nfectious iseases - Ann Lake Publications

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Sponsored in the interest of continued medical education by Volume 2 No 2 July 2013 Update

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Sponsored in the interest of continued medical education by

Infectious DiseasesVolume 2 No 2 July 2013

Update

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Volume 2 No 2 July 2013

Cover image: 3D rendering of staphylococcus

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Editorial boardEditor-in-chiefProfessor Charles FeldmanProfessor of Pulmonology and Chief PhysicianCharlotte Maxeke Johannesburg Academic Hospital and Faculty of Health SciencesUniversity of the WitwatersrandJohannesburg

PaediatricsProfessor Robin GreenProfessor of Paediatrics Dept of Paediatrics and Child Health University of Pretoria, Pretoria

MicrobiologyDr Jennifer CoetzeeMicrobioligistNational Reference Laboratory, AmpathPretoria

OtolaryngologyDr Raymond FriedmanEar, Nose and Throat SurgeonSandton Clinic, Johannesburg

Family MedicineProfessor Bruce SparksDept of Family MedicineUniversity of the WitwatersrandJohannesburg

Reproductive HealthProfessor Francois VenterDeputy Executive Director, Wits Reproductive Health and HIV Institute (WRHI)Associate Professor in the Department of Medicine, University of the Witwatersrand Head of Infectious Diseases, Charlotte Maxeke Johannesburg Academic Hospital Ex-president of the Southern African HIV Clinicians Society

The views expressed by the authors in this newsletter do not necessarily reflect those of the sponsor and editorial board.

Production Editors: Ann Lake PublicationsAnn Lake & Helen GonçalvesDesign: Jane GouveiaSponsors: SandozEnquiries: Ann Lake PublicationsPO Box 265, Gallo Manor, 2052Fax: 086 671 9397Email: [email protected] www.annlakepublications.co.za

Professor Charles Feldman MB BCh, DSc, PhD, FRCP, FCP (SA), Professor of Pulmonology and Chief PhysicianCharlotte Maxeke Johannesburg Academic Hospital and Faculty of Health Sciences University of the Witwatersrand, Johannesburg

Editorial

141248 Sintrine A4 ad Swish ®.indd 1 2012/07/23 3:22 PM

As usual, this edition of the Journal contains a number of important and interesting topics. Not surprisingly, given that we are firmly in the winter season, the first two articles deal with the appropriate management of acute coughs and colds. The first article by Robin Green deals with the issue of over the counter medications, which

are poorly regulated in South Africa, are often perceived by both practitioners and patients as being safe, but for which there are serious safety concerns in children. The second article by Andrew Black deals with the appropriate management of common acute respiratory infections.

The third article is by Jennifer Coetzee and deals with the very important issue of surveillance and antibiotic resistance. Initial antibiotic treatment in acute infections is empiric and the appropriateness of the initial choice can only be judged once the microbiological results become available some 24-72 hours later. Furthermore, in general practice, routine submission of microbiological specimens is often not performed. Thus the choice of initial empiric antibiotic therapy can best be decided upon using knowledge of the most likely pathogens and their usual antimicrobial susceptibility patterns in one’s own geographical area, clinic, hospital or practice and such information is best obtained from surveillance. The article also provides some surveillance data for 2010 for common respiratory pathogens.

The last two articles provide a slight departure from the usual submissions published in the Journal. The first one, by Shirani Naidoo, on the management of acute asthma in children, has an important antibiotic message. In the description of the management of acute asthma there is no mention at all about the routine use of antibiotics. In the situation of acute asthma, antibiotics are not recommended in the absence of clear-cut evidence or likelihood of a bacterial infection. The final article, by Ulundi Behrtel, gives us further insight into the National Health Insurance system and indicates where we are with it and future directions.

As always we welcome comments, criticisms and suggestions.

CPD Accreditation

Doctors can acquire CPD points with this newsletter by visiting www.mycpd.co.za and completing an online form of 15 questions. Accreditation is available only for a limited time on the site. Should you have any queries regarding the accreditation, please contact E2 Solutions at: 011 888 9620 or 011 340 9100 or [email protected]

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Professor Robin J GreenDepartment of Paediatrics, University of Pretoria, Pretoria

Challenges of over-the-counter ‘Cough and Cold’ Medicines

ver-the-counter ‘cough and cold’ medicines are a poorly regulated group of agents for which there is little by the way of control of use or evidence of benefit. In addition there are serious concerns for safety of these products in children. This article

intends to explore the available products, evidence of benefit, safety concerns and some of the pressures on parents to use these products in children.

‘Cough Mixtures’ - AntitussivesThere are two classes of ‘cough mixtures’ (Table 1).1

In a double blind placebo controlled study (DBPCS) of codeine (60mg), in chronic obstructive pulmonary disease (COPD), in comparison to placebo there was no effect of codeine to improve cough.1 Despite searching Pubmed there is not a single study demonstrating the ability of codeine or dextromethorphan to suppress induced cough due to upper respiratory tract infections (URTI).

Despite lack of evidence of efficacy, even South African drug formularies suggest doses for drugs such as Pholcodeine (Pholtex Linctus). The South African Medicines Formulary (SAMF) quotes the dosing as ‘ Paediatric dose for 3 months – 1 year: 1mg three times daily’. A DBPCS of 400mg of Guaifenesin versus placebo did reveal some inhibition of cough reflex sensitivity in URTI but the effect was very small.2

There are also no studies to be found of the effectiveness of antitussives in pneumonia in children.

MucolyticsTable 2 lists the available mucolytics in South Africa.

Once again the SAMF has commited itself to a position on these products; ‘Clinical efficacy has never been demonstrated’ and; ‘They liquify sputum but no more than cold water nebulisation’.

