Dela Vega,Carmela G. 5CLPH PHAR 17 CASE 1.

Identify the point drugs which caused the current condition of the patient Vaccinations including Tetanus toxoid may cause urticaria/angioedema with eyelid swelling. Xylocaine also causes eyelid edema and itchiness. 2. Was there any adverse event at the time of the second visit? Yes. 3. Relate how a skin test is performed A small amount of the suspected allergy-provoking substance (the allergen) is placed on the skin. The skin is then gently scratched through the small drop with a special sterile needle. An allergy skin test is also called a scratch test. If the skin reddens and, more importantly, if it swells, then the test is read as positive and allergy to that substance is considered probable. If the skin test is positive, it implies that the patient has a type of antibody (IgE antibody) on specialized cells in the skin that release histamine to cause redness and itching. 4. What is the Naranjo scale? The Naranjo adverse drug reaction (ADR) probability scale classifies the probability that an adverse event is related to drug therapy based on a list of weighted questions, which examine factors such as the temporal association of drug administration and event occurrence, alternative causes for the event, drug levels, dose response relationships and previous patient experience with the medication. The ADR is assigned to a probability category from the total score as follows: definite if the overall score is 9 or greater, probable for a score of 5-8, possible for 1-4 and doubtful if the score is 0. The Naranjo criteria do not take into account drug-drug interactions. Drugs are evaluated individually for causality, and points deducted if another factor may have resulted in the adverse event, thereby weakening the causal association. 5. Is the ER Physician liable for negligence? The physician is the one responsible in attempting to check if the patient is hypersensitive to a given drug and in minimizing the possibility of an adverse reaction. It is his duty to inform the patient the possible adverse effects of a drug. 6. How will the Clinical Pharmacist investigate the adverse event? Pharmacists should encourage patients to return to them if they suspect an adverse event. The pharmacist must review the product monograph and once a literature is reviewed, they should review the adverse event with the patient. They should ask the patient the onset of the symptoms, and if the patient is taking multiple drugs, the drugs should be reviewed. The pharmacist must consider possible drug interactions. The pharmacist must

then report the adverse event to be able to identify if a drug product requires further investigation.

Difference between an adverse event and an adverse reaction An adverse drug event is an injury resulting from the use of a drug. Under this definition, the term ADE includes harm caused by the drug (adverse drug reactions and overdoses) and harm from the use of the drug (including dose reductions and discontinuations of drug therapy). Adverse Drug Events may results from medication errors but most do not. An adverse drug reaction is a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function. Note that there is a causal link between a drug and an adverse drug reaction. In sum, an adverse drug reaction is harm directly caused by the drug at normal doses, during normal use. What is an Adverse Drug Reaction? An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs, and is suspected to be related to the drug. What is the prevalence of ADR in the Philippines? Compare it to World Health data. The word 'prevalence' of Adverse reaction usually means the estimated population of people who are managing Adverse reaction at any given time (i.e. people with Adverse reaction). In the Philippines there are about 22,253. The incidence of adverse drug reactions is 2.2 million. What is pharmacovigilance? Pharmacovigilance (PV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. Why are pharmacovigilance and reporting ADRs important? Pharmacovigilance through, for example, spontaneous ADR reporting or large scale databases, is used to generate hypotheses and signals about potential hazards of marketed drugs that require further investigation. Spontaneous reporting of suspected ADRs is particularly useful in identifying rare or delayed reactions; as such a system enables medicines to be monitored throughout their lifetime.