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Mbonye, AK; Buregyeya, E; Rutebemberwa, E; Clarke, SE; Lal, S; Hansen, KS; Magnussen, P; LaRussa, P (2016) Prescription for antibiotics at drug shops and strategies to improve quality of care and patient safety: a cross-sectional survey in the private sector in Uganda. BMJ Open, 6 (3). e010632. ISSN 2044-6055 DOI: 10.1136/bmjopen-2015-010632 Downloaded from: http://researchonline.lshtm.ac.uk/2537382/ DOI: 10.1136/bmjopen-2015-010632 Usage Guidelines Please refer to usage guidelines at http://researchonline.lshtm.ac.uk/policies.html or alternatively contact researchonline@lshtm.ac.uk. Available under license: http://creativecommons.org/licenses/by/2.5/

BASELINE SURVEY OF THE PRIVATE CLINICS AND DRUG SHOPS. Title of the study: Prescription of antibiotics at drug shops and strategies to improve quality of care and patient safety: a cross-sectional survey in the private sector in Uganda. Study Investigators: Prof. Anthony Mbonye, Prof. Elizeus Rutebemberwa, and Dr. Esther Buregyeya Drug Shop/Private clinic Consent Form Introduction This research study is being conducted by Makerere University School of Public Health. You are being asked to take part in a study Assessing the effect of strengthening referral of sick children from the private health sector and its impact on referral uptake in Uganda. This study aims to test a community-based intervention to encourage uptake of referral. We are asking you for your consent to be interviewed as part of this study because you are a service provider in this community. Your selection has been random, but your participation in this study is voluntary. Purpose of the Research This study aims to improve referral of sick children from the private sector to higher facilities. We are carrying out a baseline study, where we will collect information regarding address/location, staffing, drug stocks and services provided by your clinic/drug shop.in addition, we are seeking for your consent in the follow up study, i.e a randomized controlled trial (RCT).This study is intended to provide information that will help to improve referral of sick children from the private sector across the country. Your Part in the Study If you agree to participate in the study you will be interviewed for about 30minutes, and if you consent to participate in the follow up study, you will be trained in the standard management of malaria, pneumonia and diarhoea integrated community management of fever after that be given appointments for follow-up interviews. Procedures You will be interviewed to obtain basic information, including address, services offered, qualifications and number of health providers, drug availability and services offered by your clinic/ drug shops. We will also seek you consent to participate in a follow on study where we will test a community-based intervention to encourage uptake of referral. All of the information you share will be confidential and the information you provide will only be available to the research team. If You Decide not to Participate in the Study Your participation in the study is voluntary and there is no penalty for refusing to take part. There will be no cost to you as a result of participating in this study. Confidentiality The information you provide will be confidential. We will not put your name or the name of the clinic/drug shop on the questionnaire form on which your responses will be recorded. Paper records from this study will be stored in a locked file cabinet accessible only to study staff. Computerized information about you will be password-protected and accessible only to study investigators. If we publish the results of the study the name of the clinic/drug shop will not be in it. Benefits There will be no personal benefits from participating in this baseline study. However, if you consent to participating on the follow on study, you will be trained in ICCM. In addition, this study will help us understand how to strengthen referral of sick children from private sectors to higher facilities inuganda. Risks or Discomfort 1

You may lose some of your clients after referring them, however it will be to their benefit in getting proper care. But once the caretakers are made to understand the reason for the referral, they will appreciate it and will still come to your facility for care. You may refuse to answer questions that make you feel uncomfortable, and you may choose to end the interview and your participation in the study at any time. The information you provide will be kept confidential. Contact Person for Questions If you have any questions about the study or any problems with the study you may contact Assoc. Prof. Anthony Mbonye, the PI at the following telephone number (0772-411668). If you have any questions about your rights as a participant in this study please contact Dr. Suzanne Kiwanuka, the Chairperson of the School of Public Health Ethics Committee, at the telephone number 0312 291 397 or 0718 060 387. Consent to Participate in Study I have been informed of the procedures, benefits and risks of participating in this study titled: Assessing the effect of strengthening referral of sick children from the private health sector and its impact on referral uptake in Uganda.. I agree to participate as a volunteer in this study. I agree for my shop to be part of the trial: Name of Drug Shop/private clinic: Type of facility: 1. Drug shop 2. Private clinic Name of Trading Centre/Village: Identity of Enumeration Area: Sub-County: Name of Drug Shop Owner: Signature: Date: I have discussed the study with the drug shop owner/private clinic named above, in a language he/she can comprehend. I believe he/she has understood my explanation and agrees to take part in the trial. Name: Signature: Date: Q1. Do you consent that the drug shop/private clinic will participate in the study? Q2. If refused consent what was the reason? 1 Too busy 2 Too ill 3 Not interested 4 Refuses to give reason 77 Other (specify) If other: [ ] 2

