community pharmacy inspection … confidential community pharmacy inspection questionnaire to...

1

CONFIDENTIAL

COMMUNITY PHARMACY 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PLEASE NOTE: The confidentiality of this document may be withdrawn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

2

COMMUNITY PHARMACY INSPECTION QUESTIONNAIRE 2016

TABLE OF CONTENTS

(A) INSPECTION DETAILS ................................................................................................................... 3

(B) PHARMACY DETAILS .................................................................................................................... 3

(C) PHARMACY STAFFING .................................................................................................................. 5

(D) REGISTRATION DETAILS .............................................................................................................. 7

(E) PREMISES AND LAYOUT .............................................................................................................. 8

(F) EQUIPMENT ................................................................................................................................. 11

(G) STORAGE OR STORAGE AREA .................................................................................................. 12

(H) CONTROL OF MEDICINES, SCHEDULED SUBSTANCES AND ACTIVE PHARMACEUTICAL

INGREDIENTS/MEDICINES ........................................................................................................ 14

(I) THERMOLABILE MEDICINES ...................................................................................................... 16

(J) DISPENSING OF PRESCRIPTIONS ............................................................................................ 17

(K) PROVISION OF PHARMACEUTICAL CARE ................................................................................ 18

(L) WRITTEN STANDARD OPERATING PROCEDURES ................................................................. 19

(M) REFERENCES .............................................................................................................................. 20

(N) GENERAL ...................................................................................................................................... 21

(O) PROMOTION OF PUBLIC HEALTH.............................................................................................. 22

(P) RECOMMENDATIONS IN RESPECT OF TRAINING ................................................................... 23

(Q) SIGNATURES ............................................................................................................................... 24

NOTE: Throughout this questionnaire all questions carry a specific weighting and the questions in sections (B) and (C) marked with an ** 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



3


(A) INSPECTION DETAILS

1. Date of inspection

D D / M M / Y Y Y Y

2. Name of inspector

(in block capitals)

Inspector P number

3.1 Type of inspection

Monitoring

Training

New Premises

Disciplinary

Follow-up

3.2 Inspection start time

H H M M

(B) PHARMACY DETAILS

4. Name of pharmacy ** (in block capitals)1

0 3

5. Pharmacy registration number **

Y OFFICE

USE ONLY

Pharmacy

details confirm

ed

Inspection cycle

6. Licence number (if applicable) **

0 3

7. Telephone number(s)

- - Ext.

8. Cellphone number

9. Fax number

- -

10. Pharmacy and/or Responsible Pharmacist e-mail address if not the same

10.1 Pharmacy e-mail address 10.2 Responsible Pharmacist e-mail

address

11. Pharmacy: Registered postal address

P11.1 Postal code

12. Pharmacy: Registered physical address **

0 3

S12.1 Street code

13. What is the nature of the pharmacy? (for statistical purposes)

Group Independent Research Mail/courier

14. What is the type of ownership of the pharmacy

Close corporation

Sole proprietary Company Trust

15. In which province is the pharmacy situated? (for statistical purposes).

Eastern Cape

Free State

Gauteng

Kwazulu-Natal

Mpumalanga

Northern Cape

Limpopo

North West

Western Cape

1 As per the displayed SAPC recording certificate and license issued by the Department of Health.



4


16. Where is the pharmacy situated? (for statistical purposes).

City centr

e 2

City subur

b3

Town4

Towns

hip 5

Rura

l6

17. Is it in a shopping centre Y/N YES NO

18. GPS Co-ordinates. 18.1 X (Latitude) 18.2 Y (Longitude)

19. List the other facilities (by name) not registered with the SAPC (within a radius of five kilometres (5km)) that provides pharmaceutical services.

2 Refers to the central business district area. 3 A residential area within the boundaries of a town or city. 4 Usually a town or part of a town. 5 ‘township’ in South Africa referred to a 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. 6 Any area that is not classified urban. Rural areas are subdivided into tribal areas and commercial farms.



5


(C) PHARMACY STAFFING

20. Name of pharmacy owner as registered (in block capitals) 7** 20.1 20.1 Registration number as per CIPC

documents (if applicable)

0 3

0 3

21. Name and P no of responsible pharmacist as registered.**

P 0 3

22. Name and P no of pharmacist in charge during inspection as per the registration card.**

P 0 3

23. Name of (prospective) tutor(s) if applicable.

P

P

P

24. 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).

