Assessment of knowledge and practice on the identification and reporting of substandard and falsified medical products among Healthcare providers in Tanzania

doi:10.21203/rs.3.rs-4270746/v1

The circulation of substandard and falsified medical products in the pharmaceutical markets is a global health problem. The existence of these products undermines the efficiency of the healthcare delivery system and economic development. This research aimed at assessing the level of knowledge and practice among Tanzanian healthcare providers on the identification and reporting of substandard and falsified medical products. Participants included pharmacists, medical doctors, nurses, dentists, and medical laboratory scientists holding bachelor’s degrees and providing health services in Tanzania. Google forms were used for data collection and the Statistical Package for Social Sciences (SPSS) 23 was used for data analysis. About 81.9% and 71.2% of respondents were found to have a good level of knowledge and practice on substandard and falsified medical products identification and reporting respectively. However, 92.5% and 84% of the pharmacists were having higher knowledge and practice than other cadres. The age, experience, facility type, and professional cadres were significantly associated with both the respondent’s knowledge and practice. Furthermore, only 13.2% of the respondents reported having learned about substandard and falsified medical products from universities and 53.8% reported having no idea of reporting tools for these products. The level of knowledge and practice of Tanzanian healthcare providers on identifying and reporting substandard and falsified medical products was good. However, regular training and improvement of the medical school's curriculum are necessary to equip Tanzanian healthcare providers with the necessary knowledge and good practice in identifying and reporting Substandard and falsified medical products.

Substandard

Falsified

Medical products

Health care providers

Knowledge

Practice

The manufacture and sale of substandard and falsified (SF) medical products is a global problem that affects both developed and developing countries. The high demand for medical products and the high processing cost of genuine medications increase the risk of this falsification [1]. This problem is widespread in regions with less stringent regulatory authorities such as Africa and Asia compared to those with stringent regulatory authorities such as Europe and North America [2]. The production, distribution, and sale of substandard and falsified medical products constitute a substantial market valued at several billion dollars, comprising over 50% of the total products available in the market [3]. The business has also affected the development of genuine pharmaceutical industries due to unjustified competition in the markets since the quality products manufactured according to Good Manufacturing Practices (GMP) are much more expensive [4, 5].

The existence of substandard and falsified medical products threatens both patients' health and the government due to economic loss, increased disease burden, frequent hospitalizations, disabilities, and deaths [6–8]. In Africa, about 169,000 and 158,000 children die each year due to pneumonia and malaria following the administration of substandard and falsified antibiotics and antimalarial respectively [8]. Literature has shown that these problems happen when the Healthcare providers lack the appropriate knowledge for timely identification of substandard and falsified medical products before providing them to the end users[9, 10].

The problem of substandard and falsified medical products has also been observed in Tanzania [11–16]. In this case, the most important incident was the closure of the Tanzania Pharmaceutical industry (TPI) in 2012 due to a fake antiretroviral drugs (ARV) scandal [15–17]. Moreover, in 2018 the Tanzania Medicines and Medical Devices Authority (TMDA) reported that in the year 2005 to 2015 there had been removed from the market substandard and falsified medical products worth $ 13.7 million [17]. Due to the existence of these products in the market, there is a need for healthcare providers (HCPs) in Tanzania to be equipped with the appropriate knowledge necessary to handle any suspect of substandard and falsified medical products [18–20]. Therefore, this study was conducted to assess the level of knowledge and practice of Tanzanian healthcare providers on the identification and reporting of substandard and falsified medical products. So far, there is no such report in the literature. The study, therefore, presents an alert to the medical products surveillance of Tanzanian authorities in addition to the need for a review of curricula for respective higher learning institutions.

Study design

This is a descriptive cross-sectional study designed to assess the knowledge and practice of the Tanzania healthcare providers on identifying and reporting substandard and falsified medical products during the provision of healthcare services. Included are participants holding a minimum qualification of a bachelor's degree and must be licensed to practice in various medicine outlets in all administrative regions of Tanzania. Moreover, the study included only actively practising healthcare providers.

Study area and population

This study involved Medical doctors, Pharmacists, Nurse Officers, Dentists, and Medical laboratory scientists holding bachelor’s degrees. Involved participants were only those who are licensed to prescribe, dispense, administer medical products to patients and perform laboratory investigations for diagnosis, in private and public health facilities located in Tanzania. HCPs such as Radiologists were excluded from this study as they are mostly using medical equipment with few chemicals which are not directly consumed by patients for disease treatment.