Section A: Background Information A1 Date of interview (dd/mm/yy) // A2 Name of interviewer [ ] Interviewer s code A3 Enumeration area code A4 District [ ] A5 Locality 1 Urban 2 Rural A6 Village [ ] Village code A7 Parish [ ] Parish code A8 Sub-county [ ] Sub-county code A9 Name of drug shop/private clinic [ ] Drug shop/private clinic code A10 Type of facility 1. Drug shop 2. private clinic A11 GPS coordinates (xxxx). [ ] ] Section B: Characteristics of the drug shop/private clinic B1 Is this drug shop/private clinic registered? go to B2 go to B3 go to B4 B2 If not registered, why not? go to B5 [ ] B3 Who are you registered with? 1 District (DDI) (receipt seen) 2 National Drug Authority (NDA) (certificate seen) B4 When was this drug shop/private clinic / ] Year B5 B6 B7 B8 B9 established? (Year/months) Which days of the week is this drug shop/private clinic open? (please tick all day mentioned) What time do you usually open this drug shop/private clinic? (week days) What time do you usually close this drug shop/private clinic? (hh/mm)- week days What time do you usually open this drug shop/private clinic? (hh/mm)- weekends What time do you usually close this drug shop/private clinic? (hh/mm)- weekends months Mon Tue Wed Thur Fri Sat Sun : am : pm : pm : pm 3

B10 B11 B12 B13 B14 B15 What is the busiest time for this drug shop/private clinic? 1 Morning (up to 12pm) 2 Afternoon (12pm-5pm) 3 Evening (5pm-7pm) 4 Night (7pm-12am) 5 Busy 24 hours 77 Other (specify) Do you have a patient register? if No go to B13 Is the patient register present? (Ask to see it) On a typical day how many children with fever aged less than 5 years visit this drug shop/private clinic? (If don t know write 88) On a typical day how many children with cough aged less than 5 years visit this drug shop/private clinic? (If don t know write 88) On a typical day how many children with diarrhea aged less than 5 years visit this drug shop/private clinic? (If don t know write 88) If other: [ ] Section C: Staff characteristics ( staff who run the drug shop/private clinic C1 Sex 1. Male 2. Female C2 C3 What is your job or profession? 1 Nursing Aide 2 Nursing assistant 3 Enrolled nurse/midwife 4 Registered Nurse/midwife 5 Clinical Officer 6 Doctor 77 Other (specify) What is your highest level of education? 1 Primary 2 Secondary 3 Tertiary (certificate/diploma) 4 University 77 Other (specify) If other: If other: 4

C4 C5 C6 Is this your main place of work? How many people working at this drug shop/private clinic dispense medicines? What is the job or profession of the other person(s) working at this drug shop/private clinic? (write the number of staff for each profession) If no specify other place of work: Profession Number 1. Registered nurse/midwife 2. Enrolled nurse/midwife 3. Nursing Aide 3. Clinical officer 4. Doctor 88. Don t know 99. Refuses to answer Other (specify) Section D: Drug stock and supply D1 Do you sell antimalarial drugs? 99. Refuses to answer D2 If yes, which brands of antimalarials do you sell? (Tick all that apply) D3 D4 Do you sell antibiotics? 99. Refuses to answer If yes, which brands of antibiotics do you sell? (Tick all that apply) 1. Chloroquine 2.Fansidar 3. Coartem/lumatem 4. Camoquine 5. Quinine 6. Metakelfin Other (specify) 1.Amoxicillin 2.Septrin 3.Tetracycline 4.Gentamycin 5.Penicillin 77.Other (specify) 5

D5 D6 D7 D8 D9 D10 Do you sell zinc tablets? 99.Refuses to answer Do you sell ORS? 0. No 1. Yes 99. Refuses to answer Do you have stock control cards? (Ask to see them) Do you normally inject patients here in your shop/private clinic? go to D10 go to D9 go to D10 In the last week, how many injections did you give? Where do you usually purchase your drugs from? (Tick all that apply) _injections 77. Other specify 1. Pharmacies 2. Health Units 3. Open Markets 77. Other (specify) 6

