"A Study of the Pharmaceutical Quality of Chloroquine and Paracetamol Products Sold in a Major Nigerian ""Market"""

"Malaria is a major public health problem in endemic countries; and the quality of anti-malarial products is a concern in the therapeutic management of individual patient. In this study; we have evaluated the pharmaceutical quality of chloroquine and paracetamol oral products obtained from a major Nigerian drug ""market"" using a less elaborate sampling procedure. Results have shown that there are still some defects in the pharmaceutical quality of these drugs; despite the activities of the Nigeria's drug regulatory agency (National agency for Food and Drug Administration and Control; NAFDAC). 21(7/34) of the drug products were not registered by NAFDAC. The pharmaceutical properties of the products indicated that 6; 15; 9; and 9of them failed tests for disintegration; dissolution; crushing strength; and percentage of active content; respectively. 4 out of the 6 chloroquine liquid preparations evaluated had inadequate active content. These defects could have resulted from deliberate counterfeiting; poor quality control during manufacture or decomposition of the products. However; this could not be ascertained from the data available to us in this study. The implication of these findings; however; is that the newer anti-malarial drugs that have recently been introduced into the Nigerian market should be safeguarded; if their therapeutic usefulness must be sustained."

Review Article - An Overview of Pharmaceutical Validation and Process Controls in Drug Development

It has always been known that facilities and processes involved in pharmaceutical production impact significantly on the quality of the products. The processes include raw material and equipment inspections as well as in-process controls. Process controls are mandatory in good manufacturing practice (GMP). The purpose is to monitor the on-line and off-line performance of the manufacturing process; and hence; validate it. Thus validation is an integral part of quality assurance. This overview examines the need for pharmaceutical validation; the various approaches and steps involved; and other pertinent considerations

Prescribing Practices in two Health Care Facilities in Warri; Southern Nigeria : a Comparative Study

PURPOSE: Inappropriate prescribing has been identified in many health facilities in developing countries. The purpose of this study was to evaluate the prescribing practices in two health care facilities in Warri located in south-south geopolitical region of Nigeria and identify factors influencing the practices. METHOD: WHO Prescribing Indicators were applied to evaluate 2000 prescription records; retrospectively; from a private and a public hospital in Warri. Factors influencing the prescribing practices in the facilities were identified through informal interviews of 10 prescribers in the facilities. Using a self-administered questionnaire administered to 40 prescribers in the facilities; we also evaluated the order of importance of the factors affecting drug prescribing. RESULTS: Average number of drugs per encounter in the health facilities is 3.4 (3.9 in the public hospital and 2.8 in the private hospital). Generic prescribing was generally low (54 percent in the public hospital and 16 percent in the private hospital) while the percentage of encounters with antibiotics prescribed was high (75 percent in the public hospital and 55 percent in the private hospital). Antimalarials; antihypertensives; antidiarrhoeals and analgesics accounted for 47.4 percent; 7.5 percent; 1.0 percent and 18.2 percent; respectively. The overuse of drugs and generic prescribing were significantly lower in the private hospital than in the public hospital. Major factors influencing prescribing practices included drug availability; clinician's level of training; cost of drugs; feedback from patients and socio-economic status of patients. CONCLUSION: Polypharmacy; overuse of antibiotics and low rate generic prescribing still occur in the health facilities studied. Drug availability; clinician's level of training; cost of drugs; feedback from patients and socio-economic status of patients are major factors influencing prescribing in the facilities