Crushing or splitting oral solid dose forms (OSDFs) is one of the important contemporary debates from the medical perspective.1–4 OSDFs can be split in order to provide several, smaller doses for various purposes or to offer a lower amount of the active component in a single unit. Crushing solid dosage forms is commonly achieved using appropriate pharmaceutical equipment, such as a mortar and pestle, to smash pills into powder.5 Typically, patients may divide pills for a variety of reasons, including giving the patient the correct dose when the product is not accessible at the necessary strength.6 This method is beneficial for both elderly people and children who have low drug tolerance due to the presence of comorbidities in the elderly7 8 and relatively lower hepatic detoxification of the drug in children.9 10 Therefore, these patients’ groups need to begin therapy with the smallest amount possible and then gradually increase the amount administered of the drug until reaching the ideal dose. This is an ideal approach to improve the tolerability of the medication and decrease the chance of adverse reactions to certain drugs.11
Other advantages of solid dosage forms splitting/crushing include lowering the cost of drugs, making oral administration a convenient and affordable route,12–14 as well as achieving greater flexibility in medication dosage.15 16 Moreover, the large dimensions of the capsules, the unpleasant taste or the number of tablets to be administered make crushing tablets a suitable way of administering medications to patients with swallowing issues such as geriatrics and patients with cardiovascular events, for example, stroke or neurological disorders.17 Grinding pills and subsequently mixing them into food is also thought to be a practical method of administration for people with loss of memory or confusion or patients who refuse to take medications.18 However, it is critical to be aware of the potential consequences of dosage form manipulation.
Drug pharmacological and pharmacokinetic effects can be altered as a result of changing dosage form design through solid dosage form crushing or splitting. Moreover, OSDFs may be broken up or crushed, but this might cause certain issues. For instance, certain corticosteroids may expose pharmacists to dangers through the powder dusting effect.19 This includes breaking or crushing teratogenic or cancer-causing substances like methotrexate. It is well known that the powder of this category of drugs contributes to cross-contamination and poses a substantial risk to workers. Therefore, powder dust is one of the main elements that must be addressed during the production of OSDFs.20 Accordingly, crushing or splitting OSDFs might have harmful consequences.21 Crushing OSDFs also potentially affects drug bioavailability. For potent medications like digoxin and carbamazepine with narrow therapeutic windows, these alterations to the dosage form can be very detrimental. Using small amounts of drugs can produce an effect greater than expected due to the tablet crushing which can spike plasma concentration above the toxic level.22 23
Overall, previous research studies on this specific issue are very limited, particularly in low-income and middle-income countries (LMICs),24–27 and no single study date has been conducted in Jordan which is an LMIC. Therefore, this study intended to examine the practices, attitudes and knowledge of the Jordanian population regarding the splitting and/or crushing of OSDFs. Such a study can help healthcare professionals make medical decisions about whether to crush or split OSDFs and how to do so effectively without affecting patient health and treatment outcomes of the prescribed medications or therapeutic regimen.
MethodsStudy designThis is an online cross-sectional survey study that was conducted in Jordan between November 2022 and March 2023.
Sampling techniqueThis study employed the convenience sampling technique to recruit the study participants. The questionnaire link was circulated through social media platforms (Facebook and WhatsApp) inviting participants who meet the inclusion criteria to participate in the study. The study objectives and inclusion criteria were highlighted in the cover letter along with the survey link.
Study populationThe general public formed the study population for this study. The inclusion criteria for this study were individuals aged 18 years and older currently living in Jordan. There were no restrictions on gender, education level, income level or disease history for study participants.
Questionnaire toolThe questionnaire tool used in this study was adapted (modified from an existing survey) based on a previously developed questionnaire tool by Zaid et al.43 The questionnaire tool comprised three sections (online supplemental material). The first section explored the demographic characteristics of the study participants (age, gender, marital status, education level, employment status, monthly income level and history of chronic diseases). The second section examined participants’ attitudes towards medication splitting and crushing and comprised seven questions in yes/no format. The third section examined participants’ knowledge of medication splitting and crushing and comprised six multiple-choice questions. Additionally, tablet-crushing practices were examined using three further multiple-choice questions. For each correct answer, participants were given a score of 1. The maximum attainable score for the knowledge section was 6, the higher the score, the more knowledgeable the participant is about medication splitting and crushing.
