§ Mr. Malone
No immediate measures additional to those already in place are proposed. Paracetamol co-proxamol and dothiepin are effective drugs which are safe at the dosages recommended on the labelling. The Medicines Control Agency evaluates all new information on the safety of medicines carefully, particularly in relation to the controls on their availability.
§ Mr. Malone
All medicines that are effective have adverse reactions, some minor and some more serious. Effective methods and procedures are in place to reduce the incidence of these in patients taking medicines. Medicines undergo rigorous evaluation of quality, efficacy and safety by the licensing authority, and its expert advisory bodies before being allowed on the market, to ensure that the benefits of medicines outweigh their risks. Product information for doctors and patients give clear instructions on use and provide warnings and precautions on adverse reactions in order to minimise the likelihood and impact of adverse reactions.494W
Once marketed, medicines are monitored closely to identify previously unrecognised adverse reactions or changes in their frequency or severity. Effective procedures exist for investigation, expert evaluation and action on identified adverse reactions. Changes are made to a medicine's marketing authorisation and product information to minimise the occurrence and impact of any newly identified adverse reactions. Rarely, when risks are shown to outweigh benefits, a medicine may be withdrawn from the market. Doctors and pharmacists, and patients are informed of the adverse reactions of medicines they use through product information. A bulletin entitled "Current Problems in Pharmacovigilance" is also distributed to doctors and pharmacists quarterly to inform them of new adverse drug reactions and provide advice on the safe use of medicines. For more urgent issues communication by letter and electronic communication network is used.