CONFIDENTIAL HOSPITAL (INSTITUTIONAL) INSPECTION QUESTIONNAIRE TO ESTABLISH THE NATURE, EXTENT AND STANDARD OF PHARMACEUTICAL SERVICES 2016 PLEASE NOTE: The confidentiality of this document may be withdrawn should the information furnished lead to further investigation(s) Please refer this questionnaire for special attention: YES NO PHARMACY NAME Y NUMBER Y CASE NUMBER INSPECTION TYPE Monitoring Training New Premises Disciplinary Follow-up
Transcript
CONFIDENTIAL
HOSPITAL (INSTITUTIONAL)
INSPECTION QUESTIONNAIRE TO ESTABLISH THE NATURE, EXTENT AND
STANDARD OF PHARMACEUTICAL SERVICES 2016
PLEASE NOTE: The confidentiality of this document may be withdrawn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
PHARMACY NAME Y NUMBER Y CASE NUMBER INSPECTION TYPE
Monitoring Training
New Premises
Disciplinary
Follow-up
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
NOTE: Throughout this questionnaire all questions carry a certain weighting and the questions in sections (B) and (C) marked with a ** carry a weighting of 3.
WEIGHTING KEY
1. Not at all important but necessary to document
2. Low importance
3. Slight importance
4. Neutral importance
5. Moderate important
6. Very important
7. Extremely important
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
18. Where is the pharmacy situated? (for statistical purposes)
City centre 1
City
suburb2
Town3
Township 4
Rural5
19. GPS Co-ordinates S: E:
20. List the other facilities by name not registered with the SAPC (within a radius of five kilometres (5km)) that provide pharmaceutical services. (for statistical purposes)
(C) PHARMACY STAFFING 21. Name of pharmacy owner as registered (in block capitals) and Registration
number as per CIPC documents (if applicable)
0 3
22. Name and P no of responsible pharmacist as registered
P 0 3
23. The pharmacy is under the continuous personal supervision of a pharmacist.6
0 3
24. Name and P no of pharmacist in charge during inspection
P 0 3
25. Name of (prospective) tutor(s) if applicable
P
P
P
26. How many community service pharmacists are in the permanent employ of the pharmacy? (Public health facilities only)
27. How many full-time pharmacists are in the permanent employ of the pharmacy? (at least 5 hours per day) (fill in details as required in the table attached as schedule A).
28. How many part-time pharmacists are in the permanent employ of the pharmacy? (less than 5 hours per day) ? (fill in details under comments).
29. How many pharmacist interns are undergoing practical training in the pharmacy? (Fill in details as required in the table attached as schedule A).
30. How many registered pharmacist’s assistants (basic) work in the pharmacy? (Fill in details as required in the table attached as schedule A).
31. How many registered pharmacist’s assistants (post-basic) work in the pharmacy? (Fill in name and number on the table attached as schedule A).
32. How many registered pharmacist’s assistants (learner basic) are undergoing practical training in the pharmacy? (Fill in details as required in the table attached as schedule A).
33. How many registered pharmacist’s assistants (learner post-basic) are undergoing practical training in the pharmacy?
34. How many registered pharmacy technical assistant trainees are undergoing training in the pharmacy? (Fill in name and number on the table attached as schedule A).
35. How many registered pharmacy technicians work in the pharmacy? (Fill in name and number on the table attached as schedule A).
36. How many registered pharmacy technician trainees are undergoing training in the pharmacy? (Fill in name and number on the table attached as schedule A).
37. Are there any unregistered persons performing acts falling within the scope of practice of pharmacists and/or pharmacy support personnel would require training in order to register as pharmacy support personnel with the Council?. 7
0 3
1 Refers to the central business district area. 2 A residential area within the boundaries of a town or city. 3 Usually a town or part of a town. 4 ‘township’ in South Africa referred to an urban residential area created for migrant labour, usually beyond the town or city limits. Generally,
every town/city has one or several townships associated with it. 5 Any area that is not classified urban. Rural areas are subdivided into tribal areas and commercial farms. 6 Note the name of the pharmacist in charge as per his/her Council registration card. 7 Inspector to explain the legal requirement
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
38. Who does the actual picking of medicines (part of phase 2 of dispensing as per GPP) prior to dispensing?8
Other personnel Pharmacist’s
assistant Pharmacist and/or pharmacist intern
39. Who hands the medicine to the patient or care-giver?9
Driver/courier Other personnel Pharmacist’s
assistant Pharmacist and/or pharmacist intern
40. How many items prescribed by an authorised
prescriber are dispensed per day on average?