Questionnaire reliability and validityThe questionnaire instrument underwent a process of review and validation by pharmacists expert in the fields of pharmaceutics and clinical pharmacy. These experts assessed the instrument’s lucidity and intelligibility, as well as its face validity and the difficulty of comprehending the questions. Furthermore, prior to implementing the survey on a broader scale, a pilot study was undertaken involving a limited sample size of 20 participants to evaluate its clarity and readability. The outcomes of this study validated the questionnaire’s straightforward nature. The purpose of this assessment was to ascertain the questions’ clarity, comprehensibility and suitability, in addition to verifying the content’s propriety and detecting any potential misunderstandings. A content validity assessment was conducted on the questionnaire items in order to ensure that they sufficiently addressed the pertinent subject matter of the study. The task was completed through the participation of experts in a discourse verifying that the inquiries sufficiently covered the pertinent subject matter. The purpose of conducting an assessment of face validity was to determine whether or not the queries effectively captured the intended constructs. In order to ensure the queries’ pertinence and suitability, expert analysis was solicited.
Statistical analysisThe SPSS, V.29 was used to analyse the data for this study. Continuous variables were presented as a mean and (SD) as the data were normally distributed. Categorical variables were presented as frequencies and percentages. Binary logistic regression analysis was used to identify the predictors of participants’ knowledge concerning medication splitting and crushing. The normality of the knowledge score was checked using the histogram and skewness and kurtosis measures. These confirmed the data were normally distributed. The mean knowledge score of the study participants was used to define the dummy variable for the binary logistic regression analysis. The OR with 95% CI was used to present the findings of the regression analysis. The significance level was assigned as a p<0.05.
Patient and public involvementNone.
Sample sizeThe required sample size for our study population was 385 participants, based on a CI of 95%, an SD of 0.5 and a margin of error of 5%.
DiscussionUsing medications reasonably and efficiently requires ensuring that patients receive the appropriate treatments customised to their clinical requirements, in the right dosage, and for the necessary time, all while reducing expenses for both patients and their communities. In the field of pharmaceutical treatment, the act of splitting or crushing medications has long been recognised as a common method for obtaining the prescribed dosage when a specific dose is not readily available. However, it is important to note that certain pharmaceutical dosage forms should never be crushed, as established by previous research.28–30 Therefore, this study aimed to evaluate the knowledge, attitudes and practices regarding medication splitting and crushing among the general public in Jordan.
Around 22.2% of the participants acknowledged the usefulness of tablet splitting/crushing in mitigating medication expenses, while 33.5% advocated for physicians to frequently recommend tablet splitting/crushing as a cost-saving measure. However, a separate study conducted in Canada indicated that tablet splitting/crushing appears to have limited effectiveness in reducing costs.28 It is crucial to exercise caution when considering tablet splitting/crushing due to potential issues such as inconsistent dosages and an elevated risk of errors in comprehending and administering the medication.
