The need for a comprehensive medication safety module in medical education.

OBJECTIVE: A rising number of medicines and minimal emphasis on rational prescribing in the medical curriculum may compromise medication safety. There is no focused module in the curriculum dealing with factors affecting safety such as quality, medicines management, rational use, and approach to adverse effects. Creating awareness of these issues would hopefully plant a seed of safe prescribing and encourage pharmacovigilance. A study was therefore done to determine the need for such a module.
METHOD: A quasi-experimental pre-post module study. Medical students (n = 88) completing pharmacology term were recruited after informed consent. A questionnaire containing 20 questions on various themes was administered and scored. Subsequently a module was developed and relevant safety themes taught to the students. After one month, the questionnaire was re-administered.
RESULTS: The pre module score was 9.52/20. Knowledge about the various themes, adverse effects, medication management, quality issues and rational use were similar though poor knowledge was evident in specific areas such as clinical trials, look alike-sound alike medicines (LASA) and medicine storage. The post module score was 12.24/20. The improvement of score was statistically significant suggesting the effectiveness of the module.
CONCLUSION: The relatively poor knowledge and improvement with a specific educational module emphasizes the need of such a module within the medical curriculum to encourage safe use of medicines by Indian Medical Graduates (IMG). It is hoped that the policy makers in medical education will introduce such a module within the medical curriculum.

Medicines have been a part and parcel for management of many diseases. They form an essential part of the armament for any doctor. The Indian Medical Graduate (IMG) has the responsibility and mandate as a registered medical practitioner to prescribe these medicines. The availability of a wide spectrum of medicines in the pharmaceutical market can be considered an advantage to both the physician and the patient. However, it may also pose a problem in choice and a potential for poly pharmacy practices.

To add to this challenge, multiple brands, generics, fixed dose combinations and various types of other preparations are flooding the market especially in Low and Middle Income Countries (LMIC) such as India.[1] Many of these medicines may have serious adverse effects and other safety issues.[2] In order to ensure safety of patients, pharmacovigilance is a dire need in our country. Towards this, the Pharmacovigilance (PV) program has been introduced both as a national and global system for detection, understanding, reporting and prevention of these safety issues.[3] Though the number of reports in India appear to be on the upswing, the population and the number of brands are also increasing. IMGs may not be contributing optimally to the pharmacovigilance program. A possible factor for this could be that many doctors find it difficult to understand the significance of pharmacovigilance and related safety issues about medicines.[4]

A reason for this lack of responsibility towards the concept of pharmacovigilance could be a lack of emphasis or sensitization about medicine safety issues in medical education. Even though the medical pharmacology curriculum and university syllabi mention about adverse effects and pharmacovigilance, in practice, much of the teaching is didactic, information related and drug based. Often adverse effects of various medicines are mentioned in teaching sessions without really going into relevance, factors and implications. Moreover, various other safety issues such as quality of medicines and issues in medicine management, may or may not be emphasized. This may not only affect the pharmacovigilance program, but also affect rational use of medicines. A lack of emphasis on medication safety may impede safe prescribing in future graduates and as a consequence affect healthcare of our population. It would be the primary responsibility of the prescriber to have adequate awareness and knowledge in order to appropriately use medicines, and thereby safeguard the health of the population. Towards this goal, there is a need therefore for a comprehensive medication safety educational module in the medical curriculum.

A study was therefore carried out to determine the knowledge of medical students about various issues in medication safety and subsequently to assess the effectiveness of a specific educational module in improving their knowledge.

Methodology

Setting and Design

The study was done in a tertiary care teaching institution. It was done over a period of six months ending in March 2016. The design used was quasi-experimental with pre and post educational module assessments.

Intervention

The educational intervention consisted of a medication safety module (MSM). This module was developed keeping in mind the need for awareness of these issues for medical graduates as well as the areas that need to be strengthened as determined by the analysis of the questionnaire answers.

The medication safety module was developed with four themes (sub-modules) as mentioned in Tables 1 and 2:

Table 1

Knowledge about themes in medication safety (premodule)

Table 2

Knowledge about topics in medication safety (premodule)

Adverse effects – risks and meaning of adverse events, need for pharmacovigilance, clinical trials and relevance, medicine safety profile, drug interactions, genetic differences and risks in alternative systems of medicines

Medicines management – medication errors, high risk medicines, toxicity of medicines, zero order kinetics and relevance, medicine misuse, storage issues and expiry issues, LASA (Look Alike Sound Alike)

Quality of Medicines – generics, innovators, bioequivalence, regulatory needs, counterfeit medicines, substandard medicines, process for recognition and reporting

Rational use of medicines – Rational use principles, irrational use consequences and factors, essential medicines list, formularies, standard treatment guidelines.

Each sub-module was taught in a 30 minute period with a cumulative time of two hours spent on the entire module. All the topics were framed based on what would be important to improve the safety profile of patients while on medicines, to improve the safety responsibility of the IMG and to encourage an integrated style of thinking and clinical management.

Variables and Data Measurement

The variables assessed were knowledge about adverse effects, quality of medicines, medication management, and rational use [Table 1]. A questionnaire with 20 questions (maximum score of 20) was administered based on the variables mentioned before and after administering the module. Each theme was represented by five questions (maximum score of five per theme). Within each theme, there were individual topics represented by a question each [Table 2]. This questionnaire was expert reviewed and pre-tested to minimize bias.