25. How many pharmacist interns are undergoing practical training in the pharmacy? (Fill in details as required in the table attached as schedule A).

26. How many registered pharmacist’s assistants (basic) work in the pharmacy? (Fill in details as required in the table attached as schedule A).

27. How many registered pharmacist’s assistants (post-basic) work in the pharmacy? (Fill in name and number on the table attached as schedule A).

28. 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).

29. How many registered pharmacist’s assistants (learner post-basic) are undergoing practical training in the pharmacy?

30. How many registered pharmacy technical assistants work in the pharmacy? (Fill in details as required in the table attached as schedule A)

31. How many registered pharmacy technical assistants trainees are undergoing practical training in the pharmacy? (Fill in details as required in the table attached as schedule A).

32. How many registered pharmacy technicians trainees are undergoing practical training in the pharmacy? (Fill in details as required in the table attached as schedule A).

33. Are there any unregistered persons performing acts falling within the scope of practice of pharmacists and/or pharmacy support personnel who would require training in order to register as pharmacy support personnel with the Council?** 8

34. Are other health care professionals employed in the pharmacy? (e.g. nurses, homeopaths, medical practitioners and dieticians etc.)

35. If yes, please specify which: 0 3

36. Proof of registration of other health care professionals. (attach copies of registration certificates and/or licences) 9

No

Yes

37. Who does the actual picking (part of phase 2 of dispensing as per GPP) of medicines prior to dispensing?10 Other

personnel

Pharmacy support

personnel

Pharmacist and/or

pharmacist intern

7 As per the SAPC recording certificate and DOH license. 8 Inspector to explain the GPP compliance requirement 9 Inspector to explain the GPP compliance requirement 10 Inspector to explain the GPP compliance requirement

6

PHARMACY STAFFING 11

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

11 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.

7

38. Who hands the medicine to the patient or care-giver?12

Driver/ courier

Other personnel

Pharmacy technician

Pharmacist’s assistant post

basic

Pharmacist and/or pharmacist intern

39. How many items prescribed by an authorised prescriber are dispensed per day on average?

40. How many Pharmacist Initiated Therapy Items are dispensed per day on average?

Comments and/or corrective action

(D) REGISTRATION DETAILS

N/A

Do

es n

ot

co

mp

ly

Co

mp

lies Weight

41. The name of the responsible pharmacist is displayed conspicuously at the main entrance of the pharmacy.13

0

3

3

42. 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.14 & 15

0

3

3

43. 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.16

0

3

3

44. The pharmacy is under the continuous personal supervision of a pharmacist.17

0

3

3

45. A currently valid registration card(s) is available for the pharmacist(s) N/A

0

3

7

46. A currently valid registration card(s) is available for the pharmacy support personnel (qualified)18

N/A 0

3

7

47. 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

N/A 0 3 7

48. A valid original licence issued by the Director-General (in terms of section 22 of the Pharmacy Act) or a registration 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

0

3

3

49. A patients’ rights and responsibility poster is displayed conspicuously displayed for the purpose of identification by the public

Comments and/or corrective action required for all items marked ‘does not comply’

12 For information only 13. The main entrance refers to the entrance as specified on the original professionally drawn pharmacy floor plan; refer to GPP requirements. 14. GPP requirements. 15. Name and Surname of pharmacist(s) as per Council registration card. 16. Ensure that the name tag specifies both the name as well the designation (e.g. Pharmacist, Pharmacist assistant, etc). 17. The name of the pharmacist in charge as per his/her Council registration card. 18 Pharmacists assistant (basic and post basic), Pharmacy Technical assistants (PTAs) and Pharmacy Technicians



8


(E) PREMISES AND LAYOUT

N/A

Do

es n

ot

co

mp

ly

Co

mp

lie

s

Weight

50. The premises are clean.

0

3

5

51. The premises are orderly and tidy.

0

3

5

52. (a) The dispensary is suitably located in the pharmacy in relation to the consultation areas.

0

3 5

(b) The dispensary is suitably located in the pharmacy in relation to an area to clean equipment and other utensils.

