医药行业中的逆向物流文献翻译

毕业论文中的外文文献及翻译医药行业中的逆向物流

外文文献：

Reverse Logistics in Pharmaceutical Industry

Abstract:This study looks into detailed aspects of reverse logistics on the issues that pharmaceutical organizations face. Reverse logistics is now following a trend where it is seen as a competitive advantage and a source of potential revenue. The perception is changing from the tradition of returns being a barrier to profits and a cost burden. Also the sustainability issue being addressed by reverse logistics is beneficiary to pharmaceutical organizations with end-of life products. The discussion contributed to the market perspective and to back up the misconception of returns being a cost issue, when it maintains market share by retaining quality. The perception of those industry practices on the environment and sustainability practiced by organizations has shown less enthusiasm than once thought.

Keywords-Supply chain management, reverse logistic, pharmaceutical logistics, pharmaceutical reverse logistic.

1.Introduction

In common scenario a product or service is developed to be manufactured or created and go through the supply chain (e.g. manufacturer-wholesaler-retailer) to be sold to a consumer. Supply chain is integrating more activities than those concerned with supply chain alone like including service and product recovery. Here we will focus on especially reverse logistics, i.e. the handling of products back to manufacturer’s or producer’s end. The objective is to minimize the handling cost while maximizing the value from the goods, or proper disposal. Essentially, reverse logistics is the opposite of logistics management. Goods or materials move in the opposite direction of the supply chain, that is, from the customer back to the supplier. Products are returned to the manufacturer or retailer for any number of reasons. Some of the more common reasons are warranty failures, damaged products, product recalls, incorrect product orders/shipment, exchange of impaired products for functional ones, reusable packaging materials, product upgrading and so on. Whatever the reason, returned goods have to be processed in the best manner possible. Reverse Logistics has become a fairly serious issue in recent times primarily because retailers have been forced, due to increased competition, many forces drive reverse logistics, like, competition and marketing motives, direct economic motives

and concerns with the environment. Whatever the reason, returned goods have to be processed in the best manner possible.

Reverse logistics in the pharmaceutical industry is extreme important, not only from the economic point of view, but also from the environment as well as regulatory point of view. The pharmaceutical returns industry is worth US$2.5 billion. There is also an estimated reverse flow of goods worth US$5 billion. Some important considerations for the industry when it comes to reverse logistics are the security of the returned goods, keeping the cost low with the help of automation, traceability of the goods returned from the customer to the final stage of disposition.

2.Literature Review

During the last decade, reverse logistics has obtained focus in research and practice both. In early nineties, the Council of Logistics Management published two studies on reverse logistics. In 1992 Stock first recognize the field of reverse logistics as relevant for business and society generally. Rogers and Tibben-Lembke in 1999 presented a broad collection of reverse logistics business practices, but they had given special attention to the US experience. They found that four in ten logistics managers consider reverse logistics relatively unimportant compared to other company issues. During the last years, many articles dedicated to the optimization and management of reverse logistics appeared, like Guide et al. (2000) on the characteristics of reverse logistics for remanufacturing systems.

In terms of resource recovery, the most often described option was recycling and re-use/redistribution (De Koster et al., 2001). Products, components, materials, equipment and even complete technical systems may go backwards in the supply chain (for convenience we will use the term products to refer to all of them).

For some time we have been familiar with products being reworked during manufacturing due to unsatisfactory quality, or with good materials or components being returned from the production floor because they were leftover after production (manufacturing returns).

Defective products may be detected after they have entered the supply chain resulting in a pull back of products through the chain (product recalls).

3.Methodology

The methods to be used will be conducting a literature review throughout all the sections,

researching websites, books and academic journals.