Sampling techniques and sample size

A stratified sampling technique was used to get the study participants. Five strata groups were obtained with the classification based on the cadres to which the healthcare providers belong i.e., Medical doctors, Pharmacists, Nurses, Dentists, and Medical laboratory scientists. The registered personnel in each cadre were, 9538 Medical doctors, 4200 Nurse Officers, 2329 Pharmacists, 1242 Medical laboratory scientists, and 264 Dentists, this makes a total population of 17,573. The proportion sample from each cadre was 232 Medical doctors, 102 Nurse Officers, 57 Pharmacists, 30 Medical laboratory scientists, and 7 dentists. This makes a total sample size of 428 healthcare providers. The participants from each cadre were obtained through snowball sampling techniques and participated in the study conveniently.

Questionnaire and data collection methods

The questionnaire was adopted from previous similar studies [4, 18, 21, 22] and the data were collected through Google forms as an online survey. The participants recruited other targeted healthcare providers providing health services elsewhere (Fig. 1) by forwarding the tool through WhatsApp groups and email (Snowballing). A total of 773 Healthcare providers were therefore approached to fill out the questionnaire for the study as compared to the predetermined sample size of 428 Healthcare providers.

Description of variables

The main dependent variables were knowledge and practice among the healthcare providers on identifying and reporting substandard and falsified medical products. Independent variables such as age, sex, type of health facility, administrative zones, bachelor's degree studied, level of education attained, and experience were assessed to determine their association with knowledge and practice. Chi-square and Fisher’s exact test at P ≤ 0.05 were used as a measure of association. In the context of this study, Knowledge means a familiarity, awareness, or understanding of substandard and falsified medical products, their impacts on the patients, and the ways they are identified and reported. Whereas, Practice refers to any professional role played by a healthcare provider that is related to the handling of substandard and falsified medical products during the delivery of health services to clients.

Data processing and analysis

Data were analyzed using the Statistical Package for Social Sciences (SPSS) version 23. The number of questions was twelve for both knowledge and practice assessments. Each positive response (Yes) was assigned a score of 1, and negative responses (No or I do not know) were assigned a score of 0. The knowledge and practice were considered good for those who scored 7–12 questions and poor knowledge or bad practice for those who scored 0–6 questions as was done in the previous studies [21–22].

Ethical approval

The ethical clearance for conducting this study was obtained from the Institutional Review Board (IRB) of the Muhimbili University of Health and Allied Sciences (MUHAS). An informed consent form was provided to the study respondents to fill out. The privacy and confidentiality of the research participants' data were observed throughout the conduct of the study.

A total of 773 healthcare providers participated in this study. Responses from 0.8% (6) of the participants were excluded due to an incomplete filled questionnaire, therefore the results of this study were recorded from 767 (99.2%) healthcare providers. Amongst 767, there were 405 (52.8%) Medical doctors, 185 (24.2%) Nurse officers, 106 (13.8%) Pharmacists, 53 (6.9%) Medical laboratory scientists, and 18 (2.3%) Dentists. About 85.3% of the participants had a bachelor's degree, 62.1% were males and 72.6% of the participants were working in hospitals, the remaining percent were from other health facilities (Table 1). The remaining 14.7% of participants had both Bachelor's and Master's degrees qualifications.

Table 1. Demographic and professional characteristics of the study participants

Variables	Category	Frequency	Percentage
Age group (years)	20 – 29	138	18.0
	30 – 39	364	47.5
	40 – 49	184	24.0
	50 – 59	66	8.6
	≥ 60	15	2.0
Sex	Males	476	62.1
Sex	Females	291	37.9
Professional cadre	Pharmacist	106	13.8
	Medical Doctor	405	52.8
	Dentist	18	2.3
	Nurse officer	185	24.1
	Medical lab scientist	53	6.9
Education level	Bachelor degree	654	85.3
Education level	Master degree	113	14.7
Working experience (in years)	≤ 5	298	38.9
	6 – 10	222	28.9
	11 – 15	116	15.1
	16 – 20	50	6.5
	21 – 25	42	5.5
	≥26	39	5.1
Health facilities	Hospitals	557	72.6
	Health centers	77	10.0
	Community pharmacies	37	4.8
	Community laboratories	3	0.4
	Dental clinics	4	0.5
	Other clinics	89	11.6
Zones	Northern zone	80	10.4
	Lake zone	84	11.0
	Southern highlands zone	153	19.9
	Eastern zone	297	38.7
	Western zone	39	5.1
	Southern zone	48	6.3
	Central zone	66	8.6

The healthcare providers who responded to all twelve (12) knowledge questions were 767. The proportions of the responses to the questions are shown in Table 2. The scores were adopted from other studies [21-22] in which respondents who scored 7-12 questions (81.9%) were considered to have good knowledge and those who scored 0 to 6 questions (18.1%) as having poor or bad knowledge (Figure 2).

