HIBC (Health Industry Bar Code) was created in 1983 as a way to track data via bar codes and has been the method of choice for creating barcodes and tracking medical and pharmaceutical products for many years. Healthcare products need to be treated differently than consumer products since human safety requirements apply and they are monitored by the government. Labels for patient use must be error-free, and must contain specific, required information. HIBC meets the unique needs of the healthcare and medical manufacturing industries.

GS1 is an international, non-profit association that develops and implements global standards and solutions to improve supply chain management for all sectors. GS1 developed GTIN, or Global Trade Item Number, as the unique identification number on a product. GTIN ensures that every variation of a product is allocated a single reference number that is globally unique. Another GS1 identification number, GLN or Global Location Number, identifies physical locations, such as place of departure, place of delivery, and point of storage, adding security and sustainability which is so important when dealing with pharmaceuticals and medical devices.

While HIBC focuses on the healthcare industry, the GS1 standards are used across many different industries, including retail, healthcare, transport and logistics, consumer electronics, defense and collaboration.

Most in the healthcare industry agree that having two different barcoding systems is not efficient, but the more difficult task is selecting one option as the standard. The Association for Healthcare Resource and Materials Management supports GS1 and is asking for the industry to implement its Global Location Number standards by December 31, 2010 and the Global Trade Item Number by December 31, 2012. The FDA has not backed either option, but has concentrated more on the concept of developing a Unique Device Identification (UDI) system for pharmaceuticals and medical devices.

Do you support HIBC or the GS1 standards? What are your thoughts?

When designing and producing prescription labels, there are key elements which must be considered.

• MHRA compliance – For any prescription label, the correct information is vital to ensure patient wellbeing. Required information includes prescribed dose, route and frequency to be administered as well possible classification symbols/ pictograms, language requirements and supplemental information.
• Secure production – With prescription labels, accuracy is crucial. The healthcare professional administering the medication is accountable for their actions. If this role is delegated, the primary professional is responsible for all aspects of the administration, therefore controlling label production with individual user rights is essential to enable complete confidence during and post production.
• Ability to reprint and reconcile – Reprinting of printed labels needs to be quick and easy, however the reconciliation is fundamental. The ability to be able to track any reprints required for prescription labeling in an audit log against the original record is vital.

Why Patient Specific Direction?

One of the ways to combat these issues is via Patient Specific Direction (PSD). PSD is a written instruction for medicines to be supplied and/ or administered to a named patient. The prescription need to be instructed by a qualified and registered prescriber and include prescribed dose, route and frequency to be supplied or administered to a named patient. These can be instructions written in the patient’s notes, or a note sent to a treatment room for the administration of a medicine or a course of medicine. The treatment and administration should be documented and auditable.

The Solution – Painless Patient Specific Directions Labeling
To help support healthcare organizations, PRISYM ID has developed an off-the-shelf, ready labeling solution.

PRISYM Pharmacy allows you to design, review, approve, print, reprint and reconcile your labels and has purpose built user security, group security and secure audit logging as well as data integrity. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.

For more information on how we can support you, please contact us.

PRISYM Pharmacy allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging as well as data integrity. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.

PRISYM Pharmacy’s benefits include:

• Implementing one complete solution to fulfil the labeling process within your organization
• Meeting the MHRA compliance requirements
• Realising GMP compliance by meeting the GMP’s guidelines
• Ensuring complete history is maintained though the system by automatic revision and version control
• Reduce duplication and easier to manage label designs with data driven printing
• European symbol/ Global pictogram library for Classification, Labeling and Packing or Substances and Mixtures (CLP).
• Multi-language risk phrase/ hazard statement and safety phrase/ precautionary statement

For further information on PRISYM Pharmacy healthcare labeling systems please contact the PRISYMID Life Sciences team or leave a comment below.

Medicine Regulations

Whether it’s a medicine you buy, or one prescribed for you as part of a course of treatment, it’s reassuring to know that all medicines available in the UK are subject to rigorous scrutiny by the MHRA before they can be used by patients. This ensures that medicines meet acceptable standards on safety, quality and efficacy.
What is a Medicine?

The law defines a medicine as something used in disease, whether it is used to prevent, treat or diagnose it, in anaesthesia, investigating conditions or interfering with the normal operation of the body. It does not include such things as contact lens fluids, food supplements and cosmetics.

Many factors are considered in deciding whether a product is actually a medicine such as what it contains, what it’s advertised or used for, the way it will be used, any particular targeting of the marketing information and what the promotional literature says. Claims that a product “supports” health or a healthy lifestyle is not usually considered as medicinal.

Control of medicines starts as soon as they are first discovered and tested in healthy volunteers, all the way through to when a company wants to change the conditions its products are approved for, such as changing the colour of the tablet or what it is used for.

Medical Devices Regulations

The Regulations implement the EC Medical Devices Directives into UK law. They place obligations on manufacturers to ensure that their devices are safe and fit for their intended purpose before they are CE marked and placed on the market in any EC member state.
What is a Medical Device?

The term ‘medical device’ covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability. The range of products is very wide: it includes contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames or other assistive technology products – many thousands of items used each and every day by healthcare providers and patients.

Blood Regulations

The Blood Safety and Quality Regulations apply to blood establishments and to hospital blood banks. The 2006 Amendment Regulations introduce requirements for a quality system in blood establishments and hospital blood banks. They also extend traceability and record-keeping requirements to “facilities” which may receive blood and blood components (care homes, independent clinics, hospitals and other NHS facilities and services, manufacturers of medicines and medical devices and biomedical research institutes).
Who is it relevant to?

The MHRA is relevant to any organisation supplying products to the UK healthcare market. Want to know more about the MHRA? Visit www.mhra.gov.uk