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Standard Treatment Guidelines Ghana Table of Contents Standard Treatment Guidelines Ghana. However, the authors, editor and publishers are not responsible for errors and omissions or for any consequences from application of the information in this booklet and make no warranty, express or implied, with respect to the content of the publication. Key components of the reforms include regular policy review and implementation of programmes that will deliver effective and efficient health services. The main objective of the current reforms is to alleviate poverty and to "bridge the inequality gap". The reforms also take cognisance of the numerous challenges that have been identified which tend to militate against attempts at improving the health status of the population in the medium term. Key among these challenges is the need to improve quality of care and to inject efficiency into the way in which resources in the health sector are used. Through the use of well established methods of prevention, diagnosis and treatment of common diseases seen in our health facilities, this edition brings together essential and current knowledge necessary for prescribers to provide the best of care to patients. Furthermore, by developing this document within the framework of the Essential Medicines Programme, it serves as an effective way of containing cost of treatment for both patients and the health sector. This has resulted in a comprehensive and highly organised document, designed to serve as a clinical guide as well as an educational tool. Aboah, Department of Surgery, School of Medical Sciences, Kwame Nkrumah University of Science & Technology Prof. Aryee, Department of Obstetrics & Gynaecology, University of Ghana Medical School Dr. O Dodoo, Centre for Tropical Clinical Pharmacology & Therapeutics, University of Ghana Medical School Prof. Frimpong, Department of Medical Microbiology, School of Medical Sciences, Kwame Nkrumah University of Sciences Technology Dr. Owusu, Department of Medicine, School of Medical Sciences, Kwame Nkrumah University of Science & Technology Dr. Welbeck, Department of Child Health, University of Ghana Medical School Editorial Committee Members Dr. Dodoo, Centre for Tropical Clinical Pharmacology & Therapeutics, University of Ghana Medical School Prof. Ofori Adjei, University Health Services, University of Ghana Programme Managers Dr. This document has been reviewed in response to new knowledge on drugs and diseases and changes in the epidemiology of diseases in Ghana. The Ministry has also produced guidelines for specific disease control programmes, diseases and identifiable health providers. The Government of Ghana, through the National Drug Policy remains committed to ensuring the availability and accessibility of good quality medicines for all people, and that these medicines are affordable and are rationally used. Achieving these objectives requires a comprehensive strategy that not only includes supply and distribution, but also appropriate and thoughtful prescribing, dispensing and use of medicines. These Standard Treatment Guidelines have been prepared to assist and guide prescribers (including doctors, medical assistants, and midwives), pharmacists, dispensers, and other healthcare staff who prescribe at primary care facilities in providing quality care to patients. The guidelines list the preferred treatments for common health problems experienced by people in the health system and were field tested before being finalised to ensure that the opinion of the intended users were considered and incorporated. The guidelines are designed to be used as a guide to treatment choices and as a reference book to help in the overall management of patients, such as when to refer. The guidelines are meant for use at all levels within the health system, both public and private. It is recognised that the treatment guidance detailed in this book may differ from current practice. It is emphasised that the choices described here have the weight of scientific evidence to support them, together with the collective opinion of a wide group of recognised national and international experts. The recommendations have been rated on the following basis: Evidence rating A requires at least one randomised control trial as part of a body of scientific literature of overall good quality and consistency addressing the specific recommendation. Evidence rating B requires the availability of well conducted clinical studies but no randomised clinical trials on the topic of recommendation. Evidence rating C requires evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities. This indicates an absence of directly applicable clinical studies of good quality. To use treatment other than those recommended here may have to be justified to colleagues, managers, or in law. The content of these treatment guidelines will undergo a process of continuous review. Those comments or suggestions for addition of diseases should include evidence of prevalence as well as a draft treatment guideline using the format set out in this book. In the case of a request for a new drug or replacing a listed product with another product, the evidence base must be clearly defined and included with the request. Within each section, a number of disease states which are significant in Ghana have been identified. For each of these disease states the structuring of the information and guidance has been standardised to include a brief description of the condition or disease and the more common signs and symptoms. In each case the objectives of treatment have been set out, followed by recommended non pharmacological as well as the pharmacological treatment choices. That is, it is based on the international medical and pharmaceutical literature, which clearly demonstrates the efficacy of the treatment choices. The treatment guidelines try to take the user through a sequence of diagnosis, treatment objectives, choice of treatment and review of outcome. When treating patients, the final responsibility for the well being of the individual patient remains with the prescriber. Prescribers must take steps to ensure that they are competent to manage the most common conditions presenting at their practice and familiarise themselves particularly