Ontario College of Pharmacists Unanimously Approves Regulatory Proposals for
Remote Dispensing

TORONTO, June 7 /CNW/ - At its meeting today, the Council of the Ontario College of Pharmacists (OCP) unanimously approved regulatory proposals that will permit authorized Ontario pharmacies to dispense certain drugs through remote dispensing locations.

"These proposals are the result of extensive study and consultation. Our Council supports remote dispensing as a means to improve access to prescriptions and prescription services for Ontarians who would otherwise have limited or no access to such services.  We also want to make sure that the appropriate safeguards and accountabilities are in place to protect the public," said OCP President Stephen Clement.

The College's regulatory proposals are guided by five principles which reflect the College's public protection mandate.

1. accountability must be clear and assured: remote dispensing will be offered through authorized, accredited Ontario pharmacies where all rules, requirements, and standards apply
2. remote dispensing must enable the pharmacist's role in providing patient care through medication therapy management
3. public safety and security must be assured
4. patient privacy and confidentiality must be preserved at all times
5. regulations must protect against drug diversion and sub-standard products

The next phase in the development process for these regulatory proposals is consultation with pharmacists, pharmacy stakeholders and other interested parties. The proposals will now be available for comment, and all feedback received will be considered prior to final ratification of draft regulations, expected to occur at the next meeting of College Council in September. Once ratified, these proposals will be forwarded to Ontario's Ministry of Health and Long Term Care for approval.

"Since the passage of Bill 179 in December 2009 which enabled remote dispensing, the College has worked to bring forward, in a timely fashion, rational rules that ensure all aspects of remote dispensing occur in a manner that assures public safety and maintains Ontario's safe drug distribution system," said Deanna Williams,  OCP Registrar.

The complete draft regulations can be found on OCP's website at www.ocpinfo.com

REMOTE DISPENSING

Backgrounder

In December, 2009, the Ontario government passed Bill 179. Along with giving effect to legislation promoting inter-professional collaboration and enhanced scopes of practice for many health professionals, Bill 179 also gave authority to the Ontario College of Pharmacists (OCP) to develop regulations to the Drug and Pharmacies Regulation Act (DPRA) to enable remote dispensing.

OCP has been working to incorporate the safeguards and accountabilities necessary for remote dispensing into every relevant section of the regulation that deals with dispensing in accredited pharmacies under the DPRA. This process has been an extremely complex and comprehensive one in which the College has been steadfast in its goal: to bring forward, in a timely fashion, rational rules which enable remote dispensing in a manner that ensures public safety and maintains Ontario's safe and effective drug distribution system. 

In fact, developing the regulations for remote dispensing has been an extensive process that began as early as 2008 at the request of the Ministry of Health and Long-Term Care.  The College consulted with jurisdictions across Canada and internationally and conducted focus grups of pharmacists, vendors and other stakeholders before developing principles and practices that align with its mandate of protecting the public. Once the principles were developed, the College also consulted and held regional meetings in the fall of 2009 to gather input and feedback before ratifying the principles at the December 2009 meeting of the OCP Council. These principles form the basis of the regulatory proposals to enable remote dispensing.

The College Council supports embracing innovation and technology as a means to increasing access to prescriptions and prescription services for Ontarians. Enabling remote dispensing is one way that access can be improved using interesting new technology provided that the necessary safeguards and accountabilities are in place to ensure public safety and protection.

OCP drafted the regulations according to five key principles:

1. accountability is assured when remote dispensing occurs through authorized, accredited Ontario pharmacies  and all rules, requirements, laws, and standards apply;
2. remote dispensing must enable the pharmacist's role in providing patient care through medication therapy management;
3. safety and security must be assured;
4. patient privacy and confidentiality must be preserved at all times; and
5. remote dispensing must protect against drug diversion/sub-standard products.

Remote Dispensing Models

There are currently two different models of remote dispensing. One, for example, already in use in remote areas of British Columbia, involves prescriptions being dispensed at a physical location away from the accredited pharmacy which operates it. Another, being piloted through a few Ontario hospitals, involves the dispensing of drugs to patients through automated dispensing machines.

In both models, all aspects of dispensing are observed and overseen by a pharmacist located in the pharmacy that is authorized and accountable for operating that remote dispensing location. Through two-way video technology, the pharmacist must be satisfied that it is appropriate to dispense the drug(s) and that the correct drug(s) have been dispensed before he/she directs the pharmacy technician or the machine to release the dispensed drug(s) to the patient.

While the actual dispensing from remote locations may appear to happen in new or different ways, the key principles and safeguards that ensure public safety and accountability for dispensing from all Ontario pharmacies are upheld. Remote dispensing locations will be located in safe and secure environments appropriate to the delivery of health care services. Before releasing any drug through a dispensing machine, the original prescription must be in hand at the dispensing pharmacy, or given to the pharmacist/pharmacy technician verbally or by fax/scan directly from the prescriber. In a remote dispensing location where a registered pharmacy technician will be dispensing under the remote supervision of a pharmacist, patients will still be able to bring in the original prescription(s) or the prescription(s) may be provided verbally, by fax, scan or other electronic means directly from the prescriber. This long standing legal requirement - which is the standard across Canada - ensures authenticity and eliminates the risk for drug abuse, misuse or diversion.

Public Protection and Accountability

In keeping with its mandate for public protection, the College investigates all public complaints respecting the practice of pharmacy in Ontario. All pharmacists and pharmacy technicians, as well as pharmacy owners and operators and designated managers are held accountable to the College for all aspects of purchasing, storing, selling, compounding and dispensing drugs. Accordingly, the College requires clear lines of accountability through the certificates of accreditation that are issued to permit the operation of pharmacies in Ontario.

Accountability is another key principle that cannot be compromised with respect to remote dispensing which is why only a pharmacy authorized through its certificate of accreditation to operate a specific remote dispensing location (or locations) may operate such location(s). If a patient has a prescription filled at any remote dispensing location, including a machine, it must be clear to both that patient and the College where the prescriptions have actually been filled; that the labeling reflects the same and that the phone number provided for follow up connects the patient to the actual dispensing pharmacy. If there is a need to investigate a complaint, the College must be clear on all lines of accountability including ownership, purchasing and stocking of quality inventory, labeling and record keeping, and for ensuring all standards of practice for both cognitive and technical aspects of the dispensing process have been met.

Also within the context of safety, to eliminate the risk of theft, robbery and drug diversion, no narcotic or controlled substances, and no targeted substances will be permitted to be kept in or dispensed from any remote dispensing location.

Next Steps

Now that Council has approved these proposed regulations, they will be circulated for consultation and feedback to all members, pharmacy stakeholders and other interested parties. All feedback will be considered prior to final ratification, expected to occur at the College's September Council meeting. Once ratified, these proposals would then be sent to Ontario's Ministry of Health and Long Term Care for approval.

For further information:

Anjali Baichwal
OCP Communications Advisor
T: 416-847-8294 or toll-free 1-800-220-1921 ext 2294
[email protected]