Valsartan Recall

It must be slightly ironic that an email arrived this morning from the HPRA giving us a list of interchangeable Valsartan medicines.  All the more so since none of them are available or likely to be available for the foreseeable future.  It was best summed up on a pharmacy forum.

The following is a summary of the handling by the state quangos of the Valsartan withdrawal saga:

1) The Chinese are saying there’s an issue with one of their manufacturing plants processes. We know they definitely make ingredients for a few generic companies version of valsartan on the Irish market. Let’s announce on the airwaves that people using any of the generics listed should bring back their medicines to their pharmacy to be replaced with one of the ones that aren’t on the list.
2) We better tell the doctors and pharmacists about this as well , now that we put it on the news.
3) One of the generics that we thought wasn’t on the list might be affected as well now. We better quarantine that stock until they can prove otherwise.
4) We better say that other products may be added in the coming days as the picture becomes clearer(good thinking…that will cover our asses)
5) Excellent ..job well done.
6) Hmmm….pharmacies are reporting to us that there is no alternate “safe” stock available…interesting. Perhaps quarantining the stock we said was safe has contributed to this…hard to say
7) We better say that we never meant for anyone to bring back their tablets for switching , and clarify that we wanted them to bring the tablets with them for a show and tell day.
8)It’s now ok for patients to keep taking the contaminated possibly cancer causing tablets , but it’s not ok for pharmacies to keep supplying them….but if you have them already , keep taking them.
9) Wait, medicine management says to switch to candesartan.
10) The HPRA is now closed for the weekend, please call back Monday.

As for alternatives
Now the Medicines Management Programme have weighed in with their advice to switch to Candesartan, except post-MI, when specialist advice should be sought, as if making work for GPs and pharmacists isn’t enough. https://www.hse.ie/eng/about/who/cs…nce-for-prescribers-on-valsartan-shortage.pdf
I would predict a Candesartan shortage, because I’m guessing they didn’t check if there were sufficient stocks to treat 25,000 additional patients, but given how much attention doctors usually pay to their advice (like simvastatin being the preferred statin) it might be premature to stockpile
Better batten down the hatches.
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More On Garda Vetting

I’ve been thinking a bit more on this.

Many years ago the PSI stated that the ability to speak English (or Gaelige) was the responsibility of the employer.  Now they have finally got around to making it a condition of registration.  How many more years before they make Garda vetting a condition of registration.
I’m guessing 10 years.
I’ll have a running bet with myself.  Which will come first, Garda vetting carried out by the PSI or my retirement?  A pint for the winner.

Garda Vetting, Reply From PSI

I finally got a reply from the PSI to my email about Garda Vetting and why they have chosen not to get involved.  It’s a real civil service type response.  State the obvious and do not address the question.

Dear David,

 

Thank you for your email.  Sincere apologies for the delay in responding.

 

The National Vetting Bureau (Children and Vulnerable Persons) Acts 2012 to 2016 (NVB Act) provides that individuals who work with children and vulnerable persons must be vetted by the National Vetting Bureau (the Bureau). An employer may be guilty of an offence if they decide to employ a pharmacist or other staff member to work with children and vulnerable adults and do not obtain a vetting disclosure regarding that person from the National Vetting Bureau.

 

Garda vetting is a requirement of registration for some professionals and, in those cases, the vetting appears to be carried out by the regulatory authority which has responsibility for processing the applications for registration for the professionals concerned. Please note that Garda vetting is not a requirement of registration for pharmacists.  However, pharmacists and pharmacy staff who work with children and vulnerable persons must be vetted.

 

You correctly point out that the vetting legislation does not provide for individuals such as Pharmacists to contact the Bureau directly to seek a vetting disclosure for themselves. The application has to be submitted to the Bureau through a “relevant organisation”. A relevant organisation is defined under the legislation to include employers.

 

The PSI’s understanding of the current process for an individual pharmacist to access vetting is as follows:

 

  1. An employed pharmacist should contact their employer and advise them that they need to submit an application for a vetting disclosure. The employer needs to register with the Bureau as a relevant organisation.

 

  1. A pharmacist doing regular locum work for a particular employer, should contact the pharmacy concerned and request them to submit an application for a vetting disclosure. The employer needs to register with the Bureau as a relevant organisation.

 

  1. A pharmacist doing locum work for a locum agency should contact the Agency concerned and request them to submit an application for a vetting disclosure. The locum agency will need to register with the Bureau as a relevant organisation.

 

  1. It is also my understanding that the Irish Pharmacy Union (IPU), which is also a relevant organisation, will conduct vetting on behalf of relevant organisations or other persons.

 

The PSI works to safeguard public health and safety, and assure trust in pharmacy through the system of regulation and engagement with its registrants.  An employer must assure themselves of the suitability of their staff members, in regard to the roles and responsibilities assigned to them in the pharmacy.

 

If you require further information in this regard there is useful information available on the National Garda Vetting Bureau website: https://vetting.garda.ie/VettingProcedure/WhatIsVetting

 

I hope this information is helpful.

 

Regards,

There is no mention of why the PSI did not get involved despite it being part of their function to protect the public.  It would also be much more convenient if each pharmacist only had to be vetted once.  Instead we have locums and employees who have to undergo the process several times if they work for more than one employer.  It also means that the Gardaí have to duplicate the work as well.

It’s an abdication of their responsibility and they should hang their heads in shame.  How can we have any respect for any of their guidelines or directives when it seems as if they have no respect for themselves.

