The
Pharmaceutical Journal Vol 266 No 7132 p126-129
A record 20,000 people from 36 countries attended the 35th Midyear Clinical Meeting of the American Society of Health-system Pharmacists in Las Vegas in December, 2000. Laurence Goldberg and Christine Clark report the meeting’s highlights
Osteoporosis in men - an overlooked problem
Safe handling of cytotoxics
Poster sessions
Pharmacy and counter-terrorism
ASHP to recommend isolators
Innovations in Pharmaceutical Care awards
The risk of dying after a hip fracture was considerably greater for elderly
men than for women, said Dr Sheryl Follin (school of pharmacy, University of
Colorado, Denver). Dr Follin explained that 20 per cent of men over the age
of 50 could develop osteoporosis and it had been predicted that, by 2025, there
would be more than 1.1 million hip fractures world-wide among elderly men.
The main risk associated with osteoporosis was fracture of the hip or spine.
Hip fractures had particularly serious consequences, as 50 per cent of victims
would never regain their previous level of function and 40 per cent would require
long-term care. One in three men died within 12 months of such a fracture compared
with one in five women with a similar condition.
The incidence of osteoporosis in men was half that of women, partly because
men had a greater initial bone mineral density (BMD), they had bigger bones
and did not experience a menopause with its accompanying loss of estrogens.
In addition, they had a shorter life expectancy, she added.
Primary osteoporosis could be caused by ageing, or by genetic factors, or it
could be idiopathic. Men over the age of 70 typically had altered metabolic
activity in their bones, had changes in the calcium balance and tended to be
relatively inactive. However, as many as 30 per cent of cases of osteoporosis
were seen among younger men, she noted. Secondary causes of osteoporosis contributed
significantly to the overall picture, with drugs (eg, steroids and antiepileptic
drugs) and lifestyle factors, such as alcoholism, tobacco use and inactivity,
playing major roles. Other important factors were hypogonadism (testosterone
levels below 150ng/ml) and other diseases, for example, hypoparathyroidism.
The single best predictor of fracture risk was BMD, said Dr Follin. Measurements
taken at the hip and spine were useful both for diagnosis and for monitoring
of treatment. Peripheral BMD measurements, made at the wrist, heel, finger and
forearm, were useful for screening but could not be used for other purposes,
as there were insufficient reference data for men at present.
The results were usually presented as a T-score - the number of standard deviations
by which a patient’s score differed from that of a reference population of healthy
young males. For example, a T-score of –2.0 meant that the patient’s BMD was
two standard deviations below the reference value. Osteoporosis had been graded
by the World Health Organisation (see below) using T-scores. Although the definitions
were based on findings in Caucasian women, a T-score of –2.5 or worse appeared
to be a reliable indicator of osteoporosis in men, too, said Dr Follin.
|
WHO grades of osteoporosis Normal: BMD within 1 SD of a “young normal” adult (T-score above
–1) |
Treatment for osteoporosis included lifestyle changes and drug therapy. The
most important lifestyle change was to start regular, weight-bearing exercise.
Dr Follin suggested jogging, climbing stairs or playing tennis. Resistance exercise
using weights or weight machines was also good. However, swimming and cycling
were not useful in this context, as they were not weight-bearing. Patients should
be encouraged to reduce their alcohol intake and to give up smoking. It was
also important to make homes safer, so that falls could be avoided, and to avoid
medicines that caused dizziness or confusion, she said. Calcium supplements
could be given either as tablets or through the diet (1,000-1,200mg/day in divided
doses) to people below the age of 65 and 1,500mg/day, thereafter. Vitamin D
could be given in doses of 400-800IU per day. The older and more ill the patient,
the larger the dose needed, said Dr Follin.
The only drug treatment approved for osteoporosis in men in the United States
was alendronate 10mg/day. (A once-weekly dose had recently been approved for
women.) A recent placebo-controlled trial had shown that alendronate significantly
increased BMD in the spine and at other sites, and had reduced the incidence
of vertebral fractures. However, this study had provided no information on hip
fractures, which were the major problem, pointed out Dr Follin.