However, interestingly enough there have been studies of efficacy of mucolytics. In a Cochrane analysis three studies, with a total of 224 subjects (adults and children), revealed an odds ratio (OR) for benefit but obviously ‘not cured’ of 0.32 (number needed to treat for benefit [NNT] of 5).3

Oral decongestants, antihistamines and nasal irrigation Using these agents for acute bacterial sinusitis (ABS) in children has revealed no evaluable studies to document benefit.3

Use of nasal decongestants, oral decongestants and antihistamines for acute otitis media (AOM) in children has revealed interesting findings.4 Three hundred and fifty-five ears with AOM were treated with antibiotics compared to all these other therapies. Patients were followed up for 3 months and the rate of middle ear effusion (MEE) noted. There was no significant difference between groups in resolution rates (p>0.05) and the authors concluded; ‘We do not recommend the use of decongestants and antihistamines in the treatment of AOM as they do not change the natural course of the disease.’4

Legal statusThe Consumer Healthcare Products Association of the USA announced in 2008, that leading manufacturers would modify labels to state that paediatric OTC ‘cough and cold’ medicines should not be used in children under 4 years old.5

However, it has been noted that In any given week cough and cold medications were used by 10.1% of US children.6

On its website Pfizer Inc., announced plans to offer a new form of its Sudafed over-the-counter cold medicine that doesn’t include an ingredient used to make methamphetamine, the Associated Press (AP) reported, citing a company spokeswoman.

Table 1. Classes of antitussive agents1

Centrally acting:

• Narcotic opioids (codeine, hydrocodone, morphine)

• Non-narcotic opioid (dextromethorphan)

• Older (sedating) generation antihistamines

Peripherally acting:

• Benzonatate (eq procaine) – inhibition pulmonary stretch receptors

• levodropropizine – modulate sensory neuropeptide levels

• Moguisteine – activation of ATP-sensitive potassium channels

• Guaifenesin – expectorant

Table 2. Available mucolytics in South Africa• Acetylcysteine (Solmucol)• Carbocisteine (Flemex)• Bromohexine (Bisolvin) • Mesna (Mistabron)

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‘The new drug, called Sudafed PE, will be available in the U.S. on Jan. 10’, The company has replaced the substance pseudoephedrine with phenylephrine because methamphetamine is an illegal stimulant that users snort, smoke or inject.

What does our SAMF say? Correctly our own SAMF makes a clear case for these medications (Table 3).

The Web Despite the evidence or lack thereof for many of these products many of them are advertised freely on the internet and wild claims are made quite freely.

For example one product ‘xxxx’* is advertised to contain ‘the following carefully chosen pure, therapeutic-grade essential oils in a natural vegetable carrier oil’. ‘xxxx is a wonderful oil for relief of coughs and congestion. It also has antiseptic properties which help to fight infections such as colds, flu and chest infections. xxxx will lift the spirits of a sick and grouchy child naturally’. Then in fine print is a note: ‘xxxx contains less than 1% pure pharmaceutical grade ethanol when diluted as directed.’

And if you think that is a problem then consider this medication. ‘yyyy’! ‘is topically applied to the soles of the feet using a small amount of formula on a Q-Tip or on your finger. Gently massage the formula underneath your child’s feet for a few seconds, allowing the formula to be absorbed into the immune system. The constituents of yyyy have been proven to eliminate the symptoms as well as the cause of your child’s cold.’

Social networksMany of our patients talk to one another on social media and get advice from friends and family that may be seriously problematic. Here is one such conversation:

The Question: ‘Ds has been running a fever (101.5) and had a stuffy/runny nose since about midnight last night. He is also cutting his first tooth...

The problem is that we are flying home from a vacation tomorrow morning (5½ hour flight). He is also irritable and having trouble sleeping. I am worried about his ears and sinuses on the flight, so I called my paed and they reccommended giving him pediacare decongestant. I REALLY don’t want to give it to him, but I am scared that he will be in pain from the

pressure. I don’t know what to do short of changing the flight, which would cost us A LOT of money. Any experience with this or advice? I would do it for the comfort on the airplane.’

The Answer: ‘My paediatrician has told me that decongestants don’t work on children under one year old for a myriad of reasons. I trust her advice (she leans towards AP in a lot of her recommendations). Personally, I would NOT have done it with my first child. But then I have another child, and I guess I’ve “relaxed.” Since I have been through the early years already, yes, I might do it, knowing that it’s probably more helpful than harmful.’

Our patients should get advice from us or pharmacists. Everyone is an ‘expert’ on OTC products and this poses a serious problem.

ConclusionA recent ‘HealthDay’ report of a survey of more than 300 parents of children ages 6 months to 2 years has revealed that in the USA, ‘61% of parents gave OTC ‘cough and cold’ medicines to their children within the last 12 months.’ In addition, more than 50 percent of the parents ‘said their child’s doctor said the medicines are safe for children under 2 years, and about half reported that their doctor said the medicines are effective.’

We have along way to go to regulate the use of these medications but there is light at the end of the tunnel. I understand that the Medicines Control Council (MCC) is investigating regulating these medicines and we welcome that process.

*! Product names changed to save me serious legal problems

References1. Dicpinigatis PV. Dicpinigatis PV. Currently available

antitussives. Pul Pharmacol Ther 2009;22:148-151.2. Chang CC, Cheng AC, Chang AB. Over-the-counter (OTC)

medications to reduce cough as an adjunct to antibiotics for acute pneumonia in children and adults. Cochrane Database Syst Rev 2012;2:CD006088.

3. Shaikh N, Wald ER, Pi M. Decongestants, antihistamines and nasal irrigation for acute sinusitis in children. Cochrane Database Syst Rev 2010;(12):CD007909.

4. Eyibilen A, Aladağ I, Güven M, Koç S, Gürbüzler L. The effectiveness of nasal decongestants, oral decongestants and oral decongestant-antihistamines in the treatment of acute otitis media in children. Kulak Burun Bogaz Ihtis Derg 2009;19(6):289-93.

5. Centers for Disease Control and Prevention (CDC). Revised product labels for pediatric over-the-counter cough and cold medicines. MMWR Morb Mortal Wkly Rep 2008;57(43):1180.

6. Vernacchio L, Kelly JP, Kaufman DW, Mitchell AA. Cough and cold medication use by US children, 1999-2006: results from the slone survey. Pediatrics 2008;122(2):e323-9.

