Category: Public Policy

Not a good week for the Therapeutic Goods Administration and QUM

The Therapeutic Goods Administration (TGA) is charged with ensuring Australians can have confidence that the medicines and devices and other therapeutic goods that are sold in Australia and safe, effective and manufactured well. At a high level the role of the TGA is to practice evidence based medicine (EBM) and quality use of medicines (QUM). The last fortnight has seen poor outcomes on all fronts and both in the area of conventional and complementary medicines regulation.

In the first case a TGA proposed ban on combination products containing detropropoxyphene (DPP) was overturned by the Administrative Affairs Tribunal. DPP has been associated with death due to cardiac toxicity, albeit often in the situation of overdose. It is not considered to be a superior analgesic to common alternatives. Internationally the drug has been withdrawn from a number of jurisdictions because of safety concerns and available alternatives.

In the second case the vitamins giant Swisse has bypassed a ruling of the TGA that its’ diet pill does not have evidence to support its’ claims and has renamed the product and re-worded the claim. The product itself is the same. The registering process provides not oversight of this process and it can only be addressed through appeal.

Regardless of its’ best intentions in these cases the TGA seems hamstrung by the Act under which it operates. This is too the detriment of the general public and not in the spirit of the National Medicines Policy. In one case there is increased risk of harm without added therapeutic benefit, in the other little evidence of benefit. What is needed it not necessarily more onerous regulation but more thoughtful regulation and also education of the public, particular around complementary medicines.

These comments reflect my own personal opinion and not those of NPS Medicinewise.

http://www.smh.com.au/national/health/name-change-helps-swisse-sidestep-ban-on-hunger-product-20130411-2hokj.html

http://www.austlii.edu.au/au/cases/cth/aat/2013/197.html

Things they didn’t teach in medical school: Part 20 How to do meetings

So over the weekend I speed read Sheryl Sandberg’s book Lean In.

I was motivated by the useful summary by the NY Times David Brooks: “Think about Sheryl Sandberg’s recent book, “Lean In.” Put aside the debate about the challenges facing women in society. Focus on the tasks she describes as being important for anybody who wants to rise in this economy: the ability to be assertive in a meeting; to disagree pleasantly; to know when to interrupt and when not to; to understand the flow of discussion and how to change people’s minds; to attract mentors; to understand situations; to discern what can change and what can’t”.

This reminded me about something that is increasingly important in my life – going to meetings. In fact my colleagues give me a hard time because I’m a bit of a meeting junkie but this is only because they spend 4-5 hours a week in meetings as opposed to my 20.

If as a doctor you work in a hospital and you are engaged with the running of the place you will need to spend a lot of time in meetings. These range from meetings of 2-3 people to 20 or more. The reasons for the meetings will be diverse and they encompass education, environmental scanning (FYI meetings), working meetings (i.e. you are making decisions) and advisory meetings (where you are helping others make decisions).

There is a lot written about how to run effective meetings so I won’t re-iterate all of these writings. I will say however that you need to know what the purpose of the meeting is and at the end of any meeting there needs to be an outcome…a decision or an action arising. Bad meetings are staccato and without resolution whereas good meetings have ‘flow’ and resolutions. Meetings work when everybody who wants a say gets a say, diversity of opinion is expressed and the outcomes are determined by consensus (this doesn’t actually mean everybody likes the outcome but everybody agrees).

Overall David Brooks’ summary offers a nice approach to meetings.

One final thing you do need to know about meetings is when to say no….my rule is that unless it is exceptional there is no role for ‘routine’ meetings that happen only twice a year….almost by definition these don’t achieve anything.

There is a whole additional art to chairing a meeting – one which I’m just coming to grips with – and which will form another post.

Amazon Lean In

David Brooks The Practical University

When can I claim CPD points for my blogging & microblogging?

Continuing profession development or continuing medical education concerns a number of activities aimed at maintaining professional standards, skills-based competency, and currency of knowledge and practice. I’ve just lodged my 2012 CPD points with the RACP. 100 points are required over 12 months. These points are relatively easy to accrue for somebody like myself, for example, attending a conference might garner between 10 and 30 points, a publication scores 5 points, post-graduate study carries 50 points a semester. You can acquire points through online learning, logging your access of UpToDate, recording the clinical meetings you attend and teaching undertaken, and logging participation in quality improvement exercises.

One of the key points with CPD is reflective learning. In fact, in the program that I participate in, demonstrating reflection garners additional points.

After submitting my points I realised that I didn’t include my blogging and microblogging as part of my CPD and likewise – there was no category for this type of activity in the menu of options available to accrue points. When I post medical tweets it is often after having read abstracts and whole articles from the medical literature – these days often through Read by QxMD on iPad, via the popular press such as the New York Times, or several other healthcare blogs. My tweets become a potentially audit trail for my CPD activities.

My blog posts have largely been reflective learning pieces on ‘things they didn’t teach at medical school’ and commentary on health policy issues, in particular, on eHealth.

Reflective writing is increasingly adopted into medical school curricula and part the formative assessment process of students. Fischer et al found no difference between written and blogged reflections undertaken in medical clerkships (Med Educ 2011 45(2):166-75).

Although CPD is largely inwards looking blogging and microblogging serve an outward looking purpose in that it is a way of disseminating information and opinion and also communicating with other interested parties, potentially creating learning communities. In some cases the amount of influence is measurable through a variety of social media metrics (e.g. Klout and Kred Scores).

CPD programs should recognize blogging and social media activities as valid forms of reflective learning.

The Australian Local Health District Paradox or How Does One Assess LHD Board & CEO Performance

National Health Care Reform, and in fact all of Australian government, is built around the principle of subsidiarity – i.e. that delivery and implementation of services, and decisions concerning services should be made as close to the ‘coalface’ as reasonably possible. This has resulted in the creation of local health districts or LHD. The LHD receive a mixture of State and Federal funding that is predominantly administered through State ministries. The LHD governance consists of a Board and a CEO with his/her executive team.

The remit of the LHD Board is to ensure good management of the district and philosophically the Board must protect, and indeed pursue, the interests of the local community. At inception the CEO were appointed by the States rather than by the Boards and the Chairmanship of the Boards, albeit voluntary, was also essentially at the discretion of the States.

The CEO has in effect two masters – the State Ministry of Health and the Board. The CEO is bound to try and achieve the performance targets set by the State. At the current time these are largely around activity based funding. The CEO and Board and hospitals must bring the budget in on target.

The problem for hospitals and their Boards is that hospitals new improvement, renovation and redevelopment. States tend to do little to cater for recurrent infrastructure related capital expenditure so the LHD must compete politically and make the case why their institutions are more deserving than others (that might be in more politically sensitive electoral seats). The Board has a responsibility to the community it serves to try and advocate for its’ cause. The CEO should support the actions of the Board but must also accommodate the bidding of the State and not cause embarrassment for it.

We must be recognize these issues but also manage them. The Board must not let the the CEO control its’ agenda. The Board must manage the performance of the CEO and be prepared to penalise him/or for failing in either management of the LHD budget or in advocacy for the LHD.