The Impact of Intervention on Pharmacists’ Counselling on Patients’ Knowledge and Opinion of Antibacterial Usage

The knowledge and opinion of patients on antibacterial usage depends on pharmacist’s counselling. In Nigeria, study assessing patients’ perception of pharmacists’ antibacterial counselling is scarce. This study assessed the knowledge and opinion of patients on antibacterial usage as a result of pharmacists’ counselling pre and post intervention. The study was a cross sectional study among 409 outpatients with antibacterial prescriptions in 17-government-owned secondary healthcare facilities in Ogun State of Nigeria between July 2017 and May 2018. The knowledge and the opinion of the patients were determined via structured questionnaire and deficiency was addressed via intervention training for the pharmacists. Re-assessment was carried out after a month. Four hundred and nine patients participated at each of the two phases of the study. The mean age at the baseline survey, was 43.9 ± 14.9 and the age range was 19 87 years while at the post intervention survey, the mean age was 44.1 ± 15.7 and the age range was from 18 to 91 years. The Original Research Article Michael et al.; JAMPS, 22(4): 1-15, 2020; Article no.JAMPS.56834 2 patients that were probed on drugs they had at hand or at home increased from 20 (4.9%) to 263 (64.3%) between the two phases. Seventeen, (4.2%) and 171 (41.8) claimed to receive counselling on necessity of completing the course of therapy at the two phases respectively. The survey confirmed that 284 (69.4%) and 319 (77.9%) at the two phases respectively were of the view that counselling on drugs is best done by pharmacists. Two hundred and fifty six (62.7%) and 262 (64.1%) patients rated the counselling they received as ≥ 70% at the two phases respectively. There was significant improvement in the knowledge and opinion of patients on antibacterial usage due to pharmacists’ counselling post intervention p < .05. Constant training on antibacterial counselling should therefore be encouraged among pharmacists.


INTRODUCTION
Undue exposure to antibacterial agents places patients at risk of adverse events with the likelihood of increase in antibacterial resistance without any medical advantage. The emergence of antibacterial resistance has been largely attributed to the worldwide uninformed use of antibacterial agents within and outside the hospitals [1,2]. Worldwide inappropriate prescriptions, dispensing and, usage of drugs including antibacterials is said to be over 50.0% [3,4]. The continual efficacy of antibacterial agents is under a great threat mainly due to antibacterial misuse [5,6,7].
The challenge of antibacterial misuse calls for urgent action. There is the possibility of emergence of bacteria which might be resistant to all antibacterials in the nearest future if nothing is done [8]. It is therefore important to explore all possible means to ensure the continual efficacy of existing antibacterials. Pharmacists are well placed to counsel patients on proper antibacterial use [9,10,11]. Professional expertise provided by pharmacists during counselling has the potentials of reducing therapy cost, preventing unnecessary hospitalization and improving therapeutic outcome [12,13].
The success of treatment is evident on the outcome of treatment manifested by the wellbeing of the patients. Patients' lack of knowledge about proper use of antibacterials may account, to a large extent, for the inappropriate antibacterial consumption [14,15]. Insufficient public awareness on antibacterial therapy has been said to lead to self medication and incorrect use of antibacterials [2,16]. Patients or their caregiver must be adequately counselled to conform to details of rational antibacterial use [17]. The professional setting of pharmacists in health care makes them most relevant at counselling patients on antibacterial rational use [18]. Earlier studies tend to address antibacterial misuse by discouraging antibacterial use for infections of non bacterial origin. It is important to identify the quality and patients' comprehension of antibacterial counselling offered by pharmacists. The present study identified the knowledge and opinion of patients on antibacterial use due to pharmacists' counselling and gaps identified was addressed via intervention.

METHODS
The study was carried out in seventeen (17) government-owned secondary health care facilities in Ogun state, south west Nigeria. Each outpatient department had well defined pharmacy, headed by registered pharmacists. The pharmacists were involved with the dispensing and counselling of patients on antibacterials and other medications. Patients in the state depend mainly on these health facilities for their health needs. The research was a crosssectional study among patients to whom antibacterials were prescribed and dispensed at the outpatient departments of the selected hospitals. The study comprised three phases namely: (1) baseline survey (2)

intervention and (3) post intervention survey.
Baseline data collection was done on Monday to Friday within the working hours of 7.30 am -3.30 pm by the researchers for twelve weeks: July 2017 to September 2017.

