Abadir Nasr

Member: Abadir Nasr

Pharmacy: King West Pharmacy

Hearing Date: September 6, 2007

Facts

Mr. Abadir Nasr was 51% shareholder and the sole director of the corporation that owned and operated King West Pharmacy (“the Pharmacy”) in Hamilton. He was the designated manager of the Pharmacy and worked there as a dispensing pharmacist. His father, who was licensed to practice pharmacy in Egypt but not in Ontario, was 49% shareholder. Following the events described below, the Pharmacy was sold to an unrelated third party in or about August 2005.

UNAPPROVED AND COUNTERFEIT NORVASC

A patient who regularly had prescription for Norvasc filled at the Pharmacy noted in March 2005 that the Norvasc looked significantly different from the Norvasc that had previously been dispensed to her. She raised her concerns with the pharmacist at a different pharmacy, and presented two vials of Norvasc to that pharmacist, both of which she had obtained from the Pharmacy pursuant to prescriptions.

That pharmacist forwarded the vials to Pfizer Inc., the manufacturer of Norvasc. Pfizer carried out its analysis of the drug products in May 2005. The analysis by Pfizer revealed that the tablets in one of the vials were manufactured by Pfizer for sale in Turkey but were not approved for sale in Canada (“Unapproved Norvasc”). The tablets in the other vial contained little or none of the active ingredient in Norvasc (“Counterfeit Norvasc”).

Pfizer contacted the RCMP about the Norvasc dispensed by the Pharmacy in May 2005. Pfizer also arranged for a private investigator to attend at the Pharmacy in May 2005 posing as a patient to fill a prescription for Norvasc. The drug product dispensed was then analyzed by Pfizer, and was determined to be Counterfeit Norvasc.

The RCMP and the College, along with other federal and provincial agencies, attended at the Pharmacy to conduct an unannounced search of the premises in June 2005. In the course of the search, the RCMP seized all Pharmacy records and drug products related to the purchase and sale of Norvasc. The College investigators generated computer reports for all transactions at the Pharmacy involving Norvasc for the 100 days prior to the date of the search.

On the day of the search, the College seized the Pharmacy’s entire inventory of prescription drugs. The Pharmacy remained open following the day of the search with new inventory. As noted above, the Pharmacy was sold to an unrelated third party in or about August 2005.

On the day of the search, the RCMP identified two patients for whom the Pharmacy had previously filled prescriptions for Norvasc. Samples of the tablets dispensed by the Pharmacy to these patients were obtained from the patients and analyzed by both Pfizer and Health Canada. Some of the tablets were Unapproved Norvasc and some were Counterfeit Norvasc.

The Pharmacy records revealed that Mr. Nasr was the dispensing pharmacist with respect to the drug products dispensed as Norvasc to these two patients. As well, Mr. Nasr had purchased the drug products dispensed as Norvasc to these patients and others by the Pharmacy.

Subsequent to the search in June 2005, the RCMP contacted other patients who had filled prescriptions for Norvasc at the Pharmacy. These patients provided samples of the medications that had been dispensed to them by the Pharmacy as Norvasc, and these products were analyzed by Pfizer or the RCMP Forensic Laboratory Services. Of 61 samples of Norvasc dispensed by the Pharmacy, 8 samples contained Norvasc approved for sale in Canada, 9 samples contained Unapproved Norvasc, 32 samples contained Counterfeit Norvasc, and 12 samples contained a mixture of Norvasc approved for sale in Canada and either Counterfeit or Unapproved Norvasc.

INTERIM RESTRICTIONS

The College completed its investigation on an expedited basis within one week of the search of the Pharmacy in June 2005. Mr. Nasr was advised that the Executive Committee intended to make an interim order suspending or imposing terms, conditions or limitations on his certificate of registration. Mr. Nasr agreed to voluntary terms, conditions or limitations on his certificate of registration in June 2005 prohibiting him from owning or managing any pharmacy, acting as narcotic signer, or having any involvement with the purchase or acquisition of any drugs for any pharmacy until the allegations of professional misconduct had been heard and decided by the Discipline Committee.

The Coroner’s Office reviewed the deaths of 11 patients who had died in 2005, to whom Norvasc may have been dispensed by the Pharmacy. Of the 11 deaths, the Coroner determined that Counterfeit or Unapproved Norvasc could not have played any role in 7 cases. The evidence with respect to the other 4 cases was inconclusive and the manner of death was noted as “undetermined”, with the medical cause of death as “possible unauthorized medication substitution”.

