Pharmaceutical Regulatory Affairs: Open Access

Background: Specialized drug shops (SDSs) provide quick and convenient access to medicines in developing countries such as Kenya and are often the first point of call for common illnesses. Policymakers are increasingly looking for ways of including them in the provision of health services. However, concerns still linger over the quality of services SDSs offer.

Objectives: This study set out to describe the availability of antimalarials and antibiotics in rural and urban SDSs, and explore the factors that influence the dispensing practices of attendants.

Methods: The study was conducted in SDSs in 2 Kenyan districts: Bungoma South and Kakamega Central. The study had 3 data collection activities: a census to generate a list of SDSs; a provider survey to describe the availability of antimalarials and antibiotics, and characteristics of dispensers; and a mystery shopper survey to describe the dispensing practices of SDS attendants.

Results: Data were collected from 213 SDSs. The availability of most antimalarials and antibiotics was high, with TB medicines and artemisinin monotherapy treatments being the least available. Nearly all SDSs dispensed partial doses of amoxicillin without prescription, with only one quarter asking about additional symptoms, or advising against partial doses. Rural SDSs had a higher likelihood of dispensing without prescription (p<0.001), with urban pharmacies being more likely to ask about additional symptoms or advise against partial doses (p<0.001 for both). Attendants were less likely to sell ACT treatments without prescription, compared to amoxicillin, although they were also less likely to advise against buying incomplete doses. Over half of SDSs sold an ACT that had been obtained illegally from the public sector. Multivariate analysis showed recent regulatory inspection and presence of staff with pharmacy qualification to have no association with quality of dispensing practices.

Conclusions: The study highlighted the problem of inappropriate medicine use within communities. Indiscriminate dispensing habituates poor medicine use practices, which can result in the development and spread of resistance. Policy should focus on strengthening regulatory enforcement, in combination with education for dispensers, and promotion of public awareness. More research is required to describe in-depth, reasons underlying the dispensing practices observed, and how they can be improved to strengthen the role of retailers in provision of antimalarials and antibiotics within rural communities.

The mass gatherings may be the result of a special public event or a spontaneous unplanned event. A special public event is a planned and organized activity which will place 10,000 or more estimated participants in a defined geographical area, gathered at a specific location for a defined period of time where access by emergency vehicles might be delayed. Historically, planning for an event provides the prevention of risk, injury, suffering, or death that may occur at public events, however, the continuous system improvement includes expenses in order to reduce the costs by avoiding waste of resources. The aim of this work was to verify the usefulness of a formula for estimating the probable number of patients to be treated in field and to assess their needs in a special event for 50th anniversary of the Italian aerobatic team “Frecce Tricolori” air show September 11-12, 2010 Rivolto – Italy. We have developed, from these data, the following formula to calculate the number of people needed to treat and their pharmaceutical needs.

Results: The number of attendees was lower than expected number of approximately 20% for a total of about 320,000 people. 174 patients (about 0.45% of the people) required medical treatment: 30 people less than expected (14.7% overestimation). Of these, 58 (above 33%) required emergency treatment in field (8% less than expected). The mathematical model adopted was appropriate and helpful in preventing possible shortages or waste of drugs.

The aim of this study was to improve the dissolution rate of naproxen using micellar solubilization technology. Cloud point temperature of the nonionic surfactants has been used as the basis for the solubility study because there is better entrapment of the drug into the surfactant micelle at this temperature. Naproxen was solubilized in polysorbate 80 micelles at cloud point temperature; lactose was dissolved in micellar dispersion and the dispersion was directly spray-dried to obtain microparticles, which was subsequently converted into tablets using suitable excipients. The spray-dried particles were characterized and in-vitro dissolution studies were carried out. Spray-dried naproxen powder and tablets made out of it by direct compression method, have exhibited superior dissolution rate over controls in all media employed irrespective of pH conditions. Therefore, it is believed that the better dissolution characteristics conferred by the micellar solubilization of naproxen and rapid wetting of microparticles.

Background: The underlying axiom in applying generic drugs is the equivalence of their active ingredient with the (usually more expensive) innovator product, an all-embracing statement with the insidious result that physicians assume that the generic products have been subjected to the same rigorous testing regimens as the brand-name products. The present paper presents novel experimental data on an investigator-blinded comparison between the innovator imipenem antibiotic, and a number of its generics.

Methods: Particulate matter contamination of each group was visualized by means of a membrane filter method. Functional studies in an animal model–the dorsal skinfold chamber technique in mice-designed to simulate the state of microcirculatory dysfunction in intensive care patients was performed, in order to assess the influence of the particulate matter of each group on the functional capillary density of the striated skin muscle, after their intravenous injection.

Results: The results showed massive particulate contamination of the generics, in a size range relevant for impacting the microcirculation. The particulate contamination contributed in some generic groups to a significant shutdown of tissue perfusion.

Conclusion: The presented data underscore the need to raise the regulatory barriers for the entry of generics to the market, well beyond the simplistic proof of “bioequivalence”, which in no measure deals with the essential questions of quality and patient safety. If generics are used, they should be tested by a filter technique and optical microscopy, to ensure the absence especially of small particulate contaminants and their purity.