Community Pharmacy Inspections

Date: May 25, 2017

Click here for access to the Council website and Community Inspection Questionnaire.

It has come to our attention that a number of members are struggling with Inspectors and inspections. ICPA will regularly update members with the latest inspection related information.

Below are the most frequent queries from members about inspection related problems.

1. SPECIFIED S5 REGISTER: Pharmacy Council has removed the question relating to the keeping of a Specified Schedule 5 Register following a legal opinion from the PSSA. Community pharmacies do not need to keep a Specified S5 register. The MCC need to correct the ambiguity between the Medicines Act and the Regulations.

2. SOPs: A number of members have been marked non-compliant for the written Standard Operating Procedure for “product types requiring special storage or handling instructions”. ICPA has a template for members to use to ensure they are compliant for this relatively new SOP. Click here for the SOP. Annexure A, attached to the SOP, is the list of product types requiring special storage or handling instructions which should be printed out and displayed in your stock receiving area in order to be compliant with the inspection questionnaire.

3. Members have requested SOP templates for the 22 SOPs as required by the SAPC. ICPA is busy compiling this list and they will be available for download from our website shortly.

4. REFERENCES: A number of the required references are available on-line or are downloadable.

4.1 GOOD PHARMACY PRACTICE: Document is downloadable from the SAPC website. Click here.

4.2 NDOH – Primary Health Care Standard Treatment Guidelines: Click here for the electronic version. It is also available as an APP – follow these instructions to download the APP.

4.3 MCC guideline for substitutable medicines – currently the MCC only lists bio-similars as non-substitutable medicines. Click here for their guideline.

5. PREMISES and LAYOUT:

5.1 A sign designating the pharmacy as a non-smoking and non-eating area is now a requirement. ICPA has a number of printed signs (click here for a preview) available for members. Drop us an email with your pharmacy name and address if you would like one and we will post it to you. info@icpa.co.za

5.2 Fire extinguishers and or fire hose must be serviced on an annual basis – make sure you have a contract with a service provider in order to comply with the Occupational health and safety Act (OHS Act).

6. DISPENSING OF PRESCRIPTIONS: Remember that according to the Medicines Act the original prescription must state who dispensed the prescription as indicated by both the name on the trailer label and a SIGNATURE on the prescription. A number of pharmacists have been marked down because they have not signed the back of their prescriptions.

7. Council has approved the Self-Assessment Qualitative Inspection Questionnaire for pharmacists who are employed in Community and Institutional Pharmacies to do self-assessment before an inspection is conducted.

Follow the link here.

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