DPRA

• DPRA


  Describes and regulates several aspects of the operation of pharmacies and the dispensing of drugs in an environment that is safe for patients. Defines who in Ontario may prescribe, sell, advertise, and dispense drugs.
• DPRA


  Defines: pharmacist, pharmacy, drug, prescription, prescriber, etc.
• Pharmacy


  • All pharmacies - community and hospital - require to obtain the Certificate of Accreditation from OCP, renewed annually
  • Community Pharmacy Ownership: majority of directors must be pharmacists
  • Pharmacist must be physically present in the pharmacy at all times
  • Managed by a manager designated by the owner
  • Manager is required to display his/her license
• Pharmacy Designations


  • Drug store
  • Pharmacien détaillant
  • Pharmacy
  • Pharmacie
  • Drug department
  • Service de pharmacie
  • Drug sundries
  • Remèdes divers
  • Drug or Drugs
  • Médicaments
  • Drug mart
  • Comptoir de médicaments
  • Medicines
  • Remèdes
• Opening a New Pharmacy

  1. Inform the OCP in writing (letter of intent) a minimum of 45 days before planned opening

  2. Completion of application forms including trading name, ownership, designated manager and narcotic signer(s)

  3. Payment of fee

  4. Inspection (on proposed opening date)

  5. If all is well, Inspector informs OCP, relays U&C fee

  6. Issuance of Accreditation # and ODB Billing code
• Closing a Pharmacy


  1. Closing - inform the OCP within 7 days

  2. Must remove all signs and symbols relating to the pharmacy

  3. Owner has 30 days upon closing to inform the OCP in writing: the whereabouts of the drugs including narcotic and controlled substances, the whereabouts of the prescription records
• Purchasing a Pharmacy

  1. Acquiring an existing pharmacy in Ontario is equivalent to opening a new pharmacy and requires issuance of a new certificate of accreditation

  2. The purchaser contacts the OCP to initiate the process - not the person who is selling

  3. Minimum of 30 days notice or as indicated in the OCP by-laws

  4. Completion of forms as per new opening, date of ownership required, owners, DM, N Signers, etc

  5. Inspection to occur but not on the exact date of new ownership
• Pharmacy


  • Minimum floor space - 200 square feet
  • Free from conditions that pose any danger
  • Lockers/separate staff area
  • Designed to ensure all areas can be cleaned adequately; clean and sanitary condition (all furniture, equipment, all rooms, painting, floor, ceiling, décor)
  • Suitable lighting
  • Poison storage
  • Washing and toilet facilities
  • Hot and cold water
  • Washing facilities for utensils in dispensing area
  • Separate staff hand washing facilities
  • Filing system, acceptable pharmacy software programs, labels
  • Minimum 12 sq ft clear working area in pharmacy
  • Refrigerator exclusive to store drugs (temperature 2°C - 8°C (clean/sanitary; no public access, no food)
  • Containers: bottles, vials, jars, etc
  • Compounding / dispensing equipment; distilled water
  • Current library
  • Waste & refuse to be removed regularly
• Drug


  Any substance or preparation containing any substance, (a) manufactured, sold or represented for use in, (i) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state or the symptoms thereof, in humans, animals or fowl, or (ii) restoring, correcting or modifying functions in humans, animals or fowl, (b) referred to in Schedule I, II or III, (c) listed in a publication named by the regulations, or (d) named in the regulations
• Dispensing of Drugs


  Only by: (a) a pharmacist, (b) an intern acting under the supervision of a pharmacist who is physically present, (c) a student who is in the course of fulfilling the educational requirements to become a member of the College acting under the supervision of a pharmacist who is physically present, or (d) a pharmacy technician or an intern technician acting under the supervision of a pharmacist who is physically present
• Prescription Information


  Every person who dispenses a prescription drug shall ensure that the following is recorded on the prescription: (a) the name and address of the person for whom the drug is prescribed, (b) the name, strength (where applicable) and quantity of the prescribed drug, (c) the directions for use, as prescribed, (d) the name and address of the prescriber, (e) the identity of the manufacturer of the drug dispensed, (f) an identification number or other designation, (g) the signature of the person dispensing the drug and, where different, also the signature of the person receiving a verbal prescription, (h) the date on which the drug is dispensed, (i) the price charged
• Retention of Records


  The records required shall be retained for not less than ten years
• Identification Markings


