Pharmaceutical logistics
Pharmaceutical logistics includes all logistical processes that result from the special requirements placed on pharmaceuticals .
From the special regulations and laws it follows that the primary goal - in contrast to conventional logistics - is not only the efficiency of all logistic processes, but especially their transparency, reliability and compliance with regulations. The consequence of this is that the logistical mandate of the six R rule of logistics still applies, but must be interpreted under these conditions.
meaning
Pharmaceutical logistics is a special sub-area of logistics and basically includes all logistical processes in the pharmaceutical industry and its subordinate distributors. This ensures the availability of drugs and the active ingredients and ingredients required for the manufacture of these drugs along the entire supply chain . The availability of pharmaceuticals is based on the procurement and distribution strategies of market participants such as pharmaceutical companies , wholesalers and pharmacies .
According to Section 2 AMG, medicinal products are the following substances or preparations made from substances:
- which are intended for use in or on the human or animal body and are intended as agents with properties for healing or alleviating or preventing human or animal diseases or pathological complaints, or
- which can be used in or on the human or animal body or administered to a human or animal in order to either a. restore, correct or influence physiological functions through a pharmacological, immunological or metabolic effect, or b. make a medical diagnosis.
Due to the special and complex handling and the sometimes very different chemical and physical properties of drugs, pharmaceutical logistics require strict regulations that specify how drugs must be logistically differentiated. Warehousing , transport and handling are subject to rules that companies must implement in order to protect both drug quality and the environment. This requires individual and controllable processes and structures.
In addition to the differentiation of pharmaceuticals according to chemical and physical properties, drugs can also be differentiated on the basis of legal requirements. A distinction is made between prescription-only (Rx), pharmacy- only ( OTC, from English over the counter 'over the counter' ) and over-the-counter products. Special regulations also apply to narcotics , drugs that are subject to cold and cold chain requirements, or radioactive drugs.
The legal regulations as well as the special handling (storage and transport) have a direct effect on the logistical processes and provide framework conditions. For example, narcotic drugs must always be stored separately from normal drugs in safes ; In the case of medicinal products subject to cold chain requirements, however, temperature tolerances must not be exceeded or fallen short of.
Goals of pharmaceutical logistics
From a logistics perspective, two main goals can be defined in pharmaceutical logistics. On the one hand, the quality of the pharmaceuticals must be ensured across the entire supply chain (PharmaChain). On the other hand, logistical processes have to be handled without posing any threat to the environment. In order to be able to carry out standardized logistical processes with the lowest possible risk, corresponding standard operating procedures (SOPs) have been introduced in the pharmaceutical industry .
In order to be able to optimally plan both the transport and the storage, pharmaceutical logistics companies or logistics departments in companies are dependent on being able to call up precise information about the pharmaceuticals. To do this, new articles must be precisely created in the system and linked to the central pharmaceutical number (PZN).
Systems used by companies across the entire supply chain are always validated and qualified. In order to be able to guarantee complete qualification, the pharmaceutical industry relies on the V-model known from the IT industry, for example in the qualification of warehouses .
Branch
In general, the pharmaceutical industry is in constant growth. Worldwide sales amount to 1,025 billion euros. In Germany, total sales of EUR 41.5 billion were recorded in 2017, which corresponds to a growth of 5 percent. Employment also rose by around 12.1 percent from 2010 to 2016.
According to a study by Miebach Consulting on the subject of pharmaceutical logistics from 2016, end-to-end visibility , optimization of the sales network and improved forecast accuracy compared to the study results from 2012 are among the greatest challenges in pharmaceutical logistics for participants. In addition, the focus for companies is also on the complete implementation of shipment tracking (Track & Trace) and the prevention of counterfeit drugs through serialization.
In addition to pharmaceutical manufacturers, wholesalers and pharmacies, the main players in the pharmaceutical industry include logistics service providers and re-and parallel importers.
Manufacturer
With the production and marketing of pharmaceuticals, pharmaceutical companies are at the center of the pharmaceutical sector. In general, the group of manufacturers can be further divided into research-based manufacturers (e.g. Novartis ) and generic manufacturers (e.g. ratiopharm ). In contrast to research-based manufacturers, generics manufacturers are characterized by the fact that they invest only limited amounts of money in research and, after the expiry of patents and document protection from research-based manufacturers, produce drugs with the same active ingredients. With the manufacturing license (in accordance with Article 40, Paragraph 1, of Directive 2001/83 / EC ), pharmaceutical manufacturers also partly have the same license to sell and trade drugs.
