New dispensing limits imposed


pharmacy deregulation: shopping trolley full of pills

The Government has announced that it is now requiring community pharmacists to enforce new limits on dispensing and sales of prescription and over-the-counter medicines

The measure follows a run on certain medications due to concerns about the COVID-19 crisis, and follows Prime Minister Scott Morrison’s plea to Australians on Wednesday not to hoard groceries and drugs, calling such actions “un-Australian”.

Deputy chief medical officer Paul Kelly has told reporters about the new measure, saying to consumers that “as the Prime Minister said yesterday about panic buying, please do not buy more than you need”.

The Pharmacy Guild and the Pharmaceutical Society, in conjunction with the Department of Health, have now issued new advice to pharmacies. This is also supported by the National Pharmaceutical Services Association, which represents pharmaceutical wholesalers.

Pharmacies and wholesalers reported numerous product lines out of stock, which the TGA pointed out were temporary and local, though they did represent challenges for some patients as well as health care workers such as pharmacists.

“Medicines sponsors (pharmaceutical companies) report that they do not anticipate imminent or widespread national level medicine shortages resulting from the impact of COVID-19 on medicines manufacturing or logistics,” the Guild and PSA say in a joint statement.

“However, if current levels of demand through excessive purchasing continue, supply interruptions will occur at both the national level while sponsors await scheduled deliveries of new stock from international manufacturing sites and at the local level as a result of stockpiling by pharmacy customers.”

The two organisations underline the importance of protecting medicines access and outline the requirements for community pharmacists, which are as follows:

  • Pharmacists will be required to limit dispensing of certain prescription products to one months’ supply at the prescribed dose, and sales of certain over-the-counter medicines to a maximum of one unit per purchase.

These limits apply to particular classes of medicines for which unavailability or an interruption to treatment could result in significant health impacts, or which are expected to be subject to increased consumer demand associated with the COVID-19 pandemic. The list includes over-the-counter medicines such as glyceryl trinitrate, adrenaline autoinjectors and salbutamol inhalers and prescription products such as asthma and COPD medicines, insulins and oral hypoglycaemics and anti-epileptics. Other medicines may be added to the list in the coming weeks.

  • In addition, pharmacists will be strongly encouraged to limit dispensing and sales of all other medicines to one months’ supply or one unit.

Dispensing of multiple repeats is permitted only for valid Regulation 49 prescriptions, which must only be written by prescribers. PBS Regulation 49 must be used sparingly and only in exceptional circumstances in accordance with the legislated criteria. If pharmacists have doubts about the appropriateness of particular Regulation 49 prescriptions please discuss this with the prescriber.

The organisation also highlight that the two over-the-counter medicines for which there has been particularly high demand will be subject to new controls on supply:

  • Salbutamol inhalers provided on an over-the-counter basis will be subject to new controls. Pharmacists will be required to confirm that supply is appropriate by confirmation of the patient’s diagnosis, label the product indicating to whom it has been dispensed and record the supply.
  • Pharmacists will be required to place paracetamol paediatric formulations behind the counter to assist in allocating supply equitably.

In addition, only one salbutamol or paracetamol paediatric product should be supplied per customer.

The Guild, PSA and NPSA all agreed that these limits on pharmacy sales will also be accompanied by limits on orders from wholesalers, to ensure equitable distribution of stock – including to regional and rural pharmacies, which several days ago were reporting significant shortages.

“Supply of quantities that are not clinically required for an individual may be illegal under State and Territory law and contravene Pharmacy Board Professional Practice guidelines,” the organisations warn.

The National President of the Pharmacy Guild, George Tambassis, urged all pharmacists across Australia to comply with the new restrictions in the interests of the national public health and quality use of medicines.

“These sensible and timely limits announced by the Government will apply to particular classes of medicines which must remain available for patients in need. It is regrettable that such measures are needed, but these are unprecedented and drastic times. We ask all patients to understand the need for these restrictions and to be respectful towards pharmacy staff,” Mr Tambassis said.

