newsdossier

May 2014

Nekicesa

Nekicesa Packaging. Carretera de Navalcarnero a Chinchón, Km. 21,2. 28971 Griñón (Madrid)

Madrid, 12 de mayo de 2014

NEKICESA, PRESENTE CON SUS SOLUCIONES DE INNOVACIÓN EN EL XIV FORO SANITARIO DE

AECOC

El Foro Sanitario Aecoc es el principal Punto de Encuentro y relación de proveedores y

clientes del sector (hospitales, servicios de salud y mayoristas de farmacia).

En esta edición, el foro estuvo enfocado en las soluciones logísticas para la industria

farmacéutica

Nekicesa Packaging, empresa referente en la fabricación de material del acondicionamiento

secundario farmacéutico, estuvo presente en Aecoc como patrocinador de las pausas

networking. Durante estas pausas, Nekicesa expuso asuntos de actualidad como las claves de

la directiva 62/2011 y cómo pueden anticiparse los laboratorios farmacéuticos a las exigencias

en el packaging. Además, el foro estuvo enfocado en las soluciones de eficiencia de costes en

el sector hospitalario y farmacéutico, con propuestas como el Vendor Managed Inventory

(VMI), las nuevas plataformas de contratación y subasta electrónicas y el desarrollo de la ley

que impone la utilización de la factura electrónica.

Entre los asistentes se encontraban representantes de las administraciones públicas,

responsables de hospitales, laboratorios farmacéuticos, proveedores, distribuidores y

mayoristas de farmacias, quienes contribuyeron con su punto de vista y aportaron opiniones

de gran valor, reflejadas en el Test Manager.

1El foro despertó especial interés en las propuestas de implantación de procesos para la

eficiencia de costes. Los asistentes reflejaron su apoyo a estas medidas y calificaron como

ventajas la optimización del personal y el aumento de la calidad y el servicio, aunque

mostraron su reticencia a aplicar procesos como el de operador logístico único, debido a las

represalias de los sindicatos o la rigidez del personal.

1 Resultados encuesta “Test Manager” Foro sanitario Aecoc.

0%

10%

20%

30%

40%

50%

60%

70%

80%

Totalmente deacuerdo

Parcialmente deacuerdo

Parcialmente endesacuerdo

Totalmente endesacuerdo

¿En qué medida está de acuerdo con la siguiente afirmación? “La contratación electrónica va a aportar MUCHOS beneficios a los

hospitales/servicios de salud”

Proveedores / Laboratorios

Hospital / S.Salud

Otro

Pharma Serialisation: A New Challenge for the Industry

The process to introduce serialisation in the packaging lines is very complex and needs an important investment to print, read and verify the serial numbers. An appropriate procedure for handling exceptions, reworks, returns and any other issues is also a must. Very few pharma companies have already prepared their lines and processes to introduce serialisation and, as this requirement is no longer avoidable, reliable packaging suppliers will support their customers introducing

serialisation as a new part of their process. Innovative packaging suppliers must have the capability to adapt their

PACKAGING

Supply chain synergies – the unique code of each package can be accessed by pharmacists, the brand owner,

the ability to track and trace products along the chain, from the pharma facility to the consumer’s home.

counterfeiting is a very big challenge for healthcare authorities and pharma companies. Serialisation, as well as other anti-counterfeiting measures,

will be a useful tool to reduce the impact of this problem.

•

•Know and manage serial number

Improve the quality standards to take care and inform of every single loss of a batch

Integrate the serialisation procedures in the IT systems, for associating serial numbers with orders, shipments, invoices, etc.

•

•

•

platforms with serialisation equipment, and have the knowledge and experience to work properly with databases and

The process to become a packaging supplier with the capability to serialise carton boxes brings some important challenges for the whole organisation, as serialisation enforces a traceable production process, controlling and reducing production losses. Serialisation does not only consist of printing a code on a box, but leads to a deeper collaboration between the packaging supplier and the pharmaceutical company. To be part of the serialisation process, the packaging supplier has to:

Meanwhile, serialisation regulations are pending in developed countries (US, Canada and EU), and have already been implemented in several other countries like Turkey, India, China, Brazil, Argentina and South Korea. Brazil launched a three-year roll-out for Track&Trace requirements in 2009.

