A Volunteer's Web Log

Dr. Frank  Lobeck

Dr. Frank Lobeck, an employee at Pfizer Inc., was picked as one of Pfizer's Global Health Fellows, which allowed him and his wife Mary volunteer through Health Volunteers Overseas at the Christian Medical College for three months.  With backgrounds in Pharmacology, they could worked in the Pharmacy Department. Below is Dr.  Lobeck's account of his experience as a volunteer at the Christian Medical College

Entries

January 27, 2005
February 7, 2005
March 7, 2005
March 21, 2005
March 28, 2005

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January 27, 2005

Things have really come together since mid August when I received an e-mail from John LaMattina, President of Pfizer Global Research and Development (PGRD) to all PGRD colleagues. I normally just ignore these global e-mails,* but, for some reason, this one caught my eye. It essentially said that if you had thought about applying for the Pfizer Global Health Fellowship, but the timing wasn't right, apply anyway. This hit right on my reservations, so I went home that night and showed my wife, Mary, the information about the program. She encouraged me to apply (and asked if she could do it too).

So, I talked to my supervisor, Don Sizemore, and he was very supportive. After filling out the application, writing the essays, and getting the letters of recommendation, I applied on September 10. I was accepted into the first stage of the program and my application was sent to various NGOs (non-government organizations). In a process that seems to resemble football scouting and the draft, the NGOs review the applications with the Pfizer Foundations to match applicants with organizational needs.

 By early November, I had been picked up by Health Volunteers Overseas (HVO) and they assigned me to the Department of Pharmacy at the Christian Medical College (CMC) in Vellore, India. Then preparations for the trip, for the work itself, coverage at work and at home started. Vaccinations, visas, extra refills on medications, a trip to the dentist, travel reservations, paperwork, etc., all got put on the to-do list and were checked off one at a time. The Pfizer GHF office has been great about providing support and answering my many questions. HVO gave me the e-mail contact for Dr. Chandy, the head of pharmacy at CMC. We exchanged several e-mails in December and agreed on some general objectives for the trip. They included looking at processes for medication purchasing & distribution (a big task for a 2000 bed hospital that also serves 4000 outpatients a day), reviewing manufacturing procedures, and providing some input on the CMC pharmacy curriculum.

To prepare, I contacted some people for help. The Pfizer Development Operations COSi group and a friend at another company helped me gather and review process improvement and quality improvement materials. The QA leader on my project put me in contact with a Pfizer GMP auditor, Lesa Smith, who provided me with some basic manufacturing guideline references. She also offered to help via e-mail or phone while I was at CMC. Mark Tibbets, a Pfizer colleague who will be at CMC Virology Dept, is in Pfizer Manufacturing Control and offered to help me as well. Finally, I contacted Rosalie Sagraves, a friend who is Dean of the College of Pharmacy at the University of Illinois - Chicago. She kindly provided references to US standards for pharmacy education andgave me the names of some pharmacy leaders in India.

At work, my department found an Interim Development Operations Team Leader (DOTL) for my project, Mary Phelps. Mary is one of the most-experienced and well-respected DOTLs in Ann Arbor. The whole project team has been supported and the announcement that Mary will betaking my role has given everyone the confidence that our group will continue to be successful. It is tough jumping into the middle of a project, but she has been very supportive. Several colleagues in Ann Arbor grew up in India or have family there. Our safety leader, Utpal Gupta, was kind enough to have my family to his house for an Indian meal and a great discussion on culture, safety, sightseeing, cuisine and many other things to expect during our stay in India. Several other colleagues have come to my office or stopped me in the hall to provide advice and offer assistance. If they are at all representative of people of India, I know I will be working among great people.

The head of CMC hospital pharmacy is Dr. Sujith Chandy, a physician with special training in Clinical Pharmacology. He was put in charge of the pharmacy in August after the previous head retired. Dr. has kept us very busy by introducing us to all the areas of the Pharmacy. He has spent alot of time with us describing the pharmacy and being very transparent about the limitations and problems in the pharmacy. (Including 1/ 2 day on Saturday). We have learned a lot about pharmacy practice in India (at least at CMC) and will describe the differences in another journal entry. He has several projects he would like address, and is giving us such an in-depth orientation so we can sort out which projects we would like to address. I think next week we will narrow the list down to a few projects and outline possible objectives for these, then the following week settle on a couple to actually implement. It should be another very full and busy week.
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March 7, 2005

Since touring the facilities, as described in the previous note, Mary and I have been quite busy in the hospital. I summarized the finding from our tour, including a number of issues, and made a report with a series of suggestions for improving the safe storage and dispensing of medications, coordinating computer program development activities among pharmacies, and enhancing productivity. A new VAT tax structure, to replace the current sales tax, has been proposed nationwide and is scheduled for implementation on 1April 2005 (although it may be delayed here in Tamil Nadu.)

Using a list of all the pharmacy stock (over 5000 items), I did an analysis of the impact of the tax on the pharmacy margins and was able to demonstrate the tax will have a minimal impact at first and, as the current stock is exhausted, will result in a little higher margin for the pharmacy while lowering prices for the patients. This wasn’t obvious prior to the analysis, so it put a lot of people at ease.