A significant proportion of the participants (84.1%) acknowledged the challenges associated with breaking tablets, which can be attributed to their size or hardness. The study further identified that tablet splitting/crushing is influenced by various factors including tablet size, shape, hardness, the method employed for splitting/crushing and human ability. Specifically, it was observed that smaller, rounder and harder tablets posed greater difficulty in breaking, resulting in tablet fragmentation and potential loss of medication.31 32 The study’s findings indicate that a majority of participants (67.0%) expressed uncertainty regarding the appropriateness of splitting or crushing tablets. Consequently, it is imperative to improve the availability of information regarding which dosage forms can be divided or crushed in order to reduce the likelihood of medication errors.33
Furthermore, a significant proportion of the study participants (75.8%) indicated their inclination to review package leaflet information in order to determine the appropriateness of splitting or crushing tablets. It is worth noting that tablet products approved by the US Food and Drug Administration (FDA) for splitting are required to include specific instructions in the patient package insert.34 Similarly, a comparable percentage (76.8%) of participants reported that they had never sought guidance from healthcare professionals regarding tablet splitting/crushing. Conversely, a study conducted in Malaysia revealed that approximately half of their participants would seek advice from healthcare professionals when uncertain about the feasibility of tablet splitting.35 A significant proportion of our study participants (90.0%) indicated that the modification of dosage forms falls under the purview of a doctor’s role or responsibility. This is supported by the fact that clinicians often find it necessary to modify oral dosage forms for patients due to various factors such as age-related changes in drug response and the unavailability of appropriate licensed dosage options. Furthermore, the adjustment of dosage forms to accommodate patient characteristics is considered a responsibility of healthcare professionals.
In this study, the majority of participants (84.8%) responded correctly that tablets with score lines can be divided, while tablets without score lines cannot be divided. The presence of score lines on tablets allows for dose flexibility, ease of swallowing and cost savings. This finding is supported by previous research indicating that splitting scored tablets is both approved by the FDA and considered safe and effective. However, it is concerning that only 11.2% of participants were able to correctly identify tablets that should not be split or crushed, and only 24.0% could accurately identify the division of scored tablets into equal parts. These results highlight the lack of accurate information on tablet splitting in drug information sources and emphasise the need for improved information to prevent medication errors. Similar studies have also shown that many patients are unaware of which medications can be split or crushed. The findings of the study indicate that a significant proportion of the study participants, namely 72.0%, demonstrated accurate knowledge regarding the limitations associated with splitting, crushing or dissolving tablets and capsules. It is important to note that not all oral drugs can be safely subjected to these actions, as doing so can have detrimental effects. This highlights the potential harm that can arise from the incorrect splitting of medications.36
The majority of the participants (67.1%) demonstrated accurate knowledge regarding the potential exacerbation of side effects when crushing an enteric-coated NSAID tablet. It is indeed true that enteric-coated medications are specifically designed to remain intact during their passage through the stomach, thereby releasing the active drug only on reaching the intestines. This formulation is frequently used for drugs that have the potential to cause stomach irritation, are prone to breakdown by gastric acids or require a delayed onset of action. Manipulating the enteric coating of these drugs has the potential to compromise the stability of the drug, its desired therapeutic benefits, or increase the probability of adverse reactions. In addition, it has been shown that these objects possess a high resistance to deformation, making them more challenging to crush.37–39 Moreover, it was observed that around 61.0% of the participants demonstrated an accurate understanding that the therapeutic effectiveness of a sustained-release tablet is diminished when it is crushed. This finding aligns with previous research indicating that dividing extended-release formulations can lead to an overdose due to unregulated release of the active ingredient.40
This research revealed that, on average, participants attained a mean knowledge score of 2.7 out of a maximum of 6 points. The obtained score represents 45% of the highest achievable score, suggesting a limited level of understanding in relation to tablet splitting and crushing. The limited knowledge observed in this context may be attributed to the absence of comprehensive tablet splitting and crushing information in drug references. This highlights the significance of improving such information in order to mitigate medication errors. It is crucial to enhance the availability of information pertaining to the safe division or crushing of medication dosage forms, as this will decrease the probability of medication errors and promote awareness regarding tablet crushing and splitting. This recommendation is supported by a study that investigated the knowledge, attitude and practices of community pharmacists.33 41 The findings indicate that although certain pharmacists demonstrate positive attitudes and possess adequate knowledge of the practice of tablet splitting and crushing, there remains potential for improvement. It is worth noting that there exists a necessity for enhancement in the guidance provided regarding the avoidance of dividing or crushing enteric-coated or sustained-release tablets.42