In India regulations went into e�ect

in the middle of 2011, and a barcode is mandatory on every medicine that will be exported from this country. On the other hand, since 2010 China mandated printing a drug supervision code on the smallest package by March 2011.

Serialisation in the pharmaceutical industry is becoming a very important challenge, not only for the manufacturers but also for their packaging suppliers. According to the Directive 2011/62/EU, pharma companies have three years to implement a successful strategy in all their products to be distributed in the European Union. Similar regulations are in place today in India, China, Turkey and some other countries.

Every member of the industry knows the

Regulatoryand Legislative

Compliance

Supply Chain Sinergies and

Efficiencies

Brand Protection

ProductIntegrity

Supply ChainSecurity

PatientSafety

Security, Track and Trace,

Efficiency

In Europe, several countries have their own drugs, in addition to those pending from the EU. However, in 2006,

System) in collaboration with GS1, the global organisation dedicated to the

design of global standards and solutions

supply chain, recommended the adoption of a unique standard for the coding of pharmaceutical product across Europe, based on the 2D (2-Dimensional) Data Matrix ECC-200, to be introduced on all secondary packaging of prescription products sold in Europe. While other coding standards, such as the PPN1, are available, EFPIA recommends the globally used GS1 standard. EFPIA considers this the most e�ective and technological system for the current time. Despite this, the adoption of a 2D Data Matrix system does not mean that in the future, the adoption of other technologies such as RFID (Radio

will be a solution. In fact, nowadays, RFID costs double the amount and is not easy to introduce and operate, but it would probably be a natural progression of the system. EFPIA knows that national numbers

and have worked with GS1 to deliver an enhancement to the GS1

accommodation of national product

in Europe, these national numbers are used to facilitate the reimbursement processes and are embedded into IT systems, business processes and even

challenges for these countries to move to a GTIN. GS1 have therefore issued an

that describes how these national codes can be accommodated.

This code structure would make use

in use throughout the supply chain today. The EFPIA preferred structure uses only

1. The product code. 2. The serial number. 3. The expiry date. 4. The lot number (batch code).The serial number will be unique per product code and should preferably only contain either lower case or upper case letters, not a mixture. On the other hand, the alphanumeric range can include the digits 0-9 and the letters of the western alphabet, but excludes the following letters: i, j, l, o, q and u (I, J, L, O, Q and U). In order to provide a reasonable level of complexity within the serial number, the probability that a valid serial number

Source: Domino.

Example 2D Data Matrix ECC-200

can be guessed should be a minimum of 1 in 10,000. Therefore, in order to avoid the opportunity for a counterfeiter to estimate the randomisation pattern from two or more samples, two aspects will be taken into account:

On the other hand, the so-called National Healthcare Reimbursement Number (NHRN) is usually assigned by

a national authority to healthcare brand

should only be used for compliance to regulatory requirements where the GTIN alone in a barcode symbol will not meet the requirements. When a regionally-

approved (as above), the overall variable

authority, with a twenty alpha-numeric characters maximum, as noted in the general format above if applicable. In this regard, it is important to point out that including the batch number and/or expiry date within the

manufacturers incurring additional costs. Some manufacturers, particularly SMEs, may decide to print the codes and

and associate individual packs with the

number and expiry date via a reader on the production line. The batch number and expiry date would still be available via a database or repository, and could be read by online scanners, even though

approach would be more cost-e�ective, particularly for smaller manufacturers, it appears to be inappropriate and discriminatory to prevent those manufacturers adopting it. On the other hand, standardisation of the unique code

the database. The issue about applying elements that are not mandatory but nice to have, which can imply an extra cost, could be

The randomisation substrings must be equally distributed, e.g. the serial number substring should not contain

Any randomisation substring must be independent of other substrings.The randomisation substrings must not be built using an algorithm that

given set of serials or a subset thereof.

•

•

•

Country Item Level Serialization

Serialization and Aggregation

Standard Carrier

TURKEY

INDIA

CHINA

California(USA)

EUROPE

2010

2011 to 2013

-

-

2017

2013

2012

2015

-

- TBD

Any

1Dbarcode

2 Dbarcode

2 Dbarcode

Custom System

Possibly

Serialization legislation summary

PACKAGING

PACKAGING

Saul Serrano is currently South Plant Manager in Nekicesa and has been working in the graphic industry for 15 years. He is member of the Nekicesa Innovation Comittee, created to analyze and implementing new techonologies and processes concerning tamper evident, anticounterfeiting features and serialization in Nekicesa.Email: sserrano@nekicesa.com

Source: EMVS

discriminatory for some generic suppliers to enter or even remain in the market. Apart from that, this would potentially damage the resilience of the low-cost generic supply chain, and reduce the availability of medicines to patients. The extra cost associated would favour more established suppliers and reinforce market dominance of incumbent suppliers. As well as being discriminatory, this would have cost consequences for member states and possible implications for security of supply to patients across the EU.

