Manufacturing capacity restraints Revision of quality, regulatory or compliance requirements Problems in procurement of active ingredient In recognition of the National Medicines Policy, of which a responsible and viable medicines industry is one of the four pillars, pharmaceutical companies strive to take a responsible approach to the discontinuation of medicines to ensure that appropriate medicines are available to the Australian community. Before the decision is made to discontinue a medicine, a company should have carried out a risk assessment, taking into account the current therapeutic use, and whether there are therapeutic alternatives available. Where a product is being withdrawn and there is no therapeutic alternative, the company should seek a meeting with the Therapeutic Goods Administration (TGA) at least 12 months before the product is discontinued. The meeting with TGA will be informal and confidential, and focus on exchanging information. The reasons for deletion should be discussed and TGA may want to explore options for continued production, such as using another manufacturer or importation. At this stage, TGA will not share any information outside the Department of Health and Ageing, including the Pharmaceutical Evaluation Branch, without the agreement of the company. 3

4 If a product is being withdrawn for reasons of safety, quality or efficacy, companies will be aware of their legal obligations to notify the TGA. 4

5 Risk Assessment Before the decision is made to discontinue a medicine, a company should undertake a risk assessment. The key guiding principles are: 1. Take into account the impact of the product discontinuation on the customers ; and 2. ensure the level of communication is proportionate to the level of impact on customers. The risk assessment should include consideration of: The seriousness of the disease the medicine is used to treat Any unlicensed uses of the medicine, including paediatric use, and their extent Whether alternative medicines are available Whether an alternative supplier or manufacturer is available in Australia or overseas The timeframe for which no medicine may be available Options for managing available stock to ensure appropriate distribution and avoidance of stock piling To ensure that the discontinuation of a product does not cause unnecessary problems for patients and prescribers, it is important that sufficient notice is given so that alternative sources of supply can be located, or patients switched to alternative therapies safely and effectively. During the risk assessment, it is important to consult with groups and organisations that might be affected by the product discontinuation, and who could provide advice on the therapeutic importance of the medicine. These groups may include: Royal Australasian College of Physicians (RACP) Specialist colleges/associations in the therapeutic area Royal Australian College of General Practitioners (RACGP) Pharmaceutical Society of Australia (PSA) Society of Hospital Pharmacists of Australia (SHPA) State Therapeutic Advisory Groups (TAGs) National Prescribing Service Relevant Health Consumer Organisations (HCOs) Consumers Health Forum (CHF) 5

6 Notification of Product Deletions Date of Deletion from Market Once a company has made the decision to delete a product, they should assess how much stock of the product remains within the company and how long this is likely to last, based on current usage patterns and PBS listing status. This will determine the Deletion from Market Date. The Deletion from Market Date is the date that the company will no longer supply the product. It does not affect the stock that may already be in the distribution chain in wholesalers and pharmacies. Once a Deletion from Market Date has been agreed, stock levels should be closely monitored. If it appears that there will be a change in the proposed deletion date due to a reduction or increase in ex-factory sales, the impact on the notification schedules should be considered urgently. Timetable At least 12 months prior to Deletion from Market Date Initiate discussions with the TGA and Pharmaceutical Evaluation Branch (PEB) (for PBS listed products) on products for which there are no therapeutic alternatives. At least 3-6 months prior to Deletion from Market Date The TGA and PEB (for PBS listed products) should be formally notified of the proposed deletion 3-6 months prior to the Deletion from Market Date. The pro-forma attached to these guidelines should be used. Six months notice would be ideal although it is recognised that this may not always be possible due to factors outside the Australian company s control; three months should be taken as the minimum notice period. The information that the TGA and PEB requires is: company details and contact; product details; which formulations or presentations are being deleted and which will remain; licensed and significant unlicensed uses: the proposed timing; the reason for deletion; possible alternative therapies; 6