0

3

5

53. The pharmacy is accessible to persons with disabilities (OHS Act). 0

3

5

54. The floor surface in the dispensing area is of impermeable material. 0

3

5

55. All working surfaces are finished with a smooth, impermeable and washable material which is easy to maintain in a hygienic condition.

0

3

5

56. Countertops are finished with a smooth, impermeable and washable material which is easy to maintain in a hygienic condition.

0

3

5

57. Shelves are finished with a smooth, impermeable and washable material which is easy to maintain in a hygienic condition.

0

3

5

58. Walls are finished with a smooth, impermeable and washable material which is easy to maintain in a hygienic condition.

0

3

5

59. The pharmacy premises are clearly identified and demarcated from premises of any other business or practice.

N/A 0 3 5

60. 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

61. 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)19 N/A

0

3

5

62. 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; and 0 3 5

(c) Compromises the quality, efficacy and safety of the medicine. 0 3 5

(E) PREMISES AND LAYOUT (Continued)

19 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.



9


N/A

Do

es n

ot

co

mp

ly

Part

iall

y

co

mp

lie

s

Co

mp

lie

s

Weight

63. The lighting is suitable and effective to ensure sufficient vision of detail.

0 1 3 5

64. The temperature in the pharmacy is below 25C (as checked with a thermometer).

0 1 3 5

65. 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

66. There is an air conditioning system in the pharmacy.

0 1 3 5

67. The air conditioning system is in good working condition to be effective to keep the temperature at and below 25 degrees Celsius.

0 1 3 5

68. The temperature is recorded on a daily basis during working hours or operating hours as per SOP on temperature control.

0 1 3 5

69. There is at least one fire extinguisher or fire hose in the pharmacy in accordance with the Occupational health and safety Act (OHS Act).20

0 3 5

70. 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

71. The electrical equipment used in the practice of pharmacy is regularly maintained and safe as per manufacturer’s requirements (OHS Act).

0 1 3 5

72. 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

73. The total floor area is sufficient for the efficient operation of dispensary staff.

0 1 3 5

74. The workflow in the pharmacy is efficient, organized and orderly in accordance with relevant the SOP.

0 1 3 5

75. The pharmacy is designated as a non-smoking area

0 3 5

76. The pharmacy is designated as a non-eating area, other than in areas specifically designated as eating areas.

0 3 5

Comments and/or corrective action required for all items marked ‘does not comply’ or ‘partially complies’

PREMISES AND LAYOUT (Continued)

20 Occupational Health and Safety act, Act 85 of 1993



10


N/A

Do

es n

ot

co

mp

ly

Part

iall

y

co

mp

lie

s

Co

mp

lie

s

Weight

77. The waiting area is situated near the dispensary area.

0 1 3 5

78. The waiting area is under cover.

0 1 3 5

79. The waiting area is near areas for counselling and the furnishing of advice.

0 1 3 5

80. The waiting area has comfortable seating available/provided.

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 tests, in accordance with GPP standards. (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. 0 1 3 5

86. Key, key card or other device or the combination of any device which allows access to the pharmacy when it is locked, is kept in person of the responsible pharmacist or the person of another pharmacist at all times.

N/A 0 1 3 5

87. There is a separate facility for washing hands in the dispensary. 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. Only the pharmacist(s) has keys to the pharmacy area where schedules 1 – 6 items are kept.

0 1 3 5

91. There is a separate facility for cleaning of equipment. 0 1 3 5

92. There is a separate facility where extemporaneous compounding is carried out. 0 1 3 5

93. There is a suitable separate facility that complies with GMP standards where bulk compounding is carried out.

N/A 0 1 3 5

94. There is a suitable separate facility that complies with GMP standards where bulk pre-packing is carried out.

N/A 0 1 3 5




11


(F) EQUIPMENT

N/A

Do

es n

ot

co

mp

ly

Part

iall

y

co

mp

lie

s

Co

mp

lie

s

Weight

95. The pharmacy has:

95.1 adequate pestles and mortars;

0 1 3 2

95.2 adequate spatulas;

0 1 3 2

95.3 a suitable calibrated mass meter for dispensing capable of weighing at least 50mg of a substance;

0 1 3 2

95.4 an adequate range of graduated, stamped glass or plastic measures;

0 1 3 2

95.5 adequate medicine containers for the dispensing of medicines;

0 1 3 2

95.6 adequate warning labels or clearly noticeable warning indications on the hand written or computer generated label;

0 1 3 2

95.7 sufficient counting apparatus for tablets and capsules.