In-patients (a) Total (a) + (b)
Out-patients/ passing trade:
(b)
41. How many Pharmacist Initiated Therapy Items are dispensed per day on average? N/A
42. How many surgical items are dispensed/issued per day on average N/A
Comments/corrective action
8 Inspector to explain the legal requirement 9 For Information only
PHARMACY STAFFING 10 Name and Surname(as per registration card)
SAPC Registration number(as per registration card)
Id number/ Passport number
Primary Registration type (Pharmacist,
Pharmacist intern, Pharmacist assistant, etc)
Secondary
Registration type (e.g. Tutor, Responsible Pharmacist, etc)
Pharmacy support personnel per tutor
10 Inspector to capture all names and all other details as indicated on the table of all personnel in the pharmacy that are concerned with the handling of pharmaceuticals and delivery of pharmaceutical services.
(D) REGISTRATION DETAILS
N/A
Do
es n
ot
co
mp
ly
Com
plie
s Weight
43. The name of the responsible pharmacist is displayed conspicuously over the main entrance of the pharmacy.11
0
3 3
44. The name of the pharmacist(s) on duty is/are displayed conspicuously in/or outside the pharmacy for the purpose of identification of such person(s) by the public.12 &13
0
3 3
45. The pharmacist(s) on duty is/are wearing a nametag or badge indicating his/her name and designation for the purpose of identification of such person(s) to the public.14
0
3 3
46. The pharmacy is under the continuous personal supervision of a pharmacist.15
0
3
47. A currently valid registration card(s) is available for the pharmacist(s) N/A
0
3 3
48. A currently valid registration card(s) is available for the pharmacy support personnel
(qualified)16 N/A
0
3 3
49. A currently valid registration card(s) is available for the pharmacy support personnel
(learners and trainees)17 N/A
0
3 3
50. A currently valid original certificate signed by the Registrar of the SAPC for the recording of the pharmacy is available for the purpose of identification of such to the public.
0
3 3
51. A valid original licence issued by the Director-General (in terms of section 22 of the Pharmacy Act) or a registration certificate letter/certificate issued by Council (in case of the Pre-May 2003 pharmacies) is displayed conspicuously in the pharmacy for
the purpose of identification of such to the public
N/A
0 3
3
52. A patients’ rights and responsibility poster is displayed conspicuously displayed for the purpose of identification by the public.
0 3
3
Comments and/or corrective action required for all items marked ‘does not comply’ or ‘partially complies’
11 The main entrance refers to the entrance as specified on the original professionally drawn pharmacy floor plan , refer to GPP (1.2.1) requirements. 12 GPP (1.2.1) requirements 13 Name and Surname of pharmacist(s) as per Council registration card. 14 Ensure that the name tag specifies both the name as well the designation (e.g. Pharmacist, Pharmacist assistant, etc) 15. The name of the pharmacist in charge as per his/her Council registration card. 16 Pharmacists assistant (basic and post basic), Pharmacy Technical assistants (PTAs) and Pharmacy Technicians 17 Pharmacists assistant (learner basic and post basic), Pharmacy Technical assistants (PTAs) and Pharmacy Technicians (trainees)
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
55. The pharmacy is suitably located in the institution.
0
3 5
56. The pharmacy is accessible to persons with disabilities (OHS Act). 0
3 5
57. The floor surface in the dispensing area is of impermeable material. 0
3 5
58. All working surfaces are finished with a smooth, impermeable and washable material which is easy to maintain in a hygienic condition.
0
3 5
59. Shelves are finished with a smooth, impermeable and washable material which is easy to maintain in a hygienic condition.
0
3 5
60. Walls are finished with a smooth, impermeable and washable material which is easy to maintain in a hygienic condition.