Testosterone was only helpful in cases of osteoporosis related to hypogonadism,
and calcitonin had not been studied in men, so far. Another bisphosphonate,
risedronate, had been approved for glucocorticoid- induced osteoporosis in men,
and intravenous pamidronate might have a role, although there were no data concerning
its effectiveness in preventing fractures in either men or women.
Turning to unapproved uses of medicines, Dr Follin said that thiazide diuretics
reduced renal excretion of calcium and might be helpful in some patients. Two
studies of statins had suggested that there was a decreased incidence of hip
fractures among those who took them. It was thought that the mechanism of action
might be similar to that of bisphosphonates and prospective trials were now
under way.
Two possible future treatments were parathyroid hormone and fluoride. Parathyroid
hormone had a net anabolic effect and increased BMD. It was thought to be suitable
for idiopathic osteoporosis. Fluoride had been shown to increase BMD but there
were some concerns about the quality of the bone that was laid down.
When dealing with male patients, Dr Follin recommended that any with T-scores
between –1 and –2.5 should receive lifestyle advice, should be treated with
calcium and vitamin D and should be re-evaluated every two years. Men with T-scores
below –2.5 should receive thorough diagnostic examination and treatment.
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The evidence for reproductive and developmental toxicity from occupational
exposure to cytotoxic drugs among heath care workers was “crystal clear”, according
to Professor MELISSA McDIARMID (professor of medicine, occupational health project,
school of medicine, University of Maryland, Baltimore).
Over the past 20 years, evidence had grown as studies from around the world
had been published. No fewer than 15 studies had reported evidence of reproductive
toxicity among nurses, pharmacists and others exposed to cytotoxic drugs in
the workplace. These included birth defects, spontaneous abortions and both
male and female infertility. Some studies had failed to show significant adverse
effects but this might have been because inappropriate groups were used for
comparison, she suggested. For example, one study had used theatre nurses as
a control group, but they were also routinely exposed to waste anaesthetic gases
that had recognised adverse effects on reproduction.
Many of the drugs used in cancer treatment were capable of causing developmental
problems and genotoxicity - this went hand in hand with their antineoplastic
action.
Cyclophosphamide, for example, was used as a positive control treatment in animal
studies of reproductive toxicity. The evidence for reproductive and developmental
harm in humans had come from patients who were pregnant when they received chemotherapy,
she explained. The risk of carcinogenesis was a long-term phenomenon, whereas
reproductive toxicity was seen much earlier.
Cytotoxic agents were treated as carcinogens by manufacturers with corresponding
precautions but once they became medicines it appeared that a lower standard
was applied, said Professor McDiarmid.
Leakage of cytotoxic drugs during preparation, causing contamination of the
workplace and health care staff, could be reduced by the use of a closed system
for preparation of intravenous doses, said Dr THOMAS CONNOR (University of Texas
school of public health). A six-month, controlled study, using Phaseal (Carmel
Pharma, Sweden) in the pharmacy at the MD Anderson Cancer Centre had shown marked
reductions in contamination in several areas, when compared with standard techniques.
The cytotoxic preparation area in the pharmacy had recently undergone extensive
redesign and refitting, and it was in this setting that the closed system was
tested, he explained. The facility housed six class II, type B3 (vented) biological
safety cabinets (BSCs) and was in use for up to 16 hours per day. Over a six-month
study period, the closed system was routinely used for cyclophosphamide and
ifosphamide preparation; 5-fluorouracil was made in the traditional way to serve
as a control.
Before and during the study, multiple wipe samples were taken from the floor,
tables and transfer windows in the preparation area of two of the BSCs. During
the study, an average of 10g/day of cyclophosphamide, 20g/day of ifosphamide
and 20g/day of 5-fluorouracil were prepared. The results showed that levels
of contamination were low when the closed system was used but climbed steadily
when the traditional method was employed. The investigators also noticed that
when a vial of cyclophosphamide was dropped on the floor, moderately high levels
persisted in that area for several months, although it had been cleaned thoroughly.
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British pharmacists were well represented at the international poster session
at the ASHP meeting.
One of them was Dr Sarah Hiom (research and development pharmacist for Wales,
St Mary’s hospital, Llandough), winner of the Guild of Healthcare Pharmacists/Baxter
award, who presented a poster describing a study of the validation of disinfection
techniques in hospital aseptic units. The study had proved that wiping was a
critical step in the disinfection process during the transfer of ampoules into
a clean area before manipulation. In addition, wiping had been found to be superior
to spraying.