4.Discussion on Different Reverse Logistics

4.1Pharmaceutical Industry Scenario

Pharmaceutical producers combine ingredients precisely, under specific conditions, while negotiating a maze of stringent regulations and quality controls. Companies that manufacture, move or store pharmaceutical products must meet similar demands. Many drugs are highly sensitive to temperature; some are extremely valuable; and all are subject to a complex array of government and international regulations. In the pharmaceutical supply chain, every detail counts. Pharmaceutical logistics is such a specialized discipline that drug manufacturers have long been reluctant.

But some recent industry trends are making drug manufacturers rethink their strategies. One trend is that some popular drugs are coming off patent. Without popular products to boost their bottom lines, manufacturers try to make up the difference by cutting costs. One way they do this is through cutting cost in logistics operations. In country like India, Bangladesh many drug makers still manage some or all of their supply chains internally. Whichever strategy a company chooses, its supply chain team wrestles with some highly specific challenges.

Pharmaceuticals are not like other common products. When those products are recalled or returned, they can be repaired, resold, or donated. Pharmaceuticals, in contrast, are destroyed. The need for destruction relates to the inability or difficult constraint of regulated facilities of manufacturers to ensure pharmaceuticals were handled properly after leaving their control and to ensure a secure chain of custody.

4.2Streamlined Returns

Traditionally, when returns arrive at a distributor, the distributor applies the manufa cturer’s retailer policies and pricing to ensure the pharmacy, hospital, or wholesaler receives credit for the return. Then, the distributor sends the returns to a third party returns processor for destruction. Returns arrive at distributor or manufacturer are validated, policy and pricing policies are applied, accounts are reconciled, reports are filed online for the manufacturer and the shipper, and the pharmaceuticals are destroyed. Documented proof of destruction must have to be kept for regulatory purpose. Here process has to be made to ensure the elimination of errors, duplicate processing and diverted shipment.

Not all returns are credited. But, when manufacturers do credit returns, reverse logistics have the additional challenge of ensuring that returns are authorized, quantities are validated and returns data for lot or batch number and shipper are matched against the original documentation. Returns for credit, primarily, are made by retail pharmacies or wholesalers and typically involve drugs that are three to six months from expiration, explains Larry Hruska, president at GENCO Pharmaceutical Services.

“Consolidated returns tend to arrive from a pharmacy odelivery route in a box with a few hundred bottles of all shapes and sizes,” he explains.

4.3Recalls

Product recalls are similar to returns but require additional identification and have a greater sense of urgency. Recalls and returns differ mainly because of the notification aspects; there should be protocols for notification, including business reply cards. Information regarding what has been returned need to be stored and documented for FDA and other regulated market complian ce purposes. There’s also more regulatory oversight. For example, Pharmaceuticals may need to be held for inspection by regulators. Pharmaceutical manufacturers also may need to examine samples.

“Particularly as pharmaceutical manufacturers move into the developing world—mainly Latin America and Asia—they are establishing in-country collection strategies and are consolidating shipments,” Smith says. Because these compounds are returned for destruction, the requirements for temperature control and express delivery that are present on their outbound transit are non-existent for their return. Consequently, some customers using cheaper ways of carriage, substituting ocean freight for air freight in some instances. Consolidating pharmaceuticals returns has inherent risks, however. Every handoff and each delay in the supply chain increases the chance that criminals will divert the drugs into the black market where expired products will be diluted and labeled as saleable. The risk depends upon the location of the facility and the drug.

Some 3PL logistics company handles recall solutions for medical devices, applying best practices learned in the information technology sector. They had seen several recalls that often were inefficient and poorly organized, so we built a solution for our customers to handle recalls in a more structured way. That solution consists of Recall Alliance and Recall Action, With

Recall Alliance; work with customers to build knowledge around their products and the most efficient recall procedures. The most basic level focuses on industry best practices, systems, and management. The premium level also includes readiness, audits, and certifications. Recall Alliance is in the initial stages of launch. It debuted in Europe and launches in Asia and America in 2012. Recall Action is the execution arm, ensuring access to the right logistics. There's no magic pill for dealing with those issues, but the industry has developed some effective solutions. Here's a look at the state of pharmaceutical reverse logistics today.

