The law concerned with 'over the counter' dispensing

Abstract

The laws governing a profusion, have a central role to play in maintaining proper standards of practice. The presence of strictly enforced laws which ensure the safety, quality and efficacy of medicines is a necessity not a luxury. It is equally important that the relevant legislation be updated to meet modern trends in health care development. The increasing demands being made in the field of primary health care make the update of legislation regarding Over the Counter dispensing essential. This study therefore deals with the laws concerned with Over The Counter dispensing in Malta. In particular, it investigates the evolvement of these laws and the current obtaining legal position on the island. Malta's proposed entry into the European Community is considered and a comparative study regarding Malta and the European Community legislation was carried out. Current thinking regarding this issue i.e. the Over the Counter dispensing, was evaluated and various experts as for example the Malta Chamber of Pharmacists were consulted for their opinions regarding the major inadequacies of the laws. Pharmacies in different regions of Malta were contacted by telephone. The pharmacists' opinions regarding the free sale of non prescribed medicines were sought. An attempt was made to establish how pharmacists in Malta regarded the legislation of "Over the Counter" dispensing by evaluating the practice of their sales. Survey 1 involved which drugs are sold freely, without a prescription and without taking the proposed use in Malta. 35 pharmacies were contacted (approximately 25% of the total number of pharmacies in Malta). A scoring system was devised, 10 being allocated to the substance mostly told freely and with out a necessary prescription, 9 to the most common and so on. The total scores were calculated for each item and the results were recorded in descending order of frequency. Survey 2 concerned the sale of antibiotics and the contraceptive pill without the necessary prescription. 100 pharmacies were contacted, the pharmacists being asked if they normally dispense drugs, especially antibiotics and the contraceptive pill, without the necessary prescription. The results suggest that community pharmacists should be encouraged to record trends in the items which are sold freely, especially if they are "Over the Counter" drugs, because misuse could occur. In this way, potential abusers could be more easily identified and counselled. Maltese people have a strong tendency for self medication. The most common idea is that paracetamol cures everything and "Benylin" and "Actifed" products cure any cough. A point which best illustrates this is that, although in Malta there are a large number of diabetics, the use of insulin syringes has been identified in a group of consumers not known to be non-diabetics. From this study, the need for a more active participation from the pharmacist when dispensing "Over the Counter" drugs appear essential. The pharmacist must be in a position to ask the relevant question regarding medication. Consequently, he/she should be able to select the best medication accordingly. The pharmacist must ask the necessary questions regarding medication and select the best medicine himself. A high percentage of pharmacists dispense medicines, which require a prescription, as "Over the Counter". The legislation is present but not observed. The justifications and explanations offered by some respondents yield some interesting, albeit worrying, aspects of the profession. The non observance of this legal obligation is so widespread that if one pharmacist had to observe it, his endeavours would be ineffectual. When it comes to the contraceptive pill however, the results are different. This can be due to the high percentage of side effects caused by the contraceptive pill so that the pharmacist is not willing to take the risk. Another factor could be morality, due to the strong religious bonds in the Maltese population. The legislation should be revised so as to increase the scope of "Over the Counter'' medicines in Malta. However, it should be made clear that the term "Over the Counter" should not imply "freely sold" or "sold without a physician's prescription" but should imply that it is the pharmacist who takes responsibility for choosing the proper medication to try to satisfy the patient's needs. The legislation must be safeguarded and any irrational abuse should be stemmed. The organisation of Continuing Education Programmes by the local Professional Body, the Malta Chamber of Pharmacists, is a step in the right direction. The emphasis is on the need for pharmacists to be further trained in differentiating the symptoms present and dispensing the corresponding (or most effective) medication. This programme should be further developed and possibly made mandatory for pharmacists practising Over the Counter dispensing. This programme could be developed and would assess the pharmacist's ability to perform this important function.