| Your company wants to save money by outsourcing | | | | days from the moment anyone from a |
| your pharmaceutical product safety operation to | | | | pharmaceutical company or its third party contracted |
| Southern Asia. Their brochure looks glossy, they claim | | | | companies finds out about a serious reaction. If you |
| to know what they are doing but you have nagging | | | | don't get the report of that reaction in to the |
| doubts. Is it simple xenophobia or do you have | | | | regulatory authority within 15 days they have the |
| legitimate concerns? This article looks to examine | | | | power to take your product off the market until you |
| some possible issues with outsourcing your | | | | get your act together. This can cost you billions. That |
| pharmacovigilance operation to countries where the | | | | 15 days starts as soon as the call arrives at the call |
| regulatory environment is far removed from the one | | | | centre regardless of what part of the world it is in. |
| you are used to. | | | | Woe betide you should have your marketing |
| My heart sinks every time I phone my telephone | | | | authorisation revoked, they're a lot harder to |
| provider or my broadband provider. It feels unfair to | | | | reinstate than they are to get in the first place and |
| criticise someone's lack of English, to take issue with | | | | the losses can number into the billions of dollars even |
| it not being their first language. But if I'm trying to | | | | for a modestly sized pharmaceutical company. |
| get to the bottom of a complicated IT problem | | | | So are there any reputable pharmacovigilance |
| when the person running the script on the other end | | | | outsourcing companies? What if your product has |
| of the phone doesn't understand me... I feel as | | | | been on the market for years and years and |
| though my service provider has little regard for my | | | | everyone knows that it is as safe as milk? Is it really |
| custom. Of course outsourcing is a legitimate way in | | | | necessary to do all this work inhouse? The smart |
| which large companies can cut their costs - savings | | | | answer is - yes it is possible to outsource and no, |
| which are passed on to us, the consumers. | | | | you don't have to do it in house - and yes it is |
| There is, however, a worrying trend in outsourcing. If | | | | possible to have a medical information line that is |
| you speak to your phone provider and the response | | | | outsourced where your customers will still be |
| is incoherent then that's annoying. But what if you | | | | understood by the staff. A number of companies |
| were phoning the medical information line for a | | | | specialise in outsourcing pharmacovigilance to |
| pharmaceutical product and got the same level of | | | | countries where there is a strong quality control |
| service? They can't understand you, you can't | | | | culture. At least one of these outsources to Eastern |
| understand them. What if you were a doctor, faced | | | | and Southern Europe to reduce overheads, rather |
| with an alarming, even life-threatening drug reaction in | | | | than outsourcing to Southern Asia. They realise that |
| a patient, needing advice from a pharmaceutical | | | | in Eastern Europe although overheads are lower than |
| company or needing to tell the pharmaceutical | | | | in the West, they are subject to the same drug |
| company so it can warn others? What if you were | | | | safety rules that govern the whole of Europe. This |
| phoning the information line to report that reaction? | | | | means that physicians will not be expected to have |
| What if the reaction had required hospitalization or | | | | had their medical training in one regulatory |
| caused even more tragic consequences? Would you | | | | environment and then move to a different one to do |
| really want that doctor to be talking to someone | | | | their day-to-day work - they will have done all their |
| from a call centre on the other side of the world | | | | training while subject to the rules with which they are |
| who only had a basic grasp of the English language? | | | | now work. They're certainly not as cheap as the |
| And so we enter the slightly murky world of drug | | | | operation in southern Asia but then if you see |
| safety (pharmacovigilance) outsourcing. In the | | | | pharmacovigilance as life insurance for pharmaceutical |
| pharmacovigilance world, information is the weapon | | | | companies, it often pays to opt for a more |
| and the individual case safety report (ICSR) is a | | | | comprehensive policy. |
| ticking time bomb. The timer on an ICSR is set to 15 | | | | |