Around 39.2% of our study participants indicated that they engaged in tablet splitting or crushing in order to attain their desired dosage. Among this group, a significant majority (82.9%) reported doing so specifically with score tablets. It was observed that the prevailing perception of tablet splitting is primarily associated with the necessity for dose modification and the difficulty of swallowing tablets.43 Despite the ongoing importance of score tablets in facilitating patients' achievement of their desired dosage,44 it is worth noting that these tablets occasionally exhibit suboptimal performance along their scored lines.45
In our study, the findings from the binary logistic regression analysis indicated a significant association between individuals with bachelor’s degrees and those with an income level between JD500 and 1000 per month and their knowledge about tablet crushing. This suggests that education and income are influential factors in determining the level of knowledge individuals possess about tablet crushing. Moreover, the study also found that higher levels of education were linked to a greater understanding of medication, supporting the idea that education plays a role in enhancing medication knowledge.21 Additionally, the study highlights the impact of economic status on patients’ knowledge and utilisation of drugs.46 Furthermore, the findings of the study indicate that physicians were frequently cited as the primary source of guidance on tablet splitting and crushing. It was observed that community pharmacists often defer to the recommendations of physicians in this regard.42 However, it is crucial for physicians to acknowledge the challenges faced by patients in splitting tablets and to explore alternative dosage forms or strengths.47 Additionally, it is imperative for all healthcare professionals, including pharmacists, to actively participate and demonstrate attentiveness in assisting patients with tablet splitting and crushing. They should also actively engage in programmes aimed at addressing these issues for the wider population.48
In order to practice safe medicine usage, patients should take caution when dividing tablets, obtain accurate information from reputable sources, possess knowledge regarding which medications are suitable for splitting and which are not, particularly exercising care with coated and sustained-release tablets, and actively seek help from healthcare professionals. Furthermore, healthcare professionals have a pivotal role in providing guidance to patients and should take into account alternate dosage regimens as needed in order to promote the safe and economically efficient utilisation of medications. We recommend further patient education about the practice of tablet splitting to improve the public’s knowledge through dissemination by health practitioners and public health networks. This can be achieved with the help of informational materials distributed via hospitals, clinics, pharmacies and social media. Information dissemination can be improved significantly through collaboration with patient advocacy groups, healthcare organisations and governmental health agencies in disseminating clear, evidence-based guidelines concerning safe and effective practices when tablet splitting. That may extend to include education on tablet/splitting during regular clinical encounters aimed at providing patients with personalised counselling based on their individual treatment needs. The pharmacist should engage in active teaching at the time of dispensing medication regarding which medications can and cannot be crushed and provide written educational materials in a format that is easy to understand. Pharmacists are uniquely positioned to provide individual counselling and ensure that the patient is aware of potential risks. In collaboration with physicians and nurses, they can ensure consistent communication, offering alternative dosage forms, when possible, to ultimately promote safe medication practices in order to enhance patient safety and treatment efficacy. Healthcare professionals should be informed about the importance of enhancing public knowledge of tablet-splitting practices through medical conferences, journals and continuing medical education programmes. Supplementary strategies, such as incorporating pill-splitting guidelines into clinical protocols and employing decision support systems, are recommended to foster behavioural change in healthcare environments.
This study has limitations. The cross-sectional study design restricted the ability to examine causality among the study variables. The use of an online survey study is another limitation that might have affected the generalisation of our study findings as most of the study participants were young, female and had a college degree. There is justification for the dominance of younger, more educated, female participants in our study. Younger age categories are the main demographic group in Jordan and would thus engage more with online platforms leading to oversampling. In Jordan, 91.2% of the population is aged below 54 years and 52.8% aged below 25 years.49 Moreover, there is usually a greater tendency for females to respond to health-related surveys, as they are more concerned about health and show more care for their own health.50 Finally, online questionnaires are also more likely to be completed by people with a college degree because of their greater level of digital literacy and access to internet-based resources.23 Furthermore, self-administered questionnaires are vulnerable to recall and response bias.
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