Pharmacies
Pharmacies are the last step in the pharmaceutical supply chain before dispensing pharmaceuticals to the patient. In addition to finished medicinal products, prescriptions (custom-made products) and defects (“prescription in advance”) are also offered. Most, if not exclusively, deliveries to pharmacies are made by pharmaceutical wholesalers. This is particularly due to the fact that wholesalers are able to carry out more cost-effective transports through excellent distribution networks. In addition to a basic inventory that must be available in pharmacies, pharmacies can generally plan their needs well due to the fast delivery times provided by wholesalers. Computerized warehouses in pharmacies ensure that drugs can be stored and retrieved automatically and give an overview of low stocks. Due to the prevailing distribution structure in Germany with the involvement of wholesalers, the direct purchase of pharmaceuticals from the manufacturers does not pay off in almost all cases, neither for the pharmacy nor for the manufacturer.
Retail pharmacies
Retail pharmacies (“stationary pharmacies”, “on-site pharmacies”) offer their customers the option of delivering medicines to their homes that are not in stock. Pharmacies work closely with wholesalers in order processing of this type. Ordered drugs are delivered to the pharmacy and delivered to the patients in our own vehicles (so-called messengers).
Ordering via the Internet and collecting it from the pharmacy ( Click & Collect ), which many retail pharmacies offer, is intended to optimize pharmacies' service indicators. With the introduction of this alternative, which is very practical for customers, customers will be informed after the order has been sent as soon as the requested item has been delivered to the pharmacy and is ready for collection. From a logistical point of view, it is a very good alternative to traditional mail-order pharmacies on the Internet, as the last-mile problem due to customer pick-up does not apply.
Mail order pharmacies
Since 2004, the mail order business of pharmaceuticals has been allowed in Germany. Of the approximately 20,000 pharmacies in Germany (as of 2016), over 3,000 also have a mail order license. If prescription drugs are ordered, the prescription must also be sent to the mail order pharmacy.
Because mail-order pharmacies are expecting higher stocks, mail-order pharmacies purchase their medicines directly from manufacturers to a greater extent. Mail order pharmacies use the networks of CEP services such as DHL and Hermes for shipping .
As an alternative to shipping using CEP services, delivery can be made via so-called pick-up points (e.g. in drugstores) where customers and patients can collect their orders.
Wholesaler
With the interposition of wholesalers in the sales structure of the healthcare sector, it is possible to reliably supply pharmacies and hospitals with drugs one to three times a day. With the networks of wholesalers, the direct supply of pharmacies by the manufacturers decreases. This reduces the transport effort and the associated costs for retailers and manufacturers. In addition, the wholesale locations can send drugs to each other, which can usually be offered and delivered the next day in the areas in which the demand is made. By purchasing larger quantities, it is possible for wholesalers to pass on discounts that are offered by the manufacturer, from which both retailers and pharmacies, but also the patients, benefit. All wholesalers are legally obliged to act in accordance with “good sales practice” (GDP).
Import companies
Via re-importers and parallel importers, it is possible for wholesalers to procure medicines cheaper than they would be in their own market. A reimport occurs when pharmaceutical manufacturers in Germany produce drugs for the export market and sell them there cheaper. The drugs offered there are bought up by reimport companies, repackaged and sold back to Germany. Parallel import means the import of drugs manufactured and approved in other EU countries for the domestic market by another company in addition to the (more expensive) one by the manufacturer. In Germany, such drugs can then be offered cheaper than the same products that are procured domestically.
Logistics service provider
Due to the complexity and effort involved in transporting medicines and pharmaceutical products, transport services are almost exclusively provided by external transport and forwarding companies. It is common in the transport service industry that transport service providers use subcontractors themselves for the transports for various reasons.
The main types of transport in Germany and Europe-wide are trucks and vans, and sea and air freight for intercontinental transport. When it comes to international transport, the critical points are changes in climatic conditions, other legal interpretations and guidelines, as well as customs clearance and handling processes.
Statutory regulations and guidelines
Due to the regulation of the pharmaceutical market by the respective legislator, companies must observe special regulations for transport and storage.
Global legal guidelines
The WHO (World Health Organization) develops the WHO guidelines in conjunction with the WHO member states, national authorities, the participating industry and NGOs (non-governmental organizations). After successful examination by the WHO Expert Committee, these are accepted as international standards. American legislation, like the German national and European regulations, also provides for the monitoring of pharmaceutical companies. In the USA, the FDA ( Food and Drug Administration ) takes on this role. In Germany, the federal states are responsible for monitoring.
