Sharp temperature variance during Pharma supply chain - Who is to blame?

One of the most important challenges for health solutions outreach in emerging economies is; the maintenance of a safe and suitable temperature throughout the process of manufacturing, transportation, storage, retail display and administration of a drug to the patient. Several improvements are needed in the pharmaceutical Cold-Chain Infrastructure across Pakistan.

In the year 2005, more than 50% of global vaccine consignments were ruined due to poor temperature control. Specifically in Pakistan, many pharmacies and hospital storage rooms do not follow the defined temperature control guidelines. Over the past decade, the electricity shortage crisis has worsened the situation, as most pharmacies donot have electric supply backups like a generator or a UPS.

Throughout most regions of Pakistan, during a single year, there are temperature variances ranging between 5 to 40 degrees celsius. As the pharma products are displayed all over the country with poor airconditioning and excessive sunlight at most of the drug stores and pharmacies, this exposure becomes extremely detrimental for the efficacy of the medicine, vaccines and formulas. Many vaccines are rendered ineffective due to extreme heat and cold weather exposure.

Almost 25% of all drugs are temperature sensitive (below 30 degrees), and must be transported and stored under controlled temperatures. Temperature management must be ensured at every phase of manufacturing, transportation, storage,  display & even post-retail. There is a need to improve drugs storage and handling at Pharmacies and primary care health units. This necessitates specific training programs and implementation of SOPs for drug-handling staff.

This has also been cited as a major reason for the failure of Polio vaccination programs in Pakistan and India, over the years. Urgent measures are needed to ensure the protection of these products from adverse weather conditions, as the market size for complex pharma products & vaccines is expected to grow rapidly in the emerging economies, over the next decades (upto 15% annually).

Throughout the distribution process the “Traceability”, “Damage-detection” and possible “recall” mechanism for each product pack must also be ensured. It is geographically easier to enforce temperature controls at large, registered manufacturing units and Distribution houses, because the products are handled in bulk quantities at these sites, and the inspectors have an easier access to such larger establishments. The problem begins when small quantities of medicines are scattered all over the country and stored at smaller sites like; shops and small smaller clinics. Extensive manpower is needed to reach out and monitor each retail and health-care outlet.

However, the authorities must clearly define responsibilities and identify which particular participant of the supply chain is responsible for causing the heat damage in each case. It should then be backed up with an accountability mechanism. Even the truck driver who delivers the cargo to a medical store has an important role to play in the quality control system.

The whole supply chain should be well coordinated with smart quality checks at every stage. Thus the regulators must ensure that if a product loses it's efficacy due to sharp temperature variance, during the retail stage or unsafe pharmacy display, the blame for negligence should not be placed on the earlier participants in the chain e.g. the manufacturer or the distributor, who have produced a good product and already specified the handling instructions and safe temperatures on the labelled pack of the drug. Whenever any cargo damage occurs, there is a need to identify; Why, Where and When the damage had occurred, reinforcing the commitment: “Whoever is responsible for damage is accountable for the damage”.

The factors that may affect the efficacy and transportation of medicine include; Extreme variance in weather conditions, unreliable grid power, untrained staff, high ambient temperatures, poor transport infrastructure, unpaved roads, scarcity of refrigerated carriers, lack of knowledge, unevolved regulations, dusty atmosphere, difficult geographical terrain, low-priority given to public health and low awareness among public & stakeholders.

Ideally, the stages and sites at which temperature, safety and quality controls are needed, include; Pharmaceutical manufacturing facilities, Shipping vessels, Ware-houses of Importers and distributors, Road transportation, Medical stores and public hospitals, Health centers and pharmacies, Community Health workers' networks. These facilities may be operating in both the Private or Public sectors. The critical “Last-Mile” of the pharma products supply and safety starts when the drug is stored at the shelf of a pharmacy in a remote area and eventually the patient purchases the drug and takes it home. Therefore, the patient should also be aware of how to store it at home.

The Government Authorities must reallign and implement clear guidelines for ensuring temperature control throughout the supply chain, especially deploying a broad-based mechanism to monitor the conditions under which medicines are stored and displayed at the distant pharmacies, hospitals and basic health units all over the country. Moreover, a seamless gap-free cold chain must be achieved in the near future. This might require the deployment of innovative technologies like; Solar or wind-power to maintain uninterrupted small-scale refrigeration at medicine outlets and stores during power outages. Portable solar refrigerators for vaccines are already being adopted by vaccination teams all over the world.