with those aspects of the treatment guidelines relating to those conditions. It is important to remember that the guidance given in this book is based on the assumption that the prescriber is competent to handle patients at this level, including the availability of diagnostic tests and monitoring equipment. Patients should be referred when the prescriber is not able to manage the patient either through lack of personal experience or the availability of appropriate facilities. Patients should be referred, in accordance with agreed arrangements, to facilities where the necessary competence, diagnosis and support facilities exist. The patient should be given a letter or note indicating the problem and what has been done so far, including laboratory tests and treatment. It may also be necessary for the patient to be accompanied by a member of health staff and it should be remembered that the act of referral does not remove from the prescriber the responsibility for the well being of the patient. Not all patients need a prescription for a medicine; non drug treatment may be suitable and this has been highlighted in these guidelines. In all cases the benefit of administering the medicine should be considered in relation to the risk involved. This is particularly important during pregnancy where the risk to both mother and foetus must be considered. Unofficial abbreviations should not be used because there is a high risk of misinterpretation. Where decimals are unavoidable a zero should be written in front of the decimal point where there is no other figure. It is recognised that some Latin abbreviations are used and these are detailed in the section on abbreviations. Always ask how many times that day and the day before the patient has been to the toilet, and the texture of the stools. To one person who usually passes stool once in 3 days, a motion every day seems like diarrhoea, but to another person this is normal. In children, other diseases like malaria, pneumonia, ear infections, urinary infections, may cause diarrhoea; so examine the child fully to make sure there is no obvious cause for the diarrhoea there is usually a fever if there is another cause. Malnutrition causes diarrhoea, which in turn also causes malnutrition, setting up a vicious cycle. If diarrhoea plus vomiting plus no mucus plus low grade fever think viral infection If diarrhoea (very watery) plus vomiting plus cramps plus blood plus mucus plus fever think of bacterial infection If diarrhoea plus blood plus no fever think of amoebiasis 20 If profuse diarrhoea (rice water stools) plus vomiting think of cholera If diarrhoea plus excessive vomiting (in more than one member of household or group) think of food poisoning the following table can be used to assess the degree of dehydration in children with diarrhoea. Treatment Weigh Patient and use Plan C Weigh Patient and use Plan B Plan A Plan 5. The skin pinch may be less useful in patients with marasmus (severe wasting) or kwashiorkor (severe malnutrition with oedema) or obese patients. Treatment Plan B Some dehydration For the child with some dehydration, use treatment Plan B. Table for Plan C: Treat Severe Dehydration Quickly Age First give 30 ml/kg body weight in: Then give 70 ml/kg body weight in: Infants 1 hour* 5 hours (under 12 months) Children 30 minutes* 2 hours (12 months up to 5 years) * Repeat once if radial pulse is still very weak or not detectable. When the patient is passing urine, start oral potassium as coconut water or banana. If possible adults and children especially should continue to eat/breastfeed during the period of diarrhoea. Note: Anti diarrhoeal medicines like Mist Kaolin, co phenotrope, codeine, loperamide have no place in the treatment of diarrhoea and are likely to do more harm than good. Similarly, antibiotic containing kaolin or pectin preparations are of no therapeutic value in diarrhoea. If frequency and/or consistency of bowel motions is outside the expected physiological variation, or has changed recently, the patient should be fully investigated for possible underlying cause. Complaints of diarrhoea alternating with constipation may indicate a large bowel cancer especially in those aged forty (40) and above. In children and the elderly, it may indicate chronic constipation with spurious diarrhoea. If this therapy fails, second line therapy includes Senna tablets, oral 2 4 tablets at bedtime, Glycerol and Bisacodyl suppository. If constipation is resistant to the above measures, there should be a re evaluation of the underlying cause(s), including impaction. Magnesium Trisilicate 15 mls 3 times daily in between meals and at bedtime to control dyspepsia). Presently, majority of patients presenting with duodenal ulcer are also thought to be infected with Helicobacter pylori. The organism is thought to play a major role in the causation of peptic ulcer disease so eradication of the organism should be done using a Triple Therapy Regime. This consists of Omeprazole plus a combination of two of the antimicrobial agents indicated in the table below (Amoxicillin plus Clarithromycin, Amoxicillin plus Metronidazole or Clarithromycin plus Metronidazole). Treat constipation if present with liquid paraffin, oral, 10 30 mls at night or Senna granules, 1 sachet with water after supper. If this fails, apply cold compresses and sedate patient with Diazepam, oral, 10 mg. Exchange transfusion is the definitive treatment for hyperbilirubinaemia that has reached the level where kernicterus may occur. Since there is no exact test to determine the risk of kernicterus and hence the level at which exchange transfusion is necessary the following rule of thumb has proved useful as a guide. Threshold for intervention by phototherapy or exchange transfusion should be lower in the following cases sick, low birth weight, asphyxia, prolonged hypoxemia, acidosis, sepsis.