Mr. Nasr stated that he did not knowingly purchase or dispense any Counterfeit or Unapproved Norvasc. He stated that he purchased what he thought was legitimate Norvasc from a Mr. Ali Hussein who identified himself as a wholesaler from Vancouver (no other information about Mr. Hussein has been provided). According to Mr. Nasr, Mr. Hussein claimed that he was able to purchase these medications at a lower cost than other wholesalers because of the high volume of Norvasc he purchased from Pfizer. Mr. Hussein offered to sell the products to Mr. Nasr at a 5% discount compared to what other wholesalers would charge. Mr. Nasr stated that he purchased a total of 10 bottles of the Norvasc products between January 2005 and June 2005. Mr. Nasr also stated that he noticed the different appearance of the products in question but he assumed the changes had been made by Pfizer. He also stated that the bottles were appropriately sealed and bore the usual and ordinary manufacturer’s label and product information identifying it as manufactured by Pfizer for sale in Canada.

ADDITIONAL PRACTICE ISSUES

The College’s investigation continued after the initial search of the Pharmacy. The review of Pharmacy records and drug products seized from the Pharmacy revealed other problems in Mr. Nasr’s practice and in the operation of the Pharmacy.

Unapproved Risperdal

Several samples of Risperdal, a Schedule F prescription drug, were found in the dispensary area in the Pharmacy. The manufacturer, Janssen-Ortho, analyzed the samples and advised that they were approved for distribution in Egypt but not in Canada.

Mr. Nasr explained that the Risperdal was a medication prescribed for his father and purchased in Egypt. It was left at the Pharmacy by his father, and was not for sale at the Pharmacy.

Misidentified or Inadequately Identified Drugs

The College investigators identified a substantial number of discrepancies in the labeling of drugs in the inventory of drug product at the Pharmacy and in prescriptions which had not yet been dispensed to patients.

For instance, some stock bottles of drug products (and some prescriptions waiting to be picked up by patients) contained both the generic drug product from the manufacturer on the label, and equivalent generic drug products produced by other manufacturers.

Some drug products in the Pharmacy inventory were identified by hand written labels on prescription-type vials. In a number of cases, the information written on the label was incomplete and did not include the lot number for the drug product, the expiry date or the strength of the medication.

In other cases, the drug products were not adequately labeled and could not be identified in the Compendium of Pharmaceuticals and Specialties.

The College investigators also reviewed the records of various dispensing transactions against the claims submitted to insurers for those transactions. In many cases, the generic drug product identified in the claim to the insurers did not correspond to the generic drug that was actually dispensed to the patients. Handwritten notations on the hard copy receipts ostensibly identified the generic drug product that was actually dispensed to the patients. Although there was no financial advantage to submitting a claim for a different drug product than the product actually dispensed, the result was claim records that did not accurately reflect the drug products actually dispensed to the patients.

Mr. Nasr acknowledged that this practice of mixing (and dispensing mixed) generic drug products was improper.

Narcotic Discrepancies

The College investigators audited 300 narcotic prescriptions from the period May-June 2005, and identified various discrepancies in over a dozen cases. These discrepancies included a dispensing error, directions for use recorded on the label not matching the directions for use issued by the prescriber, no written authorization for the narcotic was available in the Pharmacy records, or the total quantity recorded as authorized exceeded the amount authorized by the prescriber. Mr. Nasr was the dispensing pharmacist with respect to these transactions.

Other Labeling Errors

Labels on bronchodilators and multi-medication compliance aids dispensed by the Pharmacy did not include certain required information, and the prescription labels used in a number of dispensing transactions in May 2005 incorrectly identified the owner of the Pharmacy as the former owner rather than the corporation owned by Mr. Nasr and his father. Mr. Nasr acknowledged these errors and explained that he had briefly utilized old prescription labels left behind by the prior owner.

Failing to Keep Records

The College investigators noted that the Pharmacy records removed from the Pharmacy in the course of the investigation were incomplete. The records for the period January-February 2005 were missing from the Pharmacy. As well, there were no records at the Pharmacy for any non-narcotic transactions prior to November 2004.

Subsequently, Mr. Nasr explained that he had in his car the Pharmacy records for the period January-February 2005, because he planned to take them home for storage due to the shortage of space at the Pharmacy. The non-narcotic records for the period prior to November 2004 were stored at home. Mr. Nasr provided the missing records to the College for all of the period from the date he purchased the Pharmacy in August 2004 to the start of the investigation in June 2005.

Failure to Maintain Confidentiality

The College investigators noted during the search of the Pharmacy that over 300 confidential patient records (prescription labels, receipts, authorization requests and medication records) were found in garbage bags or in a garbage bin behind the Pharmacy. The records should have been shredded before being discarded in garbage bags and in the garbage bin behind the Pharmacy.