  The container in which the drug is dispensed shall be marked with: (a) the identification number that is on the prescription, (b) the name, address and telephone number of the pharmacy in which the prescription is dispensed, (c) the identification of the drug as to its name, its strength and its manufacturer, unless directed otherwise by the prescriber, (d) the quantity where the drug dispensed is in solid oral dosage form, (e) the name of the owner of the pharmacy, (f) the date the prescription is dispensed, (g) the name of the prescriber, (h) the name of the person for whom it is prescribed, (i) the directions for use as prescribed
• Out-of-province Rx may be filled, refills are acceptable
• Out-of-country Rx is not valid and must not be dispensed
• "Piggybacking" - adding new repeats to a prescription on file that still has remaining repeats is not allowed. A new Rx must be generated. The old remaining repeats are invalid and must be erased.
• Who May Prescribe


  • Physicians (MD)
  • Dentists (DDS)
  • Nurse Practitioners (RN(EC)) (list of items)
  • Midwives (list of items)
  • Chiropodists (DC) and Podiatrists (DPM) (list of items)
  • Optometrist (list of items)
  • Pharmacists (refer to scope of practice)
  • Naturopathic Doctors (list of items)
  • Veterinarians (DVM) (refer to scope of practice)
• ODB Act does not prohibit advertising the waiving of the $2 co-pay for ODB recipients
• Advertising that we will not charge up to a $2.00 co-payment for drug card holders (Green Shield, Blue Cross, ESI, etc.) violates the act. Only the ODB co-payment advertised is allowed currently.
• Permits OCP to regulate practice site


  Pharmacy is one of the few professions in Ontario that can regulate the registrant (Pharmacy Act) & practice site (DPRA)
• Designed to work with other legislation (federal & provincial)
• Drug


  Any substance or prep containing any substance for use in: Diagnosis, treatment, prevention….for physical & mental states in humans, animals or fowl; Restoring, correcting or modifying functions in humans, animals or fowl; Referred to in schedule I, II or III; Listed in publication named by regulations; Named in regulations
• Not drugs


  Anything approved for sale as food, drink or cosmetic is not considered a drug (Health Canada); Natural health products are also not considered drugs; NHP could be a drug in Ontario if it is listed in regulations
• Not drugs

  • pseudoephedrine & ephedrine
• Schedule U


  Not considered a drug in Ontario
• Restricted to


  • Pharmacist
  • Intern or registered pharm student under supervision
  • Pharm tech under supervision
• Drugs can't be misrepresented
• Pharmacies should only sell drugs that are approved by Health Canada
• Wholesalers


  Must be registered w/ college but not regulated by College, regulated by Health Canada
• Schedule I


  Pharmacist must be physically present; Must be a prescription & approved by pharmacist
• Schedule II


  Sold w/ out prescription but pharmacist should be present & approve sale + intervention required
• Schedule III


  Pharmacy only sales; Self-selection by pt but pharmacist presence required
• Prescription


  Order for a specific individual ordered by a prescriber after a diagnosis or for a medical device
• Out of province prescriptions can be accepted provided it is written by a prescriber licensed in Canada
• Verbal prescription


  Acceptable if drug is not a narcotic; Must be received by pharmacist, intern, pharmacy student or pharmacy technicians; Pharm techs cannot accept verbal prescriptions for controlled substances (narcotics, controlled drugs, targeted substances); Date, authorized refill number & name of registrant receiving prescription should be written
• Label must include


  • Identification number (prescription number)
  • Name, address & phone of pharmacy
  • Name of owner of pharmacy
  • Drug name, strength & manufacturer
  • Directions for use
  • Quantity of drug dispensed
  • Name of prescriber
  • Name for pt
• Single entity drugs (OCP policy)

  These drugs must be labelled w/ chemical name of drug including name of manufacturer
• Mailing prescriptions

  Only done by registered mail (person signs the package); Delivery must be traceable & auditable; Any drug can be mailed or delivered within Canada
• Mailing prescriptions outside of Canada


  Other restrictions, check with their customs agency/embassy
• Requirements when transferring prescriptions

  • Name & address of pt
  • Name & strength of drug
  • Directions for use
  • Drug manufacturer
  • Name & address of prescriber
  • Id number of prescription
  • Total quantity of drug remaining to be dispended under prescription
  • Name of member transferring prescription
  • Date of first & last dispensed date (benzos also need date prescription was issued)