Essential Medicine Status of Registered Medicines
In Kenya, Tanzania, and Uganda, 72%, 50% and 60% of essential medicines had one or more registered products, respectively (see Table 1A). However essential medicine products accounted for only 29% (1801/6161) of all registered products in Kenya, 37% (1312/3590) in Tanzania, and 42% (1628/3896) in Uganda, with non-essential medicines comprising 4350, 2278 and 2268 registered products, respectively (see Table 1). The essential medicines that were not registered are described by class in Table 2.
43%, 33% and 23% of registered essential medicines Kenya, Tanzania and Uganda respectively had either one or two products only as shown in Table 1C and Fig. 1.
Table 1 The proportion of essential medicines with and without registered products. Indented are the reasons for which essential medicines did not correspond with any registered (n, %). B) The proportion registered medicines which are essential (Following exclusions). C) Number of products registered for each essential medicine (by key medicine).
|
Kenya
|
Republic of Tanzania
|
Uganda
|
A) Total Number of EML Medicines (n)
Registered Essential Medicines (n, %)
Non-registered Essential Medicines (n, %)
No Named Products
Wrong Dose
Wrong Preparation
Wrong Dose and Preparation
Incomplete Information
|
632
457 (72%)
175 (28%)
90
49
12
19
5
|
797
397 (50%)
400 (50%)
197
93
50
6
54
|
663
397 (60%)
266 (40%)
170
46
31
0
19
|
B) Total Number of Registered Products (n)
Essential Medicines (n, %)
Non-Essential Medicines (n, %)
|
6151
1801 (29%)
4350 (71%)
|
3590
1312 (37%)
2278 (63%)
|
3896
1628 (42%)
2268 (58%)
|
C) Registered Essential Medicines group by number of registered products (n)
1–2 products
3-15 products
More than 15 products
|
263
112 (43%)
122 (46%)
29 (11%)
|
220
72 (33%)
130 (59%)
18 (8%)
|
245
57 (23%)
163 (67%)
25 (10%)
|
Table 2 The proportion of essential medicines without registered products (n, %) shown by “Class” as defined by each country’s EMLS (Following exclusions). Highlighted rows indicate examples of >50% non-registration.
Essential Medicine Status of Highly Registered Medicines
There were 222 unique medicines (and fixed dose combinations) with more than 10 registered products. These accounted for 59% (8056/13637) of all products across the three countries. 42 unique medicines had over 50 registered products totalling 30% (4153/13637) of regional products. 21 of these were for non-communicable diseases and the remaining 21 were antimicrobials.
Antimicrobials
There were 21 unique antimicrobial medicines with over 50 registered products each, representing a total of 2310 products. 54% (1173/2310) were registered in a country where the medicine, including dose and formulation, appears on the essential medicine list (Table 3).
Of the total 2310 products 678 were non-antibiotic medicines such as antimalarial, antifungals and antiparasitic medicines. 64% (432/678) of non-antibiotic antimicrobials were present on national essential medicine lists. The remaining 1632 products were antibiotics. 45% (741/1632) of the antibiotics are essential medicines. When subdivided by WHO AWaRe classification, 42% (260/620) of Access antibiotics were essential and 50% (470/939) of Watch antibiotics were essential. No Reserve antibiotics had over 50 products. Combined Ampicillin and Cloxacillin is no longer recommended by the WHO but there are 73 registered products between the 3 countries. The combination is considered essential by Tanzania’s EML and 54% (13/24) of Ampicillin with Cloxacillin products registered in Tanzania met the EML specifications.
Many, sometimes the majority, of the highly registered antimicrobials were not essential. There were between 75 and 119 registered products for Amoxicillin and Clavulanic acid, also known as Co-Amoxiclav, in each country. 77% of these were not essential as they were the wrong dose, or formulation. Similarly, there were between 27 and 85 products for Cefuroxime and only 11% of these were considered essential, as it is not listed on either Tanzania’s or Kenya’s EML.
Table 3 Shows the number of antimicrobials registered in Kenya, Uganda, and Republic of Tanzania which have over 50 registered products. (EML = Product conforming to EML specification, NonEML = Non-conforming to EML specifications, Σ = Total (n), EAC = East African Community
* = Medicine does not appear on at least one national EML, n/a = not an antibiotic therefore no AWaRE category). Highlighted sections indicate examples of > 50% non-essential products.
Medicines for Non-Communicable Diseases
Highly registered medicines for non-communicable disease are shown in Table 4. The most commonly registered medicines can broadly be described as one of six classes: analgesics, cardiovascular medicines, anti-diabetic medicines, proton pump inhibitors, respiratory medicines, and steroidal medicines. The most commonly registered medicine (with 219 products in the EAC) is Diclofenac which in some forms is considered essential in The Republic of Tanzania and Uganda but not in Kenya. Other non-essential medicines are highly registered such as telmisartan, rosuvastatin and pregabalin with a total of 65, 65 and 77 products in the EAC.
Table 4 Shows the total number of non-communicable disease medicines registered in Kenya, Uganda, and Republic of Tanzania with more that 50 registered products of the same medicine and number of products. (EML= Product conforming to EML specification, NonEML= Non-conforming to EML specifications, Σ=Total (n), * = Medicine does not appear on at least one national EML, **= Medicines does not appear on any National EML in the EAC). Highlighted section indicate examples of >50% non-essential products.