S Management Allergic reactions to calcitonin are rare and usually due to non-human calcitonins erectile dysfunction oil buy avana cheap. Allergic reactions have been reported with intramuscular erectile dysfunction hand pump purchase avana master card, intraarticular erectile dysfunction doctors buffalo ny purchase 50 mg avana with mastercard, periarticular erectile dysfunction natural remedies at walmart best avana 100 mg, intra lesional impotence treatments discount avana 50mg without a prescription, oral erectile dysfunction drugs levitra discount avana on line, inhalational and intravenous routes of administration. S Incidence Hydrocortisone, prednisolone and methylprednisolone are the most frequently implicated in ana phylaxis. About 100 published reports of immediate hypersensitivity reactions occuring after oral and paren teral administration. Delayed hypersensitivity reactions: reactivation of eczema following oral, parenteral, intra-articular, intra-lesional administration of a corticosteroid. Maculopapular rash, papulo-vesicular rash, exan thematous rash, eczematous rash, annular and centrifugum eczema, flexural rash, rash with or without bullae or purpura, erythema multiforme, acute generalized exanthematous pustulosis. Patch tests may be read 48 hr and 72 hr or 96 hr after placement of tests but also on Day 7 or 10 (delayed reactions are frequent, so late reading is necessary). Controlled challenge test: Oral hydrocortisone: 5, 10, 15, 30 mg Oral prednisolone: 5, 10, 15, 20 mg Intravenous hydrocortisone: 5, 10, 20, 40, 75 mg Intravenous prednisolone: 5, 10, 15, 30, 40 mg. Formation of steroid glyoxal, cortisol degradation product, which in aqueous solution may be res ponsible for the presentation of the steroid carbon rings to the immune system as a hapten. S Management Avoidance of hydrocortisone, methylprednisolone and prednisolone in any formulation (succinate, acetate or sodium phosphate) in patients with allergic reactions to systemic corticosteroids. Cross-reactivity has been reported between: Methylprednisolone sodium succinate, methylprednisolone 21 sodium succinate and prednisolone 21 sodium succinate. One case of hydrocortisone desensitization in a patient with radiocontrast induced-anaphylactoid reaction and corticosteroid allergy. Glucocorticoid hypersensitivity as a rare but potentially fatal side effect of paediatric asthma treatment: a case report. A case of hydrocortisone desensitization in a patient with radiocon trast-induced anaphylactoid reaction and corticosteroid allergy. Oral prednisolone induced acute generalized exanthematous pustulosis due to corticosteroids of a group A confirmed by epicutaneous testing and lymphocyte transformation tests. Non immediate reactions to systemic corticosteroids suggest an immunolo gical mechanism. Used for bowel relaxation during barium gastrointestinal studies and emergency treatment of hypoglyce mia. Urticaria, erythema multiforme, delayed hypersensitivity with papulous plaques and purpuric rash, pruritus, reproduction of features of the glucagonoma syndrome, injection-site reaction. Use hyoscine butylbromide, pirenzepine, cimetropium bromide or peppermint oil mixed with barium suspension. Delayed hypersensitivity reaction after intravenous glucagon administered for a barium enema: a case report. Reproduction of features of the glucagonoma syndrome with continuous intra venous glucagon infusion as therapy for tumor-induced hypoglycemia. Anaphylactic and allergic reactions during double-contrast studies: is glu cagon or barium suspension the allergen Tripterolin, Gonadorelin, Buserelin, Leuprolide acetate, Nafarelin, Goserelin acetate. Several reports of systemic hypersensitivity reactions associated with leu prolide acetate. S Diagnostic methods Skin tests Prick tests positive in various concentrations for gonadorelin, buserilin, goserilin, leuprolide. S Mechanisms IgE-mediated hypersensitivity (positive immediate skin tests, specific IgE). Injection-site resulting from the administration of both leuprorelin acetate and goserelin acetate for the treatment of prostatic cancer. Anaphylaxis to leuprolide acetate depot injection during treatment for prostate cancer. Recurrent anaphylaxis associated with gonadotropin-releasing hormone analogs: case report and review of the literature. S Clinical manifestations I/ Local Immediate (within minutes of injection): pain + itching accompanied by erythema and swelling < 1 hour. Biphasic (immediate + late phase response): starting at 4 hours and persisting 1-3 days. Intermediate (Arthus reaction): onset at 4-8 hours, peaks at 12 hours, induration with pruritus. Delayed (tuberculin-like): onset at 12 hours, peaks at 24-48 hours, induration with erythema and pruritus. Systemic reactions: pruritus, urticaria, angioedema, leukocytoclastic vas culitis (rare). S Diagnostic methods Skin tests Insulin Prick test: pure insulin preparation 100 U/ml (low sensitivity). S Mechanisms IgE-mediated hypersensitivity (local reactions: immediate or biphasic; general reactions: anaphylac tic shock, urticaria). Tertiary structural change before or during insulin injection, insulin self-aggregation promotes the formation of anti-insulin antibodies. Cross-reactivity with animal insulins (in patients who had received them previously). Protamine, zinc (2 cases), parabens, metacresol, phenol, isophane are sometimes responsible for allergic reactions. Insulin syringes and insulin vial stoppers containing latex may lead to allergic reactions to latex in diabetics. Simple methods: dose division, variation of injection site, antihistamines, local corticosteroids. Failure to desensitize could indirectly indicate an immune complex disease, and Lispro has been efficient in this particular situation, since the formation of immune complexes might be profundly affected. Continuous subcutaneous insulin infusion therapy seems the ideal method for desensitization. Omalizumab and pancreas transplantation have been successfully used in some cases. Allergy reactions to insulin: effects of continuous subcutaneous insulin infusion and insulin analogues. Systemic allergy to human insulin and its rapid and long acting analogs: successful treatment by continuous subcutaneous insulin lispro infusion. Insulin allergy and resistance successfully treated by desensitisation with Aspart insulin. A rational clinical approach to suspected insulin allergy: status after five years and 22 cases. Leukocytoclastic vasculitis induced by subcutaneous injection of human insulin in a patient with type I diabetes and essential thrombocytopenia. Flare-up reaction with a positive patch test, so the 1% dilution is recommended to avoid this reac tion. Cross-reactivity by patch test is frequent between the different sympathomimetic drugs, especially