0 1 3 2

96 Counting trays are cleaned in order to prevent cross-contamination as per SOP.

0 1 3 2

97 All the equipment in the pharmacy is clean as per SOP.

0 1 3 2

98 All the equipment in the pharmacy is in good working order.

0 1 3 2

99 The pharmacy has suitable refuse receptacles, with closing lids where applicable.

0 1 3 2




12


(G) STORAGE OR STORAGE AREA

N/A

Do

es n

ot

co

mp

ly

Part

iall

y

co

mp

li

es

C

om

pli

es

Weight

100 Medicines are stored according to a system.

0 1 3 3

101 Storage area is large enough to allow for orderly arrangement of stock and proper stock rotation.

N/A 0 1 3 3

102 The store is kept locked at all times when not in use (if dedicated bulk pharmacy store). N/A 0 1 3 3

103 There are no cracks, holes or sign of water damage in the facility. N/A 0 1 3 3

104 The ceiling is in good condition. N/A 0 1 3 3

105 The floor is swept daily in accordance with SOP. N/A 0 1 3 3

106 Shelves are dusted daily in accordance with SOP. N/A 0 1 3 3

107 Walls are clean in accordance with SOP. N/A 0 1 3 3

108 The storage area is tidy in accordance with SOP. N/A 0 1 3 3

109 Pest control is conducted regularly in accordance with SOP N/A 0 1 3 3

110 Storage areas are situated so that products are protected from potentially harmful influences.

N/A 0 1 3 3

111 All goods are stored off the floor in accordance with SOP. N/A 0 1 3 3

112 Supplies are stored neatly on shelves in boxes, in accordance with SOP. 0 1 3 3

113 Raw materials known to be at risk of /for cross-contamination are stored separately or quarantined.

N/A 0 1 3 3

114 Proper care and control is exercised over hazardous substances (e.g. caustic soda, insecticides etc.) which are stored separately and safely.

N/A 0 1 3 3

115 Proper care and control is exercised over flammable substances (e.g. ether, methylated spirits etc.) which are stored separately and safely.

N/A 0 1 3 3

116 A system is in place to ensure effective stock rotation (refer also SOP section). 0 1 3 3

117 There are no expired medicines on the shelves (refer to relevant SOP). 0 1 3 3

118 Expired stock is kept separate from normal trading stock. 0 1 3 3

119 Damaged stock is kept separate from normal trading stock 0 1 3 3

120 Contaminated stock is kept separate from normal trading stock. 0 1 3 3

121 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

122 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

123 There is a separate and secure receiving area, which is under cover. 0 1 3 3

124 There is a separate and secure dispatch area, which is under cover. N/A 0 1 3 3

125 Stock is checked on receipt for quantity, quality, damaged containers, type, storage conditions and expiry dates.

0 1 3 3

126 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

127 There is a system for the correct handling of the various types of goods returned from patients (refer also SOP section).

0 1 3 3

128 Is any pre-packing performed on the premises?

No

Yes

129 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

130 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

131 All veterinary medicines sold comply with Regulation 48 of Act 101 of 1965 i.e. labelling requirements for veterinary medicines.

N/A 0 1 3 3



13


N/A

Do

es n

ot

co

mp

ly

Part

iall

y

co

mp

li

es

C

om

pli

es

Weight

132 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

133 There are no illegal or counterfeit medicines on the premises (as observed). 0 1 3 3

134 There are no unregistered non- proprietary medicines on the premises (as observed).21 0 1 3 3


21 This excludes vitamin preparations and complementary medicines



14


(H) CONTROL OF MEDICINES, SCHEDULED SUBSTANCES AND ACTIVE

PHARMACEUTICAL INGREDIENTS/MEDICINES

N/A

Do

es n

ot

co

mp

ly

Part

iall

y

co

mp

li

es

Co

mp

li

es

Weight

135 A computerised programme is used for dispensing.22 No Yes

136 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

137 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

138 A prescription record is kept for 5 years as required in Regulation 11(3) of Act 101 of 1965.

0 1 3 7

139 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

140 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

141 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

142 S1-S5 medicines are stored/displayed in areas inaccessible to the public. N/A 0 1 3 7

143 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.

