Procedimiento Seguridad Física de las Exportaciones

The focus groups identified multiple challenges in medicines shortages in the current environment. These included regulatory, supplier, quality, policy, and in some cases of conflicting policy pulling supply chain management of shortages from disruption in different directions. For example, participants commented:

“From a policy perspective, it is also worth pointing out that we have got things such as the Carter Report which was published early in this year [2016], and there is a direct recommendation in there for hospitals to reduce their stock holdings to around 15 days. Now, of course, that means they are going to have less stock available before they run out if there is an issue further up the supply chain. So, you have got that one particular policy directive on the one hand where hospitals are being asked to reduce their stock holding, and on the other hand you have got another policy which, where we have the emergencies buffer stock pile, which, of course, seeks to hold stocks in the event of any sort of pandemic event or emergency; so, you almost have two different policies driving different aspects by hospitals having to keep less stock. On the other hand, you have got a policy that advocates the holding of buffer stocks.”

(Participant A1)

“Increasing is sort of big regulatory global issues, I am not sure if that we have better infrastructure in place with the regulatory or if we just have a better relationship with the regulator now, so that what is happening increasingly is that an inspector will go into a factory in sort of China, India, Europe, anywhere in the world and find an issue and it is not necessarily a UK inspector, because we have something called mutual recognition agreements across the EU, and to some extent with the FDA and other global regulatory authorities, and they will find something wrong with a factory that may manufacture several hundred medicines for this country and for Europe and it will shut the factory down.”

(Participant C1)

In addition, the current state of the pharmaceutical market, a participant commented that contracting of medicines that the department has pointed out that where we procure medicines in secondary care or generics, they are procured on the basis of a commercial perspective, that is to say, for example, paracetamol tablets, there is recognition that there will be a hundred different suppliers of paracetamol tablets. Whereas participants noted:

“Market failure description, where you have many suppliers of a given product in a market (e.g. paracetamol), whereas the same cannot be said of injectable medicines which are difficult to manufacture, you are going to have a very limited number of manufacturing facilities. In some cases, you are going to have a wholly dedicated facility for things like oncology medicines, where you can’t just manufacture other product lines for risk of cross contamination, and in those incidences, we seek to adopt a more strategic view. We would take a more strategic view on the procurement of medicines in that we would seek to award to more than one supplier in the market and that is done in recognition that if one supplier has an issue or supply disruption, you have at least two or

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three other suppliers who might be able to help out, so we would not always seek to award to the cheapest supplier." (Participant A1)

The type of medicine and how it affected the severity and the length of impact and the subsequent post disruption management response was a predominant theme, although there were limited comments that shortages exist across the board. The management impact and response was less difficult due to the possibility of alternatives.

Other challenges highlighted included poor supplier engagement, minimum stock availability, and pharmaceutical suppliers' processes that were geared towards their own commercial considerations rather than the impact of possible disruptions potentially causing shortages. Participants expressed the disconnect in the following ways:

“One of our big challenges is the combination of people [suppliers] not telling us that they are going to have problems, to companies not giving us advanced warning or not giving us enough warning, so that the shortage has already happened and so there is not much that can be done in an effective manner. So, there is an element about things that go wrong in the supply chain that you cannot really be prepared for, there is a kind of, not talking across the board, but there is a kind of efficiency challenge with companies themselves where they are not holding months’ worth of stock, where there is this almost ‘just in time’ manufacturing process, where orders are placed months in advance, and so orders arrive that is just enough for the UK. There does not seem to be a lot of in-house buffering that is around.” (Participant B1)

A variety of specific examples were given to corroborate the focus groups' participants' comments on the supplier issues, including medicine type, for example:

“We had a shortage recently of an oncology drug, Bleomycin, that was ordered. Whenever it did arrive in the UK, one of the potency tests just wasn’t coming up to what it should have been according to the product licence, so they had to do more testing which was another three or four weeks, and there was just nothing the company could do to help. They had only just ordered enough for the UK supply and then the manufacture in Japan had a three to four month lead time, so I think there is a big combination of things going wrong and there is not a lot we can do to respond to it quickly. There is also just a combination of companies just not telling us when things are going to go wrong; they are not giving us enough notice, so that is one of our big challenges.” (Participant B1)

Many of the participants noted that the shortages caused by the disruptions resulted in a lot of extra resources, work, and time:

“It causes a huge amount of unnecessary activity in the day to day workload.”

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“Within every trust, there is someone who is almost full-time sorting out shortages and making stock available, usually the lead pharmacist."

(Participant A2)

On top of the additional drain on resources, a common theme throughout was the escalating number of shortage incidences, as well as broader product scope across the board from disruptions, which has resulted in both buffering and bridging actions to cope:

“I think the number of shortages we have seen over the last 12 months is significantly more than we have seen in the previous decade.” (Participant A3) “For example, dermatological treatments and ointments, that does not seem to be a problem in the past, a lot of those we have had problems with in the last 12 months. We have had to change what we are actually supplying.”

(Participant C3)

After the introduction topic of supply chain shortages as a whole, the next topic considered was the concept of supply chain disruption orientation to try and understand the practitioner’s perspective and to give further insights.