I also continue to work on mapping the entire pharmacy purchasing and inventory system. I completed a summary outline of the various processes and am about half-way through completing detailed mapping of each process. I work directly with the people doing the work to understand how they do their work, I produce a flow diagram, show it to them, make corrections and repeat until they are satisfied it describes all the details of the work. In most cases, after reviewing the flow, the staff suggests improvements or elimination of steps that save time and/or improve inventory control.

Mary is working on a redesign of one of the pharmacies. Currently medications are stored in one place in each pharmacy and several pharmacists move back and forth throughout the pharmacy to fill prescriptions. Mary, with the help of the hospital engineering department and one of the pharmacy supervisors has drawn up a plan that will basically gut the current structures in that pharmacy and install flexible shelving and furniture that is not attached to the floor. Each group of two pharmacists will have a “fast moving” section within arm’s reach that will account for most of the medications they need, then “slow movers” will be organized in such a way that all the pharmacists can quickly access them.

For a few of the specialty clinics that run one or two days a week, they are considering mobile units that can be rolled into place to transform one of the stations to match the clinics that are running that day. We are both finding that many of the pharmacy staff have good ideas, but have not been encouraged to make suggestions and, as is the case anywhere, there is also resistance to change in some areas.

But I believe the new head of pharmacy wants to make improvements in the department that will benefit the patients and, eventually elevate the role of the pharmacists here. Hopefully, we are helping to get them off to a good start, but it will be a very long road.

Outside of work: We are housed on the college campus, which is about 4 miles from the hospital. We are staying at one of the extended visitor housing units. Our place is called Johnson House. There are only two boarding rooms here with private baths, a common kitchen and common living/dining area. There are two buildings next door with similar arrangement, but the meals are shared in the Johnson House. We have met volunteers from England, US, Germany, Norway and Australia. Some are retried folks who use India as their winter escape from the cold in the native homes and volunteer at the same time. Others are working with collaborations between CMC and their home institutions. Some are medical student or residents doing an international medicine rotation.

One young woman from Colorado, is volunteering for 2 weeks in the grade school, and will then continue on her round the world tour, then main goal of which is to sort out what she wants to do now that she has completed college. One couple have been volunteering in the engineering department and PR department for a month a year for several years until they retired and they now spend 6 months a year. They have been coming here for 40 years!

 I am able to use the college computer lab for the whopping price of $7 for the 3 months. It gets be a high speed connection and web access, but it blocks VPN connections, so I am not able to log onto the Pfizer network.

So far the food has been fine. Fortunately, we like Indian food and spicy food. South Indian food is quite spicy. The meat is a bit suspicious, so we have gone vegetarian, and will probably continue veggie for the duration. There are a couple of decent restaurants in town and can have our meals cooked for us or make them ourselves. So far we have been having them cooked. The food on campus is usually pretty good and dinner is a little less $1 each and breakfast less than 50 cents. We have been on a couple local excursions and weekend trips, but I will save those stories for later.
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March 21, 2005

I finished the first draft of the Purchasing & Inventory process mapping last week. Several of the staff pharmacists were very helpful in developing this and there have been some good ideas on improving some of the processes. Today I put together a presentation for the hospital administration committee proposing to eliminate some steps, consolidate some others, and even dissolve a committee. I will review it with the head of pharmacy and present it to the committee within the next couple of weeks.

 The Department head is keen to have as many of my suggestions implemented before I leave as possible so I can see the changes (hopefully improvements). Currently the “Ward Sisters” fill out little index cards for each dose of each medication. They separate them into piles for the various administration times, and then use the cards to administer the medications. Later, they go to the chart and note each medication that was given at a particular time in the nursing notes. This ends up being a lot of writing. So, I developed a Medication Administration Record for one of the nursing units to try out. It will allow them to track the medication and write less (I hope they see it that way too). It will also give the whole team an easy way to review paients’medication therapy. If this trial is successful, the pharmacy may begin entering stop orders into the inpatient pharmacy system so these forms can be generated from the computer. It has been a long time since I worked with MARs. Cherie Woodhams from Bronson Methodist Hospital in Kalamazoo and Kevin Biglin from Children’s Hospital of Michigan in Detroit for sending me copies of MARs. These were really helpful!!! Thanks!!

Actually, other people have been very helpful and supportive of Mary and I while we have been here. Lori Thomas from Manpower in Ann Arbor has helped me order and retrieve some articles on assay methods for HIV drugs. The Clinical Pharmacology laboratory is using this information to set up assays and will begin providing therapeutic drug monitoring services to maximize therapy for HIV patients. Dennis Stalker from Fujisawa in Illinois has helped with information on assays for a immunosuppressive agent. Deb Hass from American Oncology in California was kind enough to send along some stability and safe handling guidelines for chemotoxic agents that the clinical pharmacist in the oncology ward will use to update the procedures for preparing and administering these drugs. Hopefully this will maximize the appropriate use in patients while minimizing occupational exposure to the pharmacists and nurses.

