Describe the adverse drug reaction and the mechanism of toxicity (if known).
The aim of this assignment is to gather information about a particular adverse drug reaction and to search for information in reliable scientific publication databases. You should assemble, process, and critically review scientific literature regarding an adverse drug reaction of a biopharmaceutical medicine or a vaccine. You may also focus on a small molecule and an ADR that is related to pharmacogenomics. To pass the assignment you need to do a thorough review and present your work as a scientific essay in proper English language and with a scientific vocabulary.
The information about the medicine ADR should be presented in a clear, concise and consistent manner. The essay should be objective, characterized by a high level quality. The target audience should be health professionals. Please note that all essays are checked for plagiarism using Urkund.
1. Background
Describe the drug problem. State why you think that it is an interesting adverse drug reaction and where you got the initial information of the problem – for example Pharmaceutical Newsletter, PubMed, FDA MedWatch or EMA, at the hospital/pharmacy or personal information from a patient.
2. Information retrieval using scientific publications, databases and web sites
Literature retrieval using databases Describe databases used. Add search terms, truncated search terms or combinations of search terms used to retrieve publications. State inclusion and exclusion criteria for publications to be reviewed. In addition, state if publications were obtained when cited as references by publications obtained using the preceeding method.
Information retrieval using web pages Add the date when you studied the web page.
Personal communications The name of the person who has given the information should be stated. Always ask if the information can be added to your essay. Add the date of personal communication. This information should be given in the text.
3. Pharmacological effects, mechanisms of action, indications and therapy
Give a short description of the benefits of the drug (indications and mechanisms of pharmacological effects).
4. Adverse drug reaction and mechanism involved
Describe the adverse drug reaction and the mechanism of toxicity (if known). Also search for a) preclinical toxicological animal data or mechanistic in vitro studies and b) clinical trial data that describe the problem. All types of studies may not, however, be publicly available by the pharmaceutical company. Indicate if the ADR is a type A or B reaction.
5. My benefit – risk profiling
There are no formal methods to assess the benefit-harm /effectiveness-risk. But you may discuss these issues in terms of seriousness, frequency and duration as described by Edwards and coworkers at UMC. Study the risks and benefits as described in the textbook, scientific publications and at web sites.
If possible try to discuss the
seriousness of the ADR and of the treated and untreated disease
duration of the ADR, of the disease and of the beneficial effects of the drug
incidence/frequency of the ADR, of the disease and of the successful drug treatment.
6. Risk management by medicines agencies and companies
Describe the management about the risks made by 1) the pharmaceutical company and 2) the medicines agencies for example EMA and/or FDA. Did the the company initiate a postmarketing study? Did they monitor the patients to determine if the ADR changed over time. You may also consider how the risks are perceived, complicance and improper use. Would it have been possible to warn about the adverse drug reaction earlier or to avoid the problem? Do not focus on the medical doctor’s advice and communication with the individual patient.
7. Risk communication by medicines agencies and companies
Describe the communication about the risks made by 1) the pharmaceutical company and 2) the medicines agencies EMA and/or FDA to health professionals and patients. Study the information in medication guides and patient instructions. Was the product labelling or medication guide revised? The eMC web site has approved and regulated prescribing information for licensed medicines such as Summaries of Product Characteristics (SPC) and Patient Information Leaflets. Do not focus on the medical doctor’s advice and communication with the individual patient.
8. Analysis and personal opinion
Discuss decisions made by 1) the pharmaceutical company and by 2) the medicines agencies EMA and FDA. Do you agree with the decisions taken and the consequences? Why/why not?
