Patients’ ability to read and understand dosing instructions of their own medicines – a cross sectional study in a hospital and community pharmacy setting

Providing information to patients about their medication is a fundamental responsibility of the pharmacist. The information provided needs to be comprehensive, readable and understandable for maximum benefit. Among all medicines information that needs to be communicated, the patient must at least know the dosing instructions for each medication they are taking. Failing to effectively communicate dosing instructions such as, the name, strength, frequency, duration, route of administration and important adverse effects of the medication may be detrimental to the patient.

Poor knowledge about their own medications among patients could result in misuse [1] and poor compliance [2], both of which will negatively impact medication safety. If patients are unaware of their medication names or strengths, they may consume the wrong medication, wrong strength or even duplicate medicines with different brand names. They will not be able to check if medicines they buy are appropriate, or communicate to other health professionals about the medications they use when needed. If dosing instructions are incomplete, misread or misunderstood, patients may consume medication at a wrong time, duration or even route [3]. In fact, we have come across instance where patients have swallowed suppositories and respules indicating the impact of poor medicine knowledge, on medication safety. The magnitude of this problem will increase among older patients as most take a number of medicines at a time [4].

Poor knowledge among patients about their medication could also affect the cost of healthcare in a country [5]. Sub-therapeutic outcomes or toxicities that result as a consequence of improper administration of medicines may prolong hospitalization or increase re-admissions [6]. Simply, outpatient healthcare will completely collapse if patients who are correctly diagnosed with carefully planned treatment regimens, do not take their medication as prescribed. Hence the pharmacists’ ability to effectively communicate medicines information to patients is a topic of national importance.

Studies have assessed the level of communicating dosing instructions to patients, especially the effectiveness of communication, and factors that affect proper communication, at observational and interventional levels [7, 8]. The impact of factors such as, patient literacy, number of medicines dispensed, format and organization of the medicines label, complexity of dosing instructions, precision of writing dosing instructions and the use of icons, graphics and pictograms, on communication of medicines information have been documented in the literature [9–11]. However, a considerable gap was clearly evident. Most published studies assessed patients’ readability and comprehensibility of medicines information using mock dispensing labels and not their own medications [4, 5, 12–19]. A thorough literature survey by the authors revealed that, studies that assessed these characteristics in the real-world setting were very limited. It is also important to note that, a patient’s ability to read a simulated dispensing label may not be completely indicative of the readability and comprehensibility of their own medications labels [20]. Among the few reported, is a considerably large study conducted by Athuruliya et al., [21] where completeness and understandability of dosing instructions given with dispensing labels were assessed in a house-hold survey. However, understandability of dosing instructions were assessed as a simple yes/no question without using objective criteria which the authors highlight as a limitation [21]. Unaka et al., [12] assessed written instructions provided at discharge by a hospital medication service but the study was limited to paediatric medication charts. Moreover readability and understandability of written instructions were assessed retrospectively using the Fry Readability Scale (FRS) and Patient Education Materials Assessment Tool (PEMAT) tools respectively, and not by directly assessing patients ability [12]. Law et al., [22] conducted a prospective, exploratory study on readability and understandability of dispensing labels in the real world setting by interviewing 179 patients which is relatively a smaller sample when considering cross sectional studies [22].

With an aim to bridge these gaps, we set out to study the completeness, readability and overall knowledge among patients of written dosing instructions provided by pharmacists on dispensing labels in a ‘real world’ hospital and community setting.

The mean scores for readability of dosing instructions (P < 0.001) significantly differed among different education levels, in both settings. Knowledge on dosing instruction of medicines differed by education level in the hospital setting (P < 0.001). There was a significant relationship between prescription type (new or refill) and readability in the hospital pharmacy setting (P < 0.001) but was not seen in the community pharmacy setting (P = 0.064). There was a significant relationship between knowledge of dosing instructions and type of prescription in the community pharmacy setting (P < 0.001) but not in the hospital pharmacy setting (P = 0.149).

Pharmacist are healthcare professionals who are mainly responsible for providing complete, readable and comprehensible medication information to patients. Medication information is expected to be provided in written, verbal or both forms by the pharmacist. This is one of the very few studies that assessed the completeness of dosing instructions, readability and patients’ level of knowledge of dosing instructions of their own medication. Our main findings show that these three parameters scored a mean of above 6 out of 10 in both settings which is appreciable. However, it also means that dosing instructions were not 100% complete, and patients were not able to completely read or understand dosing instructions, thus a serious gap in the communication process. This is also supported by other studies where only 49% of medicines with patients were adequately labeled [21]. Unaka et al., [12] rated paediatric discharge instructions for completeness, readability, and comprehensibility to conclude that instructions were subpar. Similar to results reported by Shrank et al., [9] and O’Hare et al., [19] readability and comprehensibility of dosing instructions significantly varied across different education levels highlighting the need for providing simplified and patient related dosing instructions.