Sample Size Determination
The target sample size was determined by employing Raosoft Sample Size calculator [19]. The margin of error was set at 5%, confidence level 95%. The total population was 10830 calculated from the pharmacy register of the selected institutions. The recommended sample size was 372. Adjustment of the sample size for non-response was achieved by addition of 10% (37): 372 + 37 = 409.

Sampling/Recruitment Technique
This involved convenient sampling of patients that reported at the outpatient pharmacy of the selected hospitals for filling of their prescriptions. Patients that had at least one antibacterial drug in their prescription were approached for participation. Details of procedure and objectives of the study as specified by the informed consent was explained to individual patients verbally either in English or Yoruba language. Those consented and were aged eighteen 18 years and above, were included. Those who declined participation and those below 18 years were excluded until the target sample size was achieved. Four hundred and nine (90.7%) patients consented out of a total of 451 approached. The questionnaire-guided interviews were administered to eligible patients after interacting with the pharmacists. This was done to verify their knowledge and opinion of antibacterial usage as a result of pharmacist's counselling. Patients or their care giver being interviewed were engaged in a private environment free from interference from the counselling pharmacist or other patients to ensure that the discussion neither influenced subsequent pharmacists' counselling nor modified other patients' responses.

Validation and Pretest of Data Collection Instruments
Face and content validity of the questionnaire was achieved by discussion with two lecturers (pharmacists) at the department of clinical pharmacy and pharmacy administration, university of Ibadan, Ibadan, Nigeria who had constructed acceptable questionnaires in related studies. This led to restatement of some questions after which the content was considered reasonable. The questionnaire was pre-tested among fifty two (52) patients at Sacred Heart Hospital, Lantoro, Abeokuta, Ogun state of Nigeria which is also a secondary health care institution like those selected for the study. The result of the pre-test was not included in the final analysis.
Findings from the pre-test were used to further validate the instrument. Some questions that were originally designed in closed-ended fashion were rephrased in an open-ended manner to allow self expression of intention more clearly. Some ambiguous questions were reconstructed while some were removed. The inclusion of patients' rating of pharmacists' counselling section was included as a result of the feedback from the pre-test.

Reliability of Data Collection Instrument
The reliability of the questionnaire was established by applying Cronbach's Alpha test in the SPSS software. The value of Cronbach's Alpha ranged from 0.723 to 0.743. Cronbach's Alpha threshold ≥ 0.7 is generally acceptable by researchers as satisfactory [10,20]

Questionnaire-guided Interview
The questionnaire comprised: (a) Demographic characteristics which include: Gender, age, marital status, educational qualification and occupation. (b) Knowledge questions to assess the patients on antibacterial use (c) Questions verifying the opinion of patients about the counselling received from the pharmacist, and (d) Patients' rating of pharmacists' counselling.

Processing of Baseline Data
Patients' knowledge was computed by allocating a score of 1 to correct response and 0 to an incorrect response. Individual percentage knowledge score was computed by dividing score obtained by individual patient with total obtainable score multiplied by 100.
Individual percentage knowledge score = (Score obtained ÷ Total obtainable score × 100) Cut off of % knowledge score of ≥ 70% was regarded as good knowledge while ≤ 70% was assumed to be poor knowledge [21]. For the patients rating of pharmacists' counselling, Excellent was allocated a score of 5, Very good a score of 4, good a score of 3, Fair a score of 2 and poor rating was allocated a score of 1 [10]. % Rating = (rating ÷ maximum obtainable rating) × 100 % rating < 70% was considered poor counselling while ≥ 70% was viewed to be good counselling.

Intervention Training
The intervention training comprised educational training seminar and scripted drama developed to address the identified gaps in patients' knowledge and opinion. The training was conducted for the pharmacists between December 2017 and January 2018. It centres on important antibacterial counselling tips.