0
3 5
61. The pharmacy premises are clearly identified and demarcated from premises of any other business or practice.
N/A 0
3 5
62. In order to comply with the requirement of accessibility to pharmaceutical services, a pharmacist has an unfettered 24 hour access to the pharmacy.
0
3 5
63. Approval has been obtained from Council in the event that a person who is not registered with Council conducts another practice/business within the pharmacy (GPP 1.2.2)18
N/A
0
3
5
64. The other business does not pose any conflicting interest either ethically or professionally to the practice of pharmacy such as:
(a) Added security risk to the keeping and supply of medicines; 0
3 5
(b) Added risk to the patients; 0
3 5
(c) Compromises the quality, efficacy and safety of the medicine. 0
3 5
65 The premises of the other business is clearly identified and demarcated from the pharmacy premises:
(a) The demarcation is permanent, solid and closed off at all times, which demarcation may be inter alia, brick and mortar, aluminium, steel, glass, dry wall or wood partition;
0 3 5
(b) The demarcation is from floor to the ceiling height
0 3 5
66 The lighting is suitable and effective to ensure sufficient vision of detail.
0 1 3 5
67 The temperature in the pharmacy is below 25C (as checked with a thermometer).
0 1 3 5
68 The temperature in the pharmacy is controlled 24 hours a day as demonstrated by a maximum/minimum thermometer as per SOP on temperature control and the records.
0 1 3 5
69 There is an air conditioning system in the pharmacy.
0 1 3 5
70 The air conditioning system is in good working condition to be effective to keep the temperature below 25 degrees Celsius.
0 1 3 5
71 The temperature is recorded on a daily basis during working hours or operating hours as per SOP on temperature control.
0 1 3 5
72 There is at least one fire extinguisher or fire hose in the pharmacy in accordance with the Occupational health and safety Act (OHS Act)
0 3 5
73 If there is a fire extinguisher or fire hose, it has been serviced/checked within the last year (12 months) as indicated on the cylinder/panel/supplier equipment’s label as well as per the service contract.
0 3 5
74 The electrical equipment used in the practice of pharmacy is regularly maintained and safe as per manufacturers requirements (OHS Act)
0 1 3 5
18 Inspector to request certificate of approval for approvals granted after June 2011. For prior year approvals, pharmacist/RP to be advised to
inform Council and request certificate of approval. In case the person not registered with Council (e.g. nurse, physiotherapist, beautician,etc) is employed by the pharmacy the question should be answered N/A.
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
75 The dispensing surface area is sufficient for the volume of prescriptions dispensed (a clear working surface area of at least 90cm to 1m must be provided for each pharmacist or other persons registered with Council who work in the dispensary).
0 1 3 5
76 The total floor area is sufficient for the efficient operation of dispensary staff.
0 1 3 5
77 The workflow in the pharmacy is efficient, organized and orderly in accordance with relevant the SOP.
0 1 3 5
78 There is a suitable waiting area, which is under cover. (N/A where there are no out-patients) N/A 0 1 3 5
79 The waiting area is situated near the dispensary area, areas for counselling and the furnishing of information and/or consultation areas. (N/A were there are no out-patients)
N/A 0 1 3 5
80 The waiting area has comfortable seating available/provided. (N/A were there are no out-
patients) N/A
0 1 3 5
81 There is a suitable semi-private area (at every dispensing point) for the provision of information and advice, in accordance with GPP standards (1.2.13.2 and 2.31).
0 1 3 5
82 There is a suitable private area for the provision of information and advice, in accordance with GPP standards. (1.2.13.3)
0 1 3 5
83 There is a suitable consultation area for the provision of screening and monitoring test.(1.2.13.4)
N/A 0 1 3 5
84 The professional image of the dispensing area is not affected by the display of any material not directly linked with health.
N/A 0 1 3 5
85 Medicinal and non-medicinal products are displayed separately in the pharmacy. N/A 0 1 3 5
86 Key, key card or other device or the combination of any device, which allows access to a pharmacy when it is locked, is kept in person of the responsible pharmacist or the person of another pharmacist at all times.
0 1 3 5
87 Only the pharmacist(s) has keys to the pharmacy area where schedules 1 – 6 items are kept.
0 1 3 5
88 Control of access to pharmacy premises, which include the design and layout of the pharmacy, is of such a nature that only registered pharmacy personnel have direct access to medicine.