Some important instructions such as the duration and route of administration were frequently missing in dispensing labels. Duration is an important dosing instructions especially in medicines like antibiotics to achieve desired therapeutic outcomes and to avoid antibiotic resistance. It was evident that most patients who attended the hospital, related a medicines duration of 28 days to 1 month in general. Even though the discrepancy is trivial, a medicine free period of 3 days can be detrimental for long term medications such as anti-hypertensives, anti-diabetics, anti-platelets and thrombolytics. Patients’ knowledge on route of administration is also important. Many unpublished cases have been reported frequently on medicines administered by the wrong route resulting in adverse effects or sub-therapeutic effects. Most commonly mis-administered medicines include, dry powder inhaler capsules, and suppositories, both of which have been swallowed. Inappropriate administration of sublingual medicines may result in sub-therapeutic effects but dosing instruction provided for sublingual tablets were noticeably low. Although the causes for missing duration and route of administration was not assessed in this study, it may be due to, missing data on prescriptions, absence of a standard procedure/format by pharmacists to provide duration and route of administration, or even perceptions by pharmacists that these type of information is not important enough to communicate to patients.

Another interesting finding was that patients often found the name and strength of medicines difficult to read. A patient should know, names and strengths of their medicine to avoid, mix-ups in administration, over dosing and duplications, to self-assess if medicines dispensed to them are correct, and to communicate to other health professionals in an emergency such as medicines allergies. It is unethical for patients to be left ignorant about the medicines they are dispensed with.

Readability, and knowledge of dosing instructions were related to education level. Similar findings were also reported by Davis et al., where poorly literate patients found it more difficult to read and understand dosing instruction [5]. This should be a motivation for pharmacists to provide patient-specific counselling to patients depending on their ability to read and comprehend information. The complex nature of the medicine regimens, and age may also have affected readability and comprehensibility. Findings by Barros et al. supports this claims [26]. A study by Nair, K.V. et al., showed that adequate provision of information is essentially needed when dispensing new prescriptions rather than re-fill prescriptions [27]. Prioritizing on detailed counselling for patients with new prescriptions and limiting to essential dosing instructions and re-clarifications for patients with refill prescriptions could also help to control communication barriers due to heavy traffic at dispensing counters.

We propose that patients with new and re-fill prescriptions be separated when providing medicines information, develop an essential and compulsory list of the minimum dosing instructions to be provided with any medication dispensed, promote pharmacists to write in block capitals or preferably have the dosing instructions printed on dispensing labels, and reconfirm with patient by asking them to read the dispensing labels and explain their medicine to the pharmacist before completing the dispensing process. A special emphasis should be given when communicating dosing instructions to, those with functional barriers, the illiterate, and those with mental illnesses.

There is much strength in our study. Our research was carried out among 800 patients, exceeding 2000 dispensing labels at two settings, a hospital and a community pharmacy. The study included three research techniques, a dispensing label review, assessment of patients’ ability to read dispensing labels in the form of an unstructured interview, and their knowledge on dosing instructions using an interviewer administered questionnaire. We also used a prospective research design and direct communication to collect data from patients/caregivers at the point of obtaining their medication which is more reliable. As acknowledged before, using patients own medicine to study these variables added uniqueness to the study.

There are also some limitations that need to be acknowledged. The settings used for study was selected through convenience sampling and hence may not reflect the pattern in the whole country. Although the study was conducted in two settings, there was no option to compare the two, as one was a hospital, the other was a community pharmacy. However it is a good stimulation for healthcare administrators to take on similar multi-centered studies in their mission to improve medication safety. There may also have been other confounding factors that affected the outcomes of this study. Some patients on long term medication may have been knowledgeable about their medicines through experience, hence scoring high on knowledge of dosing instructions. This may not actually reflect the ability to read and understand dosing instruction written on dispensing labels. We excluded patients dispensed with medical devices and local applications such as creams, ointments to minimize complications. However this exclusion was only an attempt to simplify the research process and not to underestimate dosing instructions that needs to be provided for them. Many administration errors could be related to devices and local applications and we hope to tackle these dosage forms in future studies that follow. Readability and knowledge of dosing instructions were correlated with educational level and not health literacy of patients/caregivers. This could be a limitation as most educated patients may be illiterate on health aspects. Language barriers and other functional barriers such as poor eye sight were not controlled and may have affected our findings. Both verbal and written dosing instructions need to be given by a pharmacist but this study was only limited to dosing instructions written on dispensing labels. It must also be acknowledged that the pharmacists’ ability to communicate dosing information to patients was not assessed.

This study is one of the few studies that directly appraised the quality of dosing instructions communicated to patients, by pharmacists, on their dispensed medicines. It was evident that current practices among pharmacists on providing dosing instructions varied and did not conform to a standard format. Most often it is assumed that patients are able to read and understand dosing instructions provided to them, but this study indicates that some dosing instructions are mis-read or mis-understood. We urge the need for a standard, universal procedure on providing written dosing instructions for patients. We also highlight the importance of providing clear dosing instructions preferably in clear block capitals or in printed form, devoid of abbreviations. Pharmacists should be advised to consider patient demographics such as age, education level, functional and language barriers and personalize the level of details needed when providing standard dosing instructions. It should be made routine procedure for pharmacists to ask patients to read and explain their medication dosing instructions off the dispensing labels, and clarify any doubts and misinterpretations before completing the dispensing process.