It is the view of the College of Physicians and Surgeons of Newfoundland and Labrador that the dispensing of medications should be under the supervision and control of a licensed pharmacist, excepting in emergency situations or where the services of a pharmacist to dispense the medications are not readily available.
Section 67(3) of the Medical Act 2005 states:
Nothing in the Pharmacy Act shall be construed to prevent a medical practitioner from practicing pharmacy and making reasonable charges for pharmaceutical services rendered or goods supplied in emergency situations or when the services of a pharmacist are not readily available.
By this guideline, the College of Physicians and Surgeons of Newfoundland and Labrador is recommending that the following standards of practice be followed by a medical practitioner who is intending to dispense medications:
1. This guideline is applicable to physicians in private practice providing a dispensary service consistent with Section 29(4) of the Medical Act.
2. This guideline does not apply to physicians who may from time to time provide manufacturer’s samples to patients as part of their practice.
B. Notification of College
3. Physicians who propose to establish a dispensary service as part of their practice should first obtain the approval of the College. The College’s approval will only be granted if the services of a pharmacist are not readily available and following consultation with the Newfoundland and Labrador Pharmacy Board.
C. Dispensing Standards
4. In general, dispensing physicians should employ dispensing standards of practice equal to those required of pharmacists. Current standards of practice are available from the Newfoundland and Labrador Pharmacy Board.
5. A dispensing physician should only dispense prescriptions written by that physician.
6. All medications should be dispensed with a typed, adhesive label that is affixed to the bottle or packaging containing the following information:
a. Name, address and telephone number of the dispensing physician;
b. Dispensing date;
c. Name of the patient;
d. Name of the drug (generic/brand) and strength;
e. Directions for use (e.g. Take one tablet three times per day with meals.) It is not acceptable to direct patients to “Take as directed”, “Take as per manufacturer’s instructions” or similar vague statements;
f. Quantity dispensed; and
g. Refill indication.
7. Child-proof containers should be used, unless the patient specifically requests otherwise.
8. Physicians should dispense in compliance with the Newfoundland and Labrador Interchangeable Drug Products Formulary as well as the Controlled Drugs and Substances Act.
9. No drug should be dispensed after the indicated expiry date.
10. In dispensing a medication, a dispensing physician should instruct the patient on:
a. the identity of the medication being dispensed;
b. the prescribed dosage regimen;
c. the importance of compliance with the dosage regimen and what to do if a dosage is missed;
d. the intended therapeutic effect of the medication;
e. significant drug – drug interactions including non-prescription medications and drug – food interactions;
f. common side-effects and what to do if they occur;
g. refill information; and,
h. any special storage requirements (such as refrigeration).
This information may be provided in written form in addition to being provided verbally.
D. Reports and records
11. Dispensing physicians should keep permanent records of all drugs dispensed for a period of not less than two years. These records should be kept separate from patient clinic records. The records should be in a format that is readily retrievable and open to review by the College of Physicians and Surgeons of Newfoundland and Labrador or inspectors of Health Canada.
12. The method chosen for record keeping should include the same information as the medication label. It is recommended that dispensing physicians maintain a dispensing history for each patient containing the following information:
a. Patient name, sex, address, telephone number, date of birth, allergies, known drug reactions, chronic/acute medical conditions, current weight for pediatric patients and other relevant information;
b. a prescription log, kept for each patient, which records sequentially the prescriptions dispensed to that patient; and
c. a file of prescriptions.
13. Records for narcotics and controlled drugs should be kept separately from those for other drugs.
14. Patients should be provided with a receipt for medication purchases that indicates, as a minimum:
a. the transaction date;
b. the total cost of the prescription;
c. the cost of the drug;
d. any professional fee charged for dispending;
e. any amount paid by a third party such as an insurance company; and
f. any amount paid by the patient.
15. Consistent with the Controlled Drugs and Substances Act, dispensing physicians should maintain a current inventory of controlled drugs. Any loss from pilferage or theft should be reported in writing to Health Canada within ten (10) days of the discovery of the loss, using the form specified by Health Canada. By this guideline, it is being recommended that a copy of this loss report also be provided to the College of Physicians and Surgeons of Newfoundland and Labrador.
E. Fees and charges
16. Dispensing physicians may charge for the cost of medication plus a reasonable professional fee for dispensing.
17. Dispensing physicians should take reasonable measures to secure any stocks of medication, particularly narcotics and any other controlled substances.
18. In general, dispensing physicians should maintain an inventory of drugs no greater than that required to meet immediate patient needs.
19. Access to the dispensary area should be restricted and under no circumstances should patients be allowed access to the dispensary area. Drugs in the dispensary should not be in plain view.
20. Stocks of medication should be stored in a room separated from the physician’s clinic by a locked and dead bolted solid door, preferably steel or steel reinforced. The door lock should be of high quality and be burglar resistant. Access to the key or door lock code should be tightly controlled and changed regularly.
21. Narcotics and controlled substances should be stored in a substantial storage cabinet or safe with a combination lock. The cabinet or safe should be burglar resistant. The safe should be anchored and concealed if possible. Lockable bars should be placed across a narcotic cupboard.
22. The exterior door to the clinic should be solid, preferably of steel construction and equipped with a dead bolt.
23. Where exterior windows may be accessed from the ground, the windows should be protected with exterior bars, embedded mesh, plastic laminate or other materials to frustrate break and entry.
24. An audible alarm, placed in an area where it cannot be easily disabled, will serve as a deterrent. Neighbors should be alerted to the alarm. They should be requested to notify the police of an alarm before they call the physician.
25. Ensure medications are stored at the appropriate temperature.
The College views these guidelines as setting out standards for the reasonably safe and prudent provision of dispensing services by medical practitioners. The College may consider a failure to dispense medications in a safe and prudent manner to be professional misconduct or malpractice under Section 34 through 51 of the Medical Act, 2005
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