0 1 3 5
89 There is sufficient security to prevent unauthorised access to medicines, a barrier
with a no entry sign. 0 1 3 5
90 The pharmacy is designated as a non-smoking area. 0 3 5
91 The pharmacy is designated as a non-eating area, other than in areas specifically designated as eating areas.
0 3 5
92 There is a separate facility for washing hands in the pharmacy. 0 1 3 5
93 There is a separate facility for cleaning of equipment. 0 1 3 5
94 There is a separate service area for outpatients. 0 1 3 5
95 There is a separate service area for staff. 0 1 3 5
96 There is a suitable separate facility that complies with GMP standards where compounding is carried out where applicable.19
N/A 0 1 3 5
97 There is a suitable separate facility that complies with GMP standards where bulk pre-packing is carried out where applicable.20
N/A 0 1 3 5
Comments and/or corrective action required for all items marked ‘does not comply’ or ‘partially complies’
19 Where manufacturing occurs 20 Where manufacturing occurs
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
104 Storage area is large enough to allow for orderly arrangement of stock and proper stock rotation.
N/A 0 1 3 3
105 The store is kept locked at all times when not in use (if dedicated bulk pharmacy store). N/A 0 1 3 3
106 The storage area is tidy in accordance with SOP. N/A 0 1 3 3
107 Storage areas are situated so that products are protected from potentially harmful influences.
N/A 0 1 3 3
108 Raw materials known to be at risk of /for cross-contamination are stored separately or quarantined.
0 1 3 3
109 Proper care and control is exercised over hazardous substances (e.g. caustic soda, insecticides etc.) which are stored separately and safely.
0 1 3 3
110 Proper care and control is exercised over flammable substances (e.g. ether, methylated spirits etc.) which are stored separately and safely.
0 1 3 3
111 There are no cracks, holes or sign of water damage in the facility.
0 1 3 3
112 The ceiling is in good condition.
0 1 3 3
113 The floor is swept daily in accordance with SOP.
0 1 3 3
114 Shelves are dusted daily in accordance with SOP.
0 1 3 3
115 Walls are cleaned in accordance with SOP.
0 1 3 3
116 Pest control is conducted regularly in accordance with SOP N/A 0 1 3 3
117 All goods are stored off the floor in accordance with SOP. N/A 0 1 3 3
118 Supplies are stored neatly on shelves on boxes, in accordance with SOP. N/A 0 1 3 3
119 A system is in place to ensure effective stock rotation (refer also SOP section). 0 1 3 3
120 Expired stock is kept separate from normal trading stock. 0 1 3 3
121 Damaged stock is kept separate from normal trading stock. 0 1 3 3
122 Contaminated stock kept separate from normal trading stock. 0 1 3 3
123 Expired stock is destroyed in a safe manner (e.g. returned to supplier or waste disposal company) (refer also SOP section and Regulation 21 of Act 101 of 1965).
0 1 3 3
124 Damaged and/or contaminated stock is destroyed in a safe manner (e.g. returned to supplier or waste disposal company) (refer also SOP section and Regulation 21 of Act 101 of 1965).
0 1 3 3
125 There is a separate and secure receiving area, which is under cover. 0 1 3 3
126 There is a separate and secure dispatch area, which is under cover. 0 1 3 3
127 Stock is checked on receipt for quantity, quality, damaged containers, type, storage conditions and expiry dates.
0 1 3 3
128 A list of product types requiring special storage or handling instructions is available and consulted on receipt of stock (refer also SOP section).
0 1 3 3
129 There is a system for the correct handling of the various types of goods returned from patients, wards; clinics etc. (refer also SOP section).
0 1 3 3
130 Is any pre-packing performed on the premises? (refer also SOP section). No Yes
131 Is pre-packing done in accordance with Regulation 33 of Act 101 of 1965 with regard to temperature, humidity, area and GMP requirements (specify) (refer also SOP section).