Table 3. SAMF advice on cough suppressants• It is seldom necessary to suppress a cough;• In some chronic diseases (lung cancer) cough

suppressantsmaybebeneficial;• The use of expectorants is widespread but there

is no good evidence to support the claim that they are effective;

• The use of polycomponent cough preparations cannotbesupportedonscientificgrounds.

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General Practitioners (GP) play an essential role in the healthcare system and are responsible for both the health of their individual clients as well as the broader community in which they practice. Each encounter with a client is a complex juggling

act involving many factors that may not be mutually acceptable. “Best clinical practice” based on up-to-date evidence, drug company advertising and personal experience are weighed up against perceived patient expectations and satisfaction, which is essential for the economy of a practice, and the long term effects on the general community and healthcare system.1 Antibiotic usage in patients with the common cold or Acute Respiratory Tract Infections (ARTI) is one area in General Practice where this balancing act is a challenge. This short article will address ARTI in adults without comorbidities and provide evidence and suggestions to aid the GP with the management of these patients.

The vast majority of ARTI are of viral aetiology and self-limiting with a very low complication rate (0.5-2% complicated by secondary bacterial rhinosinusitis).2 Despite being a mild self-limiting viral infection antibiotics are prescribed in 65% of ambulant outpatients presenting with ARTI and is the reason for more than half of outpatient antibiotic prescriptions in America.3,4 Of further concern is the superfluous use of broad spectrum antibiotics, 33.2% in these patients.5 This unnecessary and inappropriate antibiotic use exerts selective pressure on bacteria promoting resistance and places a large financial burden on the healthcare system.

ARTI follows a self-limited and predictable course, adults have on average 3-6 episodes a year. Initial symptoms of a sore throat begin 1-3 days post viral exposure, the sore throat resolves rapidly with rhinorrhea and nasal stuffiness predominating by day 2-3. Nasal discharge usually starts with clear watery secretions which thicken and become yellow/green in the course of the infection. Thick discoloured secretions do not indicate bacterial infection and do not require treatment with an antibiotic unless they fail to resolve after 10-14 days. Cough symptoms peak between days 3-5 and may persist for 3 weeks. Half of patients will recover at 7 days and three quarters of patients will be better by two weeks regardless of whether they receive antibiotics or not. Sudden onset of symptoms, high fever and more systemic symptoms such as myalgia distinguish influenza infection from the common cold.6

ARTI comprise of a spectrum of symptom complexes and include nonspecific upper respiratory tract infections, acute rhinosinusitis, acute pharyngitis and acute bronchitis. The division into four clinical entities is based on symptom predominance and is useful to guide management as suggested by CDC guidelines.7 Summarised and updated electronic

downloads are available from the CDC’s Get Smart about antibiotics website (www.cdc.gov/getsmart).

Several Cochrane reviews have assessed the role of antibiotics across the spectrum of ARTI. None of the reviews found significant clinical benefit from the use of antibiotics.2,8,9,10 In acute rhinosinusitis where antibiotic use may shorten symptom duration the number needed to treat for benefit was 18 while the number needed to treat for harm (adverse reactions to antibiotics) was 8 and the authors concluded that there was no place for antibiotics in uncomplicated acute rhinosinusitis in adults.2

There are indications for the use of antibiotics in patients presenting with ARTI specifically:

Sore throat predominates While the majority of cases of adult pharyngitis are due to viral infections in up to 10% Group A beta haemolytic streptococcus (GABHS) may be the aetiological agent. Patients with two or more of the Centor criteria are more likely to have GABHS infection and antibiotics are appropriate. The choice of antibiotic for these patients is penicillin or erythromycin if penicillin allergic, there is no role for a broad spectrum antibiotic in these patients. Centor criteria:1. history of fever2. tonsillar exudates3. no cough4. tender anterior cervical lymphadenopathy.3

Rhinosinusitis predominates If symptoms last for more than seven days or worsen after initial improvement and there is unilateral facial/tooth pain and tenderness antibiotics may be required. Initial therapy should be with the most narrow spectrum antibiotic that covers both S. pneumoniae and H. influenzae, in areas where there is a low frequency of H. influenzae β-lactamase production amoxicillin is appropriate. Where resistance is a problem Co-amoxiclav is an alternative. The respiratory quinolones or new generation macrolides should be restricted to penicillin allergic patients. Failure to respond within 72 hours requires a second line antibiotic or referral for aspiration and culture. Patients with high fever and facial erythema are at increased risk of having infection with S. aureus and should be considered candidates for intravenous antibiotics.11

Bronchitis In uncomplicated bronchitis antibiotics are not indicated regardless of cough duration. Abnormal vital signs (fever>380C, tachypnoea >24 breaths/minute, tachycardia >100 beats/minute) or unilateral auscultatory abnormalities are suggestive

Dr AD Black FCP(SA), Cert Pulm(SA)WitsReproductiveHealthandHIVInstitute.UniversityoftheWitwatersrand,Johannesburg

Treatment of the Common Cold (Acute Respiratory Tract Infections)

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of a pneumonia and should be treated as per the South African community acquired pneumonia guidelines (available at www.pulmonology.co.za).7

GPs are more likely to prescribe an inappropriate and unnecessary antibiotic if they believe their patient expects one. Approximately 30-70% of patients with an ARTI expect an antibiotic and GPs often prescribe to maintain client satisfaction rather than practicing good medicine.12 While a patient’s expectation of an antibiotic may influence their satisfaction around their management, it is well established that taking the time to educate, reassure and advise clients with regards symptom relief for ARTI produces a high degree of patient satisfaction despite delaying or withholding an antibiotic.8,12

While self-limiting, the symtoms of ARTI can be debilitating. Numerous over the counter products are available and all claim amazing results. It is recommended that GPs be aware of the common cold remedies and advise clients to use those with known benefit and few adverse effects for symptom relief.

The agent recommended is dependent on the symptom being targeted.

