Clinical Pharmacy News summary

Pharmacists were identified as vital in reducing adverse events caused by medication errors by the Department of Health this week...[more]

Home chemotherapy for patients with colorectal cancer is a safe and acceptable alternative to hospital outpatient treatment, according to Spanish researchers...[more]

Five cases of patients with enterococcus infection resistant to the new antibiotic linezolid have been reported in the United States...[more]

Giving probiotics to expectant mothers and neonates could reduce the incidence of allergy, according to researchers from Finland...[more]

Pharmacists should be alert to the possibility of meningococcal infection among customers returning from this year's Haj pilgrimage to Saudi Arabia, and among those who might have been in contact with them...[more]

Asthma might increase the risk of heart disease, according to research presented recently at the American Heart Association's 41st annual conference on cardiovascular disease epidemiology and prevention...[more]

Primary immunisation of infants might provide some protection against sudden infant death syndrome (SIDS), contrary to popular belief, study results have revealed...[more]

The results of a new study indicate that influenza vaccination is safe for most patients with multiple sclerosis (MS)...[more]

Women who have used oral contraceptives containing an oestrogen recently could be up to 20 per cent less likely to develop bowel cancer, say researchers...[more]

Dietary advice tips: (13) Poor appetite...[more]

Pharmacists vital in preventing intrathecal medication errors

Pharmacists were identified as vital in reducing adverse events caused by medication errors by the Department of Health this week. “Pharmacists have done a lot of work with respect to drug safety and have taken the initiative in this area,” Professor Liam Donaldson, Chief Medical Officer, Department of Health, said.

Professor Donaldson was speaking on April 18 at a press briefing, where the findings of two reports into the problems of intrathecal medication errors were presented.

The reports follow the death in February of a patient at the Queen's Medical Centre in Nottingham after being given vincristine via the intrathecal rather than intravenous route.

The reports, presented by their authors, Professor Brian Toft, a leading authority on risk management, and Professor Kent Woods, director of the National Health Service Health Technology Assessment Programme, make recommendations to the Department of Health on the strategies that must be introduced to reduce to zero the number of patients dying or being paralysed by maladministered spinal injection.

Professor Toft's report highlights systems failure as the cause of the patient's death. “The evidence presented, strongly suggests that the adverse incident was caused by more than one failure,” he said. Professor Woods identified recurring themes in the reasons why intrathecal medication errors occur. “There was a recurring observation that the people concerned were not fully aware of the potential hazards of intrathecal vincristine delivery.”

He added that an important safety strategy was to separate out the administration of intrathecal and intravenous therapy. His report highlights procedures, warnings and prompts that have been introduced by pharmacists to prevent intrathecal medication errors.

These include hazard warnings on outer packs of vinca alkaloids, reminding clinicians that it is for intravenous use only. Professor Woods commented that pharmacists were reluctant to specify the dangers of using the intrathecal route on the label, since the appearance of that word might cause confusion by association. “Pharmacists are right in this,” he said.

A specific recommendation made by Professor Woods was that vinca alkaloids should always be prepared in an infusion bag in the pharmacy and not in a syringe. This would prevent the chemotherapy, which was intended for intravenous administration, being delivered via the intrathecal route and would “act as a design barrier,” he said.

He added that the recommendation was not an instant fix and would need to be piloted to ensure that there were no problems associated with drug stability or technical issues.

Commenting on the reports, Professor Donaldson said: “These two reports point the way forward in preventing a rare but catastrophic medical error which has repeated itself for nearly 20 years. The NHS will now work to implement their recommendations at national and local level.”

Asked whether he thought that pharmacists were under-used with respect to risk management, Professor Donaldson said: “There is a big role for pharmacists with respect to the reduction of adverse events due to medication errors.”

He added that, in the light of these reports, and of the report entitled “Building a safer NHS for patients” launched earlier this week (see p527) the pharmacists' role could be expanded considerably.

The reports can be obtained free from the Department of Health, PO Box 777, London SE1 6XH. They are also available on the Department's website.

