Why Bill 117 is needed

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The recent Ontario election meant that much legislation died on the table; but we can expect some bills to resurface. Bill 117, which would significantly impact pharmacies in hospital settings, is one of them. Bill 117 – the Enhancing Patient Care and Pharmacy Safety Act – would remove an existing loophole for pharmacies in hospital settings, and bring them under the Ontario College of Pharmacists (OCP). The OCP and a number of hospitals have already expressed support for these amendments.

In March 2013, it was determined that 1,200 patients had received an incorrect mixture, effectively a case of under-dosing, of two chemotherapy drugs. The admixing of these drugs had been performed by a third-party supplier. The drugs were delivered to four Ontario hospitals and one New Brunswick hospital where they were administered to patients. It should be noted that while these hospitals did not do the admixing in their hospital pharmacy, many hospitals do perform this task.

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In the subsequent inquiry, it became apparent that pharmacies located in hospital settings were not regulated in the same manner as those located outside of hospitals. Also, the off-site locations where drugs were being compounded were not regulated with sufficient scrutiny.

The OCP is the regulator of Ontario pharmacists, pharmacy technicians and pharmacies, and its job is to protect the public. In this particular case, the admixing was not done by pharmacies in the hospitals, so no one was faulting personnel and pharmacists at those hospitals. But the gap or loophole in the regulatory landscape had to be addressed.

Bill 117 was introduced last October. It incorporated several of the recommendations made in the inquiry, and would have resulted in major changes to how hospital pharmacies are monitored. The Bill would have amended the Drug and Pharmacies Regulation Act (DPRA), which involves the accreditation of pharmacies.

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For example, as far as drug compounding is concerned, the definition of ‘pharmacy’ would have included “primary locations”. These are the off-site locations where drugs are can be compounded, dispensed or supplied. This then would have included the source of the manufacturer who admixed the chemotherapy drugs in question.

Also, as per the amendments, the OCP would license all pharmacies operating within Ontario’s clinics or hospitals. This means that such pharmacies would require a certificate of accreditation from the OCP before it can operate in a hospital. A certificate of accreditation would only be issued if the pharmacy complies with the requirements of the DPRA. These requirements include proper signage and labelling, necessary equipment, and adhering to proper storage. Thus, the OCP would have all of its regulatory powers over these pharmacies. Currently, the DPRA does not apply to hospitals.

And the amendments did even more. The OCP would be able to inspect all these pharmacies annually. All documents and objects would be open to inspection, the inspector would have authority to copy any documents under examination, and most importantly, no one would be able to obstruct an inspector. This means that all relevant information would be available to the OCP.

In addition, the amendments looked at penalties. The OCP would be able to impose a penalty on pharmacists and pharmacy technicians who do not comply with the amendments. Further, pharmacists whose certificates of registration have been revoked or suspended by the OCP (for the period of suspension), could not be employed in pharmacies, and accreditations could be revoked.

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Right now, pharmacies (outside of hospitals) must be accredited by the OCP. Accreditation includes inspection to ensure that the pharmacy meets all provincial and federal laws. If it’s determined that a pharmacy is placing the public at risk, the OCP may apply to a judge of the Superior Court of Justice for an order to immediately revoke or suspend the pharmacy’s certificate of accreditation.

What about a pharmacy owned by a non-pharmacist which places the public at risk? The OCP would be able to seek an injunction against the owner, and order them to comply with the amendments.

These amendments would have been far-reaching in scope. Every owner or designated manager of a pharmacy would be liable under the DPRA for every offence committed by any individual in the employ of, or under the supervision of, the owner or designated manager. However, directors of hospital boards would not be liable for violations of the DPRA. This was likely in recognition of the difficulty for volunteer board members to regulate the pharmacies, and an assumption that hospital employment would ensure that such matters are adhered to.

 

Pharmacies, whether in a hospital setting or not, perform valuable services to the people of Ontario. The amendments in Bill 117 recognize that and add to the protection of the public. It is hoped that these amendments, or a form of them, will be re-introduced by the Ontario Government.