teaching - learning is a dynamic process and depending on the subject it can be accomplished by various ways and means .
problem - based learning ( pbl ) is a student - centered approach in which students learn through analyzing and solving problems .
the goals of pbl are to help the students develop flexible knowledge , effective problem - solving skills , self - directed learning , effective collaboration skills , and intrinsic motivation .
pbl is a style of active learning and represents a paradigm shift from traditional teaching and learning philosophy , which is more often lecture - based .
working in groups , students identify what they already know , what they need to know , and how and where to access new information that may lead to resolution of the problem .
the role of the tutor is to facilitate learning by supporting , guiding , and monitoring the learning process .
problem - based learning addresses the need to promote lifelong learning through the process of inquiry and constructivist learning .
pbl can be considered a constructivist approach to instruction , emphasizing collaborative and self - directed learning and being supported by flexible teacher scaffolding .
yew and schmidt , schmidt et al . , and hung elaborate on the cognitive constructivist process of pbl .
this central role places high demands on the quality of problems which in turn affects the quality of the small group process and students educational achievements . in general ,
problems are composed of a relatively neutral description of phenomena or events that appear to be related in some way and require further explanation .
a problem can be of different types : explanation problem , discussion problem , strategy problem , study problem , application problem , and multi - level problem .
most of these are based on clinical scenarios and are effective in triggering the generation of learning objectives covering many areas of clinical pharmacology . however , there are topics which are not addressed because they are not within the domain of a typical clinical scenario .
it is important to sensitize students to issues such as the prerequisites for clinical evaluation of new drugs in humans , phases and types of clinical trials , ethical and legal aspects of testing drugs in humans , adverse drug reactions , postmarketing surveillance , drug safety and drug - related injuries . with these learning objectives in mind ,
 life - cycle of a drug  was introduced in the undergraduate medical curriculum during the preclerkship phase in the last unit ( unit ix ) :  medicine , science and technology .
 it is important for medical students to be aware of what is involved in terms of effort , time , resources , and professionalism in the development of a new drug .
patient safety is a relatively new discipline and introducing any new material into an existing curriculum is always challenging .
unfortunately , this increase in use has also brought with it an increase in hazards , error and adverse events associated with medication use .
several instructional strategies have been proposed to teach medical students about medication safety , and a combination of approaches is likely to be most effective .
the various options include pbl , interactive lectures , small group discussions , practical workshops , tutorials , project work including tasks to be undertaken in the clinical environment and at the bedside , online learning packages , reading and case analysis .
several organizations such as world health organization ( who ) , association of american medical colleges , and general medical council have endorsed increased teaching of patient safety and quality improvement during medical school . despite policy consensus ,
few medical schools have implemented curricula addressing these topics , and there is little evidence on the best method to teach them . perhaps the vast majority of literature on drug safety reports investigations of postgraduate teaching of these topics .
a recent systematic review of patient safety curricula in medical schools demonstrated that most teaching about patient safety occurred during the 3 year , varied in length and was taught by clinicians , ethicists , and medical education experts .
current teaching does not meet the goals established by the who and includes no controlled assessment of a standardized curriculum .
a recent study examined students preferences on timing , setting , and pedagogical methods for teaching these topics .
to address all these concerns related to new drug development in a pbl setting , we thought of using a real - life event to generate relevant learning objectives .
the story of rofecoxib ( vioxx ) , a nonsteroidal anti - inflammatory drug with selective inhibition of cycloxygenase-2 appeared very appealing as it had all the elements and issues discussed earlier .
we used it as a platform , developed it into a problem for students to trigger the necessary learning objectives and satisfy the requirements of self - directed learning in a pbl curriculum during the preclerkship phase of the medical program . in this paper , we describe our experience on these educational issues : problem development , implementation , and evaluation .
the arabian gulf university ( agu ) in the kingdom of bahrain is a regional leader in pbl .