N/A 0 1 3 3
132 All medicines sold for human use, comply with Regulation 8 of Act 101 of 1965 i.e. labelling requirements for human medicine
0 1 3 3
133 Medicines are purchased only through legally authorised (registered) entities/suppliers (as confirmed by pharmacist in charge during inspection) and crosschecked with invoices.
0 1 3 3
134 There are no illegal or counterfeit medicines on the premises (as observed). 0 1 3 3
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
136 A computerised programme is used for dispensing.22
No
Yes
137 An effective stock control system is in place that ensures that there is no damaged, expired stock. (refer to relevant SOP).
0 1 3 7
138 There are no expired medicines on the shelves (refer to relevant SOP).
7
139 A prescription book/permanent record for S1-S6 medicines is kept as required in Regulation 11 (1) and (2) of Act 101 of 1965.
0 1 3 7
140 Controls are in place for issuing ward stock (refer also SOP section). N/A 0 1 3 7
141 Controls are in place for issuing of medicines per patient to the wards (refer also SOP section).
N/A 0 1 3 7
142 The pharmacist exercises control over medicines kept in places other than the pharmacy (e.g. wards, theatres etc). (refer also SOP section).
N/A 0 1 3 7
143 A prescription record is kept for 5 years as required in Regulation 11(3) of Act 101 of 1965.
0 1 3 7
144 Original prescriptions are kept in a safe place and are easily retrievable (in a case where the original prescriptions are kept off-site, an electronic copy of the prescription should be available on inspection and the original be made available in 48 hours.)
0 1 3 7
145 A patient profile detailing all prescriptions dispensed to the patient is kept for 5 years after the last entry on site. (2.9.1 GPP)
0 1 3 7
146 Patient profile detailing all P.I.T. dispensed to the patient is kept for 5 years after the last entry on site. (2.9.1 GPP)
N/A 0 1 3 7
147 S1-S5 medicines are stored/displayed in areas inaccessible to the public. 0 1 3 7
148 All S1 medicines sales are recorded in a prescription book or other permanent record as required in Regulation 11(2) of Act 101 of 1965.
N/A 0 1 3 7
149 All S2 medicine sales are recorded in a prescription book or other permanent record as required in Regulation 11(1) of Act 101 of 1965.
N/A 0 1 3 7
150 Are S6 medicines ordered, stored or supplied at any time?
No
Yes
151 There is a system in place for the correct handling by the pharmacist of S6 medicines (refer also SOP section).
N/A 0 1 3 7
152 S6 medicines are locked away and the key is under the control of the pharmacist. N/A 0 1 3 7
153 There is an up-to-date register of all S6 purchases and sales as required in
Regulation 30 of Act 101 of 1965.
N/A 0 1 3 7
154 The S6 substances register was balanced on the last day of March, June, September
and December of each year or within 14 days as required in Regulation 30(2) of Act 101 of 1965.
N/A 0 1 3 7
Comments and/or corrective action required for all items marked ‘does not comply’ or ‘partially complies’
22 For Information only
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
(H) CONTROL OF MEDICINE/RECORD KEEPING (continued)
155 Does the pharmacy deliver medicines by mail?
Yes
No
156 Does the pharmacy deliver medicines by courier?
Yes
No
157 Does the pharmacy deliver medicines by delivery person/porter?
Yes
No
158 Does the pharmacy deliver medicines by any other means (e.g. train etc.)?
Yes
No
159 If question 158 was answered ‘yes’, PLEASE SPECIFY by which means:
160 Such indirect supplies (refer questions 155 to 158) comply with all GPP requirements i.r.o. the following:
N/A
Does n
ot
com
ply
Part
iall
y
co
mp
lie
s
Com
plie
s
Weight
160.2 Control is exercised (, in accordance with SOP) to ensure that the courier is suitable for the transport of medicines and scheduled substances.
N/A 0 1 3 7
160.3 A control system is implemented that enables detection and correction of a delay in the delivery process.
N/A 0 1 3 7
160.4 Medicines are packaged and stored in accordance with Medicines Control registration requirements throughout the delivery process.
N/A 0 1 3 7
160.5 Control is exercised so that products are not subjected to unacceptable degrees of heat, cold, sunlight or any other adverse influences during the transportation process. In accordance with SOP.