Section E: Malaria, Pneumonia and diarrhoea treatment services E1 E2 E3 E4 E5 Have you attended any training workshops on management of malaria? go to E5 go to E2 go to E5 go to E5 When was your last training? (mm/yy) (If don t know enter 88/88; if refuses to answer enter 99/99) Did the training cover 1. Microscopy? 2. Rapid Diagnostic Tests (RDTs) 3. Artemisinin Combination Therapies CTs) 4. IMCI Guidelines? Who provided the training? 1 Ministry of Health 2 The district health team 77 Other (specify).. Have you attended any training workshops on management of pneumonia? 0. No go to E9 1. Yes go to E6 88. Don t know go to E9 99. Refuses to answer go to E9 ] / 1. Yes. E6 When was the last training held? (mm/yy) ] / E7 E8 E9 Did the training cover 1. Antibiotics 2. IMCI Guidelines? Who provided the training? 1. Ministry of Health 2. The district health team 3. Other (specify).. 88. Don t know 99. Refuses to answer Have you attended any training workshops on management of diarrhoea? 0.No 1. Yes. 7

E10 E11 E12 E13 E14 E15 E15 E16 E17 1.Yes 88. Don t know 99. Refuses to answer Did the training cover 1. Microscopy? 2. Rapid Diagnostic Tests (RDTs) 3. Artemisinin Combination Therapies CTs) 4. IMCI Guidelines? Who provided the training? 3 Ministry of Health 4 The district health team 78 Other (specify).. 89 Don t know 100 Refuses to answer Is there a thermometer available for use at this drug shop/private clinic? (ask to see it) Is there a functioning microscope at this drug shop/private clinic? (Ask to see it) Do you have a malaria rapid diagnostic test (RDT) at this drug shop/private clinic? What is the first-line treatment of uncomplicated malaria as recommended by the treatment guideline? What is the first-line treatment of pneumonia as recommended by the guideline? What is the first-line treatment of diarrhea as recommended by the treatment guideline? Do you have a copy of the malaria treatment guidelines? (Ask to see it) 1. Yes. Specify the drug/s: Specify the drug/s: Specify the drug/s: 8

E18 Do you have a copy of IMCI guidelines? (Ask to see it) E 19 What treatment do you give to a child who presents uncomplicated malaria? E 20 In the last one week, how many children with severe illness did you see? E21 In the last two weeks have you referred any sick children? E22 If yes how many sick children have you referred (verify the numbers by checking the records) E23 Where did you refer the sick children? 1. Another drug shop 2. Another private clinic 3. Health centre (II, III, IV) 4. Hospital 77. Other (specify) E24 What are severe symptoms/signs of a child with severe malaria? (list as many) E25 E26 E27 What are severe symptoms/signs of a child with severe pneumonia? What are severe symptoms/signs of a child with severe diarrhoea? What constraints do you encounter in referring patients? (Tick all that apply) [ ] Other specify.. If other: [ ]......... 1. I don t have any constraints 2. Patients do not comply 3. Patients do not have the money 4. Referral facilities are too far 5. No drugs at the referral facility 77 Other (specify) 9

E28 When did this drug shop/private clinic last receive supervision from the DDI/DHT? Refuses to answer ] ] months 77. If other: [ ] 10

Section F: Observations F1 Does the shop/private clinic have a laboratory? F2 Does the shop/private clinic have disposable syringes and needles? F3 Does the shop/private clinic have a baby weighing scale? F4 Does the shop/private clinic have a respiratory timer? 0. No 1.Yes F5 Does the shop/private clinic have a bin for disposal of sharps? 11

Section G: Addendum-Malaria in pregnancy G1 G2 G3 G4 G5 Which people are most vulnerable to malaria in this community? 2. All people 3. Children (0-5) 4. Children (6-15) 5. Adults 6. Pregnant women 7. Other specify... What treatment do you give to pregnant women who present with fever to this facility? 1. Depends on gestation, if it is first trimester I give quinine, if second and third trimester i give ACT 2. ACT 3. SP 4. Quinine 5. Paracetamol 6. Other specify... What drug do you give to pregnant women for preventing malaria? 1. Quinine 2. ACT 3. SP 4. Other specify... What other malaria prevention interventions in pregnancy do you recommend 1. ITNs 2. IRS 3. Advice on nutrition 4. Other specify... What interventions do you suggest that can attract women to come for malaria prevention in pregnancy with SP at ANC?......... 12

Section H: Addendum-Family planning in drug shops/pharmacies H1 H2 Type of facility 1. drug shop 2. pharmacy Do you offer family planning methods in your shop 0.No 1. Yes H3 H4 If yes which methods (tick all applicable and verify) 1.pills 2. Condoms 3.Injectable Depo-Provera 4. IUD (coil) 5. Other specify... How much do you sell a cycle of contraceptive pills... H5 How much do you sell a packet of condoms... H6 In a week how many clients come to ask for... family planning? H7 If No would you like to offer family planning methods 0.No 1. Yes H8 H9 What are the reasons that you are not currently offering family planning methods? What do you recommend to government to do so that drug shops and pharmacies can offer family planning 1.training 2. provide family planning methods 3. Supervision 4.seminars 5.other (specify.................. 13