Ley N. It also resets the requirement of the operating health approval, prior to the initiation of the activities, and having had a previous inspection to verify the accomplishment of the actual legal devices. The law also incorporates three specific chapters about access, rational use of pharmaceutical products, medical devices and health products, as well as a chapter on research. Su reglamento, aprobado por Decreto Supremo N. La Ley N.
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In cases 7. Counterfeit medicines are a serious public health problem in Peru. A review of the data cannot determine whether counterfeit medicines in Peru increased during the study period, or if monitoring by different government health agencies highlighted the magnitude of the problem by providing more evidence.
The problem is clearly structural, since the majority of cases Most counterfeit medicines involve staple pharmaceutical products and common dosage forms.
Considerable work remains to be done to control the serious problem of counterfeit medicines in Peru. The information they provide is not entirely homogenous or standardised, which limits overall analysis. The possible health effects resulting from the use of counterfeit medicines are not addressed in the alerts.
The WHO has been receiving reports of counterfeit medicines since Since then, public awareness of counterfeit medicines has grown, 2 and it has become a major public health issue, as reflected by government initiatives worldwide in response to the problem. The issue of counterfeit medicines is so complex that different definitions are still used, or a counterfeit medicine is confused with one of poor quality substandard , a serious mistake that hampers the exchange of information between countries, and makes it difficult to grasp the true scale of a global problem.
The WHO defines counterfeit medicines as those whose labels include, intentionally and fraudulently, false information about their identity and origin. Falsification can affect both branded and generic products, and may include products with the correct or wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. According to the WHO, the highest rates of medicine falsification in the world occur in regions with the weakest regulatory and control systems, such as many African, Asian and Latin American nations and countries in transition.
In general, the deregulation of any trade or business and the existence of uninformed consumers facilitate the criminal activities of those whose sole purpose is to obtain illegitimate profits at the expense of harming consumers and the health system. In Peru, in the early s, during an economic crisis, the regulated market for medicines was replaced with an open market, in line with the neoliberal economic model of the time.
Ownership of community pharmacies was no longer the exclusive right of pharmacists, and anyone with enough capital could open a store dispensing and selling pharmaceuticals and related products in any location and without rigorous controls in place. Boticas , where the owner is not a pharmacist and pharmacies, where the owner is a pharmacist, provided the same service. This is arguably one of the main causes of the high number of cases of counterfeit medicines found in the legal supply chain today.
Attempts to resolve this problem include Law No. This situation has caused serious public health problems, including treatment failure, possible cases of added contaminants 13 and even death. It has also resulted in the deployment and disbursement of often scarce resources, a loss of faith in health systems, distrust of medications and even the failure of major global health initiatives such as the fight against malaria.
Inspectors from DIGEMID and regional health institutions carry out inspections and spot checks of pharmaceutical products in pharmaceutical and non-pharmaceutical establishments , and also receive counterfeit drugs seized by other regulatory authorities the national police, customs, etc.
Any suspected deficiency or observable abnormality in a product leads to its seizure, and its authenticity is then verified with the holder of the relevant marketing authorisation. If the suspected counterfeiting is confirmed, samples are transferred to an official control laboratory for completion of the relevant physical, chemical and microbiological analyses. All documentation and the case history is referred to the DIGEMID Alerts Committee so they can approve the publication of an alert on the institutional web page and initiate internal and external dissemination of information.
The ultimate aim is to draw attention to the situation of counterfeit medicines in Peru and highlight the efforts of various state institutions headed by DIGEMID.
A counterfeit medicine is a product improperly manufactured, in a deliberate and fraudulent manner with respect to its identity or its origin.
Counterfeit medicines may include products with the correct ingredients or the wrong ingredients, without active pharmaceutical ingredients, with insufficient or incorrect active pharmaceutical ingredients, or with falsified packaging or labelling. Medical devices, herbal products and cosmetic products were excluded, as were cases related to quality, general safety or regulation eg, products without sanitary registration. The following data were extracted from the alerts:.
Publication date of the DIGEMID alert: so that the date of each counterfeiting case could be identified and its impact over time determined. Medicinal product: this allowed the identification of medical products being counterfeited, if it was on a regular basis, to which therapeutic group it belonged, etc. Batch number: this detected if the same batches of medicinal product were seized more than once.
