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Dispensing highly specialised drugs for the treatment of HIV

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Associate Professor Levinia Crooks AM - CEO of the Australasian Society for HIV Medicine (ASHM) reports on the recent changes to dispensing of HIV drugs in Australia.  From 1 July 2015 retail pharmacists will be able to be reimbursed for the supply of highly specialised and high-cost drugs that are prescribed for the management of HIV.

Image: a bottle of blue pills is turned on its side with a clock in the background

These antiretroviral drugs are listed under section 100 of the National Health Act 1953, which has until now restricted their supply to public hospital pharmacies and their agencies or in community pharmacy if they are prescribed through private hospitals, using a complex authority.

Dispensing of maintenance prescriptions for Clozapine, a common antipsychotic drug, will also be able to be dispensed in community pharmacy using these harmonised arrangements.

Why is this happening?

Both HIV medicines and Clozapine are lifelong treatments. While current HIV medicines are much more effective than earlier products, they do not cure HIV. The drugs need to be taken daily and, as things stand, lifelong. If patients go off their HIV medicines, even for a short while, the virus rebounds. It is only consistent, daily treatment using a combination of drugs that keeps HIV under control.

Patient access?

Patients and their carers have advocated for more normalised treatment access for many years. Patients with HIV have been able to get their HIV management in the community from authorised HIV s100 prescribers for many years, but they have had to return to the hospital to collect their medicines.

While this works for some people, it can be very inconvenient, especially if people live some distance away from the hospital or are working, as hospital pharmacy hours are much more restrictive than community pharmacy hours.

There have been pilots run in a number of locations to test the acceptability of community dispensing for patients and retail pharmacists. These found that the drugs could be safely dispensed in the community and that the process was acceptable to both pharmacists and their patients.

The HIV pilot was conducted in NSW. The Pharmaceutical Benefits Advisory Committee (PBAC) has been considering the issue of supply of highly specialised drugs for many years and one of the issues complicating any change to arrangements has been the PBS reimbursement system. More recent changes to pharmacy online claiming arrangements has helped bring about changes.

The PBAC made a recommendation to the federal Department of Health that there should be expanded access to HIV drugs and Clozapine. Having the knowledge of the successful pilots no doubt contributed to their decision. The previous health minister accepted this recommendation and, in 2014, announced that HIV antiretroviral prescriptions written after July 1, 2015 would be able to be dispensed in retail pharmacy.

Why is this restricted to HIV medicines and Clozapine?

The s100 Highly Specialised Drugs Program has largely been restricted to specialists in public hospitals. Patients have had to attend a hospital to see their specialist, but, in HIV, general practitioners who have additional training and are registered as HIV s100 prescribers have been managing HIV in the community for more than 20 years.

Current estimates suggest that in Australia at least 65 per cent of HIV treatment is prescribed by general practitioners. These doctors can initiate HIV therapy, so there is no need for their patients to ever go to a public hospital for HIV management. It was logical that these drugs be the first moved to the harmonised arrangements.

There are many other drugs on the s100 Highly Specialised Drugs Program and we anticipate that if the rollout of HIV medicines and Clozapine is successful, then there will be more s100 medicines moved to this streamlined dispensing program. At ASHM we are hoping that hepatitis B medicines will be able to move over to retail pharmacy soon and have made representation to the PBAC on this. Hepatitis B is treated by a subset of drugs also used to treat HIV.

The recent recommendation of the PBAC to put the new hepatitis C drugs onto section 85 means that these medicines will also become available in retail pharmacy. There are many potential changes being considered in the pharmacy and medical benefits areas. There seems to be a real move to harmonise and simplify prescribing and dispensing arrangements.

Some of this, particularly claiming and monitoring, is facilitated by the introduction of online pharmacy ordering and reimbursing. Along with expanding access for patients, these initiatives will move care of some chronic conditions to the community and mean that retail pharmacy plays a far more strategic role in the ongoing management of patients.

