Republic of Botswana - Admin

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9. STIMULATION OF REPORTING The reporting of adverse reactions needs continuous stimulation. It is important to achieve the development of a positive attitude towards pharmacovigilance among healthcare professionals so that adverse reaction reporting becomes an accepted and understood outline. In summary, the following may stimulate reporting: easy access to pre-paid reporting forms and other means of reporting acknowledging the receipt of adverse drug reaction reports by personal letter or phone call providing feedback to reporters in the form of articles in journals, adverse drug reaction bulletins or newsletters participation of the centers staff in pre- and postgraduate education and scientific Meetings collaboration with local drug or pharmacovigilance committees collaboration with professional associations integration of pharmacovigilance in the (further) development of clinical pharmacy and clinical pharmacology in a country 10. DIRECTIONS FOR COMPLETING THE ADR REPORTING FORM A. GENERAL The ADR reporting form comprises basic information about the patient, the drug, the adverse reaction, the action taken and the outcome. The age, sex, description of the adverse reaction, information on suspected drug, and outcome are all considered essential and should be completed. The form should be completed by: Physicians, Health Officers, Dentist Pharmacist & Nurses where applicable. Complete the form to the best of your abilities. Avoid non-standard abbreviations. Use a separate form for each patient. Write legibly. B. SPECIFIC (Reaction information) ‣ The patient’s identity 14
Information about the patient’s identity, nutritional status and habit should be provided. It is not necessary to write patient’s full name. Use patients name initials only. E.g. ASZ for Addis Solomon Zerga. The patient file/card number have to be stated as the card/file number(e.g. CM, NM, PM,SM etc numbers)and patient’s identity are useful to solicit additional information if necessary and also for retrospective and prospective study of adverse drug reaction. ‣ Description of the adverse reaction Clear and brief description about the nature of adverse reaction than diagnosis, the date of onset, duration, time course and laboratory test results including “negative” and normal results of any relevant test performed should be reported. The severity of the reaction i.e. weather it has necessitated prolonged hospitalization or not, discontinuation of the drug or not, etc, have to be reported. ‣ Information on the suspected drug This information included the identity and source of the drug, the dose, route of administration and the impact of withdrawal and re-administration of the suspected drug upon the adverse reaction. ‣ Drug Name Use brand name of suspected drug(s). If generic name is used, specify the manufacturer of the drug. Avoid non-standard abbreviations such as PPF, CAF, MTC, TTC, etc. ‣ Dosage form and strength The dosage form such as tablet, capsule, syrup, suspension, elixir, emulsion, injection, eye drop/ointment, topical crème/ointment, otic drop, nasal drop, suppositories rectal/vaginal etc, should be stated. The strength must also be expressed in metric system, e.g. 500mg tab, 250mg/5ml syrup, 1gm rectal suppository etc. Sometimes strength can be expressed in % e.g. 2% hydrocortisone ointment. ‣ Frequency Frequency of drug administration should be clearly notified using standard abbreviations. e.g. 3 times a day as tid or 8 hrly, 2 times a day bid or 12hrly 4 times a day as qid or 6hrly etc. ‣ Route Route of administration expressed using standard abbreviation. E.g. Per oral as PO, Intra-muscular as IM, Intra-vascular as IV, Per-rectal as PR, Topical as TO etc. 15
Page 1 and 2: Guideline should be made available
Page 3 and 4: I. INTRODUCTION: Since drugs are in
Page 5 and 6: 8. Consumer: A person who is not a
Page 7 and 8: The use of herbal medicines which m
Page 9 and 10: Healthcare professionals need to le
Page 11 and 12: Pharmacovigilance and poison contro
Page 13: Local Reports: • Fatal or life-th
Page 17 and 18: developed by training the staff by
Page 19 and 20: Promote reporting Collect report Gi
Page 21 and 22: Department of Clinical Services & T
Page 23 and 24: IV. CLINICIAN INFORMATION (If not t
Page 25 and 26: Latin Terms and Abbreviations TIME
Page 27 and 28: IV. Correlated Time 1 Ante cibos, a
Page 29 and 30: GLOSSARY: A drug or medicine is “

Republic of Botswana - Admin

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