if the drug was administered systematically. Cross-reactivity is more frequent between pseudoephedrine and ephedrine (phenylpropanolamine derived) than between phenylephrine and epinephrine (phenylethanolamine-derived). Severe allergic contact blepharoconjunctivitis from phenylephrine in eye drops, with corresponding T-cell hyperresponsiveness in vitro. Once bonded with plasminogen, the streptokinase-plasminogen complex cleaves arginine 560 on free plas minogen molecules in plasma. Clinical uses of streptokinase include the treatment of acute myocardial infarction, deep venous thrombosis, arterial thrombosis and embolism. S Risk factors Previous exposure to streptokinase: topical (6 months), antithrombotic use (4 years). Human albumin, phosphate buffers, and sodium glutamate are contained in streptokinase prepa rations. The presence of anti-streptokinase antibodies in high titers may lead to a lower rate of coronary re perfusion if streptokinase is re-used. S Management Use alteplase, reteplase or tenechteplase in streptokinase-allergic patients. The biologic efficacy of streptokinase is not compromised by an allergic reaction. The precise relation between streptokinase allergy, antibody titers, and clinical outcome requires further studies. Hydrocortisone and antihistamines appear to have no protective effect against hypotensive reactions. If positive, do not use streptokinase; a negative skin test is predictive of safe administration of streptokinase. Rapid enzyme immunoassay of anti-streptokinase antibodies in human plasma (in 30 minutes) should allow the best thrombolytic therapy for the patient. Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction. Risk of anaphylaxis in a hospital population in rela tion to the use of various drugs: an international study. Subsequently, with the use of routine patch tests with corticosteroids, the high frequency of hypersensitivity became evident in the late 1980s. S Classification There are 5 chemical/structural classes of corticosteroids (see Isaksson, 2004). Corticosteroids in group A: hydrocortisone, hydrocortisone acetate, methylprednisolone, predni sone, prednisolone, tixocortol and esters such as pivalate, fludrocortisone (acetate), cloprednol Corticosteroids in group B: budesonide, desonide, amcinonide, triamcinolone (acetonide), fluclo ronide, fluocinonide, flunisolide, fluocinolone acetonide, halcinonide, procinonide Corticosteroids in group C: betamethasone, dexamethasone, desoximethasone, fluocortolone, halo methasone, fluprednidene acetate Corticosteroids in group D 1: beclomethasone dipropionate, betamethasone dipropionate, clobeta sone butyrate, alclometasone-17, 21-dipropionate, betamethasone-17-valerate, clobetasol propio nate, clobetasone propionate, diflucortolone valerate, diflorasone diacetate, fluticasone propionate, mometasone furoate Corticosteroids in group D 2: hydrocortisone (17-butyrate;17-aceponate;17-buteprate), methyl prednisolone aceponate, prednicarbate, hydrocortisone valerate S Prevalence 1 to 5% with positive tests to different topical corticosteroids in populations undergoing patch tests. S Exposure Topical corticoids with skin application Inhalation Gastrointestinal canal S Risk factors Long term application for leg ulcers, atopic dermatitis, contact dermatitis, psoriasis or other types of inflammatory dermatitis S Clinical manifestations Diagnosis is difficult due to the anti-inflammatory action on cutaneous lesions. S Diagnostic methods Skin tests Patch tests Standard series to detect corticosteroid allergy Budesonide: 0. Others (see Isaksson) Betamethasone dipropionate: 1% in eth Amcinonide: 1% in eth Beclomethasone dipropionate: 1% in eth Clobetasone butyrate: 1% in eth Desonide: 0. Generalized exanthematous reaction pustu losis induced by topical corticosteroids. Allergic contact dermatitis in response to budesonide reactivated by inhalation of the aller gen. They constitute the specific treat ment for snake, spider and scorpion envenomation. The risk of serum sickness is correlated with antivenom dosage (polyvalent crotalidae antivenom). Nevertheless, the specificity of Centuroides sculpturatus antivenom is 98%, the sensitivity 68%. S Mechanisms IgE-mediated hypersensitivity (foreign animal proteins present in the antivenom). Low dose subcutaneous adrenaline is useful in preventing acute adverse reactions with antivenom in patients with snake bites (grade A recommendation). No strong evidence to support the use of hydrocortisone as premedication for snake antivenom (grade B recommendation). Current evidence does not support routine antihistamines as premedication for snake antivenom (grade A recommendation). Acute hypersensitivity reactions associated with administration of crotalidae polyvalent immune Fab antivenom. Current use of Australian snake antivenoms and frequency of imme diate-type hypersensitivity reactions and anaphylaxis. Serum sickness following administration of anti venin (crotalidae) poly valent in 181 cases of presumed rattlesnake envenomation. Immediate and delayed allergic reactions to crotalidae polyvalent immune Fab (ovine) antivenom. S Incidence Uncommon: mild reactions in 1/1,000; severe reactions 1 to 5/1,000,000. S Clinical manifestations Differentiate from lymphadenitis or generalized granulomatosis. Lupus vulgaris, lichen scro fulosorum-like eruption; erythema induratum of Bazin. High titers were found in maternal serum in neonates with anaphylactoid reactions (passive reac tion). S Incidence 9% of injections (immediate manifestations: 5%, delayed manifestations: 4%). S Clinical manifestations Anaphylactic shock (occurs even with small amounts of serum): 1. S Diagnostic methods Skin tests Intradermal tests may be positive in patients presenting anaphylactic shock. However, the false negative rate is high (50%) and this test does not rule out the possibility of generalized reactions. S Mechanisms IgE-mediated hypersensitivity probably underlies anaphylactic manifestations, but IgE antibodies have never been demonstrated. Using botulinal immune globulin obtained from hyperimmunized human donors will be beneficial. S Incidence Serum sickness: 1% to 15% (in 32 patients with in vitro fertilization). Bovine serum albumin contained in culture medium used in arti ficial insemination is an important anaphylaxis risk factor.

