KEY POINTS:
Health authorities have commissioned tests on medicines which are being considered for an import ban, including an antibiotic syrup widely prescribed for children.
The Ministry of Health and Pharmac sought yesterday to reassure the public over the use of amoxicillin syrup and two other drugs, while explaining that
imports may be banned.
Their action follows the United States Food and Drug Administration on Wednesday banning imports of a number of medicines made at two plants in India operated by the drug company Ranbaxy, because of unresolved concerns from an audit in March. It has not banned sales of existing stocks in the US.
The New Zealand ministry has begun the steps to ban further imports of 12 drugs from the Ranbaxy plants, three of which are funded by Pharmac and therefore widely used.
But it will proceed only if medicines regulators from Australia and other countries cannot provide up-to-date audit results showing "good manufacturing practices" have been followed at the two plants.
Additionally, it has commissioned testing of the drugs, to ensure that they conform to specifications.
The nine affected drugs not funded by Pharmac are thought unlikely to be marketed and prescribed in New Zealand, or used on a very small scale.
The next shipment of the drugs is scheduled to arrive in New Zealand early next month. If a ban is to be imposed, it would be before then.
The ministry's chief adviser on public health, Dr Ashley Bloomfield, said there was no evidence the drugs had caused any harm or were ineffective.
The FDA's concerns involved alleged breaches of good manufacturing practice. One of the issues in the March audit was a lack of proper records, which could have led to cross-contamination of medicines with penicillin-type antibiotics, but tests so far had not revealed any actual cross-contamination.
Dr Bloomfield said virtually all of the deficiencies found by the FDA related to auditing and record-keeping.
A lower-dose formulation of amoxicillin syrup was not affected. It was the one more likely to be given to babies and toddlers, Dr Bloomfield said. Amoxicillin use had side-effects, including a rash, but there had been no reported increase in side-effects.
Pharmac's medical director, Dr Peter Moodie, said: "We have three months' supply of all the medicines that are affected ... "
Pharmac was looking for alternative suppliers of the affected drugs, he said. There were also alternatives doctors could prescribe for amoxicillin, including erythromycin.
Under scrutiny:
Amoxicillin syrup antibiotic, 125mg/5ml and 250mg/5ml. Around 400,000 prescriptions written a year.
Lovir (aciclovir) anti-viral, 200mg, 400mg and 800mg tablets. Used to treat herpes. Around 60,000 prescriptions a year.
Cefaclor antibiotic, 250mg capsules and 125mg/5ml suspension. Around 160,000 prescriptions a year.
Offical advice:
Keep taking the medicines if you have been prescribed them.
If concerned, phone Healthline, 0800-611-116, or ask your doctor.
