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Recall raises more questions; 43,000 patients affected
28 May 2010
Pharmacists have been asked to bear the burden of the latest recall by contacting 43,000 patients throughout New Zealand who are estimated to be taking Mylan NZ’s recalled cardiac drug, Pacific Atenolol, since January this year.
Unlike the recall of 50mg Pacific Atenolol on 13 May, which requested GPs to contact all patients, community pharmacists have been asked to solely manage the latest recall without any compensation for the time and expertise involved.
Today’s recall is due to the identification of several underweight tablets, while 13 May’s recall was due to the identification of several overweight tablets.
Was the decision not to involve GPs in the latest recall was due to what is being labelled as their patchy response to the previous recall?
Mylan NZ told
New Zealand Doctor the decision to involve or not involve GPs in the recall was not for the company to make.
“The direction came from Medsafe and was based on continuity of supply to patients being very important, and that pharmacists were in the best position to contact patients once they had received replacement stock from Mylan,” a company spokesman says.
Pharmacy Guild chief executive Annabel Young says community pharmacists have not been informed of the specific clinical risks associated with taking the affected tablets.
“We need to understand what is generating these recalls,” Ms Young says.
“Is it the purchase process undertaken by PHARMAC, the clinical guidelines used by Medsafe or some other factor?”
Medsafe says all recalls are different and the agency assesses the risk inherent in each individual situation and considers the clinical risk faced by patients.
“…consumer recalls are expensive and disruptive, and they are required only when it is necessary for patients to stop taking the product in question,” Medsafe manager of compliance management, Derek Fitzgerald, says.
“Medsafe has internal processes in place that ensure clinical and technical staff are brought together to discuss potential recalls and more specialised clinical advice is accessible if required to assist with decisions.”
He says many issues are considered when making these decisions.
“However, the principal consideration is whether the issue is potentially life-threatening or could cause a serious risk to health. This is the yardstick used internationally to determine how a recall should be conducted.”
In January this year, Marevan 3mg tablets were recalled because a manufacturing error resulted in some high strength tablets being incorporated in a batch. In March, Respigen inhalers were recalled because a manufacturing error led to variability in doses in some of the inhalers. This month, Pacific Atenolol (atenolol) tablets were recalled on two occasions (13 May and 27 May) because of manufacturing issues that resulted in dose variability.
On 6 May 2010, Medsafe ordered the recall of four ostensibly “herbal” products for erectile dysfunction that contained an undeclared prescription medicine.
Mr Fitzgerald says all of these recalls were conducted because the risk to patient/consumer safety was such that the products had to be removed from use.
“Consumer level recalls of medicines are not common and occur, on average, once a year. A recall may be for an over-the-counter medicine or for a prescribed medicine.
No clear procedures to manage recallsMs Young argues there are no clear procedures in place around who should be managing recalls.
And there is no sector agreement around how pharmacy - or any other health professional - is to be compensated for the time involved in managing recalls. This means that recent medicine recalls have been managed on an ad-hoc basis by community pharmacists.
“Why is the cost of this work falling onto community pharmacists when they are not the producers of the medicine and are not responsible for the purchase decision?” she asks.
“We need clear answers as to what triggers a patient level recall as well as some clear guidelines about who is to bear the cost of the work involved.”
Neither Medsafe nor Mylan have addressed those questions yet.
How successful are such recalls? What if some patients do not get the message or do not approach the pharmacy to return their medicines? During the last recall, GPs were asked to contact their patients, but many of them did not do so.
Some patients did contact their local pharmacy after seeing the advertisements in the newspaper, but not all of them did. Was it partially or fully successful and, thereby, managed to prevent the harm it intended to?
Mr Fitzgerald says as a matter of course, Medsafe requires all companies performing recalls to provide information about how well a recall was conducted. Information required includes: the response rate from recall recipients (usually pharmacies and wholesalers) and information on any difficulties encountered.
Pharmacies and wholesalers must return acknowledgment forms to the recalling company to demonstrate that they have received the recall notice and taken the required action.
“Medsafe expects a recalling company to follow up with non-responders. Pharmacies should also have processes in place to effectively carry out recalls.
Medsafe says it may, from time to time, go to the site of a recalling company and examine records and actions taken in order to ensure that they have been carried out correctly.
The progress of the Marevan recall, Mr Fitzgerald says, was closely monitored and the manufacturer underwent an audit shortly after the event in order to determine what had occurred and what measures had been put in place to prevent its recurrence.
“No decision has been made on whether a physical audit of the recent recalls will be carried out. However, information about the conduct of the recalls will be required as part of normal procedures.”
The Pacific Atenolol (atenolol) recall on 13 May 2010 was designed with an expectation that medical practitioners would be in a better position to contact patients more easily through their records.
But what if some patients are left out? What will could be the clinical implications for them?
Mylan NZ says it is difficult to quantify the risks on an individual patient basis.
“The risk is reduced by the fact that only a small number of tablets of incorrect size have been identified and there is unlikely to be any clinical impact because the affected tablets are visually different and identifiable. Medsafe has reflected this by advising patients to continue taking their medicine until they have an opportunity to replace thier tablets.”
Frequent recalls “purely coincidental”Medsafe does not believe frequent consumer level recalls like these may undermine the recall process altogether and says their clustering is just a coincidence.
“We acknowledge that there has recently been a cluster of consumer recalls. However, this should not be interpreted as a drop in the quality of medicines in general or that particular new issues have arisen to cause this effect. Medsafe's view is that the clustering of these recalls is purely coincidental,” Mr Fitzgerald says.
Comments
lol..... honestly some of the old pharmacist are a joke!!! for example that guy who went on tv1 breakfast and he couldn't put a valid argument about anything.
I think it's extremely naive of Medsafe's Derek Fitzgerald to determine that "this should not be interpreted as a drop in the quality of medicines". Of course it is! Since PHARMAC contracts only the cheapest manufacturer cost savings have to be made in the manufacturing process. As we all know...you get what you pay for! The cynic in me is trying hard not to believe that this is a good example of a government bureaucrats from separate departments closing ranks and sticking to the mantra that they're never wrong.
"Annabel Young says community pharmacists have not been informed of the specific clinical risks associated with taking the affected tablets"
When I went to school, atenolol was a betablocker and it did something to heart rate and blood pressure, so I'm guessing...
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