Sale of unapproved medications, inadequate recordkeeping
Member: Richard Mitchell
Hearing date: June 28, 2007
Facts
Mr. Mitchell was a dispensing pharmacist at a pharmacy where 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 (ThyroidŽ) was back-ordered, with shortages of the medication across Canada.
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), and no prescription could have authorized the dispensing or sale of it.
After taking Armour Thyroid for several months, the Patient reported to her physician that she was experiencing physical side effects, including hair loss, agitation, and difficulty sleeping. On the advice of her physician, the Patient stopped taking Armour Thyroid . Then, she complained to the College, stating that no one from the pharmacy, including Mr. Mitchell, ever counselled her about the drug with respect to possible side effects or interactions. The pharmacy has no documentation of counselling.
When the College investigated this complaint, and Mr. Mitchell’s practice in general, it found that:
- Mr. Mitchell had dispensed Armour Thyroid some 59 times, to a number of patients,
- the Armour Thyroid had been sold bearing a DIN, although Health Canada had never assigned it a DIN, and that
- another, similar drug, Thyroid PFI, had been dispensed by Mr. Mitchell and billed to the Ontario Drug Benefit as “30-day supply,” when the directions on the prescription indicated otherwise. The quantities actually dispensed by Mr. Mitchell ranged from 60 to 200 days’ supply. Mr. Mitchell explained that the computer software defaulted to indicate a 30-day supply, and the quantities had not been amended in these cases.
Acknowledgment of Professional Misconduct
Mr. Mitchell admitted that:
- he failed to maintain the standards of practice of the profession;
- he failed to keep records as required regarding his patients with respect to discrepancies in dispensing, billing, transferring prescriptions, and/or in record keeping;
- he contravened sections of the Drug and Pharmacies Regulation Act, the Food and Drugs Act, and the Regulations under the Food and Drugs Act;
- by reason of the above actions his conduct would reasonably be regarded by members of the profession as disgraceful, dishonourable, or unprofessional.
Reasons for Penalty
The Panel noted that Mr. Mitchell had acknowledged that it was his professional responsibility to ensure that all drugs which he dispensed had been properly approved for sale in Canada and had been assigned legitimate DINs. Mr. Mitchell clearly failed to execute this professional responsibility.
This case highlights the fundamental principle that the College’s members are individually responsible for their own actions. They cannot rely on others to discharge their professional obligations, nor can they turn a blind eye to actions in the workplace which they know, or ought to know, are inappropriate and/or illegal. Pharmacists are professionals, whether they are Designated Managers, shareholders, or simply employees. They have an obligation to do what is right, whether or not their employer or Designated Manager directs them, or puts them in a position to do otherwise.
Order
- A reprimand.
- Specified terms, conditions, or limitations on Mr. Mitchell’s Certificate of Registration, and in particular, that the Member 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. Mitchell’s Certificate of Registration for a period of two months, with one month of the suspension to be remitted on condition that Mr. Mitchell complete the above-noted remediation.
- Costs to the College in the amount of $2,000.
Reprimand
Pharmacists are continually amongst the most trusted professionals in Canada. Patients trust them to recommend and provide effective products every day. When pharmacists provide medications that have not been approved for sale in Canada, they breach that trust.
All pharmacists have a responsibility to their patients to make sure that the products they receive are suitable, whether that suitability refers to strength, dose, product chosen, or safety of the source of a product.
It is incumbent upon all pharmacists working in direct patient care to make sure that they act in the patients’ best interests. The Panel was of the belief that the course work that Mr. Mitchell had agreed to would enhance his knowledge and skills, and his interpretation of his responsibilities, and would help to make him a better pharmacist. The Panel hoped and expected that Mr. Mitchell would not appear before the Discipline Committee again. |
