August 2002 issue Pharmacy Today magazine
FIX IT!
Patients are at risk, a pharmaceutical company is in damage control and Pharmac has gone to ground in the case of the disappearing ACE inhibitors.
For the past six months, pharmacists have been reporting disintegration problems after dispensing the enalapril brand, Enahexel. They have also raised fears over patient safety.
New Plymouth pharmacist Mike Ekdahl says his close control patients first alerted him to the problem with unit dose packs at the beginning of the year. Later, complaints of tablets breaking down after being dispensed into bottles began to trickle in.
"The major issue was that patients couldn't even get them out of the bottle and I found some had been putting up with it for weeks without notifying us. The worrying question is what level of compliance are they able to maintain."
Grave concerns
Both the Heart Foundation's medical director Dr Diana North and Greenlane Hospital cardiologist and president of the Cardiac Society of Australia and New Zealand, Dr Harvey White, find the revelations disturbing.
Harvey White has "grave concerns" that patients not receiving the appropriate dose are increasing their chance of stroke or heart attack.
He is also worried doctors, unaware patients are unable to fully comply with their prescription, may double prescribed doses.
"The problem should be fixed forthwith - six months is long term," he says.
Hexal Australia, Enahexal's supplier and part of the German Hexal Group, says it has moved as quickly as possible. But identifying the scale of the problem, negotiating with Medsafe, and arranging new packaging has taken time.
Patient safety has been the primary concern says Hexal's Sydney-based New Zealand representative Andrea Kniest.
The problem, she says, stemmed from "commonly used" dispensing bottles not being sufficiently moisture resistant, particularly in areas of high humidity.
The company informed pharmacists last month, that from October, all strengths of the tablet will be supplied in blister packs with New Zealand labelling.
Until then, pharmacies will receive moisture protective dispensing bottles and desiccant packs for existing stock.
Pharmacists were still waiting on shipments as Pharmacy Today went to press.
The packaging changes will be made at Hexal's expense and are unlikely to have been factored into its Pharmac tender.
Why?
Some pharmacists are suggesting Pharmac's sole supply methods are at the root of the problem with the lowest tender taking the entire subsidised market in that class.
Hexal won the sole supply tender for enalapril which came into effect in December - about a month before the first complaints were made.
Mike Ekdahl says: "Pharmac is screwing companies down to the lowest possible price and then turns around and says the manufacturer is providing a sub-standard product. At the end of the day we have a problem with cheap drugs selected by Pharmac."
Pharmac declined to comment. Its communications manager Simon England says the issue is about efficacy and is Medsafe's responsibility.
Kerikeri pharmacist Di McFadzien says she now has three patients buying Renitec rather than use Enahexal because no fully funded therapeutic equivalent is available under sole supply.
Auckland pharmacist John Savory says Hexal's solution may solve the company's problem but not for unit dose patients.
The tablets will still have to be removed from blister packs and transferred to unit dose packs, threatening their stability.
Or they will have to be given to patients separately, throwing the rest home end of the dispensing system into confusion.
He also holds concerns for those patients packing their own medication organisers or having their children pack them. Medsafe's compliance team leader Peter Pratt urges pharmacists who identify problems with medicines to isolate a sample, and contact Medsafe immediately.
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