E-Commerce of medicinal products: risk E-Commerce of medicinal products: risk for patientsfor patients

““Nescencia necat”Nescencia necat”

Speaker:

Chief of the Health Area. Subdelgación del Gobierno en Alicante, SpainChief of the Health Area. Subdelgación del Gobierno en Alicante, Spain

Nescencia necat: Ignorance kills

• Internet is just a comunication media (it is not good or evil itself)

• In internet we have:– Information– Deformation– Formation

• E- commerce in internet has advantages and disadvantages

• Knowledge is always the best tool in health risks prevention

Medicines are “useful poisons”• Are poisons because:

– Most of them produce changes in our physiology– Most of them have adverse reactions– Most of them interact among them, with foods and other

products– Most of them have a narrow therapeutic margins

• Are useful when:– There is a correct disease diagnose– There is a correct prescription– There is a correct manufacturing, quality control, handling,

distribution and selling of the medicinal product– There is a correct pharmaceutical advice– There is a correct pharmaceutical dispensation in de medicine

adquisition– There is a correct patient fulfillment

• Risks for patients come from the nonfulfillment of Risks for patients come from the nonfulfillment of each of these stepseach of these steps

• In most countries selling through internet is forbidden• Many countries (specially in the developing ones) have no specific regulations• Some countries have regulated “internet pharmacies”. But, unfortunatelly, almost

60% of those pharmacies do not comply the regulations• Medicine e-commerce usually do not respect the basic rules of good

prescription/ pharmaeutical dispensation practices• Internet selling is the main origin of counterfeited drugs (around 75% of offered

medicines are fakes)• Many countries have no strong pharmaceutical border control• Direct fight against internet illegal commerce is very difficult: as web pages can

not always be easily tracked, are not placed in the countries with specific regulations, can change their domains very fast, etc.

Medicine selling situation in internet

Most commons frauds in internet

• Inadequate or illegal manufacturing facilities• No active ingredient in the product (WHO

Occidental Pacific office, found almost 50% of antimalarial drugs has no A.I.)

• Incorrect dosage• Substitution of the a.i. (very common in

anabolics, counterfeited vegetal medicines, etc.)• Toxic compounds in the medicine (glicols,

inorganic dyes, etc.)• Present a medicinal product as a food

suplement or “nutraceutic”• Fake leaflets or in an unkwon language

Patient risks

• Entering of counterfeit products in the legal medicine selling chain

• Trust incorrect, incomplete or spurious information• Consider internet information/medicine acquisition as a

good alternative against a direct diagnose/prescription/pharmaceutical dispensation

• Get medicines in bad conditions (expired, altered, contaminated, etc.)

• Get counterfeited drugs• No way to assure their health and consumer rights• Commit a crime or felonyPatients can suffer: adverse reactions, poisoning,

affect disease control, overdose, act as a guinea pig, unkonwn cross-reactions, etc.

Why people buy medicines through internet?

• They are not aware of the risks and they believe that as consumer have enough knowledge

• Search for cheapest medicines, and 24 hours available

• By-pass the prescription• Search of medicines hard to get in their

countries (for illegal use)• Automedication, and lost of confidence in their

sanitary professionals• Search for non yet registered/available

medicines in their countries• Search of miracolous solutions

Some examples of what tries to enter through Alicante´s border

What can be done?• Political, administrative, security and judicial authorities must be concern that medicines are not

just goods under normal commercial rules• Internet can be a source of information and formation. But we must be deeply aware of the risks

of the e-commerce of medicines and sanitary products without a deep control in all the steps of the chain: from the manufacturer to the dispensation to the final user. It is a must to mantain the security and quality control. And that must be a international effort like it has been done in counterfeit drugs fight (IMPACT)

• From the Spanish experience:– Pharmaceutical border control and inspection is an optimal tool to control the entering of

medicinal products (European Union must consider extend a complete pharmaceutical border control, as it is harmonized for animal origin products)

– A regulated and deeply controlled market, with pharmacies authorized facing only sanitary considerations

– Be careful when trying to regulate e-commerce as a source of medicines (it does not matter if they are prescription or non prescription ones)

– A complete agreement among all the interested actors in medicines must be carried out. For example in Spain: Pharmaceutical representatives, industry, distributers and Regulatory Authorities (AEMPS) made a global agreement. And also there is a continous collaboration among official authorities, pharmaceutical inspectors (in all areas), and security forces to fight counterfeits and illegal commerce

– Strengh the penalties for missuse or illegal offer of medicines– Increase the consumer knowledge about medicines: risks and benefits– Be aware the by-pass systems: like present products with a clear medicinal effect as foods

or nutritive substances; or consider that products from vegetable origin (natural?) are of low risk; authorize or allow people witouth enough qualification to promote or even prescribe products for health use

– Be deeply aware that the close future of health is realted to with the use of sanitary product, that can be also fakes

– Try to isolate the chain of legal offer of medicines, from the counterfeits wave

An always remember

-Internet is widespreading-It is a valuable tool of information-You can find there everything in a ready available way-As a comunication media it can not be demonized-E-commerce is today a truth-But medicines are a sanitary tools: an “useful poisons”. There mus be a deep control before they reach the consumer. And the control has to be always in sanitary professionals hands

Because: NESCENCIA NECATBecause: NESCENCIA NECAT

Thank you very much for your kind attention, hope you liked. Thank you very much for your kind attention, hope you liked. And we can meet again soon And we can meet again soon

Muchas graciasMuchas gracias