“With extremely high demand and panic buying, it became clear supply interruptions would occur if nothing was done.

“We are determined that no patient in need of a medicine in Australia should be deprived of that medicine because of unnecessary hoarding by others,” Mr Tambassis said.

“These measures have been designed to ensure medicines can be supplied in an equitable way to all patients that need them,” he said.

The decision follows calls by the Pharmacy Guild to patients to consider the safety and wellbeing of pharmacists and pharmacy assistants.

Earlier he said he was very disturbed to hear reports from many pharmacy owners and staff of hostile, aggressive and in some cases violent behaviour because of low stock or limits on sales in many pharmacies.

“We are calling on people to please show respect in their dealings with pharmacy staff, who are doing their best to cope in a confronting and at times frightening situation.

“Pharmacists go out of our way to help patients source medicines that may be in short supply at this time if they are needed urgently. But they will not and should not be expected to endure aggression and threatening abuse from a tiny minority of Australians who are engaging in this behaviour,” Mr Tambassis said.

“This behaviour will not be tolerated, and the Prime Minister was right to call out this kind of abuse as un-Australian. The safety and wellbeing of our staff and other patients is paramount. If people behave badly in our pharmacies they will not be served and if necessary we will call on security personnel or the police to have them removed.

“Like all Australians, pharmacists and their staff are also dealing with the personal stress and concerns about the COVID-19 crisis. Through all this, pharmacists as a profession and our caring staff are exhibiting the professionalism and courage that is needed to help us and our communities get through this crisis,” Mr Tambassis said.

Queensland branch president Trent Twomey echoed the Prime Minister’s words in calling hoarding and abuse “un-Australian”.

“Stockpiling of medication is absolutely unnecessary and if it doesn’t stop, it may cause shortages of medicine,” he said.

“If we continue to see stockpiling of medicines, and people purchasing more than they need, this will cause dire consequences as people will not be able to access critical medication when they need to.

“The behaviour we have seen is absolutely ridiculous. It is un-Australian. And it is putting other people’s health at risk. That is totally unacceptable.”

PSA National President Associate Professor Chris Freeman said limiting the dispensing of prescription and over-the-counter products to one month’s supply was necessary to address the issue of people stockpiling medicines due to the current COVID-19 pandemic.

“The Government has made it clear to the public that it is critical to stop stockpiling medicine to protect the access of medicines to all Australians,” he said.

A/Prof Freeman said pharmacists were working in the interests of the community and patients and it was important they were treated with respect.

“Pharmacists are working in the best interests of the community and their patients. The current supply network for medicines is adequate to meet demand and if we all do the right thing there will be enough medicines for all who need them.”

 

Affected medicines

This list, provided by the Pharmacy Guild, is not exhaustive and is subject to change.

Medicines where interrupted supply could result in serious health consequences – prescription

Category

Class

Medicine Name/s (examples only)

Analgesics

Opioids, NSAIDs, gabapentinoids

tramadol, oxycodone, fentanyl, hydromorphone, tapentadol, morphine, methadone, celecoxib, pregabalin etc.

Anaphylaxis treatment

adrenaline

Anti-anginals

isosorbide mononitrate, glyceryl trinitrate

Anti-arrhythmics

digoxin, amiodarone, flecainide etc.

Anti-coagulants

warfarin, rivaroxaban, dabigatran, apixaban, enoxaparin

Anti-depressants

TCAs, SSRIs, SNRIs, MAOIs

amitriptyline, sertraline, venlafaxine, moclobamide etc.

Anti-diarrhoeals

Opioid antidiarrhoeals

Loperamide, diphenoxylate

Anti-epileptics

Carbamazepine, lamotrigine, phenytoin, topiramate, valproate, levetiracetam etc.

