Patient Safety
Generic Drugs
En Español | Most generic drugs are manufactured aboard, and although they need to be approved by the FDA to be sold in the United States, some manufacturers have become experts on the art of deceit, gaining so approval by the FDA.
Generic Drug Considerations
FDA classification: Generics are rate as A for the drugs that release the active ingredients at the same rate and levels as the brand name medication, and B if the release is at different levels. If a drug enters your bloodstream to quickly or to slowly it may cause side effects or prove ineffective. Check with your pharmacy what is the rate of your generic.
Undisclosed side effects: Brand name medications can change their original packaging if they discover new side effects after they had been at use for years on the market, but generic drugs cannot alter their original packaging, meaning they cannot disclose any new adverse effects. Check always the brand name medication packaging for updated side effects.
Inactive ingredients: While the active ingredients in brand name drugs and generic remain the same, the inactive ingredients may vary. Tell your doctor if you are allergic to ingredients such as gluten, sulfites, or Yellow 5, usually found in medications.
Lack of performance: If a generic doesn’t work like the original drug, be concerned, particularly if it is an extended release (often called “XL”) product.
Copied labels: Be aware that the labeling on a generic drug describing its performance is copied from the labeling of the original product and may not reflect the performance of the generic. This is a deception required by the FDA, perhaps to create the perception of generics as interchangeable.
When they work: If a generic works for you, look carefully at the label and identify the manufacturer. Request the same manufacturer each time you refill that prescription. Other generics may not behave the same way.
How to Investigate Your Drug’s Safety
This guide is based on the recommendations provided by Katherine Eban. She is a journalist specialized in pharmaceutical investigations, who has written many articles and books, such as Bottle of Lies.
1. Find out who is the manufacturer. This information is provided on the drug label.
2. Go to the manufacturer’s website and search for:
Recalls of the drug.
National Drug Code (NDC). It’s the product number identifier for the drug.
The brand name of the drug.
3. Go to DailyMed and with the NDC number look at all the the information of the drug, specially it’s contraindications, warnings, and the package/label display for your drug and dose.
4. Check for recalls at the FDA safety recalls page and other international pages such as the ones shown below. Type in the manufacturer’s name and you will see a list of recalls from the company, if any.
5. Check out if the manufacturer has received a warning letter from the FDA. The two most important problems would be “sterility” and “data integrity” (meaning that the data has been altered or they have inadequate control over it.) If both issues are present it should raise a red flag.
If you want to change manufacturer
1. Find out who else makes the drug. You can find out at the FDA’s Orange Book.
2. Find out if the brand name manufacturer has a “authorized generic”, which is a generic authorized by the brand name manufacturer (sometimes even manufactured at the same plant) and which more likely will have the same formula, the same time-release of the active ingredient in the body, and with the same additional ingredients. You can look at authorized generics here.
3. Ask your pharmacy if you can have the drug from another manufacturer.
Resources
INTERNATIONAL DRUG SAFETY ADVISORY SITES
Canada: Health Canada (HC) – Advisories, Warnings and Recalls
UK: Medicines and Healthcare products Regulatory Agency (MHRA) – Drug Safety Update
Australia: Therapeutics Goods Administration (TGA) – Safety Alerts
Pharmacy Pick-Up
Be sure to provide your birthdate, address, or other identification, so you are sure the right medication is given to you.
Before leaving the pharmacy open the bag and check the label on the medicine for your name.
Check for accuracy of the full person’s name, name of the medication, dosage, and directions.
If the medicine is a powder needed to be mixed with water, the pharmacist is the one that should be adding the water, to make sure they did, shake the bottle before you leave the pharmacy.
All medicines should be labeled with specific instructions on how to be used, if it says use as directed, ask the pharmacists to call your doctor to request specific instructions.
Check that the medication provided is for the right use. The information is in the leaflet provided.
When transferring prescriptions to another pharmacy
Update you medicine list with your provider and pharmacist before you ask them to have your prescriptions transferred.
Be sure you have enough medication to last during the transition, if you are moving 6 months should be enough time to find another pharmacy.
Some prescriptions need to have a new prescription to be transferred or if you need a refill.
Counterfeit Drugs
Counterfeit drugs are those drugs that are unlawfully-manufactured or the people packing them lie about the contents.
Adulterated drugs are those that have been compromised during the manufacturing process, not meeting the specification of the regulatory authority such as the FDA. Drugs can be also adulterated if they are not stored properly or if they pass the expiration date, meaning that its efficacy is compromised.
Even if steps are taken to protect the public from counterfeit or adulterated medications, the truth is that it has become increasingly more prevalent. These drugs cause great harm and many fatalities as their ingredients might not be the same and sometimes even toxic. They are a real threat to the public.
How to protect yourself guide
1. Request a sample (only available from brand name medications) to your physician so you can compare it to the one you will be purchasing. Check for appearance, taste, texture, packaging.
2. If you are purchasing online make sure to purchase from a site that ends in .pharmacy, this means the pharmacy has been approve by the National Association of Boards of Pharmacy.
3. Compare their appearance with the website WebMed or at your local library.
4. Ask your physician when should you start to notice improvement, and what to expect.
5. If the quality of the drug raises concerns, contact your pharmacy, and the FDA or call them at 1 (800) FDA.1088.
Signs that an online pharmacy might be not reputable
No physical address or phone number.
Does not have a licensed pharmacist or any other person available to speak with.
Does not asks for your prescription, or asks you to fill out a questionnaire in lieu of the prescription.
Offers to sell you a prescription.
Does not asks for your doctor information such as name, address, phone number
Advises you of drug importation laws and why it is permissible to buy drugs from foreign countries.
Encourages you to have the drugs sent to post office boxes to avoid detection by the US authorities.
Requires you to waive some rights.
when buying from a canadian pharmacy, keep in mind
1. “Canadian” online pharmacies may be just shipping companies that pretend to sell medicines for Canadians, they might not even be located in Canada.
2. Drugs shipped from Canada may not even come from Canada, they come from unscrupulous sellers sometimes even selling counterfeit medications.
3. Drugs may be counterfeited, contaminated or substandard.
4. Canadian pharmacies are not regulated by (or accountable to) authorities, they are just regulated for Canadian consumption.
5. You can check how reputable your online Canadian (or any other country) pharmacy is at Pharmacy Checker.
Resources
Information about Drugs and Supplements
Information about drugs and its side effects, interactions, dosage, and precautions.
Drug Interactions
Review safety drug information.
Medication Safety
Physicians Desk Reference Health
Independent watchdog dedicated to public health related to drug information, vitamins, herbs, and home remedies.
On-line pharmacy that performs chemical analysis for every batch of medication they dispense.
Phone: (833) 497.7370
e-Prescribe at NPI#1740771021
Online Pharmacy Verification
Provides accredited online pharmacies also from Canada and other countries.
Verified Internet Pharmacy Practice Sites (VIPPS)
Provides the safest way to buy online as they accredit pharmacies approved by the National Association of Boards of Pharmacy (NABP) which are usually household name US online pharmacies.
Medication Risks
Institute for Safe Medication Practices
Psychiatric Drug Side Effects
The Mental Health Watchdog.
Deprescribing
Reclaim your seized med from the FDA or US Customs and Border Patrol