Chairmans Letter - Community Edition

How will the responsible pharmacist regulations change your life?

01-DEC-08

Mark KoziolThe plan to replace some of the outdated provisions of the 1968 Medicines Act with the updated Health Act was, in principle, a very good one. As an example of the old Act, the idea that members of the public could not legally purchase GSL medicines from a pharmacy because the pharmacist was at lunch – but that they could do so instead by going to a petrol station, where they could make their purchase with no legal impediment – was just downright silly.

So it was with some eager anticipation that the consultation on Health Act proposals was first published in 2006. However, the Department of Health went much farther with its Health Act proposals than anyone had ever anticipated and it included concepts which were highly controversial.

  1. Introduction of responsible pharmacist (RP) provisions

    The idea is to appoint and record the name of an individual pharmacist who would be made personally and legally responsible, not only for the sale and supply of medicines to the public, but also for ensuring the safe and effective running of the pharmacy – in so far as it relates to medicines.

  2. Introduction of remote supervision

    This would allow a pharmacy to be operated in the absence of a pharmacist. Many concerns about this idea have been expressed, none more so than by the PDA. Many senior politicians have publicly expressed their support for the concerns of the PDA, particularly in Parliament. The DoH has now agreed to temporarily postpone implementation.

The concept of the RP however, was initially given a cautious welcome by the PDA. While the added responsibility for pharmacists was in some ways a scary prospect, we felt that it would be would be worth it, if indeed the RP was to be given the authority over important operational matters within the pharmacy.

Imagine this: the RP, rather than the area manager or superintendent, would decide what constitutes a safe staffing level in the pharmacy; the RP, rather than the area manager or superintendent, would decide what constitutes a safe and appropriate workload, in terms of services to be provided, from that pharmacy.

However, the DoH’s final position on this matter, as revealed in September 2008, is very disappointing. It does not point to the opportunity described above, which could have rid community pharmacies of the scourge of low staffing levels and dangerously high workloads. The Department states that the RP will still need to work under the direction of the superintendent pharmacist.

The result is that it looks as if the DoH wants a significant extra responsibility to be placed on the shoulders of the RP in the event that something goes wrong, but is not prepared to give the RP the authority to decide operational matters such as those described above. This is tantamount to being told to go into the boxing ring with both hands tied behind your back.

We have many more concerns about these proposals and unless some change of emphasis can yet be made, then these proposals will represent an unwelcome development for pharmacists and patients alike. After some significant lobbying, the PDA has been invited, belatedly, to join the Society, employer representative organisations, employer trade organisations, Government lawyers and others, to produce the regulations; a series of meetings is being held throughout autumn 2008. The DoH has scheduled these regulations to ‘go live’ (and therefore govern pharmacists) from autumn, 2009.

Despite the fact that you cannot make a silk purse out of a sow’s ear and also the fact that we have few, natural supporters at these meetings, we will, nevertheless, be doing our level best to argue against the worst of the proposals in the interests of both pharmacists and patients.

PDA members wishing to know more about how these regulations will affect them are urged to read the special feature online or on pages 11 12 and 13 of the PDA's Insight magazine.

For more detailed information, why not read the formal PDA response to the DoH consultation on the RP via the button below:

Read the formal PDA response to the DoH consultation on the RP

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