Antibacterial Training Seminar
The antibacterial training seminar was handled by a hospital based pharmacist with doctorate degree in pharmaceutics in collaboration with the principal researcher. The training was done in three locations. Each participant attended one of the training sessions. From the baseline survey, the patients were deficient in the following important areas of antibacterial usage: Missed doses, Regular dosing intervals, complete course of therapy, Side effects, Duration, Antibacterial awareness and identification, Food and drug interactions and action to take in case of Therapy delay or failure [22]. A mnemonic, MR CS DAFT was coined by the investigator as antibacterial counselling tips. MR C S DAFT signifies: M = Missed dosage, R = Regularity of dosages, C = Completing the course of therapy, S = Side effects, D = Duration of therapy, A = Antibacterial awareness and identification, F = Food and drug interactions, T = Therapy delay/failure. All the forty five pharmacists in charge of patients' counselling at the selected sites participated in the training and a pre and post intervention test was conducted to ascertain the success of the training.

Participatory Scripted Drama
This was the second training approach. The pharmacists were engaged in five different drama scenarios of antibacterial counselling. These were to demonstrate the possibility of result-oriented antibacterial counselling by employing MR C S DAFT-guide. The pharmacists were thus informed on the neglected areas of antibacterial counselling.
The drama addressed among others: A patient with a single antibacterial drug with emphasis on regularity of dosage intervals and completion of course of treatment, the use of empathy to gain the attention and cooperation of nervous patient, antibacterial-drug interactions, antibacterial-drug and antibacterial-food interactions while the fifth scenario was on patients with more than one antibacterials. All the scenarios took place in a semi-private setting to de-emphasize window dispensing. In each scenario, one pharmacist acted the part of a pharmacist counsellor and the other as a patient while the investigator moderated. Every pharmacist participated in at least one of the scenarios and had the opportunity of acting both as the pharmacist and patient in turns.

Post Intervention Survey
This involved the re administration of the same questionnaire-guided interview to patients as at the baseline after being counselled by the pharmacists. This was carried out from March to May 2018.

Data Analysis
Descriptive statistics such as frequency, percentage and mean ± standard deviation were used to summarize the data. The data collected were coded and entered in to the SPSSpackage version-20. Association between patients' socio-demographic characteristics and knowledge of antibacterial use as well as patients' opinion and rating of pharmacist's counselling were examined using the Chi square (X 2 ) test. Independent sample t-test was employed for the comparison of patients' means scores on knowledge and rating of pharmacists' antibacterial counselling at the baseline and post intervention studies. McNemar test was used to compare the difference of scores between each response at the two phases. P < .05 was considered to be statistically significant.

Socio-demographic Characteristics of Patients at Baseline and Post Intervention Surveys
Four hundred and nine, (409) patients participated at each of the two phases of the study. The mean age at the baseline survey, was 43.9 ± 14.9 and the age range was 19 -87 years while at the post intervention survey, the mean age was 44.1 ± 15.7 and the age range was from 18 to 91 years. There was no significant difference in age and gender of patients at the two phases, p > 0.05 (Table 1).

Antibacterials Dispensed to the Patients Pre and Post Intervention
The penicillins, 149 (36.0%) and the cephalosporins, 139 (33.9%) were the most frequently prescribed and dispensed class of antibacterial agents at the two phases respectively. Fig. 1 compared the classes of antibacterials prescribed and dispensed at the two phases.

Baseline and Post-intervention Knowledge of Patients on Antibacterial Usage
One hundred and sixty two patients (39.6%) and 338 (82.6%) were aware that antibacterial drug(s) was dispensed to them at the baseline and post intervention surveys respectively. One hundred and sixty one (39.4%) and 335 (81.9%) were able to correctly identify the antibacterial drug(s) at the two phases respectively. Good knowledge of antibacterial usage, depicted by a score ≥ 70.0% was displayed by 11 (2.74%) and 262 (64.1%) of the patients at baseline and post intervention surveys respectively ( Table 2).

Patients Knowledge of Drugs at Home and Antibacterial Usage Pre and Post-intervention
The patients that were probed on drugs they had at hand or at home increased from twenty, 20 4.9%) to 263 (64.3%) between the two phases. Seventeen, (4.2%) and 171 (41.8) claimed to receive counselling on necessity to complete the course of therapy at the two phases respectively (Table 3).