4.4One Batch at a Time

In a typical batch process associated with pharmaceutical reverse distribution, the reverse distributor consolidates and ships returns from pharmacies that have nothing in common other than the wholesaler they purchase products through. These products are then sent back to the pharmaceutical manufacturers in one consolidated shipment that might contain several hundred products from several hundred different pharmacies. It’s much more efficient for the wholesalers, manufacturers and reverse distributors to handle the returns this way.

4.5Managing Regulations

The interesting part of regulation is you have to maintain it all through the value chain. So when products are in their backward journey even it is for destruction it has to be regulated. In highly regulated market in addition to requiring drug makers to ship their products in country and across borders and over long distances, the pharmaceutical industry's nature stymies manufacturers with a complicated array of regulations governing transporting drugs in different countries.

The industry is also seeking global standards for tracking drug pedigrees. Different countries and U.S. states have established their own requirements for serializing drugs. This typically involves attaching a two-dimensional bar code or other device that uniquely identifies

a unit of the product so it can be tracked throughout the supply chain.

5.Conclusion

Reverse logistics in the pharmaceuticals industry works differently from many other industries. Drugs or products returned in a pharmaceutical industry are seldom repaired or resold. Instead, they need to be destroyed and disposed properly. There are various considerations to be taken into account such as

?Need for accurate tracking and visibility

?Batches and Expiry control

?Cold Chain requirements

?Proper storage and disposal

?Pedigree reporting

?Anti-counterfeiting and so on.

Reverse logistics is considered a bullet in company’s profits and an expensive process most times. Yet, it is an imperative process in modern times due to various reasons such as government regulations, growing environmental concerns, growing consumerism, and competitive advantage. An important consideration for companies is to perform the operations in reverse logistics effectively so that it reduces the cost involved.

When it comes to legal complexities, especially in the global context, the regulation states that, goods once sold by the manufacturer can be brought back only through declaration to excise authorities and proper documentation. This process is cumbersome and takes time. Non-compliance also leads to legal actions.

中文译文：

医药行业中的逆向物流

摘要：这份报告详细探讨了在医药物流各个层面上的问题。把逆向物流看作一种相对优势以及潜在收入的来源是在目前的一种趋势。这种看法是在关于回报的传统观念在盈利以及成本负担方面遇到了障碍而开始改变的。而且逆向物流对于生产临终医药产品的企业的益处这一可持续性问题被得到强调。当需要通过保持产量而维护市场份额时，会导致市场的角度以及对收益的错误理解的讨论是一个很严重的问题。对被一些组织尝试的环境和可持续问题的一些产业的惯例的察觉已经没有以往那么热情了。

关键词：供应链管理，逆向物流，医药物流，医药行业中的逆向物流

1前言：

在通常的情形下，一个产品或者一种服务被制造或者产生出来之后，会通过供应链（生产者-批发商-零售者）出售给消费者。相较于一些人文供应链仅仅包括服务和产品的回收，其实供应链包含更多的事项。这里我们将重点关注逆向物流，比如说，对返回到生产制造商的产品的处理，这项活动的目标是在最大化产品的价值的同时去最小化处理成本，或者说是恰当的处理。本质上来说，逆向物流是物流管理的对立面。产品和原材料朝着供应链相反的方向运动，即，从消费者到生产者，产品由于各种各样的原因回到生产制造商手里。一些比较普遍的原因是没能达到承诺，货品损坏，产品召回，错误的产品订单或者运送，交换损坏的产品致正常的产品，可重用的包装材料，产品升级等等。不管什么原因，被退回的商品必须以最好的行为去处理，逆向物流最近已经成为十分严肃的问题主要的原因是零售商因为逐渐增强的竞争被强迫这么做，导致逆向物流的因素很多，比如：竞争和市场动机，直接的经济动机和对环境的影响，不管什么原因，被退回的商品必须被尽量以最好的方式处理。