Pharmaceutical dosage form: so that it could be determined which pharmaceutical dosage forms were being regularly falsified. Establishment or place where seizure took place: this identified the types of establishments involved in the sale of counterfeit medicinal products and the geographical spread of cases across Peru.
Seizure promoter: this indicated which authority assisted the seizure of the counterfeit medicinal product. Examination of data concerning the establishment where the counterfeit medicine was found allowed the type of establishment to be categorized into one of three groups as follows:. Specialty stores: connected to a public health establishment for the storage and distribution of pharmaceuticals and related products.
Laboratory: engaged in manufacturing, packaging, bottling, conditioning, reconditioning, quality control, storage and export of pharmaceuticals and related products. Non-pharmaceutical commercial establishments: any authorised commercial establishment that is not a pharmaceutical establishment. The results are distributed across the 24 regions of Peru and Callao Constitutional Province so the geographical spread of the falsification of medicinal products can be determined.
This information was included in the analysis. All counterfeit medicines were classified according to the WHO Anatomical Therapeutic Chemical Classification System ATC , where medicines are grouped into five different levels; the first three levels were used in this review.
The first level classifies the medicine according to the system or organ on which it acts, the second level classifies the medicine according to its therapeutic subgroup and the third level classifies the medicine according to its pharmacological subgroup.
Medicines with the same batch number as a previous alert are not taken into account so as not to bias results. Each counterfeit medicinal product was categorized into one of four groups: does not contain any active ingredient, contains active ingredients other than those stated on the label, contains the active ingredient at a different dosage to that claimed on the label claims or DIGEMID assessment result missing in the alerts.
Analysis and drafting the work was carried out by the first author, followed by verification and reconciliation of the results by the other authors.
A total of cases of counterfeit medicines were identified see online supplementary table S1. Of these, cases In the remaining Overall, Type of establishment or business associated with the possession or sale of counterfeit medicines. Regarding the region where counterfeit medicines were seized, Lima province had the highest number of cases with Interestingly, no cases were reported in the Huanuco or Tumbes regions. More details are shown in table 2.
Number of cases of counterfeit medicines according to the geographical location where they were seized and regional population. Regarding the institutions whose actions ultimately resulted in the counterfeit medicine alerts, cases In Interestingly, monitoring activity increased with decentralisation, resulting in greater effectiveness, as can be seen in figure 3.
A total of cases of counterfeit medicines had batch numbers included in more than one alert, many of them in different years. The numbers of cases of counterfeit medicines classified according to the organ or system on which they act, and the therapeutic and pharmacological subgroups of the ATC code are detailed in table 3. Among the therapeutic subgroups, painkillers were the most frequent counterfeit medicines, representing Twenty-six different dosage forms were identified in the study period, the most common being tablets including coated and chewable , with a total of cases A total of cases It is noteworthy that in most cases , Regarding the type of establishment involved in the possession or sale of counterfeit medicines, cases DIGEMID alerts are a valuable resource for warning the general public about the safety of some supposed medicines and related products.
To be effective and efficient, the alerts should provide detailed, homogenised and standardised data. It is worthwhile assessing the impact of the alerts on efforts to control and minimise the risks associated with the use of counterfeit medicines.
This review demonstrates that there is a substantial problem regarding counterfeit medicines in Peru. A troubling finding in this study is the extent to which the medicine supply chain in Peru is compromised, with the highest rate of counterfeit drugs found in pharmaceutical establishments pharmacies and boticas : This situation is particularly worrying since, according to the Institute of Statistics and Informatics of Peru INEI , the Peruvian population mainly relies on pharmacies or boticas for healthcare.
This situation requires the active and joint participation of regulatory authorities and institutions representing the pharmaceutical establishments. Ways to solve the problem would be to: i grant a leading role to the pharmacist, who should procure medicines from recognised and reliable sources; ii warn patients against acquiring medicines from informal establishments or places including the internet ; iii ensure that distributors buy products from approved suppliers; iv check the alerts on counterfeit medicines issued by health authorities; v be vigilant for products with suspicious features; vi collaborate with the pharmaceutical industry, distributors and health authorities to establish safety procedures to prevent violations of the legal supply chain; vii make use of available technology for the safe management and traceability of medicines; and viii provide training and safety refresher courses in the workplace, with any suspicious activity or product reported to health authorities.