Sore throat and fever Both paracetamol and NSAIDs are effective, however as several respiratory symptoms such as rhinorrhea and congestion may be linked to inflammatory responses secondary to viral infection a NSAID such as ibuprofen is the agent of choice.6 Lozenges with anaesthetic properties are also of value.

Rhinorrhea and sneezing +/- cough First generation antihistamines may be effective, their sedating properties make them useful agents in clients experiencing disturbed sleep from their symptoms.6

Nasal congestion Pseudoephedrine is an effective oral decongestant however it is now a schedule 6 drug due to it being used for the synthesis of methamphetamine. It is however useful in clients with significant nasal congestion. Topical decongestants such as Xylometazoline should not be used for more than 3 consecutive days.6

Cough Dextromethorphan shows some benefit in cough reduction and guaifenesin may relieve the physical symptoms of chest discomfort. Honey has been shown to offer cough relief in children.6

Agents that are of no or doubtful benefit are Vitamin D, Vitamin C, Zinc, Echinacea and “Chinese herbal medicine” and their use should not be encouraged.11

Cough hygiene and frequent hand washing should be encouraged to decrease the spread of respiratory viruses.

In conclusion ARTI are of viral aetiology, are self-limiting with minimal complications and they should be managed symptomatically and without antibiotics.

References1. Hart AM, Pepper GA, Gonzales R. Balancing acts: Deciding for

or against antibiotics in acute respiratory infections. J Fam Pract 2006; 55(4):320-325.

2. Lemiengre MB, van Driel ML, Merenstein D, Young J, De Sutter AIM. Antibiotics for clinically diagnosed acute rhinosinusitis in adults. Cochrane Database of Systematic Reviews 2012, Issue 10. Art.No.: CD006089.DOI.10.1002/14651858.CD006089.pub4.

3. Zoorob R, Sidani MA, Fremount RD, Kihlberg C. Antibiotic Use in Acute Upper Respiratory Tract Infections. Am Fam Physician. 2012;86(9):817-822.

4. Roberts RM, Hicks LA. Appropriate Antibiotic Use: Family Physicians Have the Power of the Pen. Am Fam Physician. 2012;86(9):810

5. Ladd E. The Use of Antibiotics for Viral Upper Respiratory Tract Infections: An Analysis of Nurse Practitioner and Physician Prescribing Practices in Ambulatory Care, 1997-2001. Journal of the American Academy of Nurse Practitioners. 2005;17(10):416-424.

6. Allen PJ, Simenson S. Management of Common Cold Symptoms With Over-the Counter Medications: Clearing the Confusion. Postgrad Med. 2013;125(1):73-79.

7. Gonzales R, Bartlett JG, Bresser RE, et al. Principles of appropriate antibiotic use for treatment of acute respiratory tract infections in adults: background, specific aims, and methods. Ann Intern Med. 2001;134(6):479-486)

8. Spurling GKP, Del Mar CB, Dooley L, Foxlee R, Farley R. Delayed antibiotics for respiratory infections. Cochrane Database of Systematic Reviews 2013, Issue 4. Art. No.: CD004417. DOI: 10. 1002/14651858. CD004417.pub4.

9. Arroll B, Kenealy T. Antibiotics for the common cold and acute purulent rhinitis. Cochrane Database of Systematic Reviews 2010. DOI:10.1002/14651858.CD000247.pub2.

10. Smith SM, Fahey T, Smucny J, Becker LA. Antibiotics for acute bronchitis. Cochrane Database of Systematic Reviews. 2009. DOI:10.1002/14651858.CD000245.pub2.

11. Hart AM. An Evidence-Based Approach to the Diagnosis and Management of Acute Respiratory Infections. J Nurse Pract. 2007;3(9):607-611.

12. Tomii K, Matsumura Y, Maeda K, et al. Minimal Use of Antibiotics for Acute Respiratory Tract Infections: Validity and Patient Satisfaction. Intern Med. 2007;46(6):267-272.

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In general practice, almost all suspected bacterial infections are treated with empiric antibiotics. Microbiological results only become available between 24 and 72 hours, and clinical samples for culture and sensitivity testing are infrequently submitted for

uncomplicated community acquired infections.

In deciding which empiric antibiotic to prescribe, there are a number of factors for the practitioner to consider, which would include the following:

1. The site of the suspected infection.2. What are the most likely pathogens? Is it a bacterial

infection, requiring antibiotics, or could it be viral?3. What are the predicted susceptibility patterns of the most

likely bacterial pathogens?4. Severity of illness, co-morbidities of the patient.5. History of antibiotic use, especially in the past 3 months.6. Safety, including patient allergy and possible antibiotic

side effects.

Bacterial resistance to antibiotics in community-acquired respiratory tract infections is increasing world-wide, and predicting susceptibility in this era has become a challenge.1 Data from local microbiologic resistance surveillance programmes may help general practitioners in establishing appropriate empiric antibiotic therapy, as well as in the establishment of national guidelines.

The only surveillance data that is made available on a regular basis in South Africa is the data from the South African Society for Clinical Microbiology (SASCM).

Results for both the private as well as public sector are released bi-annually, and published on the website for the Federation of Infectious Diseases Societies of Southern Africa (FIDSSA).2 Any medical practitioner with an interest may join for a minimal annual fee, and membership benefits include access to the SASCM data.

The rest of the article will focus on the latest published surveillance data of 2010 for respiratory pathogens3 and understanding the limitations of laboratory surveillance data so as to make clinically useful decisions from it.

National surveillance of private sector respiratory tract pathogens for 2010The SASCM data is compiled from data submitted by four private sector laboratory groups. The methodology and details about susceptibility testing is published elsewhere.3 H. influenzae was the most commonly reported respiratory pathogen (n=9341), although the data for H. influenzae included both upper and lower respiratory tract specimens, while only the data from lower respiratory tract samples was included for S. pneumoniae. Beta-lactamase production in H. influenzae was 12.2% (range 9.5 – 15.5%) (see table I).

In reporting susceptibility data for S pneumoniae, the minimum inhibitory concentration (MIC) for isolates is used. MIC’s can be interpreted according to the site of infection, and the interpretive breakpoints include categories for parenteral, oral as well as meningeal breakpoints.