0 1 3 7

144 All S2 to S6 medicine dispensed or sold are recorded in a prescription book or other permanent record as required in Regulation 11(1) of Act 101 of 1965.

0 1 3 7

145 Are S6 medicines ordered, stored or supplied at any time?23

No

Yes

146 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

147 S6 medicines are locked away and the key is under the control of the pharmacist. N/A 0 1 3 7

148 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

149 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


22 For information only 23 For information only



15


CONTROL OF MEDICINE/RECORD KEEPING (continued)

150 Does the pharmacy deliver medicines by mail?

Yes No

151 Does the pharmacy deliver medicines by courier?

Yes No

152 Does the pharmacy deliver medicines by delivery person?

Yes No

153 Does the pharmacy deliver medicines by any other means (e.g. train etc.)?

Yes No

154 If question 161 was answered ‘yes’, PLEASE SPECIFY by which means:24

155 Such indirect supplies (refer questions 158 to 162)) comply with all GPP requirements i.r.o. the following: N

/A

Doe

s n

ot

co

mply

Part

iall

y

co

mp

lie

s

Com

plie

s

Weight

155.2 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

155.3 A control system is implemented that enables detection and correction of a delay in the delivery process.

N/A 0 1 3 7

155.4 Medicines are packaged and stored in accordance with Medicines Control registration requirements throughout the delivery process.

N/A 0 1 3 7

155.5 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


24 For information only (question 158 to 162)



16


(I) THERMOLABILE MEDICINES

NB. Mark N/A only in the case where the answer to 164 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

li

es

Co

mp

li

es

Weight

156 Are thermolabile medicines purchased, stored or supplied at any time?25

No

Yes

157 All thermolabile medicines are stored in a refrigerator. N/A 0 1 3 6

158 Only medicines are stored in the refrigerator. N/A 0 1 3 6

159 Medicines are stored in the refrigerator according to a system. N/A 0 1 3 6

160 The refrigerator is suitable and in good working order. N/A 0 1 3 6

161 The refrigerator is fitted with a warning system to indicate that refrigeration has failed

or temperatures were above or below 2C and 8C2627

N/A 0 1 3 6

162 The temperature of the refrigerator is between 2C and 8C (as checked with a thermometer).

N/A 0 1 3 6

163 The temperature of the refrigerator/cold room is controlled 24 hours a day by a WHO approved dial thermometer or alcohol thermometer as demonstrated by the use of either chart recorders, or electronic recorders to continuously record the temperatures.28

N/A 0 1 3 6

164 The temperature of the refrigerator is recorded twice daily in accordance with GPP standards.

N/A 0 1 3 6

165 Thermolabile medicines are stored/supplied maintaining the cold chain. N/A 0 1 3 6

166 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 as to how the temperature is controlled is provided and/or kept.

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 165.


25 For Information only 26 This refers to continuous temperature monitoring to alert the pharmacist even when they are off-site of the variations in temperatures. 27 Always Check page 20 for the SOP’s on delivery of medicines and cold chain management (question186 and 188) and ensure that these are congruent. 28 Expanded Program of Immunization (EPI) provisions applies.



17


(J) DISPENSING OF PRESCRIPTIONS

N/A

Do

es n

ot

co

mp

ly

Part

iall

y

co

mp

li

es

Co

mp

li

es

Weight

167 Generic substitution is applied in accordance with Section 22(F) of Act 101 of 1965. 0 1 3 5

168 Dispensed medicine is labelled as required in Regulation 8(4) of Act 101 of 1965. 0 1 3 5

169 Every prescription dispensed is checked and signed off by a pharmacist. 0 1 3 5

170 The original prescription states who the dispenser as indicated by both the name on the trailer label and a signature on the prescription.

0 1 3 5

171 The final price that the patient pays is indicated on the copy for the payer (as applicable). 0 1 3 5




18


(K) PROVISION OF PHARMACEUTICAL CARE

N/A

Do

es n

ot

co

mp

ly

Part

iall

y

co

mp

li

es

C

om

pli

es

Weight

172 The pharmacist obtains all the relevant patient information before dispensing the prescription.

0 1 3 2

173 The pharmacist evaluates the prescription to identify any possible problems before dispensing the prescription.

0 1 3 2

174 The pharmacist takes the necessary action if there are any problems with the prescription and/or medicine prescribed.