7 whether or not the deletion is just for Australia or world-wide; and whether or not the product will be removed from the Australian Register of Therapeutic Goods. * At this stage, following discussion between the company and TGA and PEB, it will be assumed that this information can be shared widely, including relevant stakeholders and specialist groups, the Royal Colleges, groups with an interest (e.g. patient groups) and other companies, unless the company specifies otherwise. The TGA or PBB will not communicate with these other parties prior to discussion with the company. The TGA will contact the company with any feedback they receive regarding the deletion. This will enable the company to target the notifications more effectively. Two to three months prior to Deletion from Market Date State Medicines Information Centres The State Medicines Information Centres, State Therapeutic Advisory Groups (TAGs), National Prescribing Service Therapeutic Advice and Information Service (TAIS) and Medicines Line should be notified of the proposed deletion three months prior to the Deletion from Market Date. The letter should include: the proposed timing of the deletion; whether the deletion is for Australia or world-wide; and alternative therapies. This information will then be disseminated via the usual communication channels. Specialist Groups Feedback from the TGA together with internal company knowledge will enable notifications to be targeted at specific specialist groups (eg doctor, pharmacist, patient) depending on the product being deleted. A letter, similar to that sent to the State Medicines Information Centres, should be sent to the specialist groups with a particular interest. For example, discontinuation of a diabetes product would be notified to Diabetes Australia and the Endocrinology Society. State Government Departments If the product to be deleted is supplied under contract to a State or Territory government department, the relevant departments should be notified of the proposed deletion. * It is preferable to maintain the registration of the product on the ARTG to facilitate the transfer of the registration if an alternative sponsor is identified. 7

8 Specialist medical and pharmacy media The company should issue a press release or letter regarding the product deletion. In timing this, the company needs to consider the Deletion from Market Date and what stock remains in the distribution chain. The press release should be sent to the following media depending on the market concerned: The Australian Prescriber (e-version); Journal of Pharmacy Practice and Research; The Australian Journal of Pharmacy; medical press as appropriate; professional bodies/organisations including RACP, RACGP, SHPA, PSA, TAG s). For products where there is no therapeutic alternative, it is also suggested that the company has a list of Q&As regarding the product deletion, which can be used to respond to any telephone queries. A copy of the Q&A should be sent to TGA. Product Information Compendiums The company should ensure that the following annual compendium entries are updated to remove Product Information for deleted products: MIMS Australia (CMPMedica Australia Pty Limited) PP Guide (Australian Pharmaceutical Publishing Company) Australian Medicines Handbook It may be appropriate to keep the Product Information in these compendiums for up to 12 months following the product deletion, after which the information would no longer be required. GP Databases, Prescribing and Dispensing Software suppliers In Australia most GPs have electronic clinical management systems and use the computer during a consultation and to produce the prescription. To ensure that a deleted product is removed from the GP database, a letter should be sent to the prescribing software distributors who will then include the information in the update discs that are issued to the GP system suppliers. The process of having a product removed from a GP database can take anything from eight to twelve weeks depending on the cut-off date for the inclusion of new information on the discs that are issued. Alternatively, a company could notify each GP system supplier individually, which may speed up the process. Again in timing this, the company needs to consider the Deletion from Market Date and what stock remains in the distribution chain. 8

9 Dispensing software is updated monthly, and any monthly updates to the Pharmaceutical Benefits Schedule will be included automatically. One Month Prior to Deletion from Market Date Wholesalers Wholesalers should be notified of the deletion one month prior to the Deletion from Market Date. This notification is left until one month prior to the deletion date to ensure that the product is not removed from the wholesalers computer systems prematurely which would prevent the wholesalers from ordering further product from the company. 9

10 Pro-forma for Product Discontinuation Send to: (For all products): By TGA (Head of relevant clinical unit) By fax: By post: Director, Drug Safety and Evaluation Branch Therapeutic Goods Administration PO Box 100 WODEN ACT 2606 (For products listed on the PBS): By By fax: By post: Mr Axel Godeck Pharmaceutical Evaluation Branch Department of Health and Ageing GPO Box 9848 CANBERRA ACT 2601 Company details Company name:... Company contact:... Contact telephone number:... Contact fax number:... address:... Product Details Product name:... ARTG Number:... Will the product be deleted from the ARTG? 1... Active Ingredient(s):... Licensed/unlicensed uses:... Presentation:... Presentations remaining on the market:... Proposed date of discontinuation:... (3-6 month s notice if possible, 12 months if there is no therapeutic alternative) 1 It is preferable to maintain the registration of the product on the ARTG to facilitate the transfer of the registration if an alternative sponsor is identified.

