When I write a post like this it should be said I am not preaching from Sinai, at one time I violated every patient safety guideline listed here. It was only through concerted effort to study global health work and medical missions over many years did we grow in our understanding of how to improve medication safety. When I write on patient safety it is to help you avoid mistakes I have made at one time or another. In my last post, I discussed the problem of adverse drug events. The horror stories related to this topic are extensive; we collected many case studies from the receivers of medical mission programs, some of which you can find in my book When Healthcare Hurts: An evidence based guide to best practices in global health initiatives. Remember that more than half of all medications are prescribed, dispensed, or sold inappropriately, and half of all patients fail to take medicines correctly (WHO, 2010). It is no surprise then that most of the patient-safety concerns with community-based healthcare programs revolve around medication usage and dispensing practices.
Pharmacovigilance policies may vary according to respective global health organizational deployment strategy and type of group (e.g., medical, surgical, dental, or health education). However, all policies need to reflect WHO safety standards and guidelines as well as the safety practices volunteer providers use in their home country. There are a number of applicable standards that should be followed by all teams. It is also important to note the WHO makes no distinction between safety practices in developed versus developing countries.
I would like to explore ways to establish and maintain pharmacovigilance as an operational priority. The following are basic evidence-based global health pharmacovigilance standards. Each volunteer should review and understand these basic standards.
1) Medications should only be prescribed when absolutely necessary and dispensed in child-resistant containers (not Ziploc plastic bags).
Remember, there are no double standards for patient safety; standards that exist in developed countries also apply in developing countries. Remember also patients are at much higher risk from medications in this setting. Young moms often take those bagggies of medication back to their one room dirt floor homes where there is nowhere to store them away from her children. These safety regulations exist in our country for good reason. Prior to the 1970 PPPA, child poisonings were largely considered the leading cause of death in children age one to five in the U.S. with pharmaceuticals as the leading poisons (The Consumer Product Safety Commission, 2005). Another point that it is important to note is that WHO estimates that approximately 125 children per day lose their lives as a result of poisonings, the vast majority of which are pharmaceutical related (WHO, 2008).
There are many pharmaceutical supply companies where child resistant containers can be purchased in bulk, are light weight and easy to transport. Here is one such supplier https://biorxlabs.com/ but a quick google for pharmacy suppliers will result in many options.
2) Know the country’s pharmaceutical dispensary laws, and respect them.
Ideally, a local pharmacist or team pharmacist should oversee the dispensing of medication. Unlicensed staff should never package, label, or dispense medication.No central pharmacy medication dispensing.
This means that prescriptions may be filled in a central pharmacy area. However, medications should only be dispensed in the private consultation rooms or exam rooms. A licensed provider, pharmacist, or nurse may provide medication education and counseling. One-time dose medications (e.g., parasite prophylaxis, vitamin A supplementation) may be dispensed at a central location.
3) Mothers or caretakers of children prescribed home medication must (for each child) verbalize the medication instructions, demonstrate measuring the dose of medication, and administer the first dose of the medication under the supervision of a licensed provider (nurse or physician).
Again, this must happen in private pharmacy consultation rooms or exam rooms. Attempt to limit the number of prescriptions for each family. PPNN (a pill for every problem and a needle for every need) thinking should never be part of global health initiatives for both patient-safety and developmental reasons. Each child treated should have medication dosages labeled with each child’s name and age. Education before medication!
When we were leading medical mission teams, the system we deployed to prevent overprescribing and to ensure the WHO private consultation requirements are met is to have a healthcare provider go to the pharmacy, get the medication, and go back and instruct the patient himself or herself. Prior to leaving the clinic, the patient who receives medication is asked to explain the use of his or her medications by another team member to ensure full understanding. The educator then reinforces medication usage and provides education on one or two priority health-education areas.
To some, this sounds like it impedes patient flow. However, we have found it does not significantly decrease the number of patients seen. Even if it did, the improvements in patient safety would far outweigh any decreased numbers. Remember, one of the central culprits in adverse outcomes in healthcare projects is prioritizing the number of patients seen over patient safety. It is better to see one hundred patients well than a thousand patients and end up with a tragedy.
4) No expired medications should ever be taken into a country.
This is unlawful, and some countries have restrictions on the use of short dates—know the country’s standards. Some countries send a health inspector to the airport to ensure no medications coming in are less than 12 months from expiration.
5) No sample or unlabeled medications should ever be used unless a complete dosing regimen can be given.
6) Know and adhere to the WHO/UNICEF standards of practice in developing countries.
The IMCI chart booklet has prescribing and dosing information using the 26 child health medications for resource poor communities. See What is IMCI.
7) A detailed inventory of pharmaceuticals (with expiration dates) and/or medical supplies should be with the team at all times.
This often facilitates customs transfers and can avoid many potential legal problems. Medications should be left in their original containers and never re-packaged for distribution.
8) Surplus medications should never be left with unqualified healthcare personnel.
If supplying medications to horizontal community health worker programs, it is important to ensure adequate training on medications dispensing and the need for safe storage. Supplying medications for such programs comes with the responsibility of supplying child-resistant containers. Usually, families are instructed to keep such containers so they later can be refilled with other medications and relabeled. Pharmaceuticals should be carefully secured throughout the mission, and patients must receive training on safe home storage to keep them away from children.
10) Never attempt to sneak medications into a country.
Think about what would happen to you if you were caught smuggling drugs into your home country. Pharmacy laws vary from country to country, but the least you can expect is for medications to be confiscated; in some countries, imprisonment is very likely. Medications can often be purchased at very low cost in local pharmacies. So, it is very helpful to develop relationships with local pharmacists.
Following these protocols will help assure the safety of our patients. It takes diligence and awareness to implement these standards, but the benefits in patient safety are well worth the effort.