the pbl curriculum of the college of medicine and medical sciences ( cmms ) is a 6-year program leading to the md degree and is divided into three phases , as shown in the curriculum map [ table 1 ] : phase i ( premedical ) , phase ii ( preclerkship ) and phase iii ( clerkship ) . a comprehensive description of the medical curriculum of cmms , agu has been reported .
medical curriculum map of the agu phase ii has 9 units , of which units iii  viii are system - based while units i , ii , and ix are more conceptual and integrative . in each unit , problems are discussed in small tutorial groups to generate learning objectives in session 1 . during the week
, students undertake self - study supplemented with structured educational activities such as resource sessions , laboratory sessions , professional clinical skills training , community health activity , and interaction with faculty members . in session 2 ,
the group assembles again , and students present and discuss what they have learned . in the beginning of the next week
, students review the problem and provide feedback about the previous week 's problem . at the end of each unit
development of a problem starts with expected learning outcomes and learning objectives within the broader framework of the unit and the entire curriculum .
we retrieved the literature available on the internet and gathered information about vioxx , its development , trials , marketing , adverse effects , withdrawal from the market , and the legal and ethical ramifications . keeping in mind the expected learning outcomes and objectives [ table 2 ] ,
the information was organized into a problem :  life - cycle of a drug  consisting of a series of triggers to encompass the different stages and steps involved in the process of new drug development [ table 3 ] .
the intended learning needs of  life - cycle of a drug  problem the triggers of  life - cycle of a drug  in session 1 , students discussed the problem in small groups facilitated by a faculty tutor .
any difficult terms were clarified , and discussion focused on the events in the triggers , revisiting previously acquired knowledge , and more importantly , what new knowledge was required to fully understand the contents of a trigger .
they came up with learning objectives as generated by each trigger [ table 2 ] .
after completing the discussion in session 1 , students devoted themselves to self - study about the learning objectives , acquiring new knowledge .
this was supplemented with a mini problem on fen - phen ( an appetite suppressant withdrawn from the market in the 90s due to concerns about its safety ) , mcqs , interaction with resource people and attending structured resource sessions , and a workshop on medication errors and patient safety . in session 2 , each tutorial group gathered again and students shared the knowledge acquired about various learning objectives with each other . in the following week , the problem was reviewed , and queries were addressed .
each tutorial group of students , along with respective tutors , provided feedback about different aspects of the problem and the educational activities of the week as a whole .
problem evaluation feedback was provided by each group of students in discussion with the tutor by completing a questionnaire with close - ended and open - ended items [ table 4 ] .
the close - ended items were scored from 1 to 5 ( 1 = disagree , 5 = strongly agree ) .
each year , based on the previous year 's feedback , the problem is modified .
the arabian gulf university ( agu ) in the kingdom of bahrain is a regional leader in pbl .
the pbl curriculum of the college of medicine and medical sciences ( cmms ) is a 6-year program leading to the md degree and is divided into three phases , as shown in the curriculum map [ table 1 ] : phase i ( premedical ) , phase ii ( preclerkship ) and phase iii ( clerkship ) . a comprehensive description of the medical curriculum of cmms , agu has been reported .
medical curriculum map of the agu phase ii has 9 units , of which units iii  viii are system - based while units i , ii , and ix are more conceptual and integrative . in each unit , problems are discussed in small tutorial groups to generate learning objectives in session 1 . during the week
, students undertake self - study supplemented with structured educational activities such as resource sessions , laboratory sessions , professional clinical skills training , community health activity , and interaction with faculty members . in session 2 ,
the group assembles again , and students present and discuss what they have learned . in the beginning of the next week
, students review the problem and provide feedback about the previous week 's problem . at the end of each unit
development of a problem starts with expected learning outcomes and learning objectives within the broader framework of the unit and the entire curriculum .
we retrieved the literature available on the internet and gathered information about vioxx , its development , trials , marketing , adverse effects , withdrawal from the market , and the legal and ethical ramifications . keeping in mind the expected learning outcomes and objectives [ table 2 ] ,
the information was organized into a problem :  life - cycle of a drug  consisting of a series of triggers to encompass the different stages and steps involved in the process of new drug development [ table 3 ] .