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Contact allergy is a T cell-mediated allergy that proceeds in two steps: (i) the phase of sensitisation where the allergen provokes an immunological T cell mediated response in the skin and the individual becomes sensitised to this allergen; (ii) the phase of elicitation where the sensitised individual is re-exposed to the same allergen or to an allergen with chemical similarities resulting in an elicitation at the site of contact (1) erectile dysfunction treatment in rawalpindi purchase 100 mg avana mastercard. The elicitation clinically manifests as allergic contact dermatitis with redness erectile dysfunction injections trimix order genuine avana on line, scaling impotence synonym order generic avana line, swelling and/or vesicles erectile dysfunction doctor in miami purchase avana mastercard. The background for the four manuscripts included in the thesis is presented in the following sections erectile dysfunction drugs sales buy genuine avana. Contact allergy may develop after only few exposures to erectile dysfunction nclex questions buy avana 100 mg with mastercard, for example, highly concentrated biocides in the industry or after repeated and prolonged exposures to consumer products, for 3 instance (16). Allergens are relatively small molecules (<500 Da; referred to as haptens) that may penetrate the stratum corneum (21). Upon activation, the Langerhans cells begin their migration towards the afferent lymph node and their further maturing (maturing Langerhans cells) (17, 18, 29). In the paracortical area, a cascade of T cell receptor binding between matured Langerhans cells (or other antigen presenting cells) and naive T cells is initiated. Within hours the delayed reaction is fully activated and the allergic contact dermatitis has developed. The recruitment of cells and proinflammatory cytokines and chemokines results in vascular dilation within hours and infiltration of effector cells, which initiates the allergen-specific effector phase, resulting in allergic contact dermatitis. Cosmetic products include a wide range of product categories: creams, deodorants, hair conditioners, hairstyling products, liquid soaps, make-up, mouthwashes, nail-care products, shampoos, shaving products, self-tanning products and so forth. Although large retrospective studies have shown that the prevalence of contact allergy to preservatives remains relatively stable, a Danish retrospective study from 2010 found that the overall prevalence of contact allergy to selected preservatives from the European Baseline Series and Extended Series increased throughout the study period (43-45). In 1997, Dillarstone postulated that mandatory ingredient labelling of cosmetic products and post-market surveillance of contact allergy would prevent future epidemics of contact allergy (47). The overall prevalence of preservative contact allergy may exceed >10% in consecutive patch tested patients (45). The prevalence ratio of contact allergy to methylisothiazolinone in European countries based on consecutive patch-tested patients with suspected allergic contact dermatitis. A 90-day scrutiny period followed where the European Parliament and Council were consulted before the final draft was adopted. Additionally, evidence of undisclosed methylisothiazolinone in chemical products for occupational use has previously been published, for example, in wet wipes and in an ultrasound gel for hospital settings (50, 87, 88). B: Allowed in rinse-off cosmetic products up to a maximum concentration of 15 ppm. C: Not included in Annex V and therefore not allowed for use in cosmetic products. D: Not included in Annex V and therefore not allowed for use in cosmetic products. The conclusion in the observational studies showed that the observed coupled reactivity may be due to co-sensitisation rather than cross-reactivity (106, 114). The initial risk assessment was based on the established methods at that time (119). Additionally, surveillance data showed in the mid and late-1990s that the prevalence ratios of contact allergy to methyldibromo glutaronitrile had increased proportional with its use in cosmetic products and toiletries in several European countries (42, 44, 123-125). In a comprehensive observational study, the prevalence ratio of contact allergy to methyldibromo glutaronitrile in consecutive patch-tested patients with contact dermatitis (collected in 16 centres in 11 European countries) increased from 0. These high prevalence ratios across European countries paved the way for a re-evaluation of the sensitising risk of methyldibromo glutaronitrile. Later it was further recognized that rinse-off cosmetic products accounted for a substantial amount of the increase in cases with relevant contact allergy to methyldibromo glutaronitrile (127, 128). As of 2008, methyldibromo glutaronitrile was fully banned in rinse-off cosmetic products. Decreasing trends of contact allergy to methyldibromo glutaronitrile were seen throughout the second half of 2010s (41, 43, 130). Surveillance data across decades can be used to describe and evaluate temporal trends of preservative contact allergy and to study the potential effects of intervention. Risk assessment refers to the pre-market procedure before a substance is granted permission for use in cosmetic products. After the substance is granted permission for use in cosmetic products, the 16 risk management is initiated. The process refers to the continuous monitoring of any adverse effects that may arise with the use of the substance in cosmetic products, for example, contact allergy. Surveillance data on contact allergy from dermatology departments and from dermatologists in private practices serve as the basis. The European Parliament and member states may thereafter approve chemical substances (with a positive opinion) for use in cosmetic products on the European cosmetic market. Only preservatives listed in Annex V are allowed for use in cosmetic products in the European Union (121, 133). Accordingly, the National Allergy Research Centre is engaged in research and the continuous surveillance of the prevalence ratio of contact allergies in the population. Data from a single centre may also be extracted for research purposes as the systematic registration of data for contact allergy dates back to 1985 for the Department of Dermatology and Allergy, Copenhagen University Hospital, Herlev-Gentofte, while for others it is an activity more recently initiated. On Day 5, mice are given an intravenous injection of tritiated thymidine (3H-TdR) and killed 5 hours later. Data are pooled of each experimental group or experimental animal basis and processed for scintillation, counting of the cells in the draining lymph nodes. Ear thickness was measured by engineer micrometre on Day 5 in sensitisation phase (a) and on Day 23 in challenge phase (b). All other Centres followed their regional/national guidelines for storage of data and only anonymous data were sent to the National Allergy Research Centre for inclusion in the study. Statistical analyses for dichotomous variables were done using the Chi Square test and Fishers Exact test when appropriate. Continuous variables were presented as mean when data were normally distributed th th and as median scores with interquartile range (25 and 75 percentiles) when data were non normally distributed. Normal distribution was assumed only after visual inspection of histogram, and Kolmogorov-Smirnov