Motions For IPU AGM

The IPU AGM has all the potential of being a humdinger this week end.  Apart from all the various sessions over the three days, which I am sure will be interesting in themselves I’m talking about the AGM proper on Sunday morning at 11:15am.  There are 17 motion down for discussion and decision.  That’s more than I can remember for a long time.  While this can be taken as an indicator of greater unease within the membership it means that given that there is only 2 hours scheduled for this session this would mean that there will be only 5-10 minutes per motion.

To keep it brief here I only propose to write about the two motions that I am involved with.

The first, proposed by Margaret O’Doherty and seconded by myself proposes “That this AGM calls upon all superintendent pharmacists to suspend completion of the PSI’s assessment folder pending a full review and consultations between the IPU, superintendents and the PSI.”  I think that this is self explanatory.  This assessment folder is one of the greatest box ticking exercises that I have seen in a long time.  The registrar admitted that he feels it needs to be looked at but nobody seems to want to take the initiative.  I feel that this motion can be the kick in the ass that this process needs.  It allows the PSI a chance to save face and for everybody involved to get around the table.

The second that I am proposing and Michael Tierney is seconding is “That this AGM calls upon the IPU members not to cooperate with the PCRS in certain administrative tasks , such as the high tech stock take, until the PCRS agrees to consult with the IPU prior to making any changes which affect current practice.”  This comes about because I for one am fed up with all the arbitrary decisions and changes to practice that are being forced upon us without consultation by the PCRS.  Particularly those which save money for the PCRS at our expense. The two examples that I use are both related to the high tech scheme.  Firstly the return of the unused stock some years ago saved the PCRS in the order of millions of euro and yet we who did most of the work involved received nothing in return.  Not even a letter of thanks if memory serves me.  Then there’s the online stock take that they want us to conduct every year.  Again this saves them many man hours in not having to input the details themselves.  What do we get in return, nothing!  There is no obligation in the contract on us to enter the stock levels on line.  We can still put the stock sheets into an envelope and stick them in post them or  the yellow bag.  Most of us will still have to fill in the paper sheets before entering them on the computer so it is extra work for us that we receive nothing for in return.

In any other relationship between union and employer the proceeds of productivity are shared.  If the PCRS want to save money off our backs then I want my share!

If you want to have a say in these but will be unable to attend then the AGM there is a facility for you to appoint another IPU member as your proxy. I would suggest your regional rep.  The process is outline on page 185 of the IPU Yearbook and Diary, Art. 47, 48 & 49.

If I find time I might get around to giving my opinion on the other 15 motions before then.

 

Claim Checkers

Getting back to my post of 9th April last about claim checkers.  I had a phone call from the PCRS about the disappeared prescription this morning. Apparently it did appear on my reject list.  The entire claim was rejected because of one item.  However it only appeared on the reject list as the one item and not seven items that were actually rejected.  When I asked why the other items were not paid for I was told that if one item is rejected then the whole prescription is rejected.  “That’s just the way it has always been.”  As a stop gap they have now agreed to pay for the other six items (2 months late) and I have to chase up the prescriber for another prescription for the rejected item.

The claim checker paid for itself in that I was made aware and able to chase it up.  However I think that it is a disgrace that pharmacists have to pay for these programs just so we can deal with arbitrary decisions by the PCRS. Ultimately it would be nice if the PCRS were subject to the Ombudsman and we could have somebody to ensure fair play.

A Question For The PSI

There is still no mention on the PSI’s website about Garda vetting despite it being a requirement to practice as a pharmacist.  So I decided to email them and ask why they decided not to become involved.  Here is the email that I sent.

I note that from 1st May it is a requirement that all pharmacists and qualified assistants in a patient facing role will needed to be Garda vetted. I would like to know why the PSI has chosen not to involve itself in this process given that other regulatory bodies such as the Teaching Council have taken this task upon themselves. http://www.teachingcouncil.ie/en/Vetting/

Surely overseeing Garda vetting for pharmacists and qualified assistants falls within the PSI’s role to protect the public. It would also ease the administrative burden on individuals who now require vetting every time that they change jobs and an inordinate burden on locums who now require vetting for each pharmacy that they provide cover for. Given that there is now a difficulty in obtaining locums particularly at short notice is there not now a case to be made for the PSI to become the authorised administrative body for vetting pharmacists and qualified assistants meaning that each individual would only need to be vetted once.

It would also reduce the administrative burden on the Garda’s vetting office as presently they have to duplicate the process for a large number of individuals.

I’ll keep you update when i get any reply.

 

Garda Vetting For Pharmacists

Is it just me or does it strike anybody else as being odd that the PSI want nothing to do with Garda vetting for pharmacists and qualified assistants?  All the more so when their primary purpose is to protect the public.  It’s probably because there’s no money in it for them.

Let’s leave aside that all this has been sprung on us at less than 3 weeks notice and that most of the other regulatory bodies see it as part of their role.  Anybody who has been involved with Garda vetting in any other situation knows that a 3 week time frame is ridiculous. Also because of the PSI’s action any pharmacist who works in more than one pharmacy will have to obtain clearance for each pharmacy.  Every time that a pharmacist or Qualified Assistant changes job they will have to obtain clearance.  A once off vetting managed by the PSI could prevent a lot of this messing around.

This also throws up an interesting anomaly. What if a pharmacists for whatever reason cannot obtain clearance.  Is their employer now obliged to sack them?  And as up to now very few if any pharmacists would have it in their contract of employment that they must have Garda vetting could they then sue for unfair dismissal?

For now kudos to the IPU for stepping up to the mark at short notice but why did the PSI shirk their responsibility to the public?  Even as I write their is zero mention of it on their website.  It would be nice for them to even acknowledge that the issue even existed.