This letter to DoHA appeared last week
Changes to generic description for PBS medicines with multi-ingredients
24 June 2013
Download the PDF document (297KB) titled "Joint Letter re Generic Listing of multi-active PBS Medicines"
Here is the letter:
17 June 2013
Mr Paul Madden
Deputy Secretary and Chief Information and Knowledge Officer
Department of Health and Ageing
GPO Box 9848
Canberra ACT 2601
Dear Mr Madden
Re: Changes to generic description for PBS medicines with multi-ingredients
The undersigned groups represent the medical profession, the pharmacy profession, the medical software industry and the professional indemnity insurance sector. We are writing to you to urge immediate action, led by the Department of Health and Ageing, in relation to a serious issue affecting the safe prescribing and dispensing of PBS medicines.
The decision to change the generic description of multi-active PBS medicines to an alphabetical listing in the PBS Schedule is causing confusion for pharmacists, difficulties for prescribers and software vendors and safety concerns for consumers. Alphabetising the listing of active ingredients in multi-active products to be consistent with Australian Medicines Terminology (AMT) has resulted in the generic descriptions imported by software vendors from the PBS data to be displayed for drug selection in a manner conflicting with the packaging and product description approved by the Therapeutic Goods Administration (TGA).
This results in listing incorrect information regarding the strength of the ingredients and raises the possibility of the incorrect item being supplied. We are concerned that decisions are being made to arbitrarily change the generic description of medicines with multi-active ingredients without consideration of the impact on pharmacists and prescribers, consumers, the medical software industry or manufacturers. We believe that broad consultation with all relevant groups should be undertaken before any changes are made and the TGA be consulted as a priority as it is currently conducting a review into the labelling and packaging of medicines.
Examples of medicines that are affected are included in Attachment A, including multi-active products that may be impacted with future changes. While this is not a complete list, it indicates that more consideration needs to be given to any changes in the generic description of multi-active PBS products.
It is important to note that this issue was raised with the PBS Information Management section of your Department in the first week of May, as soon as the safety issues relating to the Coveram and Reaptan brands were identified. However the problem has been carried through to the June Schedule and now to the July Schedule, with more examples now identified.
The changes already implemented have caused significant confusion and consternation with health care professionals (see Attachment B), and increases the safety risks to consumers frompotential supply errors.
The undersigned groups request that these changes be immediately reversed, ahead of implementing a consultation with all relevant stakeholders to review the impact of such changes and consider if, when and how such changes are to be implemented in a manner that manages any negative outcomes. This consultation must also consider steps necessary to avoid other PBS schedule implementation issues such as the PBS item code confusion resulting from the rosuvastatin listings from 1 June 2013 and the inability for dispensing software or prescribing software vendors to test for PBS Schedule file issues prior to the date of effect of each Schedule.
We look forward to your urgent attention to this issue. Email addresses have been included below to allow for communication with the most relevant people in all the undersigned groups.
Yours sincerely
Prof Geoff Dobb
Vice President
Australian Medical Association
Kos Sclavos
President
The Pharmacy Guild of Australia
Grant Kardachi
President
Pharmaceutical Society of Australia
Marie Ritchie
Chief Executive Officer
PDL (Pharmaceutical Defence Limited)
Bridget Kirkham
Chief Executive Officer
MSIA
All the attachments can be downloaded from here:
All I need to say about this is that this is a clear cut example of how lives can be put at risk when bureaucrats - despite warnings - just go ahead and implement changes which affect the operation of clinically important software.
Now - just to make sure we have even more confusion we have this:
Consultation: International harmonisation of ingredient names
15 May 2013
This consultation closes on 10 July 2013
International Harmonisation of Ingredient Names - Consultation paper
- Consultation document: International Harmonisation of Ingredient Names (IHIN) (pdf,1.28Mb)
- Consultation document: International Harmonisation of Ingredient Names (IHIN) (Microsoft Word,2.07Mb)
Here is what it is about:
“About the consultation
The TGA maintains a list of approved names for medicines ingredients in the form of the TGA Ingredients database. The World Health Organization's International Non-proprietary Name (INN) terminology has been adopted for new medicines ingredients as standard policy wherever possible from 2002 onwards. However, several hundred ingredients added to the ARTG prior to this time have names inconsistent with INN terminology, and require harmonisation.
The proposal put forward in this consultation is to harmonise the names of these ingredients contained within medicines, not the names of the medicines themselves. The vast majority of the proposed ingredient name changes are minor, consisting of a single letter change (e.g. amoxycillin to amoxicillin; oestrogen to estrogen; cholecalciferol to colecalciferol).
The proposed changes may affect sponsors of the following products:
- prescription medicines
- over the counter medicines (including sunscreens)
- complementary medicines (both registered and listed)
- Export Only medicines
Consumers who use products that contain these ingredients, and healthcare professionals who prescribe and dispense them will also be affected.
Feedback received from these different stakeholder groups as part of this consultation will be used to determine an appropriate strategy to implement the changes in a way that presents the least possible inconvenience to stakeholders.”
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So we are just going to change a few hundred spellings and create extra work for all sorts of people.
I wonder is all this being co-ordinated with the solution to the first issue raised? I fear not.
Bottom line is that again we have the failure of leadership and governance in the e-health space. Sadly I don’t see either side of politics (new or old) having the will or wit to improve things. I wish I could be proven wrong.
Exhausting isn’t it.
David.
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