Table 2. The proportion of responses on the knowledge of health care providers regarding substandard and falsified medical products

Questions	Responses	Frequency	Percentage
What are substandard/falsified medicine, medical devices, and diagnostics products?	Are products from an unknown source	206	26.9
	Are placebo products	54	7.0
	Are orphan products	21	2.7
	Are fake medical products	486	63.4
In which areas do these substandard/falsified medical products are available?	Urban areas	112	14.6
	Rural areas	58	7.6
	Both urban and rural	531	69.2
	Don't know	66	8.6
The following are some of the medical products that may be falsified or produced as substandard, which ones are most common?	lifestyle medicines	264	34.4
	Antimalarial and antibiotic medicines	204	26.6
	Diagnostics like blood glucose test strip	100	13.0
	Protective devices like Face Masks	199	25.9
What factor contribute to the product of your choice above being at high risk of being falsified or being out of standard?	Unavailable & unaffordable	132	17.2
	Highly demanded	466	60.8
	Highly promoted on the internet	116	15.1
	Don't Know	53	6.9
The following are the health impact of using substandard and falsified medical products, which one is correct?	Increase in mortality and morbidity	95	12.4
	Promote drug resistance	146	19.0
	Prevalence of diseases increases	15	2.0
	All of the above	511	66.6
The following are the economic outcome of SF medical products, select the appropriate answer	Increase in productivity	116	15.1
	Reduced poverty	16	2.1
	Limited resources are wasted	407	53.1
	All of the above	228	29.7
From which source did you become aware/learned about substandard and falsified medical products	During practice	532	69.4
	From university	101	13.2
	From conferences	38	5.0
	Not aware of it	96	12.5
What factors contribute to the circulation of SF medical products
Highly-priced medical products	Yes	588	76.7
Highly-priced medical products	No	179	23.3
Inadequate control of medical products by the regulatory authority	Yes	655	85.4
	No	112	14.6
Poor reporting culture of identified SF medical products by HCPs	Yes	702	91.5
	No	65	8.5
Allowing patients to buy medical products anywhere due to stock out.	Yes	582	75.9
	No	185	24.1
Lack of knowledge of SF medical products	Yes	682	88.9
Lack of knowledge of SF medical products	No	85	11.1

The findings show that 92.5% of Pharmacists, 88.9% of Dentists, 84.9% of Medical laboratory scientists, 81.7% of Medical doctors, and 74.6% of Nurse Officers had good knowledge regarding substandard and falsified medical products. The difference in knowledge within the cadres was statistically significant with P = 0.003 (Figure 3).

The Pharmacist's knowledge regarding substandard and falsified medical products was significantly higher (92.5%) than other cadres (80.2%) with P = 0.003. However, the knowledge of Nurse Officers was significantly lower (74.6%) than other cadres (84.2%) with P= 0.004 (Table 3). The age, experience, professional cadres, and facilities show a positive correlation to the respondents' knowledge of substandard and falsified medical products with P< 0.05 (Table 4).

Table 3. The knowledge between health professional cadres on substandard and falsified medical products

Variable	Category	Knowledge frequency(n)		P value
		Poor knowledge	Good knowledge
Pharmacists	Pharmacists	8 (7.5 %)	98 (92.5%)	0.003
	Other cadres	131 (19.8%)	530(80.2%)
Medical doctors	Medical doctors	74 (18.3%)	331(81.7%)	0.925
	Other cadres	65 (18.0%)	297 (82.0%)
Dentists	Dentists	2 (11.1%)	16 (88.9%)	0.755
	Other cadres	137 (18.3%)	612 (81.7%)
Nurse officers	Nurse officers	47 (25.4%)	138 (74.6%)	0.004
	Other cadres	92 (15.8%)	490 (84.2%)
Medical laboratory scientists	Medical laboratory scientists	8 (15.1%)	45 (84.9%)	0.589
	Other cadres	131 (18.3%)	583 (81.7%)

Notes: P is significant at <0.05, n is the number of participants

Table 4. Factors associated with the knowledge of the respondents on substandard and falsified medical products

