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Counterfeit medicines, a major problem in many countries (developed and undeveloped) now a days and are progressively being furnished over the cyberspace. According to industry sources, it is estimated that between 10 -30% of all pharmaceuticals in developing countries are counterfeit, more than 10% of the global pharmaceutical market is now counterfeit. In some Asian and African countries, this figure is closer to 40-50%, As well as constituting purposely fraudulent, there is high possibilities of health damage with these medicines when treatment get failured. Medical professionals, patients should be wakeful for any unexpected results from drugs and report these to the appropriate health authorities.
WHO definition :- Counterfeit medicines are those medicines that are described as “deliberately and fraudulently mislabelled with respect to identity and / or source. Counterfeiting can apply to both branded and generic products. Counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients, or with fake packaging”.
In simplest terms, adverse drug reactions can arise from three main mechanisms: medication errors, impurities in the product, and the inherent chemical toxicity of the drug itself. Counterfeit medicines can impair patients health in two ways: individually and at the community level. Taking adulterated substances can harm an individual, from unexpected adverse reactions to toxicity or anaphylaxis. Counterfeit medicines can also be life threatening and have caused many deaths especially in Africa and Asia.
In addition to these, the believability of a National Healthcare system can be damaged if counterfeit medicines are get into the licit supply chain, which may result in to patients becoming irrationally horrific of absolutely safer treatments.
Factors connected with increased counterfeiting of drugs:
А variety of factors that are influencing for why Pharmaceutical medications are entrancing for counterfeiting. Medicaments are high value products in relation to their bulk formates, ingredients and there is infinite demand for them. Moreover, for the counterfeiter, ingredient costs can be very low if formulation is mixed with cheap substitutes or if active ingredients are omitted, Making counterfeit drugs may not require huge infrastructure or mapower needs. They can be produced at lower operational costs with limited resources. There are also no overhead costs due to GMP standards, or any other quality assurance norms since such standards are never implemented by counterfeiters and that are resulting in to huge gross margins.
А counterfeit drug has а improved capability to deceive, specially if it is imitated to make it look like the originator products and if it gets from а putatively licit source so that buyers are incredibly to be suspicious. Furthermore, the procedures by which patients get their drugs is dissimilar from that for other consumer goods they get: usually Medical practitioners prescribe to them. How ever if patients choose their own medication they may be lack the specialized knowledge to detect if the opted product they are purchased is of good quality, whether, the product is counterfeit. Other factors that are encourages counterfeiting of medicines are : - Easy approachability of global markets has made distribution of counterfeit products easier
- Easily available of various technologies to produce everything from labels to active pharmaceutical ingredients
- An raise in the self-prescribing culture and self care practices
- Lack of political will and commitment
- Lack of appropriate drug legislation
- Absence of or weak presence of drug regulation
- Weak enforcement and penal sanctions
- Corruption and conflict of interest
- Demand exceeding supply
- High prices of medicines
- Inefficient cooperation between stakeholders
- Lack of regulation by exporting countries and within free trade zones
- Trade through several intermediaries
- Impact on public health
Role Of Pharmacists:
- Pharmacists have a major role in fighting against battle against counterfeit medicines, they are trained in clinical and community pharmacy aspects
- Pharmacists must always keep an eye watch in concerning with the medicines, distribution and their usage, they must investigates all the aspects at every stage like labeling, packaging, ingredients by evaluating a sample from each batch. They must be exceedingly careful while delivering formulations to the pharmacies. If in any case pharmacist may founds any un ethical medicines they immediately report to concern authorities.
- Pharmacists must be aware of ounterfeit medicines and create required awareness among the public and patient groups to elucidate the adverse effects of counterfeit medicines and they must explain the signs of identifying the counterfeit medicines.
- Always purchase the medicines from a authentic sources so that the probability of being involved by these counterfeit medicines can be lowered.
- Pharmacists must ensures traceability for better medication, the safety of medicines that are provided to patients.
Tips for evaluating product sources and detecting counterfeit medicines:
- Establish the integrity of the source prior to requirement. If possible, make out a list of authenticated suppliers
- If a product is being offered up at an outstandingly at cheaper price or in unusually large quantities (of the same batch number), treat with extra caution
- Consider developing a list of key pharmaceutical products that will not be purchased from sources other than the manufacturer or authorised distribution channels
- Check for an altered expiry date. Counterfeiters commonly purchase ‘short-dated’ products and then alter the labels
- Check with the physical characteristics of the product. Look at colour, tablet or capsule markings, shape and thickness of the medicine.
- Notwithstanding the obvious differences in the packaging of legitimate parallel imported products, look for signs of a removed or switched product label. One common practice by counterfeiters is to remove the original label and replace it with a counterfeit label. To do this, they use lighter fluid, acetone or some other solvent which may leave a tacky residue on the container. Also, the label may be faded or discoloured along the edges due to the solvent
• Check for subtle changes in the product’s package (compare with previously purchased products)
- Examine the package for differences in paper texture, size and thickness of the labels, also the gloss or finish on the paper. Look for differences in fonts and font sizes, print colour or raised print.
- Examine all printing on flaps and surfaces of the box in comparison with previously purchased products where possible. Look for overt security features such as holograms or colour shifting inks. Finally, look for breaks or tears in the sealing tape and seals. • Look for variations in the size of the container (compare with previously purchased products)
- Listen to patients to Counterfeit medicines around the world are often first detected by patients
There are several advanced packaging technology that may prove helpful in combating this problem like
- Holograms
- Pilfer-proof packing
- Radio Frequency Identification (RFID)
- Electro-magnetic identification (EMID)
- Acousto magnetic identification (AMID)
- Bar code
- Pharma code
- Security label
- Pedigree system of labeling
- Verification Systems
Source: Ref 1 & Ref 2 This article is for information purposes only. Readers must take full responsibility of use of information provided. The information compiled here is resourced from various sources, which may change without prior notice and depend on market dynamics. HarNeedi.com will not be responsible for any of the damages and claims thereof. For more articles “Click Here” or Log on to www.HarNeedi.com.
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