The assessment of the pharmaceutical sector in Ethiopia was conducted from November - December 2002 G.C by PASS in collaboration with the World Health Organization Country Office. The assessment was mainly based on a cross-sectional survey carried out in five national regional states (Tigray, Amahra, Oromia, SNNPR, Benishangul-Gummuz) and Addis Ababa. It involved 7 hospitals, 19 health centers, 85 health stations, 5 regional drug stores of PHARMID, 24 private pharmacies/ drug shops and 490 households. This represents respective percentage sample sizes of 11.3%, 5.5%, 4.6% 71.4% and 5.4% of the hospitals, health centers, health stations, regional drug stores and private pharmacies/drug stores found in the surveyed regions.
The main objective of the study was to identify strengths and weaknesses in the pharmaceutical sector and give recommendations for improvement. Specifically, it was to see whether the target outcomes of the pharmaceutical sector (i.e. access, quality assurance and rational drug use) have been achieved and also determine whether Ethiopia has the necessary structures and mechanisms in place for improving its pharmaceutical sector.
The study has shown that the necessary structures and mechanisms required for the implementation of the NDP are more or less in place and a lot of achievements have been made. However, weaknesses in the implementation of the proclamation and some elements of the NDP were noted. For example, all manufacturers except one operate without having "certificate of competence" from DACA. Only drugs imported by the private sector are subjected to registration. The drug registration process is not linked to inspection of manufacturing sites abroad. The allocated drug budget was inadequate as revealed by a low per capita government drug budget of ETB 1.6(US$ 0.18), which is much lower than the target set in HSDP I (US$ 1.25) and the WHO's recommendation of US$ 1.00. There is no proper stock management in health facilities as revealed by absence of stock control tools such as stock card in 60 % of the surveyed health facilities.
Moreover, there is no specific NDP implementation plan that sets responsibilities, budget and time line although some elements of the NDP are incorporated in HSDPI. Monitoring and evaluation of the NDP was not included as an element of the policy itself.
The results of the survey have also revealed the following short comings in relation to achievement of the major out come of the implementation of the policy:
Accessibility of drugs
The national average for availability of key essential drugs in health facilities was 70%, 85% and 91 % for public health facilities, regional drug stores and private drug retail out lets, respectively. The figures are lower than the ideal value of 100 % and the 100 % target set in HSDP I.
The affordability of adult and child preparations in public heath care facilities was 135 % and 68 %, respectively. This means that approximately 1.4 days' and 0.7 days' salary of the lowest paid unskilled government employee is required to cover the cost of a single course of therapy of pneumonia in adult and children, respectively. On the other hand, affordability of adult and child preparations in private retail out lets was 195 % and 127 %, respectively and the same interpretation applies to this as well.
From the above data, we can conclude that drugs are less available but more affordable in public health facilities than in private drug retail outlets.
Average stock out durations in public health facilities and regional drug stores were 99.2 days, and 99 days, respectively. These figures are in stark contrast with the recommendation of zero stock out. Eighty-six percent of prescribed drugs are dispensed in public health facilities as compared with the ideal value of 100%.
It is obvious that all the above deviations from the standard norms have a cumulative negative impact on access to essential drugs.
Quality
On the average, the score for storage conditions were 6 and 8 on a scale of 0-11 in public health facilities and regional drug stores, respectively. These results are equivalent to an acceptable quality of drugs. However, the significant variations between health facilities and regions indicate the need for handling individual cases separately.
The national averages for presence of expired drugs in facilities were 8%, 2% and 3% in health facilities, regional drug stores and private drug retail outlets, respectively. Although the results are not alarming, the significant variation between health facilities and regions calls for precaution and further investigation.
In general, it is important to note that the factors investigated here are only indirect indicators of quality. It is difficult to make conclusion about the quality of drugs in the drug supply system since variables other than those investigated here also determine the quality of drugs.
Rational Drug Use
• The number of drugs prescribed per encounter was 1.9 and this is encouraging when compared with the ideal value of less than 2. However, the significant variations between health facilities and regions need careful investigation for future action.
• The percentage of antibiotic use was 58% and this is a bit high when compared with the ideal value of less than 20% and needs improvement.
• The percentage of injection use was 23% and this is an encouraging result when compared with the accepted norm of less than 15%.
• It was observed that on the average, 43% of drugs dispensed to patients in health facilities were inadequately labeled while the accepted norm is that 100% of them should have adequate label.
• The percentage of patients who knew how to take the drugs dispensed to them was 67% as compared with an ideal value of 100%.
• Only 39% of the health facilities surveyed had Standard Treatment Guidelines (STG) or list of essential drugs for the health facility or the region.
• Oral Rehydration Salt (ORS) was used in the treatment of uncomplicated diarrhea in children in 82% of cases as compared to an ideal value of 100%. Antibiotic and antidiarrhea/ antispasmodic drugs use was 50% and 3%, respectively, compared to the ideal value of zero percent in both cases.
• Percentage use of antibiotics in the treatment of non-pneumonia Acute Respiratory Tract Infection (ARTI) was 61% compared to ideal value of zero percent.
• Percentage use of first line antibiotics in the treatment of mild/ moderate pneumonia was 54% compared with the recommendation of 100% use. Prevalence of use of more than one antibiotic in treating the same condition was 2% as compared to recommended value of zero percent.
Although some of the above values are close to the ideal values, most of them deviate from the ideal value and they require proper interventions as indicated in the recommendation section of this report.
Household Survey
The results show that the major health care providers (68%) were public heath facilities. The percentage of people who did nothing about their illness (10%) was more than those who went to the private clinics (7%).
Public health facilities were the main sources of medicines (71%) followed by private pharmacies (18%) while the contribution of the informal sector as source of drugs was insignificant (< 1%). Forty-one percent of patients who could not get prescribed medicines mentioned the absence of medicine in public pharmacies as the main reason followed by lack of money (35%).
The level of compliance of patients to prescriptions was 91%, partial compliance 7% and absolute non-compliance 2%. The drug expenditure to income ratio has revealed that on the average 21% of estimated family weekly income or total weekly household expense is required to cover the cost of drugs to treat a single episode of illness.
Conclusion and recommendation
The study has shown both strengths and weaknesses in the pharmaceutical sector, which are related to policy /proclamation implementation and achievements of the target outcomes of the sector. To improve the situation, it is necessary to implement the interventions enumerated under the "recommendations" section of this report.