Sale of unapproved medications, sale of prescription-only medication without prescriptions, inadequate recordkeeping
Member: Jack Mark Rosenhek
Hearing date: June 28, 2007
Facts
Mr. Rosenhek was the owner and Designated Manager of a pharmacy at which the Patient obtained Armour Thyroid on a number of occasions in 2003 and 2004. Armour Thyroid is a natural preparation derived from porcine thyroid glands for use in the treatment of hypothyroidism and other medical conditions. At that time, a similar drug (ThryroidŽ) was back-ordered, with shortages of the medication across Canada.
There was a dispute as to whether Mr. Rosenhek had obtained prescription authority from a physician to dispense Armour Thyroid on these occasions. More important, and undisputed, was the fact that Health Canada had not tested the quality and safety of Armour Thyroid, and had not approved it for sale in Canada. Therefore, Armour Thyroid had not been assigned a Drug Identification Number (DIN), so no prescription could have authorized the dispensing or sale of it.
After taking Armour Thyroid for several months, the patient experienced negative side effects, and stopped taking it. The patient stated that no one from the pharmacy, including Mr. Rosenhek, ever counselled her about the drug with respect to possible side effects or interactions. There is no documentation of counselling.
During a routine inspection of the pharmacy after these events, a College inspector observed Armour Thyroid in the dispensary, but did not advise that it was not approved for sale in Canada. However, when the College later investigated this specific complaint, it found that:
- Armour Thyroid had been dispensed to a number of patients over 200 times (many with “purported prescriptions” for this unapproved medication);
- Armour Thyroid had been assigned a DIN at the pharmacy, although Health Canada had never assigned it a DIN. Mr. Rosenhek advised that he had assigned the DIN merely to track inventory;
- Fifteen other unapproved medications were available for sale in the pharmacy; ten of those medications contained substances which federal and provincial legislation required be sold only further to a prescription, but they were available for purchase in the self-serve or over-the-counter part of the pharmacy;
- On several occasions, the pharmacy had dispensed medications pursuant to a fax prescription, where the original of the prescription had not been obtained, as required under the College’s fax policy;
- On several occasions, the pharmacy had dispensed medications labelled as “30-day supply” when the quantity dispensed actually represented a much larger supply. Mr. Rosenhek explained that the computer software defaulted to indicate a 30-day supply, and this number had not been amended on these occasions.
Acknowledgment of Professional Misconduct
Mr. Rosenhek admitted his responsibility in respect of this misconduct in that:
a) he failed to maintain the standards of practice of the profession,
b) he failed to keep records as required, and was responsible for the discrepancies in dispensing and transferring prescriptions and/or record- keeping,
c) he falsified records in relation to his practice,
d) he signed or issued, in his professional capacity, documents that he knew contained a false or misleading statement,
e) he contravened sections of the Drug and Pharmacies Regulation Act, the Food and Drugs Act, and the Regulations under the Food and Drugs Act,
f) by reason of the foregoing acts, his conduct would reasonably be regarded by members of the profession as disgraceful, dishonourable, or unprofessional.
Reasons for Penalty
The Panel accepted the penalty proposed jointly by the parties, finding it to be appropriate and commensurate with Mr. Rosenhek’s misconduct. The Panel found that Mr. Rosenhek’s misconduct was very conscious and deliberate, and that there was no indication that he was unaware that Armour Thyroid and the other medications in question were not approved for sale in Canada. The fabrication of a DIN by Mr. Rosenhek represented to the public at large that Armour Thyroid was a safe drug which had been approved for use in Canada, which it was not.
Pharmacists dispense only drugs which are approved for sale in Canada, and pursuant to valid and legitimate prescriptions. To do otherwise, or to label medications falsely or misleadingly regarding these requirements, undermines the authority under which pharmacists practise.
Order
- A reprimand
- Specified terms, conditions, or limitations on Mr. Rosenhek’s Certificate of Registration, and in particular, that he complete successfully, at his own expense, within twelve months of the date of this Order, the following courses, seminars, and evaluations:
- a) Law Lesson 2 (The Regulation of Pharmacy Practice), Law Lesson 4 (Standards of Practice), and Law Lesson 7 (Professional Liability), from the Canadian Pharmacy Skills Program, offered through the Leslie Dan Faculty of Pharmacy at the University of Toronto,
- b) the Jurisprudence seminar and evaluation offered by the College, and
- c) Applied Ethics in Pharmacy Practice, offered through the Leslie Dan Faculty of Pharmacy at the University of Toronto, and taught by Professor Zubin Austin.
- A suspension of Mr. Rosenhek’s Certificate of Registration for a period of four months, with two months of the suspension to be remitted on condition of completion of the above-noted remediation.
- Further specified terms, conditions, or limitations on Mr. Rosenhek’s Certificate of Registration, to take effect on October 1, 2007, for a period of one year, prohibiting him from acting in the capacity of a Designated Manager of any pharmacy.
- Costs to the College in the amount of $10,000.
Reprimand
Mr. Rosenhek purchased, stocked, and made available for sale in his pharmacy medications that were not approved for sale in Canada. This was done under the guise of them having been approved for sale in Canada when in fact they were not. Some of those medications contained ingredients that would normally require prescriptions for them to be sold in Canada, yet Mr. Rosenhek sold them in the self-serve section of his pharmacy, without prescriptions. The public was thus put at risk in that people could have purchased potentially dangerous products.
The public puts their trust in pharmacists to stock, sell, and recommend products which have been approved for sale in Canada as safe and effective. As a pharmacist, Mr. Rosenhek should respect the regulations that govern the practice of pharmacists and the availability of drugs in Canada, whether or not he agrees with those regulations. The Panel trusts that medications that are currently available in Mr. Rosenhek’s pharmacy are approved for sale in Canada, and that Mr. Rosenhek will not appear before the Discipline Committee again. |