When oral penicillin breakpoints are applied, on average 68% (3,189/4,690) (range 33 – 73%) were fully susceptible, with MIC’s of ≤ 0.06 µg/ml (see table II). The majority of strains with an MIC of ≤ 2 µg/ml will be empirically covered by using the recommended higher doses of amoxicillin, amoxicillin-clavulanate or cephalosporins such as cefuroxime.4,5

Macrolide resistance for S. pneumoniae overall was recorded as 39.43% (1,847/4,690) (range 18 – 46%). Although the laboratories test susceptibility to erythromycin, the results can be interpolated to the newer macrolide and azalide antibiotics, such as clarithromycin and azithromycin, as the resistance mechanisms result in cross resistance among the whole class. All strains were fully susceptible to the ketolide telithromycin. Resistance to the respiratory fluoroquinolones, levofloxacin and moxifloxacin, were rare.

Dr Jennifer CoetzeeMicrobiologistNational Reference Laboratory, Ampath, Pretoria

Infectious disease update: Surveillance, assessment of resistance

Table I: Antibiotic susceptibility of Haemophilus influenzae from respiratory tract specimens (January – December 2010)Laboratories(total=14)

Jhb(3)

Pta(3)

Dbn(2)

CT(2)

PE(1)

EL(1)

Bfn(2)

Isolates(total=9,341) 2,729 2,949 937 1,853 340 45 488

Β-lactamaseproduction(%)(total=12.2%) 11.5 9.5 9.5 13.0 15.5 15.5 10.7

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Interpretation of susceptibility dataIn order to have a better understanding of how this susceptibility data translates into clinical practice, it is vital to understand the limitations of it.

1. Passive surveillanceThe SASCM data that is reported depends on samples submitted by clinicians. Most of the infections in the outpatient, general practice setting, are treated empirically without any specimens submitted for microbiological investigation. Samples are usually only submitted from patients who presents with treatment failure, or who have been on antibiotics recently. This might potentially select for more resistant organisms, and might not represent a true reflection of the susceptibility patterns in the community.

2. Laboratory based surveillanceThe SASCM data is laboratory based, without any clinical information other than the site of the infection taken into account. The data does not distinguish between hospital or community acquired infections, colonisation versus infection, or provide any correlation between susceptibility data and clinical outcome.

ConclusionDespite the limitations of the SASCM data, local surveillance data does provide potentially useful information to help clinicians in choosing empiric antibiotics when treating bacterial respiratory infections. For treatment of pneumococcal infections, high doses penicillin or amoxicillin will still be effective. In prescribing empiric antibiotic therapy though a beta-lactamase inhibitor, such as amoxicillin-clavulanate, or an oral cephalosporin should be considered in view of the rate of beta-lactamase production in H. influenzae. Macrolides and azalides should be used with caution, considering the high rates of resistance in private practice in South Africa.

References1. Felmingham D et al. Surveillance of resistance in bacteria causing

community-acquired respiratory tract infections. Clin Microbiol Infect 2002; 8(Suppl. 2):12-42

2. www.fidssa.co.za3. Zietsman IL et al. National surveillance of private sector respiratory tract

pathogens in South Africa, 2010. South Afr J Epidemiol Infect 2011; 26(2):51-53

4. Brink A, et al. Working Group of Infectious Diseases of Southern Africa. Updated guideline for the management of upper respiratory tract infections in South Africa: 2008. SouthAfr J Epidemiol Infect 2009; 24(1): 25 -36

5. Feldman C, et al. Working group of the South African Thoracic Society. Management of community-acquired pneumonia in adults. South Afr J Epidemiol infect 2008; 23(2): 31-34, 36 – 38, 40-42

Table II: Antibiotic susceptibility of Streptococcus pneumoniae from lower respiratory tract specimens (January – December 2010)Laboratories(total=14)

Jhb(3)

Pta(3)

Dbn(2)

CT(2)

PE(1)

EL(1)

Bfn(2)

Isolates (total=3,201) 931 1,842 278 1,346 109 17 167

aPenicillin

≤0.06µg/ml - 40.2% 33.0% 72.7% - 60.0% 71.0% -0.12-2µg/ml - 59.2% 67.0% 26.6% 100% 40.0% 29.0% 99.4%>2-4µg/ml - 0.6% 0 0.7% 0 0 0 0.6%>4-8µg/ml - 0 0 0 0 0 0 0

Telithromycin 100% 100% 100% 100% 100% 100% 100% 100%Erythromycin 60.6% 55.0% 54.0% 59.0% 61.0% 56.0% 82.0% 58.0%

bThird-generation cephalosporins

≤1µg/ml 98.7% 99.0% 96.7% 100% 99.0% 98.0% 100% 98.5%>1-2µg/ml 1.2% 1.0% 3.0% 0 1.0% 2.0% 0 1.5%≥4µg/ml 0.1% 0 0.3% 0 0 0 0 0

Quinolones Levofloxacin 99.27% 99.9% 100% 95.0% 100% 100% 100% 100%Moxifloxacin 99.98% 99.9% 100% 100% 100% 100% 100% 100%

aPenicillinMICbreakpoints(oral,µg/ml):sensitivity≤0.06,intermediateresistance0.12-1,high-levelresistance≥2PenicillinMICbreakpoints(parenteralnon-meningitis,µg/ml):sensitivity≤2,intermediateresistance8,high-levelresistance≥8

bParenteralthird-generationcephalosporins(non-meningitis,µg/ml):sensitivity≤1,intermediateresistance2,high-levelresistance≥4)

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frica has seen marked increases in the prevalence of both paediatric asthma as well as the prevalence of severe asthma over the last 15 years. This, coupled with on-going suboptimal access to controller therapy and poor access to

care means that asthma morbidity and mortality remains unacceptably high.1-3

Acute asthma therefore remains an important challenge not only for paediatricians but for all emergency room staff.The role of the ER in the management of acute asthma is as follows:• Assess the severity of the episode.• Institute appropriate therapeutic interventions.• Perform relevant investigations.• Assess the response to therapy. • Arrange definitive management i.e. discharge/admit for

ongoing therapy or escalate to a High Care/PICU.