Variables	Category	Knowledge of SF medical products		P-Value
Variables	Category	Poor n (%)	Good n (%)	P-Value
Age groups (years)	20-29	14 (10.1)	124 (89.0)	<0.001
	30-39	55 (15.1)	309 (84.9)
	40-49	52(28.3)	132(71.7)
	50-59	14 (21.2)	52 (78.8)
	≥ 60	4(26.7)	11(73.3)
Sex	Males	86 (18.1)	390 (81.9)	1.000
Sex	Females	53 (18.2)	238 (81.8)	1.000
Professionals	Pharmacists	8 (7.5)	98 (92.5)	0.003
	Medical Doctors	74 (18.3)	331 (81.7)
	Dentists	2 (11.1)	16 (88.9)
	Nurse officers	47 (25.4)	138 (74.6)
	Medical laboratory scientists	8 (15.1)	45 (84.9)
Education level	Bachelor degree	124 (19.0)	530 (81.0)	0.185
Education level	Master degree	15 (13.3)	98 (86.7)	0.185
Experience (years)	≤5	32 (10.7)	266 (89.3)	0.001
	6-10	42 (18.9)	180 (81.1)
	11-15	32 (27.6)	84 (72.4)
	16-20	13 (26.0)	37 (74.0)
	21-25	10 (23.8)	32 (76.2)
	≥ 26	10 (25.6)	29 (74.4)
Zones	Northern zone	15 (18.8)	65 (81.3)	0.053
	Lake zone	21 (25.0)	63 (75.0)
	Southern highland zone	25 (16.3)	128 (83.7)
	Eastern zone	40 (13.5)	257 (86.5)
	Western zone	10 (25.6)	29 (74.4)
	Southern zone	13 (27.1)	35 (72.9)
	Central zone	15 (22.7)	51 (77.3)
Health facilities	Hospitals	101 (18.1)	456 (81.9)	0.029
	Health centers	21 (27.3)	56 (72.7)
	Community pharmacies	1 (2.7)	36 (97.3)
	Community laboratories	0	3 (100)
	Dental clinics	0	4(100)
	Other clinics	16(18)	73 (82)

Notes: P is significant at <0.05

On the other hand, the healthcare providers who responded to all twelve (12) practice questions regarding substandard and falsified medical product identification and reporting were 767. The proportions of the responses to the questions are shown in Table 5. Participants who scored 7-12 questions (71.2%) were considered to have good practice and 0 to 6 (28. 8%) as having bad practice (Figure 4).

Table 5. The proportion of responses on identifying and reporting practice of substandard and falsified medical products

Questions	Responses	Frequency	Percent
What is the source of information you heard about the presence of substandard and falsified medicines, medical devices, and diagnostic tools?	Media and advertising materials	313	40.8
	Patients and Colleagues	171	22.3
	Encountered in routine work	221	28.8
	Never heard	62	8.1
How do you identify substandard/falsified medicine/medical devices/diagnostics from the original?
Through label	Yes	621	81.0
Through label	No	146	19.0
Through packaging materials	Yes	578	75.4
Through packaging materials	No	189	24.6
Through expire date	Yes	565	73.7
Through expire date	No	202	26.3
Through cost/price of medical products	Yes	462	60.2
Through cost/price of medical products	No	305	39.8
Through package insert( leaflet)	Yes	455	59.3
Through package insert( leaflet)	No	312	40.7
Through unexpected adverse reactions to a few patients after using the same medical product of the same batch.	Yes	610	79.5
	No	157	20.5
Wrong diagnosis through laboratory results	Yes	524	68.3
Wrong diagnosis through laboratory results	No	243	31.7
Through reporting treatment outcomes to regulatory authorities	Yes	610	79.5
	No	157	20.5
(When/if) you encounter SF medical products (do you/will you) report them?	Yes	665	86.7
	No	102	13.3
Which form (do you use/will you use) to report them to the regulatory authority?	Yellow form	273	35.6
	Green form	36	4.7
	Blue form	45	5.9
	Don't know	413	53.8
In your opinion, what is the current situation regarding the circulation of substandard and falsified medicine, medical devices, and diagnostics in Tanzania?	It is a big problem	203	26.5
	Substandard and falsified medical products are not existing	13	1.7
	The products are existing but not identified and reported	344	44.8
	Detection of SF medical products is increasing but reporting is a problem.	207	27.0
In which action do you suggest can help to reduce the penetration of substandard and falsified medical products in our country?	Through public sensitization to raise their awareness against SF medical products.	146	19.0
	Adherence to ethics and reporting the identified SF medical products	72	9.4
	The strictness of entry points(Borders)	46	6.0
	All of the above	503	65.6

Moreover, the findings show that 84% of Pharmacists, 75.5% of Medical laboratory scientists, 73% of Nurse Officers, 66.7% of Dentists, and 66.7% of Medical doctors had good practice in substandard and falsified medical product identification and reporting. The difference in practice within the cadres was statistically significant with P = 0.009 (Figure 5).

In between the cadres, the practice of Pharmacists was significantly higher (84%) compared to other cadres (69.1%) with P = 0.002. However, the practice among Medical doctors was significantly lower (66.7%) than for other cadres (76.2%) with P = 0.004 (Table 6). The age, experience, and professional cadres revealed a positive association in identifying and reporting substandard and falsified medical products among the respondents with P < 0.05 (Table 7). The knowledge of the respondents regarding substandard and falsified medical products was found to affect the respondents’ practice of identifying and reporting substandard and falsified medical products with P< 0.001 (Figure 6).