HIV treatment mechanisms and duration

HIV is a retrovirus transmitted by blood and some body fluids (semen and vaginal fluid). As a retrovirus, HIV turns its RNA into DNA during reverse transcription. The viral DNA is then incorporated into human cell DNA, where the cell replicates. New viral particles are also liberated from infected CD4 cells. This means that the virus is hard to kill through normal immune responses or treatment because it is incorporated into the human CD4 cell.

Antiretroviral treatment attacks the virus at the various stages of its life cycle. Standard care for HIV involves using a combination of compounds, which have an impact on these different stages. These are entry inhibitors, nucleoside and nucleotide inhibitors, integrase inhibitors and protease inhibitors (see figure).

While combination therapy is very effective at driving viral replication below the limits of detection, it does not eradicate the virus. If therapy is stopped, HIV resumes replication and can rebound very quickly to levels that will cause immune system damage.

Poor adherence to treatment regimens can also render individual drugs, drug classes or multiple classes ineffective. This happens as a result of the development of resistance, which can be caused by repeated treatment interruptions, missed doses and taking medicines at incorrect intervals as the trough levels drop below the concentration required to sustain viral suppression.

The Pharmaceutical Society of Australia, in collaboration with ASHM, the Pharmacy Guild of Australia and Society of Hospital Pharmacies Australia, is producing a resource for pharmacists that explains HIV treatment in some detail. It explores the different medicines, their use and pharmacokinetics. It provides information about drug-drug interactions, adverse events, side effects and toxicities, and also provides a range of useful practice and counselling points.

Managing HIV antiretroviral therapy in the retail pharmacy

HIV medications will remain on the s100 Highly Specialised Drugs Program. This means they are outside the 5th Community Pharmacy Agreement, so there is no requirement to supply the medicines within 24 hours, but the bulk of the medication will be available through the major wholesalers so they will likely be able to be dispensed fairly quickly, probably within two days.

The drugs are also high-cost and it is expected that HIV s100 prescribing will be managed like the dispensing of other expensive drugs such as Humira or Enbrel for the management of rheumatoid arthritis. Many patients living with HIV have had to manage complex supply arrangements: accessing a hospital pharmacy with restricted hours, perhaps having to travel long distances to get to a hospital and, in many smaller centres, having to get the hospital pharmacy to order in their medicines.

Patients and their clinicians and advocates have been asking for drugs to be supplied in retail pharmacies for a long time, so working out ordering and supply arrangements in such a way that facilitates supply is something that pharmacists should discuss with the patients who have HIV. Each arrangement might be different, but may be easily included in patient-reminder systems.

How can you plan for this?

Pharmacies which are near hospitals with HIV services, sexual health clinics or community s100 prescribers are likely to have more occasion to dispense HIV medicines. You can find a list of community s100 prescribers on the ASHM website http://www.ashm.org.au/hiv/prescriber-lists. However, many people may choose to get their medicines from a pharmacy near work or home or another convenient location. Pharmacists may have regular patients they know have HIV. In this case they can initiate a discussion with the patient about whether he or she would like you to dispense their medicines.

Chris Cormack, writing in Retail Pharmacy March 2015, introduced readers to Maggie, a 60-ish female patient who probably dictates much of the medicine-taking behaviour of four generations within her family: ageing parents, adult children, grandchildren and, of course, herself and her husband. Mr Cormack described the important role Maggie plays in influencing the buying power of those around her.

People with HIV will be a bit like Maggie. We know from surveys undertaken by HIV consumer organisations that while people living with HIV want to access their medicines in the community, they also express concerns and fear that their confidentially and privacy may be at risk.

We know that pharmacists have strong ethical standards, but fears and concerns can be as restricting as actually experiencing stigma. So pharmacists will need to take special care in dealing with requests for HIV dispensing. It is probably also a good opportunity to review privacy and confidentially arrangements in the pharmacy. People who have good experiences in pharmacy will keep coming back and word of mouth referrals and recommendations will likely follow.

People living with HIV, like other patients with chronic conditions, will require lifelong care and, as such, represent a group of patients recognised as contributing most to a retail pharmacy’s bottom line.

The HIV population in Australia is ageing and experiencing the comorbidity associated with that process. They are eager to have community pharmacy access and also want their privacy respected. If treated well, they are likely to become loyal patients and customers.

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