Ventolin® metered dose inhaler (MDI)

Bronchodilator for relief of asthma symptoms

1–2 puffs (100-200 μg) inhaled when necessary for control of asthma symptoms. Delivery via spacer recommended in children.

Since the early 1970s, salbutamol delivered from the Ventolin® MDI has been the cornerstone of acute asthma management. It produces a rapid onset of bronchodilation with a duration of action of 4–6 hours. Other bronchodilator drugs, delivered in different devices, have required rigorous assessment before adoption, and some have proved inappropriate leading to their withdrawal due to safety concerns.1,2

Ventolin® MDI is the commonest bronchodilator used by asthmatics in New Zealand and worldwide. It is used by most people with asthma in New Zealand to relieve asthma symptoms due to airflow obstruction, which for some people may be life-threatening.

Serious adverse events are rare, and none have been reported from device failure.

In the 1980s, New Zealand had one of the highest asthma mortality-rates in the world. Since then, the rate has fallen but the prevalence of asthma in New Zealanders remains amongst the highest in the world.3,4

As exacerbations of asthma are potentially life-threatening, it is essential that bronchodilator therapies offered are proven to be effective, safe, and reliable.

Earlier this year, PHARMAC indicated its decision to withdraw a subsidy for Ventolin® MDI prescribed for asthma, in favour of Salamol®, an after-patent preparation of salbutamol. Salamol® had not been used significantly in New Zealand prior to this announcement, and its introduction would mean changing successful treatment for hundreds of thousands of asthma sufferers currently using Ventolin® MDI.

Early distribution of Salamol® has resulted in significant anxiety to asthma sufferers (children and adults) who regularly used Ventolin®, not only because of the change, but also because of technical difficulties with the device, resulting in them sensing it was less effective. Those wishing to continue with Ventolin® can do so, but now face an additional charge of at least NZ$2.00 per inhaler. We believe this charge will be unsustainable for many, particularly those with more than one asthmatic in the family, or with children who often require a number of relievers to be available (home, school, car, other carers, etc).

There has been no direct consultation by PHARMAC about the introduction of Salamol® with any expert groups such as the Thoracic Society of Australia & New Zealand, the Australasian Paediatric Respiratory Group, or the Paediatric Society of New Zealand.

Salamol® is being imported by Air Flow Products Ltd, a commercially independent wholly owned subsidiary of the Asthma and Respiratory Foundation of New Zealand (ARFNZ).

Most often, the first an asthma sufferer or family has heard about this fundamental change to their therapy has been when they present to their pharmacy with a prescription for Ventolin® MDI and when the product is delivered, they are told that Ventolin® MDI is no longer available with the same subsidy, and that Salamol® is the replacement.

Acute asthma can not only be provoked by anxiety in some asthmatics, but also in acute events anxiety can worsen the severity of the event. An unexpected change from a trusted medication may have serious consequences in these patients.

Already, asthmatic children and adults have expressed concern about how ‘different’ the inhaler feels, in taste, physically, and in its delivery of medication. Indeed, several children have complained of the taste and some have been more reluctant to use the medication. The device is smaller and wider, and may be more difficult for especially elderly asthmatics or those with arthritis to manage. The typical patient grips the Ventolin® MDI in the palm of the hand and uses the thumb to activate it. The Salamol® device is too small to comfortably grip this way, and it may slip through the palm when the patient attempts to activate it.

A more serious issue is the tendency for the device to block its outlet thereby failing to deliver any medication. There has been a response by the supplier that the device should be washed regularly, with specific instruction about drying it. This is problematic for a number of reasons. Users may not remember to regularly clean the device per the manufacturers instructions, thus increasing risk of malfunction. The advice given does not specify a drying method, and there is a risk that a patient requiring medication acutely might only have a currently wet and unusable device. Finally, the manufacturer’s instructions specifically require that the device not be washed in detergent. This is directly contrary to the washing instructions for spacer devices necessary for use in children and many adults, and will surely result in confusion.

Disregarding the issues of palatability etc, it would seem that the most dependable way (of ensuring that patients always had access to a reliable Salamol® inhaler) would be to provide them with two, rather than one inhaler. Clearly this would not be a cost-effective measure.

The device has alcohol in the propellant in sufficient quantities for a user to fail a traffic alcohol screening test.5 As paediatricians, the authors are also concerned that children are unnecessarily being exposed to alcohol.

A search of the National Library of Medicine using PubMed for ‘Salamol®’ on 29 June 2005 produced only three papers. One described the failure of a roadside alcohol breath test,5 a second discussed Salamol® as a nebulising solution,6 and the third discussed the lung bioavailability of salbutamol (Salamol®) which the researchers reported to be the same as Ventolin®.7 There was no comment on the device being prone to clogging. Clearly there has not been enough published clinical research of this drug/device combination to enable doctors to support its adoption.

This decision has created a potential conflict of interest for the Asthma & Respiratory Foundation of New Zealand because its subsidiary, Airflow Products Ltd, imports and distributes Salamol®. The ARFNZ states that its vision is “to create an environment in which people with respiratory conditions can breathe more easily” and its mission is “to advocate on behalf of all people with respiratory conditions”. Despite its policy of not advocating any specific medication, the Foundation now stands to gain financially from Salamol®.

These events would appear to the authors to represent a poorly considered decision by PHARMAC. PHARMAC has chosen a potentially defective product as the sole salbutamol MDI for use without charge in New Zealand. The disruption and potential risk to asthma sufferers in New Zealand does not seem to justify the purported annual savings of less than NZ$2 million over 16 months.8

PHARMAC has managed to confuse and potentially endanger the asthma sufferers of New Zealand by this unfortunate experiment, and alienated the medical practitioners who strive to do their best for patients with asthma.

Perhaps this is a lesson not to assume that an apparently small change (in this case a change of medication brands and their delivery systems) cannot have an adverse outcome. Certainly there are sufficient experts in the field that could have advised on this, if asked.