医药行业中的逆向物流尤其重要，不仅仅是从经济学的角度来讲，更重要的是从环境以及管制的角度。制药回报行业价值25亿英镑，而回流的产品的估计值大概为五十亿英镑。关于这个产业中关系到的逆向物流中一些重要的思考是保障被退回物品的完好，在自动化的前提下保持低成本，以及产品从被顾客退回到最终处理之间的可追踪性。

2. 文献回顾

在过去的十年当中，逆向物流在研究以及实践领域都获得了关注，在九十年代早期，

物流管理理事会发表了两篇关于逆向物流的论文。在1992年斯托克第一次认识到逆向物流领域是和商业以及社会整体上有关联的。Rogers和Tibben-Lembke 在1999年提供了一系列关于逆向物流在商业实践中的应用，但是他们把过多的注意力放在了美国的经验上，他们发现百分之四十的物流管理人员认为逆向物流相对于公司其他的问题是相对不重要的，在过去十年，很多论文致力于逆向物从资源回收,最经常描述的选择是回收和重用/再分配流出现后优化以及管理，比如说Guide et al.发表的关于逆向物流在产品再造系统中的角色从资源回收的角度上,最经常描述的选择是回收重用/再分配，产品部件，物料，装备甚至完整的技术系统都可能会在供应链中反向进行（方便起见我们将用期间产品区代指他们）。

在很长的一段时间内我们已经熟悉了产品会因为是生产后的残余物（生产退回）由于不令人满意的质量或者材料或部件质量问题被从产品层退回。

有缺陷的产可能会在进入供应链之后被发现，从而导致了产品通过供应链被退回（产品召回）。

3．方法

被用到的方法包括进行在此领域的文献回顾，互联网调查，图书以及期刊

4. 对不同的逆向物流的讨论

4.1 医药物流总体上的概括

医药生产企业在一系列严格的监管和质量控制的前提下，将各种成分在特定的条件下精确的结合在一起。生产企业以及运输或者存储医药产品的企业必须达到相似的要求。有一些药品对温度很敏感，有一些则很珍贵，以及所有的药品都要经过一系列复杂的政府以及国际管制。在医药物流供应链中，每一个细节都有重要作用，医药物流如此特殊的规定以至于药品生产商一直以来都缺乏积极性。

但是最近的一些行业趋势使药品生产商重新思考了他们的策略。其中的一个趋势就是一些流行的药品不受专利的限制，制造商尝试通过消减成本来创造优势，其中一个方法就是通过减少物流操作的成本来接解决。在印度巴基斯坦很多药品制造商仍然控制部分或者全部的供应链，不论企业选择哪一种战略，他的供应链团队都会纠结于一些非常具体的挑战。

医药并不像是其他普通的产品，当这些产品被回购或者退回时，他们可以被修复再销售或者捐赠，而医药则想反，为了确保药品在离开他们之后被合理的控制以及确保安全的保管链，无法或者很难遵守管制的生产设备需要被解除。

考虑到温度之后重新在这个角度思考。储存一部电视机或者其他的商品在任意的温度是不

会有害的，但是，近半数的新药进入市场之后，保持精确的温度是十分必要的。温度失去控制可能会降低药效，简短保质期，或者改变一种药性使其变得有害。在医药行业中，证明的产销监管链跟踪和追溯要求是十分严格的，这只会让见惯链更加庞大，但是，从制造商的角度来说，产销监管链一旦在药品达到他的目的地便不再起作用。因为产品的高价值性，医药收益相对于其他的产品同样需要更加健全的安全保障。

4.2简化退换货

传统上来说，当退货到达分销商，分销商将会依据制造商的政策及奖励去确保药店，医院，或者批发商收到嘉奖，之后，分销商将退货送到专业第三方去销毁。退货到达分销商或制造商之后得到验证，政策和定价政策得到应用，账户被对账，网上提交报告被提交给制造商和托运人，药品被销毁。销毁的证据记录必须因为管制的目的而被保存，这些过程必须确保错误被消除，重复处理和分流装运。