11 Proposed date to inform prescribers, pharmacists and medical/pharmaceutical press:... Reason for Discontinuation (Please tick any that apply) Raw material/sourcing difficulty Manufacturing plant closure/transfer Manufacturing capacity issues Safety issues Low volume product Other (please state):. Possible alternative product(s):... Interim arrangements (if applicable):... eg Special Access Scheme (SAS) Market(s) Affected (Please tick) Australia only World-wide If the discontinuation relates to safety, quality or efficacy Date of notification to TGA:... Name of contact at TGA:... 11

12 Contact details for some key organisations Australian Medicines Handbook Pty Ltd Level 8, 10 Pulteney Street ADELAIDE SA 5000 Phone: (08) Fax: (08) Website: Australian Prescriber Suite 3, 2 Phipps Close DEAKIN ACT 2600 Phone: (02) Fax: (02) info@australianprescriber.com HealthLinks.net Pty Ltd PO Box 6593 Silverwater Sydney NSW 2128 Phone (02) Fax (02) contact@healthlinks.net.au MIMS Australia Locked Bag 3000 ST LEONARDS NSW 1590 Australia Phone: Fax: editorial@mims.com.au National Pharmaceutical Services Association Locked Bag 5061 PARRAMATTA NSW 2124 Phone: (02) Fax: (02) cheryl.nichols@api.net.au National Prescribing Service Ltd (includes National Prescribing Service Therapeutic Advice and Information Service (TAIS) and Medicines Line) PO Box 1147 Strawberry Hills NSW 2012 Phone: Fax: info@nps.org.au 12

13 Pharmaceutical Society of Australia PO Box 21 CURTIN ACT 2605 Phone: (02) Fax: (02) Australian Pharmaceutical Formulary and Handbook (Address as above) Australian Pharmacist (Address as above) inpharmation (Address as above) Pharmaceutical Evaluation Branch Department of Health and Ageing PO Box 9848 CANBERRA ACT 2600 PP Guide & Australian Journal of Pharmacy Australian Pharmaceutical Publishing Company 40 Burwood Road, Hawthorn VIC 3122 Phone: (03) Fax: (03) State Therapeutic Advisory Groups (TAGs) NSW Executive Officer NSW Therapeutic Advisory Group Level 5, 376 Victoria St, Darlinghurst NSW 2010 PO Box 766, Darlinghurst 2010, NSW VIC Executive Officer Victorian Therapeutic Advisory Group PO Box 423 Carlton South VIC 3053 WA Chairman, Western Australian Drugs & Therapeutics Committee c/- Internal Medicine Kirkman House, RPH PO Box 2213, GPO Perth WA 6847 QLD Director, Pharmaceutical Advisory Unit Queensland Hospitals Drug Advisory Committee Queensland Health Charlotte Street Brisbane

14 Therapeutic Goods Administration Drug Safety and Evaluation Branch PO Box 100 WODEN ACT 2606 The Society of Hospital Pharmacists of Australia (includes State Medicines Information Centres) PO Box 1774 COLLINGWOOD VIC 3066 Phone: (03) Fax: (03) Journal of Pharmacy Practice and Research Consultation In developing this Best Practice Guideline, the following organisations were consulted: Therapeutic Goods Administration Pharmaceutical Benefits (now Evaluation) Branch Sponsors Wholesalers (through NPSA) Prescribers (RACGP, RACP, AMA, ADGP) Pharmacists (PSA, SHPA, Pharmacy Guild) Prescribing software suppliers Dispensing software suppliers Hospitals (through SHPA and TAGs) Publishers (AMH, MIMS, PPGuide, TGL, AJP, Aust Pharmacist, Aust Prescriber, Medical Observer, Australian Doctor Weekly) National Prescribing Service State Medicines Information Centres Consumers (through CHF) 14