AssessmentAscertaining the severity of the illness and any high risk factors are the first priority. All hypoxic children must be admitted for observation.

Clinical review: A rapid assessment of whether the child requires resuscitation (i.e. urgent lifesaving measures) is required before you may proceed.

Screen for high risk patients4-6

• Previous near-fatal asthma• Previous admission to a PICU for asthma• Admission for asthma in the last year• Excessive use of/or overdependence on ß2 agonists• Current use or recent use of oral corticosteroids

• Repeated attendances at an Emergency Unit for asthma treatment (especially if in the last year)

• ‘Brittle’ asthma (sudden onset of acute severe asthma attacks)

• Poor adherence to medication*• Psychosocial and/or family problems*

* This history may not always be forthcoming on first presentation/enquiry. Always ask again.

First Line therapyAll the first line therapies discussed here are supported by very strong evidence.4-6

• Oxygen: Oxygen can be given via nasal prongs provided that saturation can be normalised.

• Corticosteroids: Early administration of systemic corticosteroids is central to the treatment of the acute exacerbation. Airway oedema responds poorly to bronchodilator therapy, and steroids have an onset of action of up to 6 hours. Corticosteroids have been shown to decrease mortality, relapses, hospital admission and bronchodilator use.

Oral steroids are standard, with intravenous steroids reserved for the child who is vomiting/unable to swallow or life threatening asthma.

• Inhaled B2 agonists: High dose SAB2 agonists via a metered dose inhaler is the treatment of choice for mild to moderate exacerbations (2 -10 puffs).

MDI use has been validated in acute exacerbations , is cost effective and may have less side effects than nebulised bronchodilator therapy.

Hypoxia is a concern in more serious exacerbations and the bronchodilator is then given via nebuliser with humidified oxygen. The most commonly used agents in South Africa are salbutamol and fenoterol.

• Ipratropium bromide is an anticholinergic agent that produces bronchodilatation within 20 - 30 minutes. Ipratropium has a synergistic effect when added to SAB2 agonists and it is a useful adjunct when there has been a poor response to SAB2 alone or if the symptoms are severe.

Dr Shirani Naidoo FCPaeds(SA) DipAllerg(SA)Ambulatory and Emergency PaediatricsRed Cross War Memorial Children’s Hospital, Cape Town

Acute asthma in childhood within the Emergency Room

“A B C”

A. Airway: assessvocalisation/chestandabdominal movement

B. Breathing: Respiratory rate, accessory muscleuse,flaring,gruntingandtrachealtugRecord oxygen saturation in room air

C. Circulation: Heart rate, pulse volume, capillary refilltime,skintemperature

Any child with severe or life-threatening asthma or oxygen saturation of less than 92% needs high flow oxygen via a mask with a reservoir during the primary review

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Volume 2 No 2 July 2013 11

Second Line therapy

Table 1 (adapted from ref. 4)Clinical features Measurements

Life-threatening asthma

Silent chest SpO2<92%

Cyanosis PEF<33%best/predictedorunabletoperform due to dyspnoea

Poor respiratory effortHypotensionExhaustionConfusion or drowsinessBradycardia – a pre-terminal event

Severe asthma exacerbation

Tachycardiaheartrate>160beats/minif<1year>140beats/minif1-5years>130beats/mininchildren>5years

Tachypnoearespiratoryrate>50breaths/minif<1year>40breaths/minif1-5years>30breaths/mininchildren>5years

Accessory muscle use during expiration SpO2<92%

Unable to complete sentences in one breath, too breathless to talk or feed

PEFR33-50%bestorpredictedorunableto perform PEFR measurements due to fatigue

Moderate asthma exacerbation

Able to talk in sentences SpO2≥92%Pulse rate within normal limits PEFR≥50%bestorpredictedRespiratory rate within normal limits

poor response

correct diagnosis?

correct drug/dose/

route

co-morbid or exacerbating

factors?

escalate therapy

Examine the child thoroughly and take an adequate history before escalating therapy. Confirm asthma and exclude any co-morbid diseases that may be impeding your treatment e.g. pneumonia, pneumothorax requiring decompression etc.

Also check that all the first line agents have been given appropriately - especially that sufficient SAB2 agents have been used. Second line agents for paediatric asthma all have a higher side effect profiles and lower categories of evidence for their use than the first line agents.4,5

• Salbutamol: low dose IV salbutamol may reduce the length of the exacerbation and shorten hospital admission when added to standard therapy in the early management of acute severe asthma in the ER. Continuous intravenous infusion should be considered for severe refractory asthma. This will require admission to a PICU for adequate monitoring.

• Magnesium Sulphate: IV Magnesium sulphate has been shown to be safe and effective in children with acute severe asthma who have had a poor response to initial therapy. Magnesium sulphate is best used in patients who present with very severe illness.

• Aminophylline: The use of aminophylline is complicated by its side effect profile which includes a narrow therapeutic index and potentially severe side-effects e.g. cardiac arrhythmias or convulsions. It should therefore be reserved for PICU use with life threatening asthma

• Adrenaline: the use of adrenaline in asthma has been superseded by the inhaled SAB2 agents but it may useful in the emergency situation where inhaled therapy is not available or possible. It remains the agent of choice for anaphylaxis which can also present with wheeze and dyspnoea.

• Inhaled steroids, long acting B2 agonists, leukotriene receptor antagonists and heliox all lack sufficient evidence to support their regular use in acute paediatric asthma.

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Volume 2 No 2 July 201312

Difficult clinical scenarios1. Acute asthma in the child under 2

These children can be very difficult to manage. The differential diagnosis is wide and includes a number of “asthma mimics” that require specific diagnostic and treatment pathways. First line agents can be given be given as with older children, according to the acuity of the episode. A MDI must used with an appropriately sized mask and spacer. Oral SAB2 solutions are not indicated in acute asthma.