Likely, from the point of view of the wholesalers, they have argued in some countries that it would be practically impossible for them to verify all medicinal products by scanning them on arrival, so they cannot meet the requirements. Additionally, they need to have batch numbers in the unique serial number to enable them to collect the data. These arguments are, of course, mutually contradictory. Checks earlier in the supply chain

disadvantages. Doing it at the dispenser level would also create workload and systems at this point of the supply chain which will be less likely to cope with this, and introduce greater costs overall to systems of medicines supply across the EU. Article 80(e) of amended Directive 2001/83/EC requires wholesalers to maintain records of the batch numbers, at least in products with safety features. The sort of focused risk assessment for which we argue below would result in only those few products of truly high

features, thus making the task faced

by wholesalers to be reasonable and proportionate. However, many medicines are administered in the hospital environment from stock held in clinical areas such as wards, theatres, accident and emergency departments, and intensive care units. In these areas it may not be practical or in the patient’s interest to scan medicines for authenticity. It is not possible to always identify in advance which packs of medicines received are destined for dispensing direct to patients and which

are destined for clinical areas. It would be unreasonably burdensome to scan stock twice (on receipt and at the point of dispensing) and may not be possible if the database holding the information

organisation such as a hospital to verify the medicine once. Concerning the recalls, the EU argues

dispensers facilitates recall of medicinal products from patients. Nevertheless, today, manufacturers control product recall by lots, which can consist of thousands of items. Instead of sending

each recall, the industry looks forward

where each serialised item in the a�ected batch/lot was distributed. Further, from a manufacturer and regulatory perspective, it would be helpful to see what percentage is actually returned and what product remains in the marketplace. The

market recall process, and the inability to

been recalled, highlight the need for a targeted process based upon serialised data. Further, from the consumer’s point of view, despite the fact that any information

sensitive should be protected, as proposed by some associations, it does not mean that data generated by meeting the requirements or in a way associated with the implementation of the Directive 2011/62/EU should not be used for commercial purposes. Finally, sustainability plays an important role and, with this requirement, the unwanted e�ect of this legislation could well be an increase in medicines wastage with consequent environmental and cost implications. If repackaging is not

repackaging, repacking of medicines within some hospital pharmacies will be discouraged. This will result in whole packs being issued (e.g. 28 tablets) when only a few doses are required. The patient would then be directed to throw the rest of the pack away. It may also encourage the issue of excess medicines which pose a threat to patient safety or a risk of diversion and abuse. Unused ward stock medicines are returned to the hospital pharmacy for examination and potential re-issue. In conclusion, taking into account the several aspects from the point of view of the di�erent players within the supply chain (consumers, multinational companies, contract manufacturers, institutions, hospitals, etc), serialisation becomes an abstract problem to solve, in which many contrary interests make

that complies with all requirements.

PACKAGING

MEDICINES ONLINE: THE CONTROL OF A NEW CHANNEL

Internet pharmacies provide consumers with the ability to purchase prescription drugs online. There are thousands of internet pharmacies, yet only 16 have been accredited by the National Association of Boards of Pharmacy (NABP). Many unaccredited internet pharmacies entice unsuspecting consumers with deep discounts on medications. In addition, they o�er a false sense of security when in fact the operation is based elsewhere and the product may be coming from a region without stringent regulatory standards. The NABP states that medicine is counterfeit in over 50% of cases when the drug is purchased from internet sites that conceal their actual physical address. Unfortunately, many consumers are not aware that many of these low-priced drugs may contain substandard active ingredients, or that they are coming from an unregulated region. The FDA has released a consumer safety guide entitled ‘Buying Prescription Medicine Online: A Consumer Safety Guide,’ which cautions consumers of the dangers of purchasing pharmaceutical drugs from internet pharmacies that are not VIPPS-accredited. In Europe, there have been several associations and initiatives, usually formed by a cross-section of European stakeholders from a variety of backgrounds, giving advice about buying medicines on the internet. Their key activities include campaigning for the safer use of unlicensed or o�-label medicines and also the exclusion of counterfeit and substandard medicines from the supply chain, raising public awareness around such issues, and promoting e�ective legislation

medicines.