Table 6. Practice in identifying and reporting substandard and falsified medical products between the cadres.

Variable	Category	Practice frequency (n)		P value
		Bad practice	Good practice
Pharmacists	Pharmacists	17 (16.0%)	89 (84.0%)	0.002
	Other cadres	204 (30.9%)	457(69.1%)
Medical doctors	Medical doctors	135 (33.3%)	270 (66.7%)	0.004
	Other cadres	86 (23.8%)	276 (76.2%)
Dentists	Dentists	6 (33.3%)	12 (66.7%)	0.792
	Other cadres	215 (28.7%)	534 (71.3%)
Nurse officers	Nurse officers	50 (27.0%)	135 (73.0%)	0.577
	Other cadres	171 (29.4%)	411 (70.6%)
Medical laboratory scientists	Medical laboratory scientists	13 (24.5%)	40 (75.5%)	0.533
	Other cadres	208 (29.1%)	506 (70.9%)

Notes: P is significant at <0.05

Table 7 Factors associated with identifying and reporting practice of substandard and falsified medical products

Variable	Category	Practice handling SF products		P-value
Variable	Category	Bad n (%)	Good n (%)	P-value
Age (years)	20 – 29	31 (22.5)	107 (77.5)	< 0.001
	30 – 39	83 (22.8)	281 (77.2)
	40 – 49	70 (38.0)	114 (62.0)
	50 – 59	29 (43.9)	37 (56.1)
	≥ 60	8 (53.3)	7 (46.7)
Sex	Males	126 (26.5)	350 (73.5)	0.071
Sex	Females	95 (32.6)	196 (67.4)	0.071
Health facilities	Hospitals	175( 31.4)	382 (68.6)	0.099
	Health centres	20 (26.0)	57 (74.0)
	Community Pharmacies	6 (16.2)	31 (83.8)
	Community laboratories	1 (33.3)	2 (66.7)
	Dental clinics	0	4 (100)
	Other clinics	17 (21.3)	70 (78.7)
Zone	Northern zone	31 (38.8)	49 (61.3)	0.237
	Lake zone	28 (33.3)	56 (66.7)
	Southern Highland zone	37 (24.2)	116 (75.8)
	Eastern zone	79 (26.6)	218 (73.4)
	Western zone	14 (35.9)	25 (64.1)
	Southern zone	13 (27.1)	35 (72.9)
	Central zone	19 (28.8)	47 (71.2)
Professional cadre	Pharmacists	17 (16.0)	89(84.0)	0.009
	Medical doctors	135 (33.3)	270 (66.7)
	Dentists	6 (33.3)	12 (66.7)
	Nurse officers	50 (27.0)	135(73.0)
	Medical laboratory scientists	13 (24.5)	40 (75.5)
Experience(years)	≤ 5	67 (22.5)	231(77.5)	< 0.001
	6-10	56 (25.2)	166 (74.8)
	11-15	46 (39.7)	70 (60.3)
	16-20	16 (32.0)	34 (68.0)
	21-25	17 (40.5)	25 (59.5)
	≥ 26	19 (48.7)	20 (51.3)
Education level	Bachelor degree	190 (29.1)	464 (70.9)	0.738
Education level	Master degree	31 (27.4)	82 (72.6)	0.738
Variable	Category	Practice on handling SF products		P value
Variable	Category	Bad n (%)	Good n (%)	P value
Age (years)	20 – 29	31 (22.5)	107 (77.5)	< 0.001
	30 – 39	83 (22.8)	281 (77.2)
	40 – 49	70 (38.0)	114 (62.0)
	50 – 59	29 (43.9)	37 (56.1)
	≥ 60	8 (53.3)	7 (46.7)
Sex	Males	126 (26.5)	350 (73.5)	0.071
Sex	Females	95 (32.6)	196 (67.4)	0.071
Health facilities	Hospitals	175( 31.4)	382 (68.6)	0.099
	Health centers	20 (26.0)	57 (74.0)
	Community Pharmacies	6 (16.2)	31 (83.8)
	Community laboratories	1 (33.3)	2 (66.7)
	Dental clinics	0	4 (100)
	Other clinics	17 (21.3)	70 (78.7)
Zone	Northern zone	31 (38.8)	49 (61.3)	0.237
	Lake zone	28 (33.3)	56 (66.7)
	Southern Highland zone	37 (24.2)	116 (75.8)
	Eastern zone	79 (26.6)	218 (73.4)
	Western zone	14 (35.9)	25 (64.1)
	Southern zone	13 (27.1)	35 (72.9)
	Central zone	19 (28.8)	47 (71.2)
Professional cadre	Pharmacists	17 (16.0)	89(84.0)	0.009
	Medical doctors	135 (33.3)	270 (66.7)
	Dentists	6 (33.3)	12 (66.7)
	Nurse officers	50 (27.0)	135(73.0)
	Medical laboratory scientists	13 (24.5)	40 (75.5)
Experience(years)	≤ 5	67 (22.5)	231(77.5)	< 0.001
	6-10	56 (25.2)	166 (74.8)
	11-15	46 (39.7)	70 (60.3)
	16-20	16 (32.0)	34 (68.0)
	21-25	17 (40.5)	25 (59.5)
	≥ 26	19 (48.7)	20 (51.3)
Education level	Bachelor degree	190 (29.1)	464 (70.9)	0.738
Education level	Master degree	31 (27.4)	82 (72.6)	0.738