A pilot study was under way that used the recommendations from this study and
could lead to a standard operating procedure for the validation of aseptic disinfection
transfer techniques and for staff training.
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A team of pharmacists from different branches of the healthcare system explained
how pharmacists contributed to counter-terrorism plans and what action they
might take in the event of a real incident.
Dr BARBARA CROUCH (director, Utah Poison Control Centre, college of pharmacy,
University of Utah, Salt Lake City) said a bioterrorist attack might unfold
in the following manner. On day one, two patients might present at a hospital
with flu-like symptoms. On day two, 20 patients with similar symptoms might
be seen in two different hospitals and emergency medical services could receive
numerous calls. By day three, more than 500 people would be absent from work
with a mystery illness. By day four, there would be 450 more cases, the “worried
well” would be clogging the system with requests for information and the possibility
of biological terrorism would have been raised.
Dr Crouch said that in the US, regional poison control centres played a crucial
role in the response to any disaster or major incident. The centres were staffed
by pharmacists, nurses and physicians and had good links with health care professionals
and local, state and federal agencies. The centres were well placed to gather
and disseminate vital information. She acknowledged that it was impossible to
prepare for all hazards but recommended that pharmacists should investigate
available resources and be aware of local disaster plans.
Lieutenant-Colonel JOHN GRABENSTEIN (deputy director, Clinical Operations, Anthrax
Vaccine Immunisation programme, US Army Medical Command) drew attention to some
of the main features of terrorist attacks.
There might be unprecedented numbers of casualties that could overwhelm normal
resources, and there was often direct personal danger to the “first responders”.
In the case of biological attack, it could take several days to recognise a
pattern and identify the causative organism or toxin. Finally, the whole incident
was likely to take place under intense media scrutiny.
Agents used for terrorist attacks could be biological or chemical (see below).
Lt-Col Grabenstein suggested that pharmacy could have a central role in a response
to terrorist attacks because it was a discipline that bridged medicine, logistics
and administration. Pharmacies, he said, could be nodes in a network for distribution
and communication.
|
Potential agents used in terrorist attacks Biological |
The National Pharmaceutical Stockpile (NPS) programme ensured that packages
of pharmaceuticals and medical material were kept at main locations in readiness
for an attack, said Dr SUSAN GORMAN (health scientist, National Pharmaceutical
Stockpile Branch, Centres for Disease Control and Prevention, Department of
Health and Human Services). In her talk, she described how the NPS was geared
for a two-tiered response.
So-called “12-hour push” packages were ready for deployment and could reach
a designated airfield within 12 hours of federal activation. Everything in these
packages was configured for rapid identification and ease of distribution. A
different package, the “vendor-managed inventory package” was designed to be
shipped within 24 to 36 hours. These could be tailored to provide specific materials
depending on the suspected or confirmed agent.
One “12-hour push package” filled one wide-bodied jet aeroplane, said Dr Gorman.
Each contained sufficient supplies to deliver prophylactic antibiotic treatment
to 830,000 people or therapeutic treatment for 14,000 people, each for three
days. The packages were sent with technical advisers, such as pharmacists, emergency
response personnel or public health advisers, to organise the breakdown of supplies
into dispensable units as only bulk supplies were shipped.
The first national bioterrorism exercise had been Operation Topoff, which had
provided the opportunity to test readiness at all levels, explained Lieutenant-Commander
DEBRA DOTSON (senior pharmacist, Bioterrorism Preparedness and Response Programme,
Department of Health and Human Services).
The operation, held with no notice in May, 2000, had involved three simultaneous
mock bioterrorist events. These had taken place in Washington DC, Portsmouth,
New Hampshire and Denver, Colorado. In Denver, the event had been the covert
release of Yersinia pestis, the organism that caused plague.
The main problems that had been encountered had been inadequate supplies of
pharmaceuticals, beds and equipment when a decommissioned hospital was reopened.