test and/or Shapiro-Wilk test for normal distribution. The distribution was graphically represented with either strip charts with means or with strip charts with overlay boxplots. The statistical threshold for statistical significance in all studies was predefined as p-value < 0. In Manuscript I, the Chi Square test linear-by-linear association was utilized to test for trends of preservative contact allergy across test years. Additional post-hoc pair-wise testing with Mann-Whitney U-test was applied between selected groups. Manuscript I is based on data from Herlev-Gentofte University Hospital in Denmark. The study population included consecutive patch tested eczema patients seen at a university hospital between 1985 and 2013. The overall prevalence of contact allergy to at least one preservative increased signifcantly over the study period, from 6. Although the proportion of patients with current clinical disease attributable to methyldibromo glu taronitrile contact allergy decreased signifcantly following the ban on its use in cos metic products (p < 0. The introduction of new preservatives in Europe with inadequate pre-market risk assessment has rapidly increased the overall burden of cutaneous dis ease caused by preservatives. We suggest that the cosmetic industry has a responsibility to react faster and replace troublesome preservatives when a preservative contact allergy epidemic is recognized, but the European Commission has the ultimate responsibility for failuresinriskmanagementafternew,majorsensitizingpreservativesareintroducedonto the market. Key words: allergic contact dermatitis; epidemic; methyldibromo glutaronitrile; methylisothiazolinone; preservatives; risk management. Schwensen, Department of Dermato-Allergology, National Allergy Research Centre, Copenhagen University Hospital Gentofte, Kildegardsvej 28, 2900 Hellerup, Denmark. White has received no grant from any funding agency in the public, commercial or not-for-pro t sectors. Con icts of interest: All authors of this manuscript declare no con icts of interest. Preservatives are used in cosmetic, household and indus safer cosmetic products and prevent the emergence of trial chemical products (when they are referred to as new preservative contact allergy epidemics. All patients were patch tested the opinions are formed) are not based on large amounts with all of the preservatives after their inclusion in the of clinical and epidemiological data, as these data are diagnostic patch test series. It was predicted that future preservative Thus, information on atopic dermatitis and information contact allergy epidemics could potentially be avoided on facial dermatitis were not collected until 1994 and by (i) adequate risk assessment, (ii) mandatory ingre 2001, respectively. Reactions of strength 1+, and 2013, and facial dermatitis between 2001 and 2+ and 3+ were interpreted as positive responses. Hand dermatitis, facial dermatitis and older age reactions, doubtful reactions and negative reactions were (age > 40 years) were all highly signifcantly associated interpreted as negative responses. In cases of repeated with having contact allergy to at least one preservative testing, patch test data from the last visit were used in the (p < 0. Binary logistic regression analysis sitization to at least one preservative increased from was performed to ascertain the effects of background vari 6. The 2-test linear-by-linear associ showed a relatively high prevalence, ranging between ation was utilized to test for trends of preservative allergy approximately 3% and 6%, the clinical relevance of across test years. All p-values are two-sided, and methyldibromo glutaronitrile, decreased signifcantly, 0. Temporal trend of preservative contact allergy of 23138 patients suspected of having allergic contact dermatitis eveluated at a hospital university clinic in Copenhagen between 1985 and 2013. Affected individuals may develop Discussion occupational skin problems because of secondary expo this 29-year retrospective epidemiological study inves sure in the work environment, resulting in sick-leave and, tigated the recurring epidemics of preservative contact ultimately, retraining. Children may also develop contact allergy among consecutively patch tested patients with allergy to preservatives, with an impact on their well dermatitis. Time trend based on the frequency of clinical relevance of methyldibromo glutaronitrile contact allergy for 483 patients with methyldibromo glutaronitrile contact allergy between 1999 and 2013. However, post-market substantiating the safety of cosmetic products and chem risk management and re-evaluation require surveillance ical substances, including preservatives, used in their to detect problems once the consumer is being exposed products. Time trend based on the frequency of clinical relevance of methylisothiazolinone contact allergy for 201 patients with methylisothiazolinone contact allergy between 2005 and 2013. Later animal studies with multi preservative for use in industrial chemical products, with ple topical applications during the sensitization phase no upper limit in concentration, for example as a preser showed methyldibromo glutaronitrile to be a sensitizer. Overview of adequate risk assessment of pre-marketed preservatives and future approaches to avoid epidemics of contact allergy to preservatives used in cosmetic products Pre-market risk assessment of preservatives Marketed preservatives Industry: Transparent and reproducible invivo, invitro and insilico testing Obligation to use less sensitizing allergens. Re-evaluation and granting of permanent permission take place in a short time frame. Using the local lymph strong sensitizing capabilities, as pointed out in an edito node assay, Basketter et al. Our data indicate that the background the frequency of any developing contact allergy to it in the population with methyldibromo glutaronitrile contact consumer had been evaluated. There are currently available a number of It is important to emphasize that patients remain preservatives permitted for use in cosmetic products that with lifelong contact allergy to the preservative, and should give manufacturers ways to adequately preserve will, with appropriate exposure to the preservative in cosmetics without using extreme or strong sensitizers, for domestic or occupational settings, develop allergic con example the less allergenic acids. The recurring epidemics of contact permission for use of the preservative would be granted allergy to preservatives represent a concern for public after the preservative had been present on the market, and health. The of 27 July 1976 on the approximation of Isothiazolinone preservative: cause of a dramatic increase in the rate of the laws of the Member States relating to continuing epidemic of cosmetic methylisothiazolinone contact allergy in cosmetic products dermatitis. Recommendation to include methylisothiazolinone contact accessed 09 November 2014). Lepoittevin J-P, Menne T, Boman A, European Society of Contact Dermatitis and the European Environmental and 14 Lammintausta K, Aalto-Korte K, Schnuch A. An epidemic of contact methodologies and approaches to assess Contact Dermatitis Research Group. Sensitization studies in the guinea pig 32 Scientifc Committee on Cosmetic 18 Aerts O, Cattaert N, Lambert J, Goossens with the active ingredients of Euxyl K 400. Final report on the safety Methylisothiazolinone methylisothiazolinone in a young child.