Notes: p is significant at <0.05

The World Health organization (WHO) recommends the need for healthcare providers to have high knowledge and appropriate practice on substandard and falsified medical product identification and reporting [4]. This study has explored Tanzanian healthcare providers' knowledge and practice in identifying and reporting those products. The findings have indicated that the majority of Tanzanian healthcare providers have good knowledge and practice regarding substandard and falsified medical products. Both the knowledge and practice of the healthcare providers appear to be influenced by factors such as age, working experience, the type of facility where a respondent is stationed, and the type of professional cadres.

The overall level of knowledge among healthcare providers on substandard and falsified medical products was high with 81.9% of the respondents having good knowledge (Figure 2). This is contrary to other studies that have reported the knowledge of substandard and falsified medical products to be low among healthcare providers in various countries [23-29].However, about 69.4% of the respondents reported learning it during practice. Similar findings were also reported from Sudan where 76% of healthcare providers reported having learned about the products during practice [21].The result shows the knowledge of the respondents to be significantly influenced by age (P < 0.001), experience (P = 0.001), professional cadres (P = 0.003), and health facilities type with P = 0.029 (Table 4). The relationship between knowledge and factors such as age and experience is known to be due to changes in the cognitive process. This has been stated by theories of mind [28-31]and the WHO report [32].Similar findings were also reported in studies conducted in Lebanon[17], Iran [23], and Italy [34].The healthcare providers from health centers were revealed to have significantly lower knowledge than those from other facilities (P = 0.029). This could be due to the limited number of medical products in health centers which limits exposure to substandard and falsified medical products among the healthcare providers in those facilities [35].

Concerning practice, the findings show that 71.2% of the respondents had good practice in identifying and reporting substandard and falsified medical products (Figure 4). This is because the respondents' knowledge regarding substandard and falsified medical products was also proportionally high. This is comparable to findings from some other studies, where the practice of healthcare providers in handling such products was reported to be poor [21, 24, 36].However, 53.8% of the respondents reported having no idea of the tool to use for reporting substandard and falsified medical products when encountered. Findings similar to these were also reported in Sweden where 66.9% of the healthcare providers reported having no idea of the reporting tools [37].Other studies have reported that healthcare providers are in a hurry with no time for identifying the authentic features of medical products before healthcare service provision [9, 24, 38].The practice among Health care providers was significantly associated with age (P < 0.001), experience (P < 0.001), and professional cadres with P = 0.009 (Table 7). The influence of practice with age and experience can also be related to cognitive changes in the healthcare provider [27-31].A similar trend of observation has been reported in Iran in which an increase in working time was also found to affect the practice of healthcare providers in identifying and reporting these products [21].

The knowledge and practice regarding substandard and falsified medical products within professional cadres were found to be good except for only a few respondents (Figures 3 and 5). The findings of this investigation are somewhat contrary to other studies where healthcare providers were reported to have limited knowledge and practice regarding substandard and falsified medical products [21, 24, 36].However, the knowledge among the five health professional cadres shows that Pharmacists’ knowledge is higher (92.5%) than other cadres (80.2%) with P = 0.003 (Table 3). This is contrary to a study done in Qatar which showed that only 18% of Pharmacists have sufficient knowledge about substandard and falsified medical products [24]. On the other side, the knowledge of Nurse Officers was lower (74.6%) than other cadres (84.2%) with P = 0.004 (Table 3). A comparable gap in the Nurses’ knowledge regarding substandard and falsified medical products was reported to be low in Medina [9]and the International Council of Nurses (ICN) [39].Again, the practice of substandard and falsified medical products identification and reporting among the cadres revealed that the Pharmacists have better conduct (84%) than other cadres (69.1%) with P = 0.002 (Table 6). This can be related to the fact that in most cases Pharmacists assume the major role in preventing the entry, distribution, and dispensing of medical products [23].Moreover, another reason for this observation could be because to some extent the University curriculum for Pharmacists in some postgraduate courses incorporated some topics about substandard and falsified medical products [35, 39].However, the practice among Medical doctors was significantly lower (66.7%) than in other cadres (76.2%) with P = 0.004 (Table 6). Some studies have shown that in most circumstances, Medical doctors overlook the identification of substandard and falsified medical products when in a hurry with a huge patient load [9, 24, 39].

