On June 13, 38-year-old Andrew Strempler, a former Manitoba pharmacist and founder of internet pharmacy RxNorth.com, was arrested and charged with one count of conspiracy to commit mail fraud and two counts of mail fraud.
It is alleged that Mr. Strempler had prescriptions made through RxNorth filled at a facility in the Bahamas, with labels on the vials and drug cartons stating they had been filled by RxNorth in Canada.
Court documents also allege that Mr. Strempler falsely represented that RxNorth was selling safe prescription drugs when in fact the drugs were obtained from various other countries without properly ensuring their safety or authenticity. Some of the drugs were counterfeit, misbranded and not FDA approved.
Good lessons from a bad example
Many measures are in place in Alberta to protect the profession and the public from having something like this happen here. What lessons should pharmacists and pharmacy technicians keep in mind?
1. Know when a mail order licence is required
Amendments to the Pharmacy and Drug Act and the Pharmacy and Drug Regulation came into effect on April 1, 2009. The amendments clarify that pharmacy services may be provided at a distance, subject to appropriate licensing. The amendments enhance accountability for all pharmacies. These measures are important to maintaining the integrity of the drug distribution system, and ensuring that pharmacy services are provided safely, effectively, and accountably.
Changes addressed in the amendments include:
- when a mail order licence is required,
- licensing requirements,
- records that must be maintained,
- the ability of the college to place conditions on a licence throughout the year, and
- the ability for the college to share information found through investigation with regulatory bodies in other professions and jurisdictions.
2. Protect the integrity and safety of drugs
Standard 5 of the Standards for the Operation of Licensed Pharmacies outlines requirements for ensuring the integrity and safety of the drugs, health care products and supplies.
Principle 1 (6) of the Code of Ethics also requires all pharmacists and pharmacy technicians to,“dispense, distribute or promote drugs, non-prescription medications or health-related products that are of good quality only.”
3. Do not mail controlled substances or unapproved drugs to the US
Medications arriving in the US from Canada are subject to the laws of the USA. Under the US federal Food, Drug and Cosmetic Act, the Food and Drug Administration (FDA) “may refuse admission to any drug that ‘appears’ to be unapproved, placing the burden on the importer [the patient] to prove that the drug sought to be imported is in fact approved by the FDA.”
According to Canada’s Controlled Drugs and Substances Act, Section 6(1):
Except as authorized under the regulations, no person shall … export from Canada a substance included in Schedule I, II, III, IV, V or VI.
This notice applies to all controlled substances, including narcotics, controlled drugs, and targeted substances.
For more about mailing across the border, see:
Summer 2010 Transition Times, page 10
FDA Information on Importation of Drugs
4. Label drugs properly
See Standard 7 of the Standards of Practice for Pharmacists and Pharmacy Technicians for labelling requirements.
