Pediatric Drug Safety

Safety in Pediatric Drug Therapy

The reasons for THRF to advocate it

  There are many commercially available drugs specially designed for children in Taiwan, but rarely prescribed by the physicians. Adult solid dosage forms are used for children instead. Tablets are pulverized and shells of capsules are removed. The powders from different drugs are mixed up and divided into small packets for each dose. The practice is so common practice in Taiwan that the National Health Insurance (NHI) even designed a special dispensing plan for this procedure. However, such practice has raised several drug safety concerns. The following is a list of pediatric drug safety issues observed by THRF:

1. The mixed drug powder is hard to be evenly divided. The patient can not be accurate dosed when the dosage in each drug packet varies. According to a research down by Taipei Medical University Hospital in 2001, the weight difference for each drug powder packet can vary up to 51.49%. [1]

2. The mortar, spatula, and packaging machine are rarely cleaned before processing for each patient, which could result in drug contamination or mix up.

3. Dividing adult dosage forms for pediatric use requires extra processes, which increases the chance for errors.

4. Some drugs are designed to be taken whole. Pulverization diminishes their intended effects.

5. It is common for Taiwan’s medical institutions or clinics to mix multiple drugs during the pulverization procedure, which may have incompatibility problems or drug interactions.

6. Changing the dosage form, especially pulverization decreases the stability of a drug and its shelf-life.

7. Coating of a tablet or shell of a capsule may mask the taste and increase the palatability of a drug. The grinding process removes coating and shell, and therefore increases the difficulty for feeding.

The following are several recent pediatric drug accidents in Taiwan:

1. June 2005, Cha-Yi Christian Hospital accidentally distributed adult drugs to a five year old boy. The accident was caused by a pulverization procedure, which gave the boy a dosage 10 times more than originally intended. The boy suffered serious liver damage and lost 6kg (13.2 pounds) in two months. [2]

2. February 2004, a six year old girl had her menarche after taking flu medicines. The investigation showed her drug powder was contaminated by female hormone left in the mortar or packaging machine (presumed to be left over from the previous pulverization procedure). [3]

3. December 2001, Ping-Dong Chun-Ai clinic accidentally pour an oral hypoglycemic into an antihistamine dispensing bottle. The mixed drugs were pulverized to give to 122 pediatric patients. This led to adverse drug events in 11 patients, including mortality of a 9-month old infant. The contaminated drug given to the infant was five times higher than an average adult dosage. [4]

  Some of these medical accidents could be prevented if the current healthcare system deployed a simple yet regularized procedure to manage the pediatric drug therapy. We believe the key change should be on utilizing the commercially-available pediatric drugs, and avoiding the practice of downsizing the adult drugs for pediatric patients.

  The pediatric drugs usually have different strengths for children of different ages. Most pediatric drugs are also designed to be easily taken or feed, i.e., they may come in with candy or chocolate flavor, or in liquid or chewable forms.

THRF's Action and Advocacy

Press Conferences

  We first launched press conference to promote pediatric drug safety on April 3, 2006 with a hope that the safety of pediatric drug therapy could be improved through a joint effort of the government, healthcare professionals, drug companies and the public. The following list is our advocacies on this topic:

*  For the Department of Health

1. The Bureau of National Health Insurance should not reimburse the pulverization of adult drug for pediatric therapy, if the said drug had pediatric version commercially available in Taiwan.

2. The pediatric drug products should be delivered to the patients in its original package. Without additional processing or packaging, the chance of drug contamination and other errors will be reduced. It also helps storage of the drug.

3. The Department of Health and the Bureau of National Health Insurance should work on and encourage the introduction of pediatric drug products into Taiwan’s healthcare system.

*  For the Hospitals and Pharmaceuticals

1. The hospitals and pharmaceuticals should begin to use commercially-available pediatric drugs. At the same time, doctors should educate the public about the benefits of using pediatric drugs.

*  For the Parents

1. Bring your children to the clinics that prescribe the commercially-available pediatric drugs.

2. Make sure that both the label and instruction on the drug bags are clear and with detail information.

Second Press Conference

  Our second press conference on the pediatric drug safety was launched on December 21, 2006. The goal of this conference is to do a follow-up check the impact of our first press conference and the pediatric drug use in Taiwan. We found that the pediatric dosage forms are still rarely used and large proportion of pediatric prescriptions still have overdose problem.

  With the help from pharmacists, we analyzed 15 recent pediatric prescriptions sent to us after the first press conference in April, and found that 13 of them had problems, which included overdose, redundant medicines, or drugs that had been withdrawn from market.

  Two third of the15 prescriptions contain at least seven ingredients per dose. One of the prescriptions prescribed 17 different ingredients for a 5.5-year-old child. In another case, cisapride is prescribed to a 2.25–year-old. Cisapride has long been banned by the Department of Health due to 2 deaths caused by the drug reported overseas 2 years ago.

  All the drugs prescribed in these 15 cases utilized adult dosage forms to divide into small doses. Some physicians ordered extraordinary dosage, such as dividing 2.1 tablets into 12 doses, or issuing 0.1 tablets per dose. There is also a case that the doctor grinded enteric-coated tablets, which is designed to be taken whole, into powders.

Our advocacies from the second press conference:

*  The Department of Health and the Bureau of National Health Insurance should introduce a payment plan for the commercially-available pediatric drugs. A schedule should be set to gradually reduce pulverization of drugs in pediatric care.

*  Parents should request the clinics to issue pediatric dosage form for their children.

*  The healthcare facilities should be more careful about the pediatric prescriptions, making sure that the child’s age and weight are accurately measured and recorded before issuing the drug.

  The Taiwan Healthcare Reform Foundation also published a guideline on our website to remind the parents of important issues and questions that they should pay attention to when taking their children to the clinics.

Government's Responses

  The Department of Health responded to our 2006 press conferences by agreeing the commercially available pediatric drugs in Taiwan were under-utilized. On the other hand, the Bureau of National Health Insurances stated that any immediate pediatric drug dispensing reform was unlikely, but they would look further into this issue.

[1] 2001 年台北醫學院藥學研究所林攸美的碩士論文「磨粉分包作業之品質及小兒用藥指導之成效探討」

[2] 2005.6.30 UDN News

[3] 2003.9.21 China Post

[4] 2002.12.18 UDN News