Accreditation Standards for the Release of Information to Third Parties and Guidelines to those Standards
(Council Approved, Pending Ontario Government Regulation)

At the May 1996 Council meeting, Council directed the Professional Practice Committee to develop guidelines respecting the provision of prescription data to third parties. The Committee proposed these standards in order to ensure that all key pharmacy personnel are informed as to what prescription information is being released, to whom, and what its intended use will be. The guidelines have been proposed for use as a tool by members when considering entering into an agreement with a third party for the release of prescription information.

The standards were presented to September 1996 Council for approval in principle as a Standards for Accreditation under the Drug and Pharmacies Regulation Act. At the February 1997 Council meeting, the Professional Practice Committee recommended to Council that it approve the following AAccreditation Standards for the Release of Information to third Parties. In addition, Council approved the guidelines to those standards. Members are invited to submit comments on these proposed standards in writing to Mr. James Gay, Manager, Pharmacy Practice Programs, by June 30, 1997.

STANDARDS RELATING TO USE OF PRESCRIPTION INFORMATION
(For inclusion in standards for accreditation under the Drug and Pharmacies Regulation Act)

(1) In this section,

"Designated Manager" means the pharmacist identified by the operator of a pharmacy, in information provided to the College, as the pharmacist responsible for managing the pharmacy;

"operator" means an individual or corporation who holds the certificate of accreditation of a pharmacy; and

"prescription information" means information recorded in a pharmacy that relates to the prescribing and dispensing of drugs pursuant to prescriptions, and includes the names of prescriber and other information relating to them.

(2) For the purposes of releasing prescription information, at no time shall the name of the patient be released without the patient=s knowledge and consent. This includes any information that may identify the patient in the absence of a name.

"provider" means provider of computer software.

(3) It is a standard for the accreditation of a pharmacy that the operator comply with this section.
(4) Prescription information shall not be disclosed, provided or sold to any third party without the prior knowledge and written agreement of the operator and the Designated Manager (where the Designated Manager is not the operator of the pharmacy/holder of the Certificate of Accreditation).

(5) Any agreement with a provider of computer software that is used in connection with prescription information shall contain the following provisions:

1. The provider will give written notice to the operator who in turn will inform the Designated Manager whether use of the software will result in prescription information being disclosed, provided or sold to any third party and, if so, the nature of the information, to whom it is being provided and its intended use.

2. The provider will give the operator and the Designated Manager at least sixty days notice in writing of any changes in the information referred to in clause 1.

3. The changes will not take effect without the prior written agreement of the operator and the Designated Manager (where the Designated Manager is not the operator of the pharmacy/holder of the Certificate of Accreditation).

4. The agreement must contain provisions for changes in ownership and/or management of the operator.

5. If the operator and the Designated Manger do not agree to the changes, the provider may not terminate the agreement.

6. A copy of the agreement must be made available to the Designated Manager.

(6) Where an agreement with a provider of computer software exists on the day this section comes into force, the pharmacy operator shall use reasonable efforts to have the provisions in subsection (4) included in the agreement and any renewal or extension of the agreement as soon as possible.

(7) Every pharmacist practising in the pharmacy, and every patient or prescriber, shall be informed, on request, whether prescription information relating to patients or prescribers has been or will be disclosed, provided or sold to any third party and, if so, the nature of the information and the identity of the party receiving the information.

Pharmacy Connection May/June 1997


GUIDELINES RELATED TO USE OF PRESCRIPTION INFORMATION

1. The operator of a pharmacy is ultimately responsible for the pharmacy. This responsibility includes protecting the confidentiality of patient information. It also includes responsibility for decisions about the use of prescription information from which patient identifiers have been removed. Factors influencing this decision should include:

~ what information is being taken from their system,
~ what information is being released,
~ what is the intended use for the released information.

2. In making decisions about selling, sharing or providing such prescription information to third parties (such as data collection companies), the operator shall consider the intended use of the information and whether that use will benefit the public.

The college considers that appropriate uses of information would include the following:

~ drug utilization review,
~ research,
~ identifier of inappropriate prescribing,
~ reduction of abuse of drugs by patients and prescribers,
~ feedback of data to doctors and pharmacists.

3. The operator must ensure that agreements and arrangements involving the sale, sharing or provision of prescription information are made known to the Designated Manager and are available to all pharmacists working in the pharmacy.

Pharmacy Connection May/June 1997