 Curt Swanson and Sharon Salah from St. Joseph Medical Center in Ann Arbor and Cherie Woodhams from Bronson Methodist Hospital in Kalamazoo sent pictures of the pharmacies that Mary used in giving a presentation on US pharmacy practice to most of the 100+ pharmacists here at CMC. The presentation was very well-received and brought alive by these pictures. Peter Carberry who recently moved from J&J to Genetech in San Francisco provided resource materials on process improvement and Shekhar Potkar the Director of Clinical Research for Pfizer in Mumbai, India sent several copies of international and Indian guidelines/regulations on clinical research. Don Sizemore and Karen Lanning sent me slides on drug development that I will be using soon to give an in-service. And many people have e-mailed their encouragement to use. This has all been very helpful!!!! Thanks!!!!!

The working environment still amazes me. Private patients at the hospital may get a private or semi-private room with a bath, possible air conditioning, and a second bed for their attendant. General patients are in huge wards, sometimes as many as 30 patients. Then there is the attendant that each patient is required to have with them 24 hours a day. At night it must be a female attendant to avoid problems. This attendant is usually a family member. They are responsible to taking care of the general needs of the patient--bathing, feeding, picking up meds from the pharmacy (more on this later), or whatever else the patient needs. They sleep on the floor next to the patient’s bed. They are also responsible for keeping tabs on the patient’s meds and belongings. People each lunch and take naps in the hallways.

Computers, printers, copy machines, FAX machines, and other "normal" technology are sparse. We have found ourselves not able to simply print something off our computers because many of their computer only have a floppy drive (didn't bring one of those for our computer), do not have a CD drive, won't accept a memory stick, and even if we find something compatible with our computer, it doesn't have a printer. All the dust and dirt that flies in the open windows also does a number on the machinery. Many systems are covered in plastic when not in use. The power seems to go out at least once a day for a few minutes and for at least on Saturday a month, the power in the whole town is shut off from 9 – 5 for maintenance. Since, there is a 5 ½ day work week, we are in the hospital when the power goes down. Only another month or so until I am back at my nice environment controlled building (OK the temperature is a little uneven in the Ann Arbor office, but I don’t think I’ll complain about that again) with several network printer to choose from, wire less internet, etc.
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 March 28, 2005

The Medication Administration Record has been instituted on a nephrology ward. There have been a few “bugs”, but the nurses and pharmacist are resolving those problems themselves. In a week or two, I will revise the form to incorporate all the suggestions. The pharmacy is hoping the experience will support expanding the use of MARs hospital-wide.

 I am also starting on a Pharmacy Department position paper on selecting suppliers. Right now the process is a bit random. I have found guidelines and statements from WHO and The American Society of Health System Pharmacists and will use this to draft a policy for the hospital that can later be used for improving their bid processes. CMC is doing their own research and participating in multinational Phase II and III clinical research studies.

As I have toured around the hospital departments, I have met a number of people working on clinical trials. However, each department runs its own research program and there seems to be little interchange among the researchers. In talking to one of the clinical department heads, I suggested that the CMC clinical research community would benefit from forming a CMC clinical research forum/society for sharing learnings, opportunities and sharing resources. He said it sounded like a good idea and asked if I would give a presentation at the first meeting. So I did that last week. It seemed to be well-received and further meetings are planned.

 I was invited to attend a meeting of the Rationale Drug Committee of the Christian Medical Association of India. The first day of the meeting was with a core team of clinical pharmacologists and heads of pharmacy for larger hospitals (the “Core Group”) and pharmacists from a representative number of small “mission” hospitals. These are hospitals that are run by churches and they serve primary poor, rural areas. It was the first time that the Core Group had brought in mission hospital pharmacist to talk about what they may want help with. They talked about setting up model drug policies, essential drug lists, and formularies. There are WHO resources for these documents, but the feeling was they need to be modified for Indian mission hospitals.

The mission hospitals tend to have just one or two pharmacist and they don’t have the time, resources or experience to make the modifications. So the Core Group was asked to take some of this on. There was also discussion about the difficulty the mission hospitals have assuring their drug supplies are not substandard or counterfeit. A purchasing cooperative was discussed as a possible mechanism for reducing costs while assuring quality as the more experienced medical centre pharmacist have more resources to evaluate quality of selected products and the mission pharmacies could just follow suit. While everyone was interested in this idea, there are a number of issues to work out before they can take any steps toward this.

The second day was a meeting of just the core group. The main topic was the content of the quarterly drug bulletin put out by the group. One issue they may have an article on is the effect of the Indian government’s agreement to uphold drug patents on prices and access to medication. They view the Indian pharmacy that break international patents as heroes serving the needs of the poor. They gave examples of HIV drugs being produced at 10% or less cost than the multinational sources. This discussion really impressed me in regards to how deep seated these feeling are among health care providers serving the poor in developing countries. They also talked about ADR monitoring and the possibility involving the mission hospitals in a national ADR network. Overall, it was a very educational couple of days.

The weather is getting rather hot. Up to now, it was rough in the direct sun, but OK in the shade. Most of the rooms in the hospital and area we are living in have high ceilings and ceiling fans. But now it is warm in the shade and the fans blow hot air. Better than nothing, but I am definitely drinking more water.

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