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Bacteriological quality of skin-moisturizing creams and lotions distributed in a tropical developing country

JOURNAL OF APPLIED MICROBIOLOGY, Issue 5 2001
I.N. Okeke
Aims: To evaluate the bacteriological quality of skin moisturizing products in the South-west part of Nigeria and study factors predisposing their bacterial contamination under tropical conditions. Methods and Results: Viable counts for bacteria exceeded 103 cfu ml,1or cfu g,1 in 8 (16·3%) commercially available creams and lotions at time of purchase. Escherichia coli (8), Pseudomonas spp. (7), Staphylococcus spp. (9) and Bacillus spp. (6) were the most commonly recovered bacteria. Following use by volunteers, the proportion of E. coli and other Gram-negative organisms recovered increased. Organic matter, particularly in the absence of preservatives, enhanced survival and growth of bacteria in creams stored under ambient tropical conditions during challenge experiments. Conclusions: Contaminated products are relatively uncommon but some products present a potential health hazard because they are unable to suppress the growth of organisms of likely faecal origin during use. Significance and Impact of the Study: Quality assurance during manufacture, pack size, preservative evaluation, organic matter and water content were identified as factors to be considered during the development of creams and lotions for use in tropical developing countries. [source]

Latest news and product developments

PRESCRIBER, Issue 9 2007
Article first published online: 3 SEP 200
Clinical trials flatter anti-TNFs in RA The efficacy of anti-TNF agents in clinical trials is not matched by experience in daily practice in patients with rheumatoid arthritis, say Dutch investigators (Ann Rheum Dis online: 10 April 2007; doi:10.1136/ard.2007.072447). They compared outcomes from a systematic review of trials of etanercept (Enbrel), infliximab (Remicade) and adalimumab (Humira) and a national postmarketing surveillance scheme (DREAM). In 5 of 11 comparisons, the response rate in DREAM was significantly lower than that in RCTs. Responses among DREAM patients who met the inclusion criteria for clinical trials were significantly greater than among noneligible patients and comparable with those of patients participating in the trials. The authors conclude that patients in trials have more severe disease and therefore a response to treatment that is not matched in daily practice. Methadone prescriptions double in 10 years Methadone treatment for opiate addicts has more than doubled in the past 10 years, according to an audit of opiate substitution in England by the National Treatment Agency for Substance Misuse (www.nta.nhs.uk). The total number of methadone prescriptions increased from 970 900 in 1995 to over 1.8 million in 2004. The introduction of buprenorphine (Subutex) has not reduced methadone prescribing , 96 per cent of responding centres prescribed methadone and 88 per cent prescribed buprenorphine. Seventy-two per cent of centres prescribe benzodiazepines to opiate addicts, causing the NTA some concern. GPs were involved in prescribing management in about 60 per cent of centres. Next NICE guidelines The Department of Health has referred eight topics to NICE for the development of clinical guidelines: preventing venous thromboembolism, acute coronary syndromes, chest pain, social complications during pregnancy (eg drug misuse), benign prostatic hyperplasia, constipation in children, neonatal jaundice and metastatic disease of unknown primary origin. Errors with children , Every step of drug treatment for children, from prescribing to writing notes, is associated with a substantial level of error, say US investigators (Quality and Safety in Health Care 2007;16:116-26). Their systematic review of 31 studies reporting medication errors in paediatrics found that 3-37 per cent were associated with prescribing errors, 5-58 per cent with dispensing errors, 72-75 per cent with errors of administration, and 17-21 per cent with documentation errors. Suggestions for remedial strategies were not evidence based, the authors found. , and transplant patients Errors in medication are common among outpatients who have received liver, kidney or pancreas transplants, a second US study has found (Arch Surg 2007;142:278-83). Twelve months' follow-up of 93 patients revealed a total of 149 errors of drug treatment, with a frequency of 15 in 219 visits over a four-week period. One-third of errors were associated with adverse events including hospital admission