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1 CCOONNFFIIDDEENNTTIIAALL self ASSESSMENT Qualitative inspection Questionnaire for Services Provided in Community and Institutional Pharmacies PLEASE NOTE: The confidentiality of this document may be withdrawn should the information furnished lead to further investigation(s) Please refer this questionnaire for special attention: YES NO Encircle or mark applicable number/block with an Responsible Pharmacist or Pharmacist Initials/signature 2 self - ASSESSMENT QUESTIONNAIRE TABLE OF CONTENTS 1. DISPENSING PROCEDURES (CODE 0001) PHASE 1,2 & 3 2. COMPOUNDING OF AN EXTEMPORANEOUS ITEM (CODE 0002) .. 6 3. PREPARATION OF A STERILE PRODUCT .. 8 4. PREPARATION OF AN INTRAVENOUS ADMIXTURE OR PARENTERAL SOLUTION (CODE 0004) .. 10 5. PREPARATION OF TOTAL PARENTERAL NUTRITION (CODE 0005) .. 12 6. PREPARATION OF CYTOTOXIC MEDICINES (CODE 0006) .. 15 7.

2 EMERGENCY POSTCOITAL CONTRACEPTION (CODE 0027) .. 17 8. PHARMACIST INITIATED THERAPY (PIT) (CODE 0028) .. 19 9. CLINICAL PHARMACY PHARMACO-KINETIC DOSING OF A MEDICINE AND THERAPEUTIC DRUG MONITORING (CODE 0007) .. 20 10. PROVISION OF PATIENT INFORMATION CONCERNING A PATIENT S CONDITION OR MEDICINE (CODE 0008) .. 21 11. APPLICATION OF PHARMACEUTICAL EXPERTISE MAXIMIZE MEDICINE EFFICIENCY AND MINIMIZE TOXICITY (CODE 0009) .. 23 12. PRIMARY CARE DRUG THERAPY (CODE 0010) .. 24 13. MEDICINE USE REVIEW SERVICE (CODE 0011) .. 26 PROMOTING PUBLIC HEALTH SCREENING AND TESTING OF BIOLOGICAL AND PHYSICAL PARAMETERS .. 28 14. BLOOD GLUCOSE SERVICE (CODE 0012) .. 28 15. CHOLESTEROL MONITORING SERVICE (CODE 0013) .. 29 16. URINE ANALYSIS (CODE 0014) .. 31 17. BLOOD PRESSURE MONITORING SERVICE (CODE 0015) .. 32 18. HIV PRE-TEST COUNSELING (CODE 0016) .. 34 19. HIV TESTING AND POST TEST COUNSELING (CODE 0017) .. 35 20. PREGNANCY SCREENING SERVICE (CODE 0018).

3 37 21. PEAK FLOW MEASUREMENT (CODE 0019) .. 38 22. REPRODUCTIVE HEALTH SERVICES (CODE 0020) .. 39 23. ADMINISTRATION OF AN INTRA-MUSCULAR OR SUB-CUTANEOUS INJECTION (CODE 0021).. 41 24. ADMINISTRATION OF IMMUNISATION (CODE 0022) .. 42 Encircle or mark applicable number/block with an Responsible Pharmacist or Pharmacist Initials/signature 3 self - ASSESSMENT QUESTIONNAIRE DDIISSPPEENNSSIINNGG PPRROOCCEEDDUURREESS ((CCOODDEE 00000011))11 PPHHAASSEE 11,,22 && 33 Procedure Performed by Categories of pharmacies in which services maybe provided Phase 1: Independent evaluation of a prescription with regard to appropriateness of items prescribed for the individual, legality, content and correctness. It includes evaluating the dosage, safety of the medicine, interactions with other medicines used by the patient, pharmaceutical and pharmacological incompatibilities, treatment duplications and possible allergies to the medicine prescribed.

4 Pharmacist Community and Public or Private Institutional Phase 2: Preparation of the medicine(s) as per a prescription, which includes the picking, packaging, labelling of medicine, checking of expiry dates and keeping of appropriate dispensing records in compliance with the Medicines and Related Substances Act, Act 101 of 1965, as amended. Pharmacist Community and Public or Private Institutional Phase 3: Handing of medicines to the patient/caregiver, including the provision of advice/instructions and a patient information leaflet/ written material regarding the safe and efficacious use of the medicine dispensed. Pharmacist Community and Public or private Institutional Indicate your choice performed = 3 or not performed = 0 or mark N/A if not applicable Steps to be performed in the procedure N/A Not Performed Performed 0 3 Phase 1: Interpretation and evaluation of the prescription 1.

5 Receipt of the prescription and confirmation of the integrity of the communication. Ensure the legality/authenticity of the prescription (a) the name, qualification, practice number and address of the prescriber (b) the name and address of the patient (c) the date of prescription (d) the approved name or the proprietary name of the medicine (e) the dosage form (f) the strength of the dosage form and the quantity of the medicine to be supplied (g) instructions for administration of the dosage, frequency of administration (h) the number of times the prescription may be repeated age and gender of the patient (i) whether the prescription is signed in person by the prescriber. 2. Interpret the type of treatment and the prescriber s intentions. 3. Inform the patient of the benefits and implications of the substitution for a branded medicine of an interchangeable multi-source medicine.