The findings revealed that 81.9% and 71.2% of HCPs have good knowledge and practice regarding substandard and falsified medical product identification and reporting. However, only 13.2% of respondents reported learning it at Universities and only 5.9% of the respondents reported using the right form to report the products. Therefore regulatory authorities in the country are recommended to ensure the availability of Standard Operating procedures (SOP) for identifying and reporting the products in all health facilities. Higher learning institutions are recommended to include modules on substandard and falsified medical products in their curricula. This study further presents an alert and a need for medical product surveillance and legal implications from the responsible Tanzanian authority.

Funding statement

No funding was received for this study

Conflict of Interest Statement

The authors declare no conflicts of interest for this work.

Data availability

The data utilized to draw this conclusion are accessible from the corresponding author upon reasonable request.

Code availability

Not applicable.

Author contributions

VPMand SN participated in conceptualization, study design, data collection, data analysis and writing the initial draft of the manuscript. ID participated in study design, data collection and data analysis. YM, EY, GGN, PMM, RS, NEM, NN and JS participated in data collection and data analysis. EK participated in guiding the study design, data analysis, manuscript writing and ensuring integrity of the research. The submission of the final version of the manuscript followed the approval of all authors of this research work.

Acknowledgments

The authors would like to acknowledge all healthcare providers who participated in this study. We wish to thank registrars of Medical doctors and dentists, Pharmacists, Nurses, Midwifery, and Medical laboratory scientist’s councils for providing statistical data on registered personnel. We also thank all staff from MUHAS for their dedicated cooperation during the study.