Anti-hypertensives

ramipril, irbesartan, metoprolol, dihydropyridines, methyldopa etc.

Anti-parkinson drugs

carbidopa/levodopa, levodopa/benserazide

Anti-platelets

clopidogrel, aspirin, ticagrelor, prasugrel

Anti-psychotics

olanzapine, risperidone, aripiprazole, paliperidone, quetiapine

Anti-virals

eg treatments for hepatitis c

Benzodiazepines

diazepam, clonazepam etc.

Cancer/Palliative care medicines

chemotherapy and symptom management (anti-nauseants etc).

Diuretics

spironolactone, frusemide, HCT

Endocrine medicines

Thyroxine, carbimazole/PTU, hydrocortisone etc.

Gastrointestinal medicines

Pancreatic enzymes

Glaucoma eye drops

Beta blockers, prostaglandin analogues

Timolol, latanoprost

Immunosuppressants

Steroids, DMARDs, bDMARDs

Prednisolone, methotrexate, adalimumab etc.

Insulins

Multiple

Oral contraceptives

Multiple

    

 

Oral hypoglycaemics

Sulfonylureas, DPP4s, SGLT2is, GLP1s

Metformin, glicazide, sitagliptin, empagliflozin, exenatide etc.

Respiratory

B2 agonists, anticholinergics, inhaled corticosteroids, theophyllines, montelukast

    

 

Medicines where interrupted supply could result in serious health consequences – non-prescription

Adrenaline auto-injector

Chloramphenicol eye drops/ointment

GTN

Levonorgestrel

Naloxone

Salbutamol

Medicines that may be subject to increased demand due to COVID-19 symptom management –prescription

Asthma/

COPD

Short acting B2 agonist

Salbutamol, Terbutaline – inhaled

LABA, long-acting beta2 agonist

Salmeterol, Formoterol, Indacaterol, Vilanterol – inhaled (including in combination inhalers)

SAMA, short-acting muscarinic antagonist

Ipratropium – inhaled

LAMA, long-acting muscarinic antagonist

Tiotropium, aclidinium, umeclidinium, glycopyrronium – inhaled

ICS, inhaled corticosterioid

Fluticasone propionate, fluticasone, furoate, budesonide, beclomethasone, ciclesonide, olodaterol – inhaled (including in combination inhalers)

    

Leukotriene receptor antagonist

Montelukast sodium – oral

Cromones (mast cell stabilisers)

Sodium cromoglycate – inhaled, nedocromil sodium – inhaled

Theophyllines

Theophylline

Anti-IgE

Omalizumab

Anti-IL-5 receptor

Benralizumab

Anti-IL-5

Mepolizumab

Systemic corticosteroid

Prednisolone – oral, dexamethasone – oral

Adrenaline

Adrenaline

Saline

Saline – inhaled

Cystic Fibrosis medicines

Cystic fibrosis transmembran e conductance regulator (CFTR) protein progenitor

Ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor

Anti-infectives

Antibiotic

Amoxycillin – oral

Amoxycillin and clavulanate – oral

Doxycycline – oral

Clarithromycin – oral

Cefuroxime – oral

Moxifloxacin – oral

Azithromycin – oral

Ciprofloxacin – oral

Moxifloxacin – oral

Clindamycin – oral

Benzyl-penicillin – injection

Ceftriaxone – injection

Erythromycin – oral

Roxithromycin – oral

Influenza medicine s

Neuraminidase inhibitors

Oseltamivir, zanamivir

Vaccines

Vaccine

Influenza vaccines – injected

Pneumococcal vaccinations – injected

Oxygen

Domicillary Oxygen Therapy

Oxygen – inhaled

    

Medicines that may be subject to increased demand due to COVID-19 symptom management – non-prescription

Anti-histamines

Cough suppressants

Decongestants

Expectorants

Ibuprofen

Mucolytics

Aspirin

Paracetamol

Throat preparations (lozenges, gargles)

 

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