6 1 GPP manual Sections: Facilities: through , (institutional pharmacies), (mobile pharmacies) Dispensing service: , , , , Standards for patient information and advice: and (b) Encircle or mark applicable number/block with an Responsible Pharmacist or Pharmacist Initials/signature 4 self - ASSESSMENT QUESTIONNAIRE Indicate your choice performed = 3 or not performed = 0 or mark N/A if not applicable Steps to be performed in the procedure N/A Not Performed Performed 0 3 4. Enter details on computer. 5. Assess the prescription to ensure the optimal use of medicine (a) Check therapeutic aspects - pharmaceutical and pharmacological (i) the safety of the medicine (ii) possible contra-indications (iii) drug/drug interactions (iv) drug/disease interactions (v) treatment duplications (vi) allergies (b) Check appropriateness for the patient and the indication for which the medication is prescribed (c) Check whether the prescribed dose(s) and dosing frequency is appropriate (within the usual therapeutic range and/or modified for patient factors) (d) Pharmacist interventions* - (i) Communicate with the prescriber regarding any identified problems and work out a plan of action with the prescriber and/or the patient whenever necessary (ii) Intervene and/or communicate with medical scheme change in prescribed minimum benefits or registration of a new member (iii)

7 Counsel patient regarding generic substitution of medicine 6. Record the diagnosis or symptom complex (ICD 10 code) (as applicable) 7. Help the patient to resolve the problem when the prescription cannot be dispensed (a) inability of the patient to pay in full (b) inability of the patient to pay levy (c) inability of the patient to pay due to medical aid being exhausted (d) therapy unsafe (e) medicine not available 8. Document above procedures (as applicable) Phase 2: Preparation and labeling of the prescribed medicine. 9. Select patient-ready packs/pre-packed medicines 10. Record items to be re-ordered or to follow 11. Prepare the medicine as per prescription, including the picking and packaging thereof if prepacks are not used (a) the proprietary name, approved name, or the name of each active ingredient of the medicine, where applicable, or constituent (b) the name of the person for whose treatment the medicine is sold (c) the directions in regard to the manner in which the medicine should be used (d) the name and business address of the seller; (e) date of dispensing; and reference number Encircle or mark applicable number/block with an Responsible Pharmacist or Pharmacist Initials/signature 5 self - ASSESSMENT QUESTIONNAIRE Indicate your choice performed = 3 or not performed = 0 or mark N/A if not applicable Steps to be performed in the procedure N/A Not Performed Performed 0 3 12.

8 Sign the prescription 13. Record the dispensing of the medicine 14. Document the above procedures (as applicable) Phase 3: Provision of information and instructions to the patient to ensure the safe and effective use of medicine 15. Explain the effects of the medicine to the patient/ caregiver/agent - (a) Name of the medicine (b) Why is the medicine needed (c) Which symptoms will disappear, and which will not (d) When the effect is expected to start (e) What will happen if the medicine is taken incorrectly or not at all 16. Provide instructions (a) How the medicine should be taken (b) When it should be taken (c) How long the treatment should continue (d) How the medicine should be stored (e) What to do with left-over medicines 17. Give warnings (as needed) (a) When the medicine should not be taken (b) In what circumstances the patient should contact a doctor, pharmacist or other health care provider 18.

9 Check with patient/caregiver/ agent that everything is clear (a) Ask the patient whether everything is understood (b) Ask the patient to repeat the most important information (c) Ask whether the patient has any more questions (d) Determine the need for additional material patient information leaflet etc Encircle or mark applicable number/block with an Responsible Pharmacist or Pharmacist Initials/signature 6 self - ASSESSMENT QUESTIONNAIRE CCOOMMPPOOUUNNDDIINNGG OOFF AANN EEXXTTEEMMPPOORRAANNEEOOUUSS IITTEEMM ((CCOODDEE 00000022))22 Procedure Performed by Categories of pharmacies in which services maybe provided Compounding of an extemporaneous preparation for a specific patient. It refers to the compounding of any non-sterile pharmaceutical product prepared as a single preparation for a patient (a new product is manufactured) including the necessary documentation.

10 Pharmacist Community and Public or Private Institutional Indicate your choice performed = 3 or not performed = 0 or mark N/A if not applicable Steps to be performed in the procedure N/A Not Performed Performed 0 3 Perform Phase 1 of the dispensing process. 19. Check that all apparatus and equipment to be used has been cleaned/sterilised Phase 2: Preparation and labelling of the prescribed medicine. 20. Check and confirm the formula for the prescribed item. 21. Calculate the quantities of the ingredients required as per prescription/formula. 22. Prepare the ingredients to be used. 23. Weigh and measure the ingredients. 24. Mix the ingredients as required. 25. Place preparation in an appropriate container. 26. Document the above procedures. 27. In the case of Schedule 5 or 6 medicines/substances make the necessary entries in the relevant register. 28. Prepare label including the following information - (a) the proprietary name, approved name, or the name of each active ingredient of the medicine, where applicable, or constituent medicine (b) the name of the person for whose treatment the medicine is sold (c) the directions for the use of the medicine (d) the name and business address of the seller (e) date of dispensing; and reference number.