Drugs with limited clinical trials.........not an option!

Before new drugs are released, extensive research are carried out to ensure that their pharmacological advantages outweigh their negative impacts (i.e., side effects and adverse drug reactions). The trial normally starts from animals and if certain level of safety is attended, then human volunteers are used to complete it.

Nevertheless, some of these medicines are released for human consumption with further pharmacovigilance surveillance, but tagged " DRUGS WITH LIMITED CLINICAL TRIALS". They are released often due to limited alternatives at the time in question.

The concern now is why are these category of drugs often the choice prescription in the management of certain diseases when there are known safe alternatives with progressive relief? The overall safety ought to be the overriding factor in making the all important decision of what drugs to prescribe and not the immediate relieve of the symptoms. The professionals' quest to meet the unrealistic expectations of impatient clients is often the driving force, which is complicated by struggle for means of survival with the current economic status in most African countries.

A doctor once said to me over a possible prescription error, " which ever way the patient can access the drug from your pharmacist colleagues or the market without prescription, and what this implies to the patient is inefficiency on my part". I looked up at ceiling and down to my foot so as to gain equilibrium with my wedge shoe and answered " is hard to practice within the code of ethics in such an unorganized system, but the clean up can start from us. He laughed out so loud while walking up to me ,which made me quiet and in dilemma state whether to continue with the discussion or just dispense the drug to the patient . ''Energetic intelligent beautiful pharmacist straight from the oven'' were his exact words echoing into my ears. ''Do you mind an adverse? ''he asked politely''. I could not still say a word, but obliged his request by lifting my eyebrows. ''Take it one day at time and how you see them coming, drug safety is a sermon we keep to ourselves because what majority of Nigerians are keen about is if the effect of your prescription is magical. The woman in question has taken worse combination of NSAIDS and you are worked up because she has underling sign of ulcer and was prescribed just 2 type of analgesics for osteoporosis management'' the doctor advised as he grabbed the prescription paper from my hand and adjusted.

On return to the dispensary, i noticed the grabby look on some faces because of the queue my few minutes absence caused. The client whose prescription i was trying to sort out came to me filled with excitement that the doctor and pharmacist have been in a close door discussing about her medicine. ''My daughter, hope you and the doctor added a stronger one that will make here my final bus stop'' the client inquired with a dazzling smile as i asked her to enter the counselling room to see my chief, who preferred i continued. During the course of counselling a discovered she is in her early sixties , weighed about 125kg and owned a mini NSAIDS and antacids dispensary which is her big handbag. On disclosure that the outcome of the meeting lead to the reduction of her drugs, she became furious because they are few to be effective. At this point, she sampled all the products in her mobile mini dispensary, there is know type of analgesics and antacids that were not present, inclusive of the ones that their leaflets were not written English or at least one of Nigerian native languages.

Back to the title, drugs with limited clinical trials are often prescribed due to the systemic pressure, lack of awareness and unknown accrued unclaimed damages from the use of these category of drugs in Nigeria. For example,