In order to correctly implement the guidelines in the field of air freight , the IATA ( International Air Transport Association ) was commissioned to help with the implementation. The CEIV ( Center of Excellence for Independent Validators ) was then founded. The CEIV serves as a training center for participants in the pharmaceutical industry. The CEIV certificate is internationally valid and recognized and is intended to create uniformity in an increasingly global trade, as well as standards in the handling of pharmaceutical products.
At the national level, laws form the highest level, such as the German Medicines Act (AMG). With the adoption of new EU directives (directives) by the European Union , the directives are not yet effective and binding for market participants. The legislator is obliged to implement the guidelines in national law. In German law, this is done in the form of laws or ordinances. The next level in the legal hierarchy are regulations, followed by administrative regulations. In addition to laws and regulations, there are additional guidelines for market participants in the EU in the context of “Good Practices” ( GxP ), which are particularly important for pharmaceutical logistics: GDP and GMP.
The GDP guideline is aimed primarily at wholesalers, but in general it is mandatory for all persons and companies who sell and trade drugs. The content of the guideline is structured as follows:
- Chapter 1 - Quality Management
- Chapter 2 - Personnel
- Chapter 3 - Premises and Equipment
- Chapter 4 - Documentation
- Chapter 5 - Operations
- Chapter 6 - Complaints, Recalls, Returns
- Chapter 7 - Outsourced Activities
- Chapter 8 - Self-Inspections
- Chapter 9 - Transportation
Laws, ordinances and guidelines in Germany
- AMG: Medicines Act
- AM-HandelsV: Medicines Trade Ordinance
- AMRadV: Ordinance on radioactive drugs or drugs that use ionizing radiation
- AMVerkRV: Ordinance on pharmacy- only and over-the- counter drugs
- AMVV: Medicinal Prescription Ordinance
- AMWHV: Medicines and Active Substance Manufacturing Ordinance
- ANSG: Pharmacy Emergency Service Assurance Act
- AVWG: Drug Supply Economic Efficiency Act
- GMP Guideline: Guide to Good Manufacturing Practice
- GDP guideline: guidelines for good sales practice
- BtMG: Narcotics Act
- BtMAHV: Narcotics Foreign Trade Ordinance
- BtMBinHV: Ordinance on the internal trade in narcotics
- BtMVV: Narcotics Prescription Ordinance
Cold chain management
The legislation specifies regulations for the transport and storage of refrigerated and cold chain pharmaceuticals. In particular, the GMP guideline for manufacturers specifies how pharmaceuticals must be produced and handled in order not to have a lasting effect on quality. Quality control is therefore an important part of storage, production and transport and must be adequately documented and carried out by all those involved in the supply chain.
In general, cold chains are divided into active and passive cold chains. Medicines that require cooling can be cooled actively as well as passively. Cold chain drugs are handled differently. These must not be passively cooled. In the case of drugs that are subject to cold chain requirements, it must always be ensured that the cooling is continuous and uninterrupted.
Active cold chain
The aim of the active cold chain is to keep the prescribed and defined temperature intervals for drugs at all times. In addition to continuous cooling, continuous temperature control and recording is also carried out. Due to the temperature sensitivity of cold chain drugs, the handling of these products and goods has the highest priority. Vehicles that are used for the transport of medicinal products that are subject to cold chains must be qualified before use and equipped with suitable temperature control systems ( data loggers ); the same applies to storage areas.
Passive cold chain
In addition to active cooling, there is the option of passively cooling drugs. However, passive cooling is only used as an intermediate stage between active cooling, mostly when transporting between wholesalers and pharmacies. The vehicles are not equipped with cooling technology. In order to maintain the temperature intervals, suitable insulation techniques are used during transport. Depending on the geographical location in which the transports are carried out, transports with passive cooling can be carried out all year round, seasonally or only occasionally. Added to this are the duration of the transports and the interior insulation of the transporters themselves. Due to the high costs of actively cooled transports, transport service providers and wholesalers often decide whether passive transports are possible depending on the day and the weather. For this purpose, when making a decision, use is made of data that was collected as part of temperature monitoring. The decision whether transports are actively or passively cooled is also based on the insulation of the drug packaging itself. In addition to the informative use of the packaging, it must also withstand physical, biological, climatic and chemical loads.
criticism
In Germany, logistics service providers who deliver pharmaceuticals from mail-order pharmacies to customers are not subject to Good Distribution Practices (GDP), unlike pharmaceutical wholesalers for whom these regulations are mandatory. Rather, the mail-order pharmacies must ensure, according to the Pharmacy Act and the Pharmacy Operating Regulations, that a drug is “packaged, transported and delivered in such a way that its quality and effectiveness is maintained.” In practice, however, this is almost impossible to implement and control.
