Monday, November 26, 2012

FDA Repeatedly Warns Physicians Regarding Proper Prescribing

According to Administrative Order No. 62, s. 1989 all physicians should follow the guidelines on prescribing to implement the Generic Act of 1988. Physicians, veterinarians and dentists are the only professionals who can prescribe medicines in a form of prescription and have the power to influence the patients to what brand of medicines he wants to buy for his therapy. But sometimes they are the violators of the law, especially against the Generic Act of 1988 and Republic Act 9502 or The Universally Accessible Cheaper and Quality Medicine Act of 2008.

In these laws, physicians, veterinarians and dentists are to follow the specially guide prescribing, such as:
  • Generic names must be used in all prescription.
  • The generic name must be written in full but the salt or chemical form may be abbreviated.
  • The generic name of the drug ordered must be clearly written on the prescription immediately after the Rx symbol, or on the order  chart.
  • Only one drug shall be prescribed on one prescription form.
  • In prescribing drugs enumerated in List B which needs strict precautions in their use, the prescriber must comply with the following:
    1. After the Rx symbol but before the generic name, he must write clearly "List B".
    2. He must ensure that the following pieces of information are accurately written on the prescription:
      • The generic name of the active ingredients and the specific salt or chemical form;
      • The manufacturer.
      • The brand name, if so desired.
      • The strength or dose level using units of the metric system
      • The delivery mode or delivery system and the corresponding, appropriate dose frequency or dose interval.
But all of these are violated by most of doctors, so that the law impose a provision regarding the wrong prescription writings, info and habits of doctors. They are Violative, Erroneous and Impossible Prescriptions.
The FDA is strictly imposing this provision, but there is lacked of participation of pharmacists, who directly held and received prescriptions. But even though this is the situation, FDA is still enthusiast to redeem wrong prescriptions to correct doctors.

Thus, when FDROs are routinely inspecting drugstores, they do not forget to check the Prescription Book, where pharmacist is inputting the dispensed prescription and filed it. By seeing the filed prescriptions, FDROs are looking for such erring or wrong habits of prescribing of doctors . The officer will collect the wrong prescriptions, either violative, erroneous and impossible prescription, or combination of the three, to surrender them to their office and notify the concerned doctor regarding his violation (so pharmacists do not be worried to show your Prescription Book, because it is one way to catch violators and correct them, unless you do not write and file, you will be the violator then). FDA will send letter to doctor who committed violation that in the letter, the doctor is given 15 days to write an explanation regarding his violation in a letter also and send back to FDA Philippines. Until the concerned perpetrator is not responded to the letter, thus FDA will impose a necessary sanction up to the revocation of the his PRC license as the severe penalty.

I know two Physicians that were committed the same violation. They were not able to place the generic name of the drug as it is the brand name is written alone. The FDA caught them through unanticipated inspection from a branch drugstore (Mercury Drugstore somewhere in Mandaluyong City). They both received letter that informing them that a case has been opened to them with the copy of the prescription error attached to the letter. The physicians were immediately responded to it and sent them in expressed mail. They were anxious about what had happened and said never to prescribe without generic names or the completeness of the proper prescription as it is written in the law to avoid open up cases against them.

Other physicians error are:
1. Multiple drugs are written in one prescription.
2. Prescribing Regulated Drugs in an ordinary prescription.
3. Wrong dosage.
4. Lack of description of the drugs, if syrup, suspension, the dose and ect.
5. Insufficient patient's information
6. No prescriber's name, PRC No., PTR No.(except for government employee) or S2 license (if available)
7. Using others S2 license or yellow pad
8. Forcing for "No Substitution" for drug's brand name.
9. Illegible hand writing and ciphering or using codes.
10. No salt or chemical form.
11. No Rx symbol
10. All the situation said in the Erroneous, Violative and Impossible Prescriptions

So I advice doctors to follow the proper guidelines in prescribing provided in the law, because you may not know that one of these days you are sent by FDA Philippines a letter regarding your erring in prescription and enforcing you to write an explanatory letter about this case.