0 1 3 2

175 The pharmacist gives advice to the patient or care-giver after the prescription has been dispensed.

0 1 3 2

176 The pharmacist gives advice to patients who receive Pharmacist initiated therapy (PIT). N/A 0 1 3 2

177 Advice is given to the patient in a suitable semi-private area. 0 1 3 2

178 Support aids are used when supplying advice (as observed). 0 1 3 2

179 Form(s) of support aids used:29 (multiple selections)

Pamphlets/ informati

on leaflets

Manufacturers

package inserts

Compute

r printouts

Visual aids

e.g. diagrams/post

ers

Others: Please specify

180 Patient information leaflets are available at the dispensary. 0 1 3 2

181 Procedure is in place for monitoring the patient’s progress.

0 1 3 2

182 A pharmacist can be contacted 24 hours a day and their contact details are displayed conspicuously at the main entrance of the pharmacy

0 1 3 2

The pharmacy is open From To And

again: From

To Total hours

open/day N/A

183 Mondays to Thursdays:

184 Fridays:

185 Saturdays:

186 Sundays:

187 Public holidays:


29 For Information only



19


(L) WRITTEN STANDARD OPERATING PROCEDURES

There are written standard operating procedures for: N/A

Do

es n

ot

co

mp

ly

Part

iall

y

co

mp

li

es

C

om

pli

es

Weight

188 good housekeeping (cleaning procedures etc.).

0 1 3 3

189 pest (insects, rodents etc.) elimination. 0 1 3 3

190 receipt of stock. 0 1 3 3

191 effective stock rotation (FEEFO – First entry, expiry, first out). 0 1 3 3

192 disposal or removal of S1 – S6 expired, damaged and/or contaminated stock as required in Regulation 27 of Act 101 of 1965.

0 1 3 3

193 product types requiring special storage or handling instructions. 0 1 3 3

194 separation and handling of goods returned from patients. 0 1 3 3

195 recall of medicine. 0 1 3 3

196 delivery of medicines. N/A 0 1 3 3

197 procedures to be followed regarding the handling of keys, money, etc for a locum or relief pharmacist(s) (where applicable).

N/A 0 1 3 3

198 cold chain management (including procedures to be followed in the event of a power failure). N/A 0 1 3 3

199 enquiry or complaint procedure 0 1 3 3

200 stock-taking. 0 1 3 3

201 obsolete or unusable stock. 0 1 3 3

202 storage of medicine. 0 1 3 3

203 procurement of medicine. 0 1 3 3

204 handling of product complaints. 0 1 3 3

205 pre-packing (including quality assurance procedures) (where applicable). N/A 0 1 3 3

206 handling of S5 and S6 medicines. 0 1 3 3

207 reporting of adverse drug reactions. 0 1 3 3

208 SOPs are reviewed/updated on a regular basis and are adapted to the operations of the specific pharmacy, and staff trained on the SOP’s.

0 1 3 3




20


(M) REFERENCES

The pharmacy has copies of, or electronic access to30: N/A

Do

es n

ot

co

mp

ly

Part

iall

y

co

mp

li

es

C

om

pli

es

Weight

218. - one of the last 5 editions of the Martindale. 0 1 3 3

219. - the latest edition of the Good Pharmacy Practice (GPP) Manual. 0 1 3 3

220. - the latest edition of MIMS. 0 1 3 3

221. - a comprehensive textbook on complementary medicine. 0 1 3 3

222. - the latest edition of Daily Drug Use (Tincture Press Publications) or other Drug Interactions reference source.

0 1 3 3

223. - the latest edition of either MDR or SAMF. 0 1 3 3

224. - a recent and comprehensive textbook on Pharmacology (not older than 10 years).

0 1 3 3

225. - a medical dictionary. 0 1 3 3

226. - a guideline for non-substitutable list of medicine31 0 1 3 3

227. - 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.