Patients' Opinion and Rating of Counselling Received from Pharmacists
The survey confirmed that two hundred and eighty four (69.4%) and 319 (77.9%) were of the view that counselling on drugs is best done by pharmacists at the two phases respectively. Two hundred and fifty six (62.7%) and 262 (64.1%) patients rated the counselling they received as ≥ 70% pre and post intervention (Table 4).

Baseline and Post Intervention Comparison of Means Scores
There were significant difference between the mean scores at the two phases (Table 5).There was no association between patients' demographics and the response.  Patients' mean knowledge scores at the two phases was 2.0 ± 1.0 and 4.7 ± 1.2 (p < 0.001) ( Table 6).      [10]. Another study [23] reported a somewhat higher proportion of patients (54.7%) with good knowledge. The difference observed here may be due to differences in environment and study approach. The study, [23] was carried out in Sweden which is probably a more developed society than Nigeria. It is possible that the ratio of pharmacists to patients is higher in Sweden thereby allowing more time for counselling.
It is likely that pharmaceutical laws are more strictly adhered to in Malaysia than in Nigeria.
Majority of the patients in the present study claimed not to be counselled on vital issues on antibacterial use. Patients' awareness and ability to identify antibacterial agents among other drugs dispensed to them is probably a step to appropriate antibacterial usage. This is likely to make them pay special attention to pharmacists' counselling on the antibacterials and may improve compliance with dosage regimen. The current study revealed low patients' awareness. Only one hundred and sixty two (39.6%) of the patients were aware of the presence of antibacterial drugs as part of their medication and only a minority, 161 (39.4%) were able to correctly identify the antibacterial drugs. This low awareness is consistent with findings in another study [24] which stated that 27.0% of patients' were aware of their medication. The poor patients' antibacterial counselling obtained in this study may be a further confirmation of that reported by [25] in which only 20.0% of patients in deprived areas of England received pharmacists' counselling of drug usage. Patients' antibacterial awareness and identification significantly improved at the post intervention survey. McNemar test revealed p < 0.001. The level of awareness in this study is in contrast with higher proportion (55.8%) reported in a study of effectiveness of pharmacists in improving patients' knowledge and attitude towards antibiotic usage [10]. Pharmacist-directed antibacterial stewardship programme have been shown to improve antibacterial treatment outcome [25] Pharmacists should endeavour to raise patients' awareness when antibacterials are dispensed.
Pharmacokinetic profile of drugs especially oral medications necessitate that drugs be used at regular intervals. This is particularly important in case of antibacterials. Failure to use antibacterial drugs at the due time may lead to gradual decrease in plasma concentration from the minimum inhibitory concentration (MIC) thereby exposing the bacteria to sub-therapeutic concentration (STC). Prolonged exposure of bacteria to STC may promote development of resistant strains [26]. It is therefore expedient to counsel patients to adhere to regular dosage intervals. For instance, antibacterials prescribed as two tablets tds are better taken every eight hours rather than just three times daily. In case of missed doses, patients should be counselled to take the missed dose immediately they remember and necessary adjustment should be made for regular intervals in subsequent administration. If the time for the next dose is close by, the patient may be counselled to wait till the next due time. This study showed that very few, eighteen (4.4%) of the patients were counselled on action to take when there is missed dosage. The result is different from 16.0% reported in another study [21]. It also contrasted value of 67.4% reported in a study carried out in Ethiopia [9]. The contrast may be because the study in Ethiopia was carried out in community pharmacies while the present study was in the hospital setting. There was significant improvement on the number of patients counselled on missed dosages at the post intervention survey p < 0.001. Co-administration of some antibacterials with food has varying consequences raging from decrease in absorption to complete loss of activity. It is therefore necessary to counsel patients on how to use their antibacterials in relation to food for those that are affected by food. Some antibacterial drugs, for example tetracycline, co-trimoxazole and azithromycin capsule should be taken one hour before or two hours after meals. Other antibacterials such as amoxycillin, ciprofloxacin and doxycycline should be taken with meals to minimize stomach upset. It is evident from the present study that only 13.7% of the patients claimed to be counselled on antibacterial-food interactions. It then means that the patients were not well counselled on antibacterial use in relation to meals and patients may not receive full activity from the drugs. The result is at variance with the 65.3% reported by [9] but the difference may be as a result of difference in study settings. The post intervention survey revealed significant increase in the proportion of patients (34.5%) counselled on antibacterial use in relation to meals p < 0.001.
Antibacterials sometimes interact with other drugs. Such interactions sometimes may have unfavourable effects. Concomitant administration of ampicillin, amoxicillin with allopurinol should be avoided as it may increase the incidence of rash. Azithromycin, ciprofloxacin, Levofloxaxin and ofloxacin have their absorption reduced when administered with antacids containing Aluminium hydroxide, Magnesium hydroxide because of absorption impairment [26]. This may lead to decrease or total loss of activity due to antibacterial serum concentration below the minimum effective concentration (MEC). Only 20.0% of the patients in this study claimed to be counselled on drug-drug interactions but this improved significantly at the post intervention p < 0.001.
Probing into drugs that patients have at home or at hand may be beneficial especially to avoid drug-drug interactions. Keeping left over antibacterial drugs has also been generally viewed to be a pointer to poor compliance and the possibility of over dosage due to multiple uses [25]. One hundred and fifty eight patients (38.6%) claimed to have drugs at home/hand while 4.6% had left over antibacterials similar to 5.0% reported in another study [25]. Patients on antibacterial therapy may sometimes experience delay in perceiving relief of symptoms of ailment under treatment or outright failure of treatment. Prompt report of delayed activity or seemingly failure in experiencing relief will afford the health practitioners the opportunity to reassess therapy options and take appropriate corrective measures early enough. Patients should therefore be counselled on action to take when there is perceived delay in antibacterial effectiveness. Majority, 61.9% of the patients received no counselling on action to take when delayed antibacterial activity is perceived in contrast to 46.4% reported by [9].

Patients' Opinion Pharmacists' Counselling on Antibacterial Usage
More than half, 69.4% of the patients had the opinion that pharmacists should be responsible for antibacterial counselling. Majority, 55.3% were satisfied with the counselling received from the pharmacist similar to that reported by another study [9]. The presents study revealed that 55.3% of patients rated pharmacists' counselling to be ≥ 70% which signified good counselling. The patients' good rating of pharmacists' counselling did not reflect in their knowledge of antibacterial use. The good rating however may be a reflection of patients' confidence in pharmacists' counselling. This is a welcome disposition as it may depict their willingness to be counselled by pharmacists. Pharmacists should take advantage of the good patients' disposition to enhance good medication counselling. Generally, the post intervention survey revealed significant improvement in patients' knowledge and opinion about pharmacists' counselling on antibacterial usage. Independent sample T-test confirmed significant improvement in the mean rating 3.3 ± 1.5 and 3.7 ± 1.3 between the two phases respectively (p < 0.001). This might be a further confirmation of the effectiveness of the intervention training process.

LIMITATIONS
This study is limited by the fact that the patients at the baseline survey were not likely to be exactly the same as those in the post intervention survey. This restriction was taken care of by ensuring gender and age balance between the two phases. There was no significant difference p > .05 between the age and gender at the two phases. Although efforts were made at the post intervention survey, not to include patients that have participated at the baseline survey, it was not unlikely that some patients might have participated at both phases. However, this is likely to be negligible as repeated courses of antibacterial treatment are not common as in the treatment of chronic diseases except when there is therapy failure. Convenient sampling was used to select the patients and this may introduce selection bias.
The use of dichotomous Yes or No questions format in ascertaining the patients' opinion rather than the Likert scale may be viewed as a limitation. Despite these limitations, the outcome of the study revealed the current patients knowledge on antibacterial usage and their opinion on pharmacists' counselling.

CONCLUSIONS
Patients' knowledge of antibacterial usage was poor but they had good opinion about antibacterial counselling. Majority of the patients were not well counselled despite patients' willingness and this resulted in deficit of patients' knowledge of antibacterial proper usage. Patients' knowledge and opinion improved significantly post intervention signifying the importance of pharmacists' continuous training.

CONSENT
Participants' written and informed consent was obtained by the author.