N/A 0 1 3 7
Comments and/or corrective action required for all items marked ‘does not comply’ or ‘partially complies’
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
NB. Mark N/A only in the case where the answer to 161 is NO and the inspector has observed that there are no thermolabile medicines, mark as N/A.
N/A
Do
es n
ot
co
mp
ly
Part
iall
y
co
mp
lie
s
Co
mp
lie
s
Weight
161. Are thermolabile medicines purchased, stored or supplied at any time?
No
Yes
162. All thermolabile medicines are stored in a refrigerator. N/A 0 1 3 6
163. Only thermolabile medicines are stored in the refrigerator. N/A 0 1 3 6
164. Thermolabile medicines are stored in the refrigerator according to a system. (22) N/A 0 1 3 6
165. The refrigerator is suitable and in good working order. N/A 0 1 3 6
166. The refrigerator is connected to a standby generator or other emergency power system to ensure uninterrupted power supply in case of power (current) failure.
N/A 0 1 3 6
167. The refrigerator is fitted with a warning system to indicate that refrigeration has
failed or temperatures are above or below 2C and 8C23
N/A 0 1 3 6
168. The temperature of the refrigerator/cold room is between 2C and 8C (as checked with a thermometer).
N/A 0 1 3 6
169. The temperature of the refrigerator is controlled and monitored 24 hours a day as demonstrated by a WHO approved dial thermometer or alcohol thermometer.24
N/A 0 1 3 6
170. The temperature of the refrigerator is recorded twice daily in accordance with GPP standards.
N/A 0 1 3 6
171. Thermolabile medicines are stored/supplied maintaining the cold chain. N/A 0 1 3 6
172. If thermolabile medicines are delivered by any supplier, temperature is being monitored to ensure that the cold chain is maintained from dispatch point to delivery point and proof on how the temperature is controlled is provide and/or kept.25
N/A
0 1 3 6
Not Applicable (N/A) may only be provided as a response in a case where the pharmacy does not keep thermolabile substances in stock and has answered no to question 161.
Comments and/or corrective action required for all items marked ‘does not comply’ or ‘partially complies’
23 This refers to continuous temperature monitoring to alert the pharmacist even when they are off-site of the variations in temperatures. 24 EPI provisions applies 25 The pharmacist must satisfy themselves that the wholesale or distributor has a specific SOP (Procedure) detailing how they ensure quality control in the cold chain. In case where the pharmacist distribute medicines by courier, they must also prove the existence of a similar SOP (Procedure).
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
193. The pharmacy performs bulk compounding (e.g. dilution of antiseptic solutions, creams, mixtures etc.) in accordance with GPP requirements. (refer also SOP section). N/A
0
1 3
6
194. TPN/large volume parenterals are prepared in the pharmacy in accordance with GPP requirements. (refer also SOP section).
N/A 0
1 3
6
195. Cytotoxic admixtures are prepared in the pharmacy in accordance with GPP requirements. (refer also SOP section). N/A
0
1 3
6
196. IV additives are prepared in the pharmacy in accordance with GPP requirements. (refer also SOP section). N/A
0
1 3
6
Comments and/or corrective action required for all items marked ‘does not comply’ or ‘partially complies’
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
220. preparation of IV additives (including quality assurance procedures). N/A 0 1 3 3
221. control over medicines kept in places other than the pharmacy (e.g. wards, theatres etc.) (including controls for issuing ward stock and medicine per patient to the wards)
N/A 0 1 3 3
222. SOPs are reviewed/updated on a regular basis, and staff trained on the SOP’s. 0 1 3 3
Comments and/or corrective action required for all items marked ‘does not comply’ or ‘partially complies’
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
The pharmacy has copies of, or electronic access to:28 N/A
Do
es n
ot
co
mp
ly
Part
iall
y
co
mp
lie
s
Co
mp
lie
s
Weight
223. - one of the last 5 editions of the Martindale. 0 1 3 3
224. - the latest edition of the Good Pharmacy Practice (GPP) Manual. 0 1 3 3
225. - the latest edition of MIMS. 0 1 3 3
226. - a comprehensive textbook on complementary medicine. 0 1 3 3
227. - the latest edition of Daily Drug Use (Tincture Press Publications) or other Drug Interactions reference source.