4.3 召回

产品召回类似于退货，但需要额外的证明，并有更大意义紧迫性。召回和退货最主要的区别在于通知方面：回购需要有通知的协议，包括商业回函卡。关于被退回的产品的信息应当被保存以及到食品药监局或者其他的管制药品市场目的的机构去存储或者记录。还有更多的监管。例如，制药可能需要监管机构查阅，制药商也可能需要检查样品。

“尤其是制药企业正在往发展中国家流动，尤其是拉丁美和亚洲，他们正在建立国家收集策略和巩固出货”史密斯说。因为这些产品收回是为了销毁，因此他们在回流中其对外交通上存在的温度控制和快递是不存在的。从而一些顾客使用便宜的运输方式，在一些情况下，他们会用海运代替空运，但是无论如何，改进药品召回是固有风险的。供应链中的每一个切换和每个延迟都将增加犯罪分子将药物转移到黑市把过期产品摊薄，并标记为可售的商品的机会。而奉献成都取决于设备和药物的地点。

一些第三方物流企业用医疗设备处理解决召回问题，并且他们在信息技术领域所学到的最佳尝试，他们已经注意到一些召回是不充分而且组织散乱的，所以我们为我们的顾客去更有效的处理召回产品构建一个方法。这个解决方案包括召回集团和召回行动，召回联盟即，和消费者合作去围绕产品和最有效的召回程序构建方案。召回联盟是最基本的要素，召回行动是执行武器，并确保召回产品进入正确的物流。在处理这些问题时没有神奇药丸，但是企业可以创造出一些有效的解决方案。

4.4一次性处理一个批次

一个典型的批处理过程与逆向物流相联系，逆向物流分销商从药店综合以及运输退货

和从批发商那里运输完全不是一回事。这些产品被用一种可能包含从数百家药店送来的数百种产品以综合运输的方式退回药品生产企业，而从如果由批发商制造商以及逆向物流经销商去处理这些问题则是一种更加有效的方式，可问题是大部分逆向物流经销商在涉及到把发放奖励作为批处理程序的一部分时都采取讨巧的方式。

4.5管理条例

监管有趣的地方是你不得不从价值链的自始至终遵守条例，所以当产品在他们被退回的途中时即使他们将要被销毁他们也将被监管。在被高度管制的市场上除了要求药品制造商在国内和长距离跨国运送他们的产品，医药行业的被一系列不同国家运输药品规则监管特性把生产商吓退。

行业也在寻求跟踪药物的全球标准，不同的国家以及洲确立了符合他们的序列化药物的标准。这通常涉及到附加一个二维条形码或其他设备，以至于一个产品单元可以在供应链被追踪。

5 结论

医药行业中的逆向物流和一些其他行业的相比有很大的不同。从医药产业中被退回的药品或者产品很少会被维修或者重新销售，相反，这些商品需要被销毁或者妥善的处理，这其中有很多因素需要被考虑到，比如：

?需要精确的追踪及可预见性

?需要成批量以及有效的控制

?需要冷链物流

?需要合适的储存和处理

?需要谱系报告

?需要防伪以及其他手段

逆向物流被认作是一个公司利润中的炮弹，它同样在大多数时候被看作是一个昂贵的程序，然而，由于各种各样的原因，例如说政府管制、逐渐关注的环境因素、逐渐增强的消费者之上理论、以及相对优势理论，这些原因使得逆向物流成为现代社会不可缺少的一部分，公司必须去考虑的一个重要因素就是必须有效的进行逆向物流操作从而使其能够减少其所涉及的昂贵成本。

当考虑到法律尤其是全世界的法律的复杂性时，法律条文是这样的表述的：商品一旦被生产商销售，他只有通过向消费税当局宣布以及需要合适的文件才能被召回，这一过程是麻烦而且耗费时间的。而不服从的违规行为同样也会导致法律的制裁。