and graft rejection. Patients were taking an average of 11 medicines; analysis showed that over half of errors originated with the patients and 13 per cent were associated with prescribing. Paracetamol pack benefit challenged A new study has challenged accepted wisdom that reducing the OTC pack size of paracetamol cut the suicide rate (PLoS Medicine 2007;4:e105). In 1998, pack sizes of paracetamol were limited to 16 in general sale outlets and 32 in pharmacies. Suicide rates subsequently decreased but, though widely assumed, a causal link has not been established. Researchers from London and the Office of National Statistics have now examined mortality trends from suicide associated with antidepressants, aspirin, compound paracetamol preparations and nondrug poisoning. They found that all fatal suicides declined at similar rates after the pack size reductions. While not excluding the possibility that restricting easy access to paracetamol may have helped, these data suggest that other factors were also important. CV risk with ibuprofen among aspirin users Ibuprofen, but not naproxen, is associated with a higher risk of cardiovascular events and heart failure than lumiracoxib (Prexige) in high-risk patients, according to a new analysis of the TARGET trial (Ann Rheum Dis online: 5 April 2007; doi:10.1136/ard.2006.066001). TARGET comprised two studies comparing naproxen or ibuprofen with lumiracoxib in a total of 18 325 patients with OA. This post-hoc analysis stratified patients by their cardiovascular risk; the primary end-point was a composite of cardiovascular mortality, nonfatal myocardial infarction and stroke at one year. Among those at high risk who were taking aspirin, ibuprofen was associated with an increased risk of the composite end-point compared with lumiracoxib (2.14 vs 0.25 per cent). The risk was similar for naproxen and lumiracoxib (1.58 vs 1.48 per cent). In high-risk patients not taking aspirin, the risk was similar for ibuprofen and lumiracoxib, but lower for naproxen than lumiracoxib. Congestive heart failure was more common in patients taking ibuprofen than lumiracoxib (1.28 vs 0.14 per cent); the risk was similar with naproxen and lumiracoxib. The authors emphasise that their findings should be considered hypothesis-generating. CVD guidelines criticised The second edition of the guidelines of the Joint British Societies on preventing cardiovascular disease have been harshly criticised for failing to meet international quality standards (Int J Clin Pract online doi: 10.1111/j.1742-1241.2007.01310.x). Kent GP Dr Rubin Minhas evaluated the guidelines against the criteria of the Appraisal of Guidelines and Research (AGREE) Collaboration. He identified areas of weakness including stakeholder involvement, rigour of development, applicability (by not considering cost) and editorial independence from the pharmaceutical industry. The guidelines should not be recommended for clinical practice, he concludes. OTC naproxen? The MHRA is consulting on switching naproxen 250mg to pharmacy-only status for the treatment of period pain in women aged 15-50. The change would offer an alternative to ibuprofen, currently the only other OTC medicine with this indication. Responses should be submitted by 23 May. The Agency is currently considering responses to its consultation on switching tranexamic acid to OTC status for heavy menstrual bleeding. Diabetes costs The total cost of prescribing for diabetes in England has doubled in only five years, official statistics show. The NHS Information Centre (www.ic.nhs.uk) report shows that spending in primary and secondary care in 2006 was £561 million, up 14 per cent on 2005. Growth was due to increased prescribing of oral hypoglycaemic agents (notably the glitazones , up by one-third over 2005) and the higher costs of insulins. Pharmacists may give flu jabs PCTs may consider using pharmacists to administer flu vaccines to some at-risk groups in the 2007/08 season, according to Department of Health plans. Flu vaccination payment for patients with diabetes, coronary heart disease, and stroke and TIA is provided under the Quality Outcomes Framework. The Department suggests that PCTs consider contracting a local enhanced service from pharmacists to reach other patients at increased risk, such as those with chronic liver disease, multiple sclerosis and related conditions, hereditary and degenerative disease of the CNS and carers. Copyright © 2007 Wiley Interface Ltd [source]

A review of pharmaceutical scheduling processes in six countries and the effect on consumer access to medicines

