1. Pharmacy Practices Provided by Dispensing Doctors in Zimbabwe Hansen EH and Trap B Danish University of Pharmaceutical Sciences, Copenhagen, Denmark & Euro Health Group, Denmark

2. Abstract Problem Statement: One crucial element of health care is access to essential medicines. Dispensing doctors both prescribe and dispense medicines and thereby can provide an alternative access to medicines in areas with no pharmacy services. While most countries strictly regulate the provision of medicines and dispensing by pharmacists, dispensing practices by doctors are less regulated and little is known about their quality. Objectives: To examine the quality of pharmacy practices as provided by dispensing doctors in relation to the international standards of Good Pharmacy Practice (GPP), assessing quality of service, medicines and dispensing. Design: Cross-sectional, observational and questionnaire study, based on indicators. Setting: Harare, the capital of Zimbabwe, with 10% of the private sector medical practitioners being dispensing doctors and with a large number of pharmacies. Study Population: Data were collected from 29 randomly selected dispensing doctors and, where feasible, compared to 20 randomly selected pharmacies or 28 non- dispensing doctors. Outcome Measures: Indicators were developed to measure (a) service quality (10) including affordability, patient care and availability; (b) quality of medicines (20) including stock management, storage, packaging and quality assurance; and (c) dispensing quality (14) including information, labelling, staffing and privacy. Results: Dispensing doctors were generally characterised by low dispensing quality. In 87% of practices, the doctor trained in dispensing did not actually do the dispensing, 41% of the patients received inadequate information and 44% of the medicines were not adequately labelled. In 28% of the practices, there was no opportunity for patient privacy and in 41% medicines were not dispensed hygienically. Medicine storage quality was substandard. Only half of the practices had a stock management system and only 4% recorded batch numbers. One-fifth of the storage areas were classified as dirty and untidy, half of the practices stored medicines in an unorganised manner and 41% had expired medicines in stock. Medicine prices were found to vary widely and were higher than in pharmacies. Conclusions: Pharmacy services from dispensing doctors were generally of low quality. There is a need for establishing a quality assurance system in line with the international standards for Good Pharmacy Practice. To this end universal indicators for pharmacy practice should be developed.

3. Background A Dispensing Doctor (DD) is defined as a medical practitioner permitted to sell and dispense a drug to some or all of his patients, either as an exemption from the general legislation governing the provision of pharmaceutical services, or as part of the overall provision of medical services In many countries, an individual is not allowed to serve as both doctor and pharmacist at the same time In these countries activities of the two professions are kept separate to avoid the conflict of interest that arises when a prescription may be influenced by the potential profit from both dispensing and selling medicine In e.g. Holland, Japan, South Africa, the UK and several states in the USA, doctors can obtain a licence to dispense medicines and become dispensing doctors (DDs) The number of DDs has increased in several countries While pharmacy services are highly regulated in most countries, there is little regulation of DDs Study from South Africa identified various quality problems in pharmacy practices related to the dispensing of medicines by doctors But empirical data on the performance of DDs are generally scarce Regardless of who is doing the dispensing, it is important to ensure the quality of the practice

4. Study Aims The quality of pharmacy practices provided by DDs To examine The study explored the quality of 1. Services 2. Medicines 3. Dispensing in relation to international standards for Good Pharmacy Practice (GPP)

5. Method Design Cross-sectional, observational and questionnaire study based on GPP indicators SettingZimbabwe, Harare Population 170 DDs, 1635 NDDs and about 200 pharmacies Sample 29 DDs/215 patients, 28 NDDs and 20 pharmacies Inclusion rate of selected and reachable 76% DDs, 74% NDDs and 91% pharmacies Data collection  Questionnaire based interviews with: DDs, the person dispensing in the DD’s practices, the pharmacists and patient exit interviews  Observations  Data collected by 3 data collection teams  Each team surveyed 17 to 21 practices equally distributed between DDs and NDDs

6. Developing measures of pharmacy practice quality Patient orientedProduct oriented Good Pharmacy Practice elements Policy aims 1 Promoting good health Avoiding ill health Achieving health objectives Affordability 2 Supply of medicines Administration of medicines Use of medicines 3 Selfcare Self-treatment Availability Accessibility Equity Quality 4 Influencing prescribing Influencing medicine use Rationel drug use Efficacy/ safety +

7. Areas measuredOutcome Services quality Medicines quality Dispensing quality INDICATORSINDICATORS

8. Methods and indicators for assessing GPP to be developed and standardised

9. Results GPP by DDs was poor in all three areas 1Service quality (SQ) NDDs prioritise SQ higher than DDs Medicine prices  Price setting by DDs less structured, resulting in major price variations  Up to 75% possible saving by buying at pharmacies  Only 4% of DDs dispense to make money Partnership  Single handed practices 76% DD vs. 61% NDDs GPP indicators in %

10. 2 Medicines Quality (MQ) 010203040506070 Patient cards available Dispensing book available Recording of batch no. DDs have insufficient administrative procedures, poor stock management, storage conditions and poor labelling  Dispensing information not recorded properly  Lack of dispensing books problematic especially where the doctor is not dispensing the drugs  Lack of batch number recording does not allow for recalls

11.  Poor implementation of stock management systems increases risk of: over/under stocking resulting in expiry, non-availability and poor quality dispensing the wrong and contaminated drugs

12. 3 Dispensing Quality (DQ) Low DQ was prevailing among DDs as measured by: training, dispensing-patient transaction, lack of privacy, unhygienic medicine counting, re-use of old bottles and inadequate dispensing conditions

13. Conclusions An indicator-based method for assessing the quality of pharmacy practices among DDs was developed. The method was practical and applicable. The method should be further refined with respect to standardisation and scoring criteria DDs provision of conventional pharmacy services was inadequate with regard to GPP 1.Service quality of DDs lower than NDDs 2.Medicine quality was not adequate as indicated by storage conditions etc. 3.Dispensing quality generally poor among DDs

14. It is essential that dispensing of medicines is provided in accordance with the standards of GPP, independent of who provides the services Most countries regulate and inspect pharmacies, DDs are regulated to a much lesser degree The pharmacy practices of DDs need to be better legislated and regulated if they are to become an acceptable part of the health care system The authorities need to set standards for medicines regulation, also for DDs, and to regulate dispensing, medicine management and the activities related to pharmacy practices WHO should consider developing recommendations re DDs GPP is not easily transformed into SMART i indicators for surveillance Need for further development of indicators for assessing GPP Policy implications and recommendations [1] SMART : Specific, measurable, achievable, realistic and time bound