PDA amendments and mail order pharmacies
April 21, 2009
Changes, effective April 1, 2009, addressed in the amendments include when a mail order licence is required, licensing requirements, and records that must be maintained,
We strongly encourage you to carefully review the amended legislation. What follows is a brief introduction to mail order pharmacy definitions, exemptions, and record keeping requirements.
Licensees and proprietors - Please consider the specific changes outlined in the summary prior to renewal of your pharmacy licence for the 2009-2010 year.
Mail Order Pharmacy definitions and requirements
Mail order pharmacy and mail order pharmacy service are now defined in the Pharmacy and Drug Act:
1(1)(n.1) A "mail order pharmacy" means a community pharmacy with respect to which a mail order pharmacy license has been issued;
1(1)(n.2) A "mail order pharmacy service" means a pharmacy service provided to or for a patient for which neither the patient nor the patient’s agent attends at the community pharmacy to receive the service.
If a pharmacy is going to offer a mail order pharmacy service, it must hold both a community licence and a mail order licence (subject to limited exceptions).
Exemptions from Mail Order Pharmacy licences
Based on the definitions, if you have patients to whom you provide services who do not come to your pharmacy or have a family member or care giver who comes to your pharmacy, you must have a mail order license. There are some exemptions from this requirement that are outlined in the amended regulation to the PDA (Section 6.1).
You do not require a mail order pharmacy licence if:
(a) the patient or patient’s agent regularly attends the community pharmacy to receive pharmacy services, but is unable to do so on a particular occasion because of a circumstance or condition affecting the patient like illness or travel or work away from the location of the community pharmacy;
(b) a clinical pharmacist or other pharmacist authorized under the Pharmacists Profession Regulation (AR 129/2006) regularly attends personally on the patient to assess the patient and monitor the patient’s response to drug therapy;
(c) there is
(i) a general health emergency or crisis, recognized by resolution of the council of the College,
(ii) a state of public emergency declared under the Public Health Act, or
(iii) a local state of public health emergency declared under the Public Health Act, that makes it unsafe or inadvisable for patients to attend the community pharmacy
Understanding Exemption (b)
If you provide pharmacy services to a nursing home, group home or other institution where the patients do not come to the pharmacy, you will require a mail order license unless there is a clinical pharmacist who visits the institution to monitor the patient’s response to drug therapy. The pharmacist(s) can be employed by your pharmacy, but they do not have to be. If the institution contracts a pharmacist to visit the institution to provide clinical services, you likely will not require a mail order licence to dispense drugs to the institution.1 If you provide pharmacy services to patients who cannot leave their homes and the patients do not have agents who visit the pharmacy, you will require a mail order licence unless you or another clinical pharmacist visits these patients to monitor their response to drug therapy.
1Please note: This does not replace the responsibilities of the dispensing pharmacist as outlined in the Standards for Pharmacist Practice.
Record keeping requirements for Mail Order Pharmacies
When patients do not attend a pharmacy in person, it is more difficult for pharmacists to assess patients and ensure appropriateness of drug therapy. For this reason, a specific reference to mail order pharmacies is included in Section 12.1(h) of the PDA Regulation with regard to records. This section specifies that, in addition to the records that must be kept in a community pharmacy, a mail order pharmacy is also required to keep the following records:
(i) policies and procedures regarding how information is collected in order to assess individual patients and to obtain all the information necessary to allow the pharmacist to ensure the appropriateness of drug therapy for the patient, and
(ii) records that identify any arrangement or agreement under which patients are referred to the mail order pharmacy in order for the pharmacy to provide mail order pharmacy services to or for the patient.
Amended Pharmacy and Drug Regulation
Originally published in the April 21, 2009, issue of The Link