Alphabetical listing of drug ingredients on PBS a safety hazard

Medical and pharmacy groups have written to the Department of Health and Ageing to demand it reverse a change to the listing of generic descriptors for multi-active medicines on the PBS, saying the change is causing problems with medical software and is potentially a serious safety issue.

Representatives from the Australian Medical Association, the Pharmacy Guild, the Pharmaceutical Society of Australia, Pharmaceutical Defence Ltd and the Medical Software Industry Association have written to DoHA about the issue, saying the main cause for concern was the potential to prescribe or dispense multi-active drugs in the wrong strength.

The organisations say the change was made to the PBS to make it consistent with the Australian Medicines Terminology (AMT), but it is now conflicting with the packaging and product description of medicines approved by the Therapeutic Goods Administration (TGA).

They use the example of Coveram, which is prescribed for patients with hypertension. Coveram has two main active ingredients – perindopril and amlodipine – and comes in different dosage strengths. One is Coveram 5mg/10mg, which has 5mg of perindopril and 10mg of amlodipine.

Coveram has always had perindopril listed first since it was approved for the PBS in 2010, and this is the way it appears on product packaging, as approved by the TGA. In prescribing and dispensing software, it was formerly listed as perindopril/amlodipine tablets 5mg/10mg.

Now, however, due to a change in listing the generic description alphabetically, it appears on the PBS as amlodipine 10mg + perindopril 5mg, which is being shown in medical software as amlodipine/perindopril tablets 5mg/10mg.

Coveram also comes as 10mg/5mg, with 10mg of perindopril and 5mg of amlodipine. The same problem is occurring – previously, it appeared in medical software as perindopril/amlodipine tablets 10mg/5mg but is now appearing as amlodipine/perindopril tablets 10mg/5mg.

Prescribing and dispensing software is updated every month with a new list imported directly from the PBS.

“Alphabetising the listing of active ingredients in multi-active products to be consistent with Australian Medicines Terminology (AMT) has resulted in the generic descriptions imported by software vendors from the PBS data to be displayed for drug selection in a manner conflicting with the packaging and product description approved by the Therapeutic Goods Administration (TGA),” the organisations say.

“This results in listing incorrect information regarding the strength of the ingredients and raises the possibility of the incorrect item being supplied.

“We are concerned that decisions are being made to arbitrarily change the generic description of medicines with multi-active ingredients without consideration of the impact on pharmacists and prescribers, consumers, the medical software industry or manufacturers.

“The changes already implemented have caused significant confusion and consternation with health care professionals ... and increases the safety risks to consumers from potential supply errors.”

The AMA, PSA and PDL first issued warnings of the potential for error when prescribing or dispensing Coveram, along with a similar drug marketed as Reaptan, in early May. NPS has also issued an alert.

The organisations have since discovered that other multi-active drugs can cause the same confusion, including Daivobet ointment for psoriasis, which previously was listed with the active ingredient calcipriol listed first and then betamethasone.

It is now appearing in the PBS the other way around, contrary to how it appears on the manufacturer's labels. Prednefrin Forte eye drops, Panadeine Forte and some oral contraceptives may also be affected.

“It is important to note that this issue was raised with the PBS Information Management section of your Department in the first week of May, as soon as the safety issues relating to the Coveram and Reaptan brands were identified,” the organisations wrote to DoHA. “However the problem has been carried through to the June Schedule and now to the July Schedule, with more examples now identified.”

The industry groups are asking that the department immediately reverse the changes.

The introduction of AMT descriptors in PBS data began with the release of the department's PharmCIS system last November. Mapping to NEHTA's AMT codes is necessary for implementing developments such as the electronic transfer of prescriptions (ETP).

However, mapping to the AMT codes means the listing of generic descriptors now follows its method, which is to list the ingredients alphabetically rather than as they appear on the packaging.

The rollout of PharmCIS caused a delay in sending the December PBS schedule updates to prescribing and dispensing software vendors in time for them to incorporate them in their software, with doctors and pharmacists having to manually check for any changes from the October schedule.

At the time, DoHA said PharmCIS aimed to improve the specification and management of restrictions by increasing clarity for prescribers and dispensers and introducing machine encoding.

Pulse+IT understands that delays are continuing in getting PBS monthly updates to software vendors in time for them to test for problems.

A DoHA spokeswoman said the issues raised in the letter "are under active consideration".

Posted in Australian eHealth

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