CRIMINAL CHARGES

The RCMP laid various criminal charges against Mr. Nasr for fraud related offences involving the possession and sale in Canada of Unapproved or Counterfeit Norvasc. To obtain a conviction, the Crown was required to prove beyond a reasonable doubt that Mr. Nasr not only had in his possession and sold Unapproved or Counterfeit Norvasc (which was not disputed) but that he also knew the Norvasc was unapproved or counterfeit, or he was willfully blind to that fact. In a criminal proceeding, the Crown could establish willful blindness on the part of Mr. Nasr only if his failure to inquire into the true state of affairs was motivated by a desire to avoid discovering that the Norvasc was Unapproved or Counterfeit.

At the end of the criminal trial, the judge concluded that the Crown had not demonstrated beyond a reasonable doubt that Mr. Nasr actually knew that he had acquired and was selling Counterfeit or Unapproved Norvasc. Nor was the judge satisfied that Mr. Nasr had been willfully blind to the status of the Norvasc product in the criminal sense that he avoided gaining that knowledge because he knew that if he made any inquiries he was certain to discover that the Norvasc was Counterfeit or Unapproved.

As a result, the judge acquitted Mr. Nasr of all of the criminal charges. However, the judge offered the assessment that Mr. Nasr was “at the very least negligent,” and noted that this matter would be adjudicated before another tribunal (i.e., the College’s Discipline Committee).

Acknowledgement of Professional Misconduct

Mr. Nasr acknowledges that his conduct in relation to the purchase and dispensing of the Counterfeit and Unapproved Norvasc displayed a serious and substantial departure from the standard of care expected of a professional pharmacist. He acknowledges that Norvasc is a drug product used to treat life threatening blood pressure and heart conditions and that a patient's health could be put at extreme risk if the patient was dispensed a drug product that was not Norvasc as prescribed by the physician and approved for sale in Canada.

Mr. Nasr acknowledges that he was exceedingly careless when he purchased drugs from Mr. Hussein without making any inquiries to ascertain whether Mr. Hussein was a reputable wholesaler. Furthermore, Mr. Nasr acknowledges that he should have been professionally skeptical about Mr. Hussein's status and his claims that he could provide Norvasc drug product at a discount not available from any other source. Moreover, Mr. Nasr recognizes his conduct amounted to a significant departure from the standard of care expected of a professional pharmacist when, having noticed the different physical appearance and characteristics of the drugs products sold to him as Norvasc, he failed to check with Pfizer prior to dispensing the drug product to patients of the Pharmacy.

Finally, Mr. Nasr acknowledges that by behaving as imprudently as he did regarding the purchase of drugs from Mr. Hussein, he failed to implement a drug purchasing system for his Pharmacy to ensure that all medications purchased for dispensing and sale to patients were acceptable standard and quality.

Mr. Nasr also acknowledges that he was responsible for the other problems in the Pharmacy, either as dispensing pharmacist, or as designated manager and owner of the Pharmacy, and that he:

· failed to maintain the standards of practice of the profession,
· failed to keep records as required,
· signed or issued in his professional capacity, documents that he knew contained false or misleading statements,
· submitted accounts or charges for service that he knew were false or misleading,
· contravened the Drug and Pharmacies Regulation Act, and the Regulations thereunder,
· contravened the Food and Drugs Act and the Food and Drug Regulations,
· engaged in conduct or performed acts relevant to the practice of pharmacy that, having regard to all the circumstances, would reasonably be regarded by members of the profession as disgraceful, dishonourable or unprofessional.

Reasons for Penalty

The most serious misconduct in this case, due to the significant threat of harm to the public, involved the sale and dispensing of Unapproved and Counterfeit Norvasc, a calcium channel blocker medication used to treat high blood pressure and chest pain. This occurred as a result of Mr. Nasr failing to discharge due diligence in the purchase of the drug, which was described as an act of extreme carelessness and a significant departure from expected standards of care.

The panel applauded the College in acting so quickly in this case, thus minimizing the risk of harm to the public.

The panel did not accept Mr. Nasr’s youth and inexperience as mitigating factors in this case, since Mr. Nasr had passed the College’s rigourous licensing requirements. Rather, the panel believed that Mr. Nasr’s misconduct flowed from him acting as a business owner focused on profits, rather than acting as a healthcare professional.

The panel also rejected the argument that the fact that drug wholesalers are not regulated by the College justified or explained Mr. Nasr having Counterfeit and Unapproved Norvasc in his Pharmacy. The panel affirmed that it is the pharmacist’s duty to be prudent and exercise due diligence when purchasing inventory. Mr. Nasr showed no such diligence, and failed to implement a drug purchasing system for his Pharmacy to ensure that all medications purchased for dispensing and sale to patients were of acceptable standards and quality. The panel found this omission to be unacceptable.

The panel also found unacceptable the other practice issues identified by the College’s investigation. For instance, Mr. Nasr’s mingling of different brand and generic medications in one stock bottle would make it impossible, for example, to implement a drug recall or warning for any of the prescription drug products. The panel found the depth and scope of the practice issues to be appalling, especially considering that Mr. Nasr had owned the Pharmacy only from August 2004 to August 2005.