Sample Size and Sampling

With a confidence level of 95% and power of 80%, assuming a gain of at least 20% knowledge between pre-and post test, the sample size estimated was 96. All medical students attending pharmacology in Phase 2 of medical curriculum were considered for participation in the study. Among those who consented, 88 students were finally included from the class since the others were not able to attend the initial session of the study.

Study Process

After students initially answered the questionnaire, analysis was done. After recognizing the areas of weakness and strengths, themes or sub-modules (dealing with above variables) were developed for content. Each of the four sub-modules was taught. Subsequently, after a period of one month, the questionnaire was re-administered and then analyzed.

Analysis

Knowledge was assessed using the questionnaire and scores given based on correctness of answer. An overall mean score was used for assessment of overall knowledge and mean scores also calculated for individual themes (sub-modules). Pre and post intervention comparison was assessed using paired t test. P < 0.05 was considered to be statistically significant.

Ethical Considerations

All information regarding the purpose and process of study were explained through an information sheet and subsequently those who agreed were asked to sign an informed consent form. Confidentiality was maintained and no individual identifiers disclosed. The participants were free to withdraw from the study at any point. Study was done after approval from Institutional Ethics Committee.

Results

There were a total of 88 students (mean age 20.8 years) who participated of which 70 were female. The overall mean score for knowledge about medication safety (before educational module) was 9.52 (SD = 2.41) out of a maximum score of 20 (47.6%).

The mean score across the themes appear to be similar though the weakest theme was quality of medications.

The weakest areas were clinical trials, storage issues, and LASA.

The overall mean score for knowledge about medication safety after the educational module was 12.24 (SD = 2.23). The difference of 2.72 between pre and post module was statistically significant (P < 0.001).

Discussion

Inspite of the huge burden due to medication errors and adverse effects of medicines,[5] there has been relatively less emphasis on this area within medical education from a concept, approach and practical relevance point of view. A separate education module dealing with various medication safety issues deserves the space and time considering the potential harm that medicine can cause to patients.

Knowledge about Medication Safety

In our study, we found that overall knowledge about medication safety was only 47%. In actual practice this could translate into a situation where there could be a potential catastrophe with a medicine in every second patient. As students move into other subjects, the chance to revise pharmacology directly again becomes minimal except for brief forays into therapeutics in the final year. The student is therefore faced with a prospect of very little pharmacological knowledge and in particular about safety aspects. To ensure patient safety, the gap in knowledge has to be bridged with a safety module before their first prescription in internship.

Our study [Table 1] showed that all of the themes in the safety module had a knowledge score between 2.26 to 2.55 (out of a maximum of 5). If one assumes that at least 50% knowledge is needed, based on the score of university exams, only the rational use theme appears to cross this cut off. However, even that score (2.55/5) is just above 50% which is not optimal. It is therefore important to develop a module with weightage in all four themes.

Table 2 shows the correct response scores and percentage for each topic within a theme. The highest score was for pharmacovigilance possibly due to the recent spur in pharmacovigilance activity within hospitals as well as some emphasis within lectures on this topic. The lowest scores were on clinical trials, medication storage and LASA. Both the latter two topics have traditionally been within the realm of pharmacy. However it is important to note the need for doctors to be aware of these topics. Firstly, doctors may need to instruct their own patients about how to store medicines, temperature and humidity issues etc. Secondly, as leaders of the medical community and hospitals, storage concerns of medicines need to be looked into. LASA is an issue that is now on the list of compliance issues for hospital accreditation. Also, mistakes in dispensing, administering or prescribing due to look alike or sound alike medications are often fatal. Clinical trials have been again within the realm of the pharmaceutical industry and B Pharm curriculum. It is important to understand that all new medications are born from clinical trials and many adverse effects may not be apparent during trials. A potential future practitioner therefore should be acquainted with these issues in order to make a judgment call on whether to use a new medicine or not.

Effectiveness of the Medication Safety Module

An increased score of approximately 28.7% demonstrates a reasonable level of effectiveness of the module. Even though this is a statistically significant increase, it would have been ideal to have a much higher increase as some of the issues taught in the module could save lives of patients and ensure an overall better health profile. There are a number of factors which could have influenced a relatively low increase in score, factors such as lack of preparedness (contrary to an actual exam), co and extracurricular activities leading to lack of reading) and so on. However, it is important to remember that an increase in even this much knowledge, could potentially translate into reducing harm for patients in real life and possibly saving lives. The difference in scores between themes or topics was not analyzed since the number of questions representing each was not adequate for such an analysis.

Limitations

The study was done only at one point of time and on one set of students i.e., phase 2 in the MBBS curriculum. The findings in other phases could be different. The post module washout period before questionnaire was re-administered was arbitrarily taken as one month to prevent recall bias. The findings could vary based on the time duration. Attitude and actual practice were not assessed. This would be important in the long run so that good habits and approach for safe prescribing could be instilled in the future Indian Medical Graduate.

Conclusion and Recommendation

Students had a relatively poor knowledge of medication safety issues. The module developed for medication safety is effective in improving knowledge to a certain extent. What is needed additionally is change in approach and attitude and a fundamental understanding of the need to use medicines appropriately in order to minimize the risk to the patient. Towards this, the module will hopefully provide an initial platform and can spur a positive approach in improving the safety profile with regard to medicine use. It is also hoped that the findings of this study will encourage policy makers in both medical education and healthcare practice to the need for specific learning modules in the area of medication safety within the medical curriculum and also continuing medical education programs.

Financial Support and Sponsorship

Nil.

Conflicts of Interest

There are no conflicts of interest.