Objective measures of episode severity must be adapted for this age group.• severe acute asthma : SpO2 <92%, marked recession,

accessory muscle use or tachypnoea and inability to feed because of shortness of breath.

• life-threatening acute asthma: Poor respiratory effort, apnoea or bradycardia

2. The child requiring PICU admissionAny child with acute severe asthma who has not responding to maximal inhaled therapy and systemic steroids, or who has features of life-threatening asthma not responding to initial therapy, should be admitted to a PICU (see table 2).

ConclusionGood management of acute paediatric asthma in the emergency room requires rapid assessment of the severity of the exacerbation and maximal use of first line agents. A good history and examination should alert one to high risk patients who may require second line agents or referral to a PICU. In that category of more severely ill patients, the literature supports the use of second line agents in the ER as long as they can be adequately monitored. A child with a poor response must however be referred on to a PICU for definitive management.

Despite the many challenges in dealing with asthma in South Africa, we have seen positive developments with the release of comprehensive, evidence based management guidelines that address all facets of paediatric asthma.5,7 The onus

is upon us as clinicians to reflect on these guidelines and implement them in our units.

References1. Zar HJ, Levin ME. Challenges in treating paediatric asthma in

developing countries. Paediatr Drugs 2012 Dec 1;14(6):353-359.

2. Pearce N, Ait-Khaled N, Beasley R, Mallol J, Keil U, Mitchell E, et al. Worldwide trends in the prevalence of asthma symptoms: phase III of the International Study of Asthma and Allergies in Childhood (ISAAC). Thorax 2007 Sep;62(9):758-766.

3. Lai CK, Beasley R, Crane J, Foliaki S, Shah J, Weiland S, et al. Global variation in the prevalence and severity of asthma symptoms: phase three of the International Study of Asthma and Allergies in Childhood (ISAAC). Thorax 2009 Jun;64(6):476-483.

4. Kling, Sharon Goussard, Pierre Gie, Robert P. Treatment of acute asthma in children: review article. Current Allergy & Clinical Immunology 2011 Mar;24(1):22-26.

5. Kling S, Zar HJ, Levin ME, Green RJ, Jeena PM, Risenga SM, et al. Guideline for the management of acute asthma in children: 2013 update. S Afr Med J 2013 Feb 5;103(3):199-207.

6. British Thoracic Society/Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. A national clinical guideline. 2012; Accessed March 20, 2013.

7. Motala C, Green RJ, Manjra AI, et al. Guideline for the management of chronic asthma in children - 2009 update: guideline. South African medical journal 2009 Dec;99(12):196-912.

Table 2: PICU Admission5

• Poor response to maximal pharmacological therapy inward/emergencyroom

• Severe retraction• Minimal chest movement, ‘silent’ chest• Deteriorating mental status, lethargy or agitation• PEFR<30%predictedorbest• Cyanosis and hypoxaemia (PaO2 <8kPa , SpO2

<90%)unrelievedbyO2• PaCO2>4.5kPa• Cardiorespiratory arrest

Table 3: Drug dosage reference table5

Nebulised SAB2 agents

2.5-5mgsalbutamolor0.5-1mgfenoteroladdedtosalinetomakenebuliservolumeupto4ml.

Prednisone or prednisolone

1-2mg/kgorally(recommendeddose20mgforchildrenaged2-5yearsand30-40mgforchildren>5years)

Methylprednisolone 2mg/kg8-hourlyIVDexamethasone 0.6mg/kgIVdaily

Ipratropium bromide IB0.25mgaddedtoβ2-agonist+saline;nebuliseevery20-30minutesx3doses,then 4-6 hourly

Salbutamol load 15μg/kgin10mlsalineover10minutes

Salbutamol infusion load5-10μg/kg/minof1mg/mlsolutionat0.3-0.6ml/kg/hfor1hour,thensalbutamolinfusion1-5μg/kg/minofa1mg/mlsolutionat0.06-0.3ml/kg/h

Magnesium sulphate (single dose)

IVmagnesiumsulphate50%solution(2mmol/ml)0.1ml/kg(50mg/kg)(maximum2g)in20mlsalineover20minutes

Aminophylline 5mg/kgover20minutes,theninfuseat0.5-1mg/kg/h

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Volume 2 No 2 July 2013 13

In August 2011, the long-awaited Green Paper on National Health Insurance (NHI) was published for public comment. The policy document spells out the government’s approach to the transformation of South Africa’s healthcare system through the adoption of a

National Health Insurance Model over a period of 15 years.

Most commentators regarded the document as disappointing as it failed in its most basic requirements: to define National Health Insurance, describe measurable objectives or provide detail on how the model would be financed. Numerous submissions were filed in response to the Green Paper and, as yet, the White Paper (essentially the second draft of the document after taking submissions into account) has not been released. The planned schedule for the introduction of the NHI therefore seems extremely optimistic as it assumed the commencement of the NHI legislative process by January 2012 already, i.e. the introduction of a draft Bill to Parliament after comments had been received on the White Paper.

Aim of NHIThe NHI model aims to ensure that all citizens of South Africa (and legal permanent residents) have access to a defined comprehensive package of healthcare services, regardless of their employment status and ability to contribute to the NHI Fund. The NHI Fund, established as a publicly administered government-owned entity reporting to the Minister of Health and Parliament, will procure the defined healthcare services from accredited providers in the private and public sector. According to the Minister of Health, 2 pre-conditions exist for a successful NHI: first, a complete overhaul of the public healthcare system, and secondly, the establishment of a pricing commission to regulate prices in the private healthcare industry. Both pre-conditions have been met with a lot of criticism and has led to intense debate on particularly the issue of how NHI will be funded.

Who is required to join the NHI?Membership to the NHI will be mandatory for all South African citizens. Members of medical schemes may however continue with voluntary medical scheme membership if they choose to

do so. In other words, while participation in the NHI will be a matter of choice, the payment of a contribution to the NHI will be mandatory for all citizens and legal permanent residents who earn above a certain income.