In all of the circumstances, and considering the fact that there was no evidence that Mr. Nasr had breached s.150 of the Drug and Pharmacies Regulation Act (“No person shall knowingly sell any drug under the representation or pretence that it is a particular drug that it is not.”), the panel accepted the Joint Submission on Penalty presented by the parties. While noting that a harsher penalty might have been considered, the panel was satisfied that the proposed penalty would protect the public interest, act as a deterrent to other members of the profession, and lead to the rehabilitation of Mr. Nasr.

Two members of the panel wrote a dissenting opinion. This dissent focused on the potential consequences of Mr. Nasr’s actions, specifically to the health and safety of the public, and on the breadth, depth and scope of practice issues revealed by the investigation. Regardless of the lack of proof of intentional wrongdoing by Mr. Nasr, the dissenting members of the panel were of the opinion that Mr. Nasr did not have the potential for rehabilitation, and that revocation of Mr. Nasr’s membership in the College would be the appropriate penalty.

Order

· Mr. Nasr to appear before the panel to be reprimanded at a date to be determined.
· A suspension of Mr. Nasr’s Certificate of Registration for a period of twelve months, with two months of the suspension to be remitted on condition that he complete the remediation coursework described below.
· A restriction prohibiting Mr. Nasr, for a period totaling five years from acting as designated manager or narcotic signer in any pharmacy; or from having any proprietary interest in any pharmacy, as a sole proprietor, partner, director or shareholder in a corporation with a proprietary interest in any pharmacy, or in any other capacity; or from working at or being employed by any pharmacy in which a family member has any such direct or indirect proprietary interest.
· Specified terms, conditions and limitations on Mr. Nasr’s certificate of registration, requiring him to complete successfully, at his own expense, within twelve months of the date of this Order, the following courses and evaluations:
o the Basic Professional Practice Labs, Advanced Professional Practice Labs, Law Lesson #2 (The Regulation of Pharmacy Practice), Law Lesson #4 (Standards of Practice) and Law Lesson #7 (Professional Liability), all from the Canadian Pharmacy Skills Program offered through the Leslie Dan Faculty of Pharmacy at the University of Toronto; and
o the Jurisprudence seminar and evaluation offered by the College; and
· Costs to the College in the amount of $12,500.

Reprimand

The following reprimand was delivered on January 16, 2008:

The panel stated that the member’s misconduct had been seriously debated by the members of the panel. Three of the members of the five person panel voted to accept the Joint Submission on Penalty, but did so with reservations. The other two members of the panel could not put their reservations aside; they voted against accepting the Joint Submission, and felt that revocation was the only just penalty in this case.

The panel stated that it was appalled during the hearing at the magnitude of the member’s misconduct, particularly given that he had so recently been licensed in this province as a pharmacist. His claim to have had no knowledge of the counterfeit nature of his Norvasc supply seemed either untrue or unsurprising since he made no effort to validate the source of supply. Unfortunately, he was not subject to cross-examination on this point and never tested on his knowledge. Accordingly, the panel could not draw any conclusion one way or the other. The panel did know, however, that as a pharmacist the member was responsible for ensuring the safety of the drug supply. The panel saw no evidence that he made any effort to safeguard the supply of this drug to his patients. Given the seriousness of the illness of the patients using Norvasc, a heightened level of due diligence was warranted. However, no indication of any level of due diligence was provided to the panel. The panel could only infer that the member did nothing in this regard. This is misconduct at the most basic level and shows a blatant disregard for his patients’ welfare.

Unfortunately, the "Norvasc" situation was not the only source of professional misconduct. Breaches of patient confidentiality, mislabelled drugs, mixtures of generic manufacturers, billing issues, unapproved Risperdal in the pharmacy, expired product on the shelves, and record keeping discrepancies were other examples of professional misconduct in this case. Those alone would have resulted in severe disciplinary action against the member. Again, the magnitude of misconduct causes alarm for the panel.

The effectiveness of the proposed remediation in the penalty order depends entirely on the member. The panel hoped that the courses, seminars and evaluations ordered will enable him to correct his practice and become a productive member of the profession. His misconduct has resulted in a loss of faith by the College in him, but most significantly, by the public in the profession of pharmacy. His actions were a disgrace. If the public doesn't trust members of the College and the safety of the drug supply chain, the profession will cease to be effective in the health care system. The member, and all other members, must separate the commercial and professional facets of their practices. The member, in the panel’s view, acted in his interest over that of his patients. The protection of the public must be paramount. The member forgot that or chose to disregard it. There will be no second chances. The panel expects that the member will not repeat the obvious failings brought out in this case again.