the intended learning needs of  life - cycle of a drug  problem the triggers of  life - cycle of a drug  in session 1 , students discussed the problem in small groups facilitated by a faculty tutor .
any difficult terms were clarified , and discussion focused on the events in the triggers , revisiting previously acquired knowledge , and more importantly , what new knowledge was required to fully understand the contents of a trigger .
they came up with learning objectives as generated by each trigger [ table 2 ] .
after completing the discussion in session 1 , students devoted themselves to self - study about the learning objectives , acquiring new knowledge .
this was supplemented with a mini problem on fen - phen ( an appetite suppressant withdrawn from the market in the 90s due to concerns about its safety ) , mcqs , interaction with resource people and attending structured resource sessions , and a workshop on medication errors and patient safety . in session 2 , each tutorial group gathered again and students shared the knowledge acquired about various learning objectives with each other . in the following week , the problem was reviewed , and queries were addressed .
each tutorial group of students , along with respective tutors , provided feedback about different aspects of the problem and the educational activities of the week as a whole .
problem evaluation feedback was provided by each group of students in discussion with the tutor by completing a questionnaire with close - ended and open - ended items [ table 4 ] .
the close - ended items were scored from 1 to 5 ( 1 = disagree , 5 = strongly agree ) .
each year , based on the previous year 's feedback , the problem is modified .
the arabian gulf university ( agu ) in the kingdom of bahrain is a regional leader in pbl .
the pbl curriculum of the college of medicine and medical sciences ( cmms ) is a 6-year program leading to the md degree and is divided into three phases , as shown in the curriculum map [ table 1 ] : phase i ( premedical ) , phase ii ( preclerkship ) and phase iii ( clerkship ) . a comprehensive description of the medical curriculum of cmms , agu has been reported .
medical curriculum map of the agu phase ii has 9 units , of which units iii  viii are system - based while units i , ii , and ix are more conceptual and integrative . in each unit , problems are discussed in small tutorial groups to generate learning objectives in session 1 . during the week
, students undertake self - study supplemented with structured educational activities such as resource sessions , laboratory sessions , professional clinical skills training , community health activity , and interaction with faculty members . in session 2 ,
the group assembles again , and students present and discuss what they have learned . in the beginning of the next week
, students review the problem and provide feedback about the previous week 's problem . at the end of each unit
development of a problem starts with expected learning outcomes and learning objectives within the broader framework of the unit and the entire curriculum .
we retrieved the literature available on the internet and gathered information about vioxx , its development , trials , marketing , adverse effects , withdrawal from the market , and the legal and ethical ramifications . keeping in mind the expected learning outcomes and objectives [ table 2 ] ,
the information was organized into a problem :  life - cycle of a drug  consisting of a series of triggers to encompass the different stages and steps involved in the process of new drug development [ table 3 ] .
the intended learning needs of  life - cycle of a drug  problem the triggers of  life - cycle of a drug 
in session 1 , students discussed the problem in small groups facilitated by a faculty tutor .
any difficult terms were clarified , and discussion focused on the events in the triggers , revisiting previously acquired knowledge , and more importantly , what new knowledge was required to fully understand the contents of a trigger .
they came up with learning objectives as generated by each trigger [ table 2 ] . after completing the discussion in session 1
, students devoted themselves to self - study about the learning objectives , acquiring new knowledge .
this was supplemented with a mini problem on fen - phen ( an appetite suppressant withdrawn from the market in the 90s due to concerns about its safety ) , mcqs , interaction with resource people and attending structured resource sessions , and a workshop on medication errors and patient safety . in session 2 , each tutorial group gathered again and students shared the knowledge acquired about various learning objectives with each other .
each tutorial group of students , along with respective tutors , provided feedback about different aspects of the problem and the educational activities of the week as a whole .
problem evaluation feedback was provided by each group of students in discussion with the tutor by completing a questionnaire with close - ended and open - ended items [ table 4 ] .
