Latest on web-based access to prescription medicines information

The Therapeutic Goods Administration recently engaged the services of mpconsulting to provide advice to the TGA on the most appropriate means for improving consumer and professional access to web-based copies of up-to-date Consumer Medicine Information ("CMI") and Product Information ("PI") documents.

Initial Discussion Paper

Consequently, mpconsulting prepared an Initial Discussion Paper on improving access to prescription medicines information, which:

• provided information about the means by which the TGA currently regulates CMIs and PIs;
• provided information about some of the ways in which consumers and professionals currently access up-to-date CMIs and PIs;
• identified certain concerns raised with the TGA regarding access to up-to-date CMIs and PIs; and
• requested information on current mechanisms of information dissemination.

While the paper was only a scoping exercise at this stage, its purpose was to facilitate better identification of key stakeholders and existing mechanisms for providing consumers and health care professionals with access to up-to-date CMIs and PIs.

Sydney Forum on 7 June 2005

We attended the forum held by mpconsulting for stakeholders in Sydney on 7 June 2005. The forum was run by Andrea Matthews of mpconsulting, with Dr John Donohoe of the TGA also present.

There was a reasonable turnout of stakeholders, with around 45 people in attendance.

Reasons for access to web-based CMIs and PIs

At the outset, mpconsulting stressed that the TGA did not intend for web-based access to CMIs and PIs to replace the current system where consumers are provided with a CMI at the time of dispensing. Rather, web-based access is intended to supplement the current system.

The reasons expressed for the improvement to consumer and professional access to web-based copies of up-to-date CMIs and PIs were:

• consumers often do not receive CMIs when medication is dispensed, or they may subsequently lose their copy of the CMI;
• caregivers may require a CMI to refer to when administering medication;
• consumers sometimes feel that a CMI does not provide sufficient information so they seek further information about their medication;
• consumers seeking further information about their medication often search for this on the internet;
• internet searches often provide consumers with an overseas version of a CMI or PI, which may vary from the Australian version of the documents;
• not all health care professionals maintain subscriptions which provide them with hard copies of PIs; and
• health care professionals may not have up-to-date hard copies of PIs.

Options discussed at the forum

The second part of the discussion turned to the five options set out in the Initial Discussion Paper.

The stakeholders' preferred option was for the TGA to provide a link on its website to existing CMI and PI databases (option 3). This is because it would provide consumers with links to CMIs and PIs from the TGA website, without involving additional time and expense to sponsors.

Although this option would not guarantee access to all CMIs and PIs, stakeholders felt that this was not essential. They also commented that consumers would be more inclined to believe information made available through an independent/third party's database, rather than from the TGA or on the sponsors' websites.

Option 4 (the TGA to provide links to sponsor websites, with sponsors being required to maintain CMIs and PIs on their websites) and option 5 (the TGA to include all CMIs and PIs directly on the TGA website, by requiring sponsors to provide up-to-date CMIs and PIs to the TGA for inclusion on the TGA website) were discussed in detail.

The advantages expressed in relation to options 4 and 5 were:

• they would ensure that 100 percent of all CMIs and PIs would be available on the internet; and
• all CMIs and PIs available would be up-to-date, as it would be the sponsors' responsibility to maintain up-to-date versions of the documents on their websites or to provide these to the TGA.

However, stakeholders were resistant to options 4 and 5 because:

• they would both be time-consuming and costly for sponsors;
• in relation to option 4, smaller sponsors may not have websites and it would be expensive for them to set up websites;
• in relation to option 4, it would be difficult to ensure that consumers were not exposed to sponsors' "promotional" material when accessing CMIs or PIs from their websites;
• in relation to option 4, consumers may view the CMIs and PIs as promotional rather than factual material given that it was on the sponsor's website; and
• in relation to option 5, stakeholders were hesitant to rely on the TGA keeping the database correctly up-to-date.

Stakeholders were also happy to simply retain the status quo (option 1) and to have the TGA strengthen existing CMI and PI databases (option 2), as these options did not involve additional time or cost to sponsors. Stakeholders expressed the view that while in theory a web-based system providing access to up-to-date CMIs and PIs was appealing, it was important to determine whether the time and expense involved for sponsors and the TGA would be worth the benefit/return to the consumer or health care professional.

Written submissions

mpconsulting informed stakeholders that it would produce a further Discussion Paper which will canvass the preferred options in greater detail, and which should be ready some time between August and October.

The TGA is encouraging stakeholders to make written submissions on this subject. Clayton Utz would be pleased to assist any stakeholders who may be interested in making any submissions, either on a named or unnamed basis. Written submissions must be sent to mpconsulting by 27 June 2005.