0 1 3 3
228. - the latest edition of either MDR or SAMF. 0 1 3 3
229. - a recent and comprehensive textbook on Pharmacology (not older than 10 years).
0 1 3 3
230. - a medical dictionary. 0 1 3 3
231. - a guideline for non-substitutable list of medicine 0 1 3 3
232. - a copy of the Pharmacy Act, 1974 (Act 53 of 1974) as amended and the Medicines and Related Substances Control Act, 1965 (Act 101 of 1965) as amended.
244. Are Family Planning services rendered at the pharmacy?30 No Yes
245. Has the pharmacist(s) registered his/her Family Planning qualification with Council?
N/A 0
3
4
246. Is the necessary Section 22(A)(15) permit from the Department of Health available for purposes of providing family planning? (previously Section 22(A)(12))
N/A 0
3
4
247. Are Primary Care Drug Therapy (PCDT) services rendered at the pharmacy?31 No
Yes
248. Has the pharmacist registered his/her Primary Care Drug Therapy (PCDT) qualification with Council?
N/A 0
3
4
249. If medicines in higher schedules are provided during the provision of PCDT, is the necessary Section 22(A)(15) permit from the Department of Health available? (previously Section 22(A)(12))
N/A 0
3
4
The following services are rendered in accordance with GPP standards32:
255. Immunisation services (in accordance with National guidelines). N/A 0 1 3 4
256. HIV testing on request from patient (in accordance with National guidelines.) N/A 0 1 3 4
257. Mother and childcare services. N/A 0 1 3 4
258. Others, please specify:
259. The above-mentioned services are rendered in a suitable consultation area. N/A 0 1 3 4
260. Who renders the above services? N/A No services
rendered
Other health care professional
Pharmacist’s assistant
Pharmacist and/or pharmacist intern N/A
Please specify other:
Comments and/or corrective action required for all items marked ‘does not comply’ or ‘partially complies’
30 For Information only 31 For information only 32 The monitoring is to ensure that services where provided are done in accordance with GPP. Inspector/RP to ensure that procedures and requirements as per GPP are followed.
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
(Q) RECOMMENDATIONS IN RESPECT OF TRAINING NB: RECOMMENDATIONS MUST ALSO BE MADE IN THE CASE OF MONITORING INSPECTIONS.
The inspector must, through his/her observations, take notice of all aspects of pharmacy practice, to give an objective evaluation of the training facilities in the pharmacy and the ability of a prospective tutor to train a pharmacist intern and/or pharmac ist’s assistant effectively.
261. A pharmacist intern was trained within the last 3 years. No Yes
262. A pharmacy support personnel was trained within the last 3 years. No Yes
263. Would the pharmacist accept responsibility as a tutor for the training of a pharmacist intern or pharmacist’s assistant?
No Yes
264. Is there evidence that the prospective tutor participates in continuing education/professional development?
No Yes
265. Is there disciplinary action pending against the prospective tutor? No Yes
266. In light of the inspection is there sufficient evidence that the prospective tutor/pharmacist upholds the principles of pharmaceutical care/GPP?
No Yes
! Recommendations made by the inspector with respect to training do
not constitute approval for training by the Council. Final approval of the pharmacy premises and tutor is made by the
Council.
Comments and/or corrective action required for all items marked ‘no’ or ‘see comments’
Encircle or mark applicable number/block with an ‘X’
Responsible Pharmacist or Pharmacist Initials/signature
I, THE UNDERSIGNED, AM FAMILIAR WITH THE CONTENTS OF THIS INSPECTION REPORT. THE RECOMMENDED CORRECTIVE ACTION TO BE TAKEN IN INSTANCES WHERE A QUESTION WAS ANSWERED AS EITHER ‘DOES NOT COMPLY’ OR ‘PARTIALLY COMPLIES’ HAS BEEN EXPLAINED AND WRITTEN IN THIS REPORT, IN EVERY SUCH INSTANCE.
267. Signature of pharmacist in charge during inspection:
268. Name and P number of above pharmacist in charge during inspection (in block capitals) (refer question 22):
P
269. Signature of inspector:
270. Duration of inspection: (refer inspection start time on page 2)
