A systems approach using the functional resonance analysis method to support fluoride varnish application for children attending general dental practice.

BACKGROUND: All children attending General Dental Practice in Scotland are recommended to receive twice-yearly applications of sodium fluoride varnish to prevent childhood caries, yet application is variable. Development of complex interventions requires theorizing and modelling to understand context. This study applies the Functional Resonance Analysis Method (FRAM) to produce a sociotechnical systems model and identify opportunities for intervention to support application. METHODS: The FRAM was used to synthesise data which were: routine monitoring of fluoride varnish application in 2015/16; a longitudinal survey with practitioners (n = 1090); in-depth practitioner and key informant interviews (n = 43); and a 'world café' workshop (n = 56). RESULTS: We describe a detailed model of functions linked to application, and use this to make recommendations for system-wide intervention. CONCLUSIONS: Rigorous research is required to produce accessible models of complex systems in healthcare. This novel paper shows how careful articulation of the functions associated with fluoride varnish application can support future improvement efforts.

High concentration aqueous sodium fluoride certified reference materials for forensic use certified by complexometric titration.

Sodium fluoride in concentrations of 1 to 2 % is used to prevent the formation of ethanol in blood and urine samples that are to be analysed for ethanol content. The majority of such samples form part of forensic investigations into alleged drunken driving. In South Africa, the laboratory performing the tests is required to prove that the sodium fluoride concentration in the blood samples is above 1 g/100 ml on receipt. This is done by using a fluoride ion-selective electrode calibrated with external aqueous solutions of sodium fluoride. The National Metrology Institute of South Africa (NMISA) prepares sodium fluoride solutions in concentrations from 0.3 to 3.0 g/100 ml. No other certified sodium fluoride reference solutions in these concentrations are available commercially. The sodium fluoride is certified by precipitation of the fluoride as lead chlorofluoride (PbClF) through the addition of a known excess of lead nitrate. The excess lead is back-titrated with ethylenediamine tetraacetic acid (EDTA) using a photometric electrode to detect the endpoint. Aqueous sodium fluoride solutions are prepared and the concentrations verified by the precipitation/back-titration method. This paper shows the application of a classical complexometric method to the certification of reference materials and describes the procedures for the preparation of the sodium fluoride solutions, verification of the concentrations, homogeneity and stability by primary titrimetry. It also briefly covers the calculation of uncertainty, the establishment of traceability and the quality control measures applied to ensure the quality of the certified reference materials (CRMs).

An efficient and aseptic preparation of "sodium fluoride ((18)F) injection" in a GMP compliant facility.

INTRODUCTION: "Sodium fluoride ((18)F) injection" is an isotonic NaCl solution containing [(18)F]NaF to be used as bone imaging agent. Although its NDA was approved by the US FDA in 1972, it has not been commercially available since 1975 due to mostly the popularity of (99m)Tc-MDP. Recently, advances in PET/CT technology and the often interrupted (99m)Tc supply have led to the renewed interest in the use of [(18)F]NaF to detect bone metastases in cancer patients. This report introduces an efficient, low-cost and aseptic preparation of "Sodium fluoride ((18)F) injection" for PET scan. METHOD: (18)F-Fluoride in target water from cyclotron was adsorbed onto four different forms of anion-exchange resins then desorbed by isotonic NaCl solution into the product vial. One of the resins that yielded the product at the suitable pH was used for the aseptic preparation. The components for this setup, including stopcocks, extension tubes, etc., were all single-use, individually packed and sterile. The process was done in a lead-line isolator maintained in grade A (PIC/S) aseptic condition. The quality of the obtained "Sodium fluoride ((18)F) injection" was analyzed according to its monograph in the European Pharmacopoeia (EP). RESULTS: The resin in the chloride form yielded the product of pH 6.7 and was chosen for the subsequent preparation. The radiochemical yield was quantitative. The product met all criteria specified in EP, including biological, physical and chemical specifications. CONCLUSIONS: This method is an efficient, space-saving and extremely low-cost operation that easily performed in an aseptic environment meeting GMP standard. The quality of the "Sodium fluoride ((18)F) injection" so yielded meets EP specifications. This setup provides hospital with facility meeting GMP standard a cost effective and efficient method for "Sodium fluoride ((18)F) injection" production without the need for the expensive automatic module and extra QC instrument.

Reversion of the steroid-induced decrease of serum osteocalcin with sodium fluoride.

Osteopenia observed in corticotherapy is due, among other causes, to a decrease in bone formation as can be shown by a steroid-induced osteocalcin decrease. Although various treatments have been proposed there is no agreement as to which one is the best. Two such treatments, sodium fluoride and vitamin D administration increase osteocalcin levels. We treated a group of 12 patients under corticoid therapy (mean dose 16 mg per day) with 50 mg/day p.o. sodium fluoride, and determined osteocalcin levels before and two weeks after sodium fluoride treatment. Similarly, another group of 9 patients with a similar mean steroid dose was treated with 0.5 micrograms/day of 1 alpha (OH)2D3 in order to assess the effect of this vitamin on osteocalcin and to determine which was the best treatment. Both groups were compared with respective control groups. A significant osteocalcin increase was observed in the control groups (p less than 0.001); similar significance was observed in the sodium fluoride group, whereas a lower significance (p less than 0.01) was observed in the vitamin D group. These results suggest that sodium fluoride could be more effective than vitamin D in the treatment of steroid-induced osteopenia.

Guidelines for the use of dietary fluoride supplements in Australia.

A survey in 1988 of brands of fluoride supplements available in a non-fluoridated town in Western Australia, and tablets described in pharmaceutical product registers, revealed that six brands of tablets and one brand of solution (drops) were on the market. Tablets contained 2.2 mg or 1.1 mg NaF; the solution contained 2.2 mg NaF per mL. All products provided age-dose schedules which would give fluoride supplementation at levels greater than the National Health and Medical Research Council guidelines. In one case, infants following the schedule would receive four times the recommended dose for the first two years of life. Compliance with several of the age-dose schedules would be certain to cause significant dental fluorosis. Whether the others caused fluorosis would depend on the quantity of fluoride in the diet, and consumption of fluoride toothpaste. The survey showed a generalized disregard on the part of the ethical pharmaceutical industry for the risk of dental fluorosis, and reveals a need for a voluntary, or legally enforced, code of conduct for manufacturers of fluoride supplements. The value of guidelines which are not monitored is doubtful.