INTERNATIONAL JOURNAL OF PHARMACY PRACTICE, Issue 2 2006
Andrew Gilbert Director, Professor
Objective This analysis determined and compared pharmaceutical scheduling arrangements in six selected countries and explored how these different scheduling arrangements affect the availability of medicines to the public for self-medication. Method A comparison of the pharmaceutical scheduling requirements for medicines in six countries was undertaken in September 2003. The six countries of comparison were Australia, Canada, France, New Zealand (NZ), the United States (US), and the United Kingdom (UK). The World Self-Medication Industry website, in September 2003, listed 216 medicines available in 27 countries. Of these, 104 medicines were available in each of the six countries selected for the study. As different scheduling arrangements pertain to different forms (external, internal) or doses and pack sizes, the total number of medicines and medicine forms for comparison was 119. The scheduling of each of the 119 products was determined and compared across the six countries. Results Of the 119 medicines and medicine forms available, Australia and NZ have 38 and 34 ,prescription-only' medicines and 81 and 85 medicines available without a prescription respectively. UK, Canada and France have 47, 53, and 55 ,prescription-only' medicines and 72, 66 and 64 medicines available without a prescription. US, which has only two schedules, ,prescription-only' and ,general sale', has the highest number of ,prescription-only' drugs (66) and the least number of medicines available without a prescription (53). Conclusion The results indicate that there is a tendency for more products to be made available without a prescription in countries that have schedules with pharmacy involvement (Australia, NZ, Canada, France and UK) and a matching tendency for preparations to be held in ,prescription-only' schedules in the USA where ,pharmacy-only' schedules do not exist. The presence of ,pharmacy-only' schedules provides a structure whereby greater consumer access to medication is available. [source]

Latest news and product developments

PRESCRIBER, Issue 9 2007
Article first published online: 3 SEP 200
Clinical trials flatter anti-TNFs in RA The efficacy of anti-TNF agents in clinical trials is not matched by experience in daily practice in patients with rheumatoid arthritis, say Dutch investigators (Ann Rheum Dis online: 10 April 2007; doi:10.1136/ard.2007.072447). They compared outcomes from a systematic review of trials of etanercept (Enbrel), infliximab (Remicade) and adalimumab (Humira) and a national postmarketing surveillance scheme (DREAM). In 5 of 11 comparisons, the response rate in DREAM was significantly lower than that in RCTs. Responses among DREAM patients who met the inclusion criteria for clinical trials were significantly greater than among noneligible patients and comparable with those of patients participating in the trials. The authors conclude that patients in trials have more severe disease and therefore a response to treatment that is not matched in daily practice. Methadone prescriptions double in 10 years Methadone treatment for opiate addicts has more than doubled in the past 10 years, according to an audit of opiate substitution in England by the National Treatment Agency for Substance Misuse (www.nta.nhs.uk). The total number of methadone prescriptions increased from 970 900 in 1995 to over 1.8 million in 2004. The introduction of buprenorphine (Subutex) has not reduced methadone prescribing , 96 per cent of responding centres prescribed methadone and 88 per cent prescribed buprenorphine. Seventy-two per cent of centres prescribe benzodiazepines to opiate addicts, causing the NTA some concern. GPs were involved in prescribing management in about 60 per cent of centres. Next NICE guidelines The Department of Health has referred eight topics to NICE for the development of clinical guidelines: preventing venous thromboembolism, acute coronary syndromes, chest pain, social complications during pregnancy (eg drug misuse), benign prostatic hyperplasia, constipation in children, neonatal jaundice and metastatic disease of unknown primary origin. Errors with children , Every step of drug treatment for children, from prescribing to writing notes, is associated with a substantial level of error, say US investigators (Quality and Safety in Health Care 2007;16:116-26). Their systematic review of 31 studies reporting medication errors in paediatrics found that 3-37 per cent were associated with prescribing errors, 5-58 per cent with dispensing errors, 72-75 per cent with errors of administration, and 17-21 per cent with documentation errors. Suggestions for remedial strategies were not evidence based, the authors found. , and transplant patients Errors in medication are common among outpatients who have received liver, kidney or pancreas transplants, a second US study has found (Arch Surg 2007;142:278-83). Twelve months' follow-up of 93 patients revealed a total of 149 errors of drug treatment, with a frequency of 15 in 219 visits over a four-week period. One-third of errors were associated with adverse events including hospital admission and graft rejection. Patients were taking an average of 11 medicines; analysis showed that over half of errors originated with the patients and 13 per cent were associated with prescribing. Paracetamol pack benefit challenged A new study has challenged accepted wisdom that reducing the OTC pack size of paracetamol cut the suicide rate (PLoS Medicine 2007;4:e105). In 1998, pack sizes of paracetamol were limited to 16 in general sale outlets and 32 in pharmacies. Suicide rates subsequently decreased but, though widely assumed, a causal link has not been established. Researchers from London and the Office of National Statistics have now examined mortality trends from suicide associated with antidepressants, aspirin, compound paracetamol preparations and nondrug poisoning. They found that all fatal suicides declined at similar rates after the pack size reductions. While not excluding the possibility that restricting easy access to paracetamol may have helped, these data suggest that other factors were also important. CV risk with ibuprofen among aspirin users Ibuprofen, but not naproxen, is associated with a higher risk of cardiovascular events and heart failure than lumiracoxib (Prexige) in high-risk patients, according to a new analysis of the TARGET trial (Ann Rheum Dis online: 5 April 2007; doi:10.1136/ard.2006.066001). TARGET comprised two studies comparing naproxen or ibuprofen with lumiracoxib in a total of 18 325 patients with OA. This post-hoc analysis stratified patients by their cardiovascular risk; the primary end-point was a composite of cardiovascular mortality, nonfatal myocardial infarction and stroke at one year. Among those at high risk who were taking aspirin, ibuprofen was associated with an increased risk of the composite end-point compared with lumiracoxib (2.14 vs 0.25 per cent). The risk was similar for naproxen and lumiracoxib (1.58 vs 1.48 per cent). In high-risk patients not taking aspirin, the risk was similar for ibuprofen and lumiracoxib, but lower for naproxen than lumiracoxib. Congestive heart failure was more common in patients taking ibuprofen than lumiracoxib (1.28 vs 0.14 per cent); the risk was similar with naproxen and lumiracoxib. The authors emphasise that their findings should be considered hypothesis-generating. CVD guidelines criticised The second edition of the guidelines of the Joint British Societies on preventing cardiovascular disease have been harshly criticised for failing to meet international quality standards (Int J Clin Pract online doi: 10.1111/j.1742-1241.2007.01310.x). Kent GP Dr Rubin Minhas evaluated the guidelines against the criteria of the Appraisal of Guidelines and Research (AGREE) Collaboration. He identified areas of weakness including stakeholder involvement, rigour of development, applicability (by not considering cost) and editorial independence from the pharmaceutical industry. The guidelines should not be recommended for clinical practice, he concludes. OTC naproxen? The MHRA is consulting on switching naproxen 250mg to pharmacy-only status for the treatment of period pain in women aged 15-50. The change would offer an alternative to ibuprofen, currently the only other OTC medicine with this indication. Responses should be submitted by 23 May. The Agency is currently considering responses to its consultation on switching tranexamic acid to OTC status for heavy menstrual bleeding. Diabetes costs The total cost of prescribing for diabetes in England has doubled in only five years, official statistics show. The NHS Information Centre (www.ic.nhs.uk) report shows that spending in primary and secondary care in 2006 was £561 million, up 14 per cent on 2005. Growth was due to increased prescribing of oral hypoglycaemic agents (notably the glitazones , up by one-third over 2005) and the higher costs of insulins. Pharmacists may give flu jabs PCTs may consider using pharmacists to administer flu vaccines to some at-risk groups in the 2007/08 season, according to Department of Health plans. Flu vaccination payment for patients with diabetes, coronary heart disease, and stroke and TIA is provided under the Quality Outcomes Framework. The Department suggests that PCTs consider contracting a local enhanced service from pharmacists to reach other patients at increased risk, such as those with chronic liver disease, multiple sclerosis and related conditions, hereditary and degenerative disease of the CNS and carers. Copyright © 2007 Wiley Interface Ltd [source]

Paracetamol-related deaths in Scotland, 1994,2000

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 4 2002
Christopher L. Sheen
Aims To investigate the death rate due to paracetamol poisoning in Scotland and what effect the reduction in over-the-counter paracetamol pack sizes in 1998 had on the death rate. Methods Records from 1994 to 2000 were examined to identify the number and annual incidence of paracetamol-related deaths. Numbers of deaths before and after the pack size reduction were compared. Results No significant differences were shown due to the pack size reduction. The Scottish paracetamol-related death rate was twice as high as in England and Wales. Conclusions Further measures to reduce paracetamol-related morbidity and mortality in Scotland should be considered. [source]