Further sales structures
Online trade
Online trading is becoming increasingly important within the current sales structures. The increasing digitization and the growing eCommerce trade are partly responsible for this development. The order of pharmacy-only or over-the-counter drugs is easily possible by creating a customer account and entering payment data via platforms. In Germany, a large mail order company offers a platform for online trading through partner pharmacies. Various concepts have so far not been able to establish themselves. Further pre-order systems and portals are in the pipeline. A Dutch mail order company has announced that it wants to establish a platform economy modeled on Amazon.
Mail order within Europe
In most EU countries, the shipping of prescription drugs is prohibited. In addition to German mail-order pharmacies, as of June 2018, distributors from Iceland, the Netherlands (if mail-order pharmacies also have a retail pharmacy), Sweden (only prescription drugs), the Czech Republic (only non-prescription drugs) and the United Kingdom are approved for the mail order trade of pharmaceuticals to Germany.
Counterfeit drugs
Counterfeit drugs represent one of the biggest problems in the pharmaceutical supply chain. Due to increasing globalization and price and demand-driven import / export trade, drugs are in many cases bought, repackaged and resold several times on their way from the manufacturer to the patient. The sale of pharmaceuticals in countries with different laws or control regulations leaves room for criminal activity. With end-to-end visibility across the entire supply chain and counterfeit-proof, standardized barcodes , companies are trying to better protect and monitor the pharmaceutical trade.
The securPharm e. V. is setting up a system for authenticity testing of pharmaceuticals in Germany. The legal basis for the work of securPharm are the EU Falsified Medicines Directive 2011/62 / EU and the delegated Regulation (EU) No. 2016/161, according to which, from February 9, 2019, every prescription drug must be authenticated before it is given to the patient . With an EU-wide serialization through the directive, the European Union wants to create uniformity and quickly detect counterfeits.
Individual evidence
- ↑ Pharma data 2017. (No longer available online.) Formerly in the original ; accessed on May 30, 2018 . ( Page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice.
- ↑ Pharmaceutical industry in Germany. Retrieved May 30, 2018 .
- ↑ Everything about the pharmaceutical industry in Germany. Retrieved May 30, 2018 .
- ↑ Miebach Consulting GmbH (Ed.): Challenges in sight! - Supply chain trends in the European pharmaceutical industry . 2016.
- ^ Avoxa - Mediengruppe Deutscher Apotheker GmbH: Pharmazeutische Zeitung online: Delivery service: Ambassador of the pharmacy. Retrieved May 30, 2018 .
- ↑ Facts and figures Pharmaceutical mail order business for prescription and OTC drugs in Germany , BVDA 2016.
- ↑ Pick-up ban for on-site pharmacies
- ↑ Import / Reimport / Parallel Import… , DAZ 40/2011.
- ↑ CW Stoller (Ed.): Pharmalogistik . 2017.
- ↑ European Commission: Guidelines of November 5, 2013 for Good Distribution Practice for Medicinal Products for Human Use
- ↑ Stoller, CW (Ed.): Pharmalogistik . 2017.
- ↑ § 11a ApoG.
- ↑ Not all shipping is the same . DAZ-online, December 14, 2015.
- ↑ Amazon starts shipping pharmaceuticals with Munich pharmacy DAZ-online, May 10, 2017.
- ↑ Dedendo is history , apotheke adhoc, December 6, 2013.
- ↑ Otto ends delivery service Vitabote , apotheke adhoc, January 13, 2014.
- ↑ The App-otheken are coming apotheke adhoc, March 22, 2018.
- ↑ DocMorris is striving for a platform economy à la Amazon , apotheke adhoc, November 22, 2017.
- ↑ Illegal drug delivery and counterfeit drugs ( Memento of the original from June 12, 2018 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , DIMDI , accessed June 7, 2018.
- ↑ securPharm eV · About securPharm. Retrieved May 30, 2018 .