0 1 3 3

228. - a paediatric Dosing Reference Guide. 0 1 3 3

229. - NDOH- Adult Standard Treatment Guidelines for Hospital. N/A 0 1 3 3

230. - NDOH-Paediatric Standard Treatment Guidelines for Hospital. N/A 0 1 3 3

231. - NDOH-Primary Health Care Standard Treatment Guidelines. 0 1 3 3


30 In case of electronic access the Responsible Pharmacist/Pharmacist in charge must produce valid subscription evidence. 31 Refer to correct document



21


(N) GENERAL

Do

es n

ot

co

mp

ly

Co

mp

li

es

Weight

232. Medicines are advertised in accordance to GPP standards, code of conduct and Regulation 45 of Act 101 of 1965.32

0 3 1

233. A pharmacist has undergone and recorded a form of continuous education/professional development within the last 2 years (No penalty)

No

Yes

Informal

Formal

234. No arms/ammunition are sold in the pharmacy. 0 3 1

235. No fireworks are sold in the pharmacy. 0 3 1

236. No alcohol, other than that registered for medicinal purposes, is sold in the pharmacy. 0 3 1

237. No tobacco, snuff, cigarettes and tobacco related substances are sold in the pharmacy (this excludes medicinal snuff and anti-smoking aides).33

0 3 1

238. Gambling services are not promoted and offered in the pharmacy 0 3 1


32 The Responsible Pharmacist must ensure that they comply with the provisions of the GPP as contained in section 4.2 (4.2.1 (d)) and 2.1. 33 Refer to the Tobacco Products control Act, Act 83 of 1993.



22


(O) PROMOTION OF PUBLIC HEALTH

N/A

Do

es n

ot

co

mp

ly

Part

iall

y

co

mp

li

es

C

om

pli

es

Weight

239. Are Family Planning services rendered at the pharmacy?34 No

Yes

240. Has the pharmacist(s) registered his/her Family Planning qualification with Council? N/A

0

3

4

241. 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

242. Are Primary Care Drug Therapy (PCDT) services rendered at the pharmacy?35 No

Yes

243. Has the pharmacist registered his/her Primary Care Drug Therapy (PCDT) qualification with Council?

N/A 0

3

4

244. 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

245. an adverse drug reaction reporting system is in place as per the provisions of the GPP (4.3.3)

0 1 3 4

The following services are rendered in accordance with GPP standards:36

N/A

Doe

s n

ot

co

mply

Part

ially

com

plie

s

Com

plie

s

Weight

246. Blood pressure monitoring. N/A 0 3 4

247. Pregnancy testing. N/A 0 3 4

248. Determining of blood sugar levels. N/A 0 3 4

249. Cholesterol screening tests. N/A 0 3 4

250. Urine analysis (screening tests). N/A 0 3 4

251. Immunisation services (in accordance with National guidelines). N/A 0 3 4

252. HIV testing on request from patient (in accordance with National guidelines.) N/A 0 3 4

253. Mother and childcare services. N/A 0 3 4

254. Others please specify: N/A 0 3 4

255. The above-mentioned services are rendered in a suitable consultation area. N/A 0 1 3 4

256. Who renders the above services?37 N/A No

services rendered

Other health care

professional

Pharmacist’s assistant

Pharmacist and/or

pharmacist intern

N/A

Please specify other:


34 For information only 35 For information only 36 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. 37 For information only



23


(P) 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 pharmacy support personnel

257. A pharmacist intern was trained within the last three years. No Yes

258. A pharmacy support personnel was trained within the last three years. No Yes

259. Would the pharmacist accept responsibility as a tutor for the training of a pharmacy support personnel?

No Yes

260. Is there evidence that the prospective tutor participates in continuing education/professional development?38

No Yes

261. Is there disciplinary action pending against the prospective tutor? No Yes

262. 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’

38 Advice prospective tutor to perform the CPD requirements by logging onto the CPD site on the SAPC website and complete the four CPD

entries required if they have not already done so



24


(Q) SIGNATURES

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.

263. Signature of pharmacist in charge during inspection:

264. Name and P-number of above pharmacist in charge during inspection (in block capitals) (refer question 20):

P

265. Signature of inspector:

266. Duration of inspection: (refer inspection start time on page 2)

Duration (no. of hours)

Inspection end time H H M M

FURTHER COMMENTS

community pharmacy inspection … confidential community pharmacy inspection questionnaire to...

Documents