Hi, everyone! :D

Our placement @ Merck, Sharp & Dohme (MSD) is a program called Industrial Pharmacy Externship Program (IPEP), which was held annually for the last 5 years. The program is about a month long. We arrived at Jaya 33, Petaling Jaya just before 9am (due to traffic jam). We were greeted by Ms. Li-Lynn, one of our mentors for the IPEP. She said we arrived at 8.57am precisely. XD

There were 2 other mentors, Ms. Rathika and Ms. Sheen Wei who also welcomed us. Each of us was given access cards for the lift and a laptop (just the normal Lenovo working laptop) which we will work on a project later on. It will be a slideshow presentation in which some of our lecturers will be coming to listen as well. They also gave us a schedule of the sessions conducted throughout the month. Some days we will learn in the office about each department, other days we will go out to observe field work (下场). 

We were also given free notebook and pen, nice!

The morning started off with a session with the HR department. We were told of the company organization chart, and there are different business groups handling products of different therapeutics classes (Cardiovascular medicine, diabetes medicine, Anti-cancer drugs etc.). The HR manager also explained how the company retains and develops their staff, or to assist staff to cross-develop in another department. Even a few pharmacists also switched to sales & marketing side to broaden their career pathways! Recently, Schering-Plough (SP) merged with MSD, hence the company also employs many contract staffs (temporary staffs) to sort out many areas of merging, such as products portfolio, licensing, network and so on. It’s happening on a global scale, with MSD and SP each having numerous branches worldwide. Lots of paperwork to do.

Here’s the eye opener. Pharmacists actually have A LOT of opportunities in the industrial field. Generally, there are the medical affairs department, the pharmacovigillance department, the regulatory affairs department, clinical research department among others. Industrial pharmacists are very sought after in these areas and not just about running manufacturing plants, producing tablets etc. Many of the staffs there are pharmacist graduates, and yes, many of them are paid to keep up to date with the latest scientific updates and journals, so learning never stops even here!

Besides that, the HR also explained that MSD Malaysia liaises with Zuellig Pharma to distribute their products nationwide. Many other pharmaceutical companies also do the same. Later this week, we will be visiting Zuellig Pharma as part of the field work of IPEP.

In the afternoon, we had a session with the Regulatory Affairs (RA) department. Every pharmaceutical company will have a regulatory affairs dept, as the companies need to work closely with the National Pharmaceutical Control Bureau (NPCB). Basically, any New Chemical Entity (NCE), or New Biological Entity (NBE) such as vaccines, antibodies, blood-derived products etc., need to be registered and approved by the NPCB before it can be marketed. Whenever a new drug is introduced into the market in Malaysia, it is called an innovator drug, which means it’s the first of its kind in Malaysia. When other companies manufacture the same drug (in a different brand name) and market it, they are termed generic products. We always hear that generic drugs are the cheap, local ones, but in actual fact, generic drugs also include the imported, not-so-cheap ones which are not the innovator product.

Okay, so what does a pharmacist in the RA department do? Basically, they register these NCE/NBE to get approval from the NPCB. These proposals are then channelled to the Drug Control Authority (DCA) which makes the final decision. DCA is a board of key healthcare professionals and leaders who meet up monthly to decide on all these proposals. The RA dpt also deal with new line-extensions. These include the introduction of a new strength for that medicinal product or a change in the indication of that medicine. Or a change in the details in the Local Circular for Physicians (LCP), which is the information paper with lots and lots of small words in each product packaging. Or a change in the Chemistry, Manufacturing and Control (CMC) details, which deals with the manufacturing process, equipment used, blister pack design, quality control procedures etc. of that one product.  Or even a change in the design or wordings on the packaging! All medicinal products in Malaysia requires a certain font size for their packaging, and certain phrases such as “Keep out of reach of children”, “Controlled Medicine” and so on. And as MSD and SP is undergoing merging procedures, all of the affected products need to be redesigned, and hence, require approval too.

ALL THESE changes need to be documented and submitted to the NPCB for approval. And there are over about 200 products per company to manage, with each having their own CMC, LCP, packaging etc.

And not to forget, each product has its own license which needs to be renewed every few years. The RA will also need to renew the import license and poisons license from time to time so that they can import the products from the manufacturing site. And as controlled substances such as those containing pseudoephedrine is tightly regulated, import permits are also needed to be applied and approved, with a certain amount of quota given to a company for a year (for example, MSD company can only import 10000 boxes of Clarinase per year).

Here’s something interesting. Look up any medicine packaging. There is a license number that starts with MAL (for Malaysia), followed by 8 digits, and a few letters. Letter A means pharmaceutical products, including OTCs. This differentiates the product from traditional herbal products, or cosmetics, which the NPCB also regulates. Letter C means contract manufacturer, meaning the manufacturing plant is not owned by the company, but a third party company. Letter R means repacked, which is printed out if the repacker is a different plant from the manufacturer plant. Letter S means second source, meaning the manufactured drug is not from the primary source plant. There is also a hologram (shiny sticker) which will be sticked onto the carton to prove its authenticity.

This is just Day 1. Wait till you see day 2! =D

It's cool being part of MSD