internet drug source that is legal, safe and meets your needs, such as convenience

businesses out there, but there are also

Medicines Online: The Control of a New Channel

“rogue” sites - online pharmacies (really pretend pharmacies) that are out to scam you. Fake online pharmacies and the products they sell are an escalating public health threat. While studies suggest that over 50% of medicines purchased from unregulated websites

the number of online pharmacies has increased in recent years to meet consumer demand. A recent review by the National Association of Boards of Pharmacy (NABP) has shown that as few as 3 per cent of websites selling prescription drugs are legitimate pharmacies, and up to half o�er foreign or non-FDA-approved drugs. Many pharmaceutical companies have launched projects to meet the needs of consumers who are increasingly going online to purchase prescription medications, and public institutions are taking measures to make buying drugs online secure, for example, by looking

Sites® (VIPPS®). To become VIPPS®-accredited, an online pharmacy must meet several privacy, security and quality-assurance requirements. Buyingfrom a VIPPS®-accredited site will help

ensure patients are getting legitimate medication and that personal health

With the proliferation of fake online pharmacies, it is important that consumers know which sites are legitimate. After a recent review of more than 10,000 internet outlets sellingprescription drugs, NABP listed almost 97 per cent of the sites as “Not

Recommended” because they did not appear to meet criteria for legitimate online pharmacies.

On the other side, consumers recognise

legitimate and fake pharmacies, yet they still may behave in ways that put them at risk of receiving counterfeit medicines. A 2011 survey of 1000 men found that

if an online pharmacy is legitimate, yet more than one in three would consider purchasing ED medicines based on an online search.

In health, as in other sectors, the internet has changed our purchasing behaviour: we are now able to compare prices easily, get advice from blogs, and buy drugs from other parts of the world. But when buying medicines online, it is even more important to be careful, because our health can be put at risk by a wrong click. Before we buy a medicine online, we should check at least if: 1. The online pharmacy is asking for

a questionnaire, but this should not be enough. 2. The pharmacy is licensed in the state where is located.

enohp a fo ytilibissop eht reffo yehT .3 conversation with a pharmacist.

uoy fi ot klat ot nosrep a evah yehT .4 have a problem.

As people usually think that online prices will be lower than those at the local pharmacy, it is also important to compare prices, because they often vary between di�erent pharmacy chains, websites, and even a single chain’s stores and website. For instance, the costs of brand-name drugs in many other countries may be substantially less than they are in your own country. On the other hand, some drugs are also available in other countries and not in your own country, or do not require a prescription in other parts of the world. In such cases, although it seems that

MEDICINES ONLINE: THE CONTROL OF A NEW CHANNEL

the patient has the responsibility to buy securely, there should be other measures to take from the public institutions.

EU Directive 62/EU/2011 introduces tougher rules to improve the protection of public health, o�ering, among other things, an EU-wide logo to identify legal online pharmacies. This would make it easier to distinguish between legal and illegal online pharmacies throughout the European Union. Also, there are other signs of an unsafe website:

ytilauq nwonknu htiw sgurd sdnes tI • or origin.• It gives the wrong drug or another dangerous product for your illness.• It doesn’t provide a way to contact the company by phone.

yllacitamard era taht secirp sreffo tI • lower than the competition.

noitpircserp lles ot reffo yam tI • drugs without a prescription—this is against the law!• It may not protect your personal information.

Buying fake medicines online is not only a question of health, which is the more important topic, it also increases the risks of credit card fraud, identity theft and malware viruses. In addition, users may not be aware that when buying these medicines they directly support organised criminal groups.

There are other initiatives like Operation Pangea, which is an international week of action targeting websites which illegally supply dangerous medicines.

Operation Pangea VI is the largest internet-based action of its kind targeting the international black market of illicit medicines. This year, it spanned 100 countries and resulted in 58 arrestsworldwide and the seizure of 9,895,926 million potentially dangerous medicines worth some USD $41,104,386. The global endeavour involved police, border security and national regulatory authorities with the support of internet service providers, payment systems providers, and delivery services.