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All the items of symptoms erectile dysfunction doctor indianapolis purchase discount avana on line, such as joint pain and hampered of joint pain had a moderate to high correlation with their accompanying items of hindrance of these symptoms erectile dysfunction evaluation order 200mg avana otc. This finding is similar to the previous study by van der Plas in 2004 which found that the correlation value ranged from 0 erectile dysfunction pump surgery purchase 100 mg avana otc. These results suggest information overlapping between these items and their accompanying items erectile dysfunction protocol review article order generic avana. Additionally erectile dysfunction medication prices buy avana 100 mg without prescription, the convergent relationships between all symptom severity items and their accompanying symptom hindrance items showed a strong relationship erectile dysfunction 60 order avana online pills, rather than with other symptom hindrance items. However, reliability and validity are interrelated criteria for the tool (Polit and Beck 2008). A measuring tool cannot assess what it is intended to measure if it is inconsistent (unreliable) (Polit and Beck 2008). Reliability means to what extent the instrument gives consistent results over time (Liobiondo-Wood and Haber 1994), and whether it is free from measurement error with repeated measures (Waltz et al. The test-retest reliability procedure is conducted by administering the same instrument to the same individuals under the same conditions on two or more separate times to evaluate whether the measurement gives the same results (Liobiondo-Wood and Haber 1994; Litwin 1995; McDowell 2006; Waltz et al. The time interval between the repeated measures depends on the phenomena being measured (Waltz et al. Internal consistency reliability the results of the current study show that the alpha coefficients for the subscales exceeded the acceptable value > 0. The study design was cross-sectional in nature; which involves the collection of data at one time. The disease stage was categorised as patients with compensated or decompensated cirrhosis according to liver disease complications during the year 196 of data collection. However, the strength of the current study is the heterogeneity of the study participants, which included patients from both outpatient and inpatient clinics, as well as males and females from both rural and urban areas in Egypt. The small sample size, from only one hospital, limited the validation that could be carried out, although the initial validity was good. The pilot study was also useful to confirm the feasibility of daily recruitment rates (minimum and maximum), and the expected sample size for the main study. Additionally, it was helpful in identifying issues of concern for the main study such as time of interviews, recruitment strategy and whether three months of field work would be enough to recruit a large enough sample for the main study. This study reinforced the importance of the researcher attending the clinic settings daily and being systematic in the recruitment of a large sample size during the three months. It is also important to acknowledge that the pilot phase findings were strengthened by the diverse range of patients that were recruited. For example, the participants were from a wide age range, males and females from rural and urban regions and with different social backgrounds, allowing a range of perceptions to be obtained. Recruitment rates were monitored and recorded on a daily basis and were accurately maintained through the study. The reasons why patients refused to take part in the study, or indeed withdrew from the interview were recorded. The recruitment phase in the study lasted three months and was conducted from June 199 to August 2011. During this time, 415 patients were identified as being eligible to participate in the study; two of them were not approached because their consultant advised that these patients were too anxious to participate. The total number of participants who gave consent and participated in the study was 401 (Diagram 6-1). The researcher obtained permission from the patient before conducting the interview as to whether her/his relative could be in the room during the interview. The majority of the patients who participated in the study preferred to be interviewed alone. Whilst interviewing the participants to complete the questionnaires some of them felt the need to "explain" their answer. Illustrative quotes from qualitative quotes are seen as a way of illuminating the quantitative results and thus are treated as part of discussion. The participants were Arabic speakers so as a result their quotes were translated into English. The following quote illustrates the interest of the participants to talk about their health status. Female (303) 200 Diagram 6-1: Sample flow diagram 415 patients were identified as being eligible to participate in the study Two were not approached because they were too anxious to participate (Male and Female) 413 persons were invited to take part in the study 12 persons refused to participate in the study Three did not give any reason (Two males and one female) One had a hearing problem (Female) One had a speech problem (Male) Seven did not have time (Males=5 and Females=2) 401 participants gave consent and participated in the study Response rate 96. Only 17% of participants in this study were currently employed, although the majority (90%) were less than 65 years old. There was no significant different between males (compensated = 81, decompensated = 93) and females 2 (compensated = 120, decompensated = 107) disease stage X (1, n = 401) = 1. This question was rated on the 5-point ordinal scale ranging from one "Excellent" to five "Poor". Table 6-5: Perceived general health compared to one year ago as rated by liver cirrhotic patients n = 401 Rating scale of health transition n (%) Much better now than one year ago 12 (3. These factors were socio-demographic characteristics, medical data, disease stage, symptoms experience and perceived adequacy of social support. Using Post-hoc statistical analysis Tukey Bonferroni identified a statistically significant difference between the two age groups [mean difference = 5. The eight domains and the two component summary scores were poorer among unemployed than employed people (p = 0. There were no statistically significant differences between people living in rural and urban regions in Egypt. Factors that were significantly associated with physical health were gender, education, employment status, disease stage, complications of liver disease, comorbidities, symptoms severity and hindrance of daily life due to symptoms. Therefore, it was essential to develop a regression model for each of these dependent variables independently. The following variables were entered all together into the regression analysis to develop Model 1 for physical health and Model 2 for mental health. The significance limit to enter and leave the multiple regression steps was set at p = 0. The first model (Model 1) included symptoms experience (severity and hindrance), the three subscales of perceived social support (spouse, family and friends), socio demographic factors and medical data. This chapter will cover the second and the third aims of this study: Second aim: To explore and describe experienced symptoms (prevalence, severity and hindrance) in Egyptian cirrhotic patients and to identify and evaluate factors associated with symptoms severity and symptoms hindrance (distress). Section I describes the symptoms experience of people with liver cirrhosis and how these symptoms affect their daily activities. It also presents factors that are