the close - ended items were scored from 1 to 5 ( 1 = disagree , 5 = strongly agree ) .
each year , based on the previous year 's feedback , the problem is modified .
the problem triggers that were created to bring out these learning needs are presented in table 3 .
feedback pertaining to various aspects of the problem was collected over a period of 5 years ; provided by 57 tutorial groups , each comprising 810 students .
the pooled results of problem evaluation are presented in table 4 . as can be seen , overall the problem has been perceived positively .
several approaches have been used in addressing this issue both from curriculum design and implementation perspectives , in traditional as well as innovative medical curricula . the speed with which new technology , including drugs ,
is introduced into health care treatments demonstrates the constant change in health care which , in turn , is changing the nature of the work or tasks undertaken by different health professionals .
taking into account the workplace context , it is necessary to bring authenticity to the learning experience and prepare the students for the work environment they will be entering .
it is important to delineate the distinction between pbl and case - based learning ( cbl ) .
there are fundamental differences in terms of educational philosophy , curriculum design , and implementation between pbl and cbl .
first , the problems must raise the concepts and principles relevant to the content domain .
second , the problem must be real . because the students are open to explore all discussions of the problem ,
there is real difficulty in creating a rich problem with a consistent set of information .
several elements need to be considered in problem design : the learning outcomes ( educational objectives ) , the type of problem and its format .
a written problem is the most common format for trigger material ; the triggers should be relevant , interesting and provoke discussion in small groups .
the curriculum committee , in consultation with different departments , identified the core learning objectives in each discipline . because of the integrated and spiral nature of pbl curriculum different departments ( epidemiology , biochemistry , family medicine , professionalism , pharmacology , and therapeutics ) worked together in contributing to the problem .
core learning objectives of basic and clinical pharmacology for undergraduate medical students have been identified and listed .
we noticed a gap : new drug development was not being addressed , and there was no way to introduce it through the existing problems .
a new problem was developed in which students could understand the different stages and issues involved in the process of drug development .
the story of vioxx appeared very appealing as it had all the elements of new drug development .
it went even further : it brought out several other important issues , such as ethics of clinical research , particularly of clinical trials , patient safety , and legal implications of drug - induced harm .
the process of developing new drugs generally starts with the identification or development of a new lead chemical molecule .
this is brought out in trigger 1 against a backdrop of nonsteroidal anti - inflammatory drugs ( nsaids ) , their widespread use , their limitations , and the need for better drugs .
students reviewed nsaids , which they had studied in previous problems , for example , in unit i ( inflammation ) , unit iii ( pulmonary embolism ) , unit v ( peptic ulcer disease ) , unit vi ( immunothrombocytopenic purpura ) and unit vii ( arthritis ) .
this raised the topic of the need for new nsaids and how new drugs are discovered and developed .
it raised discussion about the preclinical testing of new drugs in animals as a prerequisite for testing them in humans .
success in animal testing leads to the emergence of an investigational new drug ( ind ) .
consent for participation in trials , ethics , and strategies to minimize bias are also discussed .
students who were better informed also raised topics from history , e.g. , unethical testing on prisoners of war or on vulnerable people . once a drug has been successfully tested in humans , it is time for new drug application ( nda ) . in trigger
4 discussion is about the prerequisites for nda , drug regulatory affairs in general , generic name and brand name , evidence - based medicine and critical appraisal of the literature .
mk-966 ( rofecoxib ) was marketed as vioxx and merck actively advertised their new pharmaceutical product . unlike nonselective cox inhibitors , it caused fewer gastrointestinal adverse effects .
students discussed the necessity for new drugs , various influences on the prescriber , and drug nomenclature .
results from the vioxx gastrointestinal outcomes research ( vigor ) study were promising , with advantages of vioxx over naproxen , a nonselective nsaid , in terms of gastrointestinal adverse effects .
but later results showed that the incidence of cardiovascular events in the vioxx group was double compared to the naproxen group .
however , reasoning that vioxx appeared risky in comparison to naproxen because naproxen protected patients by acting like low - dose aspirin , the company decided to continue the study .