Of particular concern are websites that use questionnaires to determine the appropriateness of prescribing drugs that patients have not received before. Unlike in the traditional relationship between a patient and his or her physician, many online practitioners issue prescriptions to a patient for the

or any form of direct contact. Patients are therefore more likely to receive an inappropriate drug and to place themselves at greater risk of side-e�ects and drug interactions. By avoiding the

seeking to obtain a drug without having to see a practitioner, a patient may

a contraindication to the drug. To address this concern, in June 1999 the American Medical Association formally adopted the position that any healthcare practitioner who o�ers a prescription to a patient solely on the basis of an online questionnaire without having ever examined the patient generally has not met the appropriate medical standard of care. Therefore practitioners can play an important role by educating their patients about dangerous practices on the internet and encouraging their state law enforcement and regulatory

who engage in illegal and unethical online practices. The FDA encourages physicians and patients to report potentially illegal websites to the FDA or to the National Association of Boards of Pharmacy. The internet can serve as an important tool for providing health-related products, services, and information. However, as with any tool,

new or old, consumers must use it wisely. Until appropriate safeguards have been implemented, patients and practitioners should be cautious.Foreign websites pose other potential

sites are more likely to raise safety concerns about contamination or subpotent strengths resulting from poor manufacturing or improper storage conditions during distribution.

Drug packages only equipped with barcodes are not unique for each product and they are easy to copy. RFID tags, on the other hand, are

harder to copy or tamper with. By using RFID tagging as well as tracking and identifying the drugs on an individual basis, the likelihood of a counterfeit

Authorised drug ingredient manufacturers tag all their ingredients with RFID tags before distribution to the pharmaceutical companies. As the drugs are manufactured, the tags of the ingredients are scanned and reported. Information about medicament ingredients as well as a serial number and other essential product information are added to an RFID tag that is attached on the package of the drug. Now the drug package tag contains information not only about its own origin, but also about the ingredients and the amount of each ingredient in the drug. The information on the tag can be converted into a so-called ePedigree

with more and more information about the events on the drug’s journey through the supply chain - all the way from the factory to the pharmacy or hospital.

Scanning the tag and analysing the ePedigree allows the wholesalers and pharmacists to determine the identity and composition (and dosage) of ingredients in the drug, as well as its

information like colour, size, weight and shape of the pills can be helpful in detecting counterfeits. Information on the tag about manufacturing date and expiration date makes it hard to re-label products with a later expiration date. The RFID reader will give an alert if the drug has expired. Last but not least, if a suspected counterfeit drug is detected and reported, the product recall can be

to the RFID tracking system. Tagging drugs with RFID will make the supply chains safer and ensure that patients get the right treatment. And, as a bonus, RFID will also be an e�ective weapon against theft and shrinkage, both in the

Marga RomoInternationalSales Manager Nekicesa.Marga Romo iscurrently InternationalBusiness Manager in Nekicesa and is responsible for the expansion in Europe and the online strategy of the company. She has experience in the sales and marketing area in many sectors such as FMCG, automotive and pharmaceutical. She belongs to the innovation committee of Nekicesa, leading projects concerning external communication. Email: mromo@nekicesa.com

supply chain and at the end destination. Although e�orts by public-private

partnerships such as IMPACT have improved the enforcement of antipiracy regulations against online drug sellers, the future of such enterprises are bleak in the face of the seemingly inexhaustible and expanding criminal enterprise. Instead, what is needed is comprehensive global health policy that advocates for active and real-time online surveillance, regulation of marketing by illicit sellers, coordinated global health governance amongst private and public sector entities, consumer education and awareness regarding potential risks, and a commitment by industry and national health systems to improve equitable medicines access. Without comprehensive interdisciplinary e�orts, the global online threats to health will continue to grow and put patients at considerable risk of avoidable harm.

MEDICINES ONLINE: THE CONTROL OF A NEW CHANNEL

Solutions & Innovationt. +34 91 814 91 44f. +34 91 814 90 96Ctra. Navalcarnero a Chinchón (M-404), km 21,2. 28971 Griñón (Madrid). Spain

www.nekicesa.com

Anticounterfeiting featuresTamper evidence

Track & TraceSerialization

FOLDING CARTONS FOR THE PHARMACEUTICAL INDUSTRY

The more valuethe contents have,the more importantthe package becomes.

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