No less worrying are the cases involving non-pharmaceutical outlets, and the cases of unauthorised trade, which included 10 cases related to clandestine laboratories. Lima is home to As indicated by the WHO, there can be enormous variation in the incidence of counterfeit medicines within the same country, whether between rural and urban areas or between different cities.
It is especially interesting to note the effect of the decentralisation of public health surveillance powers as reflected in our findings. In , Ministerial Resolution No. In parallel, the operational role of the centralised body, DIGEMID, was reduced, as it concentrated more on other functions including coordination.
These results partly reflect the most frequently consumed medicines in Peru, as reported in the study by Meza-Cornejo et al , 32 which according to the IMS Health is likely to remain the same in the near future. Modern analytical methods have already been adapted to identify counterfeit medicines, leading to faster and more effective results and more timely action and communication by health authorities. In this way, the alert system is not only informative, but also becomes an effective tool.
The liberalisation of the world economy, with fewer commercial borders and a growing impact of the internet on medicine advertising and trade, demands global measures against counterfeit medicines. Solutions include an internationally accepted standard terminology for improved information management, transparency surrounding and identification of brokers and commercial intermediaries, legislative and regulatory harmonisation and the implementation of tracing systems.
Although the DIGEMID alerts do not provide data on the issue, trade in counterfeit medicines over the internet is a major global problem particularly in developed countries. Continuing the work of inspection is vital. The magnitude and nature of the problem require a thorough analysis within regions or countries as well as globally. It is necessary to evaluate the measures, activities and behaviours WHO guidelines 53 responsible for the high levels of counterfeit medicines in the pharmaceutical market in Peru, with an obvious and worrying violation of the legal supply chain.
All aspects of the problem need to be addressed, from health to economic, 7 legal, 55 technological, social and cultural perspectives, which could lead to more viable, effective and efficient strategies to combat this scourge. A review based only on data from alerts cannot indicate the extent to which counterfeit medicines have penetrated the Peruvian pharmaceutical market, or their typology. Nevertheless, the results of this study give an idea of the magnitude of the problem, and suggest that a rethinking of strategies is required to effectively combat the trade in counterfeit medicines in Peru.
Moreover, it is important to recognise that the situation could worsen, as is occurring in many African countries. In light of the results, it is clear that the falsification of medicines in Peru is currently a serious public health problem. It cannot be determined from a review based only on the data provided by alerts whether the amount of counterfeit medicines increased in Peru during the study period, or whether the magnitude of the problem was merely highlighted by the increased activity of different public health surveillance bodies.
The types of counterfeit medicines found in Peru are characteristic of developing countries. The problem is clearly either structural or due to pharmaceutical policy, since the highest incidence of cases of counterfeit medicines leading to DIGEMID alerts involve legal supply chains.
Most cases of counterfeit medicines were found in large cities, and the decentralisation of health management has had a significant impact on inspections.
Counterfeit medicines in Peru: a retrospective review (1997-2014).
Christian R. Laura R. Participaron del estudio 4. De los 4. Participation included 4, persons 18 years and older in 13 cities in Peru, categorized as Lima, large cities, and small cities.
Counterfeit medicines in Peru: a retrospective review (1997–2014)
In cases 7. Counterfeit medicines are a serious public health problem in Peru. A review of the data cannot determine whether counterfeit medicines in Peru increased during the study period, or if monitoring by different government health agencies highlighted the magnitude of the problem by providing more evidence. The problem is clearly structural, since the majority of cases Most counterfeit medicines involve staple pharmaceutical products and common dosage forms. Considerable work remains to be done to control the serious problem of counterfeit medicines in Peru.
LEY N.º 29459 - LEY DE LOS PRODUCTOS FARMACÉUTICOS, DISPOSITIVOS MÉDICOS Y PRODUCTOS SANITARIOS