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Home chemotherapy improves compliance

Home chemotherapy for patients with colorectal cancer is a safe and acceptable alternative to hospital outpatient treatment, according to Spanish researchers.

In a study comparing home treatment with hospital outpatient treatment, Dr Josep Borras and colleagues (Catalan Institute of Oncology) found that home chemotherapy improved compliance as well as the patient's satisfaction with treatment. They say that home chemotherapy was not associated with any major complications and did not increase the use of other health services.

The researchers randomly assigned 87 patients with colorectal cancer, for whom treatment with fluorouracil-based bolus chemotherapy was suitable, to receive chemotherapy either at the outpatient clinic or at home. A trained nurse delivered the home chemotherapy.

The researchers found that treatment-related toxicity was similar in the two groups but that voluntary withdrawals from chemotherapy were significantly higher in the outpatient treatment group (6 compared with 1).

There were no differences in the patients' initial satisfaction with either treatment as assessed by a questionnaire. However, after completion of treatment the researchers found that the outpatients considered that they had to wait longer to receive chemotherapy than patients treated at home.

The researchers comment that the results of the study might not apply to newer or more complicated chemotherapy regimens. However, they conclude that home chemotherapy could be advantageous for patients by increasing satisfaction and compliance with treatment (BMJ 2001;322:826).

In an accompanying leading article, A. M. Young, lead nurse, and Professor D. J. Kerr, clinical oncologist, University Hospital Birmingham Trust, say that in the United Kingdom, home chemotherapy is “chiefly the domain of a few private 'intravenous access' companies”, but that the NHS service is limited to a handful of nurse-led projects.

They comment that this contrasts with the American situation where home intravenous therapy was recently the fastest growing segment of the health care system. “The success of any home service depends on the clarity of communication between the multidisciplinary teams in the hospital and community,” they say (ibid, p809).

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Resistance to linezolid reported

Five cases of patients with enterococcus infection resistant to the new antibiotic linezolid have been reported in the United States. However, a spokeswoman for Pharmacia, the manufacturer, told The Journal on April 18 that there had been no cases of resistance had been documented in the United Kingdom.

Dr Ronald Gonzales of the section of infectious diseases, University of Illinois College of Medicine, and colleagues say that, until now, resistance has occurred rarely.

Linezolid is an oxazolidinone antibiotic used to treat infections caused by vancomycin-resistant enterococci (VRE). In all five cases, which were reported during the last three months of 2000, patients had infections caused by linezolid-resistant, vancomycin-resistant Enterococcus faecium. Four of the patients were transplant recipients, and all five had received long courses of linezolid (21 to 40 days). Three had an initial clinical response to linezolid.

The researchers note that Pharmacia previously reported the emergence of resistance in two out of 169 patients treated with linezolid for VRE infections. Both patients received lengthy courses of the drug and had mutations of 23S rRNA, thought to be the molecular basis for resistance.

Since the five patients were identified, the researchers have tested all isolates for linezolid resistance. They have found the occurrence of linezolid-resistant VRE cases to be one in 45. They conclude: “We encourage clinicians using linezolid for VRE infections to measure susceptibility of all isolates at the start of therapy. Attention to proper dosing and prompt removal of infected devices, when feasible, could limit emergence of resistance.” (Lancet 2001;357:1179.)

Commenting on the study, Pharmacia says that the cases are consistent with conditions that its researchers have already reported to regulatory authorities, and that the resistance detected was limited to a small group of seriously ill patients. There had been few confirmed cases of resistance in more than 60,000 patients who had been treated worldwide with linezolid. The company adds: “It is important to recognise that the report specifically addresses vancomycin-resistant enterococcus. There are no confirmed cases of linezolid resistance to any other bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).”

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Probiotics could prevent development of allergies

Giving probiotics to expectant mothers and neonates could reduce the incidence of allergy, according to researchers from Finland.

Dr Marko Kalliomäki, department of paediatrics, Turku University Hospital, gave either placebo or Lactobacillus rhamnosus (Lactobacillus GG) to mothers for two to four weeks before the expected birth date and to the babies postnatally for six months after birth. Since the development of atopic eczema is the main sign of atopy in the first years of life, this was the primary endpoint.