Naira G. Substandard and falsified medicines: Global and local efforts to address a growing problem. Pharm. J. 2019;1-11
Yadav S, Rawal G. Falsified drugs : the problem of developing and developed countries. J Pharm Anal. 2015; 2:46-50.
Nafiu A, Abubakar S, Abdulhakim A, et al. Unveiling the peril of substandard and falsified medicines to public health and safety in Africa: Need for all-out war to end the menace.Wichtig International. 2017; 1:145-154.
World Health Organization.WHO Global Surveillance and Monitoring System for substandard and falsified medical products. 2017. ISBN 978-92-4-151342-5
Ubajaka CF, Obi-okaro AC, Emelumadu OF, et al. Factors Associated with Drug Falsified in Nigeria : A Twelve-Year Review. BMJ. 2016; 12:1-8.
Nayyar GML, Breman JG, Mackey TK, et al. Falsified and Substandard Drugs : Stopping the Pandemic. Am. J. Trop. Med. Hyg. 2019; 00:1-8.
Syafri, Edi; Endrizal N. A study on the public health and socioeconomic impact of substandard and falsified medical products. J. Chem. Inf. Model. 2013; 53:1689-1699.
Beargie SM, Higgins CR, Evans DR, et al. The economic impact of substandard and falsified antimalarial medications in Nigeria. PLoS One, 2019; 14:1-16.
Imam SH, Khan ZM. Knowledge, Attitude, and Practices regarding falsified drugs among Nurses of Medina teaching hospital Faisalabad. Ann. Punjab Med. Coll. 2014; 8:45-50.
Sholy L, Gard P, Williams S, et al. Pharmacist awareness and views towards falsified medicine in Lebanon. Int. J. Pharm. Pract. 2018; 26: 273-280.
Moremi N, Claus H, Mshana SE. Antimicrobial resistance pattern : A report of microbiological cultures at a tertiary hospital in Tanzania. BMC Infect. Dis. 2016; 16:1-7.
Horumpende PG, Mshana SE, Mouw EF, et al. Point prevalence survey of antimicrobial use in three hospitals in North-Eastern Tanzania. Antimicrob. 2020; 3:1-6.
Hamill H, David-Barrett E, Mwanga J, et al. Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania,” BMJ Glob. Heal. 2020;6:1-8
Mhando L, Jande MB, Liwa A, et al. Public Awareness and Identification of Falsified Drugs in Tanzania: A View on Antimalarial Drugs. Adv. Public Heal. 2016:1-8.
Association of Journalists against AIDS in Tanzania (AJAAT). Who’s lying in the fake ARVs scam ? www.ajaat.or.tz. 2012; 195:10-16.
Mziray S. Quality of Selected Anti-retroviral Medicines : Tanzania Mainland Market A Case Study Current Status : Under Review. BMC Pharm. Toxicol. 2020; 2: 1-27.
Mori AT, Meena E, Kaale EA. The economic cost of substandard and falsified human medicines and cosmetics with banned ingredients in Tanzania from 2005 to 2015 : A retrospective review of data from the regulatory authority. BMJ Open, 2018; 1-7.
Blomberg B, Mwakagile DSM, Urassa WK, et al. Surveillance of antimicrobial resistance at a tertiary hospital in Tanzania. BMC Public Health. 2014; 4:1-12.
Hamilton WL, Doyle C, Halliwell-Ewen M, et al. Public health interventions to protect against falsified medicines : a systematic review of international, national and local policies. Health Policy and Plan. 2016; 31:1448-1466.
Karunamoorthi K. The falsified anti-malarial is a crime against humanity : a systematic review of the scientific evidence. Malar. J. 2014; 13: 1-13.
Yadav V, Budania N, Mondal A, et al. A questionnaire-based study on knowledge and attitude towards falsified medication among the doctors in tertiary care hospital. Int. J. Basic Clin. Pharmacol. 2018; 7:802-806.
Wala WW, Shaza WS, Imad OA, et al. Community pharmacists Awareness and Attitude toward Falsified medicine in “Khartoum Locality : Cross-Sectional Survey, 2020; 1-14.
Chambliss WG, Carroll WA, Kennedy D, et al. Role of the Pharmacist in Preventing Distribution of Falsified Medications. J. Am. Pharm. Assoc. 2012; 52:195-199.
Alfadl AA, Ibrahim MIM, Maraghi FA, et al. The general public and community pharmacist’s perception on falsified medicines: A preliminary cross-sectional study in Qatar. J. Clin. Diagnostic Res. 2018; 12: IC01-IC06.
Hagan AO, Garlington A. Falsified drugs and the online pharmaceutical trade, a threat to public safety. FRCIJ. 2018; 6:151-158.
Health G. Medical Product Quality Report – COVID-19 Issues. Med. Qual. Res. Gr. University OXFORD, 2020; 5:1-72.
Moran JM. Lifespan development: The effects of typical aging on the theory of mind. Behav. Brain Res. 2013; 237:32-40.
Hess TM, Smith BT. Aging and the impact of irrelevant information on social judgments. Psychol Aging. 2014:29:542-553.
Fischer AL, Rourke NO, Thornton WL. Age differences in cognitive and affective theory of mind: Concurrent contributions of neurocognitive performance, sex, and pulse pressure. J Gerontol B Psychol Sci Soc Sci, 2016; 00, 1–11.
Grainger SA, Steinvik HR, Henry JD, et al. The role of social attention in older adults’ ability to interpret naturalistic social scenes. Q. J. Exp. Psychol. 2019; 72:1328-1343.
World Health Organization. World report on Ageing and Health. 2015; 1-260.
Shahverdi S, Hajimiri M, Pourmalek F, et al. Iranian pharmacists’ knowledge, attitude, and practice regarding falsified drugs. Iran. J. Pharm. Res. 2012; 11:963-968.
Lombardo S, Marino F, Cosentino M. A nationwide web-based survey of a sample of Italian community pharmacists’ perceptions and opinions about online sales of medicines and falsified drugs. Pharm. Pract. (Granada). 2019; 17:1-8.
WHO Member State mechanism on substandard and falsified medical products, Online Handbook on existing training resources, and reference documentation for the prevention, detection, and response to SF medical products. 2019.
Yousuf SA, Alshakka M, Badulla WFS, et al. Attitudes and practices of community pharmacists and barriers to their participation in public health activities in Yemen : mind the gap. BMC Health Serv. Res. 2019; 19:1-8.
Funestrand H, Liu R, Lundin S, et al. Substandard and falsified medical products are a global public health threat. A pilot survey of awareness among physicians in Sweden. J. Public Health (Oxf). 2018; 41:95-102.
Mcmanus D, Naughton BD. A systematic review of substandard, falsified, unlicensed, and unregistered medicine sampling studies : a focus on context, prevalence, and quality. BMJ Global Health, 2020; 5: 1–9.
Ferrario A, Orubu ESF, Adeyeye MC, et al. The need for comprehensive and multidisciplinary training in substandard and falsified medicines for pharmacists. BMJ Global Health. 2019; 4:1-3.
International Pharmaceutical Federation (FIP). Curriculum for pharmacy students on substandard and falsified medicines. Pharm. Res, 2021; 85:1-80.

No competing interests reported.

Assessment of knowledge and practice on the identification and reporting of substandard and falsified medical products among Healthcare providers in Tanzania

Status:

Version 1

Abstract

Figures

Introduction

Materials and methods

Study design

Study area and population

Sampling techniques and sample size

Questionnaire and data collection methods

Description of variables

Data processing and analysis

Results

Discussion

Conclusion

Declarations

References

Additional Declarations

Status:

Version 1