Adverse Drug Reactions in Summaries of Product Characteristics and Patient Information Leaflets
Recommendations about the mentioning of adverse reactions according to their frequency (CIOMS III) and classification of adverse reactions according to their organ systems (MedDRA) in the Summary of Product Characteristics and Package Leaflet (revision 1)
Categories of adverse reactions frequency
According to the Guidelines for Preparing Core Clinical Safety information on Drugs) of the CIOMS III Working Group, whenever possible, the calculation of adverse reaction frequency should be expressed according of the categories of adverse reactions frequency.
| CIOMS III Working group recommended following categories for description of adverse reaction frequency | |
|---|---|
| Very common | ≥ 1/10 (≥ 10 %) |
| Common, Frequent | ≥ 1/100 and < 1/10 (≥ 1% and < 10%) |
| Uncommon, Infrequent | ≥ 1/1000 and < 1/100 (≥ 0,1% and < 1%) |
| Rare | ≥ 1/10000 and < 1/1000 (≥ 0,01% and < 0,1%) |
| Very rare | < 1/10000 (< 0,01 %) |
The recommendation of the Agency for Medicinal Products and Medical Devices is that the frequency of adverse reactions be mentioned in the Package Leaflet in a descriptive form, so that the information is understandable for patients (i.e. the adverse reaction occurs in 1 out of 100 patients taking the medicine).
| Classification of organic systems according to MedDRA | |
|---|---|
| I. | I. Blood and lymphatic system disorders |
| II. | Cardiac disorders |
| III. | Congenital, familial and genetic disorders |
| IV. | Ear and labyrinth disorders |
| V. | Endocrine disorders |
| VI. | Eye disorders |
| VII. | Gastrointestinal disorders |
| VIII. | General disorders and administration site conditions |
| IX. | Hepatobiliary disorders |
| X. | Immune system disorders |
| XI. | Infections and infestations |
| XII. | Investigations |
| XIII. | Injury, poisoning and procedural complications |
| XIV. | Metabolism and nutrition disorders |
| XV. | Musculoskeletal system and connective tissue disorders |
| XVI. | Neoplasms benign, malignant and unspecified (incl. cysts and polyps) |
| XVII. | Nervous system disorders |
| XVIII. | Pregnancy, puerperium and perinatal conditions |
| XIX. | Psychiatric disorders |
| XX. | Renal and urinary disorders |
| XXI. | Reproductive system and breast disorders |
| XXII. | Respiratory, thoracic and mediastinal disorders |
| XXIII. | Skin and subcutaneous tissue disorders |
| XXIV. | Social circumstances |
| XXV. | Surgical and medical procedures |
| XXVI. | Vascular disorders |
