Post on 14-Jan-2016
transcript
Pharmacy Practices Provided by Dispensing Doctors in Zimbabwe
Hansen EH and Trap B
Danish University of Pharmaceutical
Sciences, Copenhagen, Denmark &
Euro Health Group, Denmark
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.
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
Study Aims
The quality of pharmacy practices provided by DDs
To examine
The study explored the quality of
1. Services2. Medicines3. Dispensingin relation to international standards for Good Pharmacy Practice (GPP)
Method
Design Cross-sectional, observational and questionnaire study based on GPP indicators
Setting Zimbabwe, Harare
Population170 DDs, 1635 NDDs and about 200 pharmacies
Sample29 DDs/215 patients, 28 NDDs and 20 pharmacies
Inclusion rateof 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
Developing measures of pharmacy practice quality
Patient oriented Product 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
+
Areas measured Outcome
Services quality
Medicines quality
Dispensing quality
INDICATORS
Methods and indicators for assessing GPP to be developed and standardised
no. of pt
time/pt
affordability
”one-stop –no shop”
availability
stock management
batch number
cleanliness
organisation
expiry
dispensing person
information
labelling
hygiene
privacy
Service quality (10)
Medicines quality (20)
Dispensing quality (14)
no. of pt
time/pt
affordability
”one-stop –no shop”
availability
stock management
batch number
cleanliness
organisation
expiry
dispensing person
information
labelling
hygiene
privacy
Service quality- 10 indicators
Medicines quality - 20 indicators
Dispensing quality - 14 indicators
Results
(Significant differences)
42
8,7
41
1010 13
72
00
20
40
60
80
>40 pt/day Consultation time(minutes)
Appointmentpossibility
Out of stock
DD
NDD
• GPP by DDs was poor in all three areas
1 Service 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 %
2 Medicines Quality (MQ)
0 10 20 30 40 50 60 70
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
Storage practices by DD in Zimbabwe in %
3
20
31
41
50
79
79
83
17
17
0 10 20 30 40 50 60 70 80 90
Stock cards in use
Stock management in place
Storage on table
Stores dirty/untidy
Several brands of one active ingredient
Expired drugs
Systematic storage system
Drug ordering by Dr
Refrigeration/ cool storage available
Quantification by memory
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
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
Dispensing quality by DD in Zimbabwe in %
34
41
26
56
59
0
50
28
14
0 10 20 30 40 50 60 70
Availability of glass/plastic containers
Unhygienic counting
Dispensing of medicines prescribed elsewhere
Appropriate labelling score
Appropriate information average score
Adverse information provided
Availability of essential drugs list
Lack of privacy
Dispensing staff trained in dispensing
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
• 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 SMARTi
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