In a supply chain crisis
AN efficient supply chain network allows a product in demand to be supplied in a timely manner to the end user, beginning from the manufacturer of that product through the regulatory channels, courier systems, warehousing, retail outlet and then to the consumer.
A glitch at any point in the supply chain can create a crisis for companies which utilise efficient operational systems to maximise profits such as “lean” or “just-in-time” inventory management systems.
However, the most recent global emergencies: the pandemic, climate change and the war in Ukraine created additional unpredictable constraints in the availability of raw materials due to logistics of manufacturing sites in various key countries, human resources, transportation and other economic costs. Such disruption impedes a continuous supply of medications in healthcare delivery systems.
Globally, the pandemic induced drug shortages in oral prescription medications such as salbutamol, antidepressants, HRT (hormone replacement therapy), contraceptives, anti-hypertensive and children’s paracetamol. The categories most affected were antimicrobial, oncology, analgesics and some injectibles.
In 2011, due to an imposed US FDA quality control measure, Health Canada enforced a factory closure resulting in the unavailability of morphine for terminally ill patients. In 2016 Iran was out of stock of seventy three cancer drugs. In 2019 patients requiring an anti-emetic for vomiting due to chemotherapy were denied ondansetron.
Medication shortage has been a recurring universal problem in the delivery of healthcare in high, middle and low level countries. But with instituted systems in place, supply chain performance can be enhanced if there is continuous review in forecasting, inventory management, information sharing and establishment of lead times.
There has not been a standardised definition of “drug shortage” and hence no universal matrix to measure and rank the scale of the problem. Some explanations highlight the demand aspect while others the supply side and yet still, some are only focused on the timing of order fulfilment for the patient.
Although drug shortages cut across all categories of medications, the two mostly affected are the essential and the emergency supplies, resulting in a greater negative impact. Generic medications, although there are multiple manufacturers, are more affected than branded or patented medications.
Although no local data has been recently published, Guyana like many other developing countries utilise a lot of imported generic equivalent medicines because of cost. According to the United Nations COMTRADE database on International Trade, in Guyana, the total value of pharmaceuticals imported in 2021 was US$44.3M.
Australia healthcare system, like many other countries, depend heavily on pharmaceutical importation and as such experienced drug shortages as high as 300 percent during 2019 and 2020, due to stock piling and distribution restrictions as a result of COVID-19. Hence the Pharmacy Guild of Australia, the Pharmaceutical Society of Australia and the Ministry of Health put systems in place by August 2021 to address the escalating crisis by restricting sale, empowering pharmacists to substitute via legislative amendments under the “Serious Shortage Substitution Notice” scheme and created a new initiative referred to as the Medicine Supply Security Guarantee.
The Canadian system encouraged information sharing with the general public on the Health Canada website, where manufacturers can post the shortages of active ingredients that cannot meet the anticipated demands and also those products which have been discontinued.
The USP (US pharmacopeia) has mapped out products to have a high risk of shortages due to the unavailability of the API (active pharmaceutical ingredient) because of risk drivers such as manufacturer location, cost, quality assurance, chemical information and dosage formulation.
The total importation of API into the US corresponds to about seventy-two percent and are from facilities in China, India and Europe. This may help to forecast shortages and hence better prepare for inevitable situations.
A UK General Practitioner poll in June 2021 indicated eighty percent prescribing adjustments from first option to second option, according to protocols which meant a greater risk and increased monitoring than usual for the patient.
As seen in Australia, legislation was passed allowing pharmacists to substitute where necessary so as to allow continuous treatment and preventing worsening of the ailment as a proactive measure.
There are two (2) types of drug substitutions: generic substitution and therapeutic substitution. The former is usually acceptable unless the prescriber states that no substitution is allowed. This is the replacement of the brand name by its generic equivalent, which has the same active ingredient in the same formulation and the same strength. The name and the presentation varies according to the manufacturer of the product.
The substitution policy allows the pharmacist to dispense either double dose of half the strength prescribed (like two twenty milligram tablets in place of a forty milligram), or to dispense an immediate release preparation instead of an extended release version of the same medication (such as Vastrel versus Vastrel MR), or different drug formulations (such as a tablet version instead of a suspension), or to dispense individually available medications for prescribed combination preparations like instead of Presartan H (50mg Losartan+12.5mg hydrochlorothiazide) for hypertension a pharmacist may be allowed to dispense two separate tablets to get the same results; losartan 50mg and half of twenty-five milligram hydrochlorothiazide.
The next type of substitution, therapeutic substitution, is where a different active ingredient in the same therapeutic class is recommended by the pharmacist. However, this is currently on hold based on the evaluation of the impact of the drug shortage. Therapeutic substitution is not universally allowed by many societal bodies such as The American Psychiatric Association, The American Heart Association and The Epilepsy Foundation, among others.
Healthcare institutions instituted protocols to manage drug shortages using alternative options. The Australian government has posted a drug shortages website giving public information on how long the shortage is expected to last, suggested approved alternatives, suitable unregistered alternatives from a SAS (Special Access Scheme), as well as considering the SSSI (Serious Scarcity Substitution Instrument) which enables suggestions for substitutions by the pharmacist without prior approval from the prescriber. These are monitored and accountable systems for substitution which requires total participation from all stakeholder bodies so that treatment for the patient or the end user will be consensual, continuous and complete.
For further pharmacological guidance and physician referral, contact the pharmacist of Medicine Express PHARMACY located at 223 Camp Street, between Lamaha and New Market Streets. If you have any queries, comments or further information on the above topic kindly forward them to medicine.express@gmail.com or send them to 223 Camp Street, N/burg. Tel #225-5142.