They found that the occurrence of atopic eczema in the group given Lactobacillus GG was half that in the placebo group (23 per cent versus 46 per cent, respectively), with the number needed to treat being 4.5. “Our insight might provide an opportunity to devise strategies against allergy,” the authors say.

The notion of using probiotics was based on their ability to reverse increased intestinal permeability, enhance gut-specific IgA responses, promote gut barrier function and restore normal gut microflora, they add (The Lancet 2001;357:1076).

In an accompanying leading article, Dr Simon Murch, Centre for Paediatric Gastroenterology, Royal Free and University College School of Medicine, London, says: “These figures are remarkable and, if confirmed in other studies and applicable to other allergic diseases, probiotics would represent an important therapeutic advance.”

He says that the exact mechanisms by which probiotics might have an effect is not clear but may be explained by a “discordance” between the initial flora of infants and that of their mothers. The initial gut flora seen in infants in the developing world (and, according to a paper published in 1885, that of 19th century European children) is predominantly the same as that of their mothers. However, this is often not the case now in developed countries, where hospital-acquired organisms predominate in the infant (ibid, p1057).

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Meningococcal infection alert

Pharmacists should be alert to the possibility of meningococcal infection among customers returning from this year's Haj pilgrimage to Saudi Arabia, and among those who might have been in contact with them. The Public Health Laboratory Service Communicable Diseases Surveillance Centre has received reports of 28 cases of meningococcal infection in the United Kingdom, including seven deaths, following this year's Haj.

In a press release issued by the Department of Health, Dr Pat Troop, deputy chief medical officer, said that some of those affected had attended the Haj but two-thirds of the cases resulted from contacts in the community. She warns general practitioners to be aware of patients presenting with septicaemia, especially a rash and non-specific illness, and says that early treatment may be lifesaving.

The Department of Health issued a warning in February that pilgrims travelling to Saudi Arabia should receive quadrivalent meningococcal vaccine to protect them against the A, C, W135 and Y strains of meningitis (see PJ, February 17, p210).

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Asthma linked with coronary heart disease

Asthma might increase the risk of heart disease, according to research presented recently at the American Heart Association's 41st annual conference on cardiovascular disease epidemiology and prevention.

American researchers found that in approximately 1,000 people, self-reported asthma was associated with a 33 per cent increased risk of developing heart disease, whether or not the patient was being treated for asthma. Individuals receiving treatment for asthma at the start of the study were 82 per cent more likely to develop heart disease.

The researchers suggest that the airway and systemic inflammatory state associated with asthma might contribute to coronary heart disease risk. Inflammation is known to be important in the development of atherosclerosis, they say. However, they plan to look into the possibility that medicines for asthma cause increased risk.

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Immunisation might prevent SIDS

Primary immunisation of infants might provide some protection against sudden infant death syndrome (SIDS), contrary to popular belief, study results have revealed.

Professor Peter Fleming, Institute of Child Health, Royal Hospital for Children, Bristol, and colleagues investigated 456 sudden deaths (explained and unexplained) of infants aged between one week and one year that had occurred in selected areas of England over a three-year period. They compared the primary immunisation status of each of these infants with those of four matched controls.

They found that after major confounding factors had been taken into account, immunisation uptake remained strongly associated with a lower risk of SIDS (odds ratio 0.45). However, this became non-significant when the sleeping environment was taken into account (eg, placing the infant prone or finding the bedclothes over the infant's head).

The researchers say that if immunisation and SIDS were linked “one would expect a higher immunisation uptake among the infants who died than among age-matched, surviving infants, or at least some temporal pattern compatible with a reaction to immunisation. The findings from this study suggest the opposite.”

The immunisations in question were those against Haemophilus influenzae type b, oral poliomyelitis, and diphtheria, tetanus and pertussis. The age at which infants normally receive these corresponds to the age of peak incidence of SIDS and there had been speculation that the two might be related, the authors say (BMJ 2001;322:822).