What healthcare services will be funded by NHI?In the early years of NHI, the defined package of comprehensive health services will focus primarily on a Primary Healthcare (PHC) approach, with a strong focus on health promotion and preventative care. Quality curative and rehabilitative services appropriate to this level of care will also be rendered at a secondary, tertiary and quaternary level. The NHI service package will be delivered via a District Health System (DHS) according to three main streams, namely: district-based clinical specialist support teams, school-based PHC services

and municipal ward-based PHC agents. In addition, PHC services will be delivered through contracted private practitioners practicing within a particular district. In time, other benefits will be added based on specific clinical, health and economic evaluations.

Human resource strategyIn October 2011 the Department of Health launched a human resource strategy to increase the number of healthcare workers. The 8 medical schools were requested to increase their student intakes by 40 students a year and more than 100 medical students would be sent to Cuba for training annually. In addition, the department recruited 95 medical specialists from Cuba to start working in South Africa in 2013.

‘Roll out’ of NHIIn March 2012 the Minister of Health published draft regulations on the reclassification of hospitals

into district, regional, tertiary, central and specialist hospitals, as well as services to be provided at each level. At the same time he announced that 11 sites had been identified for the ‘roll out’ of a NHI pilot project with effect from 1 April 2012. The sites were chosen according to the vulnerability of their communities and would therefore focus on the strengthening of the healthcare system and improving the service delivery platform. Funding for the pilot phase will be via a conditional grant from the Treasury whereafter additional districts will be

Ulundi Behrtel BLC.LLB (UP)Senior Associate, Elsabé Klinck ConsultingPretoria

A National Health Insurance for South Africa

To date, the much awaited Discussion Paper on the

funding of NHI (due mid-2012) has still not been

published. Government however has indicated

that the document will be released during the second

half of 2013.

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Volume 2 No 2 July 201314

rolled out on an annual basis provided conditions for inclusion are compiled with.

The pilot phase would also serve to assess whether the health service package, the PHC teams and a strengthened referral system will improve access to healthcare services, test the ability of districts to assume greater responsibilities associated with the purchaser-provider split required under NHI, and assess the feasibility, acceptability, effectiveness and affordable ways of engaging private sector resources for public purpose. Although more than a year has passed since the ‘roll out’ of the pilot project began the involvement of the private sector remains as challenging as before. The main question being: how will private practitioners be remunerated?

How will healthcare service providers be remunerated in terms of NHI?The policy document proposes a reimbursement system for healthcare service providers based on a risk-adjusted capitation system linked to performance management. While this approach may be appropriate for the public sector it poses a significant challenge to the financial survival of the private practitioner, especially in an environment where pricing in the private healthcare sector will be regulated. The Department of Health therefore recently stated that although the payment methods for private doctors employed at NHI pilot sites had not been finalised it would differ from current systems and use a combination of “fee for service” (the current method of payment if the private sector) and “capitation” (a fixed rate based on the potential number of patients a doctor sees).

How much will the NHI cost and how will it be funded?The government intends implementing the NHI model gradually until 2025 and estimates the cost at R125 billion in 2012, increasing to R214 billion in 2020 and R255 billion in 2025 (figures expressed in real 2010 financial terms). The policy document makes the point that the estimated cost of NHI should be placed within the context of current total healthcare spend estimated at R227 billion in 2010 (which figure includes medical aid contributions estimated at R92 billion in 2010) or 8.5% of GDP.

The Green Paper also assumes that the increased spending on NHI will be partially offset by the likely decline in spending on medical schemes (as all South Africans will be entitled to access NHI services). While the policy paper acknowledges that the NHI will require an increase in spending on healthcare from public resources that is faster than projected GDP increases, it makes the point that the ultimate estimated level of spending on NHI relative to GDP (of 6.2%) is less than current government spending and medical scheme contributions combined (of 8.5%).

As mentioned in the introduction of this article, the Green Paper is vague in the detail regarding the funding of NHI. It

emphasises that funding will come from a combination of sources including the Fiscus (through the increase in VAT), employers (through the introduction of a payroll tax) and individuals (a dedicated personal tax). In his budget speech this year, the Minister of Finance added that using money from medical schemes is also being considered as a possible resource. He stressed that the subject is a matter of continuing technical work with further clarity to be provided at a later stage. To date, the much awaited Discussion Paper on the funding of NHI (due to have been released by National Treasury in mid-2012) has still not been published. Government has however indicated that the document will be released during the second half of 2013.

What is the role of medical schemes in the NHI model?Although lacking in specifics, an encouraging aspect of the NHI Green Paper is the provision made for the continued exis-tence of medical schemes while acknowledging that the exact form of services offered by medical schemes may evolve into

a fully-fledged NHI system. The existing ex-pertise in the area of private healthcare ad-ministration and management of insurance funds is also seen as relevant to the devel-opment of adequate in-house capacity.

Summary of events in pilot phase to dateSince the ‘roll out’ of the pilot phase of NHI 47% of the district clinical specialist team members have started training, focussing on better healthcare for mothers, newborns and children. In addition, an integrated school health programme has been launched to provide primary and reproductive health services to schools.

The National Health Amendment Act was passed by Parliament and the Office for Health Standards Compliance was established to inspect and accredit health facilities. Almost 200 public health facilities have been inspected to date with re-inspection of facilities needing correction scheduled for 2013. The Department of Health has launched an Academy for Leadership and Management in Healthcare, focussing on training programmes for senior managers and hospital executives in the public sector.

The next stepsThe purpose of the Green Paper is to outline the broad policy proposals for the implementation of the NHI. After the consultation process, a White paper will be finalised and thereafter draft legislation will be developed and published for further public engagement, before the legislation is finalised and submitted to Parliament for consideration and approval. In April 2013, the Minister announced that he had received the proposed White Paper and would be studying it for urgent release. In the meantime, the Discussion Paper on funding of NHI is awaited from National Treasury.

The existing expertise in the area of

private healthcare administration and

management of insurance funds is

also seen as relevant to the development

of adequate in-house capacity.