Pharmacist imprisoned on Medicines Act charges
Pharmacist imprisoned on Medicines Act charges
A 32-year-old Auckland pharmacist been sentenced to four months and two weeks in prison for a series of breaches of the Medicines Act 1981 related to sales of unapproved prescription medicines.
At a defended hearing in the Auckland District Court, Fadi Iskander was convicted and sentenced on 47 of the 49 charges laid by the Ministry of Health.
These charges related to a wide variety of breaches of the Medicines Act in relation to offending prior to June 2010 when Mr Iskander operated a website from which he was selling unapproved prescription medicines for the treatment of male sexual dysfunction.
He was also found to have possessed medicines at two addresses without having a reasonable excuse to do so.
The products he advertised and sold were manufactured without approval and represented as herbal in nature despite containing prescription medicines as active ingredients.
The products contained erectile dysfunction medicines vardenafil or phentolamine.
Mr Iskander was conducting this business separately to a pharmacy which went into receivership in February 2010. The Pharmacy Council has suspended Mr Iskander’s pharmacy practising certificate.
The Medicines Act sets out the framework protecting the public from misuse of medicines by limiting prescriptions medicines to supply only on the authority of a healthcare professional (such as a medical practitioner).
This ensures that the benefits and risks of using a medicine have been carefully considered by the medical practitioner and that appropriate ongoing care is available.
Medsafe warns the public to treat any products advertised and sold for a therapeutic purpose outside of the usual medicines supply system with caution. The products may be sold illegally, may have false claims and may be adulterated.
In particular, it is difficult for consumers to be sure about the safety, quality and legality of medicines purchased over the internet.
What is the Medicines Act 1981?
The Medicines Act 1981 regulates the manufacture, sale and distribution of medicines, medical devices and related products. The framework of the Act is designed to ensure that consumers receive medicines that are safe, effective and of an acceptable quality. The Act sets out legislative requirements for the sale, advertising, distribution, manufacture and importation of medicines.
The Ministry of Health is responsible for administering the Medicines Act 1981 and the Medicines Regulations 1984.
What is Medsafe?
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. It is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products in New Zealand in relation to pre-market approval and post market surveillance. These products include medicines and related products, medical devices and controlled drugs used as medicines.
What were the charges Fadi Iskander was convicted of?
Twenty charges of selling a new medicine without the consent of the Minister of Health (section 20(2)(a) of the Medicines Act 1981).
Fifteen charges relating to the storage and possession of prescription medicines without reasonable excuse (section 43(1) of the Medicines Act 1981).
Three charges of having medicines not in a proper container (section 46 of the Medicines Act 1981).
Three charges of advertising new medicines without the consent of the Minister of Health (section 20(2)(c) of the Medicines Act 1981).
Three charges of packing and / or labelling a medicine without a licence (section 17(1)(c) of the Medicines Act 1981).
Two charges of selling medicines with misleading labelling (section 61 of the Medicines Act 1981).
One charge of manufacturing a medicine without a licence (section 17(1)(a) of the Medicines Act 1981).
What were the significant public health risks posed by Mr Iskander’s activities?
By supplying unapproved prescription medicines outside the regulatory system, Mr Iskander put the health of members of the public at risk.
Prescription medicines were made available to the public unsupervised by a doctor with no consideration as to their safety and suitability for the consumer. Prescription medicines are potent substances used for treating patients with conditions that require thorough and effective diagnosis by a medical professional.
The prescription medicines sold to the public
The products Mr Iskander sold to the public went under various versions of the trade name Exotic.
Vardenafil is used to treat erectile dysfunction and is legally available in New Zealand in the approved product Levitra. There are certain cautions that have to be considered before vardenafil is prescribed as it should not be used with certain heart medications and may not be suitable for certain patients. The danger posed by the products being sold illegally is that consumers for whom vardenafil is unsuitable may use them believing they are totally herbal.
Phentolamine is a medicine with effects on the circulatory system. It has also been used to treat erectile dysfunction, however, there are no products currently approved in New Zealand for that purpose.