it is a turning point , and merck could have avoided litigations associated with vioxx if only it had taken the alternative decision to discontinue the study .
the vigor study was completed , and the paper was published in the new england journal of medicine .
this trigger raised important issues of ethics and professionalism in research . no doubt developing new drugs
other topics raised in this trigger were the use of controls in study design , type of controls , conflict of interests , and bias in data interpretation and nondisclosure .
trigger 7 is about one of the first reported deaths associated with the use of vioxx and the subsequent lawsuit against merck .
postmarketing surveillance and reporting ( phase iv ) is the last ( but not the least ) step in new drug development .
, there was an increased risk of cardiovascular events ( myocardial infarction and stroke ) associated with vioxx . in september 2004
revisiting adverse drug reactions , there was a discussion about the possible reasons for myocardial infarction and stroke associated with vioxx .
it triggered interesting discussions : publication bias , critical appraisal of the scientific literature , and public accountability and liability of the medical profession .
it was also pointed out that the company did win some legal cases , because in other cases with multiple diseases and multi - drug therapy , it can be impossible to link an adverse event to one particular cause with certainty due to nonestablishment of causality .
along with the main problem , mini - problems and mcqs are also given to the students for elaboration and self - assessment .
mini - problems are used for elaboration or for presentation in different clinical settings or contexts . in general
one approach is to evaluate whether students are able to generate the same learning goals as intended by the curriculum .
the degree of congruence between the two is considered to be reflective of problem effectiveness .
the problem was perceived positively with a mean overall score of 3.8  0.4 out of 5 .
all close - ended items scored 3 and above except item no . 5 :  problem cuts across disciplines  which scored 2.9 .
it seems most groups perceived the problem as mainly pharmacology / clinical pharmacology discipline - oriented .
nevertheless , the problem does integrate with some other discipline , e.g. , biochemistry , evidence - based medicine , epidemiology , and professionalism . according to the open - ended comments by various groups ,
the problem was perceived as very interesting , informative , and an eye - opener .
it indicates the effectiveness and success of this innovative approach in teaching - learning such important topics of clinical pharmacology .
in a pbl curriculum , having identified the learning outcomes , problems can be developed from real - life events for teaching - learning clinical pharmacology topics for which patient - based scenarios might be inadequate .
a systematic approach described in this paper can be used for the development and validation of educational material for introducing focal topics of pharmacology / clinical pharmacology integrated with other disciplines in innovative medical ( and other health profession ) curricula .
the world federation of medical education and the medical council of india have recommended the introduction of innovative medical curricula .
other variants like case - based learning and team - based learning are also used in some schools across the world .
these being relatively novel concepts in india , we chose to publish this article to create awareness among the readers about the trends in health professions education ( including pharmacology education ) . a note of caution , however , against adopting these methods without evaluating its feasibility and validity in the indian context .
 aim : this paper describes how in a problem - based learning ( pbl ) medical curriculum , having identified the learning outcomes , problems can be developed from real - life events for teaching - learning clinical pharmacology topics for which pbl cases might be inadequate . 
 such problems can be very interesting and educational.methodology:using the story of the development and withdrawal of rofecoxib ( vioxx ) , we developed a problem for undergraduate medical students to address important issues related to clinical pharmacology and therapeutics such as new drug development , preclinical testing , clinical trials , adverse drug reactions , professionalism , and critical appraisal of literature . 
 these topics would otherwise be difficult to address in patient - based problems.results:the evaluation of the problem based on pooled feedback from 57 tutorial groups , each comprising 810 students , collected over 5 years , supported the effectiveness of the problem.conclusion:a systematic approach described in this paper can be used for the development and validation of educational material for introducing focal topics of pharmacology / clinical pharmacology integrated with other disciplines in innovative medical ( and other health profession ) curricula . 
Introduction
Methodology
None
Setting
Problem Designing
Problem Implementation
Problem Evaluation
Results
Discussion
Conclusion
Note: