Knowledge of community pharmacists in the Kathmandu Valley,Nepal about the risks associated with medication use during pregnancy

1. Introduction

Medicines should be used in pregnancy with great caution. Some medicines like folic acid have beneficial effects on the developing fetus whereas other medicines like thalidomide may have harmful effects. Because pregnant women may have various acute and chronic illnesses, they may require prescribed medicines for the short term and long term [1]. The use of medicines in pregnancy is a challenging task because it may have harmful effects on both fetus and mother; at least one prescribed or non-prescribed medicine is taken by approximately 90% of pregnant women [2]. Some medicines adverse effects on the fetus are seen only after a long time. Therefore, the use of over-the-counter (OTC) medicines should be limited in pregnancy as far as possible. Iron and folic acid supplementation is routinely provided to pregnant women to reduce the incidence of anemia and prevent the anomaly of “neural tube defects” – a serious anomaly that can occur in the developing fetus [3].

Various complications occurring in pregnancy may require the administration of different medicines and antibiotics may also be used [4–7]. Some medicines may have teratogenic effects on the fetus and may cause abnormal development of the offspring [8]. When these medicines are used for a prolonged period during pregnancy, they may cause defects in developing fetus [9–12]. Some medicines consumed by the mother can have serious side effects on the developing fetus as well as the neonate. Drugs that can cause various complications in neonates are benzodiazepines, amphetamines, cocaine, and barbiturates [13]. These medicines may affect the nervous system, respiratory system, gastrointestinal system as well as other systems [13]. The use of opioids in pregnancy has been associated with neonatal abstinence syndrome [14]. Neonatal abstinence syndrome is associated with low birth weight, respiratory complications, difficulties in feeding as well as seizures [15]. The Selective Serotonin Reuptake Inhibitors (SSRI) are well known for their withdrawal symptoms. The withdrawal symptoms that are commonly seen in newborns include nervousness, hypertonia, abnormal crying, tremor, and involuntary muscle contractions. Among the various SSRIs available, paroxetine is mostly associated with withdrawal symptoms [16]. It has been suggested that the dose of SSRI can be reduced before and during pregnancy. This may help to prevent the recurrence of neonatal withdrawal syndrome [17]. Hence, proper knowledge is required to balance the risks and benefits of medicines during pregnancy.

Community pharmacists (CPs) are the most accessible healthcare professionals and can provide information about medicines to pregnant women. Therefore, it is essential that the pharmacists must have adequate knowledge about prescription as well as over-the-counter medicines [18]. CPs should feel responsible for providing safe medicines to pregnant women. Also, they must have adequate information about the use of medicines during pregnancy and the possible risks [8]. CPs have a vital role in dispensing drugs to pregnant women. Hence, they should possess correct information regarding the use of these medicines and can play a major role to improve maternal health.

Kathmandu valley also encompasses “Kathmandu” – the capital of Nepal. It houses a large population and is the most developed part of Nepal. Hence, the present study was undertaken in Kathmandu valley to obtain information about the knowledge of community pharmacists regarding the risk associated with the use of various medicines in pregnancy.

2. Materials and methods

The study was conducted after obtaining ethical approval from the Institutional research committee of KIST Medical College. A cross-sectional descriptive study was carried out among the community pharmacists of Kathmandu Valley. CPs registered with the Department of Drug Administration (DDA), the national drug regulatory authority, and working in/running community pharmacies located in the Kathmandu Valley were included in the study. There are three districts in the Kathmandu valley – Kathmandu, Lalitpur, and Bhaktapur. Community pharmacies from all three districts were included. According to DDA, there are a total of 12,865 community pharmacies in the country. The total number of community pharmacies in the three districts of the Kathmandu valley is 3276 [19]. The sample size calculated from the Raosoft sample size calculator is 344 with a 5% margin of error and 95% confidence interval.

Proportional sampling was done based on the number of pharmacies in each district – Kathmandu, Lalitpur, and Bhaktapur registered with DDA. A sample proportional to the number of pharmacies in each district was selected so that the sample was representative of the population. CPs working in these pharmacies who provided consent were included in the study. Data was collected using a questionnaire distributed to a random sample of CPs using a convenience sampling method. A previously validated questionnaire was used in the study [8]. The permission to use the questionnaire was obtained from the authors by email. The authors added more questions and modified the questionnaire according to the study requirements. CPs were explained about the objective of the study and their written informed consent was obtained.

The questionnaire was pretested by administering it to 10 CPs. CPs participating in the pretesting of the questionnaire were not included in the study. The pretesting was done in two places of the Kathmandu Valley – Kathmandu and Lalitpur. The questionnaire was revised by the research team after the completion of the pilot study and was divided into seven sections. The first section examined the knowledge of CPs regarding the United States Food and Drug Administration (USFDA) medicine risk category in pregnant women. The second section was associated with the knowledge of CPs regarding the safe use of prescribed medicines during pregnancy. The third section was associated with knowledge of CPs regarding the safe use of over-the-counter medications during pregnancy. These sections of the questionnaire comprised a total of 29 items. Each correct answer was given a score of “1” and each incorrect answer a score of “0”. The fourth, fifth, and sixth sections of the questionnaire evaluated the most dispensed groups of medicines by the CPs, their major concern while dispensing medicines to pregnant women, and the most used resources to obtain information while dispensing medicines. Safety of use of medicines during pregnancy was noted by asking their responses to the use of prescribed and OTC medicines during pregnancy and checking the response against standard sources.

The last section obtained demographic information of the CPs. Statistical package for the social sciences (SPSS) version 26 (IBM Corp., Armonk, NY, USA) was used for the data entry and analysis. The data were analyzed using descriptive statistics and non-parametric tests as the scores were not following a normal distribution. The scores among different subgroups were compared using appropriate non-parametric tests. Mann–Whitney U test was used for dichotomous variables and Kruskal Wallis test for the others.

3. Results

Among the 344 CPs who participated in the study, 264(76.7%) were male and 94.2% were between the age of 21 to 30 years; 53.1% of the CPs had work experience of less than one year and 57.6% of the respondents had completed diploma in pharmacy. Approximately 50.3% of the pharmacies were in the Kathmandu district of the valley. The average number of medicines dispensed daily was less than a hundred in 63.7% of the pharmacies. The number of medicines dispensed to pregnant women daily was less than 10 in 61.6% of the pharmacies. Only 28.8% of the community pharmacists always inquired about the pregnancy status of a woman of reproductive age (Table 1). The median knowledge score among the different age groups of respondents was 16. The maximum possible score was 29. There was a significant difference in the median knowledge score among respondents according to their work experience and the qualification of respondents (p < 0.001). Furthermore, the median knowledge score based on the average number of medicines dispensed per day also showed a significant difference (p = 0.006). In addition to this, a difference in median knowledge score based on the average number of medicines dispensed to a pregnant woman (p < 0.001) was also observed. The median knowledge score was also different based on the status of inquiring about pregnancy (p < 0.001) (Table 1).

Regarding the knowledge of the respondents about US FDA medicine risk categories, 89.2% of the respondents had knowledge about category A, Category B, and Category C. Antiemetics (88.1%) were the most dispensed medicines by the community pharmacists followed by analgesics 63.4% and antacids 56.4% (Table 2). The major concern of community pharmacists while dispensing medicines to the pregnant women was the unknown stage of pregnancy mentioned by 64.2%, risk-benefit ratio not clear mentioned by 54.1%, only animal studies available which may be not reliable 34%, lack of clinical trials 21.2% and most data obtained from the observational study was mentioned by 12.5%.

The resources most used by the community pharmacists to obtain information while dispensing medicines to the pregnant women were the Current Index of Medical Specialties (CIMS)/Nepal Drug Review (NDR) mentioned by 61.3%, followed by World Health Organization guidelines mentioned by 39%, Lexicomp mentioned by 28.5%, Nepalese National Formulary mentioned by 18.3%, Micromedex mentioned by 8.9%, Journals mentioned by 4.4% and Pregnancy specific books were mentioned by 2%.

The CPs had very good knowledge regarding the safety of use of Vitamin A, oral iron, folic acid, calcium, cold remedies, acetaminophen, OCPs, alprazolam, and amoxicillin. However, the knowledge of CPs was not good about the safety of the use of lamotrigine, valproic acid, bismuth subsalicylate, guaifenesin, ibuprofen, and pseudoephedrine (Table 3).

Community pharmacists are the most accessible health personnel to the public. Hence, the current study was undertaken to evaluate the knowledge of CPs regarding the use of various medicines during pregnancy.

In our study, 94.2% of community pharmacists were between the age group of 21 to 30 years. However, in another study conducted in India, 49.4% of community pharmacists were more than 30 years of age [20]. This may be because Nepal is a developing country and many people in Nepal are still living below the poverty line. Therefore, the community pharmacists from the lower socioeconomic background may have started working immediately after passing their pharmacy degree to earn their living. Many pharmacy graduates in Nepal start their careers as CPs. In addition to this, the drug act in Nepal 1978 has regarded a person who is graduate in pharmacy as qualified pharmacists and community pharmacists have been regarded as professionals based on their completing qualifications as specified by the Drug Advisory Committee [21]. Also, another study conducted in Nepal among community pharmacists stated that most of the population in Nepal is young, which is also reflected among the CPs [22].

As most of the community pharmacists were from a younger age group, they may have less experience prescribing medicines to pregnant women. Our study showed that only 28.8% of CPs asked about pregnancy status while dispensing medicines. However, in another study conducted in Saudi Arabia, 54.7% of the community pharmacists asked for pregnancy status while dispensing medicines to pregnant women [8]. More than half of the CPs had completed diplomas in pharmacy in our study which is different from another study which showed only 39.2% had done so [20].

The use of some medicines during pregnancy may have teratogenic effects on the developing fetus [8]. In our study, 89.2% of the community pharmacists had knowledge about FDA medicine categories A, B and C. However, in another study conducted in India 80% were unaware of the pregnancy risk category [20].

There was a significant difference between the knowledge score of CPs with work experience of less than one year, one to five years, and more than five years. This finding is like another study conducted in Ethiopia [23]. In this study, an association was observed between years of experience of the pharmacy professionals and the knowledge score. The work experience of the CPs also influences their knowledge. As CPs are easily accessible health care professionals, they must remain up to date about medicines. This will help them share proper information with pregnant women regarding the use of various medicines during pregnancy.

Furthermore, a significant difference was observed in the knowledge score among respondents with different qualifications. This may be because of different levels of competencies addressed during different courses and due to a lack of continuing pharmacy education. A significant difference was also observed between the knowledge score and the average number of medicines dispensed per day. The lack of experience in dispensing medicines among pharmacists dispensing a lesser number of medicines to pregnant women may be a responsible factor. CPs are considered to have good knowledge about the use of various medicines in different conditions including pregnancy. The current study revealed that the knowledge of CPs regarding the use of different medicines during pregnancy was inadequate. The findings of this study on the knowledge of community pharmacists may help the Ministry of Health, Department of drug administration, and other regulatory authorities to plan educational programs to improve the knowledge of community pharmacists regarding the use of various drugs during pregnancy.

In our study, antiemetics (88.1%) were the most dispensed medicines for pregnant women which was followed by vitamins 68.3%. This finding is different from another study conducted in Qatar where vitamins (96.6%) were the most dispensed medicines to pregnant women followed by antiemetics (95.7%) [24]. In our study, 61.3% of the CPs used CIMS/NDR as an information source while dispensing medicines to pregnant women. However, in another study, British National Formulary (BNF) was used by most of the community pharmacists 77.8% [23]. This may be because CIMS/NDR is one of the most used books to obtain information about the various medicines. However, the information available in this book should be cross-checked with other sources. This will help the community pharmacists to obtain proper information about the use of various medicines during pregnancy. In addition to this, there are various medicine advertisements in CIMS/NDR which may also influence the dispensing patterns of various drugs to pregnant women and the information provided.

The major concern expressed by community pharmacists in our study was the unknown stage of pregnancy mentioned by 64.2%. This finding is like another study where an unknown stage of pregnancy was the major concern mentioned by 76.5% [24]. This might be because pregnant women requesting various medicines during pregnancy from the CPs may not be aware of their stage of pregnancy. Furthermore, the community pharmacists may also be hesitant to ask about the pregnancy status of women because of social issues. Most CPs were men, and they may find it uncomfortable asking about pregnancy status and the women may find it uncomfortable answering the query.

The medicines that are easily available as over-the-counter drugs are folic acid, oral iron, calcium, acetaminophen, oral contraceptive pills, cold remedies vitamin A, amoxicillin, tetracycline, ciprofloxacin, ibuprofen, and aspirin. They can be officially supplied as over-the-counter drugs in Nepal [25]. Furthermore, community pharmacists play an important role in the health care system of Nepal. They have an important role in dispensing drugs as well as preventing drug-related problems [22]. Dispensing of prescription-only medicines without a prescription has been noted in previous studies in different regions in Nepal [26,27]. Previous studies have shown dispensing of antibiotics among CPs of Kathmandu valley [28]. In a study conducted in India, it was shown that only 27.5% of the pharmacies refused to give antibiotics to the public without prescription [29].

Our study revealed that the CPs had very good knowledge on the safety of use of Vitamin A, oral iron, folic acid, calcium, cold remedies, acetaminophen, OCPs, alprazolam, and amoxicillin. This finding is like another study conducted in Saudi Arabia where the majority of the CP identified that amoxicillin and acetaminophen are safe for use in pregnancy [8]. In our study, only 11.7% of the community pharmacists could give the correct answer regarding the use of ibuprofen in pregnancy. This finding was also like the study conducted in Saudi Arabia where only 18.4% of the CPs could identify correctly regarding the safety of ibuprofen [8]. Our study mainly focuses on the knowledge of CPs regarding the use of medicines during pregnancy.

The major limitation of this study is that it was done only in the Kathmandu Valley and may not represent the knowledge of CPs of the entire country. Another, limitation is that the study has only focused on the knowledge of the community pharmacists. Their attitude and practice regarding drug use during pregnancy have not been evaluated. In addition to this, we did not explore dispensing of prescription-only medicines by pharmacists without a prescription. Furthermore, the study was conducted only during the day shift. Therefore, it might be possible that the knowledge level of CPs working the night shift may be different.

5. Conclusion

The current study shows that the knowledge score of the community pharmacists needs improvement. Various educational activities and continuing education programs may help the community pharmacists to improve their knowledge about prescribing different medicines during pregnancy.