Many lessons had been learned, mostly about logistics and communication, said
Lt-Com Dotson. In particular, it was important to have pre-printed information,
where possible, about the diseases or chemicals, for both the press and the
public.
Responders to terrorist incidents might have to work in biological or chemical
isolation suits, with breathing apparatus, said Commander KATHLEEN DOWNS (medical
readiness co-ordinator, education specialist, Office of Emergency Preparedness,
Department of Health and Human Services). It was important to be aware of this
because it was not easy to do normal work in a protective suit and thick rubber
gloves.
There was no requirement for pharmacists to be trained in counter-terrorism.
However, Com Downs said it was important to know the potential for terrorist
use of nerve, biological and chemical agents, to be aware of the signs and symptoms
of exposure to these agents and to understand response plans and what action
was required.
She recommended attending conference sessions and looking at websites such as
the ASHP emergency preparedness counter-terrorism resource (www.ashp.org/
public/proad/emergency).
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New ASHP guidelines for handling hazardous drugs were likely to say that the
class II biological safety cabinets (BSCs) were not sufficient to contain cytotoxic
drugs, said Dr Luci Power (senior consultant, Power Enterprises, San Francisco).
A broad-based team of experts and practitioners would contribute to a revision
of the 1990 ASHP Technical Assistance Bulletin in 2001 and the new document
would be called “guidelines”.
There was nothing wrong with the cabinets themselves, she explained. Fifteen
years ago, on the basis of the Ames test, they had appeared to be effective.
Newer research, based on more sensitive techniques, showed that they did not
contain contaminants and could no longer be considered sufficient on their own.
The new guidelines would recommend a different type of cabinet or the use of
additional measures, such as adjunct products and improved techniques, to prevent
or contain contamination. Cabinets would need to be vented to the outside and
this might be costly, she added. Alternatively, a barrier isolator that would
not need to be vented to the outside could be used.
Class III cabinets and barrier isolators offered the advantage of containing
contamination and careful decontamination procedures could then ensure that
little was transferred to the exterior. If neither of these options was possible
then pharmacists should take other steps to reduce contamination.
Adjunct products, such as Phaseal, could be used to reduce the amount of drug
generated. Effective decontamination within the cabinet using, for example,
swabs designed specifically for mopping up cytotoxic drug spillages, could reduce
the amount of drug that could escape the cabinet.
Dr Power urged everyone to re-examine their practice, as good technique and
working procedures could make a big difference to the level of contamination.
For example, a “double gloving” procedure could be adopted. In other words,
when work was complete, the decontamination procedure could be carried out and
then the outer gloves removed. The clean inner glove could then be used to handle
the cleaned product, she said.
The ASHP intended to research the effectiveness of the recommendations in the
guidelines in the future.
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The increasingly important role that pharmacy technicians play in pharmacy
practice was emphasised by the Pharmacy Technician Certification Board, at the
2000 Innovations in Pharmaceutical Care awards.
Projects highlighted included the pharmacy at the North Mississippi medical
centre, which was using a technician for medication error tracking and reporting.
Another team of technicians, working in a busy branch of a chain pharmacy (Osco
Pharmacy), had developed a programme of special care for diabetic patients.
The aim was to prevent or delay long-term complications by helping patients
to understand their disease and keep blood glucose levels stable.
A team from the Zive Disease State Management Company had introduced an HIV
adherence project that included the development of patient empowerment aids.
The team showed that, after the introduction of the programme, patient adherence
rates ranged from 85-95 per cent - significantly higher than the national average
of 30 per cent.
Technicians at Duke university medical centre had taken over most of the roles
previously carried out by pharmacists. This had allowed pharmacists more time
to focus on patient care.
Mrs Loraine Edwards, a senior pharmacy technician at North Staffordshire hospital
NHS trust presented a poster describing a project that had won her the AAH technician
of the year award - “The role of the directorate liaison technician”. Her project
had resulted in a saving of £35,000 on drug expenditure for the medical directorate
during 1999-2000. A further £16,000 had been saved on HIV drugs as a result
of a repeat prescription service and detailed drug usage data had allowed a
successful bid to be made for additional funding of £69,000 for 2000-01.
Since 1998, she had developed a comprehensive portfolio of drug usage analyses
and budget profiles that were fed back to directorates.
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