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Influenza vaccine reported to be safe for most MS patients

The results of a new study indicate that influenza vaccination is safe for most patients with multiple sclerosis (MS).

The study's authors suggest that many MS patients worry that the vaccine will cause a flare-up of symptoms. However, in four months after vaccination, none of the 12 patients with MS involved in the study had any worsening of symptoms or side effects related to the vaccine, they say.

No change in T cells reactive against myelin proteins, regarded as disease-causing factors in MS, was found. In people who developed respiratory infections in the study, an increase in these T cells was seen.

Patients in the study had relapsing-remitting or secondary-progressive forms of the disease. The authors warn that the results might not apply to patients with other forms of MS or high disease activity. The study was published in Neurology on April 10.

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Bowel cancer risk reduced by oral contraceptives

Women who have used oral contraceptives containing an oestrogen recently could be up to 20 per cent less likely to develop bowel cancer, say researchers.

Dr Carlo La Vecchia, from the Institute of Pharmacological Research in Milan, Italy, and colleagues say that over the past 20 years, mortality rates for bowel cancer have dropped more in women than in men and that this might be partly because of the protective effects of oestrogen in oral contraceptives.

“For a while now we have suspected oestrogen in the pill could protect against bowel cancer and our research has gone some way to confirm this,” Dr La Vecchia says.

The researchers analysed the results of 18 international studies that compared the incidence of bowel cancer in women who had taken an oral contraceptive between the mid-1960s and 1980s, with those who had not.

They found that the protective effects of oral contraception were stronger in women who had stopped using oral contraceptives within 10 years of the research period than they were in women who had stopped before this. The researchers believe that oestrogen blocks the growth of cancer cells by reducing bile acids and the levels of insulin-like growth factor-1, both of which have been linked to an increased risk of bowel cancer.

They conclude: “In the future, it might be possible to develop new treatments that take advantage of the anti-cancer qualities of the pill.”

The research is published in the British Journal of Cancer (2001;84:722).

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Dietary advice tips: (13) Poor appetite

During some illnesses (eg, some cancers, chronic obstructive pulmonary disease, Parkinson's disease) and after surgery, the effort of eating a normal meal can be overwhelming. Patients who are ill might have no appetite for “meat and two vegetables”, but they can often manage soup, soft rolls, desserts made with milk, breakfast cereals or small sandwiches. Fried and fatty foods can be particularly unwelcome. Although most dietary problems in the UK result from dietary surplus, poor appetite for prolonged periods can make it difficult to obtain sufficient energy and nutrients. There are a number of dietary measures that can help to improve this situation.

• Eat smaller meals at more frequent intervals. Consuming a small meal, snack or energy-providing drink can substantially increase energy and nutrient intake.
• Encourage the use of foods that are concentrated sources of energy (eg, full-cream milk, custard, milk puddings, eggs, cheese, meat).
• Make ordinary foods more energy- or nutrient-dense (eg, adding milk or cream to soups, butter to vegetables and extra sugar, jam or honey to desserts).
• Increase consumption of energy and nutrient-providing drinks (eg, milk, fruit juice, Build-up, Complan) rather than tea and coffee.
• Drink minimal amounts of fluid with meals so that the stomach is not filled too quickly.
• Have a glass of wine or other aperitif before a meal might help to stimulate the appetite.
• Consume foods that are enjoyed. Although the above suggestions will help to improve nutritional status, there is no point in trying to get people to eat foods that they do not fancy.
• If these measures do not help, the patient might benefit from a ready-to-drink sip feed (eg, Ensure, Fortisip). These products are ACBS-prescribable (Advisory Committe on Borderline Substances). Many are nutritionally complete and can, if necessary, be used as the sole source of nutrition or they can be used to supplement the diet.

This series of “dietary advice tips” is intended to be a reminder of the main points to be made by pharmacists when giving nutritional information to the public. The conditions included in the series are those where diet is a well recognised risk factor, those in which diet contributes to the management of the condition, and others for which patients may welcome sound dietary advice. The series is written by Dr Pamela Mason (a pharmacist with a postgraduate qualification in nutrition).

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