associated with and predicted symptoms experience. One subscale assesses the severity of various physical and 234 psychological symptoms as well as the social dysfunctional experience over the previous week, which consists of 15 items. Additionally, the prevalence of symptoms severity and the prevalence of the impact of symptoms on daily or social activities in patients with cirrhosis are presented. The mean score of the symptoms severity subscale was higher than the mean score of the symptoms hindrance subscale, suggesting that symptoms severity was higher than hindrance of daily life due to these symptoms among these patients. Table 7-2 shows the prevalence of the 15 symptoms that were reported by the patients who answered yes. The majority of the patients had one or more of a wide range of physical and psychosocial symptoms (Table 7-2). On the other hand, jaundice was the only symptom that few of these people experienced (27. The increased score means impaired daily and social activities as a result of symptoms. Some of the patients had one or more of a wide range of physical and psychosocial 237 symptoms that impacted on their daily and social activities (Tables 7-2 and 7-3), such as hindrance of daily life due to joint pain (70. This suggests that gender, educational level and employment status have a significant impact on the perceived severity of symptoms. Moreover, the limitation in their daily activities because of symptoms was higher in those same groups. Therefore, further statistical analyses (chi-square test) were done to compare these groups. Table 7-5 shows the prevalence of symptoms severity and hindrance of daily life due to symptoms among males and females. There was a significant difference in the types of symptoms experienced between men and women. Women were more likely than men to report symptoms of joint pain, right abdominal pain, decreased appetite, depression, jaundice, memory problems, changing personality and difficulty in managing time (p 0. On the other hand, men were more likely than 238 women to report symptoms of sexuality problems (decreased sexual interest and activity) (p = 0. However, males and females have the same symptoms of worry about the family situation, itching, fear of disease complications and problems in financial affairs. Women were more likely than men to have limitations in their daily life due to this symptom. Therefore, the assessment of symptoms experience showed to include not only the severity of the symptom but also the effect of this symptom on daily life. Table 7-6 presents the prevalence of symptom severity and hindrance of daily activities due to symptom among single and married people. There was a significant difference in the types of symptoms experienced between married and single people. Singles were more likely than married people to report symptoms of joint pain and worry about the family situation (p 0. In contrast, married people were significantly more likely to report a decrease in sexual interest and activity (p = 0. In terms of the impact of symptoms on daily life, single and married people were likely to experience a similar level of impact of symptoms on their daily activities. The proportion of symptoms of right abdominal pain, depression, changing personality, difficulty managing time and jaundice was significantly higher among the unemployed than the employed (p 0. In terms of the impact of symptom on daily life, the prevalence of the impact of joint pain, right abdominal pain, decreased appetite and depression on daily and social activities was higher among the unemployed than the employed (p 0. Table 7-7: the proportion of symptom severity and hindrance of symptom among employed and unemployed Symptom severity Employment status Chi-square p value phi 2 Employed Unemployed (X) coefficient N=68 N=333 n (%) n (%) Itch 30(44. In other words, it seems that the perceived severity of symptoms increases with the progressive stage of cirrhosis. Besides that, the mean score of perceived symptoms severity extensively increased with the increasing number of complications and comorbidity (p 0. This means that there was a significant positive correlation between the number of both comorbidities as well as liver disease complications and severity of symptoms. Table 7-8 shows that severity of symptoms also had a significant positive association with the number of admissions to hospital because of liver disease. For example, whereas the mean score of symptoms severity for those never admitted to hospital was 30. On the other hand, the severity of symptoms did not have a significant association with the causes of cirrhosis. Furthermore, the mean score of the impact of the symptoms on daily activities significantly increased with the advanced stage of cirrhosis, comorbidities, complications and hospitalizations (p < 0. The disease stage has a relationship with the type of symptoms experienced similar to those found in prior studies. Therefore, it was important to run further statistical analyses (chi-square test) to compare the two groups of disease stages (compensated and decompensated cirrhosis). For instance, patients with decompensated cirrhosis were more likely than patients with compensated cirrhosis to have sexual problems (decrease in desire and activity) and difficulty in managing time (P 0. Moreover, in terms of the symptom hindrance, the impact of right abdominal pain, sleepiness during the day and decreased appetite on daily and social activities was higher among patients with decompensated cirrhosis than in patients with compensated cirrhosis (p 0. Table 7-9: the proportion of symptom severity and hindrance of symptom among compensated and decompensated patients Symptom severity Disease stage (n) Chi-square p value phi 2 Compensated Decompensated (X) coefficient N=201 N=200 n (%) n (%) Itch 101(50. This result suggests that with a perceived high social support there is a low perception of symptoms severity or vice versa. These results agree with the theory of unpleasant symptoms, which indicates that with insufficient social support there is a potential increase in the severity of symptoms (Lenz et al. It was found that the severity of symptoms was negatively associated with the perceived availability of social support, particularly support from spouse and family (r = 0. There was a significant negative association between perceived symptoms severity and general health perception. This suggests that the increase of symptoms severity and hindrance of daily activities due to symptoms worsens the perceived general health and vice versa (r=-0. Related to the factors associated with symptoms severity (Table 7-11 Model 1) the results show that the model significantly explained 19. Six variables significantly associated with symptoms severity [spouse support (b = 0. Low perceived spouse support, being married, females, increasing number of liver cirrhosis complications, being unemployed, and low perceived family support were significantly associated with increasing symptoms severity among this group of patients with liver cirrhosis. Perceived spouse support, marital status and gender made the strongest contribution in explaining severity of symptoms (20. This suggests that these psychosocial variables are most important in explaining severity of symptoms among these patients. On the other hand, somatic factors such as number of liver disease complications made less contribution although this explained about 15. People with a high perception of social support from spouse and family were more likely to have a low perception of severity of symptoms. Although